A randomized phase II trial of two different schedules of mitomycin C and vinorelbine in pretreated breast cancer.
Explore the source record for details and available documents.
Adult↗
Biomedical subjects
P Nelli
Publications and source records attributed to P Nelli.
Pain at tumor site after vinorelbine injection: description of an unexpected side effect.
AIMS AND BACKGROUND: Vinorelbine is a new semisynthetic vinka alkaloid that has demonstrated good tolerability and interesting activity in a large spectrum of solid tumors. It was the aim of this paper to report the presence of a rarely documented side effect. METHODS: In our experience, 135 patients were treated with vinorelbine during the period 10/92 to 11/94 for a total of 1080 cycles. In 26% of the cycles, vinorelbine was administered in monochemotherapy and in 74% in polychemotherapy regimens. The dose of vinorelbine, administered in a weekly schedule, was 25 mg/m2 in 109 patients and 30 mg/m2 in 26 patients. In general, no analgesic premedication was used. Sixty-five patients had lung cancer, 45 had breast cancer, and 25 miscellaneous cancer. Only 4 patients had a previous history of neurotoxicity. RESULTS: Ten patients (7%) had pain in the tumor site within a few minutes of the vinorelbine injection. According to WHO grade, 5 cases had moderate and 5 severe pain. Pain was always reversible. In 5 cases ketorolac was administered after pain detection with resolution of the symptoms; in 4 cases it was necessary to deliver buprenorphine. One patient was admitted to the coronary unit because a myocardial infarction was suspected after retrosternal pain and required i.v. morphine. Seven cases refused to continue the treatment, and 3 cases had no further problem after ketorolac premedication. CONCLUSIONS: Although rare, the presence of severe pain after vinorelbine injection may adversely affect the treatment course. Such data are helpful in the recognition and management of this reversible side effect.
Adult↗
Clinical development of new fluoropyrimidines: a major improvement in colorectal cancer treatment?
AIMS AND BACKGROUND: Colorectal cancer represents an increasing problem and is responsible for about 16,000 deaths per year in Italy. Fluorouracil represents the most widely used agent, but therapeutic responses have remained consistently discouraging. The overall response rates for fluorouracil as a single agent range from 5% to 15%, and the addition of biochemical modulators, although able to improve response rate, has not been shown conclusively to prolong survival. METHODS: In recent years, several new compounds characterized by a high therapeutic index, optimal absorption through the gastrointestinal tract when administered orally and selective hepatic metabolization have been synthesised. In this review we analyzed published data on new fluoropyrimidines in an attempt to better define their role and to evaluate any significant improvement over fluorouracil. RESULTS: Although no sure advantage over fluorouracil has been detected, interesting results have been reported for fluorouracil analogs with alternative routes of administration such as oral or intra-arterial chemotherapy. CONCLUSIONS: Further studies, possibly randomized, should also measure quality of life and treatment-related costs in order to define their real advantage over fluorouracil in the palliation of advanced colorectal cancer.
Antimetabolites, Antineoplastic↗
Megestrol acetate in unresectable hepatocellular carcinoma.
AIMS AND BACKGROUND: No consolidated medical treatment has yet been established for unresectable hepatocellular carcinoma (HCC). A possible interference of hormones in the pathogenesis and cellular growth of HCC has been suggested. METHODS: To evaluate the activity and tolerance of progestins in HCC, patients were treated with megestrol acetate orally at a dose of 160 mg daily until progression of disease or grade III-IV toxicity was observed. RESULTS: Eleven patients entered the study and were assessable for response and side effects. Median duration of treatment was 80 days (range 60-150). No major responses were observed, 4 patients had stabilization of disease for at least 2 months, and 7 had progressive disease. Median time to disease progression was 3 months (range 2-5). Three patients required interruption of treatment because of toxicity (2 patients had worsening of concomitant diabetes and 1 patient had gastric bleeding). CONCLUSIONS: The results of the present study suggest that hormone therapy with megestrol acetate has no significant role in HCC.
Aged↗
Surgery followed by intracavitary plus systemic chemotherapy in malignant pleural mesothelioma.
