Concomitant administration of weekly oxaliplatin, fluorouracil continuous infusion, and radiotherapy after 2 months of gemcitabine and oxaliplatin induction in patients with locally advanced pancreatic cancer: A groupe coordinateur multidisciplinaire en oncologie phase II study
Concomitant administration of weekly oxaliplatin, fluorouracil continuous infusion, and radiotherapy after 2 months of gemcitabine and oxaliplatin induction in patients with locally advanced pancreatic cancer: A groupe coordinateur multidisciplinaire en oncologie phase II study
复制标题
DOI：
10.1200/jco.2007.12.8223
复制
发表时间：
2008-03-01
影响因子：
45.3
通讯作者：
Louvet, Christophe
中科院分区：
文献类型：
--
作者：
Moureau-Zabotto, Laurence;Phelip, Jean-Marc;Louvet, Christophe
背景根据先前报道的局部晚期胰腺癌（LAPC）多学科肿瘤协调小组（GERCOR）研究，对于全身诱导化疗（CT）后未发生疾病进展的患者，可推荐同步放化疗（CCRT）。为了进一步改善经典氟尿嘧啶（FU）为基础的CCRT的患者结局，本研究旨在前瞻性研究在吉西他滨和奥沙利铂（GEMOX）诱导化疗2个月后，采用FU输注和每周奥沙利铂的CCRT。患者和方法WHO体能状态（PS）为0至2的LAPC患者接受4个GEMOX诱导周期（吉西他滨1 g/m2，第1天;奥沙利铂100 mg/m2，第2天; 15天周期的第1天）。第4周期后1个月，未发生PS 0 - 2疾病进展的患者接受45戈伊治疗5周+ 10戈伊（作为最后2周的伴随加强）放疗（RT），每日250 mg/m2 FU作为连续输注，每周60 mg/m2奥沙利铂。84.7%的患者接受了CCRT，而9例患者由于疾病进展（7例患者）、CT毒性（1例患者）或个人决定（1例患者）而未接受CCRT。44例患者（74.5%）完成了完全计划的CCRT。整个人群的中位无进展生存期和总生存期分别为7.6和12.2个月，完成CCRT的患者中位无进展生存期和总生存期分别为9.4和12.6个月。CCRT 3级至4级毒性（国家癌症研究所常见毒性标准）是中性粒细胞减少症（10.4%），血小板减少症（8.4%），恶心和呕吐（16.7%），腹泻（12.5%）。尽管患者选择非最佳（由于诱导时间短），但观察到的令人鼓舞的结果表明，值得进一步随机评价，以更好地确定奥沙利铂在CCRT中的具体作用。
BackgroundAccording to previously reported Groupe Coordinateur Multidisciplinaire en Oncologie (GERCOR) studies in locally advanced pancreatic cancer (LAPC), concomitant chemoradiotherapy (CCRT) may be recommended for patients who do not experience disease progression after systemic induction chemotherapy (CT). To further improve patient outcome with classical fluorouracil (FU)-based CCRT, this study was designed to prospectively investigate a CCRT with FU infusion and weekly oxaliplatin after 2 months of gemcitabine and oxaliplatin (GEMOX) induction chemotherapy.Patients and MethodsNonpretreated patients with LAPC having WHO performance status (PS) of 0 to 2 received four induction cycles of GEMOX (gemcitabine 1 g/m(2) on day 1 and oxaliplatin 100 mg/m(2) on day 2; day 1 of a 15-day cycle). One month after cycle 4, patients who did not experience disease progression with PS 0 to 2 received 45 Gy over 5 weeks + 10 Gy (as a concomitant boost during the last 2 weeks) of radiotherapy (RT), with daily 250 mg/m(2) FU as a continuous infusion and 60 mg/m(2) of oxaliplatin weekly.ResultsOf 59 patients, 50 patients (84.7%) received CCRT, whereas nine patients did not because of disease progression (seven patients), CT toxicity (one patient), or personal decision (one patient). Forty-four patients (74.5%) completed the fully planned CCRT. Median progression-free survival and overall survival durations were 7.6 and 12.2 months, respectively, for the whole population and 9.4 and 12.6 months, respectively, for patients who completed CCRT. CCRT grade 3 to 4 toxicities (National Cancer Institute Common Toxicity Criteria) were neutropenia (10.4%), thrombocytopenia (8.4%), nausea and vomiting (16.7%), and diarrhea (12.5%).ConclusionConcomitant administration of weekly oxaliplatin, continuous-infusion FU, and RT in patients with LAPC is feasible, with an acceptable acute and late safety profile. The encouraging results observed despite a nonoptimal patient selection (owing to the short induction time) indicates that further randomized evaluation to better define the specific role of oxaliplatin in CCRT is deserved.