|
|
|
|
Context: Concomitant chemo-radiation (CRT) with weekly cisplatin is the “standard of care” for treatment of advanced cases of carcinoma cervix. Although this standard of care reduces the risk of disease recurrence by as much as 50%, efforts are on for further improvement in response rate and local control. Aims: The present trial was planned to compare the response and toxicity of CRT with weekly paclitaxel versus weekly cisplatin in locally advanced carcinoma cervix. Subjects and Methods: Biopsy proven cases of squamous cell carcinoma, stage IIB–IIIB were randomized into two Arms. In Arm A, patients received external beam radiotherapy (EBRT) dose of 50 Gy in 25 fractions over 5 weeks with weekly Cis-platinum 40 mg/m2, whereas in Arm B patients received same EBRT with weekly paclitaxel 35 mg/m2 for 5 weeks, followed by intracavitary brachytherapy of 7 Gy x3# in both the arms. The primary endpoint was response at 3 months of completion of treatment, and secondary endpoints were to compare toxicity and compliance. Results: Thirty-two patients of carcinoma cervix were randomized to concurrent ciplatin arm (Arm A) and thirty patients to the concurrent paclitaxel Arm (Arm B). Most of the patients in both Arms had stage III B disease. Five cycles of weekly concomitant chemotherapy were received by 83.3% in Arm A and 60% in Arm B. 56.25% of patients in Arm A and 46.7% of patients in Arm B completed treatment within 8 weeks. There were statistically significant more Grade 2 and 3 diarrhea Arm B as compared to Arm A (P = 0.003). There were no Grade 4 adverse events or deaths. Response assessed at 3 month follow up and showed complete response of 83.33% in Arm A and 73.33% in Arm B (P = 0.521). The 18 months progression free survival was 86.6% in the cisplatin Arm as compared to 78.3% in the paclitaxel arm (P = 0.13). Conclusion: Concurrent paclitaxel with external beam radiation in locally advanced carcinoma cervix produces response comparable to concurrent cisplatin.
|
||||||||
