Subcutaneous adjuvant regimen for breast cancer reduces ‘time toxicity’ of treatment
Key takeaways:
- Subcutaneous administration of a breast cancer therapy significantly decreased treatment time compared with IV administration.
- The subcutaneous regimen also reduced pharmacy burdens.
Subcutaneous administration of trastuzumab and pertuzumab significantly shortened the time patients with stage I HER2-positive breast cancer spent getting treatment compared with IV delivery, according to results of a prospective study.
The administration change reduced patients’ time in the treatment chair by more than an hour. It also decreased the treatment experience by more than 80 minutes and shortened the workflow for the pharmacy.
“Time toxicity doesn’t get talked about enough,” Adrienne G. Waks, MD, associate director of breast oncology clinical research at Dana-Farber Cancer Institute and assistant professor of medicine at Harvard Medical School, told Healio. “It is a huge burden on our patients, and one that we need to think a lot more about as we roll out increasingly complex treatments, in many cases that require increasingly intensive monitoring that is incredibly important. We obviously need to be able to offer the most effective treatments to the patients who need them, but there is a real downside to taking away more of people’s time by needing extra lab draws, extra time sitting to get a drug administered and more frequent office visits to monitor for side effects.”
‘Patient-centered’ question
Trastuzumab (Herceptin, Genentech) and pertuzumab (Perjeta, Genentech) launched as IV-only formulations. However, subcutaneous versions have been approved and have demonstrated noninferiority to IV formulations, according to study background.
“We decided that we could hopefully look into this patient-centered and important question about time toxicity with subcutaneous as compared with the older standard of IV,” Waks said.
The ADEPT trial is a phase 2 investigation of adjuvant trastuzumab and pertuzumab plus endocrine therapy for individuals diagnosed with hormone receptor-positive and stage I HER2-positive breast cancer.
Waks and colleagues enrolled 22 adults (median age, 58 years; range 42-83; 95.5% women; 81.8% white) who participated in the ADEPT trial into their time and motion crossover study.
During the crossover examination, participants received two cycles of IV trastuzumab and pertuzumab, and then two cycles of the subcutaneous regimen.
Researchers used multiple time points to track patients’ treatment duration, including floor check-in, drug start and stop times, and conclusion of the post-administration observation period.
They also tracked pharmacists’ workflow, which included clinical checks from two pharmacists, drug preparation and completion, drug review, and the time it left the pharmacy.
Mean time difference between IV and subcutaneous administration in the treatment chair served as the primary endpoint. Mean overall treatment experience time, drug administration time and pharmacy workflow served as secondary endpoints.
‘Sobering reminder’
The subcutaneous injection significantly reduced time in the treatment chair for patients compared with IV (mean, 22.5 minutes vs. 84.3 minutes; P < .0001).
The subcutaneous formulation also significantly reduced drug administration time (7.4 minutes vs. 61.6 minutes; P < .0001) and treatment experience time (96 minutes vs. 177.8 minutes; P < .0001).
“The amount of time that was saved, which was about an hour, was on par with what I expected. That’s about the difference in administration times,” Waks said. “What was a surprising and sort of sobering reminder from the results was that there are so many other things our patients have to spend their time on. In addition to just the drug administration — even though it was definitely shorter to get the subcutaneous, which is what we hoped to see — there was still a substantial time commitment for patients.”
Pharmacists had a significantly shorter workflow with subcutaneous preparation, too (41 minutes vs. 119.2 minutes; P < .0001).
“The subcutaneous is a fixed dose,” Waks said. “There’s no mixing. There’s no preparation that’s individualized for that patient’s weight on that day. Something we couldn’t measure directly was the amount of time that infusion nurses have to spend on drug administration, but presumably because the administration time is so much shorter with subcutaneous vs. IV, it also can improve the efficiency of the infusion nursing, and the number of patients that they’re able to take care of in a day.”
Researchers acknowledged study limitations, including lack of data on how the different administration styles impacted study participants’ quality of life.
“That’s a really important corollary,” Waks said. “Do patients prefer the subcutaneous over the IV? We didn’t [assess] that in this study. That has been done in other studies, and what that has shown is that most patients, though not all, prefer the subcutaneous administration.”
One downside to subcutaneous administration is cost.
“A lot of the IV formulations have biosimilars and, therefore, are cheaper for the health care system,” Waks said. “They’re off patent pricing, whereas the subcutaneous formulation only exists for the brand-name drugs.”
However, when possible, Waks said subcutaneous administration could give patients a significant time benefit, and it could be applicable across all cancer types.
“We would love to get to a point where at least sometimes these drugs could be administered at home and save patients a lot of that travel time and waiting time,” she said. “Obviously we’re not there yet, but I think it’s an interesting precursor to wondering about a future where that might be more widespread.”
For more information:
Adrienne G. Waks, MD, can be reached at adrienne_waks@dfci.harvard.edu.
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