Erlotinib Has Moderate Single-agent Activity in Chemotherapy-naïve Castration-resistant Prostate Cancer

Final Results of a Phase II Trial

Chadi Nabhan, Timothy M. Lestingi, Angel Galvez, Kathy Tolzien, Susan K. Kelby, Dean Tsarwhas, Steven Newman, Jacob D. Bitran

Research output: Contribution to journalArticle

32 Citations (Scopus)

Abstract

Objectives: To investigate the efficacy and toxicity of single-agent erlotinib in chemotherapy-naive castration-resistant prostate cancer. Methods: Eligible patients received erlotinib at 150 mg daily until disease progression. Toxicity was assessed every 2 weeks and responses every 8 weeks. Primary end point was assessing the overall clinical benefit measured as the sum of stable disease, partial response, and complete response. Secondary end points included time to disease progression, overall survival, and toxicity using the National Cancer Institute Common Toxicity Criteria version 3.0. Results: A total of 29 patients were enrolled in this study. Median age was 77 and median prostate-specific antigen was 66.3 ng/mL. Of 22 evaluable patients, 2 met the criteria for partial response and 5 demonstrated stable disease for an overall clinical benefit of 31%. PSA-doubling time improved in all responding patients to a median of 6 months from 3 months before entry into the study. One patient remained in study at 28 months, and 2 had > 50% decrease in their serum PSA level. Median time to disease progression was 2 months, but at 12 months, 9% of patients were progression-free. Median overall survival was 16.3 months, with 1- and 2-year survival rates of 58% and 27%, respectively. Erlotinib was well tolerated, with only 2 patients requiring dose reductions. Adverse events were as expected with grade 3 or 4 diarrhea, fatigue, and rash occurring in 10%, 6%, and 6% of patients, respectively. Conclusions: Erlotinib has moderate activity in chemotherapy-naive castration-resistant prostate cancer, with some patients showing biochemical response. Future studies investigating this agent in combination are warranted. (This trial was registered at http://NCI.gov, NCT00272038).

Original languageEnglish
Pages (from-to)665-671
Number of pages7
JournalUrology
Volume74
Issue number3
DOIs
StatePublished - Sep 1 2009
Externally publishedYes

Fingerprint

Castration
Prostatic Neoplasms
Drug Therapy
Disease Progression
Erlotinib Hydrochloride
Survival
National Cancer Institute (U.S.)
Prostate-Specific Antigen
Exanthema
Fatigue
Diarrhea
Survival Rate

ASJC Scopus subject areas

  • Urology

Cite this

Nabhan, C., Lestingi, T. M., Galvez, A., Tolzien, K., Kelby, S. K., Tsarwhas, D., ... Bitran, J. D. (2009). Erlotinib Has Moderate Single-agent Activity in Chemotherapy-naïve Castration-resistant Prostate Cancer: Final Results of a Phase II Trial. Urology, 74(3), 665-671. https://doi.org/10.1016/j.urology.2009.05.016

Erlotinib Has Moderate Single-agent Activity in Chemotherapy-naïve Castration-resistant Prostate Cancer : Final Results of a Phase II Trial. / Nabhan, Chadi; Lestingi, Timothy M.; Galvez, Angel; Tolzien, Kathy; Kelby, Susan K.; Tsarwhas, Dean; Newman, Steven; Bitran, Jacob D.

In: Urology, Vol. 74, No. 3, 01.09.2009, p. 665-671.

Research output: Contribution to journalArticle

Nabhan, C, Lestingi, TM, Galvez, A, Tolzien, K, Kelby, SK, Tsarwhas, D, Newman, S & Bitran, JD 2009, 'Erlotinib Has Moderate Single-agent Activity in Chemotherapy-naïve Castration-resistant Prostate Cancer: Final Results of a Phase II Trial', Urology, vol. 74, no. 3, pp. 665-671. https://doi.org/10.1016/j.urology.2009.05.016
Nabhan, Chadi ; Lestingi, Timothy M. ; Galvez, Angel ; Tolzien, Kathy ; Kelby, Susan K. ; Tsarwhas, Dean ; Newman, Steven ; Bitran, Jacob D. / Erlotinib Has Moderate Single-agent Activity in Chemotherapy-naïve Castration-resistant Prostate Cancer : Final Results of a Phase II Trial. In: Urology. 2009 ; Vol. 74, No. 3. pp. 665-671.
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abstract = "Objectives: To investigate the efficacy and toxicity of single-agent erlotinib in chemotherapy-naive castration-resistant prostate cancer. Methods: Eligible patients received erlotinib at 150 mg daily until disease progression. Toxicity was assessed every 2 weeks and responses every 8 weeks. Primary end point was assessing the overall clinical benefit measured as the sum of stable disease, partial response, and complete response. Secondary end points included time to disease progression, overall survival, and toxicity using the National Cancer Institute Common Toxicity Criteria version 3.0. Results: A total of 29 patients were enrolled in this study. Median age was 77 and median prostate-specific antigen was 66.3 ng/mL. Of 22 evaluable patients, 2 met the criteria for partial response and 5 demonstrated stable disease for an overall clinical benefit of 31{\%}. PSA-doubling time improved in all responding patients to a median of 6 months from 3 months before entry into the study. One patient remained in study at 28 months, and 2 had > 50{\%} decrease in their serum PSA level. Median time to disease progression was 2 months, but at 12 months, 9{\%} of patients were progression-free. Median overall survival was 16.3 months, with 1- and 2-year survival rates of 58{\%} and 27{\%}, respectively. Erlotinib was well tolerated, with only 2 patients requiring dose reductions. Adverse events were as expected with grade 3 or 4 diarrhea, fatigue, and rash occurring in 10{\%}, 6{\%}, and 6{\%} of patients, respectively. Conclusions: Erlotinib has moderate activity in chemotherapy-naive castration-resistant prostate cancer, with some patients showing biochemical response. Future studies investigating this agent in combination are warranted. (This trial was registered at http://NCI.gov, NCT00272038).",
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