Download PDF
CC BY-NC-ND 4.0 · South Asian J Cancer
DOI: 10.1055/s-0044-1791783
Consensus

Practical Consensus Guidelines on the Use of Cetuximab in Head and Neck Squamous Cell Carcinoma (HNSCC)

Purvish M. Parikh
1   Department of Clinical Hematology, Mahatma Gandhi University of Medical Sciences and Technology, Jaipur, Rajasthan, India
,
Ghanashyam Biswas
2   Department of Medical Oncology, Sparsh Hospitals and Critical Care Pvt Ltd, Bhubaneswar, Orissa, India
,
Nilesh Ashok Dhamne
3   Department of Medical Oncology, Kolhapur Cancer Center, Kolhapur, Maharashtra, India
,
Chetan Dilip Deshmukh
4   Department of Medical Oncology, Deenanath Mangeskar Hospital, Pune, Maharashtra, India
,
Sewanti Limaye
5   Department of Medical and Precision Oncology, Sir H.N. Reliance Foundation Hospital, Mumbai, Maharashtra, India
,
Ashish Singh
6   Department of Medical Oncology, Christian Medical College, Vellore, Tamil Nadu, India
,
Hemant Malhotra 
7   Department of Medical Oncology, Sri Ram Cancer Center, Mahatma Gandhi University of Medical Sciences and Technology, Jaipur, Rajasthan, India
,
Viashsta Pankaj Maniar
8   Department of Medical Oncology, MOC Cancer Care and Research Center, Mumbai, Maharashtra, India
,
Bhupendra Nath Kapur
9   Department of Medical Oncology, Yashoda Hospital, Ghaziabad, Uttar Pradesh, India
,
Prasad V.S.S. Sripada
10   Department of Medical Oncology, Apollo Cancer Centers, Hyderabad, Telangana, India
,
Vikas Tulsidas Talreja 
11   Department of Medical Oncology, Regency Hospital, Kanpur, Uttar Pradesh, India
,
Poonam Patil 
12   Department of Medical Oncology, Manipal Hospital, Bengaluru, Karnataka, India
,
Suhas Vilasrao Agre
13   Department of Medical Oncology, Hirandani Hospital, Mumbai, Maharashtra, India
,
Amit Dilip Bhat
14   Department of Medical Oncology, Avinash Cancer Clinic, Pune, Maharashtra, India
,
Priya Privadarshini Nayak
15   Department of Medical Oncology, Sum Ultimate Medicare, Bhubaneswar, Orissa, India
,
Arun Seshachalam
16   Department of Medical Oncology, Dr GVN Cancer Institute, Trichy, Kerala, India
,
Boman Nariman Dhabhar
17   Department of Medical Oncology, Fortis Mulund, Mumbai, Maharashtra, India
,
Ajay Sharma
18   Department of Medical Oncology, AS lifeline Cancer Care Hospital, New Delhi, India
,
Niraj N. Bhatt
19   Department of Medical Oncology and Hematology, Hemato Oncology Clinic, Vadodara, Gujarat, India
,
Pratap Kishore Das
20   Department of Medical Oncology, Apollo Hospital, New Delhi, India
,
Atul Sharma
21   Department of Medical Oncology, Max Hospital Saket, New Delhi, India
,
Govind Babu Kanakasetty 
22   Department of Medical Oncology, St. Johns Medical College Hospital, Bengaluru, Karnataka, India
,
Suresh Hariram Advani
23   Department of Medical Oncology, Sushruth Hospital, Mumbai, Maharashtra, India
› Author Affiliations
› Further Information
Also available at
   Permissions and Reprints

Abstract

Zoom Image
Purvish M. Parikh

Head and neck squamous cell carcinoma (HNSCC) is the most common malignancy group in India and several other low- and middle-income countries. Currently, majority of the patients present in advanced stage where systemic therapy is standard of care. Multiple relapses are also not uncommon. Almost all HNSCC tumors have epidermal growth factor receptor (EGFR) overexpression, making an attractive target. Cetuximab is the most successful method to target EGFR in HNSCC. After decades of its use, it still is a prominent part of the current management guidelines. Since other agents have also been proven to be useful, we felt it was necessary to develop a real-world consensus guideline to help the decision-making process among the community oncologists. Our expert committee therefore put together currently available data, insights from their real-world clinical practice, and voted to arrive at a consensus. These consensus guidelines represent how cetuximab should be used today in the management of HNSCC.

