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SUBMITTED BY
DR. SUNIL KRISHNA MUKTINENI
DEPARTMENT OF SURGERY
B. L. D. E. A’S SHRI B. M. PATIL MEDICAL COLLEGE,
HOSPITAL & RESEARCH CENTRE, BIJAPUR.
B. L. D. E. A’S
SHRI B. M. PATIL MEDICAL COLLEGE HOSPITAL & RESEARCH CENTRE,
BIJAPUR.
DEPARTMENT OF SURGERY,
Certificate
This is to certify that the dissertation entitled “A CLINICAL STUDY
OF LOCALLY ADVANCED CARCINOMA OF BREAST - A RETROSPECTIVE
STUDY” is a bonafide research work done by Dr. Sunil Krishna
Muktineni, under my overall supervision and guidance, in partial fulfillment of the
requirement for the degree of M. S. (General Surgery) examination to be held in
March 2006.
DEPARTMENT OF SURGERY
Certificate
This is to certify that Dr. Sunil Krishna Muktineni post graduate
student in M. S. (General Surgery) has prepared this dissertation entitled
“A CLINICAL STUDY OF LOCALLY ADVANCED CARCINOMA OF
BREAST -A RETROSPECTIVE STUDY” under overall supervision and
guidance of DR. (Mrs) TEJASWINI UDACHAN, professor at B.L.D.E.A’s Shri B.
M. Patil Medical College Hospital and Research Centre, Bijapur.
DR. P. L. KARIHOLU
M.S.,F.A.I.S. (ONCO SURG)
PROFESSOR AND HEAD
DEPARTMENT OF SURGERY
Place: Bijapur B. L. D. E. A’S SHRI. B. M. PATIL
Date: MEDICAL COLLEGE HOSPITAL
AND RESEARCH CENTRE,
BIJAPUR.
B. L. D. E. A’S
SHRI B. M. PATIL MEDICAL COLLEGE HOSPITAL & RESEARCH CENTRE,
BIJAPUR.
DEPARTMENT OF SURGERY,
Certificate
DEPARTMENT OF SURGERY,
DECLARATION
Karnataka shall have the rights to preserve, use and disseminate this dissertation /
challenge as the majority of patients with this diagnosis develop distant metastasis despite
appropriate therapy. Patients presenting with LABC constitute a diverse group for which a
variety of treatment modalities have been instituted with co-ordinated treatment planning
among the medical oncologist, surgical oncologist and radiation oncologist. In this study, the
epidemiology, evaluation and treatment for LABC is discussed with special reference to
METHODS: Patients diagnosed as LABC in our hospital and referred patients between Jan
1993 and Dec 2002 were analyzed retrospectively with regard to the outcome of the
RESULTS: All patients underwent surgery as the initial procedure with acceptable
morbidity in the form of wound infection and seroma formation (12.82% each). After
receiving adjuvant chemotherapy (CMF) there was 38.96% loco regional recurrence. The 1
year, 3years and 5years survival rates were found to be 98.80%, 67.53% and 23.38%
respectively.
CONCLUSIONS: The surgery, adjuvant chemo and hormonal therapy did not improve the
loco regional recurrence over radiotherapy in a combined modality setting but had an
1. INTRODUCTION 1
3. REVIEW OF LITERATURE 3
6. DISCUSSION 57
7. SUMMARY 63
8. CONCLUSION 65
9. BIBLIOGRAPHY 66
10. ANNEXURES
I ) Proforma 71
CARCINOMA BREAST
CARCINOMA BREAST
CARCINOMA BREAST
INVOLVEMENT
PRESENTATION
6. SIDE OF INVOLVEMENT 49
9. MODALITY OF TREATMENT 52
12. COMPLICATIONS 55
ABBREVIATIONS
UK - United Kingdom.
Radiation Therapy
Radiation Therapy
ER - Estrogen receptor
RM - Radical Mastectomy
INTRODUCTION
Carcinoma of breast is the second commonest malignant condition and is the leading
cause of death from cancer in females in western countries and in our country, the incidence
carcinoma breast clinically present in late stages due to their ignorance of the disease despite
the survival rate of the patients has improved significantly. But at district levels and its
interiors, in spite of this advancement, patients present with advanced stage due to lack of
awareness and deficit of facilities required for its early diagnosis and management.
This also causes difficulty in selecting the best suitable treatment modality in these
patients, who mainly underwent surgery and chemotherapy due to lack of radiotherapy
facility locally and the outcome of the treatment in the last ten years.
AIMS AND OBJECTIVES
HISTORICAL ASPECTS
Breast cancer has been described since ancient times. The Edwin Smith surgical
papyrus (3000-2500 BC, Egyptian Pyramid age) was the first document that referred to
carcinoma of the breast. The author of the Papyrus concluded “there is no treatment (for
Hippocrates (the father of medicine) who was born in the later half of the 5th century
B.C., has considered cancer of the breast incurable and a classic description of a woman
succumbing of late breast cancer appears in his volume ‘Diseases of women’. However direct
Hippocraticum.”
.Celsius (1st century AD) recognized the value of operations for early breast cancer (prototype
of Radical mastectomy) in his early Roman writings. “None of these can be removed but the
cacoethes (early lesion), the rest are irritated by every method of cure. The more violent the
operations are, the angrier they grow”, he had written. The same point was stressed 1800
years later by Haagenson. He also argued against removal of pectoral muscles in amputation
of breast.
Galen attributed the disease to excess of “black bile” and advocated excision of
pathological tumor, in a circle in the region where its borders were on the healthy tissues.
Lanfranchi “the father of French surgery,” in the treatment of breast cancer favored a deep
incision, extirpation and cauterization in small cancers. Whereas arsenic and zinc chloride
perspective and advocated mastectomy with a wide surgical excision of the tumor with
Marcus Aurelus Seveninus (1580) of school of Salerno was the first surgeon to
remove enlarged axillary lymph glands at the time of breast amputation. Le-Dran repudiated
Galen’s humoral theory and stated that the cancer of the breast was a local disease that spread
by way of the lymphatic to regional nodes. He removed enlarged nodes in his operations and
Jean Louis Petit, a famous French surgeon and the first director of French Surgical
Academy, set the precedent for modern mastectomy. He believed enbloc dissection of axilla
with wide excision along with pectoral fascia and muscle fibers. He recognized poorer
Joseph Pan coast in Philadelphia was among the earliest American surgeons to
emphasize the importance of excision of breast with axillary lymph nodes, but he did not
Sir Jances syme (1842) averred that removal of involved axillary nodes does not
The concept of carcinoma, develops from the epithelial germ layer was advanced in
the mid 19th century by Remak and Thersch in Germany; Robin and Cornil in France. This
currently accepted idea represented a major departure from Virchow’s theory of the
carcinoma. Moore1 outlined the principles of radical mastectomy except for pectoral muscle
removal and advocated axillary dissection only when the neoplasm was evident in axilla.
