Docetaxel and oxaliplatin combination as second-line treatment in patients with advanced gastric cancer

Abstract

4188 Background: Chemotherapy is the only treatment option for advanced gastric cancer (AGC) patients (pts). First line regimens are able to provide a slight but significant increase of survival rates. Pts with good performance status could receive a second line, even though there are no established indications. Several new drugs, like docetaxel, irinotecan and oxaliplatin have recently been shown to be active also for AGC, but no data are available on the efficacy and safety of a newer drugs combination regimen after progression to a platinum or a non platinum-based first line chemotherapy. Methods: Pts with histologically confirmed AGC and PS (ECOG) < 2, progressed after a first line were eligible. Based on a previous phase I study (Agelakis, ASCO 2000) pts were treated with docetaxel 75 mg/m2 day 1 and oxaliplatin 80 mg/m2 day 2, every 3 weeks, until progression or unacceptable toxicity. According to the Simon design, at least one response had to be achieved among the first 18 pts, followed by a second step with 22 more pts. Results: From September 2003 until now, twenty-three pts were enrolled. Male 75%, median age 62. Metastatic site was liver in 85% and lung in 35%; primary tumor not resected in 50%. First line treatment ECF 60%, cisplatin and infusional 5-FU 30%, irinotecan and infusional 5-FU 10%. Median number of cycles 4.8. The treatment was well tolerated with no toxic deaths. The incidence of NCI-CTC grade 3–4 toxicities was low: 8 pts (40%) had grade 3–4 neutropenia, febrile neutropenia was never observed. Three pts (15%) had grade 3 asthenia and 2 (10%) grade 3 neurotoxicity. Concerning efficacy, among 20 evaluable pts 3 (15%) had a confirmed PR, 8 (40%) a SD and 9 (45%) PD. An improvement of PS and a symptoms palliation have been seen in 7 pts (35%). Median time to progression was 4.8 months. Median overall survival has not been reached yet and the study is still ongoing. Conclusions: This regimen is safe and shows an interesting profile of efficacy. If data will be confirmed in larger phase II-III studies, it should be considered a suitable option as second line therapy for AGC in pts with good PS. No significant financial relationships to disclose.