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| |  Gemcitabine Plus Cisplatin Reduces Risks of Death and Progression in Biliary-Tract Cancer: Presented at ASCO By Deborah Brauser ORLANDO, Fla -- June 3, 2009 -- Gemcitabine plus cisplatin improves overall and progression-free survival for patients with advanced biliary-tract cancer (ABC) compared with gemcitabine treatment alone, according to results from a large phase 3 trial presented at the 45th Annual Meeting of the American Society of Clinical Oncology (ASCO). The addition of cisplatin does not appear to add clinically significant toxicity. “This is the largest study ever done for this rare but difficult-to-treat cancer, and [it] demonstrates a clear survival advantage for gemcitabine plus cisplatin, which we now consider to be the worldwide standard of care,” said co-chief investigator Juan W. Valle, MD, University of Manchester, United Kingdom, in a presentation here on June 1. Dr. Valle’s investigative team previously reported on progression-free survival in gemcitabine plus cisplatin treatment versus gemcitabine alone in ABC-01, a randomised phase 2 trial of 86 patients. That study was then extended into the phase 3 ABC-02 trial, with additional patients recruited. Between May 2005 and October 2008, these additional 324 patients were enrolled from 34 centres in the United Kingdom. They were randomised to receive either cisplatin (25 mg/m2) followed by gemcitabine (1,000 mg/m2 days 1 and 8, every 21 days for 8 cycles) or gemcitabine alone (1,000 mg/m2 days 1, 8 and 15, every 28 days for 6 cycles). The initial treatment was continued for 3 months and, in the absence of disease progression, was repeated for another 3 months. This study reports on combined analysis of the 410 patients from both ABC-01 and ABC-02 (median age 64 years, 53% female), with 206 patients receiving the gemcitabine plus cisplatin combined therapy and 204 receiving gemcitabine alone. The primary endpoint was overall survival. With a median follow-up of 6.1 months, there were 263 deaths: 122 (59.8%) in the combination group and 141 (68.5%) in the gemcitabine-alone group. The median overall survival was greater with the gemcitabine plus cisplatin group at 11.7 months versus 8.2 months for the gemcitabine-only group (hazard ratio [HR], 0.70; 95% confidence interval [CI], 0.54 to 0.89; P = .002). “In other words, the combination treatment improved overall survival by reducing risk of death by 30%,” said Dr. Valle. The median progression-free survival rate was also higher for the patients treated with the combined therapy (8.5 months) compared with the rate for those treated with gemcitabine alone (6.5 months) (HR, 0.70; 95% CI, 0.56 to 0.88; P = .003). Toxicity was similar between the 2 arms, with 57% of the patients in both groups experiencing a grade 3/4 toxicity. There was also, however, a slight excess of neutropenia in the combination-treatment patients compared with the gemcitabine-only group (22.6% vs 17.9%, respectively). “There is, to date, no standard of care for patients with advanced biliary-tract cancer,” said Dr. Valle. “This relates in part to disease-related factors such as uncommon malignancies. Patients are often unwell, elderly, and have comorbidities -- and they may have ongoing infection and biliary obstruction.” “This trial proves that large, collaborative, randomised studies [of] patients with advanced biliary-tract cancer are feasible,” Dr. Valle concluded. “We would like to recommend the combination treatment as a worldwide standard of care and the backbone of future studies.” Funding for this study was provided by Cancer Research UK. [Presentation title: Gemcitabine With or Without Cisplatin in Patients (pts) With Advanced or Metastatic Biliary Tract Cancer (ABC): Results of a Multicenter, Randomized Phase III Trial (the UK ABC-02 Trial). Abstract 4503]
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