Randomized Phase II trial of nintedanib, afatinib and sequential combination in castration-resistant prostate cancer

L Rhoda Molife, Aurelius Omlin, Rob J Jones, Vasilios Karavasilis, David Bloomfield, Graeme Lumsden, Peter C Fong, David Olmos, Joe M O'Sullivan, Ian Pedley, Tamas Hickish, Peter Jenkins, Emilda Thompson, Nikhil Oommen, Duncan Wheatley, Catherine Heath, Graham Temple, Katy Pelling, Johann S de Bono

Research output: Contribution to journalArticlepeer-review

22 Citations (Scopus)

Abstract

AIMS: The aim of this article was to evaluate afatinib (BIBW 2992), an ErbB family blocker, and nintedanib (BIBF 1120), a triple angiokinase inhibitor, in castration-resistant prostate cancer patients.

PATIENTS & METHODS: Patients were randomized to receive nintedanib (250 mg twice daily), afatinib (40 mg once daily [q.d.]), or alternating sequential 7-day nintedanib (250 mg twice daily) and afatinib (70 mg q.d. [Combi70]), which was reduced to 40 mg q.d. (Combi40) due to adverse events. The primary end point was progression-free rate at 12 weeks.

RESULTS: Of the 85 patients treated 46, 20, 16 and three received nintedanib, afatinib, Combi40 and Combi70, respectively. At 12 weeks, the progression-free rate was 26% (seven out of 27 patients) for nintedanib, and 0% for afatinib and Combi40 groups. Two patients had a ≥50% decline in PSA (nintedanib and the Combi40 groups). The most common drug-related adverse events were diarrhea, nausea, vomiting and lethargy.

CONCLUSION: Nintedanib and/or afatinib demonstrated limited anti-tumor activity in unselected advanced castration-resistant prostate cancer patients.

Original languageEnglish
Pages (from-to)219-31
Number of pages13
JournalFuture oncology (London, England)
Volume10
Issue number2
DOIs
Publication statusPublished - 2014

Keywords

  • Aged
  • Aged, 80 and over
  • Antineoplastic Combined Chemotherapy Protocols
  • Humans
  • Indoles
  • Male
  • Middle Aged
  • Neoplasm Grading
  • Neoplasm Metastasis
  • Neoplasm Staging
  • Prostatic Neoplasms, Castration-Resistant
  • Quinazolines
  • Treatment Outcome

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