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