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PubMed1999

Assignment and pH dependence of the 19F-NMR resonances from the fluorouracil anabolites involved in fluoropyrimidine chemotherapy.

Fluoropyrimidine chemotherapy relies on the intracellular anabolic conversion of 5-fluorouracil and the corresponding nucleosides to cytotoxic fluorinated nucleotides (F-Nuctd), such as 5-fluorouridine-5'-triphosphate (FUTP) or 5-fluoro-2'-deoxyuridine-5'-monophosphate (FdUMP), which can be detected by 19F-NMR spectroscopy. We have made 19F-NMR signal assignments at 11.7 T and 4 degrees C for model solutions containing 5-fluorouracil (FUra), 5-fluorouridine (FUrd), 5-fluoro-2'-deoxyuridine (FdUrd), 5-fluorouridine-5'-monophosphate (FUMP), FdUMP, 5-fluorouridine-5'-diphosphate (FUDP), FUTP and 5-fluorouridine-5'-diphospho(1)-alpha-D-glucose (FUDPG), and we have studied the effects of pH over the range 4.5-7.8, of Mg2+ concentration and addition of EDTA. This information provides a basis for the analysis of 19F-NMR spectra obtained from cells, tissues or extracts following fluoropyrimidine treatment.

Antineoplastic Agents↗
PubMed2000

Postsurgical sequential methotrexate, fluorouracil, and leucovorin for stages 3 and 4 gastric carcinoma: A preliminary study.

BACKGROUND AND OBJECTIVES: The present study compared the effects of sequential methotrexate and fluorouracil followed by leucovorin rescue (MFL), as an adjuvant chemotherapy vs. UFT (a combination of uracil and tegafur), on patient survival and recurrence following surgery for advanced gastric carcinoma. METHODS: Between July 1990 and June 1998, a total of 54 patients with advanced gastric cancer were treated postoperatively by adjuvant chemotherapy using MFL or UFT. Surgical treatment was performed according to standardized procedures for radical resection of gastric cancer. The patients were stratified into two groups following surgery. The MFL regimen consisted of methotrexate (100 mg/m2) and 5-fluorouracil (600 mg/m2) at hour 3, followed by leucovorin rescue. The oral UFT (375 mg/m2/day), a combination of tegafur and uracil in a molar ratio of 1:4, was continued for 3 years or longer depending on the patients tolerance. RESULTS: In stage 3 gastric cancer, the overall survival rates following surgery was significantly (p < 0.05) higher in the MFL than the UFT group. Difference in disease free survival was not statistically significant between the groups. Recurrence rates showed a trend (p = 0.08) to decrease in the MFL than the UFT group. In stage 4 gastric cancer, no significant difference was obtained in the overall survival rates between the groups. CONCLUSIONS: The present results suggested the superiority of MFL treatment for improving postoperative survival in patients with advanced gastric cancer, in particular for those patients with a high risk of recurrence following potential curative resection. In patients with stage 4 gastric cancer, however, MFL treatment showed similar effects as UFT on the postsurgical survival of the patients.

Aged↗
PubMed1980

Infusional 5-fluorouracil and X-ray therapy for non-resectable esophageal cancer.

Six patients with unresectable carcinoma of the esophagus received a combined course of external radiation therapy (1000 rads in four fractions in four days commencing on day 2) combined with constant infusional 5-fluorouracil (20 mg/kg every 24 hours for five days beginning on day 1). This program was repeated every other week to give a total x-ray dose of 6000 rads. This regimen has been well-tolerated by the majority of the patients and resulted in a complete response rate within the x-ray treatment field of 83% (5/6). All patients who showed a demonstrable systemic response to 5-fluorouracil reached complete response. The median survival has not yet been reached at six months with post-treatment survivors alive and without disease (four patients) at one, six, nine, and 22 months. Our previous median survival by x-ray therapy alone was 4 1/2 months. Toxicity consists primarily of hematologic suppression at a subclinical level. Although the length of therapy is substantial (11 weeks), the program appears tolerable and is capable of inducing long-term remissions. The program is currently being studied for dose escalation because neither local nor systemic side effects of a dose-limiting nature have been observed at 20 mg/kg 5-FU.

