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PubMedDate not supplied

Phase II study of the etoposide, leucovorin and fluorouracil combination for patients with advanced gastric cancer unsuitable for aggressive chemotherapy.

Many patients with advanced gastric cancer cannot be treated with intensive chemotherapy. In an attempt to provide a feasible regimen for such patients, the combination of etoposide, leucovorin and fluorouracil (ELF) has been developed with promising results. The present study involved 42 patients with advanced gastric cancer who where unsuitable for cisplatin- or anthracycline-containing regimens because of their age (24 patients over 65 years), poor performance status (12) or the presence of concomitant illness (6). The treatment consisted of etoposide 120 mg/m2 i.v., 1-leucovorin 150 mg/m2 i.v. and fluorouracil 500 mg/m2 i.v. for 3 consecutive days every 3 weeks. Among the 41 evaluable patients, there was a 32% objective response rate (95% confidence interval 19-48%), with 7% of complete remissions. The median response duration was 4 months, the median time to progression in all patients was 5 months and the median overall survival was 10 months. No drug-related deaths or WHO grade 4 side effects were observed. On the basis of these results, we concluded that the ELF regimen is feasible and that its activity warrants randomized studies comparing the ELF combination with fluorouracil plus folinic acid.

Adult↗
PubMedDate not supplied

Phase II study of 5-fluorouracil and interferon-gamma in patients with metastatic colorectal cancer. A Hellenic Cooperative Oncology Group Study.

Preclinical data have shown a synergism between 5-fluorouracil and interferon-gamma against human colon carcinoma cell lines. We conducted a phase II trial of this combination in 34 patients with metastatic colorectal cancer. 5-Fluorouracil was administered as an intravenous bolus of 500 mg/m2 weekly and interferon-gamma subcutaneous injection at a dose of 200 micrograms (6 x 10(6) IU) 3 times a week. Thirty-two patients were evaluable for response. There was one complete and two partial responses (response rate 9.0%, 95% CI 1.98-25.02%). Eleven patients (34%) had stable disease. Common toxicities included fever 81%, nausea/vomiting 19%, diarrhea 16%, flu-like syndrome 16%, malaise 12.5% and leukopenia 12.5%. These results indicate that the above combination of 5-fluorouracil and interferon-gamma has an unimpressive activity in patients with advanced colorectal carcinoma. Toxicity was very tolerable.

Antineoplastic Combined Chemotherapy Protocols↗
PubMed1990

Inhibition of posterior capsule opacification by 5-fluorouracil in rabbits.

An extracapsular cataract extraction was performed on both eyes of 24 rabbits. Irrigation for 10 min of the capsular bag of the left (test) eye with 8-12 cm3 of 1 litre of BSS-plus to which had been added 50 mg of 5-fluorouracil significantly inhibited proliferation of the anterior capsular epithelium as compared with the right (control) eyes identically treated except for the omission of 5-fluorouracil (p less than 0.001). Corneal endothelial counts did not differ significantly. A reduction in opacification of the posterior capsule is expected from 5-fluorouracil treatment.

Animals↗
PubMed1980

Schedule-dependent cytotoxicity of methotrexate and 5-fluorouracil in human colon and breast tumor cell lines.

The effect of sequential methotrexate and 5-fluorouracil on the clonal growth of the human colon adenocarcinoma cell, HCT-8, and the hormone-dependent human breast carcinoma cell, 47-DN, was examined. In both cell lines, when 5-fluorouracil was given during the last 6 h of a 24 h methotrexate exposure period, there was marked synergistic inhibition of clonal growth. Shorter intervals or the reverse sequence of drugs were either additive or antagonistic. These results indicate the importance of the drug sequence and time interval between drug administration for optimal cytotoxicity in these human cell lines. This information suggests that the administration of methotrexate 18 h before 5-fluorouracil may have potential application in the design of clinical trials for these malignancies.

Adenocarcinoma↗
PubMedDate not supplied

Chemotherapy with cisplatin and 5-fluorouracil chronomodulated infusion in locally advanced or metastatic/recurrent carcinoma of the cervix.

