LOS ANGELES--An aggressive 16-week, multidrug chemotherapy regimen
afforded a survival advantage over six cycles of CAF (cyclophosphamide,
Adriamycin, and fluorouracil) in 646 women with receptor-negative,
node-positive breast cancer, preliminary results of an Intergroup
study have shown.
In this early analysis, women treated with the 16-week regimen
had a better 3-year overall survival rate than those who received
CAF (84% vs 76%), John H. Fetting, MD, associate professor of
oncology, The Johns Hopkins University School of Medicine, reported
at the American Society of Clinical Oncology (ASCO) meeting.
Disease-free survival at 3 years also favored the 16-week treatment
program (71% vs 64%, respectively). Although there was a trend
toward fewer recurrences in the group treated with the 16-week
regimen, this difference did not reach statistical significance,
Dr. Fetting said.
Just over half of the study participants were premenopausal, slightly
more than half had between 1 and 3 positive nodes, and the majority
(more than 85%) had T1 or T2 tumors.
Patients assigned to the CAF arm received six 28-day cycles of
CAF, whereas those randomized to the 16-week regimen received
eight 2-week cycles, in which cyclophosphamide, doxorubicin, vincristine,
methotrexate, fluorouracil, and leucovorin were given on odd-numbered
weeks and a 2-day continuous infusion of fluorouracil was given
on even-numbered weeks.
The 16-week regimen developed at Johns Hopkins is based on three
principles: (1) rapid exposure of the tumor to multiple active
agents, (2) dose intensity, and (3) optimal administration of
Dose intensity, in particular, may have been responsible for the
superior survival attained with the 16-week regimen, Dr. Fetting
said. The dose of doxorubicin in the 16-week regimen was 30% higher
than that in the CAF regimen (17 vs 13 mg/m²/wk) and the
fluorouracil dose was approximately 2.5 times higher (534 vs 219
mg/m² /wk), he noted. The addition of methotrexate and vincristine
to the 16-week regimen may also have contributed to the favorable