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PubMed1991

Further observations on the prevention of experimental proliferative vitreo-retinopathy by 5-fluorouracil.

The rate of retinal detachment in fellow control eyes of rabbits following fibroblast administration is progressively lower with increased dose of 5-Fluorouracil in the test eyes. Thus, it seems mandatory to choose control eyes in other animals rather than the fellow eyes of the treated ones. Retinal detachment appeared in the second week or earlier after intravitreal fibroblast administration. However, in eyes treated intravitreally with 5-Fluorouracil, retinal detachment or pucker appeared later, even in the second month suggesting routine follow-up of at least 2 months in future studies.

Animals↗
PubMed1994

Hypotonic maculopathy after trabeculectomy with postoperative use of 5-fluorouracil.

We evaluated two patients who developed hypotonic maculopathy following trabeculectomy and adjunctive 5-fluorouracil injections. Both patients had ocular hypotony and decreased visual acuity following these injections. The first case showed marked choroidal foldings, retinal striae, increased retinal vascular tortuosity, engorgement and optic disc oedema. The second case had radial perifoveal retinal striae, increased retinal vascular tortuosity and engorgement. The first patient regained pre-operative visual acuity while the second case had a visual acuity of 20/25 without any intervention. Fundus changes were less marked 12 months after initial evaluation in both cases. Hypotonic maculopathy is a reversible complication of trabeculectomies with adjunctive use of 5-fluorouracil.

Adult↗
PubMed1980

Determination of 5-fluorouracil in human plasma by high-pressure ion-exchange chromatography.

A method has been developed for the measurement of 5-fluorouracil by isocratic high-pressure ion-exchange liquid chromatography. Chlorpheniramine was added to the standards and samples before extraction with 16% isopropanol in ethyl acetate. The extracts were then chromatographed using a mobile phase of 0.014 mol/l ammonium dihydrogen phosphate buffer, pH 3.5, at a flow rate of 1 ml/min. Ultraviolet detection at 266 nm was used, and quantitation was by measurement of the peak height ratios of 5-fluorouracil to chlorpheniramine.

Chlorpheniramine↗
PubMed1982

A rapid high-performance liquid chromatographic method for quantitation of 5-fluorouracil in plasma after continuous intravenous infusion.

A fast, simple, precise, high-performance liquid chromatographic method for the assay of 5-fluorouracil in plasma from humans receiving continuous intravenous infusion is described. After a single extraction, underivatised 5-fluorouracil is assayed by high-performance liquid chromatography using a variable-wavelength ultraviolet detector. After extraction of 1 ml plasma, 0.3 mumol/l can be assayed. The assay is reproducible and linear up to at least 40 mumol/l. A single determination takes 3 hours and a batch of 40 specimens can be extracted and assayed in 4 working hours if automated equipment is used, enabling injections and calculations to be done overnight.

Chromatography, High Pressure Liquid↗
PubMedDate not supplied

Nucleic acid labeling with [3H]orotic acid and nucleotide profile in rats in protein deprivation, enteral and parenteral essential amino acid administration, and 5-fluorouracil treatment.

Rats were fed a 0% casein diet for 1 week, with or without enteral or parenteral administration of essential amino acids, or a 25% casein diet, in one group supplemented with 5-fluorouracil treatment. Ninety minutes before sacrifice the rats were given a tracer of [3H]orotic acid. Incorporation into the acid soluble fraction, RNA, and DNA was determined in liver, small intestine, bone marrow, and kidney. Nucleotide profile was examined in liver and intestine. Protein deficiency caused inter alia a decrease in body weight; a decrease in RNA/DNA ratio and an increase in the specific RNA labeling in liver and kidney; an altered nucleotide profile in the liver; an increase in the nucleotide/DNA and RNA/DNA ratios and a decrease in the specific labeling of the acid soluble fraction, RNA, and DNA in the bone marrow. These changes were prevented to the same extent by giving essential amino acids, either orally or intravenously. The minor changes in intestinal nucleotide profile in protein deprivation were prevented to a slightly larger extent by amino acids orally than parenterally. 5-Fluorouracil treatment gave a decrease in the RNA/DNA ratio in the liver and kidney but an increase in the nucleotide/DNA and RNA/DNA ratios in the bone marrow. Nucleotide profiles were unaltered. The amount of DNA per gram of tissue decreased in bone marrow and increased in kidney. Parenteral administration per se resulted in almost no changes.

Amino Acids↗
PubMedDate not supplied

Epirubicin, cisplatin and continuous infusion 5-fluorouracil (ECF) in locally advanced or metastatic gastric cancer: a single institution experience.

