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PubMed1987

[Sequential methotrexate-5-fluorouracil (MTX-5-FU) treatment of patients with advanced gastric and colorectal cancer. Sequential Methotrexate-5-FU Study Group].

A multicenter cooperative study was conducted from July 1984 to March 1986 to evaluate the clinical efficacy of sequential MTX-5-FU treatment in 96 cases of advanced gastric cancer and 39 cases of colorectal cancer. 5-FU 600 mg/m2 i.v. was given and MTX 30 mg/m2 (A), 100 mg/m2 (B) and 300 mg/m2 (C) i.v. were given, and the administration interval between MTX and 5-FU was 1 to 3 h for the gastric cancer group, and 7 h for the colorectal cancer group. Leucovorin rescue of 10 mg/m2 p.o. was given 24 h after MTX administration. In the gastric cancer group, the response rate for Regimen A was 23.2% (CR 1 and PR 12) out of 56 evaluable cases, and for Regimen B, 40.5% (CR 1 and PR 14) out of 37 evaluable cases. In the colorectal cancer group, the response rate for Regimen A was 28.6% (PR 6) out of 21 evaluable cases and for Regimen B, 20.0% (PR 3) out of 15 cases. Median survival time for the gastric cancer group was 5.5 months with Regimen A and 7.6 months with Regimen B, and for the colorectal cancer group 10.9 months with Regimen A and 7.9 months with Regimen B. Main adverse effects were marrow impairment and gastrointestinal symptoms such as nausea, diarrhea, and stomatitis. In this study Regimen B showed relatively good results. In order to evaluate the biochemical modulation occurring with sequential MTX-5-FU treatment, a further phase III study in gastric cancer patients should be conducted.

Adult↗
PubMed1984

[Experimental toxicologic and therapeutic studies on the activity of the CMF(cyclophosphamide-methotrexate-5-fluorouracil) scheme versus the VMF(vincristine-methotrexate-5-fluorouracil) scheme].

Experimental administration of the CMF scheme, which is used in adjuvant chemotherapy in humans, resulted in carcinogenic effects in rats. When substituting cyclophosphamide by vincristine, no carcinogenic activity was observed. The therapeutic effect of the VMF scheme was approximately equivalent to that of the CMF scheme in various experimental designs. It is discussed whether in adjuvant chemotherapy combinations should rather be used which lack any long-term toxicity such as carcinogenic effects.

Animals↗
PubMed1983

Neuropsychological study in patients with ALL. Two different CNS prevention therapies--cranial irradiation plus IT methotrexate vs. IT methotrexate alone.

Neurological, psychopedagogic, and psychologic long-term sequelae were evaluated in two groups of ALL patients in continuous CR for more than 2 years treated with two different CNS prophylaxis schemes. Group A, 19 patients (protocol 10-LLA-72 GATLA) received cranial irradiation 2400 rads plus IT MTX-DMT, and group B, 23 patients (protocol 1-LLA-76-GATLA) IT MTX-DMT only during induction and maintenance. All the patients were evaluated by performing neurological examination, EEG, EMG with nerve conduction velocity, CT scans, CSF studies, psychometric and psychologic studies, and neuropsychological evaluation. The most important findings were: 11 patients from group A (58%) showed abnormal CT (low density areas in the periventricular white matter, widening of subarachnoid space, ventricular dilatation, intracerebral calcification) and only one patient from group B showed CT abnormalities (p less than 0.0005). The neuropsychologic evaluation (performed by L. Bender technique and Picq-Vayer scale) showed more severe impairment (grade 3-4) in eight patients from group A (42%) and none in group B (p less than 0.001). Higher incidence of abnormalities in group A suggests the existence of more severe sequelae in the patients treated with cranial irradiation plus IT MTX-DMT than with IT MTX-DMT alone.

Adolescent↗