title: Survival, quality-adjusted survival, and other clinical end points in older advanced non-small-cell lung cancer patients treated with albumin-bound paclitaxel.
abstract: BACKGROUND
  This analysis compared the quality-adjusted survival and clinical outcomes of albumin-bound paclitaxel+carboplatin (nab-PC) vs solvent-based paclitaxel+carboplatin (sb-PC) as first-line therapy in advanced non-small-cell lung cancer (NSCLC) in older patients.
  
  
  METHODS
  Using age-based subgroup data from a randomised Phase-3 clinical trial, nab-PC and sb-PC were compared with respect to overall response rate (ORR), overall survival (OS), progression-free survival (PFS), quality of life (QoL), safety/toxicity, and quality-adjusted time without symptoms or toxicity (Q-TWiST) with ages ⩾60 and ⩾70 years as cut points.
  
  
  RESULTS
  Among patients aged ⩾60 years (N=546), nab-PC (N=265) significantly increased ORR and prolonged OS, despite a non-significant improvement in PFS, vs sb-PC (N=281). Nab-PC improved QoL and was associated with less neuropathy, arthralgia, and myalgia but resulted in more anaemia and thrombocytopenia. Nab-PC yielded significant Q-TWiST benefits (11.1 vs 9.8 months; 95% CI of gain: 0.2-2.6), with a relative Q-TWiST gain of 10.8% (ranging from 6.4% to 15.1% in threshold analysis). In the ⩾70 years age group, nab-PC showed similar, but non-significant, ORR, PFS, and Q-TWiST benefits and significantly improved OS and QoL.
  
  
  CONCLUSIONS
  Nab-PC as first-line therapy in older patients with advanced NSCLC increased ORR, OS, and QoL and resulted in quality-adjusted survival gains compared with standard sb-PC.
authors.affiliation: Abramson Cancer Center, University of Pennsylvania, Philadelphia, PA, USA.
authors.forename: C J
authors.initials: CJ
authors.lastname: Langer
authors.affiliation: Department of Oncology, McGill University, Montreal, Quebec, Canada.
authors.forename: V
authors.initials: V
authors.lastname: Hirsh
authors.affiliation: Department of Medical Oncology, Kinki University, Osaka-Sayama, Japan.
authors.forename: I
authors.initials: I
authors.lastname: Okamoto
authors.affiliation: Pharmerit International, Bethesda, MD, USA.
authors.forename: F-J
authors.initials: FJ
authors.lastname: Lin
authors.affiliation: Pharmerit International, Bethesda, MD, USA.
authors.forename: Y
authors.initials: Y
authors.lastname: Wan
authors.affiliation: Celgene Corporation, Summit, NJ, USA.
authors.forename: S
authors.initials: S
authors.lastname: Whiting
authors.affiliation: Celgene Corporation, Summit, NJ, USA.
authors.forename: T J
authors.initials: TJ
authors.lastname: Ong
authors.affiliation: Celgene Corporation, Summit, NJ, USA.
authors.forename: M F
authors.initials: MF
authors.lastname: Renschler
authors.affiliation: Pharmerit International, Bethesda, MD, USA.
authors.forename: M F
authors.initials: MF
authors.lastname: Botteman
mesh_terms: D000368:Aged; D000369:Aged, 80 and over; D000068196:Albumin-Bound Paclitaxel; D000418:Albumins / Q000009:adverse effects / Q000627:therapeutic use; D000972:Antineoplastic Agents, Phytogenic / Q000009:adverse effects / Q000627:therapeutic use*; D002289:Carcinoma, Non-Small-Cell Lung / Q000188:drug therapy* / Q000503:physiopathology; D005260:Female; D006801:Humans; D008175:Lung Neoplasms / Q000188:drug therapy* / Q000503:physiopathology; D008297:Male; D008875:Middle Aged; D017239:Paclitaxel / Q000009:adverse effects / Q000627:therapeutic use*; D011788:Quality of Life; D016019:Survival Analysis; D016896:Treatment Outcome
chemical_list: D000068196:Albumin-Bound Paclitaxel; D000418:Albumins; D000972:Antineoplastic Agents, Phytogenic; D017239:Paclitaxel