Keywords

oral cancer - monoclonal antibody - EGFR - targeted therapy


Publication History

Article published online:
16 October 2024

© 2024. MedIntel Services Pvt Ltd. This is an open access article published by Thieme under the terms of the Creative Commons Attribution-NonDerivative-NonCommercial License, permitting copying and reproduction so long as the original work is given appropriate credit. Contents may not be used for commercial purposes, or adapted, remixed, transformed or built upon. (https://creativecommons.org/licenses/by-nc-nd/4.0/)

Thieme Medical and Scientific Publishers Pvt. Ltd.
A-12, 2nd Floor, Sector 2, Noida-201301 UP, India

 

  • References

  • 1 Noronha V, Prabhash K, Babu KG. et al. Indian clinical practice consensus guidelines for the management of very advanced head-and-neck squamous cell carcinoma: update 2022. Cancer Res Stat Treat 2024; 7 (01) S31-S35
    CrossrefGoogle Scholar
  • 2 Gupta R, Pednekar MS, Kumar R, Goel S. Tobacco cessation in India-current status, challenges, barriers and solutions. Indian J Tuberc 2021; 68S: S80-S85
    CrossrefPubMedGoogle Scholar
  • 3 Patil VM, Noronha V, Menon N. et al. Results of phase III randomized trial for use of docetaxel as a radiosensitizer in patients with head and neck cancer, unsuitable for cisplatin-based chemoradiation. J Clin Oncol 2023; 41 (13) 2350-2361
    CrossrefPubMedGoogle Scholar
  • 4 Khadela A, Shah Y, Mistry P, Mansuri M, Sureja D, Bodiwala K. A review of efficacy and safety of cetuximab and bevacizumab-based monoclonal antibodies in head and neck cancer. Med Oncol 2022; 40 (01) 66
    CrossrefPubMedGoogle Scholar
  • 5 Urba S, van Herpen CML, Sahoo TP. et al. Pemetrexed in combination with cisplatin versus cisplatin monotherapy in patients with recurrent or metastatic head and neck cancer: final results of a randomized, double-blind, placebo-controlled, phase 3 study. Cancer 2012; 118 (19) 4694-4705
    CrossrefPubMedGoogle Scholar
  • 6 Noronha V, Joshi A, Patil VM. et al. Once-a-week versus once-every-3-weeks cisplatin systemic therapy/RT for locally advanced head and neck cancer: a phase III randomized noninferiority trial. J Clin Oncol 2018; 36 (11) 1064-1072
    CrossrefPubMedGoogle Scholar
  • 7 Patel B, Saba NF. Current aspects and future considerations of EGFR inhibition in locally advanced and recurrent metastatic squamous cell carcinoma of the head and neck. Cancers (Basel) 2021; 13 (14) 3545
    CrossrefPubMedGoogle Scholar
  • 8 Agulnik M. New approaches to EGFR inhibition for locally advanced or metastatic squamous cell carcinoma of the head and neck (SCCHN). Med Oncol 2012; 29 (04) 2481-2491
    CrossrefPubMedGoogle Scholar
  • 9 Bonner JA, Harari PM, Giralt J. et al. Radiotherapy plus cetuximab for squamous-cell carcinoma of the head and neck. N Engl J Med 2006; 354 (06) 567-578
    CrossrefPubMedGoogle Scholar
  • 10 Kao J, Genden EM, Gupta V. et al. Phase 2 trial of concurrent 5-fluorouracil, hydroxyurea, cetuximab, and hyperfractionated intensity-modulated radiation therapy for locally advanced head and neck cancer. Cancer 2011; 117 (02) 318-326
    CrossrefPubMedGoogle Scholar
  • 11 Suntharalingam M, Kwok Y, Goloubeva O. et al. Phase II study evaluating the addition of cetuximab to the concurrent delivery of weekly carboplatin, paclitaxel, and daily radiotherapy for patients with locally advanced squamous cell carcinomas of the head and neck. Int J Radiat Oncol Biol Phys 2012; 82 (05) 1845-1850
    CrossrefPubMedGoogle Scholar
