The vast majority of patients with early or metastatic breast cancer prefer to receive their medicine at home through subcutaneous administration instead of intravenous infusion in a clinic. In a clinical trial presented at the 2022 American Society of Clinical Oncology Annual Meeting, researchers used decentralized tools to allow patients to be managed at home with a nurse administering their cancer treatment through an injection.
Standard of care for HER2+ early breast cancer (EBC) or first-line metastatic breast cancer (MBC) is pertuzumab plus trastuzumab and concurrent chemotherapy. A fixed-dose, subcutaneous injection of pertuzumab plus trastuzumab offers faster, more convenient administration compared to intravenous administration, said lead author Chau T. Dang, MD, Attending Physician at Memorial Sloan Kettering Cancer Center.
"COVID-19 has caused an unprecedented strain on health care systems and disruption to cancer care. Treatment at home may enable patients to continue cancer therapy, reduce exposure to COVID-19, and free up hospital resources," said Dang.
She presented the results of an ongoing single-arm, hybrid, decentralized clinical trial (Abstract 1515). This study's main objectives were to enable continuity of care during COVID-19 and assess the safety of fixed-dose, subcutaneous injection of pertuzumab plus trastuzumab given at home.
Patients with HER2+ EBC/MBC who completed concurrent chemotherapy with pertuzumab plus trastuzumab IV and were receiving or about to receive maintenance therapy with the combination intravenously or subcutaneously, or trastuzumab subcutaneously, were switched to fixed-dose, subcutaneous injection of pertuzumab plus trastuzumab given at home by a home health nursing provider. Treatment continued until disease progression, unacceptable toxicity, patient withdrawal, or physician recommendation. Patients with EBC completed up to 18 cycles.
A group of 16 patients took part in HARRIET, a substudy of at-home cardiac surveillance with artificial intelligence-guided cardiac ultrasound and optional 6L ECG acquired by a home health nursing provider.
Study Details
In the main study, data from 143 patients, median age 49 years, were available at cutoff; 27 (18.9%) patients completed treatment, 25 patients (17.5%) discontinued, and 91 patients (63.6%) remain on study. Overall, 97 patients (67.8%) received at least one COVID-19 vaccine within 7 days of treatment initiation or while on study.
The vast majority of patients (more than 90%) lived in metropolitan areas. The trial enrolled a large proportion of Asian, Black, and Hispanic patients, who accounted for 27 percent of patients enrolled, which is higher than typical cancer trials, Dang said.
Patients received a median of 8 (EBC) and 9 (MBC) cycles. Overall, 16 (11.2%) patients tested positive for COVID-19 during the treatment phase. All of them continued treatment after appropriate COVID-19 therapy and/or quarantine.
"For both EBC and MBC patients, the majority preferred subcutaneous versus intravenous administration, mainly because of the shorter amount of time required for subcutaneous administration and feeling less emotionally distressed," said Dang. "Similarly, almost all patients (85% of EBC, 67% of MBC) preferred at-home versus clinic administration, mainly because of increased convenience, reduced risk of COVID-19 infection, and reduced perceived emotional distress."
No new adverse events emerged due to home administration. No anaphylaxis reactions were reported and hypersensitivity at the injection site occurred in two patients, both Grade 1, among EBC patients.
"In the subset, 10 of 16 patients (62.5%) preferred at-home surveillance to the clinic, mainly because of convenience, reduced risk of COVID-19 infection, and less time missed from work or family," said Dang. "Almost all patients (15 of 16) felt comfortable or very comfortable with the Caption AI device to look at their hearts to find problems."
Overall, most nurses (13 of 18) found obtaining heart images using the home cardiac equipment easy or very easy. All felt comfortable or very comfortable with doing remote assessments of patients in their home, trusted the data being sent from the digital devices, and agreed or strongly agreed that someone with the same experience would learn to use the equipment very quickly.
Dang concluded: "In this preliminary analysis, safety of fixed-dose, subcutaneous injection of pertuzumab plus trastuzumab at home was consistent with the established pertuzumab plus trastuzumab safety profile, indicating that subcutaneous injection of pertuzumab plus trastuzumab at home is a viable option for continuing breast cancer care during and beyond COVID-19." As expected, the most common adverse event reported was injection site reaction associated with the subcutaneous route of administration.
"Across both EBC and MBC, more patients preferred at-home subcutaneous administration versus clinic intravenous infusion," Dang said.
Mark L. Fuerst is a contributing writer.