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

Research output: Contribution to journalArticle

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 <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.

Original languageEnglish
Pages (from-to)227-234
Number of pages8
JournalTargeted Oncology
Volume13
Issue number2
DOIs
Publication statusPublished - Apr 1 2018

ASJC Scopus subject areas

  • Oncology
  • Cancer Research
  • Pharmacology (medical)

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    Di Bartolomeo, M., Niger, M., Tirino, G., Petrillo, A., Berenato, R., Laterza, M. M., 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., ... De Vita, F. (2018). Ramucirumab as Second-Line Therapy in Metastatic Gastric Cancer: Real-World Data from the RAMoss Study. Targeted Oncology, 13(2), 227-234. https://doi.org/10.1007/s11523-018-0562-5