Source: Kardiologiia  |  Posted 8 years ago

By Roberta Friedman, PhD

SAN FRANCISCO, CA -- January 26, 2004 -- A continuing Phase II trial of the anti-angiogenesis agent bevacizumab provides further evidence that pancreatic cancer may respond to the new approach, according to an update presented here January 23rd at the First Annual Symposium on Gastrointestinal Cancers, jointly sponsored by the American Society of Clinical Oncology (ASCO) and other societies.

Time to progression and 6 month survival data have not faltered with longer follow up, said Hedy Lee Kindler, MD, director of gastrointestinal oncology, University of Chicago, Chicago, Illinois, said in an interviewed after her presentation. Dr. Kindler updated interim results from data presented in June at the ASCO annual meeting.

"Median time to progression with gemcitabine alone is 5.5 months, and ours (adding bevacizumab) is longer," Dr. Kindler said. Six-month survival has remained the same as presented in June, she added.

The trial is testing the antibody as add-on therapy to standard treatment with gemcitabine 1000 mg/m2 on days 1, 8, and 15, every 28 days. Bevacizumab is added to the infusion at a dose of 10 mg/kg on days 1 and 15. Forty patients, enrolled from 11/01 to 9/03, have yielded eight cases of confirmed partial response. National Cancer Institute (NCI) review confirmed independently the first five responses.

Stable disease in 13 patients continued for a median 5.8 months. Six-month survival of the 42 patients is at 74%.

One gastrointestinal hemorrhage proved to be fatal for a patient whose tumor had entered the duodenum. Most bleeding was epistaxis. One patient had bowel perforation. Other toxicities were consistent with use of gemcitabine.

The trial excluded patients with bleeding disorder or any tumor involvement in a major vessel. All patients had grade IV pancreatic cancer, with 80% having metastasis to the liver.

A median of three cycles have been carried out in the trial so far, with up to 11 cycles administered.

Robert Mayer, MD, of Harvard University Medical School, commented in a talk after Dr. Kindler's presentation that the median survival rate of 9.0 months is "encouraging," but that the response rate appears to have fallen off, from 27% to 21%. Twelve-month survival of 53% also has dropped to 37%. Dr. Kindler responded in an interview that "the number of patients at the tail end are small, so you expect some wiggle room."

"We need to move beyond simply cytotoxic therapy" for pancreatic cancer, Dr. Kindler told reporters.

The NCI funded the study.

[Study title: Bevacizumab plus gemcitabine is an active combination in patients with advanced pancreatic cancer: Interim results of an ongoing Phase II trial from the University of Chicago Phase II Consortium. Abstract OP86]