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. 2017 Apr-Jun;6(2):64-68.
doi: 10.4103/2278-330X.208840.

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

Lekha Madhavan Nair  1 , R Rejnish Kumar  1 , Kainickal Cessal Thomachan  1 , Malu Rafi  1 , Preethi Sara George  2 , K M Jagathnath Krishna  2 , Kunnambath Ramadas  1
Affiliations

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

Lekha Madhavan Nair et al. South Asian J Cancer. 2017 Apr-Jun.

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).

Keywords: Chemoradiation; cisplatin; head and neck cancer.

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Conflict of interest statement

There are no conflicts of interest.

Figures

Figure 1
Figure 1
The trial design
Figure 2
Figure 2
Kaplan–Meier estimate of disease-free survival according to two cisplatin schedules
Figure 3
Figure 3
Kaplan–Meier estimate of overall survival according to two cisplatin schedules
See this image and copyright information in PMC

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