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Educational Supplement: Appendix
Evaluating
the Use of Paclitaxel Following Doxorubicin/Cyclophosphamide in
Patients With Breast Cancer and Positive Axillary Nodes
Eleftherios
P. Mamounas, M.D.
This study seeks
to determine whether four cycles of paclitaxel (Taxol) given after
four cycles of postoperative doxorubicin/cyclophosphamide (AC) prolongs
survival and disease-free survival (DFS) relative to four cycles
of AC alone, in patients with operable breast cancer and histologically
positive axillary lymph nodes. Between August 1, 1995, and May 22,
1998, 3,060 patients were randomly assigned to receive either four
cycles of AC (60/600 mg/M 2 ) every 21 days, or four cycles of AC
followed by four cycles of Taxol given at 225 mg/M 2 as a 3-hour
infusion every 21 days. Beginning on the first day of chemotherapy,
all patients >50 years of age and those <50 years of age with
tumors that were estrogen receptor (ER)-positive or progesterone
receptor (PgR)-positive received tamoxifen 20 mg orally daily for
5 years. Patients treated with lumpectomy received radiotherapy
following chemotherapy. Definitive analysis of the study was scheduled
to take place following the report of the 490th death. On October
2, 2000, the third of five scheduled interim analyses was presented
to NSABP’s Independent Data Monitoring Committee (DMC), based
on a median followup of 34 months, 269 total deaths, and 551 total
events. The DMC subsequently recommended that these interim findings
be considered for presentation to the Consensus Conference. As of
the third interim analysis, no statistically significant difference
between the two arms (control and treatment) either in terms of
survival (133 deaths on the control arm, 136 on the treatment arm,
relative risk=1.00, 95 percent CI=[0.78 to 1.27], p=0.98) or DFS
(282 events on the control arm, 269 on the treatment arm, relative
risk=0.93, 95 percent CI=[0.78 to 1.10], p=0.38). Estimated survival
at 36 months is 92 percent for the AC arm and 90 percent for the
ACTaxol arm; estimated DFS at 36 months is 81 percent in both arms.
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