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    See discussions, stats, and author profiles for this publication at: https://www.researchgate.

    net/publication/361125998

    A feasibility study of EMF(erlotinib+methotrexate+5-fluorouracil) regimen in


    recurrent head and neck squamous cell carcinoma (HNSCC) and role of
    circulating tumour cells(CTCs) in a...

    Article in Journal of Clinical Oncology · June 2022


    DOI: 10.1200/JCO.2022.40.16_suppl.e18038

    CITATIONS READS

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    12 authors, including:

    Annie K. Baa Raja Pramanik

    15 PUBLICATIONS 4 CITATIONS
    All India Institute of Medical Sciences
    114 PUBLICATIONS 370 CITATIONS
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    Atul Sharma Ahitagni Biswas


    Moradabad Institute of Technology All India Institute of Medical Sciences
    507 PUBLICATIONS 3,696 CITATIONS 147 PUBLICATIONS 585 CITATIONS

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    Some of the authors of this publication are also working on these related projects:

    Human Papillomavirus Genotyping View project

    Study to evaluate the feasibility of response adapted whole brain radiotherapy after methotrexate based chemotherapy in the patients of newly diagnosed primary
    CNS lymphoma View project

    All content following this page was uploaded by Annie K. Baa on 19 December 2022.

    The user has requested enhancement of the downloaded file.


    HEAD AND NECK CANCER

    e18038 Publication Only


    A feasibility study of EMF(erlotinib+methotrexate+5-fluorouracil) regimen in
    recurrent head and neck squamous cell carcinoma (HNSCC) and role of circulating
    tumour cells(CTCs) in assessment of outcomes.

    Annie Baa, Raja Pramanik, Atul Sharma, Ahitagni Biswas, Sachidanand JeeBharti, Mayank Singh,
    Rajeev Kumar, Aland Gourishankar, Sreeja Jayant, Alain D’Souza, Vikas Jadhav, Jayant Khandare;
    All India Institute of Medical Science (AIIMS), New-delhi, India; All India Institute of Medical Scien-
    ces, New Delhi, India; Actorius Innovations and Research Pvt. Ltd., Pune, India; OneCell Diagnostics,
    Pune, India; AIR Pvt Ltd, Pune, India

    Background: Head and neck cancer is a huge burden in South East Asia with frequent relapse after cu-
    rative therapy while the rest presenting in advanced unresectable stages. Financial constraints for tar-
    geted and immunotherapy make it inaccessible for the bulk of population. Thus, low-cost but
    efficacious regimen is highly implicated. We assessed if readily available triplet therapy of EMF, is su-
    perior in terms of extending life and maintaining quality of life along with evaluation of CTCs as a pre-
    dictive biomarker in such patients. Methods: This was a single arm, phase II, investigator initiated
    interventional study, wherein 35 patients were enrolled. Platinum resistant/refractory patients of
    HNSCC were treated with combination of erlotinib 150mg daily, methotrexate 40 mg/m2 and 5-fluour-
    ouracil 500 mg/m2 (d1, d8) q28 days till progression or unacceptable toxicities. The primary endpoint
    was overall response rate(ORR) at 3 months; additional endpoints were disease control rate(DCR) at 3
    months, overall survival (OS), progression free survival (PFS) safety and patient reported quality of
    life(QOL). The role of CTCs in gauging the responders and non-responders was monitored using anti
    Epithelial Cell Adhesion Molecule antibody based enrichment - OncoDiscover Drug Controller General
    of India (DCGI) approved platform. Results: The ORR and DCR at 3 months was 45.7% and 68.5%, re-
    spectively. The median PFS was 5 months (95%CI: 3.9-6 months) and median OS was 9 months
    (95%CI:7.4 -10.5 months). The 3 and 6 months PFS rates was 86 + 6% and 45 + 9%, respectively,
    while OS rates at 3 and 6 months were 91+ 5% and 68+ 8%, respectively. Rash, mucositis and fa-
    tigue were common adverse events occurring in 23 (65%), 14 (40%) and 9 (25.7%) respectively. The
    grade 3 events seen were rash in 5 (14.2%) and diarrhea in 2 (5.7%). Clinically significant improve-
    ment was seen in domains of role functioning, social functioning, fatigue, pain and global health sta-
    tus, swallowing, dryness of mouth and feeling ill. The mean CTC count at baseline was 0.90 + 1.1
    /1.5ml of blood. Responders showed decline in levels from 1.19 + 0.25 to 0.33 + 0.48, while non-res-
    ponders had increasing trend: 0.29 + 0.48 to 1+ 0.10 at 3 months (p = 0.010); with concordance
    rates with response being 52.9%. Additionally, CTC clearance at 3 months had numerically better PFS
    ~ 6 months (95% CI: 4.72-7.72) and OS of 10 months (95% CI: 2.3-5.65) vs 4 months (95% CI:
    2.3-5.65), p = 0.258 and 8 months (95% CI: 4.3-11.6), p = 0.203 in those with persistence of CTCs.
    Conclusions: The triplet regimen of EMF is a feasible, safe therapeutic option with favourable response
    rates and improved QOL in patients with platinum resistant/refractory HNSCC. CTCs have a promising
    futuristic role as a predictive biomarker and can be extrapolated in clinical upfront setting too. Clinical
    trial information: CTRI/2020/02/023378. Research Sponsor: NATCO PHARMA LTD. ONCOLOGY DI-
    VISION, For CTC: ACTORIUS INNOVATIONS & RESEARCH.

    © 2022 by American Society of Clinical Oncology. Visit abstracts.asco.org and search by abstract for disclosure information.
    Downloaded from ascopubs.org by 109.70.65.149 on December 19, 2022 from 109.070.065.149
    View publication stats Copyright © 2022 American Society of Clinical Oncology. All rights reserved.

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