Tumor Response and Symptom Palliation from RAINBOW, a Phase III Trial of Ramucirumab Plus Paclitaxel in Previously Treated Advanced Gastric Cancer

摘要: BACKGROUND In the intent-to-treat (ITT) population of RAINBOW study, objective response rate (ORR) was 28% and 16% in ramucirumab control arms, respectively. To further characterize tumor response, we present details on timing extent shrinkage, as well associations with symptom palliation. MATERIALS AND METHODS Tumor assessed RECIST v1.1, quality life (QoL) European Organization for Research Treatment Cancer Quality-of-Life Questionnaire-Core 30 (EORTC QLQ-C30) v3.0. Prespecified post hoc analyses were conducted ITT population, patients measurable disease, or responders, included best overall (BOR), ORR, disease (DCR), duration time to (TtR), change size, QoL shrinkage BOR. RESULTS both treatment median TtR 1.5 months. Responses more durable versus arm (median 4.4 vs. 2.8 months). (78% ITT), ORR 36% 20%; DCR 81% 61% arms. Waterfall plots demonstrated arm. Regardless treatment, stable associated improved QoL, greater CONCLUSION plus paclitaxel yielded highest reported date previously treated advanced gastric gastroesophageal junction adenocarcinoma. Additional demonstrate robustness results. The is directly palliation should be considered when evaluating patient needs selection. Clinical trial identification number. NCT01170663. IMPLICATIONS FOR PRACTICE Ramucirumab a recognized standard care it improves survival adenocarcinoma who have been recommended first-line therapy. These additional data positive association between that often symptomatic. observations nonmeasurable group underrepresented clinical trials. This knowledge can inform decisions, which align individual characteristics benefits.