AIMS AND BACKGROUND: The purpose of this study was to review our experience with the combination of circadian chronomodulated 5-fluorouracil infusion in association with cisplatin in patients with locally advanced or metastatic cancer of the cervix in order to assess the activity and tolerability of the combination. METHODS: Twenty patients with locally advanced disease and 21 patients with metastatic or recurrent disease were treated from January 1995 to May 1999. 5-fluorouracil (600 mg/m2, days 1 to 5) was administered by a continuous circadian-shaped infusion employing an external programmable portable pump; cisplatinum (20 mg/m2) was infused days 1 through 5 i.v. over a 2-hr period. Response to treatment was evaluated after 3 and 6 cycles of therapy. Patients with locally advanced disease who achieved a clinical shrinkage of their tumor or were at least stable were submitted to surgery; pelvic radiotherapy was administered to patients with disease progression. RESULTS: Seven patients with locally advanced disease achieved a partial clinical response (overall response, 35%; 95% CI, 15.4-59.2), and 12 of 20 patients were submitted to surgery. Median progression-free and overall survival were 17 months and 36 months, respectively. Objective responses were observed in 9 of 21 patients with metastatic/recurrent disease (7 partial plus 2 minor responses: overall response 43%; 95% CI, 21.8-65.9). Median time to progression and overall survival were 5 and 17 months, respectively. CONCLUSIONS: Cisplatinum plus 5-fluorouracil chronomodulated infusion showed a moderate but definite activity and was well tolerated in both groups of patients. In consideration of clinical results comparable to more toxic and expensive regimens reported in the literature, the combination appears to be a reasonable option especially for women with metastatic/recurrent cervical carcinoma and a promising treatment in combination with definitive radiotherapy in patients with locally advanced disease.

Adult↗
PubMedDate not supplied

Treatment of metastatic pancreatic cancer with a combination of gemcitabine and 5-fluorouracil: a single center phase II study.

AIM: To determine the activity and toxicity of a combination of weekly gemcitabine and 5-fluorouracil bolus intravenously in patients with metastatic pancreatic cancer. PATIENTS AND METHODS: Twenty-one patients with previously untreated metastatic pancreatic cancer were included in this phase II study. The schedule was gemcitabine (1000 mg/m2 i.v.) and 5-fluorouracil (500 mg/m2 bolus i.v.) weekly for 3 weeks every month. RESULTS: Four patients (19%) achieved a partial response and three stable disease. A clinical benefit was obtained in 7 patients (33%). Median survival for all the patients was 6 months. The treatment was well tolerated and toxicity was mild. WHO grade 3 leukopenia occurred in 2 (9.5%) patients, grade 3 anemia in 4 (19%) patients, grade 3-4 thrombocytopenia in 4 (19%) patients, grade 1 diarrhea in 1 (4.7%) patient and grade 1 mucositis in 3 (14.2%) patients. CONCLUSION: The weekly administration of gemcitabine combined with 5-fluorouracil bolus i.v. is an active and well-tolerated regimen in metastatic pancreatic cancer. However, its efficacy is relatively limited.

Adult↗
PubMed1990

A study of the pineal hormone melatonin as a second line therapy in metastatic colorectal cancer resistant to fluorouracil plus folates.

Since there is no effective second line chemotherapy in colorectal cancer resistant to fluorouracil, this study was carried out to evaluate the therapeutic activity of the pineal hormone melatonin, which has appeared to have antineoplastic activity in some experimental conditions, in patients with metastatic colorectal carcinoma who did not respond to fluorouracil. The study included 14 patients (8 men, 6 women; mean age 58 years). Melatonin was given intramuscularly at a daily dose of 20 mg at 3.00 p.m. for 2 months; after that, melatonin therapy was continued at 10 mg/day orally in responder patients, in those with stable disease and/or an evident improvement in PS. One patient had a minor response; 3 other patients had a stable disease, whereas the other 10 cases progressed. An evident improvement in PS was seen in 5/14 (36%) patients. These preliminary results show that melatonin does not have important antitumor activity in metastatic colorectal cancer patients resistant to fluorouracil. However, the pineal hormone could be usefully employed as supportive care to improve the quality of life in these patients for whom no standard treatment is yet available.

Adult↗
PubMed1991

Carboplatin, continuous infusion fluorouracil and mid-cycle high-dose methotrexate as initial treatment in patients with locally advanced head and neck cancer. Hellenic Co-operative Oncology Group Study.

