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

Molife, L. .R. et al. (2014) Randomized Phase II trial of nintedanib, afatinib and sequential combination in castration-resistant prostate cancer. Future Oncology, 10(2), pp. 219-231. (doi: 10.2217/fon.13.250)

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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.

Item Type:Articles
Status:Published
Refereed:Yes
Glasgow Author(s) Enlighten ID:Jones, Professor Robert
Authors: Molife, L. .R., Omlin, A., Jones, R. J., Karavasilis, V., Bloomfield, D., Lumsden, G., Fong, P. C., Olmos, D., O'Sullivan, J. M., Pedley, I., Hickish, T., Jenkins, P., Thompson, E., Oommen, N., Wheatley, D., Heath, C., Temple, G., Pelling, K., and de Bono, J. S.
College/School:College of Medical Veterinary and Life Sciences > Institute of Cancer Sciences
Journal Name:Future Oncology
Publisher:Future Medicine Ltd.
ISSN:1479-6694
ISSN (Online):1744-8301
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