Efficacy of bevacizumab with cisplatin and gemcitabine in Asian patients with advanced or recurrent non-squamous non-small cell lung cancer who have not received prior chemotherapy: a substudy of the Avastin in Lung trial.

Abstract

AIM:

The phase III AVAiL study evaluated the efficacy and safety of the anti-vascular epidermal growth factor agent bevacizumab combined with platinum-based chemotherapy as first-line treatment in patients with advanced non-small-cell lung cancer (NSCLC). We report the results of a preplanned analysis of Asian patients enrolled in AVAiL.

METHODS:

Patients with recurrent or advanced non-squamous NSCLC were randomized to receive bevacizumab 7.5 mg/kg, bevacizumab 15 mg/kg or placebo, plus cisplatin 80 mg/m(2) and gemcitabine 1250 mg/m(2) for up to six cycles, followed by bevacizumab or placebo until disease progression. An exploratory analysis was undertaken to assess efficacy and safety in an Asian subgroup.

RESULTS:

Of the 1043 patients enrolled, 105 were Asian and were included in the subgroup analysis. Progression-free survival was 8.5 months (95% CI 7.3-10.8) in the bevacizumab 15-mg/kg group, 8.2 (95% CI 6.6-11.7) in the 7.5-mg/kg group and 6.1 (95% CI 5.1-8.0) in the placebo group. Median overall survival in the 7.5-mg/kg bevacizumab group was prolonged compared with placebo group (HR 0.46; 95% CI 0.22-0.97). Nausea was the most common adverse event, occurring at similar rates (ranging from 69-76%) in all study groups. Hypertension was the most common adverse event of special interest, seen in 29, 55 and 16% of patients in the 7.5-mg/kg and 15-mg/kg bevacizumab and placebo groups, respectively.

CONCLUSION:

Study results strongly suggest that bevacizumab at a dose of 7.5 mg/kg improves the duration of overall survival when combined with cisplatin-gemcitabine in Asian patients. Bevacizumab was well tolerated in this patient group.

• Authors: Tony S K Mok, Te-Chun Hsia, Chun-Ming Tsai, Kenneth Tsang, Gee-Chen Chang, John Wen-Cheng Chang, Thitiya Sirisinha, Sirisinha Thitiya, Virote Sriuranpong, Sumitra Thongprasert, Daniel T T Chua, Nicola Moore, Christian Manegold
• Journal: Asia-Pacific journal of clinical oncology (Asia Pac J Clin Oncol) Vol. 7 Suppl 2 Pg. 4-12 (Jun 2011) ISSN: 1743-7563 [Electronic] Australia
• PMID: 21585703 (Publication Type: Clinical Trial, Phase III, Journal Article, Multicenter Study, Randomized Controlled Trial)
• Copyright: © 2011 Blackwell Publishing Asia Pty Ltd.

Chemical References

• Antibodies, Monoclonal
• Antibodies, Monoclonal, Humanized
• Deoxycytidine
• Bevacizumab
• Cisplatin
• Gemcitabine

Topics

• Adult
• Aged
• Antibodies, Monoclonal (administration & dosage)
• Antibodies, Monoclonal, Humanized
• Antineoplastic Combined Chemotherapy Protocols (therapeutic use)
• Asia
• Asian People
• Bevacizumab
• Carcinoma, Non-Small-Cell Lung (drug therapy, pathology)
• Cisplatin (administration & dosage)
• Deoxycytidine (administration & dosage, analogs & derivatives)
• Disease-Free Survival
• Double-Blind Method
• Female
• Humans
• Lung Neoplasms (drug therapy, pathology)
• Male
• Middle Aged
• Neoplasm Recurrence, Local (drug therapy, pathology)
• Neoplasm Staging
• Gemcitabine