Waldeyer illustrated the progressive evolution of lobular carcinoma from benign
breast, pectoral fascia and muscle for advanced cancers. Banks2 supported Moore’s concepts
and also advocated en bloc resection of axillary contents with the breast even when palpable
nodes were not evident. Banks recognized that occult involvement of axillary nodes could be
present.
cases) and added a removal of pectoral fascia in his thesis. Schinzinger4 suggested that
castration by oophorectomy might be an effective treatment for some woman with advanced
cancer. Beatson5 from Glassgow performed oophorectomy when there was no concept of an
endocrinal basis.
Halsted6 first described Radical mastectomy. His first operation was performed in
1882 without removal of pectoralis minor. Herber willy described Modified radical
By demonstrating superior local and regional control rates following en bolc radical
resection, these eminent surgeons established radical mastectomy as “State of the art” for that
era. The modern radical mastectomy is often attributed to both of these surgeons.
Halsted in a review of his results in 1907 stated “prognosis is quite good in the early
stage of breast cancer, 2 in 3 being cured, 3 in 4 succumbing when the axillary glands are
demonstrably involved”.
Joseph colt Bloodgood7 developed much of our current knowledge of the relationship
between the clinical behavior and pathologic features of early forms of ductal carcinoma of
the breast, which he termed borderline breast tumors. He described his first exposure to such
Edinburgh described the technique of postoperative external beam radiation following simple
J.C. Warren of Boston is the first who described the non invasive ductal carcinoma,
now recognized as DCIS (Ductal Carcinoma In Situ). MacCarty9 published illustration of the
Heyes Martin and Edward Ellis10 are the first to describe the technique of fine needle
clinical mammography.
Disillusion with radical surgery had in actual fact been first voiced as early as 1937 by
Sir Geoffery Keynes12, when he published the results of consecutive series of patients treated
by wide local excision supplemented with radium needles. Results for this approach matched
those for radical mastectomy both for early and more advanced cases. But the impact of
Keynes work was ignored for nearly 40 years and is only now receiving more wide spread
significance.
of comedo carcinoma of breast. Manchester staging system of carcinoma breast came into
practice in 1940.
Foote and Stewart13 published the landmark description of lobular carcinoma in-situ
(LCIS). They were the first to establish the purely non-invasive form of ductal carcinoma as a
Bilateral total adrenalectomy for carcinoma breast was first performed in 1945, but
hormonal maintenance was not available for replacement therapy. When cortisone became
Foote and Moore discussed the relatively favorable progress of medullary carcinoma
breast with lymphocytic infiltration. Hormonal theory was first considered as an adjuvant to
surgery as early as 1948. At that time a randomized control trial was instituted at the Christie
The results of these trials are of similar, in that castration lengthens the disease free survival
without affecting overall survival. The results are analogous with those achieved with
to Radical Mastectomy. He also described Simple mastectomy with four quadrant radiation.
Baclesse17 introduced radiotherapy without mastectomy for breast cancer. Urban and Baker18
advocated the Extended Radical Mastectomy in which the internal mammary lymph nodes
and part of chest wall were removed along with radical mastectomy specimen which is of no
breast. Pontes utilized the remaining breast tissue to reconstruct the breast. Mushtalka
Gillis et al19 were the first to apply the term in situ to non invasive ductal carcinoma
importance of early detection of malignancy at a stage when it should have a 90 % ten year
cure rate if properly treated. Minimal breast cancer includes -LCIS, DCIS, minimally
diagnostic x-ray examinations of the breast using a high milliamperage, low kilovoltage
Gros21 designed the first x-ray unit for mammography. Anti –estrogenic drug
The introduction of film screen mammography took place in 1972 and in the same
Fisher used tholepin during and immediately after surgery. He used chemotherapy for
premenopausal women if four or more lymph nodes positive for metastases with improved
survival rates. McMahon and co-workers (1973) raised the hypothesis that women who
The NSABP in USA used a two year course of Melphalan (L-pam) in patients with
histopathologically positive nodes and showed recurrence free survival rate as 22% in the
placebo group compared with 9.7% percent for the patients receiving Melphalan. But
subsequently Fisher (1981) in long term trails failed to show any advantage in survival and
concluded that any effect of the Melphalan is to delay the appearance of clinically
detectable metastasis without having any effect on subsequent survival. This was
chemotherapy. Bonadonna from the Milan trial started CMF regimen in both pre and
post menopausal node positive woman and showed significantly improved relapse free
survival compared to controls. Rossi in 1981 showed that the Milan CMF trial does
continued to give some encouragement after longer follow up. At five years the
predicted survival rate and for treated patients is 78% compared with 68% for
controls and this is significantly better. Exactly similar results from England for CMF
adjuvant to local treatment for patients with operable breast cancer and showed
Philip Strax and George Crile Jr., spent careers attempting to detect breast cancer
early in asymptomatic individuals by radio imaging and treating it with limited mastectomy.
operation having survival advantage of more than 10% which is still apparent at 15 years of
The Health Institute Plan of Greater New York study on the potential for
mammography to detect occult breast cancer established the principle that early detection and
treatment of the breast cancer can result in cure, at least within 18 year of follow up.
working Group, the Swedish two country trial (1977) and the Netherlands case control
studies confirmed the efficacy of the screening programmes and concluded that the benefit
was largely for women aged 50 years and over. However the yearly two view mammography
Tabar et al 22 concluded from the latest results of the Swedish two country trial in the
subgroup of 50-69 at entry, one death was prevented for every 1466 mammograms, for every
(Chamberlian 1990) shows that 76% of screened women were recalled for further
radiological investigation, 1.1% required biopsy and 6.6 cancers were detected for every
The National Surgical Adjuvant Breast Project (NSABP) of USA began a randomized
trial in 1971 comparing radical mastectomy and total mastectomy with or without
They suggested that breast cancer should not be regarded as a disease that spreads in an
orderly fashion through the lymphatics to the lymphnodes and beyond. Rather the disease has
a much more capricious nature and may spread haematogenously before metastasizing to
lymph nodes. Accepting this concept that the tumor spreads by multiple routes, allows one to
recognize that breast carcinoma is very often a systemic and not a local disease.
