Vatalanib in malignant mesothelioma: A phase II trial by the Cancer and Leukemia Group B (CALGB 30107)

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• 作者：Thierry Jahan^a ; ¹ ; ^{tjahan@medicine.ucsf.edu} ; Lin Gu^b ; ¹ ; Robert Kratzke^c ; ¹ ; Arkadiusz Dudek^c ; ¹ ; Gregory A. Otterson^d ; ¹ ; Xiaofei Wang^b ; ¹ ; Mark Green^e ; ¹ ; Everett E. Vokes^f ; ¹ ; Hedy Lee Kindler^f ; ¹
• 关键词：Mesothelioma ; Clinical trial phase II ; Vatalanib ; VEGF Receptor ; PDGFB ; Molecular targeted therapy
• 刊名：Lung Cancer
• 出版年：2012
• 期刊代码：187_01695002
• 类别：med
• 出版时间：June, 2012
• 卷：76
• 期：3
• 页码：393-396
• 文件大小：225 K

摘要

Introduction

The Cancer and Leukemia Group B (CALGB) conducted a multi-center phase II trial to evaluate the efficacy and safety of vatalanib in previously untreated patients with malignant mesothelioma and to evaluate potential biomarkers of disease response (CALGB 30107).

Methods

Treatment consisted of vatalanib 1250 mg given orally once daily. CT scans were obtained at baseline and every 6 weeks thereafter. Baseline serum levels of vascular endothelial growth factor (VEGF), platelet-derived growth factor (PDGF), thrombospondin-1 (TSP-1), and mesothelin were obtained. The primary endpoint was 3-month progression-free survival (PFS).

Results

Forty-seven patients enrolled at 19 centers. The median age was 75 years, and the majority of patients (79%) had an ECOG performance status of 1. Tumors were classified as epithelial (77%), sarcomatoid (10%), or mixed (9%) histology. Toxicity was mild; the most common grade 3/4 adverse events were neutropenia (2%), nausea (15%), elevated alanine aminotransferase (11%), hypertension (2%), and gastrointestinal bleeding (2%). Partial responses were observed in 6%of patients and stable disease in 72%of patients. The 3-month PFS rate was 55%(95%CI: 40%, 68%). The median PFS was 4.1 months. Median overall survival was 10.0 months. There was no correlation between serum levels of VEGF, PDGF, TSP-1, or mesothelin and treatment response, PFS, or survival.

Conclusions

Vatalanib as a single agent with this dose and schedule does not warrant further study in this disease.