BACKGROUND: Cetuximab in combination with docetaxel was examined in chemotherapy-refractory/resistant patients with advanced nonsmall-cell lung cancer (NSCLC) to determine response rate, survival, safety, and pharmacokinetics (PK). METHODS: Patients had evidence of epidermal growth factor receptor (EGFR) expression (> or =1 +) and tumor progression during or disease recurrence within 3 months after chemotherapy. Cetuximab was administered weekly (400 mg/m(2) initial; 250 mg/m(2) thereafter). Docetaxel was administered every 3 weeks (75 mg/m(2)). A response in 3 of the first 21 patients was required to continue accrual to the target sample size of 50 patients. RESULTS: Confirmed responses included 1 complete response (1.8%), 10 partial responses (18.2%), and 20 with stable disease (36.4%). The response rate was 20% (95% confidence interval [CI], 10.4% to 33.0%) and median time to disease progression was 104 days. There were no differences in PK parameters of docetaxel alone or with cetuximab. The most common grade 3 of 4 adverse events were leukopenia (27.3%) and acne (21.8%). Four patients (7.3%) discontinued due to allergic reaction. The median overall survival (OS) was 7.5 months with a 1-year survival of 35%. CONCLUSIONS: Cetuximab in combination with docetaxel was well tolerated. The response rate supports more definitive evaluation of this combination in the second-line setting.
BACKGROUND:Cetuximab in combination with docetaxel was examined in chemotherapy-refractory/resistant patients with advanced nonsmall-cell lung cancer (NSCLC) to determine response rate, survival, safety, and pharmacokinetics (PK). METHODS:Patients had evidence of epidermal growth factor receptor (EGFR) expression (> or =1 +) and tumor progression during or disease recurrence within 3 months after chemotherapy. Cetuximab was administered weekly (400 mg/m(2) initial; 250 mg/m(2) thereafter). Docetaxel was administered every 3 weeks (75 mg/m(2)). A response in 3 of the first 21 patients was required to continue accrual to the target sample size of 50 patients. RESULTS: Confirmed responses included 1 complete response (1.8%), 10 partial responses (18.2%), and 20 with stable disease (36.4%). The response rate was 20% (95% confidence interval [CI], 10.4% to 33.0%) and median time to disease progression was 104 days. There were no differences in PK parameters of docetaxel alone or with cetuximab. The most common grade 3 of 4 adverse events were leukopenia (27.3%) and acne (21.8%). Four patients (7.3%) discontinued due to allergic reaction. The median overall survival (OS) was 7.5 months with a 1-year survival of 35%. CONCLUSIONS:Cetuximab in combination with docetaxel was well tolerated. The response rate supports more definitive evaluation of this combination in the second-line setting.
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Authors: O S Breathnach; B Freidlin; B Conley; M R Green; D H Johnson; D R Gandara; M O'Connell; F A Shepherd; B E Johnson Journal: J Clin Oncol Date: 2001-03-15 Impact factor: 44.544
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Authors: Giuseppe Giaccone; Roy S Herbst; Christian Manegold; Giorgio Scagliotti; Rafael Rosell; Vincent Miller; Ronald B Natale; Joan H Schiller; Joachim Von Pawel; Anna Pluzanska; Ulrich Gatzemeier; John Grous; Judith S Ochs; Steven D Averbuch; Michael K Wolf; Pamela Rennie; Abderrahim Fandi; David H Johnson Journal: J Clin Oncol Date: 2004-03-01 Impact factor: 44.544
Authors: Ulrich Gatzemeier; Anna Pluzanska; Aleksandra Szczesna; Eckhard Kaukel; Jaromir Roubec; Flavio De Rosa; Janusz Milanowski; Hanna Karnicka-Mlodkowski; Milos Pesek; Piotr Serwatowski; Rodryg Ramlau; Terezie Janaskova; Johan Vansteenkiste; Janos Strausz; Georgy Moiseevich Manikhas; Joachim Von Pawel Journal: J Clin Oncol Date: 2007-04-20 Impact factor: 44.544
Authors: Maria Alsina; Fernando Rivera; Francisco Javier Ramos; Maica Galán; Rafael López; Pilar García-Alfonso; José Enrique Alés-Martinez; Bernardo Queralt; Antonio Antón; Alfredo Carrato; Cristina Grávalos; Maria José Méndez-Vidal; Carlos López; Inmaculada Ruiz de Mena; Josep Tabernero; Jordi Giralt; Enrique Aranda Journal: Target Oncol Date: 2018-02 Impact factor: 4.493
Authors: N C Tebbutt; M M Parry; D Zannino; A H Strickland; G A Van Hazel; N Pavlakis; V Ganju; D Mellor; A Dobrovic; V J Gebski Journal: Br J Cancer Date: 2013-02-14 Impact factor: 7.640