  • 12 Seiwert TY, Melotek JM, Blair EA. et al. Final results of a randomized phase 2 trial investigating the addition of cetuximab to induction chemotherapy and accelerated or hyperfractionated chemoradiotherapy for locoregionally advanced head and neck cancer. Int J Radiat Oncol Biol Phys 2016; 96 (01) 21-29
    CrossrefPubMedGoogle Scholar
  • 13 Mesía R, Garcia-Saenz JA, Lozano A. et al; Spanish Head And Neck Cancer Cooperative Group. (Study TTCC-2007/02). Could the addition of cetuximab to conventional radiation therapy improve organ preservation in those patients with locally advanced larynx cancer who respond cooperative group phase 2 study. Int J Radiat Oncol Biol Phys 2017; 97 (03) 473-480
    CrossrefPubMedGoogle Scholar
  • 14 Bonner J, Giralt J, Harari P. et al. Cetuximab and radiotherapy in laryngeal preservation for cancers of the larynx and hypopharynx: a secondary analysis of a randomized clinical trial. JAMA Otolaryngol Head Neck Surg 2016; 142 (09) 842-849
    CrossrefPubMedGoogle Scholar
  • 15 Guo Y, Luo Y, Zhang Q. et al. First-line treatment with chemotherapy plus cetuximab in Chinese patients with recurrent and/or metastatic squamous cell carcinoma of the head and neck: efficacy and safety results of the randomised, phase III CHANGE-2 trial. Eur J Cancer 2021; 156: 35-45
    CrossrefPubMedGoogle Scholar
  • 16 Le Tourneau C, Ghiani M, Cau MC. et al. First-line cetuximab + platinum-based therapy for recurrent/metastatic head and neck squamous cell carcinoma: a real-world observational study-ENCORE. Cancer Rep (Hoboken) 2023; 6 (05) e1804
    CrossrefPubMedGoogle Scholar
  • 17 De Azevedo J, Mourtada J, Bour C. et al. The EXTREME regimen associating cetuximab and cisplatin favors head and neck cancer cell death and immunogenicity with the induction of an anti-cancer immune response. Cells 2022; 11 (18) 2866
    CrossrefPubMedGoogle Scholar
  • 18 Yoshino T, Hasegawa Y, Takahashi S. et al. Platinum-based chemotherapy plus cetuximab for the first-line treatment of Japanese patients with recurrent and/or metastatic squamous cell carcinoma of the head and neck: results of a phase II trial. Jpn J Clin Oncol 2013; 43 (05) 524-531
    CrossrefPubMedGoogle Scholar
  • 19 Pontes F, Garcia AR, Domingues I. et al. Survival predictors and outcomes of patients with recurrent and/or metastatic head and neck cancer treated with chemotherapy plus cetuximab as first-line therapy: a real-world retrospective study. Cancer Treat Res Commun 2021; 27: 100375
    CrossrefPubMedGoogle Scholar
  • 20 Bahl A, Bhatia K, Choudhary P. et al. Palliative chemotherapy with or without cetuximab in recurrent or metastatic squamous cell carcinoma of the head and neck: Indian tertiary care retrospective analysis. Head Neck 2020; 42 (05) 955-962
    CrossrefPubMedGoogle Scholar
  • 21 Tiwari S, Goel V, John MC, Patnaik N, Doval DC. Efficacy and toxicity of cetuximab with chemotherapy in recurrent and metastatic head and neck cancer: a prospective observational study. Indian J Cancer 2016; 53 (04) 487-492
    CrossrefPubMedGoogle Scholar
  • 22 Burtness B, Harrington KJ, Greil R. et al; KEYNOTE-048 Investigators. Pembrolizumab alone or with chemotherapy versus cetuximab with chemotherapy for recurrent or metastatic squamous cell carcinoma of the head and neck (KEYNOTE-048): a randomised, open-label, phase 3 study. Lancet 2019; 394 (10212): 1915-1928
    CrossrefPubMedGoogle Scholar
  • 23 Hobday SB, Brody RM, Kriegsman B. et al. Outcomes among patients with mucosal head and neck squamous cell carcinoma treated with checkpoint inhibitors. JAMA Otolaryngol Head Neck Surg 2022; 148 (10) 918-926
    CrossrefPubMedGoogle Scholar
