Phase II study of erlotinib in patients with locally advanced or metastatic papillary histology renal cell cancer

SWOG S0317

Michael S. Gordon, Michael Hussey, Raymond B Nagle, Primo N. Lara, Philip C. Mack, Janice Dutcher, Wolfram Samlowski, Joseph I. Clark, David I. Quinn, Chong Xian Pan, David Crawford

Research output: Contribution to journalArticle

76 Citations (Scopus)

Abstract

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.

Original languageEnglish (US)
Pages (from-to)5788-5793
Number of pages6
JournalJournal of Clinical Oncology
Volume27
Issue number34
DOIs
StatePublished - Dec 1 2009
Externally publishedYes

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Renal Cell Carcinoma
Histology
Survival
Treatment Failure
Epidermal Growth Factor Receptor
Drug Combinations
Erlotinib Hydrochloride
Protein-Tyrosine Kinases
Pneumonia
Appointments and Schedules
Thrombosis
Genes
Neoplasms

ASJC Scopus subject areas

  • Cancer Research
  • Oncology
  • Medicine(all)

Cite this

Phase II study of erlotinib in patients with locally advanced or metastatic papillary histology renal cell cancer : SWOG S0317. / Gordon, Michael S.; Hussey, Michael; Nagle, Raymond B; Lara, Primo N.; Mack, Philip C.; Dutcher, Janice; Samlowski, Wolfram; Clark, Joseph I.; Quinn, David I.; Pan, Chong Xian; Crawford, David.

In: Journal of Clinical Oncology, Vol. 27, No. 34, 01.12.2009, p. 5788-5793.

Research output: Contribution to journalArticle

Gordon, MS, Hussey, M, Nagle, RB, Lara, PN, Mack, PC, Dutcher, J, Samlowski, W, Clark, JI, Quinn, DI, Pan, CX & Crawford, D 2009, 'Phase II study of erlotinib in patients with locally advanced or metastatic papillary histology renal cell cancer: SWOG S0317', Journal of Clinical Oncology, vol. 27, no. 34, pp. 5788-5793. https://doi.org/10.1200/JCO.2008.18.8821
Gordon, Michael S. ; Hussey, Michael ; Nagle, Raymond B ; Lara, Primo N. ; Mack, Philip C. ; Dutcher, Janice ; Samlowski, Wolfram ; Clark, Joseph I. ; Quinn, David I. ; Pan, Chong Xian ; Crawford, David. / Phase II study of erlotinib in patients with locally advanced or metastatic papillary histology renal cell cancer : SWOG S0317. In: Journal of Clinical Oncology. 2009 ; Vol. 27, No. 34. pp. 5788-5793.
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AU - Lara, Primo N.

AU - Mack, Philip C.

AU - Dutcher, Janice

AU - Samlowski, Wolfram

AU - Clark, Joseph I.

AU - Quinn, David I.

AU - Pan, Chong Xian

AU - Crawford, David

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N2 - 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.

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