The trend in favour of the less disfiguring modified radical surgical procedures
continued throughout the 1970’s , so that by the end of that decade the modified radical
mastectomy had replaced the radical operation as the standard operation for patients with
breast cancer. By this time several retrospective studies had indicated that excision of the
tumour followed by radiation produced comparable survival results to either modified radical
or radical mastectomy. Calle et al at the institute Curie, Clark et al, at princess Margaret
Hospital, Mustakallio in Helsinki and Amalric et al in Marseille, among others performed the
early studies on which later prospective studies were based. The local recurrence rate in the
Prospective randomized trials followed and were organized by Guy’s Hospital, The
National Caner Institute of Milan, NSABP (USA), The National Cancer Institute (USA), The
Institute of Gustave – Roussy, The European Organization for Research and Treatment of
Cancer23 (EORTC), The Danish Breast Cancer Co-Operative Group24 (DBCG) and The
The first Guy’s Hospital trial compared the Halsted radical mastectomy and
postoperative radiation therapy (2400 cGY) to the axillary, supraclavicular and internal
mammary group of lymph nodes to tumour resection and treatment of the residual breast and
axilla with 3000 cGs. The local / regional recurrence rate was 8% for mastectomy and 30%
for wide excision and radiation. An excess of local recurrence in the axilla in the limited
surgery group has been attributed to inadequate doses of radiation. The Milan trial which
and radiation therapy (QUART) for tumors up to 2 cm in size. Quadrantectomy was the
resection of a breast quadrant with a 2 to 3 cm of margin of normal tissue around the lesion
and en bloc resection of the overlying skin and the underlying pectoralis major muscle fascia.
All three levels of the axilla were dissected. Radiation consisted of 5000 cGy to the mid-
breast with 1000 cGy boost to the incision site. 349 patients were treated with radical
mastectomy and 352 patients with QUART. Disease – free survival and overall survival data
Prospective trials conducted by Veronesi (1981) for the QUART procedure and Fisher
equivalent disease- free and overall survival compared with more radical procedures. EORTC
trial 10801, which began in 1980 compared modified radical mastectomy with breast
conserving therapy (BCT). In 1990 it was reported that local / regional recurrence, overall
survival and distant disease- free survival were the same for the both the groups.
The NCI trial which started in 1979 also compared modified radical mastectomy with
BCT. A higher rate of local recurrence was seen in the group having lumpectomy compared
to the group having mastectomy at both 5 years (11% vs 3%) and 8 years (19% vs 6%).
The extent of surgery for an adequate tumour resection remains in debate. Veronesi et
al have compared QUART with TART (Tumourectomy, Axillary dissection and Radiation)
for tumours upto 2.5 cm in size. The local recurrence rate for the 360 patients having
QUART was 1.1 % compared to 7.2 % for the 345 patients having TART. Therefore, greater
local controls were seen at the expense of cosmesis. Approximately 20% of patients having
the QUART procedure will have a deformity that requires correction with plastic surgery.
depression and better body image have been demonstrated. Excellent to good cosmetic results
can be obtained in 82 - 90% of patients. Women usually regard the improved cosmesis in a
Development Conference Statement on the treatment of patients with early stage breast
therapy for the majority of women with stage I and II breast cancer and is preferable because
it provides survival equivalent to total mastectomy and also preserves the breast.
French Epirubicin study group (1988) and Italian Multicentre Breast Study (1988)
started using FEC regime (5- Fluorouracil, Epirubicin, Cyclophosphamide ) in clinical trials
regime.
trials. Recently, a number of prognostic variables are described for breast cancers that
cancer was conducted by Cole 26 at the Christie Hospital in Manchester. The efficacy
menopausal women, but the side effects of tamoxifen were mild in comparison. Similarly
27
Ward conducted a small dose response study of tamoxifen and found side effects to be
insignificant. Tamoxifen is now the most successful and widely used endocrine therapy for
the treatment for breast cancer. Tamoxifen’s antitumour effect is believed to be mediated
primarily through the ER, although other potential mechanisms of action may contribute. In
most of the early clinical trials of tamoxifen in patients with advanced disease, the daily oral
dose of 20-40mg was administered. No significant increase in tumor response was observed
EMBRYOLOGY
The breast is a highly modified sudoriferous gland that develops as ingrowths from
ectoderm, form the alveoli and ducts. Supporting vascularised connective tissue takes
derivation solely from mesenchyme. The development starts around 5th or 6th week of fetal
development.
Gross anatomy
Extent: Vertically 2nd to 6th ribs inclusive, horizontally the side of the sternum to the
midaxillary line. About 2/3rd of the breast rests upon the pectoralis major, 1/3rd on the serratus
anterior, with lower medial quadrant rests on the aponeurosis of the external oblique which
separates it from the rectus abdominis. The breast lies in the subcutaneous tissue and is
Axillary tail of Spence- this is a prolongation from the outer part of the gland which
passes upto the level of the third rib in the axilla through an opening in the axillary fascia
(Foramen of Langer), where it is in direct contact with main lymph nodes of the breast.
1) The lateral thoracic artery, from the second part of the axillary artery.
2) The perforating cutaneous branches of the internal mammary through the second,
3) The lateral branches of the second, third and fourth intercostal arteries.
Venous drainage
The superficial veins radiate from the breast and drain to axillary, internal mammary
Nerve supply
The secreting tissue is supplied by sympathetic nerves which reach it via the second to
sixth intercostal nerves. The overlying skin is supplied by the anterior and lateral branches of
The breast drains mainly to the axillary nodes, of which there are 5 sets according to
Consists of 4 to 6 nodes medial or posterior to the axillary vein, these receive most of
This group harbours 5 or 6 nodes along the lower border of the pectoralis minor,
contiguous with the lateral thoracic vessels. This group receives the majority of
It consists of 5 to 7 nodes lie along the posterior axillary fold in relation to the
subscapular vessels; receive lymph principally from the lower posterior neck,
This consists of 3 to 4 large groups that are embedded in the fat of the axilla
immediately posterior to the pectoralis minor muscle, receives lymph from the three
preceding groups but may receive lymphatics directly from the breast. The
pectoralis minor. This group receives lymph from all groups of axillary nodes and
unites with efferent vessels from the subclavicular nodes to form the subclavian trunk.
It consists of 1 to 4 nodes interposed between the pectoralis major and minor muscles.
Lymph from these nodes passes directly into the central and subclavicular groups.
assigned levels. Nodes located lateral to or below the lower border of the pectoralis
minor are referred to as Level I and include the external mammary, axillary vein and
scapular groups. Nodes located deep to or behind the pectoralis minor are referred to
as Level II and include the central node. Nodes located medial to or above the upper
border of the pectoralis minor are considered Level III and include subclavicular
Lymph flow
Lymphatic vessels that drain the breast occur in three interconnecting groups.
2. Within glandular tissue and overlying skin of the central part of the gland beneath the
3. On the posterior surface of the breast communicating with minute vessels that parallel
Lymphatic vessels from deeper structures of the thoracic wall drain principally into
Cross communication from the interstices of connecting lymphatic channels for each
breast provides ready access of lymphatic flow to the opposite flow, as the communicating
remainder of lymph flows into parasternal lymphatics (internal mammary group which
eventually terminating subclavian node groups). Both the axillary and the parasternal
The supraclavicular glands receive afferents from the both apical and internal mammary
nodal group. The presence of supraclavicular nodes disease results from lymphatic
permeation and subsequent obstruction of the inferior and deep cervical groups of the jugular
– subclavian confluence.
