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  • 1
    ISSN: 0003-2697
    Source: Elsevier Journal Backfiles on ScienceDirect 1907 - 2002
    Topics: Biology , Chemistry and Pharmacology
    Type of Medium: Electronic Resource
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  • 2
    ISSN: 1569-8041
    Keywords: colon cancer ; eniluracil ; 5-fluorouracil
    Source: Springer Online Journal Archives 1860-2000
    Topics: Medicine
    Notes: Abstract Purpose:To evaluate the safety and efficacy of a five-day regimenof oral 5-fluorouracil (5-FU) plus eniluracil (776C85) in patients withmetastatic colorectal cancer (CRC). Patients and methods:Seventy-five patients with metastatic CRCthat was previously untreated or refractory to 5-FU–leucovorin (LV) wereenrolled and divided into two strata based upon their treatment history.Twenty-four had not previously received chemotherapy or had received adjuvantchemotherapy that ended 〉6 months prior to enrollment on study (previouslyuntreated stratum). Fifty-one patients had disease refractory to intravenous(i.v.) 5-FU–LV (previously treated stratum). All patients received sevenconsecutive daily doses of eniluracil (20 mg/day) with once daily oral 5-FUgiven on days 2–6, repeated every four weeks. One-half of the patientsin each stratum also received 50 mg/day oral LV on days 2–6. The 5-FUdose was 25 mg/m2 when administered without LV and 20mg/m2 when administered with LV. Results:Partial response (PR) was noted in 2 of 12 patientsreceiving eniluracil–5-FU and in 3 of 12 patients receivingeniluracil–5-FU–LV in the previously untreated stratum. Noresponses were observed in the refractory disease stratum, however, 15patients (30%) demonstrated stable disease over 2–18+ courses oftherapy. Non-hematologic toxicities were mild; only 7% of patientsexperienced grade 3 diarrhea. Myelosuppression was frequent and dose limiting.Neutropenic sepsis was reported in 13.5% of patients. Conclusions:Eniluracil with 5-FU administered orally with orwithout LV on a five-day schedule is active and well tolerated when given asprimary therapy to patients with metastatic CRC.
    Type of Medium: Electronic Resource
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  • 3
    ISSN: 1569-8041
    Keywords: breast cancer ; old age ; vinorelbine
    Source: Springer Online Journal Archives 1860-2000
    Topics: Medicine
    Notes: Abstract Background: Older patients with advanced breast cancer are less likely to receive chemotherapy than younger patients. Vinorelbine is an attractive alternative in this setting because of its clinical activity and low frequency of side effects. This multicenter, phase II trial was designed to assess the safety and efficacy of intravenous vinorelbine as first-line therapy in women ≥60 years old. Patients and methods: Fifty-six women (median age, 72 years; range 60–84 years), with measurable advanced breast cancer and no prior chemotherapy for metastatic disease, were enrolled and included in the analysis. Vinorelbine 30 mg/m2 was administered weekly for 13 weeks and then every two weeks until development of progressive disease; doses were reduced or delayed to manage toxicity. Results: The objective response rate was 38% (95% confidence interval (95% CI): 24%–51%); median duration of response, nine months; median time to disease progression in all patients, six months. The major dose-limiting toxicity was hematologic, which led to a median dose intensity of 20.6 mg/m2/week. Grade 3–4 nonhematologic toxicity consisted of asthenia (7%); nausea and generalized pain (5%); vomiting, chest pain, abdominal pain, and elevated AST (4%); fever, diarrhea, constipation, and injection site reaction (2%). Neurotoxicity and alopecia were grade 1–2 and relatively infrequent. Conclusions: Vinorelbine offers a promising alternative for the management of advanced breast cancer in elderly patients who are concerned about the subjective side effects of cytotoxic chemotherapy. The dose-limiting toxicity is neutropenia, which is readily managed with dose adjustment. Nonhematologic toxicity, including gastrointestinal side effects, is minimal. Randomized studies are warranted to compare the activity of vinorelbine with that of other regimens in elderly patients.
    Type of Medium: Electronic Resource
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