A large Phase IV study confirms that the safety and efficacy reported in Phase III trials of Avastin® (bevacizumab) plus standard chemotherapy for patients with advanced non-squamous non-small cell lung cancer translate into the clinical practice setting. These findings were recently published in the journal The Lancet Oncology.
Lung cancer is the leading cause of cancer-related deaths in the United States and Europe. Non–small cell lung cancer (NSCLC) is the most common type of lung cancer.
Avastin is a targeted therapy that blocks a protein known as VEGF. VEGF plays a key role in the development of new blood vessels. By blocking VEGF, Avastin deprives the cancer of nutrients and oxygen and inhibits its growth. Avastin has been approved for the treatment of selected patients with breast cancer, lung cancer, colorectal cancer, kidney cancer, or glioblastoma.
Prior Phase III studies have demonstrated that the combination of Avastin with chemotherapy improves outcomes compared with chemotherapy alone as initial treatment of advanced NSCLC. , Researchers recently conducted a study in order to determine the safety of Avastin in the clinical practice setting versus the clinical trial setting. This type of study is referred to as a Phase IV study.
In this study 2,200 patients with locally advanced, metastatic or recurrent non–squamous NSCLC were evaluated. Patients underwent treatment with Avastin plus chemotherapy for up to six cycles and continued being treated with Avastin alone until their disease progressed.
Side effects were as expected with the incidence in the practice setting generally similar to that reported in clinical trials. Serious (grade 3 or higher) side effects included the following:
- High blood pressure (6%)
- Nausea and vomiting (3%)
- Neutropenia (6%)
- Febrile neutropenia (3%)
- Blood clots (8%)
- Bleeding (4%)
The median overall survival reported in this study was 14.6 months. Overall, efficacy was consistent regardless of which standard chemotherapy regimen was used in combination with Avastin.
The researchers concluded that Avastin combined with standard chemotherapy followed by Avastin alone for patients with advanced non–squamous NSCLC has a manageable safety profile and provides a clinical benefit in the practice setting.
 Crinò L, Dansin E, Garrido P, et al. Safety and efficacy of first-line bevacizumab-based therapy in advanced non-squamous non-small-cell lung cancer (SAiL, MO19390): a phase 4 study. The Lancet Oncology. [Early online publication July 21, 2010].
 Reck M, von Pawel J, Zatloukal P, et al. Phase III trial of cisplatin plus gemcitabine with either placebo or bevacizumab as first-line therapy for nonsquamous non-small-cell lung cancer: AVAil. Journal of Clinical Oncology. 2009;10;27:1227-34.
 Sandler A, Gray R, Perry MC, et al. Paclitaxel-carboplatin alone or with bevacizumab for non-small-cell lung cancer. New England Journal of Medicine. 2006; 355: 2542-2550.
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