ECCO-ESMO: New Review Supports Bevacizumab in Ovarian Cancer

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ECCO-ESMO: New Review Supports Bevacizumab in Ovarian Cancer


This report is part of a 12-month Clinical Context series.
By Ed Susman, Contributing Writer, MedPage Today
Published: September 28, 2011
Reviewed by Vandana G. Abramson, MD; Assistant Professor of Medicine, Vanderbilt University School of Medicine, Nashville, Tennessee.
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Action Points
Note that this study was published as an abstract and presented at a conference. These data and conclusions should be considered to be preliminary until published in a peer-reviewed journal.


Explain that patients with recurrent ovarian cancer had an improvement in progression-free survival (PFS) with the addition of bevacizumab to chemotherapy regardless of platinum-sensitivity status.


Note that patients who were off platinum therapy for six to 12 months had a greater improvement in PFS compared with patients off platinum therapy for greater than one year.
STOCKHOLM -- Bevacizumab (Avastin) remains effective in prolonging progression-free survival in patients with recurrent ovarian cancer, regardless of their platinum-sensitivity status, researchers said here.
Partially-sensitive patients -- those off-treatment with platinum-based chemotherapy for six to 12 months -- appeared to respond best to bevacizumab plus gemcitabine (Gemzar) and carboplatin, reducing their risk of progression by 64% compared with chemotherapy alone, said Carol Aghajanian, MD, from Memorial Sloan-Kettering Cancer Center in New York.

Those off therapy for more than a year reduced their risk of progression by 48% with the three-drug combination, she reported at the European Multidisciplinary Cancer Congress, formerly known as the Congress of the European Cancer Organization and the European Society for Medical Oncology.

"This regimen should be considered a new option for recurrent platinum-sensitive ovarian cancer," Aghajanian said. "This is a particularly exciting time to be presenting this data in light of the recent positive opinion of the [Committee for Medicinal Products for Human Use], the committee advising the European Medicines Agency, earlier this week for front-line use of bevacizumab in ovarian cancer."

Invited discussant Stanley Kaye, MBBS, from the Institute of Cancer Research at the Royal Marsden Hospital in London, concurred that "the use of bevacizumab in ovarian cancer represents its finest hour," he said.

Aghajanian reported substudy results of the placebo-controlled OCEANS trial, which was presented in full at a meeting earlier this year and demonstrated an improvement in progression-free survival from 8.4 months with the chemotherapy doublet to 12.4 months with chemotherapy and bevacizumab (P<0.0001).

Patients were required to have had front-line treatment with paclitaxel (Taxol) and gemcitabine. Patients were scheduled for six cycles of gemcitabine (1,000 mg/m2 on days one and eight) and carboplatin to a dose of four under the area of the curve. They were allowed to receive up to 10 cycles if continued response to therapy was documented.

Bevacizumab (15 mg/kg every three weeks) or placebo was initiated on day one of cycle one and was continued until disease progression.

For this subanalysis, the 484 patients were stratified on the basis of platinum sensitivity.

The 171 women who were defined as platinum partially-sensitive actually performed best when treated with bevacizumab, reducing their risk of progressing by 64% [HR 0.36 (0.25 to 0.53)].

The 209 women who were defined as platinum sensitive reduced their risk of progression by 48% [HR 0.52 (0.37 to 0.72)].

The 104 women who were more than two years out from their previous platinum regimen reduced their risk of progression 38% [HR 0.62(0.38 to 0.101)], although that difference did not achieve statistical significance.

At the time of analysis, 65% of the patients on the placebo arm and 41% of patients on the bevacizumab arm had discontinued the drug because of disease progression. More patients (23%) discontinued bevacizumab because of adverse events versus 5% of those on chemotherapy.

Febrile neutropenia was experienced by 2% of patients in each arm. One death occurred in each arm -- one patient in the placebo group died of a heart attack, one in the bevacizumab arm died of brain hemorrhage in the context of newly diagnosed brain metastasis.

"Bevacizumab plus carboplatin plus gemcitabine followed by bevacizumab until progression provides a clinically meaningful benefit over chemotherapy alone in recurrent ovarian cancer," Aghajanian said.

The final overall survival estimates are not yet mature, she said.

Kaye said that more data are needed on the "optimal timing, optimal duration of use, [and] the optimal patient selection," for this regimen.