AIMS AND BACKGROUND: The role of chemotherapy in locally advanced or metastatic gastric cancer has been controversial, but chemotherapy has recently been shown to relieve tumor-related symptoms, improve quality of life and prolong survival when compared with best supportive care. Furthermore, palliative chemotherapy is also cost-effective. "Second-generation" combination chemotherapy regimens were developed in the 1980s with high activity in advanced or metastatic gastric cancer (EAP, FAMTX, PELF, ECF). In randomized studies, EAP demonstrated no difference in activity but a significantly higher overall toxicity and toxic death rate than FAMTX, and the ECF (epirubicin, cisplatin, 5-fluorouracil) regimen gave a survival and response advantage, tolerable toxicity, better quality of life and was more cost-effective than FAMTX. METHODS: Sixty patients with locally advanced or metastatic gastric cancer were treated with the ECF regimen (21 weeks of 5-fluorouracil given by continuous infusion through a central line at 200 mg/m2 for 24-hr combined with cisplatin at 60 mg/M2 iv and epirubicin at 50 mg/M2 iv beginning on day 1 and repeated every 3 weeks for 8 courses). There were 42 males and 18 females, with a median age of 64 years (range, 40-74). The median performance status was 1. The histologic type was adenocarcinoma in 44 patients and undifferentiated carcinoma in 16 (27%). Three patients had locally advanced disease (5%) and 57 had metastatic disease (95%). Seven patients (12%) had received prior chemotherapy for advanced disease. RESULTS: All patients were assessable for toxicity and 55 for response (5 had insufficient treatment). Toxicity was mild or moderate, and there was no toxic death. Incidence of WHO toxicity > or = 2 was nausea and vomiting in 3%, mucositis in 3%, leukopenia in 7%, anemia in 3%, and thrombocytopenia in 2%. Port-a-Cath toxicity was thrombosis in 4, dislocation in 2 and infection in 3 patients. Seven complete responses and 13 partial responses (overall response rate, 36%) were achieved, with a response rate of 39% in untreated and 17% in pretreated patients. Nine patients (16%) had stable disease and 26 (47%) progressive disease. Most patients felt symptomatically improved on ECF. CONCLUSIONS: Our study confirms that the ECF regimen has a favorable pattern of toxicity and is feasible on an outpatient basis. However, it did not confirm the high response rate reported in other phase II trials.

Adult↗
PubMedDate not supplied

Concomitant radiotherapy with protracted 5-fluorouracil infusion in locally advanced carcinoma of the pancreas: a phase II study.

AIMS AND BACKGROUND: To evaluate the efficacy of combined radiation therapy and continuous infusion of 5-fluorouracil in patients with locally advanced carcinoma of the pancreas. METHODS: Between January 1992 and June 1999, 31 patients with locally advanced adenocarcinoma of the pancreas were treated in our Institute. In 20 patients, the tumor (65%) was located in the head of the pancreas and in 11 (35%) in the body or tail; 13 cases also showed involved nodes. Radiation therapy consisted in a median dose of 63 Gy in 33-36 fractions applied to the tumor and regional lymph nodes. Chemotherapy with 5-fluorouracil in continuous infusion, 250 mg/m2 daily, was administered in the first and fifth week of the radiation therapy. Thereafter, 22 patients received 3-10 cycles of adjuvant chemotherapy with same doses. Median follow-up of the series was 20 months. The toxicity of the treatment was scored according to WHO criteria. All patients underwent nutritional assessment at the time of radiochemotherapy. RESULTS: The median overall survival was 15.2 months (range, 4-42). At restaging, 17 cases (55%) showed no change and 14 (45%) a partial remission. At the end of radiochemotherapy in 8 (26%) of the cases there was indication for pancreatectomy, which was executed in 4 patients. At the time of the study, 2 patients (6.4%) were surgically proven disease free. Eleven of the 13 cases (85%) presenting involved nodes showed that the enlarged lymph nodes had disappeared. Nineteen patients (61%) are alive with clinical evidence of disease anti 2 cases are alive with liver metastases; 8 patients (26%) died for disease. In 74% of cases there was complete pain control. Tolerance to the regimen was good. Nutritional assistance was evaluated and was found to be correlated to survival. CONCLUSIONS: The results of the series confirm a good tolerance with low acute toxicity. Tumor down-staging and resectability rates were high, together with prolonged survival and a good quality of life.

Adenocarcinoma↗
PubMedDate not supplied

Neoadjuvant chemotherapy with taxotere-epirubicin-5-fluorouracil (TEF) in local-regionally advanced breast cancer: a preliminary report.

