Title |
Ramucirumab as Second-Line Therapy in Metastatic Gastric Cancer: Real-World Data from the RAMoss Study
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Published in |
Targeted Oncology, March 2018
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DOI | 10.1007/s11523-018-0562-5 |
Pubmed ID | |
Authors |
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 |
Abstract |
Ramucirumab-alone or combined with paclitaxel-represents one of the main options for patients failing first-line treatment for advanced gastric cancer. The RAMoss study aimed to evaluate the safety and efficacy profile of ramucirumab in the "real-life setting". 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). 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. These "real-life" efficacy data on ramucirumab treatment are in line with previous randomized trials. Ramucirumab is well tolerated in daily clinical practice. |
X Demographics
Geographical breakdown
Country | Count | As % |
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United States | 1 | 33% |
Unknown | 2 | 67% |
Demographic breakdown
Type | Count | As % |
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Science communicators (journalists, bloggers, editors) | 2 | 67% |
Members of the public | 1 | 33% |
Mendeley readers
Geographical breakdown
Country | Count | As % |
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Unknown | 65 | 100% |
Demographic breakdown
Readers by professional status | Count | As % |
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Researcher | 17 | 26% |
Other | 7 | 11% |
Student > Master | 6 | 9% |
Student > Ph. D. Student | 5 | 8% |
Student > Doctoral Student | 3 | 5% |
Other | 6 | 9% |
Unknown | 21 | 32% |
Readers by discipline | Count | As % |
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Medicine and Dentistry | 17 | 26% |
Biochemistry, Genetics and Molecular Biology | 6 | 9% |
Pharmacology, Toxicology and Pharmaceutical Science | 5 | 8% |
Business, Management and Accounting | 3 | 5% |
Agricultural and Biological Sciences | 2 | 3% |
Other | 7 | 11% |
Unknown | 25 | 38% |