PT  - JOURNAL ARTICLE
AU  - SKARLOS, DIMOSTHENIS V.
AU  - KALOFONOS, HARALABOS P.
AU  - FOUNTZILAS, GEORGE
AU  - DIMOPOULOS, MELETIOS A.
AU  - PAVLIDIS, NICHOLAS
AU  - RAZIS, EVANGELIA
AU  - ECONOMOPOULOS, THEOFANIS
AU  - PECTASIDES, DIMITRIOS
AU  - GOGAS, HELEN
AU  - KOSMIDIS, PARIS
AU  - BAFALOUKOS, DIMITRIOS
AU  - KLOUVAS, GEORGE
AU  - KYRATZIS, GEORGE
AU  - ARAVANTINOS, GERASIMOS
TI  - Gemcitabine Plus Pegylated Liposomal Doxorubicin in Patients with Advanced Epithelial Ovarian Cancer Resistant/Refractory to Platinum and/or Taxanes. A HeCOG Phase II Study
DP  - 2005 Jul 01
TA  - Anticancer Research
PG  - 3103--3108
VI  - 25
IP  - 4
4099  - http://ar.iiarjournals.org/content/25/4/3103.short
4100  - http://ar.iiarjournals.org/content/25/4/3103.full
SO  - Anticancer Res2005 Jul 01; 25
AB  - Background: 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 and Methods: 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. Results: 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. Conclusion: 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. Copyright© 2005 International Institute of Anticancer Research (Dr. John G. Delinassios), All rights reserved