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San Antonio Breast Cancer
Symposia
Authors: Dr. Sunil Verma
Date posted: January 6th, 2008
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Extended follow-up and analysis by age of the US Oncology
Adjuvant trial 9735: docetaxel/cyclophosphamide is associated with
an overall survival benefit compared to
doxorubicin/cyclophosphamide and is well tolerated in women 65
or older
Jones S, Holmes F et. al
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Background
• The US Oncology Adjuvant trial 9735 is a
randomized trial.
• Anthracyclines have been a mainstay in the
adjuvant therapy of breast cancer over the last
decade.There is increasing concern of long-term
toxicity associated with anthracyclines especially
the risk of cardiac toxicity in the elderly
population
• The previous 5 year follow up results of this trial
showed that TC chemotherapy was associated
with an improved DFS when compared to AC
chemotherapy. The OS benefit was not
statistically significant at that time.
• 7 year follow up results are presented here
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Treatment A: Adriamycin and Cyclophosphamide
x 4 cycles
R
n=1016
Stage I-III breast ca
Treatment B: Docetaxel and Cyclophosphamide
x 4 cycles
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Patient Characteristics
• The average age of patients was around
51 years.
• About 51% of patients enrolled had node
+ve disease with about 11% of them
having more than 4 lymph nodes involved.
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RESULTS
7 – year
results
AC
TC
p-value
DFS (%)
75
81
P=0.03
OS (%)
82
87
P=0.032
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STUDY COMMENTARY
• At the time of study design, AC was considered a
standard regimen for node positive women
•There is now an overall survival benefit for TC
chemotherapy as compared to AC chemotherapy.
• There was a benefit with TC chemotherapy regardless
of age, hormone receptor status and Her-2 receptor
status
• Both regimens were well tolerated in patients regardless
of age
• There were three long term AC treatment related deaths
– one case of CHF, myelofibrosis and MDS each.
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BOTTOM LINE FOR CANADIAN MEDICAL ONCOLOGISTS
•This is an important study as it provides us with an an effective nonanthracycline alternative for adjuvant therapy in breast cancer
• About 50% of patients in this trial had node positive disease. Since
the inception of this trial we now have more effective chemotherapy
regimens compared with AC including dose dense AC followed by
Paclitaxel, FEC100, FEC100 followed by docetaxel and so on. We
don’t have any data as to how TC compares this these third
generation regimens.
• TC may be considered for patients with node negative breast cancer.
We may want to consider this as an option for node positive patients
where there is a safety concern with anthracyclines.
• There is now an ongoing clinical trial of TC x 6 cycles vs. TAC for 6
cycles to help confirm these trial results against a third generation
chemotherapy regimen.
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