TY - JOUR
T1 - Ramucirumab as Second-Line Therapy in Metastatic Gastric Cancer
T2 - Real-World Data from the RAMoss Study
AU - Di Bartolomeo, Maria
AU - Niger, Monica
AU - Tirino, Giuseppe
AU - Petrillo, Angelica
AU - Berenato, Rosa
AU - Laterza, Maria Maddalena
AU - Pietrantonio, Filippo
AU - Morano, Federica
AU - Antista, Maria
AU - Lonardi, Sara
AU - Fornaro, Lorenzo
AU - Tamberi, Stefano
AU - Giommoni, Elisa
AU - Zaniboni, Alberto
AU - Rimassa, Lorenza
AU - Tomasello, Gianluca
AU - Sava, Teodoro
AU - Spada, Massimiliano
AU - Latiano, Tiziana
AU - Bittoni, Alessandro
AU - Bertolini, Alessandro
AU - Proserpio, Ilaria
AU - Bencardino, Katia Bruna
AU - Graziano, Francesco
AU - Beretta, Giordano
AU - Galdy, Salvatore
AU - Ventriglia, Jole
AU - Scagnoli, Simone
AU - Spallanzani, Andrea
AU - Longarini, Raffaella
AU - De Vita, Ferdinando
PY - 2018/4
Y1 - 2018/4
N2 - 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
AB - 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
U2 - 10.1007/s11523-018-0562-5
DO - 10.1007/s11523-018-0562-5
M3 - Article
VL - 13
SP - 227
EP - 234
JO - Targeted Oncology
JF - Targeted Oncology
SN - 1776-2596
IS - 2
ER -