Oncodigestive and Clinical Research Department, Sainte Catherine Institut du Cancer Avignon-Provence, 84918 Avignon, France.
Statistics Department, PRECIS, Nouvelles Technologies, Languedoc Mutualité, 34000 Montpellier, France.
Curr Oncol. 2023 Sep 18;30(9):8563-8574. doi: 10.3390/curroncol30090621.
Since EXTRA, a non-randomized phase II trial with 31 patients, explored the use of capecitabine, mitomycin and radiation therapy (RT) in the treatment of localized squamous cell carcinoma of the anal canal (SCCAC), this treatment has been considered as an acceptable alternative to infusional 5-FU. However, the differences in efficacy between capecitabine and 5-FU in chemoradiation therapy (CRT) with simultaneous integrated boost (SIB) radiation therapy (SIB-IMRT) for local SCCAC are not well documented. Patients included in this prospective monocentric cohort study were treated with SIB-RapidArc (a unique RT method treatment for all patients: identical technique, volume and constraints for at-risk organs), mitomycin C and 5-FU each day of RT for 7 weeks (group 1) or capecitabine each day of RT (group 2). Patients treated between July 2009 and August 2017 (group 1) and between November 2012 and April 2018 (group 2) for local SCCAC T2-4 classified as N, M0 or T, N1-3, M0 were included. Primary endpoints were progression-free survival (PFS) and acute toxicities. Results: One hundred forty-seven patients were included, 91 in group 1 and 56 in group 2. The two groups were statistically comparable in terms of sex, Eastern Cooperative Oncology Group Performance Status (ECOG PS) and TNM. With a median duration of follow-up of 53.5 months, the PFS rate at 3 years was 80% for group 1 and 75% for group 2 ( = 0.32). The 3-year colostomy-free survival rate was 92% for group 1 and 85% for group 2 ( = 0.11). The rate of patients with at least one grade 3 or higher acute toxicity was 35.5% in group 1 and 21.4% in group 2 ( = 0.10), with a trend of fewer acute toxicities with capecitabine. Conclusion: Capecitabine/mitomycin in combination with SIB RapidArc radiation therapy for anal cancer seems as effective as 5-FU-based chemotherapy and is well tolerated with minimal toxicity.
自 EXTRA 以来，一项非随机的 31 例患者的 II 期试验探索了卡培他滨、丝裂霉素和放射治疗 (RT) 在局部肛管鳞状细胞癌 (SCCAC) 治疗中的应用，这种治疗已被认为是输注 5-FU 的可接受替代方法。然而，卡培他滨和 5-FU 在局部 SCCAC 的同步整合boost（SIB）放射治疗（SIB-IMRT）中的化学放射治疗（CRT）中的疗效差异尚未得到很好的记录。这项前瞻性单中心队列研究纳入的患者接受 SIB-RapidArc（一种独特的 RT 治疗方法，适用于所有患者：相同的技术、风险器官的体积和限制）、丝裂霉素 C 和 5-FU 每天 RT 共 7 周（第 1 组）或卡培他滨每天 RT（第 2 组）。2009 年 7 月至 2017 年 8 月（第 1 组）和 2012 年 11 月至 2018 年 4 月（第 2 组）期间治疗的 T2-4 期局部 SCCAC 分类为 N、M0 或 T、N1-3、M0 的患者被纳入研究。主要终点是无进展生存期 (PFS) 和急性毒性。结果：共纳入 147 例患者，第 1 组 91 例，第 2 组 56 例。两组在性别、东部合作肿瘤学组表现状态（ECOG PS）和 TNM 方面具有统计学可比性。中位随访 53.5 个月后，第 1 组的 3 年 PFS 率为 80%，第 2 组为 75%（=0.32）。第 1 组的 3 年无造口术生存率为 92%，第 2 组为 85%（=0.11）。第 1 组至少有 1 例 3 级或更高急性毒性的患者比例为 35.5%，第 2 组为 21.4%（=0.10），卡培他滨组急性毒性较低。结论：卡培他滨/丝裂霉素联合 SIB RapidArc 放射治疗肛门癌与基于 5-FU 的化疗同样有效，且耐受性良好，毒性最小。
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