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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)
  1. Angiolo Gadducci, MD*,
  2. Dionyssios Katsaros, MD,
  3. Paolo Zola, MD,
  4. Giovanni Scambia, MD§,
  5. Michela Ballardini, BS,
  6. Enzo Pasquini, MD,
  7. Carlo Fertonani, MD#,
  8. Lorenzo Maggi, MD**,
  9. Sergio Pecorelli, MD††,
  10. Pier Franco Conte, MD‡‡,
  11. other members of the After-6 Italian Cooperative Group
  1. *Department of Gynecology and Obstetrics, University of Pisa, Pisa;
  2. Sant' Anna Hospital, and
  3. Mauriziano Hospital, University of Turin, Turin;
  4. §Catholic University of Rome, Rome;
  5. Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori (IRST), Melda (FC);
  6. Department of Medical Oncology, Cattolica Hospital, Rimini;
  7. #Cremona Hospital, Cremona;
  8. **San Giovanni di Dio Hospital, Florence;
  9. ††Department of Gynecology and Obstetrics, University of Brescia, Brescia; and
  10. ‡‡Department of Oncology and Hematology, University of Modena and Reggio Emilia, Modena, Italy.
  1. Address correspondence and reprint requests to Angiolo Gadducci, MD, Department of Procreative Medicine, Division of Gynaecology and Obstetrics, University of Pisa, Via Roma 56, Pisa 56127, Italy. E-mail: a.gadducci{at}obgyn.med.unipi.it.

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.

  • Ovarian cancer
  • Maintenance chemotherapy
  • Paclitaxel

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Footnotes

  • In memory of Giuseppe Favalli, who suddenly died on September 2005.

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