STAGING:
4) Modified TNM staging system (The American Joint committee on cancer staging and
does not affect staging. The tumor must not be adherent to the
Stage –II Same as stage I, but there are affected mobile lymph nodes in
Stage –III Skin involvement or Peau d’ orange larger than the tumor but
Stage –IV Skin involvement wide of the breast and is including cancer-
Primary Tumor (T) definitions for classifying the primary tumor (T) are the same for
examination, the examiner will use the major headings (T1, T2, orT3), if other
Tis Paget’s disease of the nipple with no tumor (Note: Paget’s disease associated
T1a Tumor more than 0.1cm but not more than 0.5cm in greatest dimension
T1b Tumor more than 0.5cm but not more than 1cm in greatest dimension.
T1c Tumor more than 1cm but not more than 2cm in greatest dimension.
T4 Tumor of any size with direct extension to (a) chest wall or (b)skin,
T4b Edema (Including Peau d’orange), or ulceration of the skin of the breast, or
N2a Metastasis in ipsilateral axillary lymph nodes fixed to one another (matted) or
to other structures
involvement.
N3b Metastasis in ipsilateral internal mammary lymph node(s) and axillary lymph
node(s).
M1 Distant metastasis.
a
--Clinically apparent is defined as detected by imaging studies (excluding
Stage0 Tis No Mo
StageI T1a No Mo
StageIIA T0 N1 M0
T1a N1 M0
T2 N0 M0
Stage IIB T2 N1 M0
T3 N0 M0
StageIIIA T0 N2 M0
T1a N2 M0
T2 N2 M0
T3 N1 M0
T3 N2 M0
StageIIIB T4 N0 M0
T4 N1 M0
T4 N2 M0
Stage IIIC Any T N3 M0
Stage IV Any T Any N M1
Etiology of Carcinoma of Breast
second most common in India. It is the leading cause of mortality from cancer for females 40
to 50 years of age.
For the surgeon to remain a manager of the care of patients with breast cancer, needs
to co-ordinate the treatment planned among the medical oncologist, surgical oncologist and
radiation oncologist. A broad knowledge of the biology of breast cancer and science of the
In spite of an immense amount of investigation, there is still no known cause and its
natural history is obscure. The following are the risk factors for breast cancer29.
• Gender
• Age
¾ Intermediate factors:
• Endocrine Factors
• Early Menarche
• Late menopause
• Nulliparity
• Irradiation
• Body size
• Stress
The following shows the relative risk for invasive breast carcinoma based on
Apocrine change
Ductal Actasia
With the exception of age, country of birth and history of breast cancer in both mother
and sister, all of the relative risks reported to date are of modest magnitude. In consistency
data suggest the protective effects of parity and lactation in various age groups.
Pathological classification:-
B. Infiltrating
2. Medullary
3. Comedo
4. Colloid
5. Papillary
6. Tubular
i. Melanoma
iii. Carcinosarcoma
chemotherapy, surgery and radiotherapy to optimize the chance of cure. The earliest therapy
for locally advanced breast cancer was radical mastectomy30 . However, patients with
supraclavicular involvement, edema of the arm, satellite skin nodules and extensive breast
edema were all found to develop recurrences and these signs were considered markers of
inoperable disease. The first reports of the use of induction chemotherapy for locally
advanced disease were published in the 1970s31. Since then, the use of systemic
chemotherapy has become standard and has substantially improved the prognosis of locally
The benefit of adjuvant chemotherapy for the treatment of breast cancer has been
clearly established, although most trials have not been specifically focused on patients with
women with node-positive breast cancer treated with CMF chemotherapy32. In the past there
have been few treatment options available and surgical treatment was the mainstay of breast
chemotherapy is also a reasonable option. The traditional approach has been to treat
women with locally advanced tumors with modified radical mastectomy. Finally,
women with hormone-receptor positive tumors should receive additional benefits from
fundamental changes. Contemporary breast cancer therapy has evolved to a point at which
multidisciplinary approaches are the standard of treatment for most breast cancer patients
of primary therapy for the majority of women with stage I and II breast cancer and is
preferable because it provides survival equivalent to mastectomy and also preserves the
breast.
The primary goal of this therapy is that tumor is controlled and an acceptable
appearance of the breast, if both goals are not obtained then the treatment is failure. The
selection criteria of BCT and contraindications are mentioned in the following lines.
• Motivated patients.
Multiple primaries.
Pregnancy
Diffused microcalcifications
Relative contraindications:
Young age.
Mastectomy
The patey’s modified radical mastectomy is the most commonly performed surgery
today. The percentage of Halsted’s radical mastectomy decreased from 48% to 3% from 1971
to 1981 in USA.
Axilla should not require irradiation following modified radical mastectomy or radical
Absolute
ii) Pregnancy.
Relative
iv) DCIS.
treatment, no differences were observed between the treatment groups (both node +ve and
node –ve ) with respective disease free, distant disease free, or overall survival at 10 years
follow up. These studies are NSABP B-04, Manchester, Milan trial, CRC-Cambridge trial,
Albana trail, NSABP protocol B -06 trial etc. concluded that “variations of local and regional
therapy were not important in determining survival of patients with breast cancer”.
reconstruction can be delayed until these treatments have been completed. The mastectomy is
ideally performed via a transverse or oblique incision. The major criticism of breast
reconstruction has been the potential for delay in diagnosis of recurrent chest wall disease.
For these patients systemic therapy with either Tamoxifen or cytotoxic therapy should
be tried first. Some times the most advanced carcinomas will respond dramatically with
disappearance of all palpable disease and healing of malignant ulceration. If the response to
systemic therapy is substantial but incomplete selected patients may benefit from
radiotherapy. Radical surgery should be kept in reserve for those cases impossible to control
locally with either chemotherapy or radiotherapy that show no evidence of distant metastases
on careful investigation.
While most patients of locally advanced stage will manifest metastases and die within
a few years, a small but unpredictable group will survive in good health for considerable
length of time.
• Endocrine manipulation
• Radiotherapy
• Immunotherapy
• Chemotherapy
Radiotherapy
irradiation, effectively controlling the local disease and maintaining satisfactory cosmesis.
adequate local surgery (MRM) has declined over the last decade. By avoidance of
postoperative radiotherapy, in operable breast cancer (after modified radical mastectomy), the
incidence of distressing lymphoedema of the arm has been reduced without much
compromise on local control. Radiation contributes greatly to the local control, in locally
advanced breast cancer (T4, N2/ N3 ) in conjunction with surgery. It also remains the main
stay of treatment in operable breast cancer. It offers effective palliation in painful bony
radiotherapy following breast preservation is very promising with 92% local control. Local
where the local failure rate, following segmental mastectomy alone was 28%.
