title: Weekly vinorelbine and paclitaxel in older patients with advanced non-small cell lung cancer: A phase II Fred and Pamela Buffet Cancer Center Clinical Trials Network study.
abstract: Platinum-based doublet chemotherapy is the standard for most patients with advanced non-small cell lung cancer (NSCLC). Toxicity concerns limit chemotherapy for patients over 70years. Vinorelbine and paclitaxel are effective as single agents in advanced NSCLC. This phase II study evaluates safety and efficacy of a combination of these two agents in patients >70years with advanced NSCLC.
  
  
  
  Patients with treatment naïve metastatic NSCLC received two cycles comprising 6 weekly doses of vinorelbine and paclitaxel, with restaging scans at week 8. Patients with radiographic progression came off study. The estimated sample size was 29. Toxicity analyses were conducted after 10 patients and again after 19 patients were enrolled. Outcomes were safety and efficacy, progression free (PFS) and overall survival (OS) and quality of life (QOL).
  
  
  
  The study closed at second interim analysis as 6/19 patients had ≥grade 4 non-hematologic toxicity (respiratory failure, sepsis, ischemic encephalopathy, pneumonia, hypoxemia, cardiopulmonary arrest, neutropenic fever, death). Of the 16 evaluable patients, 7 completed the study. Disease control rate (partial response+stable disease) was 47% (n=9); 37% (n=7) progressed. No complete responses were seen. Median PFS was 3.5months (95% CI: 1.4, 5.5) and OS 7.8months (95% CI: 1.9, 13.6). QOL did not change compared to baseline, at week 9, but increased at week 17.
  
  
  
  Although the combination met its response end points, increased toxicity makes this combination unsuitable for older patients. While QOL improved over the study, the small sample hinders interpretation.
authors.affiliation: Department of Internal Medicine, University of Nebraska Medical Center, Omaha, NE, United States.
authors.forename: Mary M
authors.initials: MM
authors.lastname: Huerter
authors.affiliation: Department of Biostatistics, University of Nebraska Medical Center, Omaha, NE, United States.
authors.forename: Jane L
authors.initials: JL
authors.lastname: Meza
authors.affiliation: CHI-St Francis Cancer Treatment Center, Grand Island, NE, United States.
authors.forename: M Sitki
authors.initials: MS
authors.lastname: Copur
authors.affiliation: Saint Luke's Cancer Institute, Kansas City, MO, United States; Avera Research Institute, Sioux Falls, SD, United States.
authors.forename: Addison
authors.initials: A
authors.lastname: Tolentino
authors.affiliation: Department of Internal Medicine, University of Nebraska Medical Center, Omaha, NE, United States.
authors.forename: Alissa S
authors.initials: AS
authors.lastname: Marr
authors.affiliation: Early Phase Therapeutic Clinical Trial Unit, Fred and Pamela Buffett Cancer Center, Omaha, NE, United States.
authors.forename: Marsha
authors.initials: M
authors.lastname: Ketcham
authors.affiliation: Department of Medicine, VA Nebraska Western Iowa Health Care System, Omaha, NE, United States.
authors.forename: Holly
authors.initials: H
authors.lastname: DeSpiegelaere
authors.affiliation: Early Phase Therapeutic Clinical Trial Unit, Fred and Pamela Buffett Cancer Center, Omaha, NE, United States.
authors.forename: Susan
authors.initials: S
authors.lastname: Kruse
authors.affiliation: Early Phase Therapeutic Clinical Trial Unit, Fred and Pamela Buffett Cancer Center, Omaha, NE, United States.
authors.forename: Mary E
authors.initials: ME
authors.lastname: Kos
authors.affiliation: Avera Research Institute, Sioux Falls, SD, United States.
authors.forename: Karin
authors.initials: K
authors.lastname: Swenson
authors.affiliation: Early Phase Therapeutic Clinical Trial Unit, Fred and Pamela Buffett Cancer Center, Omaha, NE, United States.
authors.forename: Sarah E
authors.initials: SE
authors.lastname: Radniecki
authors.affiliation: Department of Internal Medicine, University of Nebraska Medical Center, Omaha, NE, United States.
authors.forename: Anne
authors.initials: A
authors.lastname: Kessinger
authors.affiliation: Department of Medicine, VA Nebraska Western Iowa Health Care System, Omaha, NE, United States; Department of Internal Medicine, University of Nebraska Medical Center, Omaha, NE, United States; Early Phase Therapeutic Clinical Trial Unit, Fred and Pamela Buffett Cancer Center, Omaha, NE, United States. Electronic address: aganti@unmc.edu.
authors.forename: Apar Kishor
authors.initials: AK
authors.lastname: Ganti
mesh_terms: D000230:Adenocarcinoma / Q000000981:diagnostic imaging / Q000188:drug therapy* / Q000473:pathology; D000368:Aged; D000369:Aged, 80 and over; D000740:Anemia / Q000139:chemically induced; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000627:therapeutic use*; D002545:Brain Ischemia / Q000139:chemically induced; D002289:Carcinoma, Non-Small-Cell Lung / Q000000981:diagnostic imaging / Q000188:drug therapy* / Q000473:pathology; D002294:Carcinoma, Squamous Cell / Q000000981:diagnostic imaging / Q000188:drug therapy* / Q000473:pathology; D064146:Chemotherapy-Induced Febrile Neutropenia / Q000209:etiology; D018572:Disease-Free Survival; D057239:Early Termination of Clinical Trials; D005260:Female; D006323:Heart Arrest / Q000139:chemically induced; D006801:Humans; D000860:Hypoxia / Q000139:chemically induced; D008175:Lung Neoplasms / Q000000981:diagnostic imaging / Q000188:drug therapy* / Q000473:pathology; D008231:Lymphopenia / Q000139:chemically induced; D008297:Male; D009503:Neutropenia / Q000139:chemically induced; D017239:Paclitaxel / Q000008:administration & dosage; D011014:Pneumonia / Q000139:chemically induced; D011788:Quality of Life; D012131:Respiratory Insufficiency / Q000139:chemically induced; D015996:Survival Rate; D014057:Tomography, X-Ray Computed; D014747:Vinblastine / Q000008:administration & dosage / Q000031:analogs & derivatives; D000077235:Vinorelbine
chemical_list: D014747:Vinblastine; D017239:Paclitaxel; D000077235:Vinorelbine
keywords: Advanced non-small cell lung cancer; Geriatric oncology; Paclitaxel; Quality of life; Vinorelbine