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Poster display session

2912 - Clinical practice observation of trastuzumab (TRA) in patients (pts) with HER2-positive metastatic adenocarcinoma of the stomach (mGC) or the gastro-oesophageal junction (GEJ) – final analysis from the German non-interventional study HerMES

Date

09 Sep 2017

Session

Poster display session

Topics

Cytotoxic Therapy;  Targeted Therapy;  Oesophageal Cancer;  Gastric Cancer

Presenters

Salah-Eddin Al-Batran

Citation

Annals of Oncology (2017) 28 (suppl_5): v209-v268. 10.1093/annonc/mdx369

Authors

S. Al-Batran1, E. Moorahrend2, C. Maintz3, D. Hempel4, P. Thuss-Patience5, V. Gaillard6, S. Hegewisch Becker7

Author affiliations

  • 1 Institute Of Clinical Cancer Trials (icct), Krankenhaus Nordwest, 60488 - Frankfurt am Main/DE
  • 2 Department Of Hematology And Oncology, Outpatient Clinic, Porta Westfalica/DE
  • 3 Hematology And Oncology, Practice for Hematology and Oncology, Wuerselen/DE
  • 4 Department Hematology - Oncology, Oncology Donauwoerth, Donauwoerth/DE
  • 5 Department Of Hematology, Oncology, And Tumor Immunology, Charité University Medicine Berlin, Campus Virchow-Klinikum, 13353 - Berlin/DE
  • 6 Medical Affairs, Roche Pharma AG, Grenzach Wyhlen/DE
  • 7 Haematologisch-onkologische Praxis Eppendorf, hope - Facharztzentrum Eppendorf, Hamburg/DE
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Resources

Abstract 2912

Background

HER2-pos metastatic cancer of GEJ or stomach are indications with a high medical need. TRA plus standard chemotherapy (CT) has been approved as 1L therapy in HER2-pos mGC or mGEJ-C pts according to ToGA-study. HerMES (NCT01220934) was designed to collect data on clinical routine practice in 171 specialist centers in Germany.

Methods

Between January 2010 and July 2016, 434 pts were identified. 364 pts matched criteria for TRA-therapy and were treated accordingly (population of the present analysis). Another 39 pts did not match criteria for HER2-positivity with TRA-therapy and will be evaluated separately. Main parameters of interest were overall response rate (ORR), progression free survival (PFS), safety and overall survival (OS). QoL and patient reported outcomes will be presented later.

Results

Mean age was 65 years, 75% were male, and 51% had mGEJ-C. TRA was given at an average dose of 5.73 mg/kg. Mean treatment duration for TRA was 7 months (mos) and 61 pts (17%) received TRA-therapy for more than 1 year. CT regimen frequently used were cisplatin/5-FU (21%), oxaliplatin/5-FU/docetaxel (10%), and cisplatin/capecitabine (8%). ORR was 43% [95%CI 0.38;0.49], median PFS was 7 mos [6.3;7.6], and median OS was 10 mos [8.8;11.1]. Most frequent related AEs (reported in > 5% of pts) were diarrhea in 29 (8%), nausea in 24 (6.6%) and fatigue in 22 cases (6%). TRA-rel cardiac AEs occurred in 21 pts (6%).

Conclusions

To our knowledge this is the largest prospective observational trial on TRA in the daily clinical routine care of metastatic GC/GEJ-C. Chemotherapy backbones were diverse. The outcome was similar to ToGA, taking into account the unselected patient population.

Clinical trial identification

NCT01220934

Legal entity responsible for the study

Roche Pharma AG

Funding

Roche Pharma AG

Disclosure

S-E. Al-Batran: Membership on advisory board or board of directors: Lilly Pharma, BMS, Roche, Astellas C. Maintz: Membership on advisory board or board of directors: Roche, Shire P. Thuss-Patience: Membership on advisory board or board of directors: Roche, Lilly, MSD, BMS, Nordic Corporate-sponsored research: Novartis V. Gaillard: Other substantive relationship such as employment with a pharmaceutical company: Roche Pharma AG (Employment) All other authors have declared no conflicts of interest.

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