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Published on: April 12, 2024
Randomized phase III Study of Adding Paclitaxel to Chemoradiotherapy With Capecitabine and Mitomycin C in Squamous
Sergey S Gordeyev1, Marina V Chernykh2, Mikhail Yu Fedyanin3
1Department of Abdominal Oncology, No. 3 of N.N. Blokhin Russian Cancer Research Center, Moscow, Russia; Tyumen State Medical University, Moscow, Russia; Sechenov First Moscow State Medical University, Moscow, Russia.
Purpose:
In our pilot study adding paclitaxel to chemoradiotherapy (CRT) with capecitabine and mitomycin C (MMC) showed promising efficacy and we aimed to determine whether it could improve progression-free survival (PFS) in a randomized clinical trial setting.
Methods:
We performed a randomized phase III trial at 2 centers. Enrolled patients with stage I-IIIB SCAC were randomly (1:1) allocated to either CRT with capecitabine and MMC (CRT-CM arm) or CRT with capecitabine, MMC and paclitaxel (CRT-CMP arm). The CRT-CMP regimen comprised 52 to 58 Gy IMRT, paclitaxel 45 mg/m2 on days 3, 10, 17, 24, 31, capecitabine 625 mg/m2 bid on treatment days and mitomycin C 10 g/m2 on day 1. The primary endpoint was PFS. Secondary endpoints were toxicity, overall survival (OS), complete clinical response (cCR) at 12 and 26 weeks.
Results:
Between January 2016 and February 2020, 87 patients were enrolled in the CRT-CMP arm and 86 patients in the CRT-CM arm. The trial was stopped prematurely because MMC was no longer available in the country. Median follow-up was 50.3 months. Three-year PFS was 84.8% in the CRT-CMP arm and 66.9% in the CRM-CM arm (P = .009). Grade 3 or worse adverse events were observed in 45 (51.7%) patients in the CRT-CMP arm and in 20 (23.3%) patients in the CRT-CM arm (P < .0001). Seventy seven (89.5%) patients in the CRT-CMP arm and 63 (75.9%) patients in the CRM-CM arm had a cCR at 26 weeks (P = .024).
Conclusion:
Adding paclitaxel to CRT with capecitabine and MMC improves cCR rate and long-term outcomes in SCAC at the cost of higher toxicity.
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