Dr. Cocconi's group randomly assigned nearly 200 patients less than 76 years old with metastatic gastric cancer into one of two study arms. Patients received 6 cycles each of the assigned regimen. There was a 13% complete response rate among patients in the PELF group compared with a 2% complete response rate for patients treated with FAMTX. The collective complete and partial response rate was 39% for PELF and 22% for FAMTX. Median survival was 7.7 months and 6.9 months, respectively. The 12-month survival rate (30.8% vs. 22.4%) and 24-month survival rate (15.7% vs. 9.5%) also favored the PELF group.

Toxicities were similar overall, although nausea, vomiting, and diarrhea were more severe in the PELF group, and mucositis was worse among patients treated with FAMTX.

Dr. Cocconi noted that the PELF regimen was more active in producing complete and partial response rates, improved one- and two-year survival (although not significantly), and had comparable toxicity. Along with PELF, similar compound combinations (FLEP, ECF) can be considered the most advanced new-generation regimens for metastatic gastric carcinoma; FAMTX should not be in that category any longer. Trials of the PELF combination for use as adjuvant chemotherapy are now indicated, said Dr. Cocconi.