Toxicity Profile of Double‑agent Adjuvant Chemotherapy after Concurrent Chemoradiation and Brachytherapy in Locally Advanced Cervical Cancer: Comparison with Standard Chemoradiation Protocol.

Introduction: Carcinoma cervix is the most common gynecological malignancy in India and a major cause of cancer mortality and morbidity in the females despite Concurrent chemoradiotherapy (CCRT). Attempts are on to improved overall survival by addition of adjuvant chemotherapy (ACT) to CCRT. Aim: The aim of this study is to establish toxicity profile of double‑agent ACT after CCRT and ICRT in locally advanced cervical cancer (LACC) and to compare it with standard chemoradiation protocol. Materials and Methods: Patients were randomized into two arms: in conventional arm (Arm 1, n = 23), patients received a standard protocol of weekly injection cisplatin 40 mg/m2 concurrently with pelvic external beam radiotherapy (5040cGy/28 fractions) followed by ICRT (03 fractions of 7 Gy each). In interventional arm (Arm 2, n = 24), patients received CCRT/ICRT protocol; and were further offered ACT with three cycles of consolidation chemotherapy using injection paclitaxel and injection carboplatin every 3 weeks after CCRT and ICRT. Results: The incidence of anemia was 14/23 (50% Grade 1) in Arm 1 and 12/24 in Arm 2 (17% Grade 1, rest higher grade). In Arm 2, 37% of patients had ≥Grade 2 neuropathy and 16% of patients had Grade 1 alopecia, whereas nil incidence was reported in Arm 1 (P = 0.005 and 0.04, respectively). Grade 3 neutropenia was observed in 4/23 (17%) patients of Arm 1 and 8/24 patients (33%) of Arm 2. None of the patients in Arm 1 required indoor supportive care while 4/24 patients (17%) were managed as an indoor patient. Among late toxicities, in Arm 2, the incidence of Grade 2 and Grade 3 anemia was 42%, whereas in Arm 1, its incidence was 22%. In Arm 1, no patient exhibited features of neuropathy, whereas, in Arm 2, 12/24 (50%) of the patients had neuropathy (P value for these two late events was <0.05 statistically significant). No therapy‑induced mortality was noted. Conclusion: Exhibition of ACT with injection Paclitaxel and injection carboplatin in locally advanced carcinoma cervix is a technically viable option with manageable toxicity. [ABSTRACT FROM AUTHOR]