Eastern Cooperative Oncology Group Phase II Trial of lapatinib in men with biochemically relapsed, androgen dependent prostate cancer1

Glenn Liu, Yu Hui Chen, Jill Kolesar, Wei Huang, Robert DiPaola, Michael Pins, Michael Carducci, Mark Stein, Glenn J. Bubley, George Wilding

Research output: Contribution to journalArticlepeer-review

17 Scopus citations


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 D0) 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 EGFR 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 D0 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.

Original languageEnglish
Pages (from-to)211-218
Number of pages8
JournalUrologic Oncology: Seminars and Original Investigations
Issue number2
StatePublished - Feb 2013

Bibliographical note

Funding Information:
Research Support: UWMO33JK-00, Frontier Science and Technology Research. This study was conducted by the Eastern Cooperative Oncology Group (Robert L. Comis, M.D., Chair) and supported in part by Public Health Service grants CA23318 , CA66636 , CA21115 , CA21076 , CA107868 , CA16116 , CA80775 , and from the National Cancer Institute, National Institutes of Health and the Department of Health and Human Services . Its contents are solely the responsibility of the authors and do not necessarily represent the official views of the National Cancer Institute.


  • Clinical trial
  • Epidermal growth factor receptor
  • Tyrosine kinase inhibitors

ASJC Scopus subject areas

  • Oncology
  • Urology


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