AIMS AND BACKGROUND: Sixty-three patients with local-regionally advanced breast cancer were treated with neoadjuvant chemotherapy consisting of docetaxel (Taxotere), epirubicin, and 5-fluorouracil (TEF). METHODS AND STUDY DESIGN: Preoperatively, patients received four cycles of Taxotere (80 mg/m2), epirubicin (60 mg/m2), and 5-fluorouracil (500 mg/m2), repeated every 21 days. Following completion of four cycles of chemotherapy, appropriate surgery was performed. After the surgery, patients received one cycle of the TEF chemotherapy regimen; following chemotherapy, radiotherapy was applied, and at the end two more cycles of TEF chemotherapy regimen were given. RESULTS: Sixty-three patients with locally advanced breast cancer were treated. Three patients were excluded from the study before the evaluation of response. Median age of the patients was 50 years (range, 25-77). Twenty-seven and 33 patients were premenopausal and postmenopausal, respectively. Thirty-nine patients were in stage IIIA and 21 in stage IIIB. Complete and partial responses were observed in 15 (25%) and 42 (70%) of the patients following four cycles of preoperative TEF chemotherapy regimen, respectively. Overall response was 95%, and primary lesion progressed only in 3 (5%) patients. The mean disease-free survival was 15.9 +/- 6.8 (range, 3.5-28) months and the mean overall survival was 18.6 +/- 7.2 (range, 5-30) months. The most frequent side effects were nausea-vomiting, mucositis, alopecia and leukopenia. CONCLUSIONS: TEF therapy is a treatment with a high overall response rate and toxicities similar to other taxotere combinations. A longer follow-up of patients is necessary for the determination of disease-free survival and overall survival.

Adult↗
PubMedDate not supplied

Concurrent 5-fluorouracil, mitomycin C and radiation with or without brachytherapy in recurrent cervical cancer: a scoring system to predict clinical response and outcome.

AIMS AND PURPOSE: This is a prospective, phase II study aimed to evaluate the effect of concurrent 5-fluorouracil, mitomycin C, and radiation with or without brachytherapy on the clinical outcome of a series of recurrent cervical cancer patients and to determine the prognostic impact of a subset of factors. METHODS: Thirty-three patients with locally recurrent, non-metastatic cervical cancer received external beam radiation (4-week split course: 23.4 + 23.4 Gy) plus two courses of concomitant chemotherapy (5-fluorouracil, 96-h continuous infusion, days 1-4, 1 g/m2/day; mitomycin C, 10 mg/m2, bolus i.v., day 1). Twelve patients with vaginal recurrence (36.4%) underwent endocavitary low-dose rate brachytherapy boost (20-25 Gy); 11 patients with lateral pelvic recurrence (33.3%) received external beam radiation boost (14-20 Gy). RESULTS: Fourteen complete responses (42.4%), 7 partial responses (21.2%), 5 disease stabilizations (15.1%) and 7 progressions (21.2%) were obtained. After a median follow-up of 34 months (range, 6-127), overall actuarial 3-year survival, progression-free survival and local progression-free survival were 59.7%, 48.1% and 51.7%, respectively. Patients with vaginal recurrence of less than 4 cm and negative lymph nodes proved to respond best to the treatment. Two patients (6.1%) experienced hematologic grade 3 toxicity. One patient had grade 3 intestinal toxicity (3.0%). No patient had major skin or urological acute toxicity. Severe late toxicity was infrequent. Three patients had prolonged leukopenia (9.0%). Four patients showed severe vaginal stenosis (12.1%). A clinical score of 0 to 1 was assigned to each patient on the basis of the absence (score = 0) or presence (score = 1) of any of the following prognostic factors: time between surgery and recurrence shorter than 12 months, pelvic wall site of recurrence, positive lymph nodes, hemoglobin < 11 g/dL. Using this system, it was clear that patients with a low total score had a significantly better outcome (clinical remission, 51% of patients with a score < or = 2 vs 12% of patients with a score > 2, P = 0.06), local control of the disease (65% vs 20% after 3 years, P = 0.001,) and overall survival (75% vs 30% after 3 years, P = 0.032). CONCLUSIONS: Our data suggest that this combined modality therapy was relatively well tolerated and resulted in reasonable local control and survival. The scoring system proved to be helpful to identify patients with the greatest chance of benefiting from the treatment. Further studies are probably needed to salvage the other patients, whose prognosis remains severe.

Adult↗
PubMed1982

Pharmacological data and technical feasibility of intraperitoneal 5-fluorouracil administration.

