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CC BY-NC-ND 4.0 · South Asian J Cancer 2017; 06(02): 064-068
DOI: 10.4103/2278-330X.208840
ORIGINAL ARTICLE : Head and Neck Cancer

Phase IIb trial comparing two concurrent cisplatin schedules in locally advanced head and neck cancer

Lekha Madhavan Nair
Department of Radiation Oncology, Regional Cancer Centre, Trivandrum, Kerala
,
R. Rejnish Kumar
Department of Radiation Oncology, Regional Cancer Centre, Trivandrum, Kerala
,
Kainickal Cessal Thomachan
Department of Radiation Oncology, Regional Cancer Centre, Trivandrum, Kerala
,
Malu Rafi
Department of Radiation Oncology, Regional Cancer Centre, Trivandrum, Kerala
,
Preethi Sara George
Department of Cancer Epidemiology and Biostatistics, Regional Cancer Centre, Trivandrum, Kerala
,
K.M. Jagathnath Krishna
Department of Cancer Epidemiology and Biostatistics, Regional Cancer Centre, Trivandrum, Kerala
,
Kunnambath Ramadas
Department of Radiation Oncology, Regional Cancer Centre, Trivandrum, Kerala
› Author Affiliations Source of Support: Nill.
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Abstract

Background: Concurrent chemoradiation with 3 weekly cisplatin (100 mg/m2) is the standard of care for locally advanced head and neck cancer. However, this regimen has been shown to be associated with lesser compliance and higher toxicities. Hence, there is a need to explore alternative concurrent cisplatin regimens. Objectives: The objective of this study was to compare the efficacy and toxicities of 3 weekly cisplatin (100 mg/m2) with weekly cisplatin (40 mg/m2) concurrently with radiation in patients with locally advanced head and neck cancer. Patients and Methods: This phase IIb trial randomized 56 patients with Stage III and IV squamous cell carcinoma of oropharynx, hypopharynx, and larynx to Arm A or Arm B. Arm A received cisplatin 100 mg/m2 3 weekly and Arm B received cisplatin 40 mg/m2 weekly concurrently with radiation. The primary end point was disease-free survival (DFS) and secondary end points were overall survival (OS) and acute toxicity. DFS and OS were estimated using Kaplan–Meier method, and log-rank test was used to assess the difference in these distributions with respect to treatment. Results: The 2-year DFS in Arm A and Arm B was 64.5% and 52.8%, respectively (P = 0.67). The OS at 2 years was 71% and 61.1% in Arm A and Arm B, respectively (P = 0.61). There were no significant differences in acute hematological, renal, or mucosal toxicities between the two arms. Conclusion: This study showed a nonsignificant improvement in DFS and OS in the 3 weekly cisplatin arm over the weekly arm with comparable toxicities. The trial is registered with Clinical Trial Registry of India (CTRI registration number: CTRI/2013/05/003703, URL-http://ctri.nic.in).

Key words

Chemoradiation - cisplatin - head and neck cancer


Publication History

Article published online:
22 December 2020

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