TY - JOUR
T1 - Gemcitabine and liposomal doxorubicin in the salvage treatment of ovarian cancer
T2 - Updated results and long-term survival
AU - Ferrandina, Gabriella
AU - Paris, Ida
AU - Ludovisi, Manuela
AU - D'Agostino, Giuseppe
AU - Testa, Antonia
AU - Lorusso, Domenica
AU - Zanghi, Mariangela
AU - Pisconti, Salvatore
AU - Pezzella, Giuseppa
AU - Adamo, Vincenzo
AU - Breda, Enrico
AU - Scambia, Giovanni
PY - 2005/8
Y1 - 2005/8
N2 - 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.
AB - 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.
KW - Gemcitabine
KW - Liposomal doxorubicin
KW - Recurrent ovarian cancer
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U2 - 10.1016/j.ygyno.2005.04.018
DO - 10.1016/j.ygyno.2005.04.018
M3 - Article
C2 - 15975643
AN - SCOPUS:22644432004
VL - 98
SP - 267
EP - 273
JO - Gynecologic Oncology
JF - Gynecologic Oncology
SN - 0090-8258
IS - 2
ER -