JAMA:化疗药物能提高胰腺癌患者术后存活率

据3月5日《美国医学协会期刊》（JAMA）上的一则研究显示，在外科手术后胰腺癌患者的化学放射疗法中增加化疗药物gemcitabine与病患存活情况的改善有关，但这一改善在统计学意义上不显著。

美国马里兰大学医学中心的William F. Regine及其同僚开展了一项评估研究——在fluorouracil化学放射疗法（化疗加放疗）的辅助治疗中增加gemcitabine是否能改善病人的存活情况。这些病患在治疗胰腺癌时被切除了一部分的胰腺。

作者在文章中写道：“在辅助性的以fluorouracil为基础的化学放射疗法中添加gemcitabine与切除了胰腺癌病患的存活情况改善有关联，但这一改善在统计学意义上并不显著。”（来源：EurekAlert!中文版）

生物谷推荐原始出处：

（JAMA），2008;299(9):1019-1026，William F. Regine，Tyvin A. Rich

Fluorouracil vs Gemcitabine Chemotherapy Before and After Fluorouracil-Based Chemoradiation Following Resection of Pancreatic Adenocarcinoma

William F. Regine, MD; Kathryn A. Winter, MS; Ross A. Abrams, MD; Howard Safran, MD; John P. Hoffman, MD; Andre Konski, MD; Al B. Benson, MD; John S. Macdonald, MD; Mahesh R. Kudrimoti, MD; Mitchel L. Fromm, MD; Michael G. Haddock, MD; Paul Schaefer, MD; Christopher G. Willett, MD; Tyvin A. Rich, MD

ABSTRACT

Context Among patients with locally advanced metastatic pancreatic adenocarcinoma, gemcitabine has been shown to improve outcomes compared with fluorouracil.

Objective To determine if the addition of gemcitabine to adjuvant fluorouracil chemoradiation (chemotherapy plus radiation) improves survival for patients with resected pancreatic adenocarcinoma.

Design, Setting, and Participants Randomized controlled phase 3 trial of patients with complete gross total resection of pancreatic adenocarcinoma and no prior radiation or chemotherapy enrolled between July 1998 and July 2002 with follow-up through August 18, 2006, at 164 US and Canadian institutions.

Intervention Chemotherapy with either fluorouracil (continuous infusion of 250 mg/m2 per day; n = 230) or gemcitabine (30-minute infusion of 1000 mg/m2 once per week; n = 221) for 3 weeks prior to chemoradiation therapy and for 12 weeks after chemoradiation therapy. Chemoradiation with a continuous infusion of fluorouracil (250 mg/m2 per day) was the same for all patients (50.4 Gy).

Main Outcome Measures Survival for all patients and survival for patients with pancreatic head tumors were the primary end points. Secondary end points included toxicity.

Results A total of 451 patients were randomized, eligible, and analyzable. Patients with pancreatic head tumors (n = 388) had a median survival of 20.5 months and a 3-year survival of 31% in the gemcitabine group vs a median survival of 16.9 months and a 3-year survival of 22% in the fluorouracil group (hazard ratio, 0.82 [95% confidence interval, 0.65-1.03]; P = .09). The treatment effect was strengthened on multivariate analysis (hazard ratio, 0.80 [95% confidence interval, 0.63-1.00]; P = .05). Grade 4 hematologic toxicity was 1% in the fluorouracil group and 14% in the gemcitabine group (P < .001) without a difference in febrile neutropenia or infection. There were no differences in the ability to complete chemotherapy or radiation therapy (>85%).

Conclusions The addition of gemcitabine to adjuvant fluorouracil-based chemoradiation was associated with a survival benefit for patients with resected pancreatic cancer, although this improvement was not statistically significant.