title: Paclitaxel efficacy and toxicity in older women with metastatic breast cancer: combined analysis of CALGB 9342 and 9840.
abstract: BACKGROUND
  Two Cancer and Leukemia Group B (CALGB) studies were utilized to determine the efficacy and tolerability of paclitaxel (Taxol) in older patients with metastatic breast cancer.
  
  
  METHODS
  CALGB 9840 evaluated weekly paclitaxel (80 mg/m(2)) versus paclitaxel every 3 weeks (175 mg/m(2)); CALGB 9342 evaluated three doses of paclitaxel as follows: 175, 210 and 250 mg/m(2) each over 3 h every 3 weeks. Of the 1048 patients, paclitaxel was used first line in 57%. The groups: (i) <55 years (45%), (ii) 55-64 years (29%), and (iii) ≥65 years (26%).
  
  
  RESULTS
  Tumor response was also similar among age groups. First-line therapy (P = 0.0001) and better performance status (PS) (P = 0.018) were significantly related to higher response. Age did not significantly relate to overall survival (OS) or progression-free survival (PFS). First-line therapy, better PS, estrogen receptor positive status and a fewer number of metastatic sites were significantly related to improved OS and PFS. The grade ≥3 toxic effects that increased linearly with age were leucopenia (P = 0.0099), granulocytopenia (P = 0.022), anorexia (P = 0.028), bilirubin elevation (P = 0.0035) and neurotoxicity (P < 0.0001). Patients over 65 years receiving second-line therapy had the shortest time to neurotoxicity.
  
  
  CONCLUSIONS
  Older women with breast cancer derive similar efficacy from treatment with paclitaxel as younger women. Older women are at increased risk for specific toxic effects.
authors.affiliation: Department of Medicine, Memorial Sloan-Kettering Cancer Center, New York. Electronic address: lichtmas@mskcc.org.
authors.forename: S M
authors.initials: SM
authors.lastname: Lichtman
authors.affiliation: Department of Medical Oncology and Therapeutics Research and Department of Population Sciences, City of Hope, Duarte.
authors.forename: A
authors.initials: A
authors.lastname: Hurria
authors.affiliation: CALGB Statistical Center, Durham.
authors.forename: C T
authors.initials: CT
authors.lastname: Cirrincione
authors.affiliation: Department of Medicine, Memorial Sloan-Kettering Cancer Center, New York.
authors.forename: A D
authors.initials: AD
authors.lastname: Seidman
authors.affiliation: Breast Oncology Center, Dana-Farber Cancer Institute, Boston.
authors.forename: E
authors.initials: E
authors.lastname: Winer
authors.affiliation: Department of Medicine, Memorial Sloan-Kettering Cancer Center, New York.
authors.forename: C
authors.initials: C
authors.lastname: Hudis
authors.affiliation: Center for the Study of Aging and Human Development, Duke University, Durham.
authors.forename: H J
authors.initials: HJ
authors.lastname: Cohen
authors.affiliation: UNC Lineberger Comprehensive Cancer Center, University of North Carolina-Chapel Hill, USA.
authors.forename: H B
authors.initials: HB
authors.lastname: Muss
mesh_terms: D000328:Adult; D000367:Age Factors; D000368:Aged; D000970:Antineoplastic Agents / Q000009:adverse effects*; D001943:Breast Neoplasms / Q000188:drug therapy* / Q000401:mortality / Q000473:pathology; D018572:Disease-Free Survival; D005260:Female; D006801:Humans; D053208:Kaplan-Meier Estimate; D008875:Middle Aged; D009362:Neoplasm Metastasis; D017239:Paclitaxel / Q000009:adverse effects*; D016032:Randomized Controlled Trials as Topic; D012189:Retrospective Studies
chemical_list: D000970:Antineoplastic Agents; D017239:Paclitaxel