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Trastuzumab Monotherapy

DR HUDIS: We don’t have evidence for the use of adjuvant trastuzumab without chemotherapy, but we do have evidence in Stage IV breast cancer that trastuzumab is an active monotherapy. I believe that for the occasional patient for whom you have limited choices for whatever reason, it’s reasonable.

I have used trastuzumab monotherapy once in the adjuvant setting. It was for a patient who experienced a CVA when she was administered adjuvant chemotherapy several years prior. She then went on adjuvant hormone therapy and, while still on it, developed contralateral ER-negative, PR-negative, HER2-positive, node-positive breast cancer. She refused chemotherapy, so I have her on monotherapy with trastuzumab.

Clinical Use of TCH

DR HUDIS: I have used TCH in the adjuvant setting. I’ve used it preoperatively for HER2-positive breast cancer in the past and for the occasional patient who just doesn’t want to receive an anthracycline. The scenario in which I believe TCH could be particularly useful is for the woman with a second breast cancer who received, let’s say, CAF eight years ago.

It’s funny because everybody asks the question, “What about the patient with a cardiac toxicity or a limitation?” The truth is that when you’re administering adjuvant therapy to try to cure early-stage breast cancer, it’s the rare patient who I can even imagine has a significant enough cardiac dysfunction that it would limit my adjuvant therapy choice and yet not limit her life span enough to make me not care so much about her adjuvant treatment.

Breast Cancer Update: Cardiologic Issues in Breast Cancer Management 2007 (1)

DR BURSTEIN: With approximately 12 more months of follow-up, the BCIRG 006 data have changed a little. Whereas the basic findings were the same — that is, the trastuzumab-containing arms continued to outperform the nontrastuzumab-containing arm — the efficacy differences between AC TH and TCH became less apparent. In fact, the curves now track closely together, with only about a one percent difference separating them.

The updated analyses of cardiac function continue to show a lower risk of symptomatic congestive heart failure with the TCH regimen. Also, with the longer follow-up, four cases of leukemia emerged among the roughly 2,100 women who received one of the anthracycline-based regimens. That’s a low percentage in absolute terms, but it’s consistent with prior reports of anthracycline-based regimens. Among the approximately 1,100 women who received the TCH regimen, no cases of leukemia have been reported.

I believe the BCIRG 006 data will result in clinicians considering the TCH regimen much more often as an option for patients with HER2-positive, early-stage breast cancer. It seems to be as efficacious as the anthracycline-based regimens and to have a better toxicity profile with respect to certain rare, but serious, late complications.

Breast Cancer Update 2007 (3)

DR ERIC P WINER: When the BCIRG 006 data were initially presented at the 2005 San Antonio Breast Cancer Symposium, the addition of trastuzumab was found to improve disease-free survival. A suggestion emerged that the patients receiving AC followed by docetaxel/trastuzumab seemed to do better than those receiving the nonanthracycline-containing regimen. The differences were not statistically significant, but the suggestion was that more recurrences occurred in the TCH arm.

I believe that led many people to feel cautious about using TCH other than for the patient who had a contraindication to the use of an anthracycline. However, in the December 2006 update, the two trastuzumab-containing arms appeared to behave similarly. Both of the trastuzumab-containing arms recorded fewer recurrences than the nontrastuzumab-containing arm, and no dramatic difference seemed evident.

Two perspectives on these data are possible. One would be, “This is great, and we don’t have to use an anthracycline.” The other would be, “These are encouraging data, and they are a sign that perhaps we will be able to eliminate the anthracycline. At the same time, maybe it’s best not to forget that in all the other adjuvant trastuzumab studies an anthracycline was used, and we still have a lot more experience with anthracycline- than nonanthracycline-containing regimens.”

Maybe it’s not time to throw out the anthracycline yet, although it gives us courage to examine the issue further. I’m in that second camp. In my practice, for most patients I continue to use an anthracycline followed by a taxane and trastuzumab. I am, however, a little more comfortable than I was a year ago in skipping the anthracycline if a patient has a reason not to receive it.

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