Forty-nine patients with locally advanced squamous cell carcinoma of the head and neck (SCCHN) were treated with 3 cycles of induction chemotherapy prior to definitive local treatment (surgery and/or radiation therapy). Chemotherapy consisted of carboplatin 300 mg/m2 on day 1, fluorouracil 1000 mg/m2 daily as a continuous infusion on days 1 to 5 and high-dose methotrexate 1.2 g/m2 with leucovorin rescue on day 14. After completing the induction chemotherapy, 9 patients (18%) achieved a complete remission (CR), 26 (54%) a partial remission (PR), 7 had stable disease and 7 a progression. The response rates increased to 53% CR and 18% PR following locoregional treatment. Survival at 12 months was 61% and its actuarial probability at 24 months 31%. Median time to progression was 14 months. Toxicity from chemotherapy was generally mild. Nausea was observed in 35%, vomiting in 26%, stomatitis in 57%, anemia in 22%, leukopenia in 36%, thrombocytopenia in 26% and diarrhea in 6% of the patients. In conclusion, the combination of carboplatin, 5-day continuous-infusion fluorouracil and mid-cycle high-dose methotrexate is a moderately effective, well tolerated regimen in patients with SCCHN but does not seem superior to the combination of carboplatin and fluorouracil only.

Aged↗
PubMed1993

A pilot clinical trial of postoperative adjuvant intraperitoneal cisplatin, 5-fluorouracil, 6S-leucovorin and interferon alpha 2b in patients with resected gastric cancer.

AIMS AND BACKGROUND: The study was performed to assess the toxicity and impact on relapse pattern of postoperative intraperitoneal cisplatin, 5-fluorouracil, leucovorin and interferon therapy as adjuvant treatment for gastric cancer patients who are at high risk for recurrence after potentially curative resection (T2 N1-2; T3-4 N any Mo). PATIENTS AND METHODS: Starting 14 to 21 days after potentially curative resection of primary gastric cancers, 22 patients were given intraperitoneal cisplatin, 60 mg/m2; 5-fluorouracil, 1000 mg/m2; 6S-leucovorin, 250 mg/m2; interferon alpha 2b, 10 MU/m2; every other week for six times. RESULTS: After a median follow-up of 24 months, 63% of patients were alive and free of disease. Eight patients had recurred; five had an intraabdominal component, and 3 had extraabdominal failure. Toxicity was mild: no grade III-IV WHO toxicity was observed. CONCLUSIONS: Intraperitoneal cisplatin, 5-fluorouracil, 6S-leucovorin and interferon is a tolerable therapy in the postoperative setting for patients with resected gastric cancer. These data make this approach interesting for the development of new programs of adjuvant therapy of high-risk gastric cancer.

Adult↗
PubMedDate not supplied

Phase II study of oral L-leucovorin, 120-hour fluorouracil infusion and carboplatin in advanced pancreatic cancer.

BACKGROUND: No effective chemotherapy has been developed for patients with metastatic pancreatic cancer. Encouraging results have been reported with the combination of cisplatin and fluorouracil infusion. The aim of the study was to test the activity of oral L-leucovorin, carboplatin and fluorouracil infusion in untreated pancreatic cancer patients. PATIENTS AND METHODS: Patients with advanced pancreatic carcinoma were treated with carboplatin (300 mg/m2 on day 1), L-leucovorin (5 mg/m2 twice a day on days 1-5), and fluorouracil (1,000 mg/m2 as a 120-hr infusion on days 1-5), cycles being repeated every 21 days. RESULTS: Nine patients were included and were assessable for response and side effects. All patients had measurable disease and an ECOG performance status of 0-2. No patient achieved partial remission, 3 had stable disease, and 6 progressive disease. Median time to progression was 2 months (range, 2-8), and median survival was 4 months (range, 3-12). Toxicity consisted of mucositis, diarrhea and neutropenia. CONCLUSIONS: Patients with metastatic pancreatic carcinoma do not benefit from this treatment schedule.

Administration, Oral↗
PubMedDate not supplied

Sucralfate prophylaxis of fluorouracil-induced stomatitis.

