Pilot Study Opens the Door for Avastin Use in Curative Setting for Women With Breast Cancer

San Antonio, Texas (ots/PRNewswire) -

- Roche in Collaboration With Genentech Commit to Large Phase III
Adjuvant Clinical Programme Set to Unlock Avastin's Potential in
Early Breast Cancer

According to new phase II study data, Avastin (bevacizumab) can
proceed to be tested after breast cancer surgery in combination with
anthracycline containing regimens. These findings pave the way for
Avastin's use as a curative treatment for women with this devastating
disease. Data presented today at the San Antonio Breast Cancer
Symposium (SABCS) from the E2104 study showed that standard
anthracycline-based chemotherapy (doxorubicin) can be added to
Avastin after surgical removal of the breast tumour, without a
concerning increase in the incidence of cardiac adverse events
typically associated with this form of chemotherapy.

These data support the commencement of phase III adjuvant breast
cancer clinical programme which will include over 10,000 patients
with early stage breast cancer. Avastin already offers women with
late-stage (metastatic) breast cancer the chance to live twice as
long without their disease progressing(1).

"The unique way Avastin works also lends itself for use in women
with earlier stages of breast cancer" said Dr Kathy Miller of Indiana
University School of Medicine, USA and principal investigator of the
E2104 study. "We now know that Avastin use in combination with
anthracyclines does not result in concerning rates of cardiac
dysfunction in the adjuvant setting and armed with this evidence
Avastin's impact can be fully validated in a large worldwide phase
III clinical trial programme."

Data from the E2104 study have shown that cardiac dysfunction is
not a major concern with the treatment combination of Avastin and
doxorubicin. As presented in SABCS, two patients with symptomatic
congestive heart failure were reported in each of the 2
Avastin-containing treatment arms which included more than 100
patients each. This is within the range expected to occur with the
use of anthracycline based chemotherapy alone.

Following the completion of the accrual of Avastin adjuvant colon
cancer trials and now confirmation of the safety of Avastin in the
adjuvant breast cancer setting, the phase III adjuvant breast cancer
programme is already recruiting patients. The large adjuvant
programme consists of 2 trials in HER-2 negative breast cancer
patients:

- The E5103 study is set to include 4,950 patients and will
compare Avastin with the addition of an anthracycline-containing
chemotherapy course versus anthracycline-containing chemotherapy
alone.

- The BEATRICE study will investigate Avastin in combination with
standard chemotherapies compared to chemotherapies alone in 2,530
planned patients who are not candidates for hormonal therapy.

In addition, Avastin is being investigated in HER-2 positive
breast cancer patients post surgery via the BETH trial. This study
will investigate the addition of Avastin to Herceptin (trastuzumab)
in combination with established chemotherapy regimen.

Worldwide, breast cancer is the leading cause of cancer death in
women under the age of 55. Each year there are more than one million
diagnoses and more than 400,000 deaths from breast cancer(2).

About E2104

E2104 is a phase II study designed to evaluate the safety and
feasibility of incorporating Avastin into an anthracycline containing
adjuvant therapy regimen. The study included 226 women with lymph
node positive breast cancer who have had already undergone surgical
removal (mastectomy) of the lesion and lymph node dissection. The
study was sponsored by the National Cancer Institute (NCI), part of
the US National Institutes of Health, and conducted by a network of
researchers led by the Eastern Cooperative Oncology Group (ECOG).
Patients were sequentially assigned to one of two treatment arms:

- Treatment arm A received dose-dense combination of doxorubicin
and cyclophosphamide with Avastin, followed by paclitaxel and
Avastin, followed by Avastin alone. Avastin was given every 2 weeks
at a dose of 10 mg/kg for 1 year.

- Treatment arm B was only different to arm A in that Avastin was
introduced after completion of doxorubicin therapy in conjunction
with paclitaxel. As with arm A, patients remained on Avastin for 1
year after Avastin initiation.

The primary objective of the study was to determine the incidence
of clinically apparent cardiac dysfunction in patients with lymph
node positive breast cancer treated with bevacizumab and dose dense
doxorubicin/cyclophosphamide followed by paclitaxel (ddAC>T).
Patients were evaluated clinically and with serial assessments of
left ventricular function over the course of their treatment and for
six months following treatment.

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

References

---------------------------------

(1) Miller KD, et al. E2100 Breast Cancer Res Treat 2005;94:S6
(Abstract 3)

(2) Kamangar F, et al. J Clin Oncol 2006; 24(14): 2137-50.

ots Originaltext: Roche Pharmaceuticals
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