  • 24 Ferris RL, Blumenschein Jr G, Fayette J. et al. Nivolumab vs investigator's choice in recurrent or metastatic squamous cell carcinoma of the head and neck: 2-year long-term survival update of CheckMate 141 with analyses by tumor PD-L1 expression. Oral Oncol 2018; 81: 45-51
    CrossrefPubMedGoogle Scholar
  • 25 Fuereder T. Essential news of current guidelines: head and neck squamous cell carcinoma. Memo 2022; 15: 278-281
    CrossrefGoogle Scholar
  • 26 Dattatreya S, Goswami C. Cetuximab plus radiotherapy in patients with unresectable locally advanced squamous cell carcinoma of head and neck region–a open labelled single arm phase II study. Indian J Cancer 2011; 48 (02) 154-157
    CrossrefPubMedGoogle Scholar
  • 27 Patil VM, Noronha V, Joshi A. et al. Comparison of paclitaxel-cetuximab chemotherapy versus metronomic chemotherapy consisting of methotrexate and celecoxib as palliative chemotherapy in head and neck cancers. Indian J Cancer 2017; 54 (01) 20-24
    CrossrefPubMedGoogle Scholar
  • 28 Specenier P, Vermorken JB. Cetuximab: its unique place in head and neck cancer treatment. Biologics 2013; 7: 77-90
    PubMedGoogle Scholar
  • 29 Baysal H, De Pauw I, Zaryouh H. et al. The right partner in crime: unlocking the potential of the anti-EGFR antibody cetuximab via combination with natural killer cell chartering immunotherapeutic strategies. Front Immunol 2021; 12: 737311
    CrossrefPubMedGoogle Scholar
  • 30 Aggarwal S, Vaid A, Ramesh A. et al. Practical consensus recommendations on management of HR + ve early breast cancer with specific reference to genomic profiling. South Asian J Cancer 2018; 7 (02) 96-101
    Article in Thieme ConnectPubMedGoogle Scholar
  • 31 Parikh P, Babu G, Singh R. et al. Consensus guidelines for the management of HR-positive HER2/neu negative early breast cancer in India, SAARC region and other LMIC by DELPHI survey method. BMC Cancer 2023; 23 (01) 714
    CrossrefPubMedGoogle Scholar
  • 32 Niederberger M, Spranger J. Delphi technique in health sciences: a map. Front Public Health 2020; 8: 457
    CrossrefPubMedGoogle Scholar
  • 33 Parikh PM, Aggarwal S, Biswas G. et al. Practical clinical consensus guidelines for the management of cancer associated anemia in low- and middle-income countries. South Asian J Cancer 2023; 12 (02) 93-99
    Article in Thieme ConnectPubMedGoogle Scholar
  • 34 Prabhash K, Babu G, Chaturvedi P. et al. Indian clinical practice consensus guidelines for the management of squamous cell carcinoma of head and neck. Indian J Cancer 2020; 57 (Feb, Supplement): S1-S5
    CrossrefPubMedGoogle Scholar
  • 35 Bonner JA, Mesia R, Giralt J. et al. p16, HPV, and cetuximab: what is the evidence?. Oncologist 2017; 22 (07) 811-822
    CrossrefPubMedGoogle Scholar
  • 36 Johnson DE, Burtness B, Leemans CR, Lui VWY, Bauman JE, Grandis JR. Head and neck squamous cell carcinoma. Nat Rev Dis Primers 2020; 6 (01) 92
    CrossrefPubMedGoogle Scholar
  • 37 Echarri MJ, Lopez-Martin A, Hitt R. Targeted therapy in locally advanced and recurrent/metastatic head and neck squamous cell carcinoma (LA-R/M HNSCC). Cancers (Basel) 2016; 8 (03) E27
    CrossrefPubMedGoogle Scholar
  • 38 Bossi P, Platini F. Radiotherapy plus EGFR inhibitors: synergistic modalities. Cancers Head Neck 2017; 2: 2
    CrossrefPubMedGoogle Scholar
  • 39 Katase N, Nishimatsu SI, Yamauchi A, Okano S, Fujita S. DKK3 expression is correlated with poorer prognosis in head and neck squamous cell carcinoma: a bioinformatics study based on the TCGA database. J Oral Biosci 2023; 65 (04) 334-346
