NEW YORK (Reuters Health) Nov 04 - Adding bevacizumab (Avastin) to cisplatin and irinotecan had no marked effect on patients with untreated extensive stage small-cell lung cancer in a recent phase II trial.
The results "do not support the incorporation of bevacizumab into standard clinical care at this time," lead author Dr. Neal E. Ready told Reuters Health by email.
There was some evidence that development of hypertension might identify patients who do benefit from bevacizumab, he added.
Dr. Ready of Duke University Medical Center, Durham, North Carolina, and colleagues treated 72 patients with cisplatin 30 mg/m2 and irinotecan 65 mg/m2 on days 1 and 8, plus bevacizumab 15 mg/kg on day 1, every 21 days for six cycles.
The study was designed to distinguish between 50% and 65% 12-month survival rates, with the goal of improving on the 12.8-month survival reported in a trial of cisplatin and irinotecan alone.
The overall response rate was 75%, with complete responses in 5%, partial responses in 70%. Seventeen percent had stable disease, and one patient had disease progression, according to an October 3rd online paper in the Journal of Clinical Oncology.
In 64 assessable patients, the 12-month survival rate was only 43.8%. The median progression-free survival was 7.0 months and the median overall survival was 11.6 months, well short of the goal.
On adjusted analyses, however, the 18 patients who developed grade 1 or higher hypertension had significantly better odds of survival (hazard ratio, 0.55). Their median overall survival was 15.8 months, compared to 10.7 months in patients without hypertension.
The results "do not justify a phase III trial in an unselected population," the investigators write - and Dr. Ready concludes that "additional clinical research would be required to prospectively identify those patients who might benefit from bevacizumab."
SOURCE: http://bit.ly/v6Gax6
J Clin Oncol 2011.
The results "do not support the incorporation of bevacizumab into standard clinical care at this time," lead author Dr. Neal E. Ready told Reuters Health by email.
There was some evidence that development of hypertension might identify patients who do benefit from bevacizumab, he added.
Dr. Ready of Duke University Medical Center, Durham, North Carolina, and colleagues treated 72 patients with cisplatin 30 mg/m2 and irinotecan 65 mg/m2 on days 1 and 8, plus bevacizumab 15 mg/kg on day 1, every 21 days for six cycles.
The study was designed to distinguish between 50% and 65% 12-month survival rates, with the goal of improving on the 12.8-month survival reported in a trial of cisplatin and irinotecan alone.
The overall response rate was 75%, with complete responses in 5%, partial responses in 70%. Seventeen percent had stable disease, and one patient had disease progression, according to an October 3rd online paper in the Journal of Clinical Oncology.
In 64 assessable patients, the 12-month survival rate was only 43.8%. The median progression-free survival was 7.0 months and the median overall survival was 11.6 months, well short of the goal.
On adjusted analyses, however, the 18 patients who developed grade 1 or higher hypertension had significantly better odds of survival (hazard ratio, 0.55). Their median overall survival was 15.8 months, compared to 10.7 months in patients without hypertension.
The results "do not justify a phase III trial in an unselected population," the investigators write - and Dr. Ready concludes that "additional clinical research would be required to prospectively identify those patients who might benefit from bevacizumab."
SOURCE: http://bit.ly/v6Gax6
J Clin Oncol 2011.
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