AIMS AND BACKGROUND: Various attempts have been made to prevent 5-fluorouracil-induced stomatitis, with unsatisfactory results. Sucralfate is an aluminum hydroxide complex of sulfated sucrose commonly used in the treatment of gastroduodenal ulcers. We used the compound in a phase II study to reduce and minimize the stomatotoxicity of 5-fluorouracil chemotherapy administered in a multiple-day schedule. METHODS: Fifty-two patients entered the study, and 129 cycles of chemotherapy were evaluated. Seven patients refused sucralfate rinses for taste intolerance. RESULTS: A low level of stomatotoxicity was recorded: grade 2 stomatitis was observed after 14 cycles (10.8%) and grade 3 after 3 cycles (2.3%). CONCLUSIONS: Sucralfate administration could have a role in the prevention of 5-fluorouracil-induced stomatitis.

Adult↗
PubMedDate not supplied

High doses of 5-fluorouracil and epirubicin with or without cisplatin in advanced gastric cancer: a randomized study.

BACKGROUND: A prospective randomized clinical study was performed in patients with locally advanced or metastatic gastric cancer. The purpose of the study was to determine the activity of high doses of 5-fluorouracil and epirubicin (FE) vs. the same combination + cisplatin (FEP), and particularly the value of cisplatin in the combination. PATIENTS AND METHODS: A total of 122 patients was included in the study; 110 of them were assessable. In the FE arm, the treatment involved 1000 mg/m2 in a 6-hr infusion of 5-fluorouracil on days 1, 2, 3, 4 and 5 and 120 mg/m2 of epirubicin i.v. on day 1. In the FEP arm, the same combination of cytostatics + cisplatin (30 mg/m2) was administered on days 2 and 4. The cycles were repeated after 4 weeks. Altogether, 468 cycles of chemotherapy were given (FE, 240; FEP, 228). RESULTS: In the FE arm, 56 patients were assessable, with 2 complete and 14 partial remissions (28.6%); in the FEP arm, 4 complete and 19 partial remissions (42.6%) were observed in 54 assessable patients. Median survival in the FE group was 7.1 months and in the FEP group 9.6 months. The survival difference was statistically significant (Cox's test, P<0.05). The most frequent side effects included grade 2 and 3 alopecia (FE, 93%; FEP, 94%) and grade 2 and 3 vomiting (FE, 20%; FEP, 35%). Grade 3 and 4 leukopenia was observed in 9% of patients in the FE group and in 13% of patients in the FEP group, with 6 cases of febrile neutropenia (FE, 4%; FEP, 7%). Stenocardia was registered in 1 patient in the FE group and in 2 patients in the FEP group. No treatment-related death was registered. CONCLUSIONS: The addition of cisplatin to high doses of 5-fluorouracil and epirubicin resulted in a statistically significant better survival of treated patients.

Antibiotics, Antineoplastic↗
PubMedDate not supplied

Mitoxantrone, 5-fluorouracil and low-dose leucovorin in doxorubicin-resistant advanced breast cancer patients: a phase II study.

AIM: Twenty-two anthracycline-resistant advanced breast cancer patients were entered from June 1995 till November 1997 in a phase II study to assess the activity and tolerability of second-line chemotherapy consisting of mitoxantrone, 5-fluorouracil and low-dose leucovorin. STUDY DESIGN: Patients were eligible if they failed to respond to doxorubicin-containing chemotherapy, given as first-line chemotherapy for metastatic disease. Treatment consisted of mitoxantrone, 12 mg/m2 iv infusion on day 1, and leucovorin, 50 mg iv 1 hr before 5-fluorouracil, 350 mg/m2 iv infusion on days 1-3, every three weeks. RESULTS: Nineteen patients were eligible for response, 2 refused further therapy after 2 cycles, and 1 was excluded because grade 3 myelotoxicity developed during the first cycle. Partial remission of 15 months duration occurred in 1 patient, in 7/19 women disease remained stable with a median duration of 11 months (range, 5-24), and 11/19 patients experienced progressive disease. Median time to disease progression was 2 months (range, 0-17), and median survival was 8 months (range, 0-24). Toxicity was generally mild and acceptable. One patient was excluded because of grade 3 granulocytopenia and thrombocytopenia, and one due to cardiotoxicity assessed by the drop of left ventricular ejection fraction to more than 20% below the initial value. CONCLUSIONS: In spite of the very low objective response rate, almost one-fourth of our anthracycline-resistant patients achieved a disease stabilization of 27 weeks duration during mitoxantrone-based second-line chemotherapy. Hence, mitoxantrone in combination with 5-fluorouracil, especially continuous infusion, should be further investigated in this setting, particularly if new and expensive drugs, considered the most active, are not readily available.

