التفاصيل البيبلوغرافية
| العنوان: |
Ramucirumab beyond progression plus TAS‐102 in patients with advanced or metastatic esophagogastric adenocarcinoma, after treatment failure on a ramucirumab‐based therapy |
| المؤلفون: |
Goetze, Thorsten Oliver, Stein, Alexander, Lorenzen, Sylvie, Habibzada, Timorshah, Goekkurt, Eray, Herhaus, Peter, Loose, Maria, Sookthai, Disorn, Brulin, Tanita, Ihrig, Kristina, Pauligk, Claudia, Al‐Batran, Salah‐Eddin |
| المساهمون: |
Lilly Deutschland |
| المصدر: |
International Journal of Cancer ; volume 153, issue 10, page 1726-1733 ; ISSN 0020-7136 1097-0215 |
| بيانات النشر: |
Wiley |
| سنة النشر: |
2023 |
| المجموعة: |
Wiley Online Library (Open Access Articles via Crossref) |
| الوصف: |
Based on results of prior trials (TAGS, REGARD, RAINBOW), the combination of ramucirumab beyond progression with TAS‐102 (trifluridine/tipiracil) seems to be promising in advanced esophagogastric adenocarcinoma (EGA). In this multicenter, non‐randomized, open‐label, investigator‐initiated pilot trial, ramucirumab‐pretreated patients with metastatic EGA received a maximum of 4 cycles of ramucirumab (8 mg/kg i.v. on day 1 and 15, Q2W) plus TAS‐102 (35 mg/m 2 p.o. bid on day 1‐5 and day 8‐12; Q2W). Primary endpoint was tolerability and toxicity, defining a positive trial if the SAE rate according to CTCAE 5.0 will increase <30% (up to 55%) compared to historical results from TAGS trial (SAE rate 43%). Secondary endpoints were further evaluation of safety and assessment of efficacy according to tumor response and overall and progression‐free survival (OS/PFS). Twenty patients, 20% gastric and 80% GEJ cancers and 55% with ECOG 0 were enrolled. In total, nine SAEs were reported in 25% [95% CI: 8.7‐49.1] of the patients, all without relationship to the systemic therapy. The median OS and PFS were 9.1 months [5.4‐10.1] and 2.9 months [1.7‐4.8], respectively. In addition, a disease control rate of 45% was obtained. The trial showed a favorable safety profile with a numerically lower incidence of SAEs for the combination of ramucirumab with TAS‐102 compared to historical TAGS trial. Furthermore, the combination demonstrated efficacy in the beyond progression setting and therefore warrants further evaluation in a randomized trial compared to TAS‐102 alone. |
| نوع الوثيقة: |
article in journal/newspaper |
| اللغة: |
English |
| DOI: |
10.1002/ijc.34652 |
| الإتاحة: |
https://doi.org/10.1002/ijc.34652Test |
| حقوق: |
http://creativecommons.org/licenses/by-nc-nd/4.0Test/ |
| رقم الانضمام: |
edsbas.869CB383 |
| قاعدة البيانات: |
BASE |
