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.
RCT Entities:
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 cancerpatients. 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 cancerpatients.
Authors: Veronica Gil; Susana Miranda; Ruth Riisnaes; Bora Gurel; Mariantonietta D'Ambrosio; Alessandro Vasciaveo; Mateus Crespo; Ana Ferreira; Daniela Brina; Martina Troiani; Adam Sharp; Beshara Sheehan; Rossitza Christova; George Seed; Ines Figueiredo; Maryou Lambros; David Dolling; Jan Rekowski; Abdullah Alajati; Matthew Clarke; Rita Pereira; Penny Flohr; Gemma Fowler; Gunther Boysen; Semini Sumanasuriya; Diletta Bianchini; Pasquale Rescigno; Caterina Aversa; Nina Tunariu; Christina Guo; Alec Paschalis; Claudia Bertan; Lorenzo Buroni; Jian Ning; Suzanne Carreira; Paul Workman; Amanda Swain; Andrea Califano; Michael M Shen; Andrea Alimonti; Antje Neeb; Jonathan Welti; Wei Yuan; Johann de Bono Journal: Cancer Res Date: 2021-11-09 Impact factor: 13.312
Authors: Susan R Mallery; Daren Wang; Brian Santiago; Ping Pei; Steven P Schwendeman; Kari Nieto; Richard Spinney; Meng Tong; George Koutras; Brian Han; Andrew Holpuch; James Lang Journal: Cancer Prev Res (Phila) Date: 2016-10-18