    CrossrefPubMedGoogle Scholar
  • 40 Stewart JS, Cohen EE, Licitra L. et al. Phase III study of gefitinib compared with intravenous methotrexate for recurrent squamous cell carcinoma of the head and neck [corrected]. J Clin Oncol 2009; 27 (11) 1864-1871
    CrossrefPubMedGoogle Scholar
  • 41 Vokes EE. Induction chemotherapy for head and neck cancer: recent data. Oncologist 2010; 15 (Suppl. 03) 3-7
    CrossrefPubMedGoogle Scholar
  • 42 Patil VM, Prabhash K, Noronha V. et al. Neoadjuvant chemotherapy followed by surgery in very locally advanced technically unresectable oral cavity cancers. Oral Oncol 2014; 50 (10) 1000-1004
    CrossrefPubMedGoogle Scholar
  • 43 Comet B, Kramar A, Faivre-Pierret M. et al. Salvage stereotactic reirradiation with or without cetuximab for locally recurrent head-and-neck cancer: a feasibility study. Int J Radiat Oncol Biol Phys 2012; 84 (01) 203-209
    CrossrefPubMedGoogle Scholar
  • 44 Rooney M, Kish J, Jacobs J. et al. Improved complete response rate and survival in advanced head and neck cancer after three-course induction therapy with 120-hour 5-FU infusion and cisplatin. Cancer 1985; 55 (05) 1123-1128
    CrossrefPubMedGoogle Scholar
  • 45 Schuller DE, Wilson HE, Smith RE, Batley F, James AD. Preoperative reductive chemotherapy for locally advanced carcinoma of the oral cavity, oropharynx, and hypopharynx. Cancer 1983; 51 (01) 15-19
    CrossrefPubMedGoogle Scholar
  • 46 Ensley J, Crissman J, Kish J. et al. The impact of conventional morphologic analysis on response rates and survival in patients with advanced head and neck cancers treated initially with cisplatin-containing combination chemotherapy. Cancer 1986; 57 (04) 711-717
    CrossrefPubMedGoogle Scholar
  • 47 Lefebvre JL, Chevalier D, Luboinski B, Kirkpatrick A, Collette L, Sahmoud T. EORTC Head and Neck Cancer Cooperative Group. Larynx preservation in pyriform sinus cancer: preliminary results of a European Organization for Research and Treatment of Cancer phase III trial. J Natl Cancer Inst 1996; 88 (13) 890-899
    CrossrefPubMedGoogle Scholar
  • 48 Wolf GT, Fisher SG, Hong WK. et al; Department of Veterans Affairs Laryngeal Cancer Study Group. Induction chemotherapy plus radiation compared with surgery plus radiation in patients with advanced laryngeal cancer. N Engl J Med 1991; 324 (24) 1685-1690
    CrossrefPubMedGoogle Scholar
  • 49 Michelon I, Nachtigal GC, Dacoregio MI. et al. Treatment options for cisplatin-ineligible patients with locally advanced head and neck squamous cell carcinoma: a systematic review. J Cancer Res Clin Oncol 2024; 150 (08) 379
    CrossrefPubMedGoogle Scholar
  • 50 Chen TH, Pan YY, Lee TL. et al. Treatment outcomes of cetuximab-containing regimen in locoregional recurrent and distant metastatic head and neck squamous cell carcinoma. BMC Cancer 2022; 22 (01) 1336
    CrossrefPubMedGoogle Scholar
  • 51 Nair LM, Ravikumar R, Rafi M. et al. Anti–epidermal growth factor receptor monoclonal antibody therapy in locally advanced head and neck cancer: a systematic review of phase III clinical trials. Med Int (Lond) 2024; 4 (04) 41
    PubMedGoogle Scholar
  • 52 NCCN reference Ver4.2024. Accessed August 21, 2024 at: https://www.nccn.org/professionals/physician_gls/pdf/head-and-neck.pdf
  • 53 D'cruz A, Lin T, Anand AK. et al. Consensus recommendations for management of head and neck cancer in Asian countries: a review of international guidelines. Oral Oncol 2013; 49 (09) 872-877
    CrossrefPubMedGoogle Scholar
  • 54 Bokemeyer C, Ciardiello F, Dubreuil O. et al. Cetuximab every 2 weeks versus standard weekly dosing administration schedule. Future Oncol 2024; 20 (07) 393-407
