Basel, Switzerland, July 21, 2010 (ots/PRNewswire)
- New data show that
Avastin(R) (bevacizumab) based therapy provides a median overall
survival (OS) 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, published in The Lancet
Oncology, 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 (E4599and AVAiL,) have
already demonstrated that first-line Avastin-based therapy
significantly improves outcomes for patients with NSCLC. The SAiL
trial data adds to this evidence base and confirms that Avastin 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
OS of 14.2 months in patients with adenocarcinoma histology.
"The SAiL trial results confirm that Avastin-based therapy
represents a significant improvement in the treatment of
non-squamous, non-small cell lung cancer and with a favourable safety
profile. Extending survival beyond 14 months is truly good news for
patients diagnosed with this devastating disease, and I'm sure my
colleagues around the world will welcome these results. This
outstanding overall survival can now be achieved using Avastin
together with different chemotherapy combinations - this is really
important since it gives new treatment options where previously there
were only very few," said Professor Lucio Crino, Hospital S. Maria
della Misericordia, Perugia, Italy, lead study author.
Manageable safety profile
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 Avastin's well established and manageable safety profile.
- 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
- The primary objective of SAiL was to confirm safety and efficacy data
for Avastin 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 Avastin (OS,
disease control rate [DCR] and time to progression [TTP]) and the
safety of Avastin in patients who develop CNS metastases during and
for six months following treatment.
- Patients received Avastin (7.5 or 15mg/kg every 3 weeks) plus standard
chemotherapy for up to six cycles, followed by single-agent Avastin
maintenance until disease progression.
- Across the total SAiL patient population, an OS of 14.6 months was
observed together with TTP of 7.8 months, and in patients with tumour
assessments, a DCR of 88.7% was observed.
- SAiL demonstrated the consistent efficacy of Avastin 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 Avastin-based therapy across
multiple cancer types, which recommended that patients with CNS
metastases should not be generally excluded from Avastin therapy or
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For more information: http://www.roche.com
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 Crino, L et al. Lancet Oncol; early online, July 2010.
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