Gene/Protein Disease Symptom Drug Enzyme Compound
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Query: UMLS:C0038362 (stomatitis)
 8,852 document(s) hit in 31,850,051 MEDLINE articles (0.00 seconds)

Twenty-five patients with advanced breast cancer (ABC) who had failed from first-line chemotherapy entered into a phase II study employing weekly 5-fluorouracil (FU) 350 mg/m2, folinic acid (FA) 500 mg/m2, and epirubicin (EPI) 35 mg/m2, for a maximum of 18 cycles. Twenty-three patients were evaluable for response. One achieved a complete response and 7 showed a partial response, for an objective response rate of 35%; 7 (31%) patients achieved a stabilization of the disease, while 8 (35%) patients progressed under treatment. The median duration of response was 6 months and median survival amounted to 10.6 months. Side effects were in general mild with grade III leukopenia in 5 patients and grade IV leukopenia in 1 patient. Other toxicity included nausea and vomiting (88%), diarrhea (26%), stomatitis (40%) and alopecia (84%), but all of them mainly restricted to WHO grade I and II. Our results suggest that the combination of high-dose FA, FU, and EPI can be safely administered in the investigated schedule and represents an attractive alternative in the search for second-line therapies that combine effectiveness with acceptable toxicity in the treatment of refractory ABC.
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PMID:A phase II trial of weekly high-dose folinic acid and 5-fluorouracil in combination with epirubicin as salvage chemotherapy in advanced breast cancer. 797 Apr 97

A study was performed to determine whether the addition of folinic acid to a combination of methotrexate (MTX) and cyclosporin A (CsA) after allogeneic bone marrow transplantation (BMT) could improve tolerance to the regimen without inhibiting its ability to prevent graft-versus-host disease (GVHD). Sixty-nine adult BMT patients received CsA plus MTX 15 mg/m2 on day 1 and 10 mg/m2 on days +3, +6 and +11. Folinic acid 5 mg was started 24 h after each MTX dose and continued 6 hourly until 12 h before the next dose of MTX. The median age of the group was 37 years and 13 patients (19%) received bone marrow from mismatched and/or unrelated donors. No MTX doses were omitted or modified. Grade II-IV acute GVHD occurred in 18 patients (29%) and chronic GVHD in 35 of 56 (64%) patients at risk. There were no cases of grade > or = III stomatitis. Transplant-related mortality was 7% before 100 days and 20% overall (9% for low risk leukaemia) with a median follow-up of 41 months (range 24-88 months). This regimen of folinic acid rescue may contribute to a well tolerated GVHD prophylaxis protocol with reasonably low BMT-related mortality. Our results suggest that the ability of MTX to prevent acute GVHD is not abrogated by folinic acid given in this way.
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PMID:Addition of low-dose folinic acid to a methotrexate/cyclosporin A regimen for prevention of acute graft-versus-host disease. 799 61

Thirteen patients with intra-abdominal malignancies entered a phase I study of fluorouracil (5-FU) given by continuous infusion (96 h) iv and ip, simultaneously, and modulated by high-dose folinic acid-iv. Severe but reversible stomatitis was the only dose-limiting toxicity at a dose of 5-FU of 550 mg/m2/day. Local toxicity (5-FU-induced abdominal pain) was a significant side effect in patients receiving more than 1 cycle. The pharmacokinetic advantage of 5-FU-ip was confirmed in our study (ratio AUC peritoneum/plasma between 160 and 328). The systemic exposure to 5-FU (plasmatic AUC ranging from 73.4 to 173.21 microM) and to AF were found in efficacious ranges. The recommended dose of 5-FU iv and ip is 500 mg/m2/day. This regimen is feasible and may potentially have application for adjuvant chemotherapeutic programs after surgery for colorectal cancer.
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PMID:[Continuous double administration of 5 fluorouracil (intravenous and intraperitoneal) modulated by folinic acid: phase I clinical study and pharmacokinetics in patients with intra-abdominal developing cancers]. 817 94

A total of 25 patients with advanced breast cancer were treated weekly with i.v. 5-fluorouracil at 350 mg/m2, folinic acid at 500 mg/m2, and epidoxorubicin at 35 mg/m2 as first-line chemotherapy for a maximum of 18 cycles. In all, 24 patients were evaluable for response. Overall, 1 patient achieved a complete response and 11 patients showed a partial response, for an objective response rate of 50%; the median duration of response was 18.3+ months and median survival amounted to 18.8+ months. Side effects were generally mild, with grade II leukopenia occurring in 10 patients and grade III leukopenia, in 1 patient. Other toxicity included nausea and vomiting (82%), diarrhea (48%), stomatitis (48%), and alopecia (92%), all of which were mainly restricted to WHO grades I and II. Our results suggest that leucovorin modulation of 5-fluorouracil can safely be incorporated into combination chemotherapy with epidoxorubicin on the investigated schedule. The observed response rate appears comparable with that obtained with other first-line regimens.
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PMID:Weekly 5-fluorouracil and high-dose folinic acid in combination with epidoxorubicin as first-line therapy in advanced breast cancer: a phase II study. 817 6