Adult↗
PubMedDate not supplied

Influence of 5-fluorouracil and folinic acid on interleukin-18 production in colorectal cancer patients.

AIMS AND BACKGROUND: This study was carried out to evaluate the IL-18 blood concentrations of operated colorectal cancer patients and their possible variation in response to combination chemotherapy with 5-fluorouracil (5-FU) and folinic acid. METHODS: IL-18 levels were assayed in sera of 18 healthy donors and 18 surgical colorectal cancer patients before and after adjuvant chemotherapy with 5-fluorouracil and folinic acid. An ELISA kit for human IL-18 was used for the assay. RESULTS: Colorectal cancer patients showed significantly higher baseline levels of IL-18 than healthy donors (p<0.005). Furthermore, serum IL-18 levels increased significantly with respect to baseline in patients receiving adjuvant chemotherapy (p<0.005). CONCLUSIONS: This study suggests that treatment with 5-fluorouracil and folinic acid may provoke an increase in IL-18 serum levels in colorectal cancer patients. This increase may help to explain the efficacy of adjuvant chemotherapy with 5-FU in colorectal cancer.

Adult↗
PubMed2005

Treatment of a Gilbert's syndrome patient with irinotecan, leucovorin and 5-fluorouracil.

The patient was an elderly male who had radical surgery for sigmoid cancer in 2001. Owing to metastasis of his cancer to the left supraclavicular lymph nodes in 2002, the patient was admitted to our hospital for systemic chemotherapy. We started treatment with irinotecan, leucovorin, 5-fluorouracil (IFL). After administering 100 mg/m2 of irinotecan, 250 mg/m2 leucovorin and 600 mg/m2 5-fluorouracil to the patient on day 1, grade 3 leukopenia developed rapidly and grade 4 thrombocytopenia was observed on day 5. We excluded irinotecan from the medication and continued the administration of 5-fluorouracil and leucovorin, but his tumors had not been reduced sufficiently. Based on some examination results, we assumed that the patient had Gilbert's syndrome and that the severe side effects that occurred were due to prolongation of SN38 metabolism. We again administered irinotecan but at reduced dose (25 mg/m2). Four courses of this modified IFL were administered safely and the response was favorable.

Aged↗
PubMed1984

An Eastern Cooperative Oncology Group evaluation of combinations of methyl-CCNU, mitomycin C, Adriamycin, and 5-fluorouracil in advanced measurable gastric cancer (EST 2277).

In a prospectively randomized trial, patients with advanced locally recurrent or metastatic gastric adenocarcinoma were randomized to receive 5-fluorouracil (5-FU) and methyl-CCNU; 5-FU, Adriamycin (Adria Laboratories, Columbus, Ohio), and methyl-CCNU; 5-FU, Adriamycin, and mitomycin C; or Adriamycin and mitomycin C alone. One hundred eighty-three previously untreated evaluable patients were randomized among the four arms. An additional 39 patients previously treated with 5-FU, were assigned to treatment directly to Adriamycin and mitomycin C. Response rates were 14%, 29%, 39%, and 29%, respectively, among previously untreated patients and 21% for Adriamycin and mitomycin C among previously treated patients. 5-Fluorouracil, Adriamycin, and mitomycin C, the arm containing the largest number of responders (18), was the combination associated with the longest median survival. A larger proportion of patients in this arm survived one year or more. In addition, the 5-FU, Adriamycin, and mitomycin C program had the lowest rate of severe or worse toxicity of any of the treatments and was effective in patients who were less than fully ambulatory and in those who had lost weight. 5-Fluorouracil, Adriamycin, and mitomycin C appear to be a likely combination to be considered in a surgical adjuvant program.

