Efficacy and safety of nimotuzumab in unresectable, recurrent, and/or metastatic squamous cell carcinoma of the head and neck: A hospital-based retrospective evidence

Sundaram Subramanian; Nithya Sridharan; V. Balasundaram; Sameer Chaudhari

doi:10.4103/sajc.sajc_87_18

South Asian Journal of Cancer, Inhaltsverzeichnis

CC BY-NC-ND 4.0 · South Asian J Cancer 2018; 07(03): 188-192
DOI: 10.4103/sajc.sajc_87_18

ORIGINAL ARTICLE: Head and Neck Cancer

Efficacy and safety of nimotuzumab in unresectable, recurrent, and/or metastatic squamous cell carcinoma of the head and neck: A hospital-based retrospective evidence

Sundaram Subramanian

Department of Medical Oncology, VS Hospital and Cancer Center, Chennai, Tamil Nadu

,

Nithya Sridharan

Department of Medical Oncology, VS Hospital and Cancer Center, Chennai, Tamil Nadu

,

V. Balasundaram

Department of Radiation Oncology, VS Hospital and Cancer Center, Chennai, Tamil Nadu

,

Sameer Chaudhari

Medical affairs, Biocon Ltd, Bengaluru, Karnataka

› Institutsangaben

Abstract

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Abstract

Context: Role of nimotuzumab in locally advanced head and neck cancer (HNC) is well established in India; however, no clinical evidence is available for its role in recurrent and/or metastatic HNC. Aims: The aim of this study is to evaluate the efficacy and safety of nimotuzumab when added to standard treatment in unresectable, recurrent, and metastatic squamous cell carcinoma of the head and neck (SCCHN) Settings and Design: Hospital records of 14 patients diagnosed with recurrent and/or metastatic HNC with histologically confirmed squamous cell carcinoma and being treated with nimotuzumab along with standard treatments from December 2010 to December 2016 were retrospectively evaluated. Subjects and Methods: The tumor response rate and overall survival (OS) were analyzed. Toxicity and adverse events (AEs) were assessed as per common terminology criteria for adverse events (CTCAE) v 4. Results: Oral cavity was most commonly involved region followed by hypopharynx and oropharynx. At 24 weeks after completion of treatment, overall response rate (complete response (CR) + partial response (PR)) was 75%. Survival rate at 1, 2, and 3 years was 77.80%, 64.81%, and 64.81%, respectively. At a median follow-up of 15.17 months, median OS was not reached. All AEs were either Grade I (66.7%) or Grade II (33.3%). No Grade III or Grade IV AEs were observed. No added toxicity was observed due to nimotuzumab. Conclusions: In the first of its kind study, the addition of nimotuzumab to standard treatment showed promising response rate as well as survival outcomes in recurrent and/or metastatic SCCHN patients without producing additional toxicity.

Key words

Antibodies - carcinoma - head and neck neoplasms - inoperable - metastatic - monoclonal - nimotuzumab - overall survival - recurrent - squamous cell - therapy - tumor response