The purpose of this prospective clinical trial was an attempt to find an effective and relatively non-toxic schedule for patients with metastatic breast cancer who decline to receive aggressive cytotoxic chemotherapy. A total of 36 patients with disseminated breast cancer were treated with mitoxantrone 8 mg/m2 intravenously (i.v.) day 1, folinic acid 400 mg/m2 in a 2-h i.v. infusion with 5-fluorouracil 500 mg/m2 as an i.v. bolus 1 h later, days 1 and 8 at 3-week intervals plus prednisone 20 mg/m2 orally daily with diminishing doses over several weeks. Objective regressions were observed in 24/36 (67%) patients, 9 being complete (25%). Responses were seen at all disease sites, mainly pleural/lung, bone and liver. The median duration of response was 8 months (range 4-25+) and the median survival 12 months (range 3-26+). Myelosuppression, mainly leucopenia and thrombocytopenia, was the major toxicity but without complications. Other toxicities included mild or moderate nausea and/or vomiting (50%), stomatitis (33%) and diarrhoea (11%). Alopecia was minimal. No cases of cardiotoxicity were detected. The substantial response rate obtained with this relatively well tolerated regimen against advanced breast cancer warrants its assessment in a larger number of patients.
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PMID:Mitoxantrone, folinic acid, 5-fluorouracil and prednisone as first-line chemotherapy for advanced breast carcinoma. A phase II study. 826 Feb 31

Due to the pattern of tumor infiltration, hepatic resection may be accomplished in 20% of all patients with colorectal liver metastases. However, a new recurrence is observed very often and early. Up to date, systemic adjuvant treatment failed to improve the overall results. Taking into account the benefit of palliative intrahepatic chemotherapy, intraarterial therapy was performed as an adjuvant to removal of metastatic colorectal liver metastases in 51 out of 90 patients over an eight year period (1982-90). Due to abnormal arterial liver arteries 5 pat. got an intraportal catheter. The following monthly treatment schedules were applied: FUDR (fluorodesoxyuridine) 0.2-0.3 mg/kg/d/14 d (N = 12), FUDR 1,2 mg/kg/d/5d (N = 21), FUDR 1.0-1.7 mg/kg/d/5 and folinic acid 30 mg/m2/d (N = 18). Mortality (5.5%) and morbidity (36%) were not increased by catheter implantation. Local and systemic side effects were mainly stomatitis 0-22% and hepatobiliary toxicity 6-42%. Including an operative mortality of 5.5%, the median survival of 45 months was associated with a disease-free interval of 15 months. Intrahepatic recurrence was diagnosed after a median time of 26 months (extrahepatic recurrence was 25 months respectively). The following prognostic factors were associated with favourable survival: solitary metastasis (p > 0.001), curative resection, segmentectomy, normal serum levels of CA 19-9 and LDH. Although both groups were not comparable, due to more extended tumor infiltration in the treatment group (p = 0.03), adjuvant arterial chemotherapy delayed after curative resection intrahepatic recurrence to 52 versus 14 months (p = 0.036). Disease-free survival was improved to 19 versus 12 months (p = 0.08) resulting in a trend to better overall survival (p = 0.07).
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PMID:[Adjuvant regional chemotherapy after resection of liver metastases of primary colorectal tumors]. 832 38

1. The pharmacokinetics and toxicity of racemic 5-methyltetrahydrofolic (rac-5-MTHF) acid after i.v. infusion were investigated in 18 patients with advanced colorectal cancer. Doses of 100-600 mg rac-5-MTHF/m2 were administered over 2 h together with a bolus of 500 mg/m2 5-fluorouracil (5-FU) as a midpoint injection. 2. The pharmacokinetics of both diastereoisomers were linear in the range from 100-600 mg 5-MTFH/m2. Independent of the administered dose, the maximal plasma concentration of [R]-5-MTHF was nearly twice that of [S]-5-MTHF. The elimination of [S]-5-MTHF from plasma was considerably faster than that of the [R]-isomer (elimination half-life: 3.1 +/- 1.0 h vs 8.3 +/- 3.2 h). No metabolites were detected in plasma and in urine samples. 3. The plasma protein binding was stereoselective ([R]-5-MTHF bound: 88.2 +/- 2.7%; [S]-5-MTHF bound: 59.9 +/- 6.8%; P < 0.001), causing a significantly higher renal clearance for [S]-5-MTHF when compared with the [R]-isomer (37.5 +/- 23.7 ml min-1 vs 12.7 +/- 11.2 ml min-1, P < 0.001). There was no dose dependence, but gender influenced renal clearance (CLren[R]-5-MTHF: male vs female: 20.5 +/- 14.5 ml min-1 vs 7.8 +/- 4.7 min-1, P = 0.03; CLren [S]-5-MTHF: male vs female: 57.2 +/- 21.7 ml min-1 vs 25.7 +/- 16.2 ml min-1, P = 0.006). 4. Toxic side effects of the combination 5-FU/5-MTHF were rare and generally mild, and included stomatitis, nausea/emesis, diarrhoea, anaemia, leukopenia, and thrombocytopenia. 5. In combination with 500 mg 5-FU/m2 a single dose of 600 mg rac-5-MTHF/m2 can safely be administered to patients with colorectal cancer. A similar therapeutic benefit of 5-MTHF to folinic acid in the biochemical modulation of 5-FU is supported by the comparison of in vitro and in vivo data.
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PMID:Stereospecific pharmacokinetics of rac-5-methyltetrahydrofolic acid in patients with advanced colorectal cancer. 852 81

