title: A phase II study of nanoparticle albumin-bound paclitaxel plus carboplatin as the first-line therapy in elderly patients with previously untreated advanced non-small cell lung cancer.
abstract: BACKGROUND
  The objective of this clinical trial was to explore the efficacy and tolerability of first-line chemotherapy with nanoparticle albumin-bound paclitaxel (nab-paclitaxel), a novel agent that uses a drug delivery system, plus carboplatin, in elderly Japanese patients with advanced non-small cell lung cancer (NSCLC).
  
  
  METHODS
  In this phase II, single-arm, open-label, single-institutional study, we aimed to enroll 37 elderly patients, aged more than 70 years, with advanced NSCLC of performance status 0 or 1. The patients received each cycle of first-line therapy consisting of 100 mg/m(2) nab-paclitaxel intravenously administered on days 1, 8, and 15 of each 21-day cycle, plus carboplatin area under curve 6 on day 1 of each 21-day cycle, for up to six cycles. The primary end point was determining the objective response rate, and secondary endpoints were progression-free survival, overall survival, and safety.
  
  
  RESULTS
  The study was interrupted early because of two treatment-related deaths and 1 life-threatening severe adverse event; therefore, only 10 patients (median age, 77 years; range 71-82 years) were enrolled. The primary end point of the objective response was 50 % for the 10 patients analyzed. Progression-free survival was 4.48 months [95 % confidence interval (CI) 0.36-6.44], and overall survival was 7.89 months (95 % CI 0.36-26.88). Common treatment-related adverse events higher than grade 2 included decreased neutrophil counts, anemia, decreased albumin, anorexia, and peripheral neuropathy. Regarding severe adverse events, two patients had febrile neutropenia and lung infection. Two patients died, and one patient had febrile neutropenia with intubation during the first cycle. The Data and Safety Monitoring Committee therefore recommended interruption of patient enrollment.
  
  
  CONCLUSIONS
  Nab-paclitaxel plus carboplatin, without dose reduction, is indicated to be toxic and intolerable as first-line chemotherapy in elderly Japanese patients with advanced NSCLC. Care must be taken when extrapolating the results of a clinical trial into clinical practice, particularly when the resulting subgroup analysis is of elderly patients because this patient group is composed of a heterogeneous population.
  
  
  BACKGROUND
  UMIN-CTR identifier: UMIN000010738.
authors.affiliation: Department of Thoracic Oncology and Respiratory Medicine, Tokyo Metropolitan Cancer and Infectious diseases Center Komagome Hospital, Honkomagome 3-18-22, Bunkyo, Tokyo, 113-8677, Japan. y-okuma@cick.jp.|Division of Oncology, Research Center for Medical Sciences, The Jikei University School of Medicine, Minato, Tokyo, 105-8461, Japan. y-okuma@cick.jp.
authors.forename: Yusuke
authors.identifier: http://orcid.org/0000-0001-5743-0149
authors.initials: Y
authors.lastname: Okuma
authors.affiliation: Department of Thoracic Oncology and Respiratory Medicine, Tokyo Metropolitan Cancer and Infectious diseases Center Komagome Hospital, Honkomagome 3-18-22, Bunkyo, Tokyo, 113-8677, Japan.
authors.forename: Yukio
authors.initials: Y
authors.lastname: Hosomi
authors.affiliation: Department of Thoracic Oncology and Respiratory Medicine, Tokyo Metropolitan Cancer and Infectious diseases Center Komagome Hospital, Honkomagome 3-18-22, Bunkyo, Tokyo, 113-8677, Japan.|Department of Pulmonary Medicine and Oncology, Graduate School of Medicine, Nippon Medical School, Bunkyo, Tokyo, 113-8603, Japan.
authors.forename: Satoshi
authors.initials: S
authors.lastname: Takahashi
authors.affiliation: Department of Thoracic Oncology and Respiratory Medicine, Tokyo Metropolitan Cancer and Infectious diseases Center Komagome Hospital, Honkomagome 3-18-22, Bunkyo, Tokyo, 113-8677, Japan.|Department of Respiratory Medicine, Kitasato University School of Medicine, Sagamihara, Kanagawa, 252-0375, Japan.
authors.forename: Yoshiro
authors.initials: Y
authors.lastname: Nakahara
authors.affiliation: Department of Thoracic Oncology and Respiratory Medicine, Tokyo Metropolitan Cancer and Infectious diseases Center Komagome Hospital, Honkomagome 3-18-22, Bunkyo, Tokyo, 113-8677, Japan.
authors.forename: Kageaki
authors.initials: K
authors.lastname: Watanabe
authors.affiliation: Department of Thoracic Oncology and Respiratory Medicine, Tokyo Metropolitan Cancer and Infectious diseases Center Komagome Hospital, Honkomagome 3-18-22, Bunkyo, Tokyo, 113-8677, Japan.
authors.forename: Makoto
authors.initials: M
authors.lastname: Nagamata
authors.affiliation: Department of Thoracic Oncology and Respiratory Medicine, Tokyo Metropolitan Cancer and Infectious diseases Center Komagome Hospital, Honkomagome 3-18-22, Bunkyo, Tokyo, 113-8677, Japan.|MSD K.K., Chiyoda, Tokyo, 102-8667, Japan.
authors.forename: Yusuke
authors.initials: Y
authors.lastname: Takagi
authors.affiliation: Department of Respiratory Medicine, Fujieda Municipal General Hospital, Fujieda, Shizuoka, 426-8677, Japan.
authors.forename: Shinichiro
authors.initials: S
authors.lastname: Mikura
mesh_terms: D000368:Aged; D000369:Aged, 80 and over; D000418:Albumins / Q000008:administration & dosage; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000008:administration & dosage* / Q000009:adverse effects; D019540:Area Under Curve; D044466:Asian People; D016190:Carboplatin / Q000008:administration & dosage; D002289:Carcinoma, Non-Small-Cell Lung / Q000188:drug therapy* / Q000473:pathology; D018572:Disease-Free Survival; D006801:Humans; D008175:Lung Neoplasms / Q000188:drug therapy* / Q000473:pathology; D017239:Paclitaxel / Q000008:administration & dosage; D015996:Survival Rate
chemical_list: C520255:130-nm albumin-bound paclitaxel; D000418:Albumins; D016190:Carboplatin; D017239:Paclitaxel
keywords: Carboplatin; Chemotherapy; Elderly; Nab-paclitaxel; Non-small cell lung cancer