Carboplatin Plus Paclitaxel Superior to Cisplatin Plus FU in Advanced Anal Cancer
Carboplatin plus paclitaxel should be considered as a new standard of care for advanced anal cancer due to reduced toxicity and a trend toward longer survival, results from an international phase 2 trial suggest (J Clin Oncol. 2020 Aug 1. Epub ahead of print).
The purpose of the study by Sheela Rao, MD, Royal Marsden Hospital, London, United Kingdom, and co-investigators was to compare the use of cisplatin plus fluorouracil (FU) with carboplatin plus paclitaxel in chemotherapy-naïve patients with advanced anal cancer, and to establish the optimal regimen.
Between December 2013 and November 2017, a total of 91 patients were randomly assigned in a 1:1 ratio to receive intravenous cisplatin 60 mg/m2 (day 1) plus FU 1,000 mg/m2 (days 1-4) every 21 days or carboplatin (day 1) plus paclitaxel 80 mg/m2 (days 1, 8, and 15) every 28 days for 24 weeks. Treatment continued until disease progression, intolerable toxicity, or withdrawal of consent occurred.
The primary end point was objective response rate (ORR), and the median follow-up period was 28.6 months.
The ORR was 57% in the cisplatin plus FU arm compared with 59% for the carboplatin plus paclitaxel arm.
The median progression-free survival was 5.7 months in the cisplatin plus FU arm versus 8.1 months in the carboplatin plus paclitaxel arm, and the median overall survival was 12.3 months versus 20 months, respectively.
Additionally, more serious adverse events occurred in the cisplatin plus FU arm (62%) versus the carboplatin plus paclitaxel arm (36%).
Dr Rao et al noted that they believe this is the first international, randomized trial conducted in chemotherapy-naïve patients with advanced anal cancer.
“Although there was no difference in ORR, the association with clinically relevant reduced toxicity and a trend toward longer survival suggest that carboplatin plus paclitaxel should be considered as a new standard of care,” they concluded.—Kaitlyn Manasterski