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.
Ferrandina
Gabriella
G
Gynecologic Oncology Unit, Catholic University of Rome, L.go A. Gemelli, 8 00168 Rome, Italy. gabriella.ferrandina@libero.it
Paris
Ida
I
Ludovisi
Manuela
M
D'Agostino
Giuseppe
G
Testa
Antonia
A
Lorusso
Domenica
D
Zanghi
Mariangela
M
Pisconti
Salvatore
S
Pezzella
Giuseppa
G
Adamo
Vincenzo
V
Breda
Enrico
E
Scambia
Giovanni
G
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