BASEL, Switzerland, August 6, 2010 /PRNewswire/ -- This update outlines data from a preplanned analysis of the pivotal E4599 study in patients with non-small cell lung cancer (NSCLC), published in the Journal of Thoracic Oncology. The analysis looked at the impact of treatment with Avastin (bevacizumab) in combination with paclitaxel/carboplatin chemotherapy, according to histology subgroup of NSCLC.
Outstanding survival benefits:
- The results demonstrate that first line Avastin-based therapy provided
the longest median overall survival (OS) duration yet shown in a phase
III trial of patients with advanced non-small cell adenocarcinoma of the
lung, at 14.2 months, versus 10.3 months with chemotherapy alone
(HR = 0.69, 95% CI: 0.58-0.83).[1] This represents an impressive 3.9
month improvement in OS over chemotherapy alone. Adenocarcinoma is both
the most common form of lung cancer and the most common form of NSCLC.
[2],[3]
- Fifty-seven percent of patients with adenocarcinoma who received
Avastin-based therapy were alive after one year (95% CI: 0.508-0.621)
compared to 43% of patients who received chemotherapy alone (95% CI:
0.376-0.490). In addition, 27% of patients who received Avastin-based
therapy were alive after two years (95% CI: 0.216-0.326) compared to 17%
of patients who received chemotherapy alone (95% CI: 0.121-0.216).[1]
- Median progression free survival (PFS) for patients with adenocarcinoma
histology was 6.6 months with Avastin-based therapy versus 5 months for
chemotherapy alone (HR=0.65, 95%CI: 0.54-0.78).[1]
Consistent safety profile:
- The safety profile in the present analysis was consistent across types
of NSCLC, confirming Avastin's well established and manageable safety
profile.
E4599 treatment impact by NSCLC type - background
E4599 is a US-based international phase III trial, conducted by the Eastern Cooperative Oncology Group (ECOG). The primary analyses were originally published in The New England Journal of Medicine in 2006[4]. The current analysis included 878 patients with newly diagnosed recurrent or advanced NSCLC; the predominant tumor histology was adenocarcinoma (68.8%). Patients were randomly assigned to receive (1) treatment with Avastin (15 mg/kg, day 1), paclitaxel (200 mg/m2, day 1) and carboplatin (6 mg/ml, day 1) or (2) treatment with paclitaxel-carboplatin alone. The primary end point of the study was OS. The effects of histology type on duration of survival and PFS were preplanned in the statistical analysis plan of the trial.
Clinical relevance
- These findings confirm the outstanding efficacy of Avastin in the E4599
overall population, which showed that Avastin-based therapy was the first
treatment regimen to demonstrate median OS over one year in any phase III
trial of patients with advanced NSCLC.[4]
- These results demonstrate that Avastin is efficacious in patients with
advanced adenocarcinoma of the lung, showing a 3.9 month improvement in
OS over chemotherapy alone (14.2 months versus 10.3 months).[1]
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References
[1] Sandler A B, et al. Treatment outcomes by tumor histology in Eastern Cooperative Oncology Group (ECOG) study E4599 of bevacizumab with paclitaxel/carboplatin for advanced non-small cell lung cancer. Journal of Thoracic Oncology, 5: early online, 03 August 2010.
[2] Alberg AJ, et al. Epidemiology of lung cancer. Chest 123:21S-49S, 2003.
[3] Govindan R, et al: Changing epidemiology of small cell lung cancer in the United States over the last 30 years: Analysis of the Surveillance, Epidemiology, and End Results database. J Clin Oncol 24: 4539-44, 2006.
[4] Sandler A, et al. Paclitaxel-Carboplatin Alone or with Bevacizumab for Non-Small-Cell Lung Cancer. N Engl J Med 355: 2542-50, 2006.
For further information please contact: Rosemary Hennings, Galliard, Tel: +44-20-7663-2253, Mobile: +44-7799-411-325, email: rhennings@galliardhealth.com, Federico Maiardi, Roche, Tel: +41-61-688-7946, Mobile: +41-79-264-3978, email: federico.maiardi@roche.com
