A Prospective Randomised Comparative Study Between Weekly Cisplatin Versus Three Weekly Cisplatin with Radiotherapy...

To compare the efficacy, compliance and the complications of weekly cisplatin 40 mg/m2 against the three weekly cisplatin 100 mg/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 100 mg/m2 (arm 1) and weekly cisplatin 40 mg/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 4 week 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 12 months 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.