    CrossrefPubMedGoogle Scholar
  • 55 Argiris A, Heron DE, Smith RP. et al. Induction docetaxel, cisplatin, and cetuximab followed by concurrent radiotherapy, cisplatin, and cetuximab and maintenance cetuximab in patients with locally advanced head and neck cancer. J Clin Oncol 2010; 28 (36) 5294-5300
    CrossrefPubMedGoogle Scholar
  • 56 Diniz CHP, Henrique T, Stefanini ACB, De Castro TB, Tajara EH. Cetuximab chemotherapy resistance: insight into the homeostatic evolution of head and neck cancer (Review). Oncol Rep 2024; 51 (06) 80
    CrossrefPubMedGoogle Scholar
  • 57 Weidhaas JB, Harris J, Schaue D. et al. The KRAS-variant and cetuximab response in head and neck squamous cell cancer: a secondary analysis of a randomized clinical trial. JAMA Oncol 2017; 3 (04) 483-491
    CrossrefPubMedGoogle Scholar
  • 58 Mahmood H, Shaban M, Rajpoot N, Khurram SA. Artificial intelligence-based methods in head and neck cancer diagnosis: an overview. Br J Cancer 2021; 124 (12) 1934-1940
    CrossrefPubMedGoogle Scholar
  • 59 Vermorken JB, Mesia R, Rivera F. et al. Platinum-based chemotherapy plus cetuximab in head and neck cancer. N Engl J Med 2008; 359 (11) 1116-1127
    CrossrefPubMedGoogle Scholar
  • 60 Vermorken JB, Trigo J, Hitt R. et al. Open-label, uncontrolled, multicenter phase II study to evaluate the efficacy and toxicity of cetuximab as a single agent in patients with recurrent and/or metastatic squamous cell carcinoma of the head and neck who failed to respond to platinum-based therapy. J Clin Oncol 2007; 25 (16) 2171-2177
    CrossrefPubMedGoogle Scholar
  • 61 Bossi P, Miceli R, Locati LD. et al. A randomized, phase 2 study of cetuximab plus cisplatin with or without paclitaxel for the first-line treatment of patients with recurrent and/or metastatic squamous cell carcinoma of the head and neck. Ann Oncol 2017; 28 (11) 2820-2826
    CrossrefPubMedGoogle Scholar
  • 62 Lofy M, Jung L, Dow-Hillgartner E. Premedication strategy in cetuximab rechallenge after Grade 2 hypersensitivity reactions. J Oncol Pharm Pract 2024; 30 (02) 412-416
    CrossrefPubMedGoogle Scholar
  • 63 Magnes T, Melchardt T, Weiss L. et al. Prognostic score in patients with recurrent or metastatic carcinoma of the head and neck treated with cetuximab and chemotherapy. PLoS One 2017; 12 (07) e0180995
    CrossrefPubMedGoogle Scholar
  • 64 Guigay J, Aupérin A, Fayette J. et al; GORTEC, AIO, TTCC, and UniCancer Head and Neck groups. Cetuximab, docetaxel, and cisplatin versus platinum, fluorouracil, and cetuximab as first-line treatment in patients with recurrent or metastatic head and neck squamous-cell carcinoma (GORTEC 2014-01 TPExtreme): a multicentre, open-label, randomised, phase 2 trial. Lancet Oncol 2021; 22 (04) 463-475
    CrossrefPubMedGoogle Scholar
  • 65 Pfister DG, Haddad RI, Worden FP. et al. Biomarkers predictive of response to pembrolizumab in head and neck cancer. Cancer Med 2023; 12 (06) 6603-6614
    CrossrefPubMedGoogle Scholar
  • 66 Paver EC, Cooper WA, Colebatch AJ. et al. Programmed death ligand-1 (PD-L1) as a predictive marker for immunotherapy in solid tumours: a guide to immunohistochemistry implementation and interpretation. Pathology 2021; 53 (02) 141-156
    CrossrefPubMedGoogle Scholar
  • 67 Szturz P, Vermorken JB. Management of recurrent and metastatic oral cavity cancer: raising the bar a step higher. Oral Oncol 2020; 101: 104492
    CrossrefPubMedGoogle Scholar