The locoregional therapy is aimed at eradicating local disease with an acceptable
cosmetic result, low failure rate and maximum benefit to the quality of life however long it
may be “The local control may not result in a cure but there can be no cure without the local
control”.
No solid tumor has been as extensively studied to determine the effects of systemic
therapy as has carcinoma of the breast. Clinical trials indicate that adjuvant cytotoxic therapy
and possibly, hormonal therapy when used in patients with axillary metastasis but without
established distant metastasis, prolong the disease free interval and perhaps enhance survival
rates. For patients with established distant metastasis (Stage IV), therapy with several drugs
that are less effective as single agents has resulted in greater than 50% response rates when
include
Prednisolone and vincristine have sometimes been added to these regimens to potentially
enhance response rates. Liberal use of these agents however is not justified because of their
Cycle
Regimen Dose and Schedule Cycles
Interval, d
CAF
600 mg/m2 IV day 1
Cyclophosphamide 21-28 4-6
60 mg/m2 IV day 1
Doxorubicin 21-28 4-6
600 mg/m2/d IV days 1
5-Fluorouracil 21-28 4-6
and 8
AC
Doxorubicin 60 mg/m2 IV day 1 21 4
Cyclophosphamide 600 mg/m2 IV day 1 21 4
AC followed by paclitaxel
(Taxol)
60 mg/m2 IV day 1 21 4
Doxorubicin
600 mg/m2 IV day 1 21 4
Cyclophosphamide
175 mg/m2 IV day 1 21 4 (after AC)
Paclitaxel
4
AC followed by CMF 8 (cycles 5-
Doxorubicin 75 mg/m2 IV day 1 21 12)
Cyclophosphamide 600 mg/m2 IV day 1 21 8 (cycles 5-
Methotrexate 40 mg/m2 IV day 1 21 12)
5-Fluorouracil 600 mg/m2 IV day 1 21 8 (cycles 5-
12)
The decision making process for adjuvant systemic therapy involves two basic steps:
2) Assessing the known benefits, risk and complications of each systemic drug regimen.
One convenient approach to the first step is to categorize patients with early stage
breast cancer into one of three groups using currently available prognostic factors-
Low risk patients (e.g. those with tumors <1 cm in diameter and negative nodes) should
not be considered for adjuvant systemic therapy, except perhaps in prospective protocols,
because there is no proven benefit for any of the currently available agents, which are
associated with risks and additional costs. High risk patients should be considered for
adjuvant systemic therapy as standard treatment because in this sub group the benefits
outweigh the risks as documented in numerous prospective randomized clinical trials. The
recent National Institute of Health Consensus Conference concluded that “adjuvant therapy
has become the standard of care for the majority of cases of breast cancer with axillary lymph
node involvement”. Intermediate risk patients (e.g. those whose tumors are 1/5 to 3.0 cm and
who have negative nodes but other poor prognostic features) might also be considered for
adjuvant therapy. Early results from clinical trials suggest that women in this subgroup with
node negative breast cancer may benefit from systemic therapy in terms of improved disease
free survival.
Several prognostic variables are identified for breast cancer that determines recurrence
and overall survival. With the exception of clinical trials, it is not reasonable to treat the
patients with tumors < 1 cm in diameter because the chance of recurrence in 10 years is <
10% . With increasing tumor diameter ± positive nodes, other prognostic variable must be
amenorrhea.
o Methotrexate: Adverse effects may include liver toxicity, increased toxicity in the
cerebellar ataxia.
edema due to capillary leak syndrome (>80% of patients if not medicated; <10% if
premedicated with steroids), hypersensitivity reactions, neurotoxicity (less frequent than with
Hormonal receptors : Within the cytosol of breast cancer cells are specific proteins that bind
and transfer steroid moieties into the cell nucleus to exert specific hormonal effects. The most
widely studied and available receptor proteins are the estrogen and progesterone receptors.
To obtain a quantitative hormonal assay of either hormone receptor, one gram of fresh tissue
obtained from the tumor is essential. The receptors are thermal and ischaemia labile. It is
Values > 10 fmol/milligram cytosol protein are considered receptor – positive. Values <3 to 4
fmol/mg are receptor – negative. Intermediate values are considered borderline. The degree
of positivity is proportional to the differentiation and histologic subtype of the lesion. Ninety
percent or more of well differentiated ductal and lobular carcinomas are ER- positive. There
also appears to be no evolution or change of activity in metastatic sites from that of the index
lesion.
with ER activity. Less than 10% of ER negative patients are responders, greater than 60 % of
endocrine ablative procedures commonly used to treat metastatic foci. Oophorectomy was
primarily used for premenopausal patients who presented with skin and/ or bony metastases
with a prolonged disease free interval that exceeded 18 months between treatment of the
primary and the discovery of metastasis. Visceral metastases were infrequently observed to
oestrogenic therapy.
Receptor activity is the most commonly utilized measure for determining the
patients with ER positive tumors were free from disease at 24 months, compared with only
62% of ER negative patients. Younger patients were observed to have trends towards positive
nodes and greater need for adjuvant chemotherapy and more commonly had ER negative
tumours.
tumour or metastatic foci of disease. This receptor is measured concomitantly with ER from
the primary tumour. Response rates of pre-menopausal and post menopausal patients are
similar and PR activity may be more indicative of an opportunity for hormonal manipulation
The commonly used adjuvant hormonal therapeutic drug tamoxifen (anti oestrogenic )
is given in the dosage of 10 mg two times daily for minimum of 5 years. The most striking
advantage of tamoxifen over chemotherapy is the absence of toxicity of profound side effects,
mentioned above.
highest among North American and the British, in whom it constitutes 0.4 to 1.5 percent of
Male breast caner has been associated with Klinefelter syndrome (XXY), estrogen therapy,
high endogenous estrogen levels related to testicular feminizing syndromes and irradiation.
The incidence peaks between sixty and sixty nine years of age. Hormonal dependence
of the neoplasia is typical and the tumour is commonly estrogen receptor positive (Upto 80
%). An increased incidence occurs in Jewish and black males. Clinical presentations of the
disease are similar to those women except that the diagnosis is delayed owing to infrequent
recognition of the male patient, with poor prognosis (patients usually presents in stage III,
IV).