Bone Marrow↗
PubMed1986

N1-(2 tetrahydrofuryl)-5-fluorouracil (FT-207) in the postoperative adjuvant chemotherapy of gastric cancer. Delivery of a fat-emulsified agent to the lymph.

The influence of fat emulsification of N1-(2-tetrahydrofuryl)-5-fluorouracil (FT-207) on lymphatic transport was studied in seven postoperative gastric cancer patients. The water-in-oil-type of emulsion of FT-207 (FT-w/o), the oil-in-water-type emulsion of FT-207 (FT-o/w) and an enteric-coated granule of FT-207 (FT-G) each in 1-g doses, calculated in terms of FT-207, were administered orally. Lymph from a thoracic duct fistula, prepared in advance, and from the blood of a peripheral vein was collected simultaneously along a time course after administration to measure the concentrations of FT-207 and 5-fluorouracil (5-FU). For FT-w/o, FT-207, and 5-FU, concentrations were significantly higher, both in the lymph and in the blood, than those for FT-G and FT-o/w. However, no significant differences in FT-207 and 5-FU concentrations were observed between FT-o/w and FT-G. It was concluded that FT-w/o can be useful as an adjuvant chemotherapeutic drug in the postoperative treatment of gastric cancer.

Adult↗
PubMed1987

Anticancer drug distribution in lymph and blood during adjuvant chemotherapy after surgery for gastric carcinoma. A study with a combined preparation of 1-(2-tetrahydrofuryl)-5-fluorouracil and uracil.

Previously the authors reported that the fat emulsion of 1-(2-tetrahydrofuryl)-5-fluorouracil, tegafur (FT-207), yielded significantly higher concentrations of tegafur in the lymph and plasma compared to tegafur enteric-coated granules (FT-G). However, the emulsification did not improve the metabolic conversion rate of tegafur to 5-fluorouracil (5-FU). A study was performed to assay the plasma and lymphatic concentrations of tegafur, 5-FU, and uracil in seven patients after radical surgery for gastric carcinoma who were given a combined oral preparation of FT-207 and uracil (UFT). Both lymph and plasma 5-FU levels after UFT were 20 times greater than those after FT-G, although FT-207 levels were not different. Patients given UFT showed significantly greater 5-FU and uracil concentrations in the lymph compared with the plasma. The results of this study suggest a potential use of UFT as an adjuvant postoperative chemotherapeutic agent for gastric carcinoma.

Combined Modality Therapy↗
PubMed1988

Metastatic medullary thyroid carcinoma. Complete response to combination chemotherapy with dacarbazine and 5-fluorouracil.

A 20-year-old woman had a sporadic case of medullary thyroid carcinoma (MTC) metastatic to the lungs. After a transient response to streptozotocin and doxorubicin, new subcutaneous lesions appeared on the left chest wall and there was progression of pulmonary disease. Because MTC is one of the amine precursor uptake and decarboxylation (APUD) tumors, treatment was undertaken with agents active in these diseases. Dacarbazine and 5-fluorouracil, given daily for 5 days every 4 weeks, resulted in complete resolution of pulmonary and subcutaneous lesions and a sharp decrease in tumor marker levels that lasted 10 months. Recurrence of the pulmonary disease lead to her death 21 months after presentation. Thus, the chemo-responsiveness of MTC may be akin to that of other APUD carcinomas (APUDomas) and treatment of metastatic MTC and other APUDomas with the combination of dacarbazine and 5-fluorouracil appears to merit further study.

Adult↗
PubMed1989

Acquired protein C deficiency in patients with breast cancer receiving cyclophosphamide, methotrexate, and 5-fluorouracil.

Recent reports have documented an increase of thrombotic complications in patients with carcinoma of the breast receiving chemotherapy regimens containing cyclophosphamide, methotrexate, and 5-fluorouracil. The authors studied blood from nine such patients screening for abnormalities that might predispose to thrombosis or indicate that the coagulation cascade had been activated. Six of the patients were in the adjuvant setting, and three had metastatic disease. Samples were collected from each patient before, during, and after completion of the chemotherapy in question. In each patient a statistically significant decline in functional protein C activity (P = 0.001) was demonstrated at midtherapy. In seven of nine patients functional protein C level normalized after the cessation of therapy. No other positive results were found. The authors conclude that the combination of cyclophosphamide, methotrexate, and 5-fluorouracil, when administered to patients with a diagnosis of carcinoma of the breast, causes a reversible decline in the activity of protein C.