Thirty-seven patients with advanced colorectal cancer were treated with fluorouracil (5-FU) and folinic acid (FA) (Jan 1990-Dec 1992). Clinical assessment and administration of chemotherapy was incorporated as part of the daily work load of a busy general surgical unit. Records were available for all 37 patients and showed that 13 patients (Treatment failures, Group B) failed to receive more than 3 monthly cycles of treatment, while the remaining 24 received 6 or greater cycles (Treatment completed, Group A). There was no survival advantage demonstrated for the complete study cohort (n = 37) when compared to an historical group (n = 1038) of untreated patients. Median survival in Group A (14.2 months) was significantly greater (chi-squared, P < 0.0001) than survival in Group B (6.7 months). Toxicity was common with 43% experiencing mouth ulcers or stomatitis (13% severe). Three per cent had dose-limiting diarrhoea and myelotoxicity was minimal. There were six partial responses and 16 patients had no change in their disease status while on treatment. Current regimen of 5-FU/FA are well-tolerated with low toxicity but show no survival advantage for advanced colorectal cancer. However, these regimens may be administered within the confines of general surgical practice.
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PMID:Advanced colorectal cancer treated with combined 5-fluorouracil and folinic acid: the experience within a surgical department. 863 15

To evaluate ambulatory cancer chemotherapy, the clinical response, toxicities and survival time were analysed among 32 patients with non-curative or recurrent colorectal cancer who were treated by l-Leucovorin (l-LV) plus 5-fluorouracil for the past four years. Twenty-nine patients were treated with 5-FU (370 mg/m2) plus l-LV (10-100 mg/m2) for 5 consecutive days and a 23-day interval between treatments. Three patients were treated with l-LV (250 mg/m2) administered as a two-hour infusion and 5-FU (600 mg/m2) intravenous push midinfusion weekly for 6 weeks of an 8-week cycle. Partial response (PR) was observed in 9 patients (28%), no change (NC) in 18. One-year survival ratio was 61% and 4 of 32 patients survived at the end of this study. The median survival time was 14 months. Although stomatitis, nausea/vomiting, diarrhea, leukopenia and pigmentation were noted, no severe side effects were observed. These results suggested that l-LV plus 5-FU therapy might be a useful ambulatory cancer chemotherapy for patients with advanced colorectal cancer.
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PMID:[Clinical study of ambulatory cancer chemotherapy for advanced colorectal cancer]. 884 91

Etoposide, leucovorin and 5-fluorouracil (ELF) chemotherapy has been reported to be less toxic yet effective (response rates of 50%) in patients with advanced gastric cancer. A phase II study of ELF in 25 patients (11 males, 14 females, median age 53 years) with advanced adenocarcinoma of the stomach is reported. Patients received outpatient intravenous etoposide 120mg/m2 over 2 hours, folinic acid 300 mg/m2 over 2 hours, 5-fluorouracil 500 mg/m2 boluses daily for 3 days every 21 days. Of 17 measurable patients, there was one complete response (CR), 4 partial responses (PR) for a total response rate of 29.4%. Non-hematologic toxicity was modest (grade 0 vomiting 11/21, stomatitis 16/21, diarrhea 17/21). Grade 3/4 neutropenia was seen in 14/23, thrombocytopenia in 2/23, anemia in 5/23 patients. Median progression-free and overall survival was 4.1 and 7.1 months, respectively. In conclusion, ELF chemotherapy shows only modest activity in patients with advanced gastric cancer and is associated with severe hematologic toxicity.
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PMID:A phase II trial of etoposide, leucovorin and 5-fluorouracil (ELF) in patients with advanced gastric cancer. 887 37


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