The preferred treatment is radical mastectomy and use of postoperative irradiation for
ulcerative and / or highgrade anaplastic tumors to reduce local recurrence. Orchidectomy and
After receiving appropriate breast cancer treatment, the patient is still at risk for two
breast and clinical emergence of local or distant metastasis. To the extent the patient is cured,
the risk of developing a second primary breast cancer increases over the years (about 0.7%
per annum for life), whereas the risk of developing local or distant metastasis decreases over
mammography (two views), annual physician examination, and monthly breast self -
examination. For individual patients at high risks aggressive cancer prevention intervention
that includes prophylactic mastectomy may be appropriate, although this approach is not
Surveillance for distant metastatic disease should be tempered by the patient’s initial
stage of disease. For patients with early breast cancer, a judicious metastatic workup should
examination, chest X- ray and measurement of serum liver enzymes, particularly alkaline
Rehabilitation for the patient should begin at the time of diagnosis as the outcome of
treatment will depend in part on the patient’s perception, of how her goals have been
achieved. For this reason the surgeon must be a careful listener and incorporate the patient’s
The patient often assumes the changes that occur in the treated breast after surgery,
radiation therapy, and chemotherapy may be an indication of a recurrence. This fear can be
minimized by explaining and treating side effects as promptly and effectively as possible.
The patient should be reassured about her fears of resuming exercise or usual
SOURCE OF DATA:
B.L.D.E.A's Shri B. M. Patil Medical College, Hospital & Research Centre, Bijapur.
hospital and as well as the referred patients of the same disease in the last 10 years i.e from
January 1993 to December 2002 will be retrospectively analyzed with regard to the
outcome of the combined modality of treatment i.e surgical and chemotherapy available in
our hospital.
Secondary analysis of medical records of these patients will be done for observation
Inclusion Criteria: All the patients diagnosed clinically as locally advanced carcinoma of
breast (T3 & T4) irrespective of age, will be included in the study.
Exclusion Criteria: Those patients whose follow up information is not available are
Sample size:
All cases of carcinoma of breast admitted in this hospital for last 10 years.
Follow up of cases will be done for a period of minimum 18 months or till patient
survives.
Statistical Method: The data is represented and expressed in percentage and graphs.
OBSERVATION AND RESULTS
A total number of 117 patients of Locally Advanced Carcinoma of Breast (T3 and T4
lesions only) are analyzed retrospectively from January 1993 to December 2002 with the
information available from case papers of Medical records section of Shri B. M. Patil
Medical College Hospital and Research Center, Bijapur. All the patients were operated after
evaluation and counseling. However 40 patients were lost to follow up after receiving
treatment.
Age Distribution
The mean age at presentation of this series was 48.0 yrs in the retrospective group.
The youngest patient was 21 years and oldest being 90 years with the peak incidence in
between 41-50yrs.
Table 1
100
No. of Patients in percentage
90
No. of Patients in percentage
80
70
60
50
40
30
20
10
0
21-30 31-40 41-50 51-60 61-70 71-80 81-90
Age Group
Sex distribution
Table 2
Male 03 2.56
80
70
60
50
40
30
20
10
0
Male Female
Sex
Menstrual status
In our analysis, it was found that carcinoma breast occurred in all three groups with
Table 3
25.43
33.33
Premenopausal
Perimenopausal
Postmenopausal
43.85
Tumor location and size
The commonest quadrant to be involved was the upper and outer quadrant of the
breast. The distribution of tumor according to the location in the breast was as shown below.
Table 4
Central 9 7.69
7.4cm.
80
70
60
50
40
30
20
10
0
Upper & Outer Upper & Inner Lower & Outer Lower & Inner Central Multiple
Quadrants
Location of Tumor
Table 5
The maximum number of patients presented between 1-6 months after the onset of
disease while only 8 patients presented during the first month of the illness. The duration of
80
70
60
50
40
30
20
10
0
<1 month 1-6 months 6-12 months 12-24 months > 24 months
Duration (Months)
Side of involvement
In the present study carcinoma was found to involve left breast more frequently and
Table 6
Side of involvement
Left 74 63.24
Right 43 36.75
60
50
40
30
20
10
0
Left Right
Duration (Months)
Symptoms and signs
Ulceration and destruction), skin changes, Peau d’ orange, ulceration, satellite nodules. In the
analysis Peau d’ orange was found to be dominant and occurred in 46.15% of patients. Nipple
changes were found in 42.73% of patients. Most of the patients presented with various
Table 7
Puckering/Dimpling 27 23.07
80
70
60
50
40
30
20
10
0
Nipple changes Peau d' orange Puckering/Dimpling Satellite nodules
Staging of the disease was done on admission after clinical evaluation according to
Maximum numbers of patients (70%) were found to be in stage III A of the disease.
Table 8
Note: In this study, only T3 and T4 lesions of retrospective cases in last 10 years 1993-2002
were included.
7.69
22.22
Stage IIIA
Stage IIIB
Stage IIIC
70.08
Treatment
In our hospital, Modified Radical Mastectomy was the surgical treatment of choice
for patients of Locally advanced carcinoma of breast with T3 and T4 lesions. An adjuvant
chemotherapy (CMF regime-VI cycles) was given at the interval of 28 days between each
cycle. Since there is no facility of radiotherapy in our hospital, this modality of treatment
could not be given. Hence only surgery and chemotherapy were the treatment of choice for
these patients.
Table 9
Modality of treatment
Chemotherapy
+
RM and Chemotherapy 03 2.57
Out of 117 patients, 114 female patients underwent MRM and received Adjuvant
In 117 patients with breast cancer, histopathological definition of tumor type showed
infiltrating ductal carcinoma in 74% of the patients as the most common in occurrence.
Table 10
Carcinoma
Carcinoma
80
70
60
50
40
30
20
10
0
Infiltrating ductal Medullary Carcinoma Comedo Carcinoma Infiltrating lobular
Carcinoma Carcinoma
Histopathological Types
Axillary lymph nodal status
In this study 81% of patients had clinically palpable ipsilateral axillary nodes.
Table 11
In 77% of these patients there was microscopic evidence of disease and in 3.5% there was no
lymphnodes. But in 15% of these patients there was microscopic evidence of disease.
100
No. of Patients in percentage
90
No. of Patients in percentage
80
70
60
50
40
30
20
10
0
C linic a lly ne ga t iv e C linic a lly ne ga t iv e C lnic a lly po s it iv e C linic a lly po s it iv e
M ic ro s c o pic a lly M ic ro s c o pic a lly M ic ro s c o pic a lly M ic ro s c o pic a lly
ne ga t iv e po s it iv e po s it iv e ne ga t iv e
Complications
limb edema constituted 10.25%. Other complications seen were flap necrosis (8.5%), wound
gaping (6%), difficulty in shoulder movements (5%) and chest complications (4.2%).
Table 12
Complications
90
80
70
60
50
40
30
20
10
0
a
is
m
ns
ng
s
t
en
m
tie
io
s
ar
io
pi
ro
ro
ct
em
bi
at
ga
of
Se
ne
fe
le
ov
ic
in
ph
nd
pl
ap
m
nd
om
bo
ou
de
Fl
er
ou
m
W
Oe
tc
ld
ro
W
ou
es
Th
sh
Ch
in
lty
cu
f fi
Di
Nature of Complication
Outcome
advanced carcinoma of breast (with T3 and T4 lesions) were treated by combined modality
Comparison of 5 year survival rates for selected series of patients with locally advanced
breast Cancer.
