Stay Up to Date
Breaking News,
Updates, & More
Click Here to

Biosimilar Effective for Chemotherapy-Induced Anemia in Patients with Colorectal Cancer

TOP - May 2015, Vol 8, No 2 - Best Practices

San Francisco, CA — An interim subanalysis of an ongoing French national observational study (OncoBOS) demonstrated the real-life clinical efficacy and safety of the biosimilar epoetin alfa (HX575, Binocrit) for the treatment of chemotherapy-induced anemia (CIA) in patients with colorectal cancer receiving chemotherapy, according to data presented at the 2015 Gastrointestinal Cancers Symposium.

“These results demonstrate the ability of HX575 to safely correct anemia and maintain hemoglobin levels, in line with current recommendations, using a weekly dosing regimen,” noted the lead author of the study, Jean-Philippe Metges, MD, Institut de Cancérologie et d’Hématologie, CHU Morvan, Brest, France.

As Dr Metges observed, anemia is a common condition in patients with cancer receiving chemotherapy because of the cytotoxic effect of chemotherapy on erythroid precursors in bone marrow and cells in the kidney that are responsible for erythropoietin production. It also has a negative impact on recovery. Studies in patient populations with solid tumors and hematologic malignancies have shown that CIA symptoms, including extreme fatigue, reduced physical capacity, and impaired cognitive function, can negatively impact patients’ quality of life (QoL).

HX575—the first biosimilar recombinant human erythropoietin to be granted marketing authorization—has been licensed in 30 countries worldwide, not including the United States, since 2007. As of October 2014, the estimated exposure to HX575 was 300,000 patient-years.

“OncoBOS is an ongoing, national, prospective, non-interventional, longitudinal, observational study examining HX575 use in routine practice in France,” Dr Metges explained. “Its primary objective is to describe the conditions of use of HX575 for the correction of hemoglobin levels in patients receiving chemotherapy treatment for solid tumors, lymphoma, or myeloma. A key secondary objective is to describe the efficacy and safety of HX575 in real life clinical practice.”

The interim subanalysis included 96 patients with colorectal cancer, recruited from 28 French centers (university/academic hospitals, and public and private care units) between September 2011 and April 2014. Patient characteristics, data on CIA and CIA management, and the main factors considered by the clinician when prescribing HX575 were recorded at 3 different intervals: treatment initiation; 3 to 4 weeks; and 12 (±1) weeks posttreatment.

Assessed hemoglobin outcomes included the proportion of patients achieving hemoglobin increases of ≥1 g/dL and ≥2 g/dL, and mean hemoglobin changes from baseline.

“Clinicians considered QoL (n = 47, 49%), fatigue (n = 23, 24%), and avoidance of blood transfusion (n = 15, 15.6%) as the predominant factors influencing prescription of treatment for CIA,” Dr Metges elaborated on the results. “The 3 most common factors influencing prescription of treatment with HX575 were cost decrease (n = 59, 61.5%), product efficacy (n = 21, 21.9%), and maintenance of chemotherapy dose (n = 14, 14.6%).”

The mean and median range hemoglobin levels at baseline were 9.9 g/dL and 10 g/dL, respectively. The mean level increased to 11.0 g/dL at weeks 3 to 4, and 11.7 g/dL at week 12 (both P

A hemoglobin increase of ≥1 g/dL from baseline was achieved by 56.8% of patients at weeks 3 to 4, and 77.6% at week 12. An increase of hemoglobin ≥2 g/dL was achieved by 17.9% and 47.4% of patients at the same time points, respectively. The mean dose of HX575 was 31,458 IU/week. Patients received a median HX575 dose of 30,000 IU/week, and only 4 (4.2%) of the 96 patients required a dose increase. Two patients required a blood transfusion at weeks ­3 to 4, and only 1 blood transfusion was required at week 12. No treatment-related adverse events were recorded.

Related Items
Alum Irrigation, a Standard of Care, Is Once Again Readily Available for the Treatment of Hemorrhagic Cystitis
Dawn Holcombe, MBA, FACMPE, ACHE
TOP - May 2022 Vol 15, No 3 published on May 6, 2022 in Best Practices
Addressing and Overcoming Challenges in the Use of Biosimilars
Dawn Holcombe, MBA, FACMPE, ACHE
TOP - October 2021 Vol 14, No 6 | Biosimilars published on November 5, 2021 in Best Practices, Biosimilars
Multidisciplinary Team Approach Leads to Rapid Biosimilar Adoption in Community Oncology Practice
Charlie Dawson
TOP - October 2021 Vol 14, No 6 | Biosimilars published on November 5, 2021 in Best Practices, Biosimilars
Study Shows Increase in Biosimilar Use Among Oncology Providers
Anne Rowe
TOP - October 2021 Vol 14, No 6 | Biosimilars published on November 5, 2021 in Best Practices, Biosimilars
ASCO Updates Its Oncology Medical Home Payment Model, Putting Patient Needs Up Front
Chase Doyle
TOP - July 2020, Vol 13, No 4 published on July 15, 2020 in Value-Based Care
First National Study: Geographic Socioeconomic Disparities Mirror Substantial Gaps in Survival in Children with AML
Chase Doyle
TOP - March 2020, Vol 13, No 2 published on March 11, 2020 in Value-Based Care
Tazemetostat Demonstrates Antitumor Activity in Relapsed/Refractory Follicular Lymphoma
Chase Doyle
TOP - March 2020, Vol 13, No 2 published on March 11, 2020
Delivering High-Value Personalized Interventions
Chase Doyle
Web Exclusives published on December 9, 2019 in Clinical Pathways
Patients with Medicaid or No Insurance Have Worse Survival in Clinical Trials
Chase Doyle
Web Exclusives published on November 14, 2019 in Clinical Trials
Patient-Centered Clinical Pathways Should Incorporate the Patient’s Voice
Chase Doyle
TOP - November 2019, Vol 12, No 4 published on November 7, 2019 in Clinical Pathways
Last modified: July 22, 2021