Originally published as JCO Early Release 10.1200/JCO.2008.18.8821 on November 2 2009

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Phase II Study of Erlotinib in Patients With Locally Advanced or Metastatic Papillary Histology Renal Cell Cancer: SWOG S0317

From Premiere Oncology of Arizona, Scottsdale; Arizona Cancer Center, Tucson, AZ; Southwest Oncology Group Statistical Center, Seattle, WA; University of California at Davis, Sacramento; University of Southern California School of Medicine, Los Angeles, CA; Our Lady of Mercy Medical Center Comprehensive Cancer Center, New York Medical College, Bronx, NY; Nevada Cancer Institute, Las Vegas, NV; Loyola University Stritch School of Medicine, Maywood, IL; and University of Colorado, Denver, CO.

Corresponding author: Michael S. Gordon, MD, Premiere Oncology of Arizona, 9023 E Desert Cove Ave, Ste 101, Scottsdale, AZ 85260; e-mail: mgordon{at}premiereoncology.com.

Purpose Patients with advanced papillary renal cell cancer (pRCC) have poor survival after systemic therapy; the reported median survival time is 7 to 17 months. In this trial, we evaluated the efficacy of erlotinib, an oral epidermal growth factor receptor (EGFR) tyrosine kinase inhibitor in patients with advanced pRCC, a tumor type associated with wild-type von Hippel Lindau gene.

Patients and Methods Patients with histologically confirmed, advanced, or metastatic pRCC were treated with erlotinib 150 mg orally once daily. A RECIST (Response Evaluation Criteria in Solid Tumors) response rate (RR) of 20% was considered a promising outcome. Secondary end points included overall survival and 6-month probability of treatment failure.

Results Of 52 patients registered, 45 were evaluable. The overall RR was 11% (five of 45 patients; 95% CI, 3% to 24%), and the disease control rate was 64% (ie five partial response and 24 stable disease). The median overall survival time was 27 months (95% CI, 13 to 36 months). Probability of freedom from treatment failure at 6 months was 29% (95% CI, 17% to 42%). There was one grade 5 adverse event (AE) of pneumonitis, one grade 4 thrombosis, and nine other grade 3 AEs.

Conclusion Although the RECIST RR of 11% did not exceed prespecified estimates for additional study, single-agent erlotinib yielded disease control and survival outcomes of interest with an expected toxicity profile. The design of future trials of the EGFR axis in pRCC should be based on preclinical or molecular data that define appropriate patient subgroups, new drug combinations, or potentially more active alternative schedules.

Supported in part by Public Health Service Cooperative Agreement Grants No. CA32102, CA38926, CA13612, CA46441, CA46282, CA42777, CA58861, CA45808, CA58882, CA58416, CA20319, CA27057, CA35119, CA35431, CA04919, CA35090, CA35176, CA35281, CA74647, CA11083, CA67663, CA45461, CA58658, CA14958, and CA21115, awarded by the National Cancer Institute, Department of Health and Human Services.

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

Clinical trial information can be found for the following: NCT00060307 [ClinicalTrials.gov] .

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