Abstract
PurposeHypertension (HTN) is frequently associated with the use of angiogenesis inhibitors targeting the vascular endothelial growth factor pathway, such as ramucirumab. The aim of this study was to retrospectively evaluate if occurrence of HTN is correlated with response to second line treatment with ramucirumab+paclitaxel for metastatic gastric cancer.MethodsTreatment consisted of ramucirumab 8 mg/kg intravenously (iv) on days 1 and 15, plus paclitaxel 80 mg/m2 iv on days 1, 8, and 15 of a 28-day cycle. Patients received study treatment until disease progression, unacceptable toxicity, or withdrawal of consent.ResultsThirty-four patients were retrospectively evaluated. Among these, 6 (17.6%) developed grade 3 ramucirumab-induced HTN. These patients had a better outcome than those with lesser grades events, with a progression-free survival (PFS) of 7.8 months (95% CI 4.4-not reached) versus 4.2 months (95% CI 3.1-5.2) (p=0.001). overall survival (OS) was 11.9 months (95% CI 9.3-not reached) in the grade 3 HTN group, versus 7.2 months (95% CI 5.9-10.1).ConclusionsDespite the small number of patients and the retrospective nature of the data, our analysis showed that occurrence of ramucirumab-related HTN, in particular G3 HTN, predicts response to treatment with ramucirumab+paclitaxel in patients with metastatic gastric cancer.
Highlights
Gastric cancer is considered one of the main causes of cancer-related death worldwide [1, 2]
Despite the small number of patients and the retrospective nature of the data, our analysis showed that occurrence of ramucirumab-related HTN, in particular G3 HTN, predicts response to treatment with ramucirumab+paclitaxel in patients with metastatic gastric cancer
Two large meta-analyses quantified the risk of occurrence of any grade and high grade hypertension in patients treated with ramucirumab [10, 11]
Summary
Gastric cancer is considered one of the main causes of cancer-related death worldwide [1, 2]. Ramucirumab, a novel anti-angiogenic agent has been approved, initially as monotherapy, and subsequently in combination with paclitaxel for second line treatment of patients with metastatic gastric cancer, in the presence of a good performance status [5,6,7,8]. As expected from an anti-angiogenic agent, hypertension represents a frequent adverse event recorded during treatment with ramucirumab. Two large meta-analyses quantified the risk of occurrence of any grade and high grade (grade 3 and above) hypertension in patients treated with ramucirumab [10, 11]. In the phase III RAINBOW trial, HTN of any grade was reported in 25% of patient treated with the combination of paclitaxel and ramucirumab, while grade 3 HTN occurred in 15% of patients.
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