Phase I--II study of the combination of 5-FU, doxorubicin, mitomycin, and semustine (FAMMe) in the treatment of adenocarcinoma of the stomach, gastroesophageal junction, and pancreas.

One hundred and fifteen patients with advanced gastrointestinal cancer (stomach cancer, 42 patients; gastroesophageal junction cancer, ten; pancreatic cancer, 32; and other upper gastrointestinal cancers, 31) were treated with a combination chemotherapy regimen consisting of 5-FU, doxorubicin, mitomycin, and semustine (methyl-CCNU) (FAMMe). Of the 31 patients with stomach cancer who were evaluable for response and had had no previous chemotherapy, 12 (39%) achieved complete or partial remission. One of eight (12%0 patients with gastroesophageal junction cancer and five of 23 (22%) patients with pancreatic cancer achieved a partial remission. The median duration of survival for all patients with adenocarcinoma of the stomach was 7.1 months. The median duration of survival for responding patients with stomach cancer was 13.6 months, and the median survival for nonresponding patients was 6.1 months. FAMMe chemotherapy was generally well-tolerated and can be administered in adequate doses without producing prohibitive myelosuppression. The starting dose should be reduced for patients greater than or equal to 70 years old or for patients who have received pelvic or vertebral radiation therapy. FAMMe is effective against advanced gastric cancer; however, because this was not a randomized comparative study of the relative effectiveness of FAMMe and FAM (5-FU, doxorubicin, and mitomycin), no recommendation for the use of one regimen instead of the other for advanced adenocarcinoma of the stomach can be made. FAMMe chemotherapy cannot recommended for advanced adenocarcinoma of the pancreas and gastroesophageal junction.

RCT Entities:   Population Interventions Outcomes