title: Phase II study of docetaxel and vinorelbine as adjuvant chemotherapy for resected non-small cell lung cancers.
abstract: OBJECTIVE
  For patients with resected stage II-III non-small cell lung cancers (NSCLCs), adjuvant cisplatin-based chemotherapy improves survival over surgery alone. For cisplatin ineligible patients, there is no standard adjuvant option. We evaluated drug delivery and toxicity of docetaxel and vinorelbine in patients who could not receive cisplatin.
  
  
  METHODS
  Patients with completely resected stage IB-III NSCLCs were treated with up to 4 cycles of docetaxel and vinorelbine at the recommended phase II dose. The primary endpoint was drug delivery compared to historical delivery of adjuvant cisplatin plus vinorelbine. Secondary endpoints were toxicity and feasibility.
  
  
  RESULTS
  Twenty-five patients were enrolled. Overall, 13/25 (52 %, 95 % CI 34-70) completed 4 cycles, and 19/25 (76 %, 95 % CI 60-87) completed ≥3 cycles. Twenty of 25 patients (80 %) experienced a Grade 3 or 4 adverse event.
  
  
  CONCLUSIONS
  Delivery of this dose and schedule of docetaxel and vinorelbine was difficult with a dose delivery comparable to cisplatin plus vinorelbine, and cisplatin plus docetaxel, used in this setting.
authors: Thoracic Oncology Service, Division of Solid Tumor Oncology, Department of Medicine, Memorial Sloan-Kettering Cancer Center, 300 E, 66th Street, New York, NY, 10065, USA, chaftj@mskcc.org.
authors: Jamie E
authors: JE
authors: Chaft
authors: Natasha
authors: N
authors: Rekhtman
authors: Camelia S
authors: CS
authors: Sima
authors: Valerie
authors: V
authors: Rusch
authors: Mark G
authors: MG
authors: Kris
authors: Maureen
authors: M
authors: Zakowski
authors: Christopher G
authors: CG
authors: Azzoli
mesh_terms: D000368:Aged; D000369:Aged, 80 and over; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D002289:Carcinoma, Non-Small-Cell Lung / Q000473:pathology / Q000628:therapy*; D017024:Chemotherapy, Adjuvant / Q000379:methods; D000077143:Docetaxel; D016503:Drug Delivery Systems; D005240:Feasibility Studies; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D008175:Lung Neoplasms / Q000473:pathology / Q000628:therapy*; D008297:Male; D008875:Middle Aged; D009367:Neoplasm Staging; D043823:Taxoids / Q000008:administration & dosage; D016896:Treatment Outcome; D014747:Vinblastine / Q000008:administration & dosage / Q000031:analogs & derivatives; D000077235:Vinorelbine
chemical_list: D043823:Taxoids; D000077143:Docetaxel; D014747:Vinblastine; D000077235:Vinorelbine
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