Findings from a study published in the NEJM demonstrated that standard adjuvant chemotherapy is superior to Roche’s Xeloda (capecitabine) in women 65 years of age and over who have early-stage breast cancer. Women who took Roche’s drug were twice as likely to have a relapse and almost twice as likely to die as patients in the chemotherapy arm, researchers noted.

In the study, 600 women aged 65 years and over with stage I, II, IIIA or IIIB breast cancer were randomised to receive standard chemotherapy or Xeloda. Data at three years showed the rate of relapse-free survival was 68 percent for those who took Xeloda, compared with a rate of 85 percent for women who were given standard chemotherapy.

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Lead researcher Hyman Muss noted that “this study is important because it is among the first several trials specifically targeted to older women with early-stage breast cancer and shows that chemotherapy can make a difference.” He remarked: “In this trial, we had hoped that [Xeloda] would be as good as standard therapy, so we would have a pill treatment with [fewer] side effects, but it turned out it wasn’t as good.” Muss suggested that “women who fit the criteria for the trial should be considered for standard chemotherapy or even more aggressive newer chemotherapy depending on their general health and risks for breast cancer recurrence.”

In response to the news, Roche spokeswoman Virginia Valenze said the findings were unexpected based on previous studies that showed Xeloda benefited women with more advanced cancer. She stated that no single drug has yet proven superior to combination therapy after surgery. In addition, Nancy Davidson, director of the University of Pittsburgh Cancer Institute, commented that “this trial does not say that capecitabine is an inactive drug — rather its routine use should be limited to women with advanced breast cancer,” adding that “it is also very useful in other cancers like colon cancer.”

Source: FirstWord

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