ORIGINAL RESEARCH ARTICLE Ramucirumab as Second-Line Therapy in Metastatic Gastric Cancer: Real-World Data from the RAMoss Study Maria Di Bartolomeo 1 & Monica Niger 1 & Giuseppe Tirino 2 & Angelica Petrillo 2 & Rosa Berenato 1 & Maria Maddalena Laterza 2 & Filippo Pietrantonio 1 & Federica Morano 1 & Maria Antista 1 & Sara Lonardi 3 & Lorenzo Fornaro 4 & Stefano Tamberi 5 & Elisa Giommoni 6 & Alberto Zaniboni 7 & Lorenza Rimassa 8 & Gianluca Tomasello 9 & Teodoro Sava 10 & Massimiliano Spada 11 & Tiziana Latiano 12 & Alessandro Bittoni 13 & Alessandro Bertolini 14 & Ilaria Proserpio 15 & Katia Bruna Bencardino 16 & Francesco Graziano 17 & Giordano Beretta 18 & Salvatore Galdy 19 & Jole Ventriglia 2 & Simone Scagnoli 20 & Andrea Spallanzani 21 & Raffaella Longarini 22 & Ferdinando De Vita 2 # Springer International Publishing AG, part of Springer Nature 2018 Abstract Background Ramucirumab—alone or combined with paclitaxel—represents one of the main options for patients failing first-line treatment for advanced gastric cancer. Objective The RAMoss study aimed to evaluate the safety and efficacy profile of ramucirumab in the “real-life setting”. Patients and Methods Patients from 25 Italian hospitals started therapy consisting of ramucirumab 8 mg/kg i.v. d1,15q28 with or without paclitaxel 80 mg/m 2 i.v. d1,8,15q28. The primary endpoint was safety, and secondary endpoints were overall response rate (ORR), progression-free survival (PFS), and overall survival (OS). Results One hundred sixty-seven patients with disease progression on first-line therapy received ramucirumab as monotherapy (10%) or combined with paclitaxel (90%). Median treatment duration was 4 months (1–17 months). Global incidence of grade (G) 3–4 toxicity was 9.6%, and for neutropenia 5.4%; treatment was discontinued due to toxicity in 3% of patients. The most frequent adverse events (AE) were G1–2 fatigue (27.5%), G1–2 neuropathy (26.3%), and G1–2 neutropenia (14.9%). ORR was 20.2%. Stable disease was observed in 39.2% of patients, with a disease control rate of 59.4%. With a median follow-up of 11 months, median PFS was 4.3 months (95% confidence interval [CI] 4.1–4.7), whereas median OS was 8.0 months (95% CI: 7.09–8.9). In a multivariate analysis, ECOG performance status <1 or ≥1 (HR 1.13, 95% CI 1.0–1.27, p = 0.04) and the presence versus absence of peritoneal metastases (HR 1.57, 95% CI 1.63–2.39, p = 0.03) were independent poor prognostic factors. Conclusions These “real-life” efficacy data on ramucirumab treatment are in line with previous randomized trials. Ramucirumab is well tolerated in daily clinical practice. Maria Di Bartolomeo and Ferdinando De Vita contributed equally to this work. * Maria Di Bartolomeo maria.dibartolomeo@istitutotumori.mi.it Extended author information available on the last page of the article Key Points Randomized trials have shown a survival benefit for ramucirumab with or without paclitaxel as a second-line therapy in advanced gastric cancer patients. This is the first report that documented the efficacy and safety of ramucirumab in daily practice. With a median follow-up of 11 months, median PFS was 4.3 months (95% CI: 4.1-4.7) and median OS was 8 months (95% CI:7.09-8.9). Targeted Oncology https://doi.org/10.1007/s11523-018-0562-5