Maria Di Bartolomeo1, Monica Niger2, Giuseppe Tirino3, Angelica Petrillo3, Rosa Berenato2, Maria Maddalena Laterza3, Filippo Pietrantonio2, Federica Morano2, Maria Antista2, Sara Lonardi4, Lorenzo Fornaro5, Stefano Tamberi6, Elisa Giommoni7, Alberto Zaniboni8, Lorenza Rimassa9, Gianluca Tomasello10, Teodoro Sava11, Massimiliano Spada12, Tiziana Latiano13, Alessandro Bittoni14, Alessandro Bertolini15, Ilaria Proserpio16, Katia Bruna Bencardino17, Francesco Graziano18, Giordano Beretta19, Salvatore Galdy20, Jole Ventriglia3, Simone Scagnoli21, Andrea Spallanzani22, Raffaella Longarini23, Ferdinando De Vita3. 1. Department of Medical Oncology, Fondazione IRCCS Istituto Tumori, via G. Venezian, 1, 20133, Milan, Italy. maria.dibartolomeo@istitutotumori.mi.it. 2. Department of Medical Oncology, Fondazione IRCCS Istituto Tumori, via G. Venezian, 1, 20133, Milan, Italy. 3. University of Campania "Luigi Vanvitelli" - School of Medicine, Naples, Italy. 4. Department of Medical Oncology, Istituto Oncologico Veneto-IRCCS, Padova, Italy. 5. Oncology Department, Azienda Ospedaliero-Universitaria Pisana, Pisa, Italy. 6. Department of Oncology and Haematology, Oncology Unit, Faenza Hospital AUSL Romagna, Ravenna, Italy. 7. Medical Oncology, Azienda Ospedaliero-Universitaria Careggi, Florence, Italy. 8. Medical Oncology Unit, Fondazione Poliambulanza, Brescia, Italy. 9. Medical Oncology and Hematology Unit, Humanitas Cancer Center, Humanitas Clinical and Research Center, Milan, Italy. 10. Division of Medicine and Medical Oncology, Azienda Istituti Ospitalieri, Cremona, Italy. 11. Department of Medical Oncology, Azienda Ospedaliera Universitaria Integrata Verona, Verona, Italy. 12. Fondazione Istituto G. Giglio di Cefalu, Palermo, Italy. 13. Medical Oncology Hospital Casa Sollievo della Sofferenza, San Giovanni Rotondo, Foggia, Italy. 14. Department of Oncology, Ospedali Riuniti, Università Politecnica delle Marche, Ancona, Italy. 15. Azienda Ospedaliera della Valtellina e della Valchiavenna, Sondrio, Italy. 16. Medical Oncology, Ospedale di Circolo e Fondazione Macchi, Varese, Italy. 17. Department of Hematology and Oncology, Niguarda Cancer Center, Niguarda, Milan, Italy. 18. Medical Oncology Unit, Azienda Ospedaliera-Ospedali Riuniti Marche Nord, Pesaro, Italy. 19. Medical Oncology Unit, Humanitas Gavazzeni, Bergamo, Italy. 20. Unit of Gastrointestinal Medical Oncology and Neuroendocrine Tumors, European Institute of Oncology, Milan, Italy. 21. Medical Oncology Department, University of Rome Sapienza, Rome, Italy. 22. Medical Oncology and Hematology Department, Azienda Ospedaliero-Universitaria Policlinico di Modena, Modena, Italy. 23. Unit of Medical Oncology, San Gerardo Hospital, Monza, Italy.
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.
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 G1-2fatigue (27.5%), G1-2 neuropathy (26.3%), and G1-2neutropenia (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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