Modified ECF/wPELF in advanced gastric cancer. Results of a phase II trial

Abstract

4170 Background. Although ECF represents the treatment of choice in advanced gastric cancer, weekly PELF (wPELF) may be considered an interesting alternative schedule in such a subset of patients. We present activity and safety data of a modified-ECF/alternating wPELF, in which a 21-day ECF was alternated with 6 courses of wPELF in advanced gastric cancer. Methods. All the patients with advanced or relapsed gastric cancer were considered eligible and enrolled into the trial. All the patients were treated with cisplatin 60mg/mq on day 1, epidoxorubicin 50mg/mq on day 1 and 5FU 200mg/mq on day 1→21, followed by 6 courses of weekly cisplatin 25mg/mq, epidoxorubicin 10mg/mq, etoposide 40mg/mq, and 24-hours infusion of l-folinic acid 120mg/mq and 5FU 2200mg/mq until progression of the disease or intractable toxicity. G-CSF support was used during wPELF. Results. 29 patients were considered eligible and enrolled into the trial. 22 patients (75.8%) presented a measurable, metastatic disease, and 7 patients (24.2%) an valuable, but not-measurable disease. After a median follow up of 10 months 3 complete responses (10.4%), 6 partial responses (20.7%) and 9 stable diseases (34.4%) were observed, with a median time to progression of 257 days. Till today 22 patients (75.9%) were dead, with a median survival of 229 days and 18 (62%), 15 (51.7%) and 12 (41.4%) patients alive respectively after 6, 9 and 12 months of follow up. Toxicity was mild, with grade III leucopenia in 6 patients (20.7%), grade III-IV neutropenia in 15 patients (51.7%), grade III vomiting in 3 patients (10.3%), grade III diarrhoea in 1 patient (3.4%), grade III mucositis in 1 patient (3.4%). No febrile neutropenia, nor haemorrhagic thrombocitopenia occurred in any patient. Conclusions. The addition of wPELF to ECF seems to add nothing in terms of activity against metastatic gastric cancer; otherwise the high effectiveness in terms of median survival and 1-year survival rate, with the interesting safety make the modified ECF/wPELF an interesting option as first line treatment of gastric cancer for further phase III trials. (Supported by IOR) No significant financial relationships to disclose.