Background The phase II SNAP trial was designed to evaluate the efficacy of alternative chemotherapy schedules for prolonged administration in HER2-negative metastatic breast cancer (MBC), after a short induction at conventional doses. Patients and methods Between April 2013 and August 2015, 258 women untreated with chemotherapy for MBC were randomly assigned to receive three different maintenance chemotherapy schedules after three cycles of identical induction chemotherapy: arm A, nab-paclitaxel 150 mg/m2 days 1 and 15 Q28; arm B, nab-paclitaxel 100 mg/m2 days 1, 8 and 15 Q28; arm C, nab-paclitaxel 75 mg/m2 days 1, 8, 15 and 22 Q28. Induction was three cycles nab-paclitaxel 150/125 mg/m2, days 1, 8 and 15 Q28. The primary objective was to evaluate the efficacy of each maintenance schedule, in terms of progression-free survival (PFS), as compared with the historical reference of 7-month median PFS reported by previous studies with first-line docetaxel. One-sample, one-sided log-rank tests were utilized. Quality-of-life (QoL) evaluation was carried out, and the global indicator for physical well-being was defined as the primary QoL end point; completion rates of QoL forms were >90%. Results In total, 255 patients were assessable for the primary end point. After 18.2-month median follow-up, 182 PFS events were observed. Median PFS was 7.9 months [90% confidence interval CI 6.8-8.4] in arm A, 9.0 months (90% CI 8.1-10.9) in arm B and 8.5 months (90% CI 6.7-9.5) in arm C. PFS in arm B was significantly longer than the historical reference of first-line docetaxel (P = 0.03). Grade ≥2 sensory neuropathy was reported in 37.9%, 36.1% and 31.2% of the patients in arm A, B and C, respectively (Grade ≥3 in 9.1%, 5.6% and 6.6% of the patients, respectively). Noteworthy, the QoL scores for sensory neuropathy did not worsen with prolonged nab-paclitaxel administration in any of the maintenance arms. Conclusion The SNAP trial demonstrated that alternative nab-paclitaxel maintenance schedules with reduced dosages after a short induction at conventional doses are feasible and active in the first-line treatment of MBC. Registration: ClinicalTrials.gov NCT01746225.

中文翻译：

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一项随机II期研究，评估nab-紫杉醇在转移性乳腺癌一线治疗中的不同维持方案：IBCSG 42-12 / BIG 2-12 SNAP试验的最终结果。

背景SNAP II期临床试验旨在评估常规剂量的短暂诱导后，HER2阴性转移性乳腺癌（MBC）中长期给药的替代化疗方案的疗效。患者和方法2013年4月至2015年8月，将258名未经MBC化疗的妇女随机分配为接受三个相同诱导化疗周期的三种不同的维持化疗方案：A组，nab-紫杉醇150 mg / m2第1天和第15天Q28 ; B组，纳布-紫杉醇100 mg / m2，第1、8和15天Q28；C组，nab-紫杉醇75 mg / m2，第1、8、15和22天Q28。诱导是三个周期的纳布-紫杉醇150/125 mg / m2，第28、1、8和15天。主要目的是根据无进展生存期（PFS）评估每个维护计划的功效，与先前关于一线多西紫杉醇的研究报告的7个月中位PFS的历史参考值相比。使用了单样本，单侧对数秩检验。对生活质量（QoL）进行了评估，并将身体健康的全球指标定义为QoL的主要终点；QoL表格的完成率> 90％。结果总共评估了255名患者的主要终点。中位随访18.2个月后，观察到182例PFS事件。A组中位PFS为7.9个月[90％置信区间CI 6.8-8.4]，B组中位9.0个月（90％CI 8.1-10.9），C组中8.5个月（90％CI 6.7-9.5）。 B明显长于一线多西他赛的历史参考值（P = 0.03）。A，B和C组分别有37.9％，36.1％和31.2％的患者出现2级以上的感觉神经病，（分别在9.1％，5.6％和6.6％的患者中≥3级）。值得注意的是，在任何维持治疗组中，长期服用nab-paclitaxel都不会使感觉神经病的QoL评分恶化。结论SNAP试验表明，在常规剂量的短暂诱导后，降低剂量的替代性nab-紫杉醇维持方案是可行的，并且在MBC的一线治疗中有效。注册：ClinicalTrials.gov NCT01746225。结论SNAP试验表明，在常规剂量的短暂诱导后，降低剂量的替代性nab-紫杉醇维持方案是可行的，并且在MBC的一线治疗中有效。注册：ClinicalTrials.gov NCT01746225。结论SNAP试验表明，在常规剂量的短暂诱导后，降低剂量的替代性nab-紫杉醇维持方案是可行的，并且在MBC的一线治疗中有效。注册：ClinicalTrials.gov NCT01746225。