Milan : Chemotherapy
& Surgery
1983
M.D. Anderson
Year 1987
All three modalities
1993
Our Study
0 20 40 60 80 100
DISCUSSION
Age:
In this series age distribution showed peak incidence in age group of 41-50 years i,e.
In our series the average mean age for carcinoma breast was 48 years.
In India it occurs a decade earlier. The average age in which the breast cancer is
common is 30-50 years. In South African black women also the maximum age incidence of
Haagensen found a fall in the incidence of carcinoma breast in age group of 47-52
years which can be explained on hormonal basis, where as in India age incidence falls
between 40-45 years.33 However, this finding is not seen in our study.
Sex:-
Carcinoma of the male breast represents only 1.2% of all mammary cancers. The ratio
male to female is 1:100. In India the largest reported series of carcinoma male breast was
from Mumbai by De Souza et al34 who reported 116 cases. In the present study the incidence
Menstrual Status:-
evidence from epidemiologic studies that populations at higher risk for breast cancer
have higher levels of circulating estrogens. Unlike other cancers for which rates
continue to climb with age, breast cancer incidence slows substantially after
women constituting 25.43% of 114 patients analyzed . Whereas ,Grady D et al37 in their
commentary stated that every year in United States approximately 175000 women are
diagnosed as breast cancer and among them 75-90% are in postmenopausal group.
Whereas in our study, the peak occurrence of carcinoma breast was found in perimenopausal
The upper and outer quadrant of breast is the most frequent site of cancer38. It may be
argued that this quadrant contains greater bulk of breast tissue than the other quadrants. In our
series 42.73% of tumors were situated in the upper and outer quadrant.
Duration of Symptoms:-
Haagensen has reported a mean delay of 7 months before treatment of 495 patients
with breast cancer. In our series most of the patients presented themselves between 1-6
Side of Involvement:
In this study the tumor seen in left side more frequently i..e., 63.24% and the ratio of
Haagensen39 gives the ratio of the left to right side breast cancer as 1.07:1
cases. However higher rates have been reported from women who have the opposite breast
biopsied routinely at the time of mastectomy40. No patients in our series had bilateral
carcinoma breast.
In our series 100% of patients presented with lump in the breast. Most breast lumps
were discovered by patients themselves but a fair number were identified by the surgeon at a
important for all the surgeons. Most of the lumps were painless. Ulceration and fungation as
presenting symptom was noted in 23.07% of 117 patients. Nipple changes as a symptom was
found in 42.73% of 117 patients. Ten patients presented with oedema of arm.
Thus it is seen that most of the woman with carcinoma of breast presented with a
painless lump. Both these authors stressed the frequency of local pain in primary breast
cancer. Haagensen41 found pain to be an uncommon presenting symptom and in his series it
many of the symptoms of breast cancer closely mimicked benign conditions, including
masses, infections and skin rashes. “The price of skill in the diagnosis of breast carcinoma is
a kind of eternal vigilance”. He wrote based upon an awareness that “any indication of
Clinical Staging:
The TNM classification had been used for staging of carcinoma breast. According to
this classification, maximum number of patients i.e 70% was found to be in stage IIIA of the
disease.
The reason for this significant delay in presenting to the surgeon is lack of awareness
Treatment:
Surgery and adjuvant chemotherapy was the mainstay of treatment given in our
hospital for the patient of locally advanced carcinoma of breast and continues to follow the
All the female patients analyzed in our study underwent modified radical mastectomy
and received adjuvant chemotherapy of CMF regime. Three male patients underwent radical
mastectomy.
Adjuvant chemotherapy consisted of Cyclophosphamide, Methotrexate and 5-
Fluorouracil in the dose of 600mg / m2, 40mg / m2, and 600mg / m2respectively. All the
patients received six cycles with an interval of 28 days with clinical evaluation from time to
time.
resource constraints, modified radical mastectomy which was feasible was considered in
an attempt to achieve local – regional control. After local- regional therapy, most women
received systemic chemotherapy. The treatment of LABC requires multiple disciplines and is
resource intensive.
Histopathology:
As already shown in observation tables infiltrating ductal carcinoma was the leading
histological type of the tumors in 75.21% of the 117 patients. Medullary carcinoma, comedo
carcinoma and infiltrating lobular type were found to be 11.96%, 10.25% and 2.56%
Haagensen41 showed that 40.6% of carcinoma breast patients will have metastasis at
In our series 81.19% of 117 patients clinically showed axillary lymph nodal
involvement. Only in 8 patients, i.e. 6.83% of 117 patients there was no histopathological
evidence of metastasis in the axillary lymph nodes. This is because of the patients presenting
Complications:
Complications after the surgical intervention were negligible except for a few
incidences of seroma formation, wound infection which commonly occurred. Few developed
oedema of arm which responded to elevation and crepe bandaging. Flap necrosis occurred in
Outcome:
All the 117 patients were analyzed who were diagnosed as locally advanced
carcinoma of breast and received the complete treatment. However, 40 patients were lost to
38.96%.Schaake-Koning C et al,42 studied 118 patients with LABC treated by either of (i)
radiotherapy alone, (ii) radiotherapy followed by CMF 12 cycles and observed local
recurrence in 24 i.e., 28% of the 86 patients who had reached complete remission in a median
follow-up period of 5 years. In another study done by Hortobagyi GN et al43 on 174 patients
with LABC of stage III treated by primary chemotherapy (FAC regime), surgery and
period. Thus in our study, there was significant increase in the loco regional recurrence.
Mortality:
After one year follow-up, 73 patients were surviving giving a survival rate of 94.80%.
At three years follow up 52 patients were surviving giving a survival rate of 67.53%.
After 5 years ,18 patients were still surviving out of 77 giving a survival rate of
23.37%. Milan in his study found a 5 year survival rate of 48% and Anderson MD found a 5
The patients who were diagnosed as locally advanced carcinoma breast (T3 & T4
lesions only) during the period of January 1993 to December 2002 were taken for study in
order to analyze the clinical mode of presentation, management & the out come of these
patients retrospectively with available information from medical record section of Shri. B.M.
¾ The mean age of presentation was 48 years with the youngest being 21 years and
eldest patient being 90 years. Maximum of 117 cases 42.73% presented in the age
¾ The disease incidence was found more common in the perimenopausal women i.e
43.85%.
¾ Most of the cases presented between 1-6 months after the onset of disease. The initial
presentation was as a lump in breast in all the patients. The left side was found to be
¾ The upper and outer quadrant was the most common site of primary tumor i.e
42.73%.
¾ 81.2% of patients had clinically palpable lymph nodes among which 77.77% had
¾ Major surgical therapy constituted modified radical mastectomy in all the female
patients and simple mastectomy with axillary clearance in the male patients. The
histopathologically.