Via a surgically implanted Tenckhoff catheter, 5-fluorouracil was intraperitoneally administered to patients with malignant disease confined to abdominal space. Treatment was well tolerated without local complications. Peritoneal and plasmatic drug levels were measured, showing that: 1) peritoneal drug levels declined as a first order function; 2) plasmatic levels were very close to those reported for continuous i.v. administration, but peritoneal concentrations were much higher (log 1 to 3); 3) concentration x time product had a peritoneum: plasma ratio ranging from 120 to 1350. The hypothesized role of intraperitoneal 5-fluorouracil administration and the questions still to be answered are summarized.

Aged↗
PubMed1983

5-Fluorouracil, vincristine and hydroxyurea combination chemotherapy in metastatic colorectal cancer.

Twenty consecutive patients who had biopsy proven metastatic colorectal cancer were treated with combination chemotherapy. The drug regimen (FVH), in a 4 week cycle, consisted of 5-fluorouracil (600 mg/m2 i.v. on days 1, 8, 15 and 22), vincristine (1.4 mg/m2 i.v. on day 4), and hydroxyurea (2400 mg/m2 p.o. on days 3, 10, 17 and 24). Three of the 18 evaluable patients achieved an objective tumor remission (2 CR and 1 PR) and 15 patients had stable disease. The overall response rate to FVH was therefore not superior to that achieved in patients who received 5-fluorouracil alone, and the overall survival in this study was comparable to that of other studies involving patients with metastatic colorectal cancer.

Antineoplastic Combined Chemotherapy Protocols↗
PubMed1984

Ineffectiveness of 5-fluorouracil and cis-platin as second-line chemotherapy in head and neck cancer.

Seventeen patients with heavily pretreated head and neck squamous cell carcinoma were submitted to a combination of 5-fluorouracil, 500 mg/m2 on days 1-4, and cis-platin, 50 mg/m2 on day 5, repeated every 21 days. Before administration of 5-fluorouracil, N5,N10-methyltetrahydrofolate, 200 mg/m2 i.v., was given. Only 1 partial response and 4 stable disease were observed, and the median survival of the entire group was 5 months. Although all patients had been heavily pretreated and a considerable percentage (6/17, 35.2%) of these showed resistance to first-line therapy, this combination seems to be ineffective as second-line therapy in head and neck cancer.

Adult↗
PubMed1984

Sequential combination chemotherapy with methotrexate and 5-fluorouracil in advanced colorectal carcinoma.

Twenty patients bearing advanced colorectal carcinoma, confirmed by histology, were evaluated after undergoing a sequential chemotherapeutic schedule which consisted of methotrexate, 200 mg/m2 in intravenous infusion during 4 h followed 1 h later by 5-fluorouracil, 600 mg/m2 in intravenous bolus. Twenty hours after ending the MTX administration, leucovorine, 14 mg/m2, was given intramuscularly every 6 h, in 8 doses. Courses were repeated every 15 days. Of 20 patients, 3 bearing colon carcinoma, without previous radiotherapy or chemotherapy, had a partial response. No change was registered in 6 cases. There was no significant difference in the survival of responders, those with stable illness and those with progression. Results were no better than those obtained with 5-fluorouracil used as a single drug and are in agreement with studies that established a 1-h interval between the administration of both drugs.

Adult↗
PubMed1987

Results of two controlled studies on antiemetic combination against vomiting induced by 5-fluorouracil.

A group of 132 patients with different disseminated solid tumors entered two consecutive antiemetic trials in which 5-fluorouracil given in a 120-h continuous infusion was the emetogenic stimulus. The purpose of the trials was to investigate the validity of Peroutka and Snyder's hypothesis. These authors suggested that CNS receptors other than the classical dopamine D-2 (e.g., histamine H-1 and muscarinic cholinergic receptors) were involved in emetic response. Hence, a combination of a phenothiazine (an antidopaminergic drug) with an antihistaminic or a tricyclic antidepressant (H-1 and muscarinic cholinergic blockers) was suggested to be possibly superior to phenothiazine alone against antineoplastic chemotherapy-induced vomiting. The first study showed the antiemetic superiority of a phenothiazine (thiethylperazine) over placebo but failed to show a superiority of the combination of thiethylperazine and an antihistaminic (diphenhydramine) over thiethylperazine alone. In contrast, the second study proved the superiority of the combination of thiethylperazine and a tricyclic antidepressant (amitriptyline) over thiethylperazine alone. In conclusion, tricyclic antidepressants - but not antihistaminics - potentiate the antiemetic activity of thiethylperazine against 5-fluorouracil-induced vomiting.

Adult↗
PubMed1990

Open phase II with 5-fluorouracil, 4-epi-doxorubicin and mitomycin C (FEM) in advanced gastric cancer.

