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3 Versus 6 Cycles of CMF in Breast Cancer Patients with 1 to 9 Positive Nodes: Results of the German Adjuvant Breast Cancer Group (GABG) III Trial

James Metz, MD
OncoLink Associate Editor
Last Modified: May 21, 2000

Presenter: H. Maass
Affiliation: GABC

Background:

For breast cancer, one of the standard adjuvant chemotherapy regimens is CMF for 6 cycles. Although there is clear data that prolonging CMF for more than 6 cycles is not beneficial, there are limited data evaluating the efficacy of fever cycle of CMF. This study was performed to better establish the optimal duration of adjuvant CMF chemotherapy.

Materials and Methods:

• Premenopausal patients with 1-9 positive axillary lymph nodes regardless of hormone receptor status were eligible.
• Postmenopausal patients with 1-9 positive axillary lymph nodes and negative hormonal receptors were eligible.
• Patients were randomly assigned to receive 3 versus 6 months of CMF chemotherapy (Cyclophosphamide 500mg/m² methotrexate 40mg/m², 5-flourouracil 600mg/m² day 1+8, every 28 days)
• All patients started chemotherapy within 6 weeks of surgery.
• 789 patients with a median follow up of 35 months were randomized. 122 patients were deemed ineligible for evaluation. Thus, analysis of 667 patients were presented.

• Overall, there was no significant difference in disease free survival between 3 and 6 cycles of CMF.
• Overall, there was no significant difference in overall survival between the two groups.
• There was a borderline improvement in outcome for patients </= 40 years old and in patients with 4-9 lymph nodes. Treated with 6 cycles of CMF.

• Overall, for some patients with breast cancer, 3 cycles of CMF seem to be equally effective as 6 cycles.
• Patients 40 </= years old and 4-9 positive nodes may benefit more from 6 cycles of CMF than from 3.
• Further studies are needed to identify subsets of patients that may benefit from reduced chemotherapy.

• Patients who receive adjuvant chemotherapy typically recieve either CMF fro 6 cycles or AC (doxorobicincytoxan) for 4 cycles. Some physicians and patients chose AC chemotherapy because of the shorter duration of treatment. This is one of the first studies to question if 6 cycles of CMF are any better than 3.
• Further study is needed to identify subgroups of patients that may be candidates for a reduction in number of cycles of chemotherapy before this becomes standard practice, and to confirm the findings of this analysis.