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

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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 <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.

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Author notes

  1. Maria Di Bartolomeo and Ferdinando De Vita contributed equally to this work.

Authors and Affiliations

  1. Department of Medical Oncology, Fondazione IRCCS Istituto Tumori, via G. Venezian, 1, 20133, Milan, Italy

    Maria Di Bartolomeo, Monica Niger, Rosa Berenato, Filippo Pietrantonio, Federica Morano & Maria Antista

  2. University of Campania “Luigi Vanvitelli” – School of Medicine, Naples, Italy

    Giuseppe Tirino, Angelica Petrillo, Maria Maddalena Laterza, Jole Ventriglia & Ferdinando De Vita

  3. Department of Medical Oncology, Istituto Oncologico Veneto-IRCCS, Padova, Italy

    Sara Lonardi

  4. Oncology Department, Azienda Ospedaliero-Universitaria Pisana, Pisa, Italy

    Lorenzo Fornaro

  5. Department of Oncology and Haematology, Oncology Unit, Faenza Hospital AUSL Romagna, Ravenna, Italy

    Stefano Tamberi

  6. Medical Oncology, Azienda Ospedaliero-Universitaria Careggi, Florence, Italy

    Elisa Giommoni

  7. Medical Oncology Unit, Fondazione Poliambulanza, Brescia, Italy

    Alberto Zaniboni

  8. Medical Oncology and Hematology Unit, Humanitas Cancer Center, Humanitas Clinical and Research Center, Milan, Italy

    Lorenza Rimassa

  9. Division of Medicine and Medical Oncology, Azienda Istituti Ospitalieri, Cremona, Italy

    Gianluca Tomasello

  10. Department of Medical Oncology, Azienda Ospedaliera Universitaria Integrata Verona, Verona, Italy

    Teodoro Sava

  11. Fondazione Istituto G. Giglio di Cefalu, Palermo, Italy

    Massimiliano Spada

  12. Medical Oncology Hospital Casa Sollievo della Sofferenza, San Giovanni Rotondo, Foggia, Italy

    Tiziana Latiano

  13. Department of Oncology, Ospedali Riuniti, Università Politecnica delle Marche, Ancona, Italy

    Alessandro Bittoni

  14. Azienda Ospedaliera della Valtellina e della Valchiavenna, Sondrio, Italy

    Alessandro Bertolini

  15. Medical Oncology, Ospedale di Circolo e Fondazione Macchi, Varese, Italy

    Ilaria Proserpio

  16. Department of Hematology and Oncology, Niguarda Cancer Center, Niguarda, Milan, Italy

    Katia Bruna Bencardino

  17. Medical Oncology Unit, Azienda Ospedaliera-Ospedali Riuniti Marche Nord, Pesaro, Italy

    Francesco Graziano

  18. Medical Oncology Unit, Humanitas Gavazzeni, Bergamo, Italy

    Giordano Beretta

  19. Unit of Gastrointestinal Medical Oncology and Neuroendocrine Tumors, European Institute of Oncology, Milan, Italy

    Salvatore Galdy

  20. Medical Oncology Department, University of Rome Sapienza, Rome, Italy

    Simone Scagnoli

  21. Medical Oncology and Hematology Department, Azienda Ospedaliero-Universitaria Policlinico di Modena, Modena, Italy

    Andrea Spallanzani

  22. Unit of Medical Oncology, San Gerardo Hospital, Monza, Italy

    Raffaella Longarini

Authors
  1. Maria Di Bartolomeo
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  2. Monica Niger
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  3. Giuseppe Tirino
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  4. Angelica Petrillo
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  5. Rosa Berenato
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  6. Maria Maddalena Laterza
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  8. Federica Morano
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  9. Maria Antista
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  10. Sara Lonardi
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  11. Lorenzo Fornaro
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  15. Lorenza Rimassa
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  16. Gianluca Tomasello
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  17. Teodoro Sava
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  21. Alessandro Bertolini
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  22. Ilaria Proserpio
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  23. Katia Bruna Bencardino
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  24. Francesco Graziano
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  26. Salvatore Galdy
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  27. Jole Ventriglia
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  28. Simone Scagnoli
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  29. Andrea Spallanzani
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  30. Raffaella Longarini
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  31. Ferdinando De Vita
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Corresponding author

Correspondence to Maria Di Bartolomeo.

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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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Di Bartolomeo, M., Niger, M., Tirino, G. et al. Ramucirumab as Second-Line Therapy in Metastatic Gastric Cancer: Real-World Data from the RAMoss Study. Targ Oncol 13, 227–234 (2018). https://doi.org/10.1007/s11523-018-0562-5

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