Targeted Oncology

, Volume 13, Issue 2, pp 227–234 | Cite as

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 Bittoni
  • Alessandro Bertolini
  • Ilaria Proserpio
  • Katia Bruna Bencardino
  • Francesco Graziano
  • Giordano Beretta
  • Salvatore Galdy
  • Jole Ventriglia
  • Simone Scagnoli
  • Andrea Spallanzani
  • Raffaella Longarini
  • Ferdinando De Vita
Original Research Article

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.

Notes

Compliance with Ethical Standards

Funding

No external funding was used in the preparation of this manuscript.

Conflict of Interest

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 Bittoni, Alessandro Bertolini, Ilaria Proserpio, Katia Bruna Bencardino, Francesco Graziano, Giordano Beretta, Salvatore Galdy, Jole Ventriglia, Simone Scagnoli, Andrea Spallanzani, Raffaella Longarini, and Ferdinando De Vita declare that they have no conflict of interest that might be relevant to the content of this manuscript.

Ethical Approval

All procedures followed were in accordance with the ethical standards of the responsible committee on human experimentation (institutional and national) and with the Helsinki Declaration of 1964 and later versions.

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Copyright information

© Springer International Publishing AG, part of Springer Nature 2018

Authors and Affiliations

  • 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
  1. 1.Department of Medical OncologyFondazione IRCCS Istituto TumoriMilanItaly
  2. 2.University of Campania “Luigi Vanvitelli” – School of MedicineNaplesItaly
  3. 3.Department of Medical OncologyIstituto Oncologico Veneto-IRCCSPadovaItaly
  4. 4.Oncology DepartmentAzienda Ospedaliero-Universitaria PisanaPisaItaly
  5. 5.Department of Oncology and Haematology, Oncology UnitFaenza Hospital AUSL RomagnaRavennaItaly
  6. 6.Medical OncologyAzienda Ospedaliero-Universitaria CareggiFlorenceItaly
  7. 7.Medical Oncology UnitFondazione PoliambulanzaBresciaItaly
  8. 8.Medical Oncology and Hematology Unit, Humanitas Cancer CenterHumanitas Clinical and Research CenterMilanItaly
  9. 9.Division of Medicine and Medical OncologyAzienda Istituti OspitalieriCremonaItaly
  10. 10.Department of Medical OncologyAzienda Ospedaliera Universitaria Integrata VeronaVeronaItaly
  11. 11.Fondazione Istituto G. Giglio di CefaluPalermoItaly
  12. 12.Medical Oncology Hospital Casa Sollievo della SofferenzaFoggiaItaly
  13. 13.Department of Oncology, Ospedali RiunitiUniversità Politecnica delle MarcheAnconaItaly
  14. 14.Azienda Ospedaliera della Valtellina e della ValchiavennaSondrioItaly
  15. 15.Medical OncologyOspedale di Circolo e Fondazione MacchiVareseItaly
  16. 16.Department of Hematology and OncologyNiguarda Cancer CenterMilanItaly
  17. 17.Medical Oncology UnitAzienda Ospedaliera-Ospedali Riuniti Marche NordPesaroItaly
  18. 18.Medical Oncology UnitHumanitas GavazzeniBergamoItaly
  19. 19.Unit of Gastrointestinal Medical Oncology and Neuroendocrine TumorsEuropean Institute of OncologyMilanItaly
  20. 20.Medical Oncology DepartmentUniversity of Rome SapienzaRomeItaly
  21. 21.Medical Oncology and Hematology DepartmentAzienda Ospedaliero-Universitaria Policlinico di ModenaModenaItaly
  22. 22.Unit of Medical OncologySan Gerardo HospitalMonzaItaly

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