¾ All the postmenopausal patients received tamoxifen at the dose of 10 mg twice a day.
¾ The 1year, 3years and 5years survival rates were found to be 94.80%, 67.53% and
23.37% respectively.
CONCLUSIONS
Results of the present study suggest that in our patients the ignorance of the disease
lead to the late presentation inspite of the facilities available for early diagnosis.
Modified radical mastectomy was the procedure of choice in cases of operable breast
cancer.
If the surgeon is to retain the primary coordinating role in breast cancer management,
then he or she must fully understand all modalities of oncology therapy and know
Proper motivation is needed in convincing the patients for surgery, chemotherapy &
as well as radiotherapy.
radiotherapy) for locally advanced breast cancer even though at the cost of loco
regional recurrence. This is applicable in centres where there are no facilities for
radiotherapy.
BIBLIOGRAPHY
1) Moore CH. On the influence of inadequate operation on the theory of cancer. J Med Chir
2) Banks M. A plea for the more free removal of cancerous growths. Liverpool and
3) Gross SW. A Practical Treatment of Tumors of the Mammary Gland Embracing Their
Histology, Pathology, Diagnosis and Treatment. New York; D Appleton & Co: 1880. p
222-227.
Suggestions for a new method of treatment, with illustrative cases. Lancet 1896. 162-
165.
6) Halsted WS. The results of radical operation for the cure of cancer of the breast. Trans
8) Shield AM. A Clinical Treatise on Diseases of the Breast. New York; MacMillan 1898.p
150.
10) Martin HE, Ellis EB. Biopsy by needle procedure and aspiration. Ann Surg 92:169-181.
11) Warren SL. Roentgenologic study of the breast. AJR Am J Roentgenol 1930; 24:113-124.
12) Keynes G. Conservative treatment of cancer of the breast. BMJ 1937; 2:643-647.
13) Foote FW. Stewart FW Lobular carcinoma in situ: A rare form of mammary carcinoma.
Am J Pathol 1941;17:491-495.
14) Madden JL. Modified radical mastectomy. Surg Gynecol Obstet 1965; 121:1221-1230.
15) Huggins C, Bergenstal DM. Inhibition of human mammary and prostatic cancer by
16) McWhirter R. The value of simple mastectomy and radiotherapy in the treatment of
17) Baclesse F. Roentgen therapy alone in cancer of the breast. Acta Un Int Contra Cancrum
1959; 15:1023
18) Urban JA, Baker HW. Radical mastectomy in continuity with en bloc resection of the
19) Gillis DA, Dockerty MB, Clagett OT. Preinvasive intraductal carcinoma of the breast.
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21) Gros CM, Sigrist RF. Radiography and transillumination of the breast. Strasbourg
22) Tabar L, Fagerberg G, Duffy S, Day N. The Swedish Two County Trial of
mammographic screening for breast cancer: recent results and calculation of benefit. J
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of breast-conserving therapy in stages I and II breast cancer. EORTC 10801 trial. J Natl
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a randomized clinical trial comparing total mastectomy with lumpectomy with or without
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HISTORY SHEET
1. NAME : I. P. NO.:
2. AGE : UNIT:
3. SEX : D.O.A.:
4. RELIGION : D.O.O.:
5. OCCUPATION : D.O.D.:
6. RESIDENCE :
7. CHIEF COMPLAINTS :
- Duration
- Rate of growth
- Pain
Nipple discharge –
Hemoptysis,
Bony tenderness
Menopause.
4. Breast
Position
Any dimpling
Presence of swelling/ulcer
Movement of breast
Leaning forward
Retraction of nipple
Palpation
a. Situation
b. Size and shape
c. Surface
d. Margin
e. Consistency
f. Fixity to the skin
g. Fixity to breast tissue/Fascia & muscle/ chest wall
Examination of lymph nodes:
Cardiovascular system
FNAC/Biopsy-
19. Treatment :
21. Follow-up
Response
Local
Recurrence
Other complications
22. Period of survival: No of months/ years
Time:
Cause of Death:
********
ANNEXURE - II
PURPOSE OF RESEARCH:
This study will help the researcher to analyse about advance carcinoma of breast
PROCEDURE:
I understand that advanced carcinoma of breast can be managed both by surgery and
chemotherapy and both are effective modalities of management. I am aware that in addition I
will be examined and asked a series of questions by the investigator. I have been asked to
undergo the necessary investigations which would help the investigator to give appropriate
I understand that I may experience some pain and discomfort during the examination
or during my treatment. This is mainly the result of my condition and the procedures of this
study are not expected to exaggerate these feelings which are associated with the usual course
of treatment.
BENEFITS:
I understand that my participation in the study will have no direct benefit to me other
than potential benefit of the treatment for locally advanced carcinoma of breast which is
I understand the medical information produced by this study will become part of my
hospital record and will be subject to the confidentiality. Information of sensitive personal
nature will not be part of the medical record, but will be stored in the investigator’s research
file.
If the data are used for publication in the medical literature or for teaching purpose, no
names will be used and other identifiers, such as photographs will be used only with my
special written permission. I understand that I may see the photographs before giving the
permission.
I understand that I may ask more questions about the study at any time; Dr. Sunil
understand that I will be informed of any significant new findings discovered during the
course of the study, which might influence my continued participation. A copy of this consent
may withdraw consent and discontinue participation in the study at any time without
prejudice. I also understand that Dr. Sunil Krishna may terminate my participation in this
study at any time after he has explained the reasons for doing so.
INJURY STATEMENT:
participation in this study, if such injury were reported promptly then appropriate treatment
would be available to me. But no further compensation would be provided by the hospital. I
understand that by my agreement to participate in this study and not waiving any of my legal
rights.
I confirm that Dr. Sunil Krishna has explained to me the purpose of the research, the
study procedure that I will undergo and the possible risks and discomforts as well as benefits
that I may experience in my own language. I have been explained all the above in detail in
my own language and I understand the same. Therefore I agree to give my consent to
Participant Date
Q - Quadrant
S - Side
Dc - Discharge
R - Retraction
D - Distorted
Pu - Paeu – de-orange
Puc - Puckering
OA - Oedema of Arm
CT - Chemo therapy
HT - Hormonal therapy
LN - Lymphnode
Sl Name Age Sex IP No/ Symptoms and Signs TNM Staging Rx Histopathology Com Outcome
No Year Lump Nipple Pd’O Puc/ Sn IIIA IIIB IIIC MRM HT Tu LN
Changes Dim CT ty Status
Q Du/M S Dc Rt D C1- C1- C1+ C1+
Ms- Ms+ Ms+ Ms-
1 Mallawwa 56 F 10274/93 UO 3M L - - - - - - √ - - Rec Rec IDC - - P - - FUL
DSM
DSM
DSM
WG #
OA
OA #
WG
WG