- Results Confirm Previously Demonstrated Survival Advantages of Tarceva in
This Difficult-to-Treat Disease
- ABSTRACT No: 4507
BASEL, Switzerland, May 31 /PRNewswire/ -- Adding Avastin (bevacizumab)
to a combination of Tarceva (erlotinib) and chemotherapy significantly
improves the time patients with metastatic pancreatic cancer live without
their disease getting worse ("progression free survival"). These data,
presented for the first time today at the 44th annual meeting of the
American Society of Clinical Oncology (ASCO) in Chicago, also showed a
trend towards extending life expectancy.
Pancreatic cancer is the sixth leading cause of cancer death in
Europe(1) and is extremely difficult to treat because it spreads rapidly to
other parts of the body and often shows resistance to chemotherapy and
radiotherapy(2). It is also difficult to diagnose, with no effective early
diagnostic test available(3) so the majority of patients are diagnosed with
advanced disease.
"For patients with advanced pancreatic cancer, the treatment options
are limited," commented Professor Eric Van Cutsem, Professor of Medicine,
Gastrointestinal Oncology Unit, University Hospital Gasthuisberg, Leuven,
Belgium. "The interesting results show the need for further exploring which
patients benefit from the combination of gemcitabine plus Avastin and
Tarceva in view of the statistically longer PFS which trends towards
improved survival."
The results of the phase III AVITA (BO17706) study showed that the
addition of Avastin to a Tarceva/gemcitabine combination resulted in:
- A 37% increase in the time patients live without their disease getting
worse compared to Tarceva/gemcitabine alone
- Almost 14% of patients experiencing a complete disappearance or
shrinkage of their tumor
- A trend towards improved overall survival
- No new safety signals for Avastin
In addition, data from the Tarceva/gemcitabine control arm were
consistent with previous results from the PA3 study, reinforcing the
already established survival benefits of Tarceva in pancreatic cancer(4).
About AVITA
The AVITA (BO17706) study is a Roche-sponsored, randomized,
double-blind, placebo-controlled phase III study that included 607 patients
with metastatic pancreatic cancer. Study participants received first-line
treatment with either gemcitabine, Tarceva and placebo or gemcitabine,
Tarceva and Avastin (at 5mg/kg every two weeks).
The AVITA study did not meet its primary endpoint of overall survival
(OS), however results showed that adding Avastin to a combination of
Tarceva and chemotherapy significantly improved the time patients with
pancreatic cancer lived without their disease getting worse (PFS). A trend
towards improved OS was also observed.
In addition, the findings in the gemcitabine/Tarceva control arm of
this trial were consistent with the efficacy observed in the metastatic
patient population in the pivotal Phase III PA3 study led to the regulatory
approval of Tarceva for the treatment of pancreatic cancer in the US in
2005 and in the EU in 2007.
Additional information
- Roche in Oncology:
http://www.roche.com/pages/downloads/company/pdf/mboncology05e_b.pdf
- Roche Health Kiosk, Cancer: http://www.health-kiosk.ch/start_krebs
- Avastin: http://www.avastin-info.com
To access video clips about Avastin in broadcast standard, free of
charge, please go to: http://www.thenewsmarket.com .
References
(1). Michaud. Minerva Chir, 2004; 59: 99-111.
(2). Khosravi Shahi. Anales de Medicina Interna, 2005; 22: 390-4.
(3). Stewart. et al. World Health Organisation and the International
Agency for Research on Cancer, IARC Press/Lyon, 248-9.
(4). Moore et al. J Clin Oncol, 2007; 25: 1960-6.
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Via: Healthcare
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