CP-152 Applying the results from the toga trial into clinical practice: Data from the agamenon multicentre study. (14th February 2016)

• Record Type: Journal Article
• Authors: Manceñido, FJ Alvarez; Palomo, A Rodriguez; Garcia, I Zapico; Lorenzo, L Sanchez; Diaz-Serrano, A; Izquierdo, M Mangas; Gil, R Hernández San; García, T García; Fonseca, P Jiménez; Carmona-Bayonas, A
• Is Part Of: European journal of hospital pharmacy. Volume 23(2016)Supplement 1
• Page Start: A67
• Page End: A67
• Publication Date: 2016-02-14
• Subjects: Pharmacy -- Periodicals; Hospital pharmacies -- Periodicals; 615.1
• DOI: 10.1136/ejhpharm-2016-000875.152
• Languages: English
• ISSNs: 2047-9956

Abstract

Abstract : Background: The addition of trastuzumab to chemotherapy (cisplatin and fluoropyrimidine) significantly improved overall survival without compromising safety in patients with HER2 positive advanced gastric adenocarcinoma (BO18255 phase III international randomised controlled ToGA (Trastuzumab for Gastric Cancer) trial). 1 Purpose: To evaluate the efficacy of trastuzumab in combination with a wider variety of firstline chemotherapy regimens in a multicentre cohort of patients with HER-2 positive advanced gastric or gastro-oesophageal junction cancer in clinical practice. Material and methods: AGAMENON is a multicentre observational study to assess prognostic factors and patterns of care in advanced gastric cancer treated with chemotherapy using ≥2 drugs between 2008 and 2015. Clinical data were obtained by medical record review after approval by the ethics committee and introduced into the website of the study. The main clinical variables: progression free survival (PFS) and overall survival (OS) were analysed using the Kaplan-Meier method. HER2 positivity was defined by immunohistochemistry (IHC) 3+ or IHC2+/fluorescence in situ hybridisation. Results: This analysis comprised 92 eligible patients (erbB2+) from 946 registered on the web platform of the AGAMENON study. Clinical baseline characteristics were: ECOG performance status 0–1, 91.3%; male 77.17% and median age 65.1 years. Tumour baseline characteristics were: primary tumour site, body 33.7%; Lauren classification, intestinal 77.17%; overexpression of HER-2 protein by IHC3+ 64.13%; and ≥3 metastatic sites in 22.83%. Median follow-up was 27.2 months (IQR 16–38). Patients were treated with trastuzumab for a median of 7 months (10 cycles). 47 patients received cisplatin containing chemotherapy (5-fluorouracil/cisplatin (FP) in 27.66% and cisplatin/capecitabine (CX) in 72.34%). 45 patients received oxaliplatin regimens (5-fluorouracil/leucovorin plus oxaliplatin (FOLFOX) in 24.44% and capecitabine/oxaliplatin (CapeOX) in 75.56%). The response rate was 60.87%, median PFS reached was 8.8 months (95% CI 7.8 to10.5 months) and median OS was 19.3 months (95% CI 11.9 to 23.8 months)). Median lines of treatment received were 1 (range 1–4); the majority of patients maintain trastuzumab in consecutive lines. Conclusion: These outcomes are consistent with the efficacy data from the ToGA trial, showing a benefit from the association of trastuzumab with any chemotherapy in patients with advanced gastric or gastro-oesophageal junction cancer that overexpress HER2. References and/or Acknowledgements: Lancet 2010;376:687–97 The investigators of the AGAMENON study. No conflict of interest.