Clinical trial in older women reveals important findings in breast cancer

Big kudos go to Dr. Hyman Muss and all his CALGB colleagues for running and last week publishing (in The New England Journal of Medicine — not bad!) their trial, "Adjuvant Chemotherapy in Older Women with Early Stage Breast Cancer."

This study is important in many ways, but notably to me is that this study is proof that thoughtful, scientifically interesting and clinically important trials can be successfully done in older adults. Can I also point out that they don't use "elderly" in the title? (Bravo!) This was a randomized study of stage I, II, IIIA/B breast cancer where women were randomized to cyclophosphamide, methotrexate and fluorouracil 5-FU or cyclophosphamide plus doxorubicin vs. capecitabine (Xeloda, Roche). At first analysis, after 600 patients, it was clear that the experimental arm was inferior, so the trial was stopped and now the results have been published.

Regarding the trial participants, 65% of patients enrolled were aged 70 or older; most were node positive; 56% of those in the standard chemotherapy arm received cyclophosphamide plus doxorubicin (with 40% receiving cyclophosphamide, methotrexate and fluorouracil 5-FU); and 67% were hormone receptor positive. Most (nearly all) were of excellent performance status. Although the dose intensity was better in the capecitabine arm owing to less side effects, it was also less effective, with inferior relapse-free survival and OS for the capecitabine arm. In fact, there was a convincing hazard ratio for disease recurrence or death of 2.09 (P<.001; 95% CI, 1.38-3.17) showing that for older women that you would think need adjuvant chemotherapy, strong consideration should be given to standard chemotherapy.