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Long-Term Data Support Neoadjuvant Chemo Regimen in HER2+ Breast Cancer

Gina Columbus @ginacolumbusonc
Published: Tuesday, Oct 20, 2015

Hans-Christian Kolberg, MD

Hans-Christian Kolberg, MD

Neoadjuvant chemotherapy with docetaxel (Taxotere), carboplatin, and weekly trastuzumab (Herceptin)—the TCH regimen—demonstrated significant clinical activity in patients with HER2-positive, early-stage breast cancer, according to long-term follow-up data presented at the 2015 Breast Cancer Symposium.

A total of 51 patients treated with the chemotherapy regimen of docetaxel at 75 mg/m2, carboplatin (AUC 6) 3 times weekly, and trastuzumab at a 4 mg/kg-loading dose followed by 2 mg/kg once weekly. At a median follow-up of 4.5-years, the overall survival (OS), disease-free survival (DFS), and distant disease-free survival (DDFS) rates were 94.18%, 82.35%, and 90.2%, respectively. Of the 21 patients who experienced a pathologic complete response (pCR), the OS rate was 100%.

The mean age of diagnosis was 55 years, 68.6% had ER-positive tumors, 39.2% presented with grade 3 disease, and 49% were node-positive. Patients were monitored by ultrasound and then underwent surgery following 6 cycles of the TCH regimen. Trastuzumab was still administered to these patients 3 times weekly up to 1 year after surgery.

Earlier studies examined the effects of neoadjuvant treatment with TCH and how it is as effective as anthracycline-containing regimens, though survival data had not yet been published, explains lead study author Hans-Christian Kolberg, MD. The median follow-up results, he added, are commensurate with results from the HERA and BCIRG 006 studies, which looked at the efficacy of trastuzumab in the adjuvant setting.

In an interview with OncLive, Kolberg, doctor of Medicine, Marien Hospital Bottrop in Bottrop, Germany, discusses these updated results and the impact they may have on the treatment paradigm for HER2-positive breast cancer.

OncLive: Can you give an overview of this study and the follow-up data?

Kolberg: After we learned about the results of the BCIRG 006 study, which compared an anthracycline-containing regimen with docetaxel, carboplatin, and trastuzumab in the adjuvant setting, we were interested to see if that works in the neoadjuvant setting, too. This is because we believe that the sooner the tumor gets the antibody, it is better for the patient. We did not want to wait for surgery, but the other paradigm is that, we are treating any patient we know will need chemotherapy in a neoadjuvant fashion. Only in situations where we did not know the patients had cancer, or there were unexpected findings of the postoperative histology, they would receive adjuvant therapy. All other patients, where we only needed immunohistochemistry or grading, would receive their treatment in a neoadjuvant fashion. That is why it was important for us to test TCH in that setting, because the data from the adjuvant treatment trial were so good for patients.

Neoadjuvant therapy is not only an academically interesting idea to test chemotherapies and the effective therapies, but it is also simply doing the same thing before surgery as what you are doing in the adjuvant setting. That is opening a diagnostic and prognostic window for the patient, because if she has a pCR, we can talk about her prognosis, which is a lot more information than we have if we just apply adjuvant chemotherapy and just wait to see if she responds or not. That is why we treated patients in the neoadjuvant setting. We have presented the pCR rates, such as the classically neoadjuvant data 4 years ago, and now we have the 4.5-year follow-up. You realize there are limited data on neoadjuvant chemotherapy with TCH and there have been two or three studies that have been presented.

One of these studies has been fully published, but there is no outcome data in the end. We decided to do a follow-up, and we identified 51 patients where we had a full follow-up. The outcome data that we found compared favorably to the known outcome data for adjuvant trials with trastuzumab. The patient group we have been treating is a classical neoadjuvant group with several grade 3 patients. Fifty percent of the patients were node-positive, and of course, all of them were HER2-positive, and 60% to 68% were ER-positive.

Before we started neoadjuvant therapy, we did an axillary diagnosis such as a sentinel biopsy or core biopsy for patients with clinically suspect lymph nodes. The tumors were marked with titanium clips and then patients received 6 cycles of docetaxel and carboplatin with trastuzumab. After that, we did surgery and, in the cases of involved lymph nodes, the axillary dissection took place after the neoadjuvant chemotherapy.

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