Objectives.:Platinum resistance is a significant problem in patients with ovarian cancer. The aim of this phase II study was to define the response rates,the progression-free survival and the toxicity profile of the combination of PEG liposomal doxorubicin (L-DXR) and gemcitabine (GEM). Material and methods.:Thirty one patients with histologically confirmed platinum-refractory or-resistant epithelial ovarian cancer were scheduled to receive 6 cycles of L-DXR 30 mg/m2 on day 1 as well as GEM 650 mg/m2 on days 1 and 8 every 28 days. Results.:The median number of chemotherapy cycles given was 4. The mean dose intensity for L-DXR and GEM on day 1 was 96%and 97%,respectively. The mean dose intensity for GEM on day 8 was 93%. The overall response rate was 33%(10 of 30 evaluable patients; 20%complete responses). The median progression-free survival was 3.8 months,and the median overall survival was 15.8 months,respectively. Toxicity was acceptable. One quarter of patients developed grade 3 or 4 neutropenia,but none developed febrile neutropenia. Palmoplantar erythrodysesthesia (PPE) grades 2 and 3 occurred in 13%and 3%only,respectively,and no grade 4 PPE was observed. Grades 1 to 3 stomatitis was found in 58%of patients (10%grade 3). Conclusion.:The combination of L-DXR and GEM is an active and acceptably tolerated option in the treatment of patients with platinum-resistant and-refractory ovarian cancer. Dose reductions seem advisable in the case of ≥grade 2 stomatitis and/or PPE ≥grade 2.
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