Dear Colleagues,

We are now over halfway through the 2400 patient accrual on the 01062 trial, and accrual continues to go very well at 70-75 patients/month. With your willingness to identify just one additional patient per month whom you feel would benefit from this therapy, we can easily increase accrual to 100 patients/month and complete accrual in less than one year.

The safety of the study is now being evaluated by the Independent Data and Safety Monitoring Committee. From my perspective as the principal investigator, the tolerability of the docetaxel/capecitabine combination at the new doses of 75/1650 mg/m² is much improved over the original starting doses. I do recommend the use of prophylactic Nystatin swish and spit q.i.d. starting with day 2 of each cycle of docetaxel/capecitabine to prevent yeast mucositis, which might occur between days 4 and 7 of the cycle, complicating docetaxel/capecitabine delivery following AC in a subset of patients. I urge you strongly to encourage your patients who do develop toxicity with the docetaxel/capecitabine combination to continue with the treatment, with an appropriate dose reduction per protocol, because a 25% capecitabine dose reduction in those patients who require it results in markedly reduced toxicity. So doing will give patients the best chance of benefiting from adjuvant chemotherapy, since the docetaxel/capecitabine combination has a very strong clinical rationale and upholds the study integrity, helping to ensure that we and our participating patients will determine whether capecitabine improves the outcome of early-stage breast cancer.

The exciting results of Dr. Coombes’ IES trial of 2-3 years of tamoxifen followed by 2-3 years of exemestane promises to change adjuvant endocrine therapy of breast cancer. We will be amending the protocol to allow postmenopausal patients on tamoxifen on 01062 to switch to exemestane, probably once they have been on tamoxifen for 2-3 years. I am discussing this issue now with the study sponsors and we will get further information about this issue out to the USON network soon. This will require a protocol amendment, so I request that patients be continued on tamoxifen for now, since the first patients enrolled on 01062 are just over a year into their tamoxifen therapy.

Aren’t adjuvant breast cancer trials fascinating in these times of very rapid accrual and rapid progress?! With all of us in US Oncology working together we can complete accrual to 01062 within the year and bring these hopefully important results to future breast cancer patients and their physicians worldwide.

With best regards,
Joyce O’Shaughnessy, MD