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Multicenter Phase 2 Study of Combined Gemcitabine and Epirubicin as Second-Line Treatment for Patients With Advanced Ovarian Cancer
  1. Viviana Murgia, MD*,
  2. Roberto Sorio, MD,
  3. Claudia Griso, MD,
  4. Orazio Caffo, MD*,
  5. Carmela Arcuri, MD*,
  6. Antonella Ferro, MD*,
  7. Alessia Caldara, MD*,
  8. Simona Scalone, MD,
  9. Emilio Arisi, MD§ and
  10. Enzo Galligioni, MD*
  1. * Department of Medical Oncology, Santa Chiara Hospital, Trento;
  2. Department of Medical Oncology C, Oncology Centre of Aviano;
  3. Department of Medical Oncology, Civil Hospital of Verona; and
  4. § Department of Gynecology, Santa Chiara Hospital, Trento, Italy.
  1. Address correspondence and reprint requests to Viviana Murgia, MD, Department of Medical Oncology, Santa Chiara Hospital, Largo Medaglie d'Oro, 38100, Trento, Italy. E-mail: viviana.murgia{at}apss.tn.it.

Abstract

Objective: The aim of this phase 2 trial was to evaluate the tolerability and efficacy of combined gemcitabine (G) and epirubicin (E) as second-line treatment for patients with advanced ovarian cancer.

Methods: Treatment with G 1000 mg/m2 (days 1 and 8) and E 60 mg/m2 (day 1) every 3 weeks for 3 or, in the absence of progression, 6 courses.

Results: Fifty patients with advanced ovarian cancer (31 serous, 2 endometrioid, 10 unclassified adenocarcinoma, and 7 other) and a median age of 60 years (range, 38-74 years) were enrolled after giving their informed consent. Performance status according to the Eastern Cooperative Oncology Group was 0 in 29 patients (58%), 1 in 17 patients (34%), and 2 in 4 patients (8%), and the initial stages according to the International Federation of Gynecology and Obstetrics were I to II in 4 patients (8%), III in 31 patients (62%), and IV in 15 patients (30%). They had previously received a median of 1.5 lines of treatment (range, 1-4). The median platinum-free interval was 5 months (range, 0-12 months): 32 patients had relapse within 6 months and 18 patients had relapse after 6 months.

The response rate was 42% (2% complete response and 40% partial response), with a median duration of 7.2 months: the corresponding figures were 37.5% and 5.2 months in the platinum-resistant patients and 50% and 8.8 months in the platinum-sensitive patients. The main grade 3 to 4 hematological toxicity was neutropenia (56% of cases). After a median follow-up of 13.5 months, median progression-free survival was 5 months, and median overall survival was 23.5 months.

Conclusions: This E + G combination seems to be active and safe in platinum-resistant/refractory patients.

  • Ovarian cancer
  • Epirubicin
  • Gemcitabine

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Footnotes

  • The authors declare no conflicts of interest.

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