Gemcitabine plus pegylated liposomal doxorubicin in patients with advanced epithelial ovarian cancer resistant/refractory to platinum and/or taxanes. A HeCOG phase II study.
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).


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.


CONCLUSIONS
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.
Skarlos
Dimosthenis V
DV
Second Department of Medical Oncology, "Henry Dunant" Hospital, Athens, Greece. hecogiat@otenet.gr
Kalofonos
Haralabos P
HP
Fountzilas
George
G
Dimopoulos
Meletios A
MA
Pavlidis
Nicholas
N
Razis
Evangelia
E
Economopoulos
Theofanis
T
Pectasides
Dimitrios
D
Gogas
Helen
H
Kosmidis
Paris
P
Bafaloukos
Dimitrios
D
Klouvas
George
G
Kyratzis
George
G
Aravantinos
Gerasimos
G
D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; 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; D018432:Drug Resistance, Multiple; D019008:Drug Resistance, Neoplasm; D005260:Female; D006801:Humans; D008875:Middle Aged; D009944:Organoplatinum Compounds / Q000627:therapeutic use; D010051:Ovarian Neoplasms / Q000188:drug therapy*; D043823:Taxoids / Q000627:therapeutic use; D000093542:Gemcitabine
D009944:Organoplatinum Compounds; D043823:Taxoids; D003841:Deoxycytidine; D004317:Doxorubicin; D000093542:Gemcitabine