Panel Leaves Tamoxifen-Alone Option in Guidelines

ST. GALLEN, Switzerland—The give-and-take characterizing a good consensus-panel discussion was clearly seen here in an exchange during the 8th International Conference on Primary Therapy of Early Breast Cancer. During the consensus-panel discussion session, the question arose whether adjuvant tamoxifen treatment alone—that is, tamoxifen without chemotherapy—should be recommended along with chemotherapy-plus-tamoxifen as a preferred option for treatment of postmenopausal women with ER/PR-positive node-positive breast cancer. By the end of this part of the discussion the majority of panelists evidently wanted tamoxifen-alone kept as a recommended treatment for these patients, but those opposed had put up a good fight. The 2001 guidelines had stated that the higher the risk of relapse, the larger might be the advantage of a chemotherapy-plus-tamoxifen regimen versus tamoxifen-alone in these women. Those guidelines noted that tamoxifen-alone may be justified by individual considerations related to risk of relapse, age, toxic effects, socioeconomic implications, and assessment of patient's preference. The question broached in 2003 was whether tamoxifen-alone should be included at all in the table of recommendations for these cases, or handled as an exception in special cases. “Is it time to take out the tamoxifen-alone recommendation for node-positive patients, based on the prospective data showing the superiority of the combined regimen?,” asked panel-session co-moderator William C. Wood, MD, Professor and Chairman of the Department of Surgery at Emory University School of Medicine. Kathleen Pritchard, MD, Professor and Chair of the Breast Cancer Site Group at Toronto-Sunnybrook Regional Cancer Center, said there was certainly enough evidence to recommend upfront chemotherapy-plus-tamoxifen for the patient who is fit enough to have chemotherapy, but she asked what the panel would recommend for women who cannot handle chemotherapy. Age a Reason? Age was suggested as a way to choose between chemotherapy-plus-tamoxifen and tamoxifen-alone, but John H. Glick, MD, Director of the Abramson Cancer Center at the University of Pennsylvania, warned against this. “There are fit people who are 83 or 84 and can tolerate chemotherapy, and there are people 59 or 60 with comorbid illnesses who can't,” he said. But, he continued, based on the evidence, the tamoxifen-alone option should be dropped from the table of recommendations, and the use of tamoxifen-alone for non-fit individuals should only be discussed in the guidelines text. Martine Piccart, MD, PhD, Head of the Chemotherapy Unit at Institute Jules Bordet in Brussels, responded that while some data indicate chemotherapy-plus-tamoxifen can be more beneficial than tamoxifen alone, she was worried about the fit 65-year-old woman with one positive node and a very high ER/PR status. “I am not entirely sure that this woman is having a benefit from chemotherapy that is more than 1%,” Dr. Piccart said. Alan Coates, MD, of Cancer Council Australia, echoed Dr. Piccart's concern: “You get a lot of benefit by adding tamoxifen to these women, and you get a smaller additional benefit by adding chemotherapy depending on the likelihood of getting a very good endocrine responsiveness,” he said. But tolerability depends on the individual patients, “so I think it's appropriate to leave both [options] in, and to put in a footnote saying there is evidence that chemotherapy adds benefit but whether it's worth [the side effects] needs to be individualized.” Panel co-moderator, Aron Goldhirsch, MD, Head of the Department of Medicine at the European Institute of Oncology, voted to leave tamoxifen-alone in the table. “You must, because there is enough data that support it, and there is also enough data to show that as soon as you go to higher risk groups you need to give something more,” he said. “But you cannot avoid tamoxifen alone.” Henning Mouridsen, MD, of Righospitalet in Copenhagen, also wanted both approaches left in the table. “If you look at the overview trials, the benefit of adding chemotherapy is there, but with increasing age it is smaller, and in patients more than 65 years old, it's extremely small,” he said. “So both modalities should be in the box.” But Dr. Glick again disagreed. ‘Sends Wrong Kind of Message’ “That [leaving in tamoxifen-alone] sends the wrong kind of message,” Dr. Glick said. “I think people will take that statement and just start giving node-positive patients tamoxifen-alone even though chemotherapy followed by tamoxifen is the preferred option.” Kathy S. Albain, MD, Professor of Medicine at Loyola University Medical Center, also believed it could be dangerous to give both options equal weight in the table. “There has to be a way to convey to the reader that consideration should first be given to chemotherapy-plus-tamoxifen, based on the data that we have,” Dr. Albain said. “I'm just very concerned that if [both options] are given equal weight [in the table of recommendations] it will lead to undertreatment of a large percentage of women with breast cancer around the world.” And Dr. Pritchard pointed out that in patients who are clearly receptor positive, “the amount of additional benefit with CAF chemotherapy is huge,” and so she would prefer only a footnote about tamoxifen-only be included, for cases in which the patient does not want or cannot tolerate chemotherapy. Dr. Pritchard added that there might be problems with the published data on the efficacy of treatments for postmenopausal endocrine-responsive women, in that the older the patients the fewer the data, while more of the patients are receptor positive which is now suspected of confounding the issue. “And many patients may have been treated with lower doses of chemotherapy because they're older,” Dr. Pritchard said. “I think there are huge confounders that have been misleading us.” Co-moderator Dr. Wood had the last word. “If we're going to be a consensus panel, we can't take this out, because clearly there are many members of the panel who believe it should be left in. It's not based upon strength of feeling or evidence, it's a consensus, and the consensus is clearly that many people [in this panel] are telling me by the way they're working their heads that they want this left in.”

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