Final survival analysis of topotecan and paclitaxel for first-line treatment of advanced cervical cancer: An NRG oncology randomised study

Title	Final survival analysis of topotecan and paclitaxel for first-line treatment of advanced cervical cancer: An NRG oncology randomised study
Authors	Krishnansu S. Tewari, Michael W. Sill, Michael J. Birrer, Richard T. Penson, Helen Huang, David H. Moore, Lois M. Ramondetta, Lisa M. Landrum, Ana Oaknin, Thomas J. Reid, Mario M. Leitao, Helen E. Michael, Bradley J. Monk
Magazine	Gynecologic oncology
Date	03/08/2023
DOI	10.1016/j.ygyno.2023.01.010
Introduction	The study aimed to assess whether a non-platinum chemotherapy combination improves overall survival (OS) in patients with recurrent/metastatic cervical carcinoma. The Gynecologic Oncology Group protocol 240 was a phase 3, randomised, open-label clinical trial evaluating paclitaxel 175 mg/m² plus topotecan 0.75 mg/m² (n=223) against cisplatin 50 mg/m² plus paclitaxel 135 or 175 mg/m² (n=229) in 452 patients. Both combinations were tested with and without bevacizumab (15 mg/kg). Treatment cycles were repeated every 21 days until disease progression, unacceptable toxicity, or complete response. The primary goals were OS and the incidence and severity of adverse effects. This final analysis presents the OS results. Median OS at the final analysis was 16.3 months for the cisplatin-paclitaxel group and 13.8 months for the topotecan-paclitaxel group (HR 1.12; 95% CI, 0.91–1.38; p=0.28). Median OS for the cisplatin-paclitaxel and topotecan-paclitaxel groups was 15 vs 12 months (HR 1.10; 95% CI, 0.82–1.48; p=0.52), and for cisplatin-paclitaxel-bevacizumab vs topotecan-paclitaxel-bevacizumab was 17.5 vs 16.2 months (HR 1.16; 95% CI, 0.86–1.56; p=0.34). Among patients previously exposed to platinum, median OS was 14.6 vs 12.9 months (HR 1.09; 95% CI, 0.86–1.38; p=0.48). Post-progression survival was 7.9 vs 8.1 months (HR 0.95; 95% CI, 0.75–1.19). Grade 4 hematologic toxicity was similar between groups. The study concludes that the topotecan-paclitaxel combination does not offer a survival benefit for women with recurrent/metastatic cervical cancer, including those previously treated with platinum. Consequently, its routine use in this population is not advised.
Quote	Krishnansu S Tewari, Michael W Sill and Michael J. Birrer et al. Final survival analysis of topotecan and paclitaxel for first-line treatment of advanced cervical cancer: An NRG oncology randomised study. Gynecol. Oncol. 2023. DOI: 10.1016/j.ygyno.2023.01.010
Element	Platinum (Pt)
Industry	Pharmaceutical Industry