Ramucirumab as Second-Line Therapy in Metastatic Gastric Cancer: Real-World Data from the RAMoss Study

Maria Di Bartolomeo, Monica Niger, Giuseppe Tirino, Angelica Petrillo, Rosa Berenato, Maria Maddalena Laterza, Filippo Pietrantonio, Federica Morano, Maria Antista, Sara Lonardi, Lorenzo Fornaro, Stefano Tamberi, Elisa Giommoni, Alberto Zaniboni, Lorenza Rimassa, Gianluca Tomasello, Teodoro Sava, Massimiliano Spada, Tiziana Latiano, Alessandro BittoniAlessandro Bertolini, Ilaria Proserpio, Katia Bruna Bencardino, Francesco Graziano, Giordano Beretta, Salvatore Galdy, Jole Ventriglia, Simone Scagnoli, Andrea Spallanzani, Raffaella Longarini, Ferdinando De Vita

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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
Original languageEnglish
Pages (from-to)227-234
Number of pages8
JournalTargeted Oncology
Volume13
Issue number2
DOIs
Publication statusPublished - Apr 2018

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Stomach Neoplasms
Paclitaxel
Neutropenia
Disease-Free Survival
Confidence Intervals
Therapeutics
Safety
Survival
Fatigue
Disease Progression
Multivariate Analysis
ramucirumab
Incidence

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Ramucirumab as Second-Line Therapy in Metastatic Gastric Cancer : Real-World Data from the RAMoss Study. / Di Bartolomeo, Maria; Niger, Monica; Tirino, Giuseppe; Petrillo, Angelica; Berenato, Rosa; Laterza, Maria Maddalena; Pietrantonio, Filippo; Morano, Federica; Antista, Maria; Lonardi, Sara; Fornaro, Lorenzo; Tamberi, Stefano; Giommoni, Elisa; Zaniboni, Alberto; Rimassa, Lorenza; Tomasello, Gianluca; Sava, Teodoro; Spada, Massimiliano; Latiano, Tiziana; Bittoni, Alessandro; Bertolini, Alessandro; Proserpio, Ilaria; Bencardino, Katia Bruna; Graziano, Francesco; Beretta, Giordano; Galdy, Salvatore; Ventriglia, Jole; Scagnoli, Simone; Spallanzani, Andrea; Longarini, Raffaella; De Vita, Ferdinando.

In: Targeted Oncology, Vol. 13, No. 2, 04.2018, p. 227-234.

Research output: Contribution to journalArticle

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 & De Vita, F 2018, 'Ramucirumab as Second-Line Therapy in Metastatic Gastric Cancer: Real-World Data from the RAMoss Study', Targeted Oncology, vol. 13, no. 2, pp. 227-234. https://doi.org/10.1007/s11523-018-0562-5
Di Bartolomeo, Maria ; Niger, Monica ; Tirino, Giuseppe ; Petrillo, Angelica ; Berenato, Rosa ; Laterza, Maria Maddalena ; Pietrantonio, Filippo ; Morano, Federica ; Antista, Maria ; Lonardi, Sara ; Fornaro, Lorenzo ; Tamberi, Stefano ; Giommoni, Elisa ; Zaniboni, Alberto ; Rimassa, Lorenza ; Tomasello, Gianluca ; Sava, Teodoro ; Spada, Massimiliano ; Latiano, Tiziana ; Bittoni, Alessandro ; Bertolini, Alessandro ; Proserpio, Ilaria ; Bencardino, Katia Bruna ; Graziano, Francesco ; Beretta, Giordano ; Galdy, Salvatore ; Ventriglia, Jole ; Scagnoli, Simone ; Spallanzani, Andrea ; Longarini, Raffaella ; De Vita, Ferdinando. / Ramucirumab as Second-Line Therapy in Metastatic Gastric Cancer : Real-World Data from the RAMoss Study. In: Targeted Oncology. 2018 ; Vol. 13, No. 2. pp. 227-234.
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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",
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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 -