Gastric cancer : official journal of the International Gastric Cancer Association and the Japanese Gastric Cancer Association · 2006
A phase II study of combined chemotherapy with methotrexate, 5-fluorouracil, and low-dose cisplatin (MFP) for histologically diffuse-type advanced and recurrent gastric cancer (KDOG9501).
Клиническое исследование II фазыСтатьяНазвание и аннотация: Перевод пока не подготовлен
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Nakayama Norisuke, Koizumi Wasaburo, Tanabe Satoshi, Sasaki Tohru, Saigenji Katsunori
Аннотация
BACKGROUND: Histologically diffuse-type gastric cancer is well known to have a poor prognosis and is often complicated with abdominal and pleural effusions. We evaluated the efficacy of a low dose of cisplatin combined with methotrexate and 5-fluorouracil (MFP therapy) in diffuse-type advanced gastric cancer.
METHODS: The study group comprised 47 patients. Patients with pleural effusion or ascites were actively enrolled. Methotrexate (30 mg/m(2) per day) plus 5-fluorouracil (600 mg/m(2) per day) was administered on days 1 and 8. Cisplatin (6 mg/m(2) per day) was given daily for 14 days after which there was 14 day's rest. Calcium leucovorin (15 mg) was administered after methotrexate.
RESULTS: The overall response rate was 38.3%. Ascites disappeared or decreased in 15 of 23 patients (disappeared in 9). Pleural effusion disappeared or decreased in 6 of 8 patients (disappeared in 4). Of the 21 patients with poor oral intake at study entry, 15 (71.4%) were able to orally ingest food. Hematologic toxicity of grade 3 or higher comprised leukopenia in 10 patients (21.3%) and neutropenia in 9 (19.1%). Nonhematologic toxicity included anorexia and nausea/vomiting, in 1 patient each (2.1%). The median survival time was 211 days.
CONCLUSION: MFP therapy is useful for the management of diffuse-type inoperable and recurrent gastric cancer, even in patients with conditions such as pleural effusion, ascites, or lymphangitis carcinomatosa who have a poor prognosis or cannot eat solid food.
METHODS: The study group comprised 47 patients. Patients with pleural effusion or ascites were actively enrolled. Methotrexate (30 mg/m(2) per day) plus 5-fluorouracil (600 mg/m(2) per day) was administered on days 1 and 8. Cisplatin (6 mg/m(2) per day) was given daily for 14 days after which there was 14 day's rest. Calcium leucovorin (15 mg) was administered after methotrexate.
RESULTS: The overall response rate was 38.3%. Ascites disappeared or decreased in 15 of 23 patients (disappeared in 9). Pleural effusion disappeared or decreased in 6 of 8 patients (disappeared in 4). Of the 21 patients with poor oral intake at study entry, 15 (71.4%) were able to orally ingest food. Hematologic toxicity of grade 3 or higher comprised leukopenia in 10 patients (21.3%) and neutropenia in 9 (19.1%). Nonhematologic toxicity included anorexia and nausea/vomiting, in 1 patient each (2.1%). The median survival time was 211 days.
CONCLUSION: MFP therapy is useful for the management of diffuse-type inoperable and recurrent gastric cancer, even in patients with conditions such as pleural effusion, ascites, or lymphangitis carcinomatosa who have a poor prognosis or cannot eat solid food.