role of gemcitabine and cisplatin as first line therapy in patients with advanced ovarian carcinoma

ABSTRACT

This study included 40 patients with histopathologically proved advanced stages III and IV ovarian carcinoma according to 1998 criteria of International Federation of Gynecology and Obstetrics [FIGO] staging system. Patients were divided into two groups Group I a prospectively studied group of 20 previously untreated patients, seen during the period from December 1999 to December 2000, who received cisplatin [100mg/m[2]] day I and gemcitabine [1250mg/m[2]] day and day 8 and the cycle was repeated every 21 days. Group II a retrospectively 20 patients, fulfilling the same eligibility criteria, who received cisplatin [100mg/m[2]] and cyclophosphamide [750mg/m[2]], both in day I and the cycle was repeated every 21 days. All patients in both groups received a total of six courses of treatment and the response was determined by clinical examination as well as pelvi-abdominal ultrasound, and pelvi-abdominal computed tomography. Complete response was achieved in 35% of cases in group I vs 15% in group II, while partial response was obtained in 35% in both groups. There were no statistical significant difference between overall response rate [O.R.R] in both groups [X2 = 3.86, P 0.277]. Patients who received gemcitabine/ cisplatin combination chemotherapy showed less anemia and less renal toxicity with better tolerance than the cyclophosphamide / cisplatin arm. There were no statistical significant difference between overall survival [O.S] in both arms, however the progression free survival [P.F.S] was better in group I and reached the level of significance compared to group II [P=0.03]