Gemcitabine and liposomal doxorubicin in the salvage treatment of ovarian cancer: updated results and long-term survival.

Abstract

OBJECTIVE:

The combination of GEM/PLD has been tested for its efficacy on survival of recurrent ovarian cancer patients.

METHODS:

This is a multicenter phase II study of GEM/PLD regimen in recurrent ovarian cancer patients previously treated with at least one platinum/paclitaxel regimen, and with evidence of measurable disease. PLD, 30 mg m(-2), was administered on day 1 followed by GEM, 1000 mg m(-2), on days 1 and 8, every 21 days.

RESULTS:

106 patients were available for response evaluation. 9 complete responses (8.5%) and 27 partial responses (25.5%) have been registered. 36 patients (34.0%) experienced stabilization of disease, while 34 (32.1%) cases progressed during treatment. OS was significantly shorter in platinum-resistant (median OS = 50 weeks) than in platinum-sensitive patients (median OS = 92 weeks) (P value = 0.0016). In the group of platinum-sensitive patients, cases responsive to GEM/PLD combination showed a better OS with respect to patients unresponsive to GEM/PLD (median OS = 120 weeks versus median OS = 60 weeks, P value = 0.019). The same trend was observed in platinum-resistant patients. Grade 4 hematological toxicity affected 20 patients (18%). Grade 3 palmar-plantar erythrodysesthesia (PPE) was registered in 16 patients (14.4%). Grades 3 and 4 mucositis was documented in 16 (14.4%) and 2 (1.8%) patients, respectively.

CONCLUSIONS:

GEM/PLD combination represents a valid approach in recurrent ovarian cancer patients. The hematological toxicity was easily managed, and the incidence and severity of PPE was low.

• Authors: Gabriella Ferrandina, Ida Paris, Manuela Ludovisi, Giuseppe D'Agostino, Antonia Testa, Domenica Lorusso, Mariangela Zanghi, Salvatore Pisconti, Giuseppa Pezzella, Vincenzo Adamo, Enrico Breda, Giovanni Scambia
• Journal: Gynecologic oncology (Gynecol Oncol) Vol. 98 Issue 2 Pg. 267-73 (Aug 2005) ISSN: 0090-8258 [Print] United States
• PMID: 15975643 (Publication Type: Clinical Trial, Clinical Trial, Phase II, Journal Article, Multicenter Study, Research Support, Non-U.S. Gov't)

Chemical References

• Deoxycytidine
• Doxorubicin
• Gemcitabine

Topics

• Adult
• Aged
• Antineoplastic Combined Chemotherapy Protocols (adverse effects, therapeutic use)
• Deoxycytidine (administration & dosage, adverse effects, analogs & derivatives)
• Doxorubicin (administration & dosage, adverse effects)
• Drug Administration Schedule
• Female
• Humans
• Middle Aged
• Neoplasm Recurrence, Local (drug therapy)
• Ovarian Neoplasms (drug therapy)
• Salvage Therapy
• Survival Rate
• Gemcitabine