Skarlos Dimosthenis V, Kalofonos Haralabos P, Fountzilas George, Dimopoulos Meletios A, Pavlidis Nicholas, Razis Evangelia, Economopoulos Theofanis, Pectasides Dimitrios, Gogas Helen, Kosmidis Paris, Bafaloukos Dimitrios, Klouvas George, Kyratzis George, Aravantinos Gerasimos
Second Department of Medical Oncology, "Henry Dunant" Hospital, Athens, Greece.
Anticancer Res. 2005 Jul-Aug;25(4):3103-8.
A phase II study was conducted to evaluate the efficacy and toxicity of the combination of gemcitabine (GEM) and pegylated liposomal doxorubicin (PLD) in patients with platinum- and/or taxane-resistant/refractory advanced epithelial ovarian cancer (AEOC).
Patients (pts), who had been treated with platinum or paclitaxel and met the criteria of resistant/refractory AEOC, received GEM 650 mg/m2 days 1 and 8 and PLD 25 mg/m2 day 1 every 4 weeks up to a total of 6 cycles, unless disease progression or adverse effects prohibited further therapy.
Thirty-seven patients entered the study. There was 1 complete (3%) and 7 partial responses (19%) for an overall response rate of 22%. Two patients had stable disease (5.5%). After a median follow-up of 16.2 months, the median survival was 8.4 months and time to treatment failure 2.7 months. The most frequent severe toxicity was myelosuppression recorded in 13 (35%) patients. Severe stomatitis was recorded in only 2 (5%) cases and severe palmar-plantar erythrodysesthesia in 1 patient. One severe allergic reaction (grade 4) to PLD was recorded following the third cycle of treatment.
The combination of GEM and PLD in patients with AEOC, who are resistant/ refractory to platinum and/or Taxanes, did not show any superiority over monotherapy. However, in view of the acceptable toxicity profile, the above combination may deserve further investigation in a randomised setting.
