A PROSPECTIVE STUDY COMPARING CONCURRENT CHEMORADIATION WITH OR WITHOUT GEFITINIB IN TREATMENT OF LOCALLY ADVANCED HEAD AND NECK CARCINOMA

BISWARUP BANERJEE; SUMITAVA DE; LINKON BISWAS; SRIKRISHNA MANDAL

doi:10.22159/ajpcr.2022.v15i4.44177

Authors

BISWARUP BANERJEE Department of Radiotherapy, Nil Ratan Sircar Medical College and Hospital, Kolkata, West Bengal, India.
SUMITAVA DE Department of Radiotherapy, Nil Ratan Sircar Medical College and Hospital, Kolkata, West Bengal, India.
LINKON BISWAS Department of Radiotherapy, Nil Ratan Sircar Medical College and Hospital, Kolkata, West Bengal, India. https://orcid.org/0000-0003-0589-769X
SRIKRISHNA MANDAL Department of Radiotherapy, Nil Ratan Sircar Medical College and Hospital, Kolkata, West Bengal, India.

DOI:

https://doi.org/10.22159/ajpcr.2022.v15i4.44177

Keywords:

Concurrent chemoradiation, Gefitinib, Head and Neck Carcinoma

Abstract

ABSTRACT

BACKGROUND-Concurrent chemoradiotherapy (CTRT) is now an acceptable definitive therapy for locally advanced head and neck carcinomas. But, multiple studies revealed that addition of anti-EGFR agent with CTRT improves the loco-regional response at a cost of higher but acceptable toxicity. Our study aimed at assessing CTRT with or without Gefitinib in terms of treatment response and acute toxicity profile.

MATERIALS AND METHODS- Patients with Locally advanced, non-metastatic, squamous cell carcinoma of Head-neck were randomised in two groups-the control group received external beam radiotherapy 66Gy/33 fractions/6.5 weeks along with concurrent injection Cisplatin at the dose of 100mg/m2 on day 1, 22, and 43 during radiation and the study group received concurrent chemoradiotherapy along with Tab Gefitinib-250 mg during the duration of radiotherapy. Response assessment was done after completion of treatment and all patients were followed up for treatment related acute toxicity during the course of treatment and then at every month for at least 6 months.

RESULTS- 46.66% of study arm (CTRT+Gefitinib) patients showed complete response and Overall response was 79%. In control arm (CTRT alone), there was 51.6% complete response and Overall response was 77%, though difference was statistically not significant (p value 0.84). Although statistically not significant, Gefitinib containing arm had numerically higher hematological, gastro-intestinal toxicity and weight loss.

CONCLUSION- Gefitinib along with chemoradiation showed numerically higher overall response (complete response + partial response) and comparable acute toxicity profile in comparison to chemoradiation alone.

Downloads

Download data is not yet available.

References

Sung H, Ferlay J, Siegel RL, Laversanne M, Soerjomataram I, Jemal A, et al. Global cancer statistics 2020: GLOBOCAN estimates of incidence and mortality worldwide for 36 cancers in 185 countries. CA Cancer J Clin 2021;71:209-49. doi: 10.3322/caac.21660, PMID 33538338

Fu KK. Combined-modality therapy for head and neck cancer. Oncology (Williston Park) 1997;11:1781-90. PMID 9436185

Pignon JP, le Maître A, Maillard E, Bourhis J, MACH-NC Collaborative Group. Meta-analysis of chemotherapy in head and neck cancer (MACH-NC): An update on 93 randomised trials and 17,346 patients. Radiother Oncol 2009;92:4-14. doi: 10.1016/j.radonc.2009.04.014, PMID 19446902

Perisanidis C. Prevalence of EGFR tyrosine kinase domain mutations in head and neck squamous cell carcinoma: Cohort study and systematic review. In Vivo 2017;31:23-34. doi: 10.21873/invivo.11020, PMID 28064216

Smilek P, Neuwirthova J, Jarkovsky J, Dusek L, Rottenberg J, Kostrica R, et al. Epidermal growth factor receptor (EGFR) expression and mutations in the EGFR signaling pathway in correlation with anti- EGFR therapy in head and neck squamous cell carcinomas. Neoplasma 2012;59:508-15. doi: 10.4149/neo_2012_065, PMID 22668015

Bonner JA, Harari PM, Giralt J, Azarnia N, Shin DM, Cohen RB, et al. Radiotherapy plus cetuximab for squamous-cell carcinoma of the head and neck. N Engl J Med 2006;354:567-78. doi: 10.4149/neo_2012_065, PMID 22668015

Lawrence TS, Blackstock AW, McGinn C. The mechanism of action of radiosensitization of conventional chemotherapeutic agents. Semin Radiat Oncol 2003;13:13-21. doi: 10.1053/srao.2003.50002, PMID 12520460

Siddiqui MS, Chandra R, Aziz A. Suman SEpidemiology and histopathological spectrum of head and neck cancers in Bihar, a state of Eastern India. Asian Pac J Cancer Prev 2012;13:3949-53. doi: 10.7314/apjcp.2012.13.8.3949, PMID 2309849

Shintani S, Li C, Mihara M, Terakado N, Yano J, Nakashiro K, et al. Enhancement of tumourradioresponse by combined treatment with gefitinib (Iressa, ZD 1839) an epidermal growth factor receptor tyrosine kinase inhibitor,is accompanied by inhibition of DNA damage repair and cell growth in oral cancer. Int J Cancer 2003;107:1030-7. doi: 10.7314/apjcp.2012.13.8.3949, PMID 2309849

Saini SK, Srivastava S, Dixit AK. Gefitinib with concurrent chemoradiation in locally advanced head neck cancer. Gac Mex Oncol 2016;15:138-44. doi: 10.1016/j.gamo.2016.04.002

Bhattacharya B, Adhikary S, Basu J, Pal S, Chattopadhyay B, Ghosh T. A prospective randomised controlled trial of concurrent chemoradiation versus concurrent chemoradiation along with gefitinib in locally advanced squamous cell carcinoma of head and neck. Clin Cancer Investig J 2014;3:146-52. doi: 10.4103/2278-0513.130160

Chen C, Kane M, Song J, Campana J, Raben A, Hu K, et al. Phase I trial of gefitinib in combination with radiation or chemoradiation for patients with locally advanced squamous cell head and neck cancer. J Clin Oncol 2007;25:4880-6.