Incidence of thromboembolic events (TEEs) before and during chemotherapy of patients with advanced gastric and gastroesophageal junction carcinoma (AG-GEJC) on clinical trials

Abstract

4073 Background: TEEs are associated with AG-GEJC and chemotherapy can further increase its incidence. We assessed TEEs before and during protocol chemotherapy for AG-GEJC patients. Methods: Patients with AG-GEJC on four approved protocols between August 1997 and September 2003 were assessed for baseline TEEs, new TEEs during therapy, histology, location of the primary, and overall survival. Three protocols evaluated camptothecin-based chemotherapy (irinotecan, peg-camptothecin, and rubitecan) and one evaluated non-camptothecin-based chemotherapy. Results: We studied 191 patients. Median age was 56 (range 20–80), Male:Female 151:40, chemotherapy naïve 132 (69%). 136 patients received irinotecan-based therapy and 55 patients received non-camptothecin-based therapy. Overall, TEEs occurred in 13.6% of patients. At baseline, TEEs were diagnosed in 5.3% of untreated patients and were diagnosed in 8.5% of patients with one prior chemotherapy regimen. During protocol therapy, TEEs occurred in 6.8% of untreated patients and 10.2% of previously treated patients. The most common TEE during protocol treatment was deep vein thrombosis (46.7%). First-line camptothecin-based chemotherapy was associated with TEEs in 6.5% of the patients. Non-camptothecin-based chemotherapy was associated with TEEs in 7.3% of the patients. Untreated patients receiving irinotecan plus cisplatin had the lowest incidence of TEEs (2.6%) during treatment. TEEs increased to 10.3% in second-line therapy with irinotecan plus cisplatin. Age, gender, location of the primary tumor, and histology did not differ between patients with or without a TEE during treatment. Survival data was available for 67 patients. The median survival of patients with a TEE at anytime was 3.7 months while it was 8.1 months for patients with no history of TEE. Conclusions: This is the first report describing TEEs at baseline and during chemotherapy for patients with AG-GEJC treated on chemotherapy protocols. The data show that chemotherapy is associated with higher risk of TEEs and TEEs influence survival. No significant financial relationships to disclose.