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Patients with HER-2–positive breast cancer preferred subcutaneous trastuzumab to IV administration
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More than 90% of patients with HER-2–positive breast cancer treated with trastuzumab preferred subcutaneous administration of the drug rather than intravenous infusion, according to results of a multicenter, open-label study.
The Preference for Herceptin SC or IV Administration (PrefHer) study included 236 patients with nonmetastatic disease and a baseline left-ventricular ejection fraction of at least 55%. All patients were aged 18 years or older (median age, 53 years).
Xavier Pivot, MD, of the University Hospital of Besançon, France, and colleagues randomly assigned 117 patients to receive cycles of subcutaneous adjuvant trastuzumab (Herceptin, Genentech), followed by four cycles of IV trastuzumab. The other 119 patients received trastuzumab via IV infusion first, followed by subcutaneous administration.
The subcutaneous dose was 600 mg/5 mL. IV trastuzumab was administered in a 8 mg/kg loading dose, followed by 6 mg/kg maintenance doses.
Patient preference for administration method, obtained through phone interviews, served as primary endpoint. Safety and tolerability served as secondary endpoints.
Overall, 216 patients (91.5%) preferred subcutaneous trastuzumab (95%CI, 87.2-94.7). Sixteen patients (6.8%) preferred IV infusion (95% CI, 3.9-10.8), and four (1.7%) had no preference (95% CI, 0.5-4.3).
Of those who received subcutaneous therapy first, 112 (95.7%) preferred it to IV administration. Among patients assigned to the other sequence, 104 (87.4%) preferred subcutaneous administration.
Patients expressed preference for subcutaneous administration regardless of prior trastuzumab treatment. In addition to the reduced time required for subcutaneous administration, more patients indicated they preferred that regimen because it was less painful (66.9% vs. 14%), caused less irritation from bruising (46.2% vs. 14%) and resulted in less irritation to the injection site (35.6% vs. 14.8%).
Overall, 67.2% of patients experienced one or more adverse events; of those events, 92.7% were grade 1 or 2. Six patients experienced serious adverse events. Those events — which included mental crisis, axilla abscess, expander infection and hematoma during the subcutaneous period, as well as influenza and fibroadenoma during the IV period — were unrelated to trastuzumab, and all were resolved, researchers said.
“Patient preference and safety results from PrefHer — combined with known noninferior efficacy and pharmacokinetic and safety profile data — suggest that a fixed dose of 600 mg trastuzumab administered subcutaneously every 3 weeks is a validated, well-tolerated treatment option of HER-2–positive breast cancer,” Pivot and colleagues wrote.
The study provided invaluable information about patient preference, and it also demonstrates the feasibility of subcutaneous treatment for patients who live far away from treatment centers, Bohuslav Melichar, PhD, of the department of oncology at the Palacký University Medical School and Teaching Hospital in the Czech Republic, wrote in an accompanying editorial.
“The significance of the concept of subcutaneous delivery of a targeted agent goes beyond the treatment of HER-2–positive breast cancer,” Melichar wrote. “This route of delivery of monoclonal antibodies could have implications for the management of a wider range of malignant disorders.”
Disclosure: The researchers report research funding, honoraria and travel grants from, employment, consulting and advisory board roles with, and stock ownership in Amgen, Celgene, F. Hoffman-La Roche, GlaxoSmithKline, Pierre-Fabre, Sanofi-Aventis and Teva.
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