Gemcitabine and liposomal doxorubicin in the salvage treatment of ovarian cancer: updated results and long-term survival.
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.
Gynecologic Oncology Unit, Catholic University of Rome, L.go A. Gemelli, 8 00168 Rome, Italy. gabriella.ferrandina@libero.it
Gabriella
G
Ferrandina
Ida
I
Paris
Manuela
M
Ludovisi
Giuseppe
G
D'Agostino
Antonia
A
Testa
Domenica
D
Lorusso
Mariangela
M
Zanghi
Salvatore
S
Pisconti
Giuseppa
G
Pezzella
Vincenzo
V
Adamo
Enrico
E
Breda
Giovanni
G
Scambia
D000328:Adult; D000368:Aged; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000009:adverse effects / Q000627:therapeutic use*; D003841:Deoxycytidine / Q000008:administration & dosage / Q000009:adverse effects / Q000031:analogs & derivatives; D004317:Doxorubicin / Q000008:administration & dosage / Q000009:adverse effects; D004334:Drug Administration Schedule; D005260:Female; D006801:Humans; D008875:Middle Aged; D009364:Neoplasm Recurrence, Local / Q000188:drug therapy*; D010051:Ovarian Neoplasms / Q000188:drug therapy*; D016879:Salvage Therapy; D015996:Survival Rate; D000093542:Gemcitabine
D003841:Deoxycytidine; D004317:Doxorubicin; D000093542:Gemcitabine