Low-Dose Chemo for Low Toxicity in Breast Cancer

An ASCO® Poster Brief

Lidia Schapira, MD; Laura Orlando, MD


July 01, 2013

Editor's Note: In patients with advanced HER2-positive breast cancer, researchers have used single[1,2] and dual HER2 blockade[3,4] in combination with chemotherapy to increase overall survival and reduce toxicity. At the 2013 Annual Meeting of the American Society of Clinical Oncology (ASCO®), Dr. Lidia Schapira, on behalf of Medscape, spoke with Laura Orlando, MD, an oncologist in the Medical Oncology Division and Breast Unit at Ospedale A. Perrino in Brindisi, Italy, about a study she presented for the Gruppo Oncologico dell'Italia Meridionale that combined trastuzumab and continuous low-dose chemotherapy in patients with advanced HER2-positive breast cancer.

Dr. Schapira: Could you tell us about your study?

Dr. Orlando: We tested the combination of trastuzumab and low-dose oral chemotherapy with capecitabine and cyclophosphamide for first-line therapy in advanced HER2-positive breast cancer.[5] The primary endpoint of the study was the activity in terms of overall response rate. Secondary endpoints were time to progression, clinical benefit (defined as partial remission, complete remission, and long-lasting stable disease) and tolerability. We enrolled 38 patients, and we observed an overall response rate of 61% and a clinical benefit rate of 82%. The median time to progression was 16 months.

Dr. Schapira: Those are very impressive numbers.

Dr. Orlando: A very important message is that we can prolong the delivery of this combination without cumulative toxicity, either clinical evidence (such as cardiac toxicity) or biological evidence (in terms of C-reactive protein evidence of sepsis).

Dr. Schapira: We've heard a lot about metronomic dosing at this meeting. Why did your team want to test trastuzumab and continuous low-dose chemotherapy in this setting?

Dr. Orlando: The introduction of trastuzumab as systemic medication has changed the prognosis of HER2-positive breast cancer. There are a great number of anti-HER2 drugs and/or combinations. However, the toxicity of these compounds often precludes the possibility of prolonged administration. Our schedule could overcome this problem.

Dr. Schapira: What is the next phase of your study?

Dr. Orlando: The trial is ongoing. According to the optimal statistical design, a total of 66 patients will be enrolled. If the present results are confirmed, we would like to test this combination in a phase 3 randomized trial with standard treatment (trastuzumab in association with taxanes)

Dr. Schapira: What is the message for clinicians?

Dr. Orlando: We can schedule treatment for advanced breast cancer with a very low toxicity. We can use this combination continuously without cumulative toxicity.

Dr. Schapira: Thank you very much, that was really clear, and a great study.


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