  • 68 Li Y, Wang P, Xu J, Shi X, Yin T, Teng F. Noninvasive radiomic biomarkers for predicting pseudoprogression and hyperprogression in patients with non-small cell lung cancer treated with immune checkpoint inhibition. OncoImmunology 2024; 13 (01) 2312628
    CrossrefPubMedGoogle Scholar
  • 69 Ding P, Wen L, Tong F, Zhang R, Huang Y, Dong X. Mechanism underlying the immune checkpoint inhibitor-induced hyper-progressive state of cancer. Cancer Drug Resist 2022; 5 (01) 147-164
    PubMedGoogle Scholar
  • 70 Park JH, Chun SH, Lee YG. et al. Hyperprogressive disease and its clinical impact in patients with recurrent and/or metastatic head and neck squamous cell carcinoma treated with immune-checkpoint inhibitors: Korean cancer study group HN 18-12. J Cancer Res Clin Oncol 2020; 146 (12) 3359-3369 Erratum in: J Cancer Res Clin Oncol. 2020 Dec;146(12):3371. doi: 10.1007/s00432-020-03342-3. PMID: 32671504
    CrossrefPubMedGoogle Scholar
  • 71 Yang CC, Lien CF, Hwang TZ. et al. Treatment sequences in patients with recurrent or metastatic head and neck squamous cell carcinoma: cetuximab followed by immunotherapy or vice versa. Cancers (Basel) 2022; 14 (10) 2351
    CrossrefPubMedGoogle Scholar
  • 72 Ferris RL, Licitra L, Fayette J. et al. Nivolumab in patients with recurrent or metastatic squamous cell carcinoma of the head and neck: efficacy and safety in CheckMate 141 by prior cetuximab use. Clin Cancer Res 2019; 25 (17) 5221-5230
    CrossrefPubMedGoogle Scholar
  • 73 Burcher KM, Bloomer CH, Gavrila E. et al. Study protocol: phase II study to evaluate the effect of cetuximab monotherapy after immunotherapy with PD-1 inhibitors in patients with head and neck squamous cell cancer. Ther Adv Med Oncol 2024; 16: 17 588359231217959
    CrossrefPubMedGoogle Scholar
  • 74 Cabezas-Camarero S, Cabrera-Martín MN, Merino-Menéndez S. et al. Safety and efficacy of cetuximab-based salvage chemotherapy after checkpoint inhibitors in head and neck cancer. Oncologist 2021; 26 (06) e1018-e1035
    CrossrefPubMedGoogle Scholar
  • 75 Wakasaki T, Yasumatsu R, Uchi R. et al. Outcome of chemotherapy following nivolumab treatment for recurrent and/or metastatic head and neck squamous cell carcinoma. Auris Nasus Larynx 2020; 47 (01) 116-122
    CrossrefPubMedGoogle Scholar
  • 76 Chevalier T, Daste A, Saada-Bouzid E. et al. Cetuximab combined with paclitaxel or paclitaxel alone for patients with recurrent or metastatic head and neck squamous cell carcinoma progressing after EXTREME. Cancer Med 2021; 10 (12) 3952-3963
    CrossrefPubMedGoogle Scholar
  • 77 Kreinbrink PJ, Mierzwa ML, Huth B. et al. Adjuvant radiation and cetuximab improves local control in head and neck cutaneous squamous cell carcinoma: phase II study. Head Neck 2021; 43 (11) 3408-3416
    CrossrefPubMedGoogle Scholar
  • 78 Bui LA, Hurst S, Finch GL. et al. Key considerations in the preclinical development of biosimilars. Drug Discov Today 2015; 20 (Suppl. 01) 3-15
    CrossrefPubMedGoogle Scholar
  • 79 Accessed August 17, 2024 at: https://www.ema.europa.eu/en/human-regulatory-overview/biosimilar-medicines-overview#:~:text=A%20biosimilar%20is%20a%20biological,apply%20to%20all%20biological%20medicineslast
  • 80 Accessed August 17, 2024 at: https://www.fda.gov/files/drugs/published/Biosimilar-Product-Regulatory-Review-and-Approval.pdf
  • 81 Accessed August 17, 2024 at: https://cdsco.gov.in/opencms/resources/UploadCDSCOWeb/2018/UploadAlertsFiles/BiosimilarGuideline2016.pdf
  • 82 Dhamne N, Jain M, Nagarkar R. et al. Efficacy and safety of ENZ-124 versus innovator cetuximab in combination with platinum-based chemotherapy in patients with recurrent locoregional or metastatic squamous cell carcinoma of the head and neck (SCCHN). Ann Oncol 2023; 34 (Suppl. 04) S1607-S1619
