目的:评估I-III期肛门鳞状细胞癌(SCC)初始治疗策略的有效性和危害。
方法:我们搜索了Medline®,Embase®,和CENTRAL®,2000年1月1日至2024年3月之间,用于比较初始治疗策略的随机对照试验和干预措施的非随机研究。使用标准化方法评估了预先指定的结果列表的个体研究偏倚风险(RoB)和总体证据强度(SOE)。
结果:我们确定了33项符合条件的研究并提取了数据。六个被认为是低/中等的RoB。与单纯放疗(RT)相比,5-氟尿嘧啶(FU)和丝裂霉素C(MMC)的放化疗(CRT)可能在局部失败(LRF)中显示出益处,疾病特异性(DSS),和无结肠造口生存(CFS)(中度SOE),但可能导致更大的整体和急性血液学毒性,后期危害(低SOE)没有差异。具有5FU+MMC的CRT可能在LRF中显示出优势,DSS,和CFS利率与单独的5FU相比(低SOE)。CRT联合5FU+顺铂与5FU+MMC可能在若干疗效结局或总体急性或晚期损害方面无差异,并可能增加MMC(中度SOE)的血液学毒性。与使用卡培他滨+MMC的CRT相比,CRT联合卡培他滨+MMC+紫杉醇可改善OS,DSS,CFS,但造成更多的急性伤害(低SOE)。剩余的比较证据不足。
结论:CRT联合5FU+MMC或5FU+顺铂可能比单纯RT或单药CRT更有效,但产生更大的急性血液学毒性。在卡培他滨+MMC中加入紫杉醇可能会增加治疗效果和毒性。比较治疗后监测策略和患者报告结果的证据不足,突出研究机会。
OBJECTIVE: To assess the effectiveness and harms of initial treatment strategies for stages I-III anal squamous cell cancer (SCC).
METHODS: We searched Medline®, Embase®, and CENTRAL®, between January 1, 2000- March 2024, for randomized controlled trials and nonrandomized studies of interventions comparing initial treatment strategies. Individual study risk of bias (RoB) and overall strength of evidence (SOE) were evaluated for a prespecified outcome list using standardized methods.
RESULTS: We identified 33 eligible studies and extracted data. Six were deemed low/moderate RoB. Compared with radiotherapy (RT) alone, chemoradiotherapy (CRT) with 5-fluorouracil (FU) and mitomycin C (MMC) probably shows a benefit in locoregional failure (LRF), disease-specific (DSS), and colostomy-free survival (CFS) (moderate SOE) yet may result in greater overall and acute hematologic toxicity, with no difference in late harms (low SOE). CRT with 5FU+MMC may show a benefit in LRF, DSS, and CFS rates compared with 5FU alone (low SOE). CRT with 5FU+cisplatin vs 5FU+MMC probably results in no differences in several effectiveness outcomes or overall acute or late harms, and probably increases hematologic toxicity with MMC (moderate SOE). Compared with CRT using capecitabine+MMC, CRT with capecitabine+MMC+paclitaxel may improve OS, DSS, and CFS, yet cause more acute harms (low SOE). Evidence was insufficient for remaining comparisons.
CONCLUSIONS: CRT with 5FU+MMC or 5FU+cisplatin is likely more effective yet incurs greater acute hematologic toxicity than RT alone or single-agent CRT. Adding paclitaxel to capecitabine+MMC may increase treatment efficacy and toxicity. Evidence is insufficient comparing post-treatment surveillance strategies and patient-reported outcomes, highlighting research opportunities.