Adenocarcinoma↗
PubMed1991

Concurrent cisplatin, infusional fluorouracil, and conventionally fractionated radiation therapy in head and neck cancer: dose-limiting mucosal toxicity.

After a preliminary dose-finding study involving 12 patients with advanced or locally recurrent head and neck cancer, 27 patients were treated on a phase II protocol, using fluorouracil 350 mg/m2/d by continuous intravenous (IV) infusion over 5 days, followed on the sixth day by a 2-hour IV infusion of cisplatin 50 mg/m2, administered during the first and fourth weeks of radiation therapy to total doses between 60 and 64 Gy, using 2 Gy daily fractions. Eight of these 27 patients had American Joint Committee on Cancer Staging (AJCC) stage III disease, and 12 had stage IV disease. Four had recurrent disease after surgery. Three-year follow-up is now available. Twenty-one (77.8%) remitted completely following treatment, and 11 remain free of local and regional relapse at 3 years. Four have developed systemic metastases. Following successful salvage treatment in two cases, estimated determinate survival at 3 years is 64%. Acute toxicity was manageable with this regime. Eleven instances of grade 3 Radiation Therapy Oncology Group/European Organization for Research and Treatment of Cancer (RTOG/EORTC) mucositis were observed, which caused interruptions to radiotherapy in only four cases. No late sequelae have so far been recorded. It is concluded that the protocol described is tolerable but probably did not cause a greater number of locoregional "cures" than would have been expected following conventional radiotherapy alone in this group of patients. The use of infusional fluorouracil with concurrent conventionally fractionated radiation therapy and cisplatin infusion results in mucositis that limits the dose of fluorouracil to levels that are probably subtherapeutic.

Adult↗
PubMed2001

Multicenter phase I-II trial of docetaxel, cisplatin, and fluorouracil induction chemotherapy for patients with locally advanced squamous cell cancer of the head and neck.

PURPOSE: We conducted a phase I-II, multi-institutional trial to determine the maximum-tolerated dose (MTD) of cisplatin in an induction chemotherapy regimen of docetaxel, cisplatin, and fluorouracil for squamous cell cancer of the head and neck (SCCHN) and to determine the safety, tolerability, and efficacy of the regimen at MTD. PATIENTS AND METHODS: A total of 43 patients with previously untreated, locally advanced, curable SCCHN were entered. Overall, 29 patients (67%) had N2 or N3 nodal disease and nine (21%) had T4 primary tumors. All patients received docetaxel 75 mg/m(2) on day 1; cisplatin at 75 (level I) or 100 (level II) mg/m(2) on day 1; and a continuous fluorouracil infusion at 1,000 mg/m(2)/d on days 1 through 4. Patients were treated with prophylactic antibiotics on days 5 through 15. Cycles were repeated every 21 days for a total of three cycles. Patients then received definitive therapy based on institutional preferences. RESULTS: Thirteen patients were treated at level I, and 30 patients were treated at level II. All 43 patients were assessable for toxicity. There were no major differences in toxicity between level I and level II. Cisplatin-associated grade 3 or 4 hypomagnesemia or hypocalcemia occurred in 13 (30%) and hearing loss in two patients (5%). Grade 3 or 4 neutropenia was observed in 41 patients (95%) and febrile neutropenia occurred in eight (19%). There was one serious infection (2%). There were 17 (40% [95% confidence interval [CI], 25% to 56%]) clinical complete responders (CR), 23 (54% [95% CI, 39% to 69%]) partial responders (PR), one (2%) with no change, and two (5%) unassessable patients. Major responses (CR, PR) were observed in 40 (93% [95% CI, 81% to 99%]) patients. Primary site CR was documented in 24 (54%) of patients. Postchemotherapy primary site biopsies were performed in 25 patients (58%) and pathologically negative biopsy was obtained in 11 (92%) of 12 primary site clinical CRs and seven (54%) of 13 with PR or no change. Overall, negative biopsies were obtained in 18 patients (72%). CONCLUSION: TPF induction chemotherapy can be delivered safely with a cisplatin dose of 100 mg/m(2) in previously untreated patients with SCCHN. The regimen is associated with a high rate of primary site clinical and pathologic CRs. Phase III comparison with cisplatinum and fluorouracil chemotherapy is warranted.

Adult↗