Sunil Verma, MD, MSEd, FRCPC, associate professor, University of Toronto, chair, Breast Medical Oncology, Sunnybrook Odette Cancer Centre, discusses clinical trial endpoints in metastatic breast cancer trials.

Verma says the two most talked about endpoints in metastatic breast cancer are overall survival (OS) and progression-free survival (PFS). PFS is marred by biases and may not get the complete picture of how patients will do long term. When compared to OS, PFS is considered to be substandard.

OS has always been considered the gold standard if researchers can impact the survival of the patients, Verma says. The challenge with OS as an endpoint is that it only tells researchers if the patient is alive or deceased while PFS tells researchers if the patient has progressed or not.

Verma says the journey in between the PFS and OS, termed the post-progression survival, is also a very important journey. Based on research presented at the 2014 ASCO Breast Cancer Symposium, looking at OS on its own is incomplete and researchers need to focus on the post-progression survival.

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Sunil Verma, MD, MSEd, FRCPC, associate professor, University of Toronto, chair, Breast Medical Oncology, Sunnybrook Odette Cancer Centre, discusses targeting HER2 in early-stage breast cancer.

Dr. Verma Discusses Clinical Trial Endpoints in Metastatic Breast Cancer

Verma says that data have shown that trastuzumab for 1 year leads to a reduction in breast cancer recurrence by about 40% and that survival improves, in relative terms, by about 40%. Further, 9 weeks of trastuzumab also appears to be beneficial, though data were not statistically significant. In comparison to 6 months, 1 year of trastuzumab proved to be a better option in a trial, though the primary endpoint of non-inferiority was not met. The question of duration of treatment with trastuzumab still needs to be definitively answered, but 1 year is the standard of care now.

With respect to a non-anthracycline-based approach, the combination of weekly paclitaxel and trastuzumab has shown to be well tolerated and effective. Verma says this combination represents a great option for patients who have tumors up to 2 cm.

Dr. Verma on Targeting HER2 in Early-Stage Breast Cancer

Sunil Verma, MD, MSEd, FRCPC, associate professor, University of Toronto, chair, Breast Medical Oncology, Sunnybrook Odette Cancer Centre, provides an outlook on the treatment of HER2-positive breast cancer.

The biggest shift in this space will be moving away from traditional chemotherapy. Research is planned, Verma says, to look at approaches that may consist of trastuzumab, lapatinib, pertuzumab, or T-DM1 alone, or T-DM1 in combination with pertuzumab.

Data in the metastatic setting suggest that a T-DM1-based combination may be most beneficial. Verma says that a future in which patients with HER2-positive breast cancer do not lose their hair and have no risk of infection would represent a huge achievement.

View more from the 2014 Miami Breast Cancer Conference

Sunil Verma, MD, MSEd, FRCPC, associate professor, University of Toronto, chair, Breast Medical Oncology, Sunnybrook Odette Cancer Centre, provides an outlook on the treatment of HER2-positive breast cancer. 

Sunil Verma, MD, MSEd, FRCPC

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Dr. Verma Discusses Clinical Trial Endpoints in Metastatic Breast Cancer

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