1. Ramucirumab as Second-Line Therapy in Metastatic Gastric Cancer: Real-World Data from the RAMoss Study
- Author
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Lorenzo Fornaro, Rosa Berenato, Gianluca Tomasello, Stefano Tamberi, Elisa Giommoni, Andrea Spallanzani, Federica Morano, Sara Lonardi, Ferdinando De Vita, Francesco Graziano, Katia Bencardino, Maria Di Bartolomeo, Raffaella Longarini, Monica Niger, Jole Ventriglia, Simone Scagnoli, Giuseppe Tirino, Salvatore Galdy, Maria Maddalena Laterza, Massimiliano Spada, Ilaria Proserpio, Lorenza Rimassa, Filippo Pietrantonio, Maria Antista, Alessandro Bertolini, Teodoro Sava, Tiziana Latiano, Alberto Zaniboni, Giordano D. Beretta, Alessandro Bittoni, Angelica Petrillo, Di Bartolomeo, M, Niger, M, Tirino, G, Petrillo, A, Berenato, R, Laterza, Mm, Pietrantonio, F, Morano, F, Antista, M, Lonardi, S, Fornaro, L, Tamberi, S, Giommoni, E, Zaniboni, A, Rimassa, L, Tomasello, G, Sava, T, Spada, M, Latiano, T, Bittoni, A, Bertolini, A, Proserpio, I, Bencardino, Kb, Graziano, F, Beretta, G, Galdy, S, Ventriglia, J, Scagnoli, S, Spallanzani, A, Longarini, R, and De Vita, F
- Subjects
0301 basic medicine ,Adult ,Male ,Cancer Research ,medicine.medical_specialty ,monoclonal ,Neutropenia ,Antibodies, Monoclonal, Humanized ,Gastroenterology ,Ramucirumab ,law.invention ,03 medical and health sciences ,0302 clinical medicine ,Randomized controlled trial ,law ,Stomach Neoplasms ,Internal medicine ,80 and over ,medicine ,Clinical endpoint ,antibodies ,Humans ,adult ,aged ,antibodies, monoclonal ,humanized ,female ,humans ,male ,middle aged ,neoplasm metastasis ,retrospective studies ,stomach neoplasms ,Pharmacology (medical) ,Neoplasm Metastasis ,Adverse effect ,Aged ,Retrospective Studies ,Aged, 80 and over ,business.industry ,Incidence (epidemiology) ,Antibodies, Monoclonal ,Retrospective cohort study ,Middle Aged ,medicine.disease ,Confidence interval ,030104 developmental biology ,Oncology ,030220 oncology & carcinogenesis ,Female ,business - 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/m2 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
- Published
- 2018