RAINBOW: A global, phase 3, double-blind study of ramucirumab (RAM) plus paclitaxel (PTX) versus placebo (PL) plus PTX in the treatment of advanced gastric and gastroesophageal junction (GEJ) adenocarcinoma following disease progression on first-line platinum- and fluoropyrimidine-containing combination therapy—An age-group analysis
| العنوان: | RAINBOW: A global, phase 3, double-blind study of ramucirumab (RAM) plus paclitaxel (PTX) versus placebo (PL) plus PTX in the treatment of advanced gastric and gastroesophageal junction (GEJ) adenocarcinoma following disease progression on first-line platinum- and fluoropyrimidine-containing combination therapy—An age-group analysis |
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| المؤلفون: | Yee Chao, G. Kurteva, Alvydas Česas, Oleg Lipatov, Yasuhiro Shimada, Yoshito Komatsu, Tomohiro Nishina, Naotoshi Sugimoto, Sang Cheul Oh, György Bodoky, Eric Van Cutsem, Atsushi Ohtsu, Philip Clingan, Shuichi Hironaka, Roberto Carlesi, Kumari Chandrawansa, Hansjochen Wilke, Kei Muro |
| المصدر: | Journal of Clinical Oncology. 33:11-11 |
| بيانات النشر: | American Society of Clinical Oncology (ASCO), 2015. |
| سنة النشر: | 2015 |
| مصطلحات موضوعية: | Cancer Research, medicine.medical_specialty, Chemotherapy, Combination therapy, business.industry, medicine.medical_treatment, medicine.disease, Placebo, Gastroenterology, Surgery, Ramucirumab, chemistry.chemical_compound, Oncology, Paclitaxel, chemistry, Internal medicine, medicine, Clinical endpoint, Adenocarcinoma, Progression-free survival, business |
| الوصف: | 11 Background: RAM is a human IgG1 monoclonal antibody VEGF-R2 antagonist. The RAINBOW trial demonstrated that RAM added to PTX significantly improved overall survival (OS), progression free survival (PFS), and objective response rates (ORR) in 2nd-line gastric and GEJ adenocarcinoma patients (pts). Outcomes are reported by pts aged 2IV on days 1, 8, and 15 of a 28-day cycle. Eligible pts had ECOG PS ≤ 1 and adequate organ function. OS was the primary endpoint. Secondary endpoints included PFS, ORR, and safety. Results: Baseline characteristics were generally well balanced. Outcomes are summarized in the Table. The incidence of Grade ≥3 adverse events (AEs) was higher in the RAM+PTX arms for both age groups and similar across age groups. Grade ≥3 AEs occurring in ≥10% of pts and at higher rate in the RAM+PTX arm, and febrile neutropenia are shown in the Table. Conclusions: RAM+PTX conferred similar improvements over PL+PTX for OS, PFS, and ORR in both age groups. Toxicity profiles were similar in both groups, although a relatively higher incidence of Grade ≥3 neutropenia and leukopenia in pts ≥65 years was noted. [Table: see text] |
| تدمد: | 1527-7755 0732-183X |
| DOI: | 10.1200/jco.2015.33.3_suppl.11 |
| URL الوصول: | https://explore.openaire.eu/search/publication?articleId=doi_________::09dc763c3f1dbd6f8c288dd96273ea26 https://doi.org/10.1200/jco.2015.33.3_suppl.11 |
| رقم الانضمام: | edsair.doi...........09dc763c3f1dbd6f8c288dd96273ea26 |
| قاعدة البيانات: | OpenAIRE |
| تدمد: | 15277755 0732183X |
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| DOI: | 10.1200/jco.2015.33.3_suppl.11 |