Antineoplastic Combined Chemotherapy Protocols↗
PubMed1989

5-Fluorouracil and UFT-sensitive gastric carcinoma has a high level of thymidylate synthase.

The authors examined the relationship between the level of thymidylate synthase (TS) and the sensitivity to 5-fluorouracil (5-FU) and UFT, a combined oral preparation of 1-(2-tetrahydrofuryl)-5-fluorouracil (tegafur) and uracil in a molar ratio of 1:4. For the studies we used the subrenal capsule (SRC) assay and 15 human gastric cancer tissues. The TS levels were assayed by the ligand-binding technique, using [6-3H]FdUMP. The relative variation of tumor size (delta TuS/TuS0) was calculated to be as follows: delta TuS/TuS0 = [(TuS6 - TuS0)/TuS0] x 100 (%), where TuS6 was the tumor size on day 6 and TuS0 on day 0. The chemosensitivity was considered to be positive when delta TuS/TuS0 in the treated group decreased to below -10%. Decrease in tumor size was marked in case of exposure to UFT (-19.8 +/- 13.0%) (mean +/- standard deviation), compared with that to 5-FU (-9.0 +/- 7.2%), with a statistically significant difference (P less than 0.001). The TS level varied from 1.7 to 30.8 pmol/g gastric cancer tissue and the mean was 7.1 +/- 7.2 pmol/g tissue. A correlation was noted between the TS level and decrease in size of the tumor exposed to 5-FU (r = -0.671) or UFT (r = -0.758): gastric cancer tissue with higher level of TS is more sensitive to 5-FU and UFT than is that with a lower TS level. These findings show that the sensitivity to 5-FU and UFT of gastric cancer tissue is related to the TS level and that UFT shows promise for the treatment of patients with gastric cancer.

Animals↗
PubMed1991

A phase II multi-institutional trial of low-dose N-(phosphonacetyl)-L-aspartate and high-dose 5-fluorouracil as a short-term infusion in the treatment of adenocarcinoma of the pancreas. A Southwest Oncology Group study.

Adenocarcinoma of the pancreas is a highly lethal malignancy and chemotherapy has had little impact on the natural history of this disease. PALA, used to potentiate 5-fluorouracil (5-FU), has been shown to have synergy in vivo and in vitro. Twenty-seven patients were treated with an intravenous push dose of PALA (250 mg/m2) followed 24 hours later with a 24-hour infusion of 5-FU (2600 mg/m2). This regimen was repeated weekly. There was one partial response of 21 eligible patients with an estimated response rate of 5%. Toxicity was severe with one toxic death and four patients experiencing Grade 4 toxicity. 5-Fluorouracil and PALA, given in the schedule described, do not appear to be effective against adenocarcinoma of the pancreas.

Adenocarcinoma↗
PubMed1991

Vaginal adenosis and clear cell carcinoma after 5-fluorouracil treatment for condylomas.

Vaginal adenosis and clear cell adenocarcinoma of the vagina occurred in a 44-year-old woman after treatment for condylomata acuminata. She had no known exposure to diethylstilbestrol (DES) in utero. Biopsy-proven vaginal adenosis appeared 8 months after intravaginal 5-fluorouracil application for recurrent urogenital condylomata acuminata. Forty months later, biopsies showed residual adenosis with foci of clear cell adenocarcinoma. Although clear cell adenocarcinoma is associated with vaginal adenosis and cervical ectropion in DES-exposed women, its occurrence in adenosis after 5-fluorouracil therapy has not been reported to the authors' knowledge. In this report, this rare but serious complication of treatment of condylomata acuminata is highlighted, and the literature regarding the development of non-DES-associated vaginal adenosis is discussed.

Adenocarcinoma↗
PubMed1993

Cyclophosphamide, methotrexate, and 5-fluorouracil in the treatment of metastatic prostate cancer. A Southwest Oncology Group study.

