Platinum-based combinations as first-line chemotherapy in advanced, persistent, or recurrent cervical cancer.

Abstract

e15543 Background: Platinum compounds are the most active agents in cervical carcinoma. The aim of this study was to evaluate the activity and toxicity of platinum-based chemotherapy as first line treatment in patients with advanced/recurrent cervical cancer. Methods: Since 2005 to 2011years 68 pts were include in the pilot study. Patients with histological proven primary carcinoma, measurable tumors, age ≥ 18, PS of 0-1, adequate bone marrow, renal and hepatic functions were eligible for this trial. Prior chemotherapy was allowed only in the context of radiosensitization. Treatment consisted of 2 modes: PC - paclitaxel 175 mg/m2 3-h I.v. + cisplatin 75 mg/m2 or carboplatin AUC-6 ( 6 pts)- d1x 21d; IC – irinotecan 65 ìg/m2 + cisplatin 40 mg/m2 on d 1 and 8 x 21 d. Responses were assessed using RESIST. Results: 68 pts were identified. There were no differences between the groups in terms prior radiation or radiochemotherapy. Group PC: 28 pts were included. Efficacy and toxicity was available for 27. Two pts continue treatment. Median age 43,5 years (range 28-69). The ORR was 55.5% (CR - 5(18.5%) and PR -10(37.0%)). 8 pts (29.6%) SD and 4 (14.8%) PD. The median TTP was 7 months. Overall, 148 cycles were administered with a median of 5 (range 2-8) cycles. Major toxicities were as follows: GIII and GIV neutropenia in 22.2% and 11.1% pts; GIII anemia - in 2 pts; GI-II neuropathy in 45.9% pts. G III nausea/vomiting were in 3 pts (11.1%). Group IC: 40 pts were included, 38 were available for efficacy. Median age 49,8 years (range 25-67). The ORR was 47.3% (5 CR(13.2%) and 13 PR (34.2%)). 13 (34.2%) pts had SD and 7 (18.4%) - PD. The median TTP was 6 months. All 40 pts receved 254 cycles ( median 6.3 (range 1-11) cycles. GIII and IV neutropenia were in 40% and 10% pts; GIII anemia in 20% pts. G I-II neuropathy and G I-II diarrhea in 15% pts and 30%pts. G IV of diarrhea observed in 1 pt. GIII-IV nausea and vomiting were in 20% and 15%pts. There were no statistical differences in clinical outcome (OR(p= 0,69) and TTP(p=0,65)) between these 2 platinum-based regimes. Conclusions: Our data indicate that both regimes had high efficacy and well tolerated as first line treatment in patients with advanced/recurrent cervical cancer. The randomized study is necessary.