AIMS: To determine the maximum tolerated dose (MTD), safety and anti-tumor activity of afatinib combined with docetaxel in advanced cancer. PATIENTS & METHODS: The MTD was determined from dose-limiting toxicities in the first cycle. RESULTS: Thirty-one patients received 10, 20 and 30 mg oral afatinib, plus 60 and 75 mg/m(2) intravenous docetaxel (six cohorts; 3-week cycles). The MTD of afatinib was 20 mg/day (days 2-21) with 75 mg/m(2) docetaxel (day 1). Dose-limiting toxicities were grade 3/4 diarrhea (n = 3) and febrile neutropenia (n = 6). Most frequently occurring adverse events were diarrhea, neutropenia and rash. Disease stabilization occurred in 14 patients. CONCLUSION: Afatinib 20 mg/day plus docetaxel was suboptimal and the study could not yield Phase II dose recommendations. The combination resulted in a manageable safety profile.
AIMS: To determine the maximum tolerated dose (MTD), safety and anti-tumor activity of afatinib combined with docetaxel in advanced cancer. PATIENTS & METHODS: The MTD was determined from dose-limiting toxicities in the first cycle. RESULTS: Thirty-one patients received 10, 20 and 30 mg oral afatinib, plus 60 and 75 mg/m(2) intravenous docetaxel (six cohorts; 3-week cycles). The MTD of afatinib was 20 mg/day (days 2-21) with 75 mg/m(2) docetaxel (day 1). Dose-limiting toxicities were grade 3/4 diarrhea (n = 3) and febrile neutropenia (n = 6). Most frequently occurring adverse events were diarrhea, neutropenia and rash. Disease stabilization occurred in 14 patients. CONCLUSION:Afatinib 20 mg/day plus docetaxel was suboptimal and the study could not yield Phase II dose recommendations. The combination resulted in a manageable safety profile.
Authors: Sandrine Hiret; Nicolas Isambert; Carlos Gomez-Roca; Jaafar Bennouna; Mouna Sassi; Hélène de Mont-Serrat; Jean Fan; David Schnell; Jean-Pierre Delord Journal: Invest New Drugs Date: 2018-05-29 Impact factor: 3.850
Authors: C Massard; J Mateo; Y Loriot; C Pezaro; L Albiges; N Mehra; A Varga; D Bianchini; C J Ryan; D P Petrylak; G Attard; L Shen; K Fizazi; J de Bono Journal: Ann Oncol Date: 2017-01-01 Impact factor: 32.976
Authors: Hasan Baysal; Ines De Pauw; Hannah Zaryouh; Marc Peeters; Jan Baptist Vermorken; Filip Lardon; Jorrit De Waele; An Wouters Journal: Front Immunol Date: 2021-09-07 Impact factor: 7.561
Authors: D W Bowles; W W Ma; N Senzer; J R Brahmer; A A Adjei; M Davies; A J Lazar; A Vo; S Peterson; L Walker; D Hausman; C M Rudin; A Jimeno Journal: Br J Cancer Date: 2013-08-13 Impact factor: 7.640