Dana-Farber Cancer Institute, Boston, MA, USA.
NRG Oncology, Clinical Trial Development Division, Biostatistics & Bioinformatics, Roswell Park Comprehensive Cancer Center, Buffalo, NY, USA.
Gynecol Oncol. 2022 Feb;164(2):428-436. doi: 10.1016/j.ygyno.2021.11.021. Epub 2021 Dec 11.
Chemotherapy plus radiation (Cis-RT + CP) did not demonstrate superiority in prolonging relapse-free survival compared to chemotherapy alone in patients with stage III or IVA endometrial carcinoma. The impact of treatment on quality of life (QOL), neurotoxicity (NTX) and psychometric properties of the gastrointestinal (GI) symptoms subscale during treatment and up to 1 year are described herein.
QOL assessments were scheduled at baseline, 6 weeks (post completion of RT (Cis-RT + CP) or prior to cycle 3 (CP)), then 18 weeks (end of treatment) and 70 weeks (1 year after the end of treatment) after starting treatment. QOL instruments included the FACT-En TOI, FACT/GOG-neurotoxicity (Ntx) subscale (short), and the gastrointestinal (GI) symptoms subscale.
At the end of treatment, patients receiving Cis-RT + CP reported a statistically significant decreased QOL when compared to CP. The decline in QOL was reflected in physical well-being, functional well-being, and endometrial cancer specific concerns, but the minimally important differences (MID) were not considered clinically meaningful. Patients in both groups reported increased chemotherapy-induced Ntx symptoms with the CP group having worse scores and reaching peak symptoms at the time of chemotherapy completion. Patients on Cis-RT + CP reported statistically significantly worse GI symptoms after radiation therapy compared to patients on CP, this occurred across assessment intervals, though the MID was not meaningful. Psychometric evaluations indicated that the GI symptom scale is reliable, valid, and responsive to change.
PROs indicate that the chemoradiotherapy group experienced worse HRQoL and GI toxicity compared to patients randomized to chemotherapy alone for locally advanced endometrial cancer though based on the MID, these were not clinically meaningful differences. The GI symptom subscale was a reliable and valid scale that has value for future trials.
NCT00942357.
在 III 期或 IVA 期子宫内膜癌患者中，与单纯化疗相比，化疗加放疗（顺铂-放疗[Cis-RT]+卡铂[CP]）并未显示出在延长无复发生存期方面的优势。本文描述了治疗对生活质量（QOL）、神经毒性（NTX）以及治疗期间和 1 年时胃肠道（GI）症状子量表的心理测量特性的影响。
在开始治疗时、治疗后 6 周（顺铂-放疗[Cis-RT+CP]完成后或 CP 第 3 周期前）、18 周（治疗结束）和 70 周（治疗结束后 1 年）安排 QOL 评估。QOL 量表包括 FACT-En TOI、FACT/GOG-NTX（短）量表和胃肠道（GI）症状子量表。
在治疗结束时，与 CP 相比，接受 Cis-RT+CP 治疗的患者报告 QOL 显著下降。生活质量下降反映在身体功能、功能状况和子宫内膜癌特有的问题上，但最小重要差异（MID）未被认为具有临床意义。两组患者均报告 CP 组化疗引起的 Ntx 症状增加，CP 组的评分更差，在化疗完成时达到症状高峰。与 CP 组相比，接受 Cis-RT+CP 治疗的患者在接受放疗后报告的 GI 症状明显更差，这种情况在所有评估间隔均存在，但 MID 无意义。心理测量评估表明，GI 症状量表是可靠、有效且对变化敏感的。
PROs 表明，与单独接受化疗的患者相比，接受放化疗的患者经历了更差的 HRQoL 和 GI 毒性，尽管基于 MID，这些差异无临床意义。GI 症状子量表是一种可靠有效的量表，对未来的试验具有价值。
NCT00942357。
