Patients without comorbidities who received subcutaneous trastuzumab with their chemotherapy and endocrine therapy showed a significant improvement in emotional function, and reported that they were less upset by hair loss than the patients in the control group.
While the first trastuzumab biosimilar (Ontruzant) has recently launched in the European Union as an intravenously (IV) administered therapy, subcutaneously administered trastuzumab, available only as the reference product (Herceptin), has shown some possible advantages over IV therapy. A recent Spanish study demonstrated that subcutaneous administration of trastuzumab is associated with cost savings, reduced provider time spent administering the treatment, and reduced patient time in the treatment facility. The PrefHer study found that patients generally preferred to receive subcutaneous therapy versus the IV threapy.
Now, a new Greek study1 suggests that the subcutaneous administration does not have a negative impact on health-related quality of life (HRQOL) in patients with either early or metastatic breast cancer.
The authors of the prospective study identified 163 patients with HER2-positive breast cancer who were treated at 5 clinics in Athens between December 2015 and May 2016. Among these patients, 90 (55.21%) received subcutaneous trastuzumab, while 21 received intravenous trastuzumab (12.88%). A control group of 52 patients received chemotherapy without trastuzumab (31.90%). Patients in the subcutaneous therapy arm were older and had more advanced disease than those receiving chemotherapy only.
The patients voluntarily completed the European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire-Core 30 (EORTC QLQ-C30) and the supplemental form BR-23, which assess a patient’s physical, role, emotional, social, and cognitive functioning, as well as symptoms and global health status.
The researchers say that their analysis did not show any significant differences in HRQOL parameters between the subcutaneous trastuzumab band intravenous trastuzumab groups.
However, the patients without comorbidities who received subcutaneous trastuzumab with their chemotherapy and endocrine therapy showed a significant improvement in emotional function, and reported that they were less upset by hair loss than the patients in the control group. In a multivariate analysis, patients receiving the subcutaneous trastuzumab who has undergone a mastectomy improved their role functioning compared with patients in the control group. (P =.021)
The authors caution that, because this study was observational in nature, the results should be interpreted with caution, and additional studies will be necessary to confirm these findings. However, they conclude that subcutaneous trastuzumab did not negative impact HRQOL in any of the parameters assessed in all subgroups of patients.
Reference
1. Syrios J, Pappa E, Volakakis N, et al. Real-world data on health-related quality of life assessment in patients with breast cancer receiving subcutaneous trastuzumab. [Published online February 20, 2018.] Breast Cancer (Auckl). doi:10.1177/1178223418758031.
Empowering Vulnerable Populations: The Path to Equitable Biologic Therapy Access
December 22nd 2024Elie Bahou, PharmD, senior vice president and system chief pharmacy officer at Providence, discusses strategies to improve equitable access to biologic therapies, including tiered formularies, income-based cost sharing, patient assistance programs, and fostering payer partnerships.
Biosimilars in America: Overcoming Barriers and Maximizing Impact
July 21st 2024Join us as we explore the complexities of the US biosimilars market, discussing legislative influences, payer and provider adoption factors, and strategies to overcome industry challenges with expert insights from Kyle Noonan, PharmD, MS, value & access strategy manager at Cencora.
Biosimilars Oncology Roundup for June 2024—Podcast Edition
July 7th 2024On this episode of Not So Different, we review biosimilar news coming out of June, with clinical trial results from conferences and a study showcasing how to overcome economic and noneconomic barriers to oncology biosimilars.
Eye on Pharma: Golimumab Biosimilar Update; Korea Approves Denosumab; Xbrane, Intas Collaboration
December 10th 2024Alvotech and Advanz Pharma have submitted a European marketing application for their golimumab biosimilar to treat inflammatory diseases, while Celltrion secured Korean approval for denosumab biosimilars, and Intas Pharmaceuticals partnered with Xbrane Biopharma on a nivolumab biosimilar.
Pertuzumab Biosimilar Shows Promise in HER2-Positive Breast Cancer Treatment
December 9th 2024The proposed pertuzumab biosimilar QL1209 demonstrated equivalent efficacy and safety to reference pertuzumab (Perjeta) in neoadjuvant treatment of HER2-positive, ER/PR-negative early or locally advanced breast cancer, offering a cost-effective alternative with comparable clinical outcomes.