BACKGROUND The Stop&Go study randomized patients with advanced breast cancer to intermittent (two times four) or continuous (eight subsequent cycles) first- and second-line chemotherapy. METHODS QoL was measured with RAND-36 questionnaires every 12 weeks. The primary objective was to estimate differences in changes from baseline between intermittent and continuous treatment. An effect size of 0.5 SD (5 points) was considered clinically meaningful. RESULTS A total of 398 patients were included with a median follow-up of 11.4 months (IQR 5.6-22.2). Mean physical QoL baseline scores were 38.0 resp. 38.2, and mental scores 45.0 resp. 42.4 for intermittent and continuous treatment. Physical QoL declined linearly in the intermittent arm causing a clinically meaningful difference of 5.40 points at 24 months (p < 0.001), while scores in the continuous arm stabilized after a small decline of ± 3.4 points at 12 months. Conversely, mental QoL was fairly stable and even improved with 1.58 (p = 0.005) and 2.48 points (p < 0.001) at 12 months for intermittent and continuous treatment, respectively. When comparing arms for both components in changes from baseline, the maximum differences were 2.46 (p = 0.101) and 1.95 points (p = 0.182) for physical and mental scores, both measured at 30 months and in favor of continuous treatment. CONCLUSION Intermittent first- and second-line chemotherapy in patients with HER2-negative advanced breast cancer showed a trend for worse impact on QoL compared to continuous chemotherapy, with neither significant nor meaningful differences in course. We recommend prescribing chemotherapy continuously until progressive disease or unacceptable toxicity. Trial registration EudraCT 2010-021519-18; BOOG 2010-02.

中文翻译：

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HER2阴性晚期乳腺癌一线、二线化疗间歇安排对生活质量的影响


背景 Stop&Go 研究将晚期乳腺癌患者随机分配到间歇性（两次四次）或连续（后续八个周期）一线和二线化疗。方法 每 12 周使用 RAND-36 问卷测量一次生活质量。主要目标是估计间歇性治疗和连续治疗之间相对于基线的变化差异。 0.5 SD（5 分）的效应量被认为具有临床意义。结果共纳入 398 名患者，中位随访时间为 11.4 个月（IQR 5.6-22.2）。平均身体 QoL 基线得分分别为 38.0 和 38.0。 38.2，心理分数分别为 45.0。 42.4 用于间歇和连续治疗。间歇组的身体生活质量呈线性下降，导致 24 个月时具有临床意义的差异为 5.40 分 (p < 0.001)，而连续组的分数在 12 个月时小幅下降 ± 3.4 分后趋于稳定。相反，间歇性治疗和连续治疗的 12 个月时，心理 QoL 相当稳定，甚至有所改善，分别为 1.58 (p = 0.005) 和 2.48 分 (p < 0.001)。当比较各组相对于基线的变化时，身体和心理评分的最大差异分别为 2.46 (p = 0.101) 和 1.95 分 (p = 0.182)，均在 30 个月时测量，支持持续治疗。结论 与连续化疗相比，HER2 阴性晚期乳腺癌患者的间歇性一线和二线化疗对生活质量的影响有更差的趋势，但在疗程上没有显着或有意义的差异。我们建议持续进行化疗，直至疾病进展或出现不可接受的毒性。试用注册EudraCT 2010-021519-18；博格 2010-02。