Table 1.: Assessment of Response

448 M. S.
IYIKESICI
Table 1. Demographical and clinical characteristics of the patients at baseline. of hyperthermia was to obtain a tumoral tissue temperature
Characteristic n ¼ 44 over 43 C at the tumor site as it is reported to be cytotoxic
Age, year, median (range) 65 (35–87) at such temperatures. The OncoTherm EHY-3010 HT device
Age >65 years 20 (44.5%)
Male gender 39 (88.6%)
used in our patient group uses modulated electrohyperther-
Histology mia (mEHT) approach to specifically heat malignant cells to
Adenocarcinoma 34 (77.3%) provide effective heat within the tumor tissue while preserv-
Squamous cell carcinoma 8 (18.2%)
Undifferentiated 2 (4.5%)a ing healthy surrounding tissues including the skin and makes
Metastatic sites an indirect temperature estimation based upon the energy
0–1 0 (0 %) applied. In all sessions, per instructions of the manufacturer,
2 4 (9.1%)
3 40 (90.9%) the power was set at 110 Watt and at the end of a 60-min
Brain metastases 18 (40.9%) session the total energy applied ranged between 380.000
Mutation status
EGFR
and 450.000 Joules (average 400.000 Joules). Based on this
Mutation present 0 (0%) amount of applied energy, the indirect temperature estima-
No mutation detected 29 (65.9%) tion of the device ranged between 43.9 and 45.2 C.
Not evaluated 15 (34.1%)
ALK fusion
For each 60-min HBOT session, Quamvis 320 hyperbaric
Fusion 5 (11.4%) oxygen chamber (OxyHealth, California, US) was used. It is a
No fusion detected 24 (54.5%) soft-walled chamber with a 32-inch diameter when inflated.
Not evaluated 15 (34.1%)
Smoking status The chamber was pressurized using a clean air compressor
Nonsmoker 6 (13.6%) which filters air to 0.01 microns and a 10 L/min O2 concentra-
Smoker 38 (86.4%) tor to produce an operating pressure of 1.5 atmospheres
Diabetes 14 (31.8%)
Presence of any comorbidity 32 (72.7%)b absolute (ATA).
Performance status
ECOG 0-1 8 (18.2%)
ECOG 2 21 (47.7%) Assessment of response
ECOG 3 15 (34.1%)
Second malignancy 1 (2.3%)c Assessment of treatment response was based on radio-
Notes: Unless otherwise stated, data presented as n (%). EGFR: epidermal graphic evaluations at the end of each 3-month period or
growth factor receptor; ALK: anaplastic lymphoma kinase; ECOG: Eastern
Cooperative Oncology Group. aOne large cell carcinoma and one bronchoal- following administration of four cycles, according to criteria
veolar carcinoma; bdiabetes, hypertension or chronic obstructive pulmonary defined by RECIST 1.1 [55]. Radiological response was always
disease; cthis patient had been diagnosed with bladder carcinoma
before NSCLC.
evaluated by PET-CT, and MRI was added in case of
brain metastasis.
Table 2. Treatment response by patient characteristics.
ORR n (%) SD n (%) PD n (%) p value Assessment of toxicity
All patients (n ¼ 44) 27 (61.4 %) 7 (15.9 %) 10 (22.7 %)
Age (years) Toxicity was evaluated in accordance with Common
65 (n ¼ 24) 15 (62.5 %) 4 (16.7 %) 5 (20.8 %) .95 Terminology Criteria for Adverse Events version 4.03 (CTCAE
>65 (n ¼ 20) 12 (60.0 %) 3 (15.0 %) 5 (25.0 %)
Histology
v4.03) [56]. Adverse events (AEs) experienced by each patient
AC (n ¼ 34) 21 (61.8 %) 6 (17.6 %) 7 (20.6 %) .29 per cycle were recorded. The worst overall AE grade per
SCC (n ¼ 8) 6 (75.0 %) 0 (0 %) 2 (25.0 %) event type throughout the study period was documented for
UC (n ¼ 2) 0 (.0 %) 1 (50.0 %) 1 (50.0 %)
Performance status each patient.
ECOG 0–1 (n ¼ 8) 5 (62.5 %) 2 (25.0 %) 1 (12.5 %) .62
ECOG 2 (n ¼ 36) 22 (61.1 %) 5 (13.9 %) 9 (25.0 %)
Metastatic sites Statistical analysis
0–1 (n ¼ 0) 0 (0 %) 0 (.0 %) 0 (.0 %) .25
2 (n ¼ 4) 4 (100.0 %) 0 (.0 %) 0 (.0 %) Data were analyzed using IBM SPSS Statistics version 20.0
3 (n ¼ 40) 23 (57.5 %) 7 (17.5 %) 10 (25.0 %)
Brain Metastases software (SPSS Inc., Chicago, IL). Descriptive data are pre-
Yes (n ¼ 18) 8 (44.4 %) 3 (16.7 %) 7 (38.9 %) .09 sented in number (percentage), median (range), mean (95%
No (n ¼ 26) 19 (73.1 %) 4 (15.4 %) 3 (11.5 %) confidence interval), where appropriate. Categorical variables
Smoking status
Yes (n ¼ 38) 25 (65.8 %) 4 (10.5 %) 9 (23.7 %) .05 were compared using Pearson’s chi-square test. Overall sur-
No (n ¼ 6) 2 (33.3 %) 3 (50.0 %) 1 (16.7 %) vival was defined as the time elapsed between the date of
Notes: ORR: Overall Response Rate (Complete Response (CR)þPartial Response the first administration of the treatment and death from any
(PR)); SD: Stable Disease; PD: Progressive Disease; AC: adenocarcinoma; SC:
squamous cell carcinoma; UC: undifferentiated carcinoma (including large cell
cause. Progression-free survival was defined as the time
carcinoma and bronchoalveolar carcinoma); ECOG: Eastern Cooperative elapsed between the date of the first administration of the
Oncology Group. p ¼ .048 before rounding to two decimals. treatment and death from any cause or progression. Patients
without event at the last follow up were censored. Survival
rates were estimated using Kaplan–Meier analysis and inter-
any). However, metastases outside the thoracic cavity were group comparisons were performed using log-rank test. Two-
not targeted. In all patients, a 30 40 cm mobile electrode sided p values <.05 were considered as an indication of stat-
was used for hyperthermia session (Figure 2). The objective istical significance.

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448 M. S.

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