Originally published as JCO Early Release 10.1200/JCO.2008.18.3301 on January 12 2009

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Phase II Trial of the Combination of Bevacizumab and Erlotinib in Patients Who Have Advanced Hepatocellular Carcinoma

From the Department of Gastrointestinal Medical Oncology; Department of Biomathematics, Division of Diagnostic Imaging; and Department of Gastroenterology, Hepatology, and Nutrition, The University of Texas M. D. Anderson Cancer Center, Houston, TX.

Corresponding author: Melanie B. Thomas, MD, Division of Hematology and Oncology, Medical University of South Carolina, Hollings Cancer Center, 86 Jonathan Lucas St, MSC 955, Charleston, SC 29425; e-mail: thomasmb{at}musc.edu.

Purpose The study objective was to determine the proportion of patients with hepatocellular carcinoma (HCC) treated with the combination of bevacizumab (B) and erlotinib (E) who were alive and progression free at 16 weeks (16-week progression-free survival [PFS₁₆]) of continuous therapy. Secondary objectives included response rate, median PFS, survival, and toxicity.

Patients and Methods Patients who had advanced HCC that was not amenable to surgical or regional therapies, up to one prior systemic treatment; Childs-Pugh score A or B liver function; Eastern Cooperative Oncology Group performance status 0, 1, or 2 received B 10 mg/kg every 14 days and E 150 mg orally daily, continuously, for 28-day cycles. Tumor response was evaluated every 2 cycles by using Response Evaluation Criteria in Solid Tumors Group criteria. A total of 40 patients were treated.

Results The primary end point of PFS₁₆ was 62.5%. Ten patients achieved a partial response for a confirmed overall response rate (intent-to-treat) of 25%. The median PFS_event was 39 weeks (95% CI, 26 to 45 weeks; 9.0 months), and the median overall survival was 68 weeks (95% CI, 48 to 78 weeks; 15.65 months). Grades 3 to 4 drug-related toxicity included fatigue (n = 8; 20%), hypertension (n = 6; 15%), diarrhea (n = 4; 10%) elevated transaminases (n = 4; 10%), gastrointestinal hemorrhage (n = 5; 12.5%), wound infection (n = 2; 5%) thrombocytopenia (n = 1; 2.5%), and proteinuria, hyperbilirubinemia, back pain, hyperkalemia, and anorexia (n = 1 each).

Conclusion The combination of B + E in patients who had advanced HCC showed significant, clinically meaningful antitumor activity. B + E warrant additional evaluation in randomized controlled trials.

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

Clinical Trials repository link available on JCO.org.

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				J. M. Llovet and J. Bruix Testing Molecular Therapies in Hepatocellular Carcinoma: The Need for Randomized Phase II Trials J. Clin. Oncol., February 20, 2009; 27(6): 833 - 835. [Full Text] [PDF]