同步放化疗是肛门鳞状细胞癌患者的标准治疗方法。化疗依从性差,放射治疗中断和计划外中断可能对长期结局产生不利影响.
ACTII试验招募了940名肛门局部鳞状细胞癌患者，并将患者分配给丝裂霉素（第1周）或顺铂（第1周和第5周），与氟尿嘧啶（第1周和第5周）和放疗（50.4Gy在28分38天）。这项事后分析检查了基线因素(年龄，性别,site,T级和N级)，和治疗依从性（放疗和化疗），以及它们对局部无故障生存的影响，无进展生存期（PFS）和总生存期（OS）。合规被分成几组。放疗：按总剂量和总治疗时间（OTT）分为6组。化疗:三组(A=按照方案;B=剂量减少或延迟;C=省略)。
共有931/940例患者可评估放疗和936例化疗依从性。基线肾小球滤过率<60ml/min和顺铂与第5周化疗依从性差显著相关(P分别为0.003和0.02)。第5周化疗的省略与局部无失败生存显著恶化相关[风险比(HR)2.53(1.33-4.82)P=0.005]。剂量减少/延迟或省略第5周化疗与PFS显著恶化相关{HR:1.56[95%置信区间(CI):1.18-2.06]，P=0.002，HR：2.39（95%CI：1.44-3.98），P=0.001，分别}和OS[HR：1.92（95%CI：1.41-2.63），P<0.001和HR：2.88（95％CI：1.63-5.08），分别P<0.001]。>42天接受目标放疗剂量与较差的PFS和OS相关[HR:1.72(95%CI:1.17-2.54),P=0.006]。
化疗和放疗依从性差与局部无失败生存率较差相关，PFS和OS。应尽量减少治疗中断，和OTT和总剂量维持。
ISRCTN26715889。
Concurrent chemoradiation is standard-of-care for patients with squamous cell carcinoma of the anus. Poor compliance to chemotherapy, radiotherapy treatment interruptions and unplanned breaks may impact adversely on long-term outcomes.
The ACT II
trial recruited 940 patients with localised squamous cell carcinoma of the anus, and assigned patients to mitomycin (week 1) or cisplatin (weeks 1 and 5), with fluorouracil (weeks 1 and 5) and radiotherapy (50.4 Gy in 28 fractions over 38 days). This post hoc analysis examined the association between baseline factors (age, gender, site, T stage and N stage), and compliance to treatment (radiotherapy and chemotherapy), and their effects on locoregional failure-free survival, progression-free survival (PFS) and overall survival (OS). Compliance was categorised into groups. Radiotherapy: six groups according to total dose and overall treatment time (OTT). Chemotherapy: three groups (A = per-protocol; B = dose reduction or delay; C = omitted).
A total of 931/940 patients were assessable for radiotherapy and 936 for chemotherapy compliance. Baseline glomerular filtration rate <60 ml/min and cisplatin were significantly associated with poor week 5 compliance to chemotherapy (P = 0.003 and 0.02, respectively). Omission of week 5 chemotherapy was associated with significantly worse locoregional failure-free survival [hazard ratio (HR) 2.53 (1.33-4.82) P = 0.005]. Dose reductions/delays or omission of week 5 chemotherapy were associated with significantly worse PFS {HR: 1.56 [95% confidence interval (CI): 1.18-2.06], P = 0.002 and HR: 2.39 (95% CI: 1.44-3.98), P = 0.001, respectively} and OS [HR: 1.92 (95% CI: 1.41-2.63), P < 0.001 and HR: 2.88 (95% CI: 1.63-5.08), P < 0.001, respectively]. Receiving the target radiotherapy dose in >42 days is associated with worse PFS and OS [HR: 1.72 (95% CI: 1.17-2.54), P =0.006].
Poor compliance to chemotherapy and radiotherapy were associated with worse locoregional failure-free survival, PFS and OS. Treatment interruptions should be minimised, and OTT and total dose maintained.
ISRCTN 26715889.
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