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Patient-Reported Outcomes of Patients With Advanced Biliary Tract Cancers Receiving Gemcitabine Plus Capecitabine: A Multicenter, Phase II Trial of the Swiss Group for Clinical Cancer Research

Dieter Koeberle, Piercarlo Saletti, Markus Borner, Daniela Gerber, Daniel Dietrich, Clemens B. Caspar, Walter Mingrone, Kurt Beretta, Florian Strasser, Thomas Ruhstaller, Oreste Mora, Richard Herrmann

From the Kantonsspital, St Gallen; Istituto Oncologico della Svizzera Italiana, Bellinzona; Inselspital; Quality of Life Unit and Statistical Unit, Swiss Group for Clinical Cancer Research Coordinating Center, Bern; Kantonsspital, Baden; Kantonsspital, Aarau; Rheinfelden; and University Hospital, Basel, Switzerland

Corresponding author: Dieter Koeberle, MD, Department of Internal Medicine, Division Oncology/Hematology, Kantonsspital St. Gallen, CH-9007 St. Gallen, Switzerland; e-mail: dieter.koeberle{at}kssg.ch

Purpose To evaluate the effects of palliative chemotherapy with gemcitabine plus capecitabine (GemCap) on patient-reported outcomes measured using clinical benefit response (CBR) and quality-of-life (QOL) measures in patients with advanced biliary tract cancer.

Patients and Methods Patients had to manifest symptoms of advanced biliary tract cancer and have at least one of the following: impaired Karnofsky performance score (60 to 80), average analgesic consumption 10 mg of morphine equivalents per day, and average pain intensity score of 20 mm out of 100 mm. Treatment consisted of oral capecitabine 650 mg/m² twice daily on days 1 through 14 plus gemcitabine 1,000 mg/m² as a 30-minute infusion on days 1 and 8 every 3 weeks until progression. The primary end point was the number of patients categorized as having a CBR or stable CBR (SCBR) during the first three treatment cycles.

Results Forty-four patients were enrolled (bile duct cancer, n = 36; gallbladder cancers, n = 8). The main grade 3 or 4 adverse events included hematologic toxicity and fatigue. After three cycles, 36% of patients achieved a CBR, and 34% achieved an SCBR. Over the full course of treatment, 57% of patients achieved a CBR, and 18% achieved an SCBR. Improved QOL was observed in patients with a CBR or SCBR. The objective response rate was 25%. Median time to progression and overall survival times were 7.2 months and 13.2 months, respectively.

Conclusion Chemotherapy with GemCap is well tolerated and effective and leads to a high CBR rate. Patient-reported outcomes are useful for evaluating the effects of palliative chemotherapy in patients with biliary tract cancer.

Supported by Roche Pharma Switzerland, Eli Lilly Switzerland, and the Swiss federal government.

Presented in part at the 14th Annual European Cancer Conference, September 23-27, 2007, Barcelona, Spain.

Authors' disclosures of potential conflicts of interest and author contributions are found at the end of this article.

Clinical Trials repository link available on www.JCO.org.

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