BACKGROUND: Hormone-refractory metastatic prostate cancer remains a therapeutic challenge. Cyclophosphamide, methotrexate, and 5-fluorouracil (CMF), a drug combination that is active in solid tumors, was evaluated using specific response criteria. METHODS: Fifty-two eligible patients with measurable (19), evaluable (29), or bone scan only (4) metastatic prostate cancer were treated with cyclophosphamide, 100 mg/m2 every day by mouth, methotrexate, 15 mg/m2 intravenously weekly, and 5-fluorouracil, 300 mg/m2 intravenously weekly. Treatment was given continuously unless interrupted by toxicity or disease progression. RESULTS: There were two partial responses (7%) among the evaluable patients. Six (32%) measurable patients and four (14%) evaluable patients had stable disease. Median time to progression was 3.2 months for measurable and 2.8 months for evaluable disease patients. Median survivals were 10.9 and 10.2 months, respectively. There was no difference between the two groups with regard to response rate or survival. Toxicity was acceptable and consisted primarily of myelosuppression. CONCLUSIONS: CMF is minimally active in hormone-refractory metastatic prostate cancer.

Acid Phosphatase↗
PubMed1994

Randomized trial of cyclophosphamide, methotrexate, and 5-fluorouracil with or without estrogenic recruitment in women with metastatic breast cancer.

BACKGROUND: The fraction of breast cancer cells undergoing DNA synthesis at any one time is relatively low, which is problematic because most chemotherapeutic agents are most effective against dividing cells. Estrogens administered in vitro and in vivo can increase breast cancer cell proliferation. A randomized clinical trial was performed to determine if estrogenic recruitment could increase the effectiveness of combination chemotherapy. METHODS: One hundred sixty-five women were randomized, with two excluded from these analyses, to either an intravenous cyclophosphamide, methotrexate, and 5-fluorouracil (CMF) regimen alone (cyclophosphamide, 600 mg/m2; methotrexate, 40 mg/m2; 5-fluorouracil, 600 mg/m2) or CMF preceded by 3 days of diethylstilbestrol (DES) at a dose of 1 mg orally per day. The planned cycle length was 3 weeks. RESULTS: Objective responses were seen in 20 of 80 patients (25%) treated with CMF and 32 of 83 patients (39%) treated with DES-CMF, and this difference almost achieved statistical significance (chi-square, two-sided P = 0.06). However, duration of response, time to disease progression, and survival time were similar for the two regimens. CONCLUSIONS: Estrogenic recruitment with DES as used in this study does not substantially increase the efficacy of a CMF regimen administered intravenously every 3 weeks.

Adult↗
PubMed1994

A phase II trial of alpha-interferon and 5-fluorouracil in patients with advanced carcinoid and islet cell tumors.

BACKGROUND: 5-Fluorouracil (5-FU) has shown modest single-agent activity in patients with carcinoid or islet cell tumors. Alpha interferon (alpha-IFN) has also shown modest single agent activity in these diseases, although biologic responses have been far more prevalent than have objective tumor regressions. The combination of alpha-IFN and 5-FU has demonstrated enhanced activity in several gastrointestinal malignancies. METHODS: Twenty-one patients with advanced neuro-endocrine tumors (14 with carcinoid tumors, 7 with islet cell carcinomas) were treated with alpha-IFN and 5-FU in a Phase II study. 5-Fluorouracil was administered by intravenous bolus injection at an initial dose of 400 mg/m2/day for 5 consecutive days. After a 1-week break, 5-FU then was administered weekly by intravenous bolus at a dose of 750 mg/m2. Alpha interferon administration was begun on Day 1 of 5-FU at a daily dose of 3 x 10(6) U subcutaneously and continued for the duration of the trial. RESULTS: Of the 14 carcinoid patients with carcinoid tumors, 1 experienced a partial response (7%; 95% confidence interval [CI] 0-20%) that lasted for 6 months. Eight of the patients with carcinoid tumors achieved stable disease for a median of 6 months (range, 2-10 months). One of the patients with islet cell tumors (14%; 95% CI 0-39%) achieved a partial response that persisted after 8 months; 4 patients with islet cell tumors had stable disease for a median of 13 months (range, 4-27+ months). Even at this relatively low dose of alpha-IFN, 14 of 21 patients required a dose reduction in the alpha-IFN (13 for fatigue, 1 for ataxia). Three patients experienced myelosuppression of greater than Grade 3, and three patients had diarrhea of greater than Grade 3. One patient experienced dose-limiting hand-foot syndrome. CONCLUSIONS: These results suggest that the combination of 5-FU and alpha-IFN does not have any clear superiority over the individual agents alone; 5-FU appears to reduce patient tolerance of alpha-IFN when given on a daily schedule. Further investigations are needed to identify active agents in the treatment of neuroendocrine malignancies.

