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Paclitaxel-Bevacizumab Combination Prolongs Progression-Free Survival in Advanced Breast Cancer: Presented at EBCC

By Paula Moyer

NICE, FRANCE -- March 23, 2006 -- Patients with advanced breast cancer have a significantly longer progression-free survival when bevacizumab (Avastin) is added to their paclitaxel (Taxol), according to investigators who presented findings here at the 5^th European Breast Cancer Conference (EBCC).

Adding the monoclonal antibody bevacizumab nearly doubled progression-free survival compared with paclitaxel alone, said principal investigator Robin Zon, MD, clinical investigator, Elkhart General Hospital, Elkhart, Indiana, United States.

Dr. Zon reported the findings of the Eastern Cooperative Oncology Group (ECOG) Study E2100 in a presentation on March 22^nd.

The study was designed to see if bevacizumab, which inhibits vascular endothelial growth factor (VEGF), would be effective and safe in combination with paclitaxel as a first-line therapy for patients with locally advanced or metastatic breast cancer.

Dr. Zon and her team randomly assigned 722 women to receive paclitaxel monotherapy or a combination of paclitaxel and bevacizumab. All patients received paclitaxel at a dose of 90 mg/m² on days 1, 8, and 15 of a 4-week cycle. Those randomised to bevacizumab received the second drug at a dose of 10 mg/kg on days 1 and 15. Every 3 cycles, the investigators documented patients' progression-free survival and assessed their response using the Response Evaluation Criteria In Solid Tumours (RECIST) criteria.

Among the original 722 patients recruited from December, 2001 to March, 2004, 680 completed the trial. Data from the interim analysis which Dr. Zon presented involved 484 patients who had disease progression.

The investigators found that patients on combination treatment had a median progression-free survival of 11.4 months, while for those on paclitaxel monotherapy it was 6.11 months, for a hazard ratio (HR) of 0.51 for the combination (P <.0001).

The response rate was 29.9% for the combination group and 13.8% for the monotherapy group (P <.0001).

Dr. Zon stressed that the study has not yet gone long enough to extrapolate definitive overall survival data. However, she added that the current data -- based on 275 deaths from all causes -- show a trend toward improved overall survival in the combination group, with a median of 28.4 months compared with 25.2 months for the monotherapy group (HR 0.84 for the combination group, P =.12).

She noted that 16% of the combination group had grade 3/4 hypertension, compared with 2% in the monotherapy group (P <.0001). The combination group also had higher rates of grade 3/4 proteinuria and bleeding (2.0% and 3.0%, respectively), compared with none of the monotherapy group (P =.002 and P =.02, respectively). Both groups had low rates of grade 3/4 thromboembolic events, 2% in the combination group and 4% in the monotherapy group.

Using the Functional Assessment of Cancer Therapy (FACT), General (FACT-G), and Breast (FACT-B) scales, the researchers determined that bevacizumab had a neutral effect on quality of life, according to Dr. Zon.

"These results are good news for cancer patients," she said in a statement. "The next step will be to introduce the new drug in patients without metastatic disease."

ECOG trials conducted in the United States are funded primarily by the National Cancer Institute.


[Presentation title: A Randomized Phase III Trial of Paclitaxel With or Without Bevacizumab as First-Line Therapy for Locally Recurrent or Metastatic Breast Cancer: Eastern Cooperative Oncology Group trial E2100. Abstract 7]

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