Adrienne Waks, MD, on Subcutaneous vs IV Trastuzumab/Pertuzumab in Breast Cancer
– Reduced 'time toxicity' for patients
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Subcutaneous administration of trastuzumab/pertuzumab could save breast cancer patients and healthcare providers substantial amounts of time compared with intravenous administration, according to a study in.
Adrienne Waks, MD, of Dana-Farber Cancer Institute in Boston, and colleagues conducted a prospective substudy of 22 participants in the ADEPT trial, which is investigating trastuzumab/pertuzumab plus endocrine therapy for HER2+ breast cancer.
In the single-arm crossover substudy, patients received two intravenous treatment cycles followed by two subcutaneous cycles. The researchers found that patients spent approximately 1 hour less in the treatment chair during subcutaneous administration compared with intravenous (22.5 versus 84.3 minutes, P<0.0001).
"Our findings show that subcutaneous administration was significantly faster than intravenous administration across all measured outcomes, including patient time in the treatment chair (primary outcome), as well as pharmacy workflow time, drug administration time, and total patient experience time," Waks and colleagues concluded.
Waks, senior physician and associate director of Breast Oncology Clinical Research, highlighted additional findings and implications in the following interview.
Your study incorporates the concept of "time toxicity." What is that and how does it affect patients?
Waks: Time toxicity is the measurement of how medical care and all the associated tasks and visits take away time that patients could instead be spending at home, pursuing activities that are important to them.
I think the effect of time toxicity on patients -- and their families and caregivers -- is enormous: Time required to attend medical appointments, travel to faraway locations for studies, etc., takes away from time that can be spent with family and friends, working in order to maintain financial stability, or pursuing any number of other activities that patients may choose to support their well-being.
The term "time toxicity" (where "toxicity" is the medical term we usually use for "side effects") reflects the idea that draining patients' time when they have to interact with the medical system is very much a side effect that we should consider when we design treatment regimens, just like we rightfully also consider symptoms like fatigue and nausea.
How can oncologists be aware of and reduce time toxicity for patients in their practice?
Waks: I think the main way we can do this is that whenever it's safe and reasonable, we can try to have patients obtain tests and studies close to home (or even in-home) as opposed to having to travel to a specific office location.
Fill us in on some of the methodology of your time and motion study. What time points did you assess and how did you assess them?
Waks: We assessed the time that patients checked in for their treatment floor visit, what time their first drug administration was started, what time their final drug administration ended, and what time the post-administration observation period ended.
We also measured time points in the pharmacy workflow process (from the initial drug order release, to the time when the prepared drug left the pharmacy to travel to the infusion floor). Time points were assessed either through the medical record, or on flow sheets that were completed by infusion nurses in real time.
How did subcutaneous administration shorten pharmacy workflow and drug administration time, and what are the implications for oncology center operating efficiency?
Waks: Subcutaneous administration shortened both pharmacy workflow and drug administration time. This can translate into increased capacity to deliver care to more patients -- i.e., improving oncology center operating efficiency.
The study did not assess patient-reported quality-of-life outcomes, which would seem to be an important consideration. Do you plan to do that in the future?
Waks: Yes, this is a very important aspect. We are assessing quality-of-life outcomes on many scales (including an assessment of how patients felt about subcutaneous drug administration) in all patients in the overall trial, so therefore we didn't report these outcomes for just the small group of patients in this substudy.
Read the study here.
The study was supported by Genentech, Inc.
Waks disclosed consulting/advising for AstraZeneca and Ambrx and institutional research funding from Genentech, Merck, Gilead Sciences, and Macrogenics.
Primary Source
JCO Oncology Practice
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