Multicenter phase II trial of adjuvant therapy for resected pancreatic cancer using cisplatin, 5-fluorouracil, and interferon-alfa-2b-based chemoradiation: ACOSOG Trial Z05031
Multicenter phase II trial of adjuvant therapy for resected pancreatic cancer using cisplatin, 5-fluorouracil, and interferon-alfa-2b-based chemoradiation: ACOSOG Trial Z05031
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DOI：
10.1093/annonc/mdq384
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发表时间：
2011-02-01
影响因子：
50.5
通讯作者：
Pisters, P. W. T.
中科院分区：
文献类型：
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作者：
Picozzi, V. J.;Abrams, R. A.;Pisters, P. W. T.
背景资料：患者和方法：切除的（R0/R1）胰头腺癌患者用辅助干扰素-α-2b（300万单位s.c.）每周第1、3、5天，共5.5周）、顺铂（30 mg/m2，每周静脉注射，共6周）、5-氟尿嘧啶（5-FU; 175 mg. m2/天，共38天）持续输注，同时进行外照射（50.4戈伊）。放化疗后连续输注5-FU（200 mg. m（2）/天），疗程为6周。主要研究终点是18个月的总生存率（OS 18）; OS 18 ≥ 65%被认为是积极的研究outcome.Results：89例患者入组。84例患者可评估毒性。治疗期间全因≥ 3级毒性发生率为95%（80例患者）。未观察到长期毒性或毒性相关死亡。中位随访36个月时，OS 18为69%[95%置信区间（CI）60%-80%];中位无病生存期和总生存期为14.1个月（95% CI 11.0 - 20.1个月）和25.4个月（95%CI 23.4 - 34.1个月）。结论：尽管多机构疗效结果令人鼓舞，但该方案的进一步开发将需要额外的修改以减轻毒性作用。
Background: The American College of Surgeons Oncology Group sought to confirm the efficacy of a novel interferon-based chemoradiation regimen in a multicenter phase II trial.Patients and methods: Patients with resected (R0/R1) adenocarcinoma of the pancreatic head were treated with adjuvant interferon-alfa-2b (3 million units s.c. on days 1, 3, and 5 of each week for 5.5 weeks), cisplatin (30 mg/m(2) i.v. weekly for 6 weeks), and continuous infusion 5-fluorouracil (5-FU; 175 mg.m(2)/day for 38 days) concurrently with external-beam radiation (50.4 Gy). Chemoradiation was followed by two 6-week courses of continuous infusion 5-FU (200 mg.m(2)/day). The primary study end point was 18-month overall survival from protocol enrollment (OS18); an OS18 >= 65% was considered a positive study outcome.Results: Eighty-nine patients were enrolled. Eighty-four patients were assessable for toxicity. The all-cause grade >= 3 toxicity rate was 95% (80 patients) during therapy. No long-term toxicity or toxicity-related deaths were noted. At 36-month median follow-up, the OS18 was 69% [95% confidence interval (CI) 60% to 80%]; the median disease-free survival and overall survival were 14.1 months (95% CI 11.0-20.1 months) and 25.4 months (95% CI 23.4-34.1 months), respectively.Conclusions: Notwithstanding promising multi-institutional efficacy results, further development of this regimen will require additional modifications to mitigate toxic effects.