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The efficacy of bevacizumab in addition to platinum-based chemotherapy for first-line treatment of patients with advanced nonsquamous non-small-cell lung cancer (NSCLC): Final results of AVALANCHE, an observational cohort study.

2014; Lippincott Williams & Wilkins; Volume: 32; Issue: 15_suppl Linguagem: Inglês

10.1200/jco.2014.32.15_suppl.e19123

1527-7755

Edina Tolnay, Veronika Sárosi, Erzsébet Juhász, Zsuzsanna Sztancsik, György Losonczy, Gyula Ostoros, László Mándoky,

Hepatocellular Carcinoma Treatment and Prognosis

e19123 Background: Results of two phase III, and two phase IV trials have shown that first-line bevacizumab (BEV) in combination with chemotherapy improves clinical outcomes in patients with advanced NSCLC. The AVALANCHE (ML21783) study was undertaken to assess the clinical outcomes of first-line BEV combined with standard platinum-based regimens in the Hungarian clinical practice. Methods: This observational study was conducted in 28 Hungarian sites. Enrolment: July 2008-April 2011. Patients with untreated locally advanced, metastatic or recurrent lung adenocarcinoma received BEV (7.5 mg/kg, q3w) with any platinum-doublet for up to 6 cycles, then non-progressors proceeded to receive BEV until disease progression or unacceptable toxicity. Primary endpoint was progression-free survival, secondary endpoints included overall survival, tumor control rate and safety. Patients were also analyzed as two cohorts (non-progressors vs progressors) based on whether or not they received BEV maintenance therapy after completion of first-line chemotherapy plus BEV. Log-rank test was used for comparison between groups. Results: The study enrolled 283 patients. Baseline characteristics: median age: 58.2 (18-78) years; males: 50.5%; stage: III/B: 18.4%, IV: 79.9%; adenocarcinoma/other: 95.8/4.2%; ECOG PS 0/1/2/≥3: 30.8/59.7/2.6/1.4%; Centrally located tumor was reported in 21.6%. Cisplatin/carboplatin-based regimens: 53.8/46.2%. Forty-three percent of patients received BEV maintenance therapy. Median number of BEV cycles was 6. Median PFS was 7.2 months and OS was 15.2 months for the entire cohort. Longer PFS and OS times were observed in patients who received BEV maintenance therapy (median OS, 26.2 months versus 10.2 months (p<0.001); median PFS, 9.2 months versus 5.8 months (p<0.001)). Best tumor response: CR/PR/SD/PD/not reported were: 1.5/29.9/26.9/9.1/32.6% of all patients. Conclusions: Clinical outcomes obtained in this real-life population were consistent with pivotal studies. BEV maintenance treatment was associated with a significantly longer PFS and OS.