AIMS AND BACKGROUND: Malignant mesothelioma is associated with a median survival of 4 to 12 months. Data from the literature indicate that single modality treatment (surgery or intrapleural and/or systemic chemotherapy) does not significantly affect survival. METHODS: We therefore evaluated a combined approach consisting of surgery (pleurectomy + diaphragmatic or pericardial resection), intrapleural chemotherapy with cisplatin (100 mg/m2) and cytarabine (1,000 mg/m2) for 4 h immediately after pleurectomy, and systemic chemotherapy consisting of epirubicin (60 mg/m2) and mitomycin-C (10 mg/m2) day 1 every 4 weeks for 4 cycles. RESULTS: Twenty patients were enrolled in the study and were evaluable. Thirteen cases had residual gross disease after pleurectomy and 7 patients only minimal disease. Median time to disease progression was 7.4 months, and median survival was 11.5 months (range, 2-25+). No treatment-related death have been observed. Side effects after intracavitary chemotherapy included renal toxicity, anaemia and pain. Myelosuppression and alopecia were recorded during systematic chemotherapy. CONCLUSIONS: The results of the study indicate that the schedule is feasible, with encouraging results in terms of survival for patients with minimal residual disease after surgery.
Adult↗
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↗
Intermittent continuous infusion of fluorouracil and low-dose oral leucovorin in pretreated breast cancer: a pilot study.
AIMS AND BACKGROUND: There is evidence that fluorouracil (FU), when administered by protracted venous infusion, has antitumor activity in pretreated breast cancer. The aims of the study were to assess, in a population of heavily pretreated breast cancer patients (> or = 2 lines of chemotherapy previously administered), the feasibility and activity of a new combination of oral L-leucovorin and continuous FU infusion. METHODS: Patients were treated with the following combination: oral L-leucovorin, 5 mg/m2 days 1 through 14, plus FU, 250 mg/m2 days 1 through 14, with cycles repeated every 21 days. RESULTS: Since November 1994, 22 patients have entered the study and 20 are assessable for response and side effects. Major patient characteristics were: ECOG performance status, 0-2; median age, 56 years (range, 41-70); sites of metastasis, bone 9, lung 8, liver 2, pleura 7; 2 or more metastatic sites, 18. A total of 74 cycles has been administered (median/patient, 3 cycles). Five partial remissions (25%), 4 disease stabilizations and 11 disease progressions have been observed. Median time to progression was 3 months (range 1.6+). Grade I-II mucositis was observed in 8 patients and grade III-IV in 6 patients. Other side effects have included diarrhea and thrombocytopenia. CONCLUSIONS: The schedule has demonstrated moderate activity in heavily pretreated breast cancer, with mucositis as the dose-limiting toxicity.
Administration, Oral↗
Mitomycin C and vinorelbine in pretreated breast cancer.
AIMS AND BACKGROUND: Vinorelbine, a new semi-synthetic vinca alkaloid, has demonstrated high activity as a single agent in pretreated metastatic breast cancer. PATIENTS AND METHODS: To evaluate the activity of the combination vinorelbine-mitomycin C and to reduce the incidence of side effects, in particular myelotoxicity, patients with metastatic breast cancer pretreated with 1 or more chemotherapy regimens for metastatic disease were treated according to the following schedule: mitomycin C, 10 mg/m2 day 1, and vinorelbine, 25 mg/m2, days 1, 8 and 15, every 28 days. RESULTS: Twenty-seven patients were enrolled and were evaluable for activity and side effects. A total of 157 cycles were delivered (median 5 cycles per patient). There were 10 partial remissions (37%; 95% confidence interval 20-59%), 5 instances of stable disease and 12 of disease progression. Grade III-IV toxicity was mostly hematological and included thrombocytopenia (4%) and neutropenia (42%). CONCLUSION: Our results indicate that the combination of mitomycin C and vinorelbine has moderate activity in pretreated breast cancer.
Adult↗
Double modulation with methotrexate and L-leucovorin of weekly 24- hour fluorouracil infusion in fluorouracil-refractory colorectal cancer.
No effective second-line therapy has been developed for patients with metastatic colorectal cancer progressive after than fluorouracil(FU)-containing chemotherapy. Encouraging results have been reported with weekly 24-hour FU infusion. The aim of this study was to test the activity of weekly FU infusion plus modulation with methotrexate and L-leucovorin in pretreated colorectal cancer patients. Seventeen patients with metastatic colorectal carcinoma were treated with methotrexate (40 mg/m2 on day 1), L-leucovorin (100 mg/m2 as a 4-hour infusion on day 2), and FU (2,600 mg/m2 as a 24-hour infusion on day 2). All patients had measurable disease and a performance status of ECOG O-2. Two of the 17 evaluable patients achieved partial remission (12%; 95% confidence interval 2-24%), 9 had stable disease, and 6 progressive disease. Median time to progression was 4 months (range, 2-8) and median survival was 7 months (range, 3-12+). Toxicity was generally mild or moderate and consisted of mucositis, diarrhea and neutropenia. Pretreated patients with metastatic colorectal, carcinoma benefit only marginally from this treatment schedule.
Adult↗