Forty-four patients with advanced gastric cancer were treated with a combination including 5-fluorouracil, 4-epi-doxorubicin and mitomycin C. 4-Epi-doxorubicin was substituted for adriamycin in MacDonald's original schedule. The combined treatment involved 600 mg/m2 i.v. of 5-fluorouracil on days 1, 8, 29 and 36; 80 mg/m2 i.v. of 4-epi-doxorubicin on days 1 and 29; and 10 g/m2 i.v. of mitomycin C on day 1. The cycle was repeated on day 57 after the start of treatment. Out of 44 patients, 39 were evaluable. Thirteen partial remissions (33%) were achieved. The average duration of remission was 7 months (range, 3-12 months). The average survival of the responders was 9 months, and that of nonresponders 3.5 months. Toxicity was moderate, well-tolerated and, as compared with the FAM schedule, less pronounced, particularly as regards myelotoxicity. Thus, the substitution of 4-epi-doxorubicin for adriamycin in the original schedule of MacDonald et al. (1980) did not improve treatment results, but the observed toxicity was less pronounced.

Adenocarcinoma↗
PubMed1990

5-Fluorouracil carcinogenesis in BALB/c mice.

5-Fluorouracil, a drug mainly used in the treatment of gastrointestinal tract neoplasms, was administered i.p. to BALB/c mice at the dose of 30 mg/kg body weight once a week for 50 weeks to test its carcinogenicity. The treatment induced a significant increase in lung tumor in both sexes (males, p less than 0.05; females, p less than 0.01) and tumors of the lymphoreticular system in female mice (p less than 0.001). These results suggest that 5-fluorouracil is carcinogenic in mice.

Animals↗
PubMed1990

Alpha-2 interferon and 5-fluorouracil in advanced colorectal cancer.

A total of 21 untreated patients (5 males, 16 females; median age, 55 years; range, 28-72) with advanced measurable colorectal carcinoma were treated with an association of 5-fluorouracil (1000 mg/weekly) and alpha-2 interferon (three times a week s.c.: 6 x 10(6) U in the 1st month, 9 x 10(6) U in the 2nd month, 12 x 10(6) U in the 3rd month and then 18 x 10(6) U) until maximum response or progression of disease. Sites of disease involved liver in 10 patients, lung in 6, supraclavicular lymph nodes in 3, skin in 1, abdomen in 4, and vagina in 1 patient. Nine responses (42.8%) were documented (4 complete and 5 partial) with metastases confined to the liver, lung, nodes and skin. Median duration of response was 11 months (range, 4-17+) and median survival was 10 months (range, 2-17+). Side effects (fever, flu-like syndrome and leukopenia) required a dose reduction of 5-fluorouracil in 8 patients and interferon in 2 patients.

Adult↗
PubMed1990

A feasibility study of high-dose cisplatin and 5-fluorouracil with glutathione protection in the treatment of advanced colorectal cancer.

On the basis of previous studies supporting that glutathione (GSH) reduced cisplatin nephrotoxicity we have designed a new regimen in the treatment of advanced colorectal cancer, which included GSH as a modulator of cisplatin-induced toxicity. Eleven untreated patients with measurable metastatic colorectal cancer received 5-fluorouracil (750 mg/m2, daily continuous infusion for days 1-5) and cisplatin (40 mg/m2 1 hour-infusion for days 6-8) given every 4 weeks. Reduced glutathione (2.5 g) was delivered i.v. prior to each cisplatin infusion. Toxicity was minimal and reversible and included nausea/vomiting (11 cases), mild neurotoxicity (4 cases) and leukopenia (2 cases); only 2 patients showed moderate and transient increases of serum creatinine (less than 2 mg/dl) and BUN. Renal function impairment was also monitored by magnesemia levels and urinary marker enzymes indicating minimal cumulative nephrotoxicity. Out of 10 evaluable patients, only 2 partial responses were observed. The median survival was 9 months (range 5-26). The study was closed, since the preliminary results do not suggest any therapeutic advantage in adding cisplatin to 5-fluorouracil in the present schedule, even using an intensive regimen. Indirect evidence suggests that these disappointing results are not the consequence of interference of GSH on the cytotoxic efficacy of cisplatin. The lack of incidence of severe toxicity of this regimen supports the role of reduced glutathione as a potential protective against cisplatin nephrotoxicity. Although these preliminary results suggest that further studies with the present regimen in this disease are not warranted, in view of its safety this program deserves evaluation in the treatment of neoplastic diseases responsive to 5-fluorouracil/cisplatin.

Adult↗