    CrossrefGoogle Scholar
  • 83 Accessed September 30, 2024 at: https://cdsco.gov.in/opencms/resources/UploadCDSCOWeb/2018/UploadCTApprovals/2.%20Enzene%20Cetuximab.pdf
  • 84 Accessed September 30, 2024 at: https://timesofindia.indiatimes.com/business/india-business/alkem-launches-worlds-1st-biosimilar-for-cetuximab/articleshow/100659457.cms
  • 85 Accessed September 30, 2024 at: https://www.1mg.com/search/all?name=Cetuximab&st=cetuixmab&sl=Cetuximab&s=Cetuximab
  • 86 Soulières D, Aguilar JL, Chen E. et al. Cetuximab plus platinum-based chemotherapy in head and neck squamous cell carcinoma: a randomized, double-blind safety study comparing cetuximab produced from two manufacturing processes using the EXTREME study regimen. BMC Cancer 2016; 16: 19
    CrossrefPubMedGoogle Scholar
  • 87 Guigay J, Le Caer H, Ferrand FR. et al; ELAN Group including Gustave Roussy, Unicancer GERICO and H&N groups, and GORTEC. Adapted EXTREME regimen in the first-line treatment of fit, older patients with recurrent or metastatic head and neck squamous cell carcinoma (ELAN-FIT): a multicentre, single-arm, phase 2 trial. Lancet Healthy Longev 2024; 5 (06) e392-e405
    CrossrefPubMedGoogle Scholar
  • 88 van Caloen G, Schmitz S, van Marcke C. et al. Preclinical evaluation of the association of the cyclin-dependent kinase 4/6 inhibitor, ribociclib, and cetuximab in squamous cell carcinoma of the head and neck. Cancers (Basel) 2021; 13 (06) 1251
    CrossrefPubMedGoogle Scholar
  • 89 Peng W, de Bruijn HS, Ten Hagen TLM. et al. Targeted photodynamic therapy of human head and neck squamous cell carcinoma with anti-epidermal growth factor receptor antibody cetuximab and photosensitizer IR700DX in the mouse skin-fold window chamber model. Photochem Photobiol 2020; 96 (03) 708-717
    CrossrefPubMedGoogle Scholar
  • 90 Razak ARA, Wang HM, Chang JY. et al. A Phase 1b/2 study of alpelisib in combination with cetuximab in patients with recurrent or metastatic head and neck squamous cell carcinoma. Target Oncol 2023; 18 (06) 853-868
    CrossrefPubMedGoogle Scholar
  • 91 Voskuil FJ, de Jongh SJ, Hooghiemstra WTR. et al. Fluorescence-guided imaging for resection margin evaluation in head and neck cancer patients using cetuximab-800CW: a quantitative dose-escalation study. Theranostics 2020; 10 (09) 3994-4005
    CrossrefPubMedGoogle Scholar
  • 92 Novoplansky O, Fury M, Prasad M. et al. MET activation confers resistance to cetuximab, and prevents HER2 and HER3 upregulation in head and neck cancer. Int J Cancer 2019; 145 (03) 748-762
    CrossrefPubMedGoogle Scholar
  • 93 Patil VM, Noronha V, Menon N. et al. Low-dose immunotherapy in head and neck cancer: a randomized study. J Clin Oncol 2023; 41 (02) 222-232
    CrossrefPubMedGoogle Scholar
  • 94 Joris S, Fontaine C, Decoster L. et al. Efficacy of a flat low dose of nivolumab in advanced cancer: a retrospective case series. Anticancer Res 2022; 42 (03) 1433-1437
    CrossrefPubMedGoogle Scholar
  • 95 Patel A, Akhade A, Parikh P. et al. Pembrolizumab weight based dosing – a call for policy change. Indian J Med Paediatr Oncol 2022; 43 (03) 306-310
    Article in Thieme ConnectGoogle Scholar
  • 96 Guigay J, Tahara M, Licitra L. et al. The evolving role of taxanes in combination with cetuximab for the treatment of recurrent and/or metastatic squamous cell carcinoma of the head and neck: evidence, advantages, and future directions. Front Oncol 2019; 9: 668
    CrossrefPubMedGoogle Scholar