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Gemcitabine and Docetaxel for Hepatocellular Carcinoma: A Phase II North Central Cancer Treatment Group Clinical Trial

Alberts, Steven R. MD, MPH*; Reid, Joel M. PhD*; Morlan, Bruce W. MS*; Farr, Gist H. Jr MD; Camoriano, John K. MD; Johnson, David B. MD§; Enger, James R. MD; Seay, Thomas E. MD; Kim, George P. MD

American Journal of Clinical Oncology:
doi: 10.1097/COC.0b013e318219863b
Original Articles: Gastrointestinal
Abstract

Objectives: Few effective options are available for the treatment of unresectable hepatocellular carcinoma (HCC). Several phase I trials suggest promising activity of a combination of gemcitabine and docetaxel.

Methods: Patients with unresectable or metastatic HCC were treated with docetaxel 40 mg/m2 (later reduced to 30 mg/m2) and gemcitabine 800 mg/m2 on days 1 and 8 every 3 weeks. Twenty-five patients were enrolled in 26 months. Median age was 64 (range, 27-078), 17 were male, 14 had liver-only disease, and 11 had extrahepatic disease.

Results: Of 25 patients evaluable for the primary end point (response), 2 (8%) have a confirmed partial response. The median time to progression is 2.76 months (95% confidence interval, 1.84-6.64 mo). Median survival was 12.8 months (95% confidence interval, 5.26-28.00). Two patients died on study owing to adverse events (1 hepatic and 1 renal failure), neither of which were attributed to the study medications. Twenty patients (81%) have experienced grade 3+ adverse events, including 11 with grade 4+ adverse events, primarily neutropenia, thrombocytopenia, diarrhea, and fatigue.

Conclusions: Although this combination seems to have potential benefit, as measured by overall survival, its toxicity and the recent introduction of sorafenib has further limited the use of chemotherapy. Approaches other than chemotherapy are likely to be of the greatest potential benefit.

Author Information

*Mayo Clinic Rochester, Rochester, MN

Ochsner CCOP, New Orleans, LA

Mayo Clinic Arizona, Scottsdale, AZ

§Wichita Community Clinical Oncology Program, Wichita, KS

Carle Cancer Center CCOP, Urbana, IL

Atlanta Regional CCOP, Atlanta, GA

Mayo Clinic Jacksonville, Jacksonville, FL

This study was conducted as a trial of the North Central Cancer Treatment Group and Mayo Clinic and was supported in part by Public Health Service grants CA-25224, CA-37404, CA-35103, CA-35272, CA-35431, CA-35195, CA-45450, CA-35269, and CA-63849 from the National Cancer Institute Department of Health and Human Services.

Additional participating institutions include: Duluth CCOP, Duluth, MN 55805 (Daniel Nikcevich, MD); Missouri Valley Cancer Consortium, Omaha, NE 68131 (Gamini Soori, MD).

The authors declare no conflicts of interest.

Reprints: Steven R. Alberts, MD, MPH, Mayo Clinic, 200 First Street SW, Rochester, MN 55905. e-mail: alberts.steven@mayo.edu.

© 2012 Lippincott Williams & Wilkins, Inc.