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

ABSTRACT Aims: The aim of this article was to evaluate afatinib(BIBW 2992), an ErbBfamily 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 afatiniband Combi40 groups. Two patients had a ≥50% decline in PSA ( nintedaniband the Combi40 groups). The most common drug-related adverse events were diarrhea, nausea, vomiting and lethargy. Conclusion: Nintedaniband/or afatinib...