A multicentre, phase II study with cabazitaxel in previously treated patients with advanced or metastatic adenocarcinoma of the oesophagogastric junction and stomach (CABAGAST).

Abstract

4054 Background: This is a single-arm study to determine prolonged ( > = 4 months) disease control rate with cabazitaxel administered in second- (or later) setting for patients with advanced or metastatic adenocarcinoma of the esophagogastric junction (EGJ) and stomach. Methods: 65 patients with advanced EGJ and stomach cancer were treated with 20mg/m2 Cabazitaxel every 3 weeks for a maximum of 6 cycles. Main objective of the study was a prolonged Disease Control Rate (pDCR: CR, PR or SD lasting at least 4 months). Secondary Outcome Measures were overall survival (OS), progression-free survival (PFS), response rate by subgroup (with vs without previous treatment with a taxane) and toxicity. Patients were assessed for tumor response every 6 weeks during therapy and during follow-up (up to 12 months). Results: 65 patients (median age: 63, range 31-86 years) were assigned. Median no. of prior therapies was 2. 80% had received prior taxane therapy. Patients received a median of 2 cycles of cabazitaxel. Efficacy results are shown for the per protocol (PP) population. pDCR rate was 12.7%, (95%CI: 5,3%- 24.5%). pDCR was 20.0% in 2nd line patients (95%CI: 6.8%-40.7%) and 30.0% (95%CI: 6.7%-65.2%) in all lines in patients without prior taxane use. Response Rate was 5.5% (95%CI: 1.1%-15.1%) in total PP and 20.0% in the population without prior taxane use. Median OS was 4.6 months (7.4 months without prior taxane vs 3.8 months with prior taxane). Median PFS was 1.38 months (95%CI: 1.28- 1.87) with and 2.01 months (95%CI: 0.20- 4.67) without prior taxane use. Most common grade 3/4 toxicities were neutropenia in 13% of the patients, pain (12%), leucopenia (10%), anemia (10%), fatigue (10%) and nausea (10%). Conclusions: Cabazitaxel is active in heavily pretreated patients with metastatic and advanced esophagogastric junction and gastric adenocarcinoma. Toxicity is moderate. Patients without prior taxane use derived more benefit from Cabazitaxel. Clinical trial information: NCT01956149.