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Referenzen

References
1 Jemal A, Bray F, Center MM, Ferlay J, Ward E, Forman D, et al. Global cancer statistics. CA Cancer J Clin 2011;61:69-90.
2 Graham S, Dayal H, Rohrer T, Swanson M, Sultz H, Shedd D, et al. Dentition, diet, tobacco, and alcohol in the epidemiology of oral cancer. J Natl Cancer Inst 1977;59:1611-8.
3 Joshi P, Dutta S, Chaturvedi P, Nair S. Head and neck cancers in developing countries. Rambam Maimonides Med J 2014;5:e0009.
4 Parikh P, Patil V, Agarwal JP, Chaturvedi P, Vaidya A, Rathod S, et al. Guidelines for treatment of recurrent or metastatic head and neck cancer. Indian J Cancer 2014;51:89-94.
5 Dayal PK, Mani NJ, Bhargava K. Prevalence of oral cancer and precancerous lesions in 'pan'/'supari' chewers. Indian J Public Health 1978;22:234-45.
6 Jacob LA, Chaudhuri T, Lakshmaiah KC, Babu KG, Dasappa L, Babu M, et al. Current status of systemic therapy for recurrent and/or metastatic squamous cell carcinoma of the head and neck. Indian J Cancer 2016;53:471-7.
7 Tuljapurkar V, Dhar H, Mishra A, Chakraborti S, Chaturvedi P, Pai PS, et al. The Indian scenario of head and neck oncology – Challenging the dogmas. South Asian J Cancer 2016;5:105-10.
8 Marur S, Forastiere AA. Update on role of chemotherapy in head and neck squamous cell cancer. Indian J Surg Oncol 2010;1:85-95.
9 Molin Y, Fayette J. Current chemotherapies for recurrent/metastatic head and neck cancer. Anticancer Drugs 2011;22:621-5.
10 Vermorken JB, Specenier P. Optimal treatment for recurrent/metastatic head and neck cancer. Ann Oncol 2010;21 Suppl 7:vii252-61.
11 Agulnik M. New approaches to EGFR inhibition for locally advanced or metastatic squamous cell carcinoma of the head and neck (SCCHN). Med Oncol 2012;29:2481-91.
12 Vermorken JB, Trigo J, Hitt R, Koralewski P, Diaz-Rubio E, Rolland F, 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;25:2171-7.
13 Baselga J, Trigo JM, Bourhis J, Tortochaux J, Cortés-Funes H, Hitt R, et al. Phase II multicenter study of the antiepidermal growth factor receptor monoclonal antibody cetuximab in combination with platinum-based chemotherapy in patients with platinum-refractory metastatic and/or recurrent squamous cell carcinoma of the head and neck. J Clin Oncol 2005;23:5568-77.
14 Herbst RS, Arquette M, Shin DM, Dicke K, Vokes EE, Azarnia N, et al. Phase II multicenter study of the epidermal growth factor receptor antibody cetuximab and cisplatin for recurrent and refractory squamous cell carcinoma of the head and neck. J Clin Oncol 2005;23:5578-87.
15 Burtness B, Goldwasser MA, Flood W, Mattar B, Forastiere AA; Eastern Cooperative Oncology Group. et al. Phase III randomized trial of cisplatin plus placebo compared with cisplatin plus cetuximab in metastatic/recurrent head and neck cancer: An eastern cooperative oncology group study. J Clin Oncol 2005;23:8646-54.
16 Vermorken JB, Mesia R, Rivera F, Remenar E, Kawecki A, Rottey S, et al. Platinum-based chemotherapy plus cetuximab in head and neck cancer. N Engl J Med 2008;359:1116-27.
17 Rivera F, García-Castaño A, Vega N, Vega-Villegas ME, Gutiérrez-Sanz L. Cetuximab in metastatic or recurrent head and neck cancer: The EXTREME trial. Expert Rev Anticancer Ther 2009;9:1421-8.
18 Reddy BK, Lokesh V, Vidyasagar MS, Shenoy K, Babu KG, Shenoy A, et al. Nimotuzumab provides survival benefit to patients with inoperable advanced squamous cell carcinoma of the head and neck: A randomized, open-label, phase IIb, 5-year study in Indian patients. Oral Oncol 2014;50:498-505.
19 Babu KG, Viswanath L, Reddy BK, Shenoy K, Shenoy A, Naveen T. et al. An open-label, randomized, study of h-R3mAb (nimotuzumab) in patients with advanced (stage III or IVa) squamous cell carcinoma of head and neck (SCCHN): Four-year survival results from a phase IIb study. J Clin Oncol 2010;28 Suppl 15:428s.
20 Subramanium S, Balasundaram V, Nithya S, Kiran P. Nimotuzumab with induction chemotherapy and chemo-radiation in patients with advanced head and neck cancer. J Cancer Ther 2015;6:146-52.
21 Crombet T, Osorio M, Cruz T, Roca C, del Castillo R, Mon R, et al. Use of the humanized anti-epidermal growth factor receptor monoclonal antibody h-R3 in combination with radiotherapy in the treatment of locally advanced head and neck cancer patients. J Clin Oncol 2004;22:1646-54.
22 Rodríguez MO, Rivero TC, del Castillo Bahi R, Muchuli CR, Bilbao MA, Vinageras EN, et al. Nimotuzumab plus radiotherapy for unresectable squamous-cell carcinoma of the head and neck. Cancer Biol Ther 2010;9:343-9.
23 Guan M, Zhou YP, Sun JL, Chen SC. Adverse events of monoclonal antibodies used for cancer therapy. Biomed Res Int 2015;2015:428169.
24 Li X, Shan BE, Wang J, Xing LP, Guo XJ, Zhang YH, et al. Incidence and risk of treatment-related mortality with anti-epidermal growth factor receptor monoclonal antibody in cancer patients: A meta-analysis of 21 randomized controlled trials. PLoS One 2013;8:e81897.
25 Bhatnagar AR, Singh DP. A comparative study of a monoclonal antibody against EGFR (nimotuzumab) used in combination with chemoradiation versus chemoradiation alone in the treatment of locally advanced inoperable squamous cell carcinoma of the head and neck. J Clin Oncol 2012;30 Suppl 30:51.
26 Kumar A, Mishra KC. To assess the possibility of combining MAb (nimotuzumab) with concurrent chemoradiation in patients with locally advanced squamous cell carcinoma of head and neck. Scientific abstracts. Indian J Med Paediatr Oncol 2012;33:1.
27 Somani N. Nimotuzumab with concurrent chemo-radiotherapy in patients with locally advanced squamous cell carcinoma of head and neck. J Cancer Ther 2015;6:356-61.
28 Kondaveeti SS, Sundaram R. Therapeutic effect of concurrent radiation with single agent nimotuzumab in locally advanced and recurrent HNSCC: Retrospective analysis. Int J Radiat Oncol 2014;90:S561.
29 Talapatra K, Deshpande M, Goyle S, Majumder D, Badhwar S, Mistry R. Nimotuzumab and intensity modulated radiation therapy in the concurrent setting of locally advanced head and neck cancers: Early results of a prospective trial in India. Int J Radiat Oncol 2016;96:E359.
30 Wykosky J, Fenton T, Furnari F, Cavenee WK. Therapeutic targeting of epidermal growth factor receptor in human cancer: Successes and limitations. Chin J Cancer 2011;30:5-12.
31 Perez R, Moreno E, Garrido G, Crombet T. EGFR-targeting as a biological therapy: Understanding nimotuzumab's clinical effects. Cancers (Basel) 2011;3:2014-31.
32 Qu YY, Hu SL, Xu XY, Wang RZ, Yu HY, Xu JY, et al. Nimotuzumab enhances the radiosensitivity of cancer cells in vitro by inhibiting radiation-induced DNA damage repair. PLoS One 2013;8:e70727.
33 Garrido G, Tikhomirov IA, Rabasa A, Yang E, Gracia E, Iznaga N, et al. Bivalent binding by intermediate affinity of nimotuzumab: A contribution to explain antibody clinical profile. Cancer Biol Ther 2011;11:373-82.