title: Patient-reported neuropathy and taxane-associated symptoms in a phase 3 trial of nab-paclitaxel plus carboplatin versus solvent-based paclitaxel plus carboplatin for advanced non-small-cell lung cancer.
abstract: BACKGROUND
  nab-Paclitaxel (nab-P) is approved, in the United States, in combination with carboplatin for the first-line treatment of advanced non-small-cell lung cancer, based on a randomized phase 3 trial of nab-P plus carboplatin (nab-P/C) versus solvent-based paclitaxel plus carboplatin (sb-P/C). This trial revealed a higher overall response rate (33% versus 25%; p = 0.005) and longer, but not statistically significant, overall and progression-free survival for nab-P/C versus sb-P/C. In addition, nab-P/C demonstrated lower rates of grade 3 or higher peripheral neuropathy, myalgia, arthralgia, and neutropenia but higher rates of anemia and thrombocytopenia. This report analyzes patient and physician assessment of symptoms within this trial.
  
  
  METHODS
  Patients completed the taxane subscale of the Functional Assessment of Cancer Therapy questionnaire, which focuses on taxane toxicity, including peripheral neuropathy and neurotoxicity. Mean baseline scores and changes from baseline are reported. Physicians also graded the severity of neuropathy at each patient visit using National Cancer Institute Common Toxicity Criteria.
  
  
  RESULTS
  Patients receiving nab-P/C reported significantly less worsening of peripheral neuropathy (p < 0.001), pain (p < 0.001), and hearing loss (p = 0.002). Patient-reported edema was similar between the two treatment arms. In agreement with patient-reported symptoms, the results of a per-treatment cycle physician assessment of peripheral neuropathy also favored nab-P/C over sb-P/C (p < 0.001).
  
  
  CONCLUSIONS
  In this trial of patients receiving first-line treatment for advanced non-small-cell lung cancer, nab-P/C was associated with statistically and clinically significant reductions in patient-reported neuropathy, neuropathic pain in the hands and feet, and hearing loss compared with sb-P/C.
authors.affiliation: *McGill University, Montreal, Quebec, Canada; †Kinki University Faculty of Medicine, Osaka-Sayama, Japan; ‡Clearview Cancer Institute, Huntsville, Alabama; §The Center for Cancer and Blood Disorders, Fort Worth, Texas; ‖Essex Oncology of New Jersey, Belleville, New Jersey; ¶Saitama Cancer Center, Saitama, Japan; #Celgene Corporation, Summit, New Jersey; and **University of Pittsburgh Medical Center, Pittsburgh, Pennsylvania.
authors.forename: Vera
authors.initials: V
authors.lastname: Hirsh
authors.forename: Isamu
authors.initials: I
authors.lastname: Okamoto
authors.forename: Jeremy K
authors.initials: JK
authors.lastname: Hon
authors.forename: Ray D
authors.initials: RD
authors.lastname: Page
authors.forename: James
authors.initials: J
authors.lastname: Orsini
authors.forename: Hiroshi
authors.initials: H
authors.lastname: Sakai
authors.forename: Hui
authors.initials: H
authors.lastname: Zhang
authors.forename: Markus F
authors.initials: MF
authors.lastname: Renschler
authors.forename: Mark A
authors.initials: MA
authors.lastname: Socinski
mesh_terms: D000328:Adult; D000368:Aged; D000418:Albumins / Q000008:administration & dosage / Q000009:adverse effects; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000009:adverse effects*; D001952:Bridged-Ring Compounds / Q000009:adverse effects*; D016190:Carboplatin / Q000008:administration & dosage / Q000009:adverse effects; D002289:Carcinoma, Non-Small-Cell Lung / Q000188:drug therapy*; D005260:Female; D006801:Humans; D008175:Lung Neoplasms / Q000188:drug therapy*; D008297:Male; D008875:Middle Aged; D017239:Paclitaxel / Q000008:administration & dosage / Q000009:adverse effects; D020364:Paraneoplastic Polyneuropathy / Q000139:chemically induced*; D011788:Quality of Life; D043823:Taxoids / Q000009:adverse effects*
chemical_list: C520255:130-nm albumin-bound paclitaxel; D000418:Albumins; D001952:Bridged-Ring Compounds; D043823:Taxoids; C080625:taxane; D016190:Carboplatin; D017239:Paclitaxel