Impact of FOLFIRINOX Compared With Gemcitabine on Quality of Life in Patients With Metastatic Pancreatic Cancer: Results From the PRODIGE 4/ACCORD 11 Randomized Trial
Impact of FOLFIRINOX Compared With Gemcitabine on Quality of Life in Patients With Metastatic Pancreatic Cancer: Results From the PRODIGE 4/ACCORD 11 Randomized Trial
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DOI：
10.1200/jco.2012.44.4869
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发表时间：
2013-01-01
影响因子：
45.3
通讯作者：
Conroy, Thierry
中科院分区：
文献类型：
--
作者：
Gourgou-Bourgade, Sophie;Bascoul-Mollevi, Caroline;Conroy, Thierry
目的比较接受奥沙利铂、伊立替康、氟尿嘧啶和亚叶酸钙(FOLFIRINOX)或吉西他滨作为一线化疗方案的胰腺癌患者的生活质量(QOL)，并评估治疗前QOL是否预测转移性胰腺癌患者的生存。氟尿嘧啶400 mg/m(2)静脉滴注后2400 mg/m(2)或吉西他滨1000 mg/m(2)每周持续滴注46小时，每周7次，共8周，然后每周3次，共4周。使用欧洲癌症研究和治疗组织生活质量问卷C30每两周评估一次生活质量。结果FOLFIRINOX组的全球健康状况(GHS；P<；.001)有改善，两组的情绪功能(P<；.001)有改善，两组的疼痛、失眠、厌食和便秘都有所减少。在化疗的头两个月中，FOLFIRINOX组的腹泻显著增加。与吉西他滨相比，FOLFIRINOX在GHS、身体、角色、认知和社会功能以及六个症状领域(疲劳、恶心/呕吐、疼痛、呼吸困难、厌食和便秘)直到最终恶化的时间显著长于吉西他滨。躯体功能、便秘和呼吸困难是影响接受治疗的患者生存的独立显著预后因素。结论与吉西他滨相比，FOLFIRINOX显著降低了转移性胰腺癌患者的生存质量。此外，基线QOL评分在加入基线临床和人口学变量后，改善了对生存概率的估计。《旧约》31：23-29。(C)2012年美国临床肿瘤学会
PurposeTo compare the quality of life (QoL) of patients receiving oxaliplatin, irinotecan, fluorouracil, and leucovorin (FOLFIRINOX) or gemcitabine as first-line chemotherapy and to assess whether pretreatment QoL predicts survival in patients with metastatic pancreatic cancer.Patients and MethodsThree hundred forty-two patients with performance status 0 or 1 were randomly assigned to receive FOLFIRINOX (oxaliplatin, 85 mg/m(2); irinotecan, 180 mg/m(2); leucovorin, 400 mg/m(2); and fluorouracil, 400 mg/m(2) bolus followed by 2,400 mg/m(2) 46-hour continuous infusion, once every 2 weeks) or gemcitabine 1,000 mg/m(2) weekly for 7 of 8 weeks and then weekly for 3 of 4 weeks. QoL was assessed using European Organisation for the Research and Treatment of Cancer Quality of Life Questionnaire C30 every 2 weeks.ResultsImprovement in global health status (GHS; P < .001) was observed in the FOLFIRINOX arm and improvement in emotional functioning (P < .001) was observed in both arms, along with a decrease in pain, insomnia, anorexia, and constipation in both arms. A significant increase in diarrhea was observed in the FOLFIRINOX arm during the first 2 months of chemotherapy. Time until definitive deterioration >= 20 points was significantly longer for FOLFIRINOX compared with gemcitabine for GHS, physical, role, cognitive, and social functioning, and six symptom domains (fatigue, nausea/vomiting, pain, dyspnea, anorexia, and constipation). Physical functioning, constipation, and dyspnea were independent significant prognostic factors for survival with treatment arm, age older than 65 years, and low serum albumin.ConclusionFOLFIRINOX significantly reduces QoL impairment compared with gemcitabine in patients with metastatic pancreatic cancer. Furthermore, baseline QoL scores improved estimation of survival probability when added to baseline clinical and demographic variables. J Clin Oncol 31:23-29. (c) 2012 by American Society of Clinical Oncology