Background MITO-8 showed that prolonging platinum-free interval by introducing non-platinum-based chemotherapy (NPBC) does not improve prognosis of patients with partially platinum-sensitive recurrent ovarian cancer. Quality of life (QoL) was a secondary outcome. Patients and methods Ovarian cancer patients recurring or progressing 6-12 months after previous platinum-based chemotherapy (PBC) were randomized to receive PBC or NPBC as first treatment. QoL was assessed at baseline, third and sixth cycles, with the EORTC C-30 and OV-28 questionnaires. Mean changes and best response were analysed. Progression-free survival, response rate, and toxicity are also reported for proper interpretation of data. All analyses were based on intention-to-treat. Results Out of the 215 patients, 151 (70.2%) completed baseline questionnaire, balanced between the arms; thereafter, missing rate was higher in the NPBC arm. At mean change analysis, C30 scores were prevalently worse in the NPBC than PBC arm, statistical significance being attained for emotional functioning, global health status/QoL, fatigue, and dyspnoea (effect sizes ranging from 0.30 to 0.51). Conversely, as for OV28 scale, the other chemotherapy side-effects item was significantly worse with PBC at three and six cycles, with a larger effect size (0.70 and 0.54, respectively). At best response analysis, improvement of emotional functioning and pain and worsening of peripheral neuropathy and other chemotherapy side-effects were significantly more frequent in the PBC arm. Progression-free survival (median 9 versus 5 months, P = 0.001) and objective response rate (51.6% versus 19.4%, P = 0.0001) were significantly better with PBC. Allergy, blood cell count, alopecia, nausea, musculoskeletal, and neurological side-effects were more frequent and severe with PBC; hand-foot skin reaction, rash/desquamation, mucositis, and vascular events were more frequent with NPBC. Conclusion MITO-8 QoL analysis shows that deterioration of some functioning and symptom scales is lower with PBC, with improvement of emotional functioning and pain, despite worsening of toxicity-related items. ClinicalTrials.gov NCT00657878.

中文翻译：

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MITO-8，MaNGO，BGOG-Ov1，AGO-Ovar2.16，ENGOT-Ov1，GCIG的生活质量分析比较部分铂敏感的复发性卵巢癌患者的铂类和非铂类化疗癌症。

背景MITO-8显示，通过引入非铂类化学疗法（NPBC）延长无铂间隔不会改善部分铂敏感的复发性卵巢癌患者的预后。生活质量（QoL）是次要结果。患者和方法在先前的铂类化学疗法（PBC）之后复发或进展6-12个月的卵巢癌患者被随机分配接受PBC或NPBC作为第一治疗。使用EORTC C-30和OV-28问卷在基线，第三和第六个周期对QoL进行评估。分析平均变化和最佳反应。还报告了无进展生存期，缓解率和毒性，以正确解释数据。所有分析均基于意向性治疗。结果在215位患者中，有151位（占70.2％）完成了基线调查问卷，手臂之间保持平衡；此后，NPBC组的失效率更高。在平均变化分析中，NPBC中的C30得分普遍比PBC组差，在情绪功能，整体健康状况/生活质量，疲劳和呼吸困难（影响范围从0.30到0.51）方面达到统计学显着性。相反，就OV28量表而言，PBC在3个周期和6个周期时，其他化学疗法的副作用明显较差，且效果较大（分​​别为0.70和0.54）。在最好的反应分析中，PBC组中情绪功能和疼痛的改善以及周围神经病变的恶化和其他化学疗法的副作用要明显得多。无进展生存期（中位9个月对5个月，P = 0.001）和客观缓解率（51.6％对19.4％，P = 0）。0001）明显优于PBC。PBC对过敏，血细胞计数，脱发，恶心，肌肉骨骼和神经系统的副作用更为常见和严重。NPBC可使手足皮肤反应，皮疹/脱屑，粘膜炎和血管事件更为频繁。结论MITO-8 QoL分析显示，尽管毒性相关项目恶化，但PBC的某些功能和症状量表的恶化程度较低，情绪功能和疼痛得到改善。ClinicalTrials.gov NCT00657878。结论MITO-8 QoL分析显示，尽管毒性相关项目恶化，但PBC的某些功能和症状量表的恶化程度较低，情绪功能和疼痛得到改善。ClinicalTrials.gov NCT00657878。结论MITO-8 QoL分析显示，尽管毒性相关项目恶化，但PBC的某些功能和症状量表的恶化程度较低，情绪功能和疼痛得到改善。ClinicalTrials.gov NCT00657878。