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Oral doxifluridine plus levoleucovorin in elderly patients with advanced breast cancer
Author(s) -
Bajetta Emilio,
Biganzoli Laura,
Carnaghi Carlo,
Bartolomeo Maria Di,
Spagnoli Ivo,
Cassata Antonio,
Galante Emanuele,
Mariani Luigi,
Stampino Corrado Gallo,
Buzzoni Roberto
Publication year - 1998
Publication title -
cancer
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 3.052
H-Index - 304
eISSN - 1097-0142
pISSN - 0008-543X
DOI - 10.1002/(sici)1097-0142(19980915)83:6<1136::aid-cncr12>3.0.co;2-6
Subject(s) - medicine , tolerability , cardiotoxicity , breast cancer , chemotherapy , toxicity , fluorouracil , gastroenterology , surgery , cancer , adverse effect
BACKGROUND There currently is no agreement regarding the appropriate treatment of elderly patients with advanced breast carcinoma (ABC). Doxifluridine (5‐dFUR), a prodrug of 5‐fluorouracil, has been found to be effective in this entity, but its use is limited by neurotoxicity and cardiotoxicity that are not observed when the oral formulation is used. The objective of this Phase II trial was to evaluate the effectiveness and tolerability of oral 5‐dFUR, biomodulated with levoleucovorin (l‐leucovorin), in elderly patients (age > 70 years) with ABC. METHODS 5‐dFUR was administered orally at 600 mg/m 2 twice daily for 4 consecutive days every 12 days, and oral l‐leucovorin was administered as 25 mg 2 hours before each 5‐dFUR administration. Response was assessed every five cycles according to the World Health Organization criteria. In the presence of response or stable disease, the patients were treated for a maximum of 15 cycles. RESULTS Seventy‐three eligible patients were enrolled, 27 of whom had been pretreated with chemotherapy and/or hormonotherapy; all were assessable for response and toxicity after a median follow‐up of 15 months. The objective response rate was 26% (95% confidence interval, 17.4‐45.4). Regression predominantly occurred in the presence of soft tissue involvement (skin, lymph nodes, and breast). The median time to response was 2 months (range, 1‐2 months) and the median response duration was 7 months (range, 2‐17+ months). The median survival was 24 months (range, 2‐42+ months). The treatment was very well tolerated, and the side effects were manageable and always reversible. CONCLUSIONS The results of the current study show that 5‐dFUR plus l‐leucovorin, both given orally, are associated with excellent patient compliance. Although the results are suboptimal in terms of an objective response, this characteristic could allow 5‐dFUR to be used in elderly patients considered unsuitable for "aggressive" chemotherapy. Cancer 1998;83:1136‐1141. © 1998 American Cancer Society.