Rachel Wuerstein, MD

Rachel Würstlein, MD, Universität München, lead investigator of the KAMILLA study (NCT01702571), discusses the use of trastuzumab emtansine (T-DM1) following the KAMILLA trial which evaluated the agent in patients with HER2-positive locally advanced or metastatic breast cancer who have brain metastases.

KAMILLA was a 2-cohort, open-label, multicenter trial. Investigators aimed to evaluate the safety and efficacy of T-DM1 in patients with metastatic breast cancer. In the trial, over 2000 patients were enrolled and 182 patients were included in the Asian cohort.

In the KAMILLA trial, patients with HER2-positive locally advanced or metastatic breast cancer who had brain metastases received T-DM1 at a dose of 3.6 mg/kg given intravenously every 3 weeks until they experienced unacceptable toxicity, withdrew consent, or had disease progression. The median treatment duration was 4.9 months (range, 0-44 months) in patients with brain metastases.

Findings from the exploratory analysis of T-DM1 in the trial revealed that this patient population had promising activity as well as tolerability on the therapy. In addition, findings confirmed the safety and efficacy of T-DM1, and there were no new safety signals demonstrated.

 It’s an interesting question to think about what’s going to happen now with T-DM1. There is a well-described track in metastatic breast cancer in the second-line or further. But as we already know, also in the past-neoadjuvant treatment, we have been working on this question [and I believe] it’s time to move it to the neoadjuvant setting. We have to define the patient population. There have been some interesting presentations at [last] year’s ASCO, and I think safety populations like this are the backbone to start use of these tracks in the earliest setting. I think that it is now been moved from metastatic to first-line and we’ll have it also in the neoadjuvant setting.

Videos

Rachel Würstlein, MD, discusses the use of trastuzumab emtansine following the KAMILLA trial which evaluated the agent in patients with HER2-positive locally advanced or metastatic breast cancer who have brain metastases.


Next Steps for Trastuzumab Emtansine After the KAMILLA Trial

Rachel Wuerstein, MD, of the Unïversität Müchen, discusses the KAMILLA trial (NCT01702571) of trastuzumab emtansine (T-DM1) in metastatic breast cancer for both a global and Asian cohort.

The 2-cohort, open-label, multicenter KAMILLA trial was created to look at the safety and efficacy of T-DM1 in these patient populations. Over 2000 patients were included in the trial and 182 were in the Asian cohort.

Patients were required to be aged 18 years and older with HER2-positive disease determined locally, histologically or cytologically confirmed invasive breast cancer, prior treatment for breast cancer in the adjuvant, unresectable, locally advanced or metastatic setting with both chemotherapy, alone or in combination with another agent, and an anti-HER2 agent, alone or in combination with another agent, measurable and/or non-measurable disease, an ECOG performance status of 0,1 or 2, and adequate organ function.

KAMILLA was the safety and efficacy trial for a global and Asian cohort. It was of high importance because there was actually a need to get more safety data for T-DM1 (for patients with) metastatic breast cancer at the time. KAMILLA focused on a global cohort with large patient numbers, but also—and that’s of special interest—on an Asian cohort.

Included in the KAMILLA trial is the highest number of patients entering a trial for T-DM1…more than 2000 patients in the global cohort and 182 patients in the Asian cohort. Ultimately, the reason for this trial at the time was the need for more safety data of this new track, which, in the meantime, got standard of care for second- or first-line treatment in HER2+ metastatic breast cancer.

Rachel Wuerstein, MD, discusses the KAMILLA trial of trastuzumab emtansine in metastatic breast cancer for both a global and Asian cohort.


Examining the KAMILLA Trial of Trastuzumab Emtansine in Metastatic Breast Cancer

Rachel Wuerstein, MD, of the Unïversität Müchen, discusses future implications of the KAMILLA trial (NCT01702571) as well as the benefit of trastuzumab emtansine (T-DM1).

The KAMILLA trial was created to look at the safety and efficacy of T-DM1 in metastatic breast cancer for both a global and Asian cohort. Some differences highlighted in the trial included the rate of thrombocytopenia and dose reductions.

Results from the exploratory analysis of T-DM1 in the KAMILLA trial showed patients with HER2-positive locally or advanced metastatic breast cancer who have brain metastases to have promising activity and tolerability on the therapy.

In addition, the safety and efficacy of T-DM1 was shown as no new safety signals were demonstrated in the trial.

 There is a variety of new tracks coming in trials, but also in an off-label setting in HER2-positive metastatic breast cancer. We think T-DM1 plays a major role in this setting and is one of the main factors to prolong survival of our patients with metastatic disease. What’s going to be interesting in the near future is to see how will track combinations be working, and I already pointed out this fact: How are we going to sequence our therapies in this continuously changing field of treatment of early but also metastatic breast cancer? I’m looking forward to seeing these data in individualized sequencing of the new tracks in the field of HER2-positive metastatic breast cancer. But again, [until that time], globally T-DM1 is the second-line standard of care in HER2-positive metastatic breast cancer.

Rachel Wuerstein, MD, of the Unïversität Müchen, discusses the KAMILLA trial and the benefit of trastuzumab emtansine.

Rachel Wuerstein, MD | Authors

Articles

Next Steps for Trastuzumab Emtansine After the KAMILLA Trial

Examining the KAMILLA Trial of Trastuzumab Emtansine in Metastatic Breast Cancer

Predictions for Future Use of T-DM1 in HER2+ Metastatic Breast Cancer