Source: DGNews  |  Posted 4 years ago

By Ed Susman

ORLANDO, FL -- January 28, 2008 -- Patients with pancreatic cancer appear to tolerate the standard chemotherapy agent gemcitabine in combination with both the targeted agent erlotinib and with conformal radiation procedures.

The findings were presented here at the American Society of Clinical Oncology's 2008 Gastrointestinal Cancers Symposium (ASCO-GI).

The symposium is cosponsored by ASCO with the American Gastroenterological Association Institute, the American Society for Therapeutic Radiology and Oncology, and the Society for Surgical Oncology.

"Conformal radiotherapy -- at least up to a dose of 34 gray delivered in 17 fractions -- can be combined successfully with full-dose gemcitabine and erlotinib," said John Robertson, MD, Radiation Oncologist, William Beaumont Hospital, Royal Oak, Michigan.

In his poster presentation on January 25, Dr. Robertson explained that previous studies have shown that the combination of gemcitabine and radiation has produced activity in patients with pancreatic cancer. Since erlotinib is also a radiosensitizer, it was considered that adding the targeted agent to the regimen might enhance radiosensitization of the cancer.

Patients were eligible to enroll in the study provided they had histologically confirmed pancreatic cancer, unresected disease, a life expectancy of at least 12 weeks, good performance status, and no abdominal radiotherapy or chemotherapy in the previous 4 weeks.

The 15 patients in the study were treated with 7 weeks of gemcitabine at a dose of 1000 mg/m² intravenously once a week. Erlotinib 100 mg was taken by mouth once a day for 8 weeks. Radiation was performed 5 times a week for 3 weeks, and later the dosage was increased to treatment for 5 weeks. The treatment was performed concurrently.

The conformal radiation aimed to cover the entire