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  • 1
    ISSN: 1573-7217
    Keywords: breast cancer ; adjuvant chemotherapy ; CMF ; 5-fluorouracil ; survival post-relapse ; weight change
    Source: Springer Online Journal Archives 1860-2000
    Topics: Medicine
    Notes: Abstract Beginning in 1974, patients with ≥4 nodes positive following mastectomy were randomized to receive either 5-FU i.v. weekly or CMF i.v. every 2 weeks, both given for 12 months. Median follow-up now exceeds 112 months with nine year results below: Early results based on relapse-free survival favored CMF, but more patients currently are alive on the 5-FU arm. As the survival curves cross at 40 months, the 20% survival advantage for 5-FU did not achieve statistical significance. For 34% of patients failing adjuvant 5-FU, use of combination chemotherapy after relapse (commonly with CMFVP or CMF) resulted in long term survival. In contrast, long-term survival for patients failing adjuvant CMF was unusual. Relapse was detected while under weekly observation in a greater proportion of patients on 5-FU (36%) compared to CMF (6%) adjuvant treatment (p〈0.05), potentially influencing tumor burden at recurrence. Hormonal therapy or radiation therapy as initial therapy after relapse was ineffective, with no long term survivors resulting on either arm. Weight increase on adjuvant chemotherapy was commonly seen, with weight increase 〉10 kg associated with a poor prognosis. We conclude that initial improvement in relapse-free survival may not predict long term survival in adjuvant breast cancer trials since both the specific adjuvant therapy given pre-relapse as well as the type of salvage therapy given post-relapse may influence ultimate patient outcome.
    Type of Medium: Electronic Resource
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  • 2
    ISSN: 1573-7217
    Keywords: mitoxantrone ; liver dysfunction ; breast cancer ; performance status ; bilirubin elevation
    Source: Springer Online Journal Archives 1860-2000
    Topics: Medicine
    Notes: Abstract To determine the safety and efficacy of mitoxantrone use in hyperbilirubinemic breast cancer patients, a prospectively determined dosage schedule was evaluated in a multi-center trial. Pretreatment bilirubin prospectively defined three groups: Controls (with normal bilirubin) and two Study groups (with either moderate or severe bilirubin increase). Bilirubin determined initial mitoxantrone dose as well: bilirubin 〈 3.5 mg/dl, 14 mg/m2; and bilirubin ≥ 3.5 mg/dl, 8 mg/m2. Mitoxantrone at 14 mg/m2 was well tolerated in patients with moderate hepatic dysfunction. Patients with severe hepatic dysfunction demonstrated a mixed toxicity picture, with performance status (ECOG level 3) defining a population with limiting myelosuppression and/or early death. The survival of Study patients with severe hepatic dysfunction (median 17 days) was significantly worse than both Control (p 〈 0.01) and Study (p 〈 0.05) patients with lower bilirubin. Entry performance status (ECOG level 0–2 versus level 3) profoundly influenced survival (median survival 222 days versus 25 days, respectively, p 〈 0.0001). Objective responses were seen in patients with both normal and elevated bilirubin. Bilirubin reduction following mitoxantrone commonly occurred, representing at least an indicator of favorable prognosis. Recommendations for mitoxantrone use include: 1. Patients with moderate bilirubinemia tolerate 14 mg/m2 mitoxantrone with reasonable chance for benefit. 2. Patients with severe hepatic dysfunction and poor performance status should not be given mitoxantrone. A definitive recommendation regarding use of reduced 8 mg/m2 mitoxantrone in patients with severe hyperbilirubinemia and favorable performance status requires further study.
    Type of Medium: Electronic Resource
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