New data have shown that Bevacizumab-based therapy provides a median overall survival of 14.6 months with a range of chemotherapies routinely used in clinical practice and in a broad population of patients with advanced non-small cell lung cancer ( NSCLC ), the most commonly diagnosed type of lung cancer.
The data are from the phase IV SAiL study of more than 2,000 patients, the vast majority of whom had adenocarcinoma, the most common form of NSCLC.

Two phase III clinical trials ( E4599 and AVAiL ) have already demonstrated that first-line Bevacizumab-based therapy significantly improves outcomes for patients with non-small cell lung cancer. The SAiL trial data adds to this evidence base and confirms that Bevacizumab is an important advance for patients with NSCLC, where survival with chemotherapy alone is typically less than one year. Of note, the results observed in SAiL were consistent with those from a preplanned analysis of the pivotal E4599 study, which showed a median overall survival of 14.2 months in patients with adenocarcinoma histology.

SAiL's broad patient population included the elderly ( age greater than or equal to 65 ), those with central nervous system ( CNS ) metastases and those with poor performance status. Despite the complexity of patients' health at baseline, SAiL investigators reported a low incidence of clinically significant side effects, confirming Bevacizumab's well established and manageable safety profile.

The SaiL trial is a phase IV international open-label, multicentre, single-arm study involving 2,212 patients with untreated locally advanced, metastatic or recurrent non-squamous NSCLC. Adenocarcinoma was the most common histological type amongst patients ( 86% ).
The primary objective of SAiL was to confirm safety and efficacy data for Bevacizumab combined with a range of standard first-line chemotherapy regimens, in a broad population of patients.
The secondary objective was to assess the efficacy of Bevacizumab ( overall survival, disease control rate [ DCR ] and time to progression [ TTP] ) and the safety of Bevacizumab in patients who develop CNS metastases during and for six months following treatment.
Patients received Bevacizumab ( 7.5 or 15 mg/kg every 3 weeks ) plus standard chemotherapy for up to six cycles, followed by single-agent Bevacizumab maintenance until disease progression.

Across the total SAiL patient population, an overall survival of 14.6 months was observed together with time to progression of 7.8 months, and in patients with tumour assessments, a disease control rate of 88.7% was observed.
SAiL demonstrated the consistent efficacy of Bevacizumab across a wide range of chemotherapy regimens commonly used in clinical practice.

The overall rate of bleeding in SAiL was low ( 3.6% ) and pulmonary haemorrhage was a rare event ( 0.7% ). In addition, only two patients ( 0.1% ) experienced clinically significant CNS bleeding among the more than 200 patients with CNS metastases. These findings contributed to those reported by a recent retrospective exploratory analysis of over 13,000 patients from several trials of Bevacizumab-based therapy across multiple cancer types, which recommended that patients with CNS metastases should not be generally excluded from Bevacizumab therapy or clinical trials.

Source: Lancet Oncology, 2010


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