This article is more than 5 years old. Information may no longer be current.
Subcutaneous, IV trastuzumab similarly safe, effective for HER-2-positive early breast cancer
Click Here to Manage Email Alerts
Subcutaneous trastuzumab demonstrated comparable safety and efficacy to IV trastuzumab in patients with HER-2–positive early breast cancer, according to results of an international randomized, open-label phase 3 study.
Christian Jackisch, MD, PhD, of the Breast Cancer and Gynecology Cancer Center at Sana Klinikum Offenbach GmbH in Germany, and colleagues compared the pharmacokinetics, efficacy and safety of subcutaneous vs. IV trastuzumab (Herceptin, Genentech). The study included 596 women with HER-2–positive, operable, locally advanced or inflammatory breast cancer in the neoadjuvant/adjuvant setting.
All women underwent treatment with eight cycles of neoadjuvant chemotherapy administered concurrently with trastuzumab. Trastuzumab was administered either via 3-weekly fixed doses of 600 mg or via the standard weight-based method.
Patients continued treatment with trastuzumab for 1 year after surgery.
Previously published results showed the primary endpoints — the non-inferiority of subcutaneous vs. IV trastuzumab in terms of serum concentration and pathologic complete response — were met. The safety profiles were comparable at a median 1-year median follow-up.
Safety/tolerability, pharmacokinetic profile, immunogenicity and EFS served as secondary outcome measures. In the current analysis, the researchers reported results of updated safety and efficacy data after a median follow-up of 20 months.
Early analysis showed EFS rates of 95% in each group 1 year after randomization.
Although the researchers observed similarities in incidence of adverse events, they observed a slightly higher incidence of serious adverse events — primarily infections — with subcutaneous treatment (21.5% vs. 14.1%). The differences in adverse event incidence were “small and often based on rare events,” researchers wrote.
The investigators observed no associations between toxicity, body weight or exposure.
Disclosure: See the study for a full list of the researchers’ relevant financial disclosures.
Click Here to Manage Email Alerts