Phase II Randomized Study of Dose-Dense Docetaxel and Cisplatin Every 2 Weeks With Pegfilgrastim and Darbepoetin Alfa With and Without the Chemoprotector BNP7787 in Patients With Advanced Non-small Cell Lung Cancer (CALGB 30303)

• DOI: 10.1097/jto.0b013e318186fb0d
• Publication Date: 2008-09-24T07:12:35Z
• Authors: Antonius A. Miller; Xiaofei F. Wang; Lin Gu; Philip Hoffman; Jamil Khatri; Frank Dunphy; Martin J. Edelman; Michael Bolger; Everett E. Vokes; Mark R. Green
• Keywords: Pulmonary and Respiratory Medicine; Adult; Filgrastim; Docetaxel; Adenocarcinoma; 03 medical and health sciences; 0302 clinical medicine; Non-small cell lung cancer; Carcinoma, Non-Small-Cell Lung; Antineoplastic Combined Chemotherapy Protocols; Granulocyte Colony-Stimulating Factor; Darbepoetin alfa; Erythropoietin; Aged; Dose-Response Relationship, Drug; Brain Neoplasms; Anemia; Adenocarcinoma, Bronchiolo-Alveolar; Phase II; 3. Good health; Oncology; Carcinoma, Squamous Cell; Hematinics; Feasibility Studies; Dose-dense; Drug Therapy, Combination; Female; Cisplatin

We investigated dose-dense docetaxel and cisplatin in patients with measurable non-small cell lung cancer in a randomized phase II study without [A] or with [B] a putative chemoprotective agent, BNP7787.Chemotherapy-naive patients with stage IIIB (effusion) or IV, performance status 0 to 1, and adequate organ function were eligible. Treatment with docetaxel 75 mg/m followed by cisplatin 75 mg/m over 1 hour day 1 with darbepoetin 200 mug day 1 and pegfilgrastim 6 mg day 2 without/with BNP7787 before cisplatin was repeated every other week for up to 6 cycles. The primary end point was to differentiate between grade >/=2 neurotoxicity rates of 30% on [A] and 10% on [B]. Feasibility was prospectively defined as febrile neutropenia in <10% of patients and /=2 occurred in 32% on [A] and 29% on [B]. The incidence of febrile neutropenia was 4% on [A] and 3% on [B]. Treatment delays occurred in 13% and 20% of patients on [A] and [B], respectively. Completion rates for 3/6 cycles were 84%/51% on [A] and 84%/53% on [B]. Objective response rates were 55% on [A] and 51% on [B]. Median progression-free/overall survival times were 5.5/10.7 on [A] and 6.5/14.1 month on [B].This dose-dense treatment regimen is active, feasible, and tolerable. Its further investigation in the curative setting in non-small cell lung cancer should be considered. BNP7787 did not result in significant protection from neurotoxicity.