Randomized phase III Study of Adding Paclitaxel to Chemoradiotherapy With Capecitabine and Mitomycin C in Squamous Cell Anal Carcinoma

IF 2.7 3区医学 Q2 ONCOLOGY

Clinical colorectal cancer Pub Date : 2026-06-01 Epub Date: 2026-01-15 DOI:10.1016/j.clcc.2026.01.002

Sergey S. Gordeyev , Marina V. Chernykh , Mikhail Yu. Fedyanin , Evgeny G. Rybakov , Nataliya S. Besova , Valerii A. Ivanov , Zaman Z. Mamedli

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引用次数: 0

Abstract

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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紫杉醇联合卡培他滨和丝裂霉素C化疗治疗鳞状细胞癌的随机III期研究。

目的：在我们的试点研究中，将紫杉醇加入卡培他滨和丝裂霉素C （MMC）的放化疗（CRT）显示出有希望的疗效，我们旨在确定它是否可以在随机临床试验环境中改善无进展生存期（PFS）。方法：我们在2个中心进行了一项随机III期试验。入组的I-IIIB期SCAC患者被随机（1:1）分配到卡培他滨和MMC （CRT- cm组）或卡培他滨、MMC和紫杉醇（CRT- cmp组）的CRT组。CRT-CMP方案包括52至58 Gy IMRT，紫杉醇45 mg/m2（第3、10、17、24、31天），卡培他滨625 mg/m2（第1天），丝裂霉素C 10 g/m2（第1天）。主要终点为PFS。次要终点是12周和26周时的毒性、总生存期（OS）、完全临床反应（cCR）。结果：在2016年1月至2020年2月期间，87例患者入组了CRT-CMP组，86例患者入组了CRT-CM组。由于该国不再提供MMC，该试验过早停止。中位随访时间为50.3个月。3年PFS在CRT-CMP组为84.8%，在CRM-CM组为66.9% （P = 0.009）。在CRT-CMP组中有45例（51.7%）患者观察到3级或更严重的不良事件，在CRT-CM组中有20例（23.3%）患者观察到3级或更严重的不良事件（P < 0.0001）。CRT-CMP组77例（89.5%）患者和CRM-CM组63例（75.9%）患者在26周时出现cCR （P = 0.024）。结论：紫杉醇加卡培他滨和MMC可提高SCAC的cCR率和长期预后，但毒性较高。

本文章由计算机程序翻译，如有差异，请以英文原文为准。

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来源期刊

Clinical colorectal cancer 医学-肿瘤学

CiteScore

5.50

自引率

2.90%

发文量

审稿时长

27 days

期刊介绍： Clinical Colorectal Cancer is a peer-reviewed, quarterly journal that publishes original articles describing various aspects of clinical and translational research of gastrointestinal cancers. Clinical Colorectal Cancer is devoted to articles on detection, diagnosis, prevention, and treatment of colorectal, pancreatic, liver, and other gastrointestinal cancers. The main emphasis is on recent scientific developments in all areas related to gastrointestinal cancers. Specific areas of interest include clinical research and mechanistic approaches; drug sensitivity and resistance; gene and antisense therapy; pathology, markers, and prognostic indicators; chemoprevention strategies; multimodality therapy; and integration of various approaches.