Clinical Trials Unit, Istituto Nazionale per lo Studio e la Cura dei Tumori, IRCCS - Fondazione G.Pascale, Napoli.
Department of Protection of Women's Health, Rising Life, Child and Adolescent, Università Cattolica del Sacro Cuore, Roma.
Ann Oncol. 2018 May 1;29(5):1189-1194. doi: 10.1093/annonc/mdy062.
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.
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.
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.
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.
MITO-8 研究表明，通过引入非铂类化疗（NPBC）来延长无铂间隔期并不会改善部分铂类敏感复发性卵巢癌患者的预后。生活质量（QoL）是次要终点。
在先前铂类化疗（PBC）后 6-12 个月复发或进展的卵巢癌患者中，随机接受 PBC 或 NPBC 作为一线治疗。在基线、第 3 和第 6 个周期使用 EORTC C-30 和 OV-28 问卷评估 QoL。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，以便对数据进行适当解释。所有分析均基于意向治疗。
在 215 名患者中，151 名（70.2%）完成了基线问卷，两组之间平衡；此后，NPBC 组的失访率更高。在平均变化分析中，NPBC 组的 C30 评分普遍比 PBC 组差，在情绪功能、总体健康状况/生活质量、疲劳和呼吸困难方面具有统计学意义（效应大小范围为 0.30 至 0.51）。相反，对于 OV28 量表，在第 3 和第 6 个周期时，另一个化疗相关副作用项目在 PBC 时更差，具有更大的效应大小（分别为 0.70 和 0.54）。在最佳反应分析中，PBC 组情绪功能和疼痛的改善以及周围神经病变和其他化疗相关副作用的恶化更为频繁，且差异有统计学意义。PBC 组无进展生存期（中位数 9 个月与 5 个月，P=0.001）和客观缓解率（51.6%与 19.4%，P=0.0001）明显更好。过敏、血细胞计数减少、脱发、恶心、肌肉骨骼和神经毒性更频繁和严重，手足皮肤反应、皮疹/脱屑、黏膜炎和血管事件更频繁与 NPBC 相关。
MITO-8 的 QoL 分析表明，尽管毒性相关项目恶化，但 PBC 治疗后某些功能和症状量表的恶化程度较低，并且情绪功能和疼痛得到改善。
临床试验.gov：NCT00657878。
