{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2024,9,12]],"date-time":"2024-09-12T02:01:51Z","timestamp":1726106511671},"reference-count":41,"publisher":"American Society of Clinical Oncology (ASCO)","issue":"3","content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":["JCO"],"published-print":{"date-parts":[[2001,2,1]]},"abstract":"<jats:p> PURPOSE: To determine whether intensifying the dose of adjuvant chemotherapy improves the outcome of women with primary breast cancer and 10 or more involved axillary nodes. <\/jats:p><jats:p> PATIENTS AND METHODS: Patients (n = 150) were randomized to receive either four cycles of standard doxorubicin 60 mg\/m<jats:sup>2<\/jats:sup> plus cyclophosphamide 600 mg\/m<jats:sup>2<\/jats:sup> every 3 weeks (arm A) or four courses of intensified mitoxantrone 23 mg\/m<jats:sup>2<\/jats:sup> plus cyclophosphamide 600 mg\/m<jats:sup>2<\/jats:sup>, with filgrastim 5 g\/kg\/d from days 2 to 15, every 3 weeks (arm B). Disease-free survival (DFS), distant disease-free survival (DDFS), and overall survival (OS) were determined using life-table estimates. <\/jats:p><jats:p> RESULTS: There were no significant differences in DFS (P = .44), DDFS (P = .67), or OS (P = .99) between the two groups at 5 years; DDFS was 45% (arm A) versus 50% (arm B), and DFS was 41% versus 49%, respectively. Five-year survival was similar in both arms (61% v 60%, respectively). Failure to note an intergroup difference in outcome was unrelated to relative dose-intensity. Analysis of patients with 15 or more positive nodes revealed a significant difference in 5-year DDFS (19% v 49% in arm B; P = .01). Toxicity was generally mild in both groups, with no toxic death. The incidence of febrile neutropenia was low (0.3% v 3%). Alopecia was less frequent in arm B (P &lt; .001). <\/jats:p><jats:p> CONCLUSION: This randomized trial confirms the feasibility of administering mitoxantrone 23 mg\/m<jats:sup>2<\/jats:sup> with cyclophosphamide and filgrastim. Although there was no significant difference between conventional and intensified arms at 5 years, according to subgroup analysis, intensified treatment may decrease the risk of relapse in patients with 15 or more positive nodes compared with doxorubicin an cyclophosphamide. <\/jats:p>","DOI":"10.1200\/jco.2001.19.3.612","type":"journal-article","created":{"date-parts":[[2017,2,24]],"date-time":"2017-02-24T08:12:12Z","timestamp":1487923932000},"page":"612-620","source":"Crossref","is-referenced-by-count":25,"title":["Intensification of Adjuvant Chemotherapy: 5-Year Results of a Randomized Trial Comparing Conventional Doxorubicin and Cyclophosphamide With High-Dose Mitoxantrone and Cyclophosphamide With Filgrastim  in Operable Breast Cancer With 10 or More Involved Axillary Nodes"],"prefix":"10.1200","volume":"19","author":[{"given":"Pierre","family":"Fumoleau","sequence":"first","affiliation":[{"name":"From the Centre Ren\u00e9 Gauducheau, Nantes; Centre Antoine Lacassagne, Nice; Centre Claudius Regaud, Toulouse; Centre Ren\u00e9 Huguenin, Saint-Cloud; Centre L\u00e9on B\u00e9rard and H\u00f4pital Edouard Herriot, Lyon; Centre Fran\u00e7ois Baclesse, Caen; Centre Eug\u00e8ne Marquis, Rennes; Centre Oscar Lambret, Lille; and Wyeth-Lederle, Paris, France."}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Franck","family":"Chauvin","sequence":"additional","affiliation":[{"name":"From the Centre Ren\u00e9 Gauducheau, Nantes; Centre Antoine Lacassagne, Nice; Centre Claudius Regaud, Toulouse; Centre Ren\u00e9 Huguenin, Saint-Cloud; Centre L\u00e9on B\u00e9rard and H\u00f4pital Edouard Herriot, Lyon; Centre Fran\u00e7ois Baclesse, Caen; Centre Eug\u00e8ne Marquis, Rennes; Centre Oscar Lambret, Lille; and Wyeth-Lederle, Paris, France."}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Mo\u00efse","family":"Namer","sequence":"additional","affiliation":[{"name":"From the Centre Ren\u00e9 Gauducheau, Nantes; Centre Antoine Lacassagne, Nice; Centre Claudius Regaud, Toulouse; Centre Ren\u00e9 Huguenin, Saint-Cloud; 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