Adenoma, Islet Cell↗
PubMed1994

Release of peripheral blood progenitor cells during standard dose cyclophosphamide, epidoxorubicin, 5-fluorouracil regimen plus granulocyte colony stimulating factor for breast cancer therapy.

BACKGROUND: High dose chemotherapy with the support of peripheral blood progenitor cells (PBPC) is increasingly used in the treatment of solid tumors. Although the best method of PBPC mobilization is still under investigation, it should be optimized for different tumor types to obtain antitumor effect and mobilizing activity. The authors report these results in terms of the number of PBPC released and the time of maximum mobilization induced by standard dose cyclophosphamide, epidoxorubicin, 5-fluorouracil (CEF) (cyclophosphamide 600 mg/m2, epidoxorubicin 60 mg/m2, 5-fluorouracil 600 mg/m2) plus granulocyte colony stimulating factor (G-CSF) in patients with breast cancer. METHODS: Peripheral blood progenitor cells were studied by clonogenic assay of granulocyte macrophage colony-forming units (CFU-GM), megakaryocyte colony-forming unit (CFU-Meg) and erythrocyte burst-forming unit (BFU-E) and by flow cytometric analysis of CD34+ cells in 12 patients with early breast cancer throughout three cycles of CEF chemotherapy plus G-CSF. RESULTS: Colony assays and CD34+ cell determination were performed on 111 and 151 blood samples, respectively. The peak of CFU-GM and CD34+ cells occurred consistently at day 11 throughout all three cycles. At day 11 of the first cycle, the median peak values were 2223 CFU-GM/mL and 256 CD34+ cells/microL. A progressive decrease in peak value from the first to the third cycle was observed. CONCLUSIONS: Standard dose CEF chemotherapy plus G-CSF is a disease specific regimen allowing PBPC mobilization without any relevant toxicity. Maximum mobilization was recorded at day 11 of the first cycle.

Adult↗
PubMed1995

Split-course accelerated radiation therapy combined with carboplatin and 5-fluorouracil for palliation of metastatic or unresectable carcinoma of the esophagus.

BACKGROUND: Patients with metastatic or unresectable carcinoma of the esophagus have poor survival, but often require palliation of dysphagia. METHODS: Twenty-seven patients with unresectable carcinoma of the esophagus were treated with carboplatin, 5-fluorouracil, and split-course accelerated radiation therapy. Seventy-four percent of patients had adenocarcinoma, and 26% had squamous cell carcinoma. RESULTS: The regimen was well tolerated; 25% of the patients had disease improvement after completing therapy, although the majority of these patients had all of their disease within the radiation field. Ninety-three percent (13/14) of the patients who experienced disease progression during therapy progressed in areas treated with chemotherapy alone. Median survival was 6 months. Fifty-nine percent of the 17 patients who presented with dysphagia achieved durable relief of that symptom. CONCLUSIONS: Carboplatin and 5-fluorouracil have low activity in patients with metastatic esophageal cancer. However, in combination with radiation therapy, this regimen is tolerable when the primary goal is palliation of dysphagia near the end of life. Future studies should focus on identifying more active regimens with response and survival as endpoints.

Adenocarcinoma↗
PubMed1995

Epirubicin, cisplatin, and continuous infusion 5-fluorouracil is an active and safe regimen for patients with advanced gastric cancer. An Italian Group for the Study of Digestive Tract Cancer (GISCAD) report.

