Preprint Article Version 1 This version is not peer-reviewed

The Impact of Clinical Features on Efficacy and Safety of the Combination of Ramucirumab and Paclitaxel for Metastatic Gastro-Oesophageal Junction/ Gastric Cancer: Data of a Real Life Experience in an Italian Institution

Version 1 : Received: 23 April 2018 / Approved: 24 April 2018 / Online: 24 April 2018 (06:01:56 CEST)

How to cite: Vita, E.; Strippoli, A.; Di Noia, V.; Di Dio, C.; Zurlo, V.; Basso, M.; D'Argento, E.; Giovanni , S.; Barone, C.; Cassano, A. The Impact of Clinical Features on Efficacy and Safety of the Combination of Ramucirumab and Paclitaxel for Metastatic Gastro-Oesophageal Junction/ Gastric Cancer: Data of a Real Life Experience in an Italian Institution. Preprints 2018, 2018040307 (doi: 10.20944/preprints201804.0307.v1). Vita, E.; Strippoli, A.; Di Noia, V.; Di Dio, C.; Zurlo, V.; Basso, M.; D'Argento, E.; Giovanni , S.; Barone, C.; Cassano, A. The Impact of Clinical Features on Efficacy and Safety of the Combination of Ramucirumab and Paclitaxel for Metastatic Gastro-Oesophageal Junction/ Gastric Cancer: Data of a Real Life Experience in an Italian Institution. Preprints 2018, 2018040307 (doi: 10.20944/preprints201804.0307.v1).

Abstract

The RAINBOW Phase III study established the efficacy of the combination of paclitaxel and ramucirumab, a monoclonal antibody targeting VEGF receptor-2 (VEGF-R2), as second-line therapy. We retrospectively analyzed the data of patients treated with ramucirumab plus paclitaxel at our Institution to evaluate the impact of clinical heterogeneous figures on the efficacy and safety of this combination paclitaxel/ramucirumab in a real- life cohort of patients. After a median follow-up of 10.74 months, the median progression-free survival (PFS) was 5.8 months (95% CI: 3.04 - 5,63). Disease control rate (DCR) was 61% and the median duration of response (DOR) was 5.8 months. Median overall survival (OS) was 8.3 months. A trend toward better outcome was observed in HER2 positive patients. In multivariate analysis, nutritional status (p = 0.0001) and number of metastatic sites (p = 0.0266) resulted significantly related with longer PFS. Our analysis confirmed the efficacy and safety of the combination of ramucirumab with paclitaxel also in the real-life practice and the median PFS is significantly longer than that reported for Western population in previous studies. Subgroup analysis confirms the key-role of nutritional status as prognostic factor and suggests a possible interaction between EGF and angiogenesis pathways that deserves further investigations.

Subject Areas

gastric cancer; ramucirumab; paclitaxel; second line therapy; vascular endothelial growth factor receptor 2; targeted therapy; nutrition

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