Weekly low-dose paclitaxel as maintenance treatment in patients with advanced ovarian cancer who had microscopic residual disease at second-look surgery after 6 cycles of paclitaxel/platinum-based chemotherapy: results of an open noncomparative phase 2 multicenter Italian study (After-6 Protocol 2)

Int J Gynecol Cancer. 2009 May;19(4):615-9. doi: 10.1111/IGC.0b013e3181a4476b.

Abstract

The aim of this paper was to assess whether weekly intravenous 60-mg/m2 paclitaxel for 21 weeks is feasible and effective as maintenance treatment in 64 patients with advanced ovarian cancer who had microscopic residual disease after 6 cycles of paclitaxel/platinum-based chemotherapy. Forty-eight patients completed the planned cycles of weekly paclitaxel. The worst toxicities were grade 2 leukopenia in 22.4% of the patients, grade 2 neutropenia in 25.9%, grade 2 sensorial neurotoxicity in 20.7%, and grade 2 motor neurotoxicity in 6.9%. Seventeen patients underwent a third-look surgery that showed a pathological complete response in 6 (35.3%, 95% confidence interval [CI], 17.3%-59.0%) cases. The 3-year progression-free survival rate was 18% (95% CI, 9.6%-33.8%), and the 3-year overall survival rate was 64% (95% CI, 52.0%-78.0%). Weekly low-dose paclitaxel is a feasible and well-tolerated maintenance treatment.

Publication types

  • Clinical Trial, Phase II
  • Multicenter Study

MeSH terms

  • Adult
  • Aged
  • Antineoplastic Combined Chemotherapy Protocols / adverse effects
  • Antineoplastic Combined Chemotherapy Protocols / therapeutic use*
  • Combined Modality Therapy
  • Dose-Response Relationship, Drug
  • Drug Administration Schedule
  • Female
  • Humans
  • Middle Aged
  • Neoplasm Staging
  • Neoplasm, Residual
  • Organoplatinum Compounds / administration & dosage
  • Organoplatinum Compounds / adverse effects
  • Ovarian Neoplasms / drug therapy*
  • Ovarian Neoplasms / pathology
  • Ovarian Neoplasms / surgery*
  • Paclitaxel / administration & dosage*
  • Paclitaxel / adverse effects
  • Second-Look Surgery

Substances

  • Organoplatinum Compounds
  • Paclitaxel