A Prospective Randomised Comparative Study Between Weekly Cisplatin Versus Three Weekly Cisplatin with Radiotherapy in Unresectable Locally Advanced Head and Neck Cancer.

Abstract

To compare the efficacy, compliance and the complications of weekly cisplatin 40mg/m2 against the three weekly cisplatin 100mg/m2 with EBRT(external beam radiotherapy) in unresectable locally advanced head and neck squamous cell carcinoma(LAHNSCC) Study design was Prospective randomized and comparative.85 Patients with histologically proven stage III-IVA LAHNSCC presenting from December 2017 to May 2019 were assigned to concurrent three weekly cisplatin 100mg/m2 (arm 1) and weekly cisplatin 40mg/m2 (arm 2) with EBRT. There were 41 patients were in arm 1 and 44 patients in arm 2. Statistical analysis was done using SPSS version 2.0. At 4week of completion of treatment, response was assessed using RECIST(1.1) criteria.In Arm 1,61% patients and in arm 2 55% patients achieved complete response but the difference was statistically non- significant (p = 0.756).Median follow up was 12months after which 49% patients in arm 1 and 38% in arm 2 had complete response whereas 12% patients in arm 1 and 15.5% patients in arm 2 had locoregional relapse. There was no statistically significant difference between the two arms in terms of mucositis, nausea,vomiting, dysphagia, acute skin reaction and ototoxicity. Leukopenia (p = 0.003),thrombocytopenia (p = 0.04) and acute renal toxicity (p = 0.004) was significantly more in three weekly arm. As compared to three weekly cisplatin, weekly cisplatin with radiotherapy is an acceptable approach in a limited resource setting due to good patient compliance where a large number of patients are treated on outpatient basis.