Journal article
Eastern Cooperative Oncology Group Phase II Trial of lapatinib in men with biochemically relapsed, androgen dependent prostate cancer
Urologic oncology, Vol.31(2), pp.211-218
02/01/2013
DOI: 10.1016/j.urolonc.2011.01.002
PMCID: PMC3223557
PMID: 21784672
Abstract
Purpose: Activation of the epidermal growth factor pathway is important in prostate cancer development and the transcription of androgen receptor regulated genes. This study evaluated the potential activity of lapatinib in men with biochemically-relapsed androgen-dependent (stage DO) prostate cancer.
Patients and methods: Patients with a rising PSA after primary therapy for prostate cancer were enrolled. A PSA doubling time (PSADT) <12 months was required. Lapatinib was administered at 1,500 mg orally daily. Outcome measures were changes in PSA kinetics. Primary tumor blocks were obtained and assessed for EGFR expression, EGFR Q787Q polymorphism, and Kras 38 mutational status.
Results: Forty-nine patients were enrolled (14 ineligible), resulting in 35 patients for analysis. No PSA response was observed; best response was stable disease (n = 28, 80.0%). Pretreatment average slope was 0.19 log (PSA)/month (PSADT = 3.70 months), in contrast to on-treatment average slope of 0.13 log (PSA)/month (PSADT = 5.44 months) using linear mixed effects models (P = 0.006). Median progression-free survival (PFS) was 17.4 months for the high EGFR group and 6.0 months for the low EGER group (P = 0.50). Patients with Kras 38 mutation had shorter PFS than those without Kras 38 mutation (P = 0.09).
Conclusion: Although no PSA responses (primary endpoint) was observed, lapatinib may have biologic activity in men with stage DO prostate cancer as evidenced by a decrease in PSA slope in this non-randomized study. Additional trials assessing the role of EGFR overexpression and Kras wild type status in prostate cancer should be investigated. (C) 2013 Elsevier Inc. All rights reserved.
Details
- Title: Subtitle
- Eastern Cooperative Oncology Group Phase II Trial of lapatinib in men with biochemically relapsed, androgen dependent prostate cancer
- Creators
- Glenn Liu - University of Wisconsin Carbone Cancer CenterYu-Hui Chen - DanaJill Kolesar - University of Wisconsin–MadisonWei Huang - University of Wisconsin–MadisonRobert DiPaola - Rutgers, The State University of New JerseyMichael Pins - University of Illinois at ChicagoMichael Carducci - Johns Hopkins UniversityMark Stein - Rutgers, The State University of New JerseyGlenn J. Bubley - Harvard University PressGeorge Wilding - University of Wisconsin Carbone Cancer Center
- Resource Type
- Journal article
- Publication Details
- Urologic oncology, Vol.31(2), pp.211-218
- Publisher
- Elsevier
- DOI
- 10.1016/j.urolonc.2011.01.002
- PMID
- 21784672
- PMCID
- PMC3223557
- ISSN
- 1078-1439
- eISSN
- 1873-2496
- Number of pages
- 8
- Grant note
- Department of Health and Human Services CA23318; CA66636; CA21115; CA21076; CA107868; CA16116; CA80775 / Public Health Service; United States Department of Health & Human Services; United States Public Health Service National Cancer Institute, National Institutes of Health; United States Department of Health & Human Services; National Institutes of Health (NIH) - USA; NIH National Cancer Institute (NCI) U10CA107868 / NATIONAL CANCER INSTITUTE; United States Department of Health & Human Services; National Institutes of Health (NIH) - USA; NIH National Cancer Institute (NCI) UWMO33JK-00 / Frontier Science and Technology Research
- Language
- English
- Date published
- 02/01/2013
- Academic Unit
- Pharmacy; Pharmaceutical Sciences and Experimental Therapeutics
- Record Identifier
- 9984696544702771
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