Treatment patterns, effectiveness, and safety of Trastuzumab in Chinese patients with metastatic gastric cancer: Interim analysis of the EVIDENCE registry study.

Abstract

e15595 Background: Trastuzumab (TRA) was approved for HER2-positive metastatic gastric or gastroesophageal junction adenocarcinoma (mGC) in China in August 2012. However, real-world data on the treatment patterns, effectiveness, and safety of TRA in Chinese patients (pts) with mGC are limited. Methods: EVIDENCE is a prospective, multicenter, non-interventional, registry study of 5 cohorts (NCT01839500). Cohort I enrolled pts with HER2-positive mGC (IHC3+ or IHC2+/ISH+) diagnosed up to 6 months previously. This interim analysis evaluated the effectiveness and safety of TRA in the first 95 pts of cohort I who were treated at 33 hospitals in China between April 2013 and August 15, 2016. Results: 71 of the 95 pts (74.7%) were male and the median age at diagnosis was 61 years (range 21-87 years). At the data cut-off date, the preliminary median PFS was 9.5 months (95% CI 7.6-11.8 months), and the preliminary median overall survival (OS) was 30.0 months (95% CI 18.6-38.7 months). 90 pts were treated with TRA + chemotherapy; XELOX (capecitabine + oxaliplatin) (28 pts, 31.1%) and capecitabine (20 pts, 22.2%) were the mostly commonly used regimens with TRA for first-line therapy, while paclitaxel was most commonly used with TRA for second-line (7.8%) and third-line (2.2%) therapy. TRA was also used in neoadjuvant (7 pts) and adjuvant (8 pts) settings prior to recurrence. During follow-up, 48 pts had progressive disease, and 21 (43.8%) received TRA beyond progression; 7 pts (14.6%) continued TRA after their 2nd disease progression. TRA-related adverse events (AEs) were observed in 26 pts (27.4%), including neutropenia in 10 pts (10.5%), thrombocytopenia in 9 (9.5%), and a decreased white blood cell count in 7 (7.4%). Only 6 pts (6.3%) experienced grade > = 3 TRA-related AEs (which included neutropenia and thrombocytopenia). Conclusions: In routine clinical practice in China, TRA combined with various chemotherapy regimens proved effective and well tolerated for treating mGC HER2+ pts. In addition to its use in palliative settings, TRA was also used as neoadjuvant/adjuvant treatment. Clinical trial information: NCT01839500.