title: Impact on survival of 12 versus 3 monthly cycles of paclitaxel (175 mg/m2) administered to patients with advanced ovarian cancer who attained a complete response to primary platinum-paclitaxel: follow-up of a Southwest Oncology Group and Gynecologic Oncology Group phase 3 trial.
abstract: OBJECTIVE
  A SWOG/GOG phase 3 trial exploring the impact of 12-monthly cycles of paclitaxel given to patients with advanced ovarian cancer who achieved a complete response to primary chemotherapy was discontinued by the Data Safety and Monitoring Committee when a prospectively defined interim analysis revealed a highly statistically significant improvement in progression-free survival (PFS). At study closure, it was too early to assess the impact on overall survival.
  
  
  METHODS
  Patients (n=296) received either 3 or 12 monthly cycles of paclitaxel (175 mg/m(2) over 3 h).
  
  
  RESULTS
  Of the 146 patients on the 3-cycle arm, 9 (6%) received >3 cycles. Median (12 versus 3 cycles; intention-to-treat analysis) updated PFS (all pts) 22 versus 14 months, p=0.006; overall survival (all pts) 53 versus 48 months, p=0.34.
  
  
  CONCLUSIONS
  Twelve cycles of single agent maintenance paclitaxel significantly improves PFS. Explanations for the lack of a favorable influence on overall survival include: (a) treatment at relapse equalized outcome; (b) the sample size was insufficient to reveal a difference; (c) "crossover" of patients from 3 cycles to longer treatment masked a potential difference. An ongoing phase 3 trial will hopefully provide a definitive answer to the question of the impact of this maintenance strategy on overall survival.
authors.affiliation: University of Texas MD Anderson Cancer Center, 1515 Holcombe Boulevard, Houston, TX 77005, USA. mmarkman@mdanderson.org
authors.forename: Maurie
authors.initials: M
authors.lastname: Markman
authors.forename: P Y
authors.initials: PY
authors.lastname: Liu
authors.forename: James
authors.initials: J
authors.lastname: Moon
authors.forename: Bradley J
authors.initials: BJ
authors.lastname: Monk
authors.forename: Larry
authors.initials: L
authors.lastname: Copeland
authors.forename: Sharon
authors.initials: S
authors.lastname: Wilczynski
authors.forename: David
authors.initials: D
authors.lastname: Alberts
mesh_terms: D000972:Antineoplastic Agents, Phytogenic / Q000008:administration & dosage*; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000008:administration & dosage; D016190:Carboplatin / Q000008:administration & dosage; D002945:Cisplatin / Q000008:administration & dosage; D018572:Disease-Free Survival; D004334:Drug Administration Schedule; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D010051:Ovarian Neoplasms / Q000188:drug therapy*; D017239:Paclitaxel / Q000008:administration & dosage*; D016016:Proportional Hazards Models
chemical_list: D000972:Antineoplastic Agents, Phytogenic; D016190:Carboplatin; D017239:Paclitaxel; D002945:Cisplatin