Efficacy and tolerability of ramucirumab monotherapy or in combination with paclitaxel in gastric cancer patients from the Expanded Access Program Cohort by the Korean Cancer Study Group (KCSG)
| Autor: | In Gyu Hwang, Eun Kee Song, Samyong Kim, Sun Jin Sym, Sung Hyun Yang, Chi Hoon Maeng, Dae Young Zang, Moon Hee Lee, Sun Young Rha, Myounghee Kang, Do Youn Oh, Nam-Su Lee, Byoung Yong Shim, Ki Hyang Kim, Jin Ho Baek, Minkyu Jung, Yeul Hong Kim, Keun Wook Lee, Hong Suk Song, Hyun Woo Lee, Dong Hoe Koo, Jae Yong Cho, Jin Soo Kim, Kyoung Eun Lee, Young Seon Hong, Min Hee Ryu, Dae Ro Choi, Young Lee Park, Hye Sook Han, Yoon-Koo Kang |
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| Rok vydání: | 2017 |
| Předmět: |
0301 basic medicine
Oncology Adult Male Cancer Research medicine.medical_specialty Paclitaxel Perforation (oil well) Neutropenia Antibodies Monoclonal Humanized Ramucirumab 03 medical and health sciences chemistry.chemical_compound 0302 clinical medicine Asian People Stomach Neoplasms Internal medicine Antineoplastic Combined Chemotherapy Protocols medicine Humans Aged Aged 80 and over business.industry Gastroenterology Cancer Antibodies Monoclonal General Medicine Middle Aged medicine.disease Alkaline Phosphatase Prognosis Survival Analysis Clinical trial 030104 developmental biology Treatment Outcome Tolerability chemistry 030220 oncology & carcinogenesis Expanded access Female business |
| Zdroj: | Gastric cancer : official journal of the International Gastric Cancer Association and the Japanese Gastric Cancer Association. 21(5) |
| ISSN: | 1436-3305 |
| Popis: | Ramucirumab improves survival in gastric cancer patients. The efficacy and safety of ramucirumab outside of a clinical trial were evaluated using an expanded access program (EAP). Advanced gastric cancer patients treated with ramucirumab in combination with paclitaxel or with ramucirumab monotherapy in a Korean EAP were evaluated. Baseline characteristics were assessed for progression-free survival (PFS) and overall survival (OS), and adverse events were evaluated according to the treatment regimen. Of 265 patients, 228 received ramucirumab plus paclitaxel, and 37 received ramucirumab monotherapy. Grade 3 or 4 neutropenia was more common with ramucirumab plus paclitaxel than with ramucirumab monotherapy (46.7 vs. 8.1%). Gastrointestinal (GI) perforation developed in seven patients (3.1%) in the ramucirumab plus paclitaxel group. The overall response and disease control rates were 16.6 and 66.3% in the ramucirumab plus paclitaxel group, and 5.4 and 37.8% in the ramucirumab monotherapy group, respectively. PFS and OS were 3.8 and 8.6 months in the ramucirumab plus paclitaxel group, and 1.8 and 6.4 months in the ramucirumab monotherapy group, respectively. In multivariate analysis, alkaline phosphatase, albumin, and neutrophil-to-lymphocyte ratio (NLR) were the independent prognostic factors for PFS, while albumin, NLR, number of metastatic sites, and large amount of ascites were independent prognostic factors for OS. In the Korean EAP cohort, ramucirumab showed similar efficacy to the results of the previous trials for gastric cancer. However, the level of GI perforation was slightly increased in the ramucirumab plus paclitaxel group. |
| Databáze: | OpenAIRE |
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