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Phase III Trial of Gemcitabine Compared With Pegylated Liposomal Doxorubicin in Progressive or Recurrent Ovarian Cancer

Gabriella Ferrandina, Manuela Ludovisi, Domenica Lorusso, Sandro Pignata, Enrico Breda, Antonella Savarese, Pietro Del Medico, Laura Scaltriti, Dionyssios Katsaros, Domenico Priolo, Giovanni Scambia

From the Department of Oncology, Catholic University, Campobasso; Gynecologic Oncology Unit, Catholic University of Rome; Medical Oncology, Ospedale S. Giovanni Calibita Fatebenefratelli; Medical Oncology, Regina Elena Institute, Rome; Medical Oncology, National Cancer Institute, Naples; Medical Oncology, Ospedali Riuniti, Reggio Calabria; Department of Medical Oncology, "Ramazzini" Hospital, Carpi; Department of Obstetrics and Gynecology, Gynecologic Oncology Unit, University of Turin, Turin; and Medical Oncology, S. Vincenzo Hospital, Taormina, Italy

Corresponding author: Gabriella Ferrandina, MD, Department of Oncology, Catholic University, Campobasso, Contrada Tappino, L.Go A. Gemelli, 1, Campobasso, Italy; e-mail: gabriella.ferrandina{at}libero.it

Purpose: We aimed at investigating the efficacy, tolerability, and quality of life (QOL) of gemcitabine (GEM) compared with pegylated liposomal doxorubicin (PLD) in the salvage treatment of recurrent ovarian cancer.

Patients and Methods: A phase III randomized multicenter trial was planned to compare GEM (1,000 mg/m² on days 1, 8, and 15 every 28 days) with PLD (40 mg/m² every 28 days) in ovarian cancer patients who experienced treatment failure with only one platinum/paclitaxel regimen and who experienced recurrence or progression within 12 months after completion of primary treatment.

Results: One hundred fifty-three patients were randomly assigned to PLD (n = 76) or GEM (n = 77). Treatment arms were well balanced for clinicopathologic characteristics. Grade 3 or 4 neutropenia was more frequent in GEM-treated patients versus PLD-treated patients (P = .007). Grade 3 or 4 palmar-plantar erythrodysesthesia was documented in a higher proportion of PLD patients (6%) versus GEM patients (0%; P = .061). The overall response rate was 16% in the PLD arm compared with 29% in the GEM arm (P = .056). No statistically significant difference in time to progression (TTP) curves according to treatment allocation was documented (P = .411). However, a trend for more favorable overall survival was documented in the PLD arm compared with the GEM arm, although the P value was of borderline statistical significance (P = .048). Statistically significantly higher global QOL scores were found in PLD-treated patients at the first and second postbaseline QOL assessments.

Conclusion: GEM does not provide an advantage compared with PLD in terms of TTP in ovarian cancer patients who experience recurrence within 12 months after primary treatment but should be considered in the spectrum of drugs to be possibly used in the salvage setting.

Authors’ disclosures of potential conflicts of interest and author contributions are found at the end of this article.

Related Correspondence

• Is Single-Agent Chemotherapy Acceptable in Platinum-Sensitive Relapsed Ovarian Cancer?
  Rony M. Abou-Jawde and Satinderjit S. Oberoi
  JCO 2008 26: 2602-2603 [Full Text]

This article has been cited by other articles:

				R. M. Abou-Jawde and S. S. Oberoi Is Single-Agent Chemotherapy Acceptable in Platinum-Sensitive Relapsed Ovarian Cancer? J. Clin. Oncol., May 20, 2008; 26(15): 2602 - 2603. [Full Text] [PDF]

				G. Ferrandina, M. Ludovisi, G. Scambia, and S. Pignata In Reply J. Clin. Oncol., May 20, 2008; 26(15): 2603 - 2603. [Full Text] [PDF]