Randomized controlled trial comparing oral doxifluridine plus oral cyclophosphamide with doxifluridine alone in women with node-positive breast cancer after primary surgery.

Abstract

PURPOSE:

We compared the therapeutic usefulness of doxifluridine (5'-DFUR) alone and a combination of 5'-DFUR plus cyclophosphamide (CPM), both of which are considered effective against advanced and recurrent breast cancer, to determine which treatment is more beneficial as postoperative adjuvant chemotherapy.

PATIENTS AND METHODS:

A total of 1,131 women with node-positive primary breast cancer were randomly assigned after primary surgery to receive 5'-DFUR alone or 5'-DFUR plus CPM. All patients initially received 5'-DFUR in an oral dose of 1,200 mg/d for 4 weeks, starting 4 weeks after surgery. Chemotherapy was then not given for 2 weeks. Patients in the 5'-DFUR group subsequently received five 4-week cycles of treatment consisting of oral 5'-DFUR (1,200 mg/d) for the first 2 weeks and no chemotherapy for the next 2 weeks. Those assigned to the 5'-DFUR plus CPM group also received oral CPM 100 mg/d for the first 2 weeks and no chemotherapy for the next 2 weeks. Women 50 years or older concurrently received 20 mg/d of tamoxifen for 2 years in both groups.

RESULTS:

Of the 1,088 eligible women, 546 were assigned to receive 5'-DFUR alone and 542 were assigned to receive 5'-DFUR plus CPM. Overall disease-free survival was significantly better in women who received 5'-DFUR plus CPM than in those who received 5'-DFUR alone (log-rank test, P =.021). Toxic effects occurred in 20.0% of patients (109 of 546) in the 5'-DFUR group and 32.3% of patients (175 of 542) in the 5'-DFUR plus CPM group (chi(2) test, P <.001).

CONCLUSION:

Combination therapy with 5'-DFUR plus CPM is more effective in preventing recurrence than 5'-DFUR alone.

• Authors: Takeshi Tominaga, Hiroki Koyama, Tetsuya Toge, Shigeto Miura, Keizo Sugimachi, Susumu Yamaguchi, Koichi Hirata, Yasumasa Monden, Yasuo Nomura, Masakazu Toi, Izo Kimijima, Shinzaburo Noguchi, Hiroshi Sonoo, Kazuaki Asaishi, Tadashi Ikeda, Tadaoki Morimoto, Jun Ota, Yasuo Ohashi, Osahiko Abe
• Journal: Journal of clinical oncology : official journal of the American Society of Clinical Oncology (J Clin Oncol) Vol. 21 Issue 6 Pg. 991-8 (Mar 15 2003) ISSN: 0732-183X [Print] United States
• PMID: 12637462 (Publication Type: Clinical Trial, Journal Article, Multicenter Study, Randomized Controlled Trial)

Chemical References

• Antimetabolites, Antineoplastic
• Floxuridine
• Cyclophosphamide
• doxifluridine

Topics

• Administration, Oral
• Adult
• Aged
• Antimetabolites, Antineoplastic (administration & dosage, adverse effects, therapeutic use)
• Antineoplastic Combined Chemotherapy Protocols (administration & dosage, adverse effects, therapeutic use)
• Breast Neoplasms (drug therapy, pathology, surgery)
• Chemotherapy, Adjuvant
• Cyclophosphamide (administration & dosage)
• Disease-Free Survival
• Drug Administration Schedule
• Female
• Floxuridine (administration & dosage, adverse effects, therapeutic use)
• Humans
• Japan
• Lymphatic Metastasis
• Middle Aged
• Neoplasm Staging
• Odds Ratio
• Survival Analysis
• Treatment Outcome