BACKGROUND: A Phase II confirmatory multicenter trial was performed to evaluate a combination of epirubicin, cisplatin, and continuous infusion 5-fluorouracil (ECF) in treating patients with advanced gastric cancer. METHODS: Fifty-three patients with locally advanced (n = 7) or metastatic (n = 46) gastric cancer received a dose of epirubicin (50 mg/m2) and cisplatin (60 mg/m2) intravenously every 21 days for eight cycles with 5-fluorouracil (200 mg/m2/day) by intravenous continuous infusion for 21 consecutive weeks, administered through a central line using an external pump. RESULTS: Eight complete responses and 22 partial responses (response rate = 56%, 95% confidence interval +/- 13) were achieved. Twelve patients had stable disease. The median duration of response was 10 months (range, 3-21 months), and the median survival for all the patients was 9+ months (range, 2-28 months). Overall toxicity, which was primarily hematologic, was mild with only three patients requiring hospitalization for neutropenic fever. No death due to toxicity occurred. CONCLUSIONS: This study found that the ECF regimen is substantially active in treating patients with advanced gastric cancer and has a favorable pattern of toxicity. This schedule clearly deserves randomized comparative trials for palliation of metastatic disease and for adjuvant purposes.

Adult↗
PubMed2000

Adjuvant doxorubicin and cyclophosphamide versus cyclophosphamide, methotrexate, and 5-fluorouracil chemotherapy in premenopausal women with axillary lymph node positive breast carcinoma.

BACKGROUND: This randomized controlled trial was to determine whether a combination chemotherapy regimen that contains anthracycline (doxorubicin and cyclophosphamide [AC]) is superior to the conventional cyclophosphamide, methotrexate, and 5-fluorouracil [CMF] combination in premenopausal women with axillary lymph node positive Stage II breast carcinoma. METHODS: Premenopausal women with lymph node positive breast carcinoma were stratified according to age (younger than 35 or 35 years or older) and the number of positive axillary lymph nodes (1-3, 4-9, or >/= 10) and then randomly assigned to receive either doxorubicin 40 mg/m(2) and cyclophosphamide 600 mg/m(2) intravenously (i.v.) every 3 weeks or cyclophosphamide 100 mg/m(2) orally on Days 1 through 14, methotrexate 40 mg/m(2) and 5-fluorouracil 500 mg/m(2) i.v. on Days 1 and 8 every 4 weeks. Both arms were scheduled for six cycles. RESULTS: The median follow-up was 57 months. Eighteen of the 55 AC patients developed recurrence compared with 16 of the 69 CMF patients. The corresponding 5-year recurrence free survival rates were 64% and 78%, respectively (P = 0.12). The site of the first recurrence for AC patients was locoregional in 7%, distant in 22%, and combined in 4%. The corresponding data for the CMF arm were 4%, 16%, and 3%, respectively. Six AC patients died compared with 9 CMF patients. The corresponding 5-year survival rates were 90% and 86%, respectively (P = 0.96). More leukopenia (52%, mostly Grade 1-2) occurred in the CMF arm than in the AC arm (33%, P = 0.001), but no febrile episode was accompanied with leukopenia. CONCLUSIONS: This study showed no difference between AC and CMF with respect to both disease free and overall survival rates in premenopausal women with axillary lymph node positive breast carcinoma.

Adult↗
PubMed1990

Regional chemotherapy for colorectal liver metastases: a phase II evaluation of targeted hepatic arterial 5-fluorouracil for colorectal liver metastases.

The results of systemic chemotherapy in patients with liver metastases from colorectal cancer remain dismal. Regional chemotherapy has been advocated as a method of improving the delivery of cytotoxic drugs to tumour, while minimizing systemic toxicity. The use of vasoactive agents to redistribute arterial blood flow towards tumour, and of biodegradable microspheres to slow tumour blood flow, have also been suggested as methods of further improving tumour exposure to drug. We present 21 patients who received intrahepatic arterial chemotherapy for colorectal liver metastases. Combined treatment (angiotensin II, albumin microspheres and 5-fluorouracil) was administered 4-6 weekly, and bolus 5-fluorouracil was given in the intervening weeks. Toxicity was minimal. Responses were seen in seven patients. Fewer than half of the deaths were from liver metastases; a quarter of the patients died from non-cancer-related causes. Survival was prolonged in the treated group compared with historical controls. These results suggest that this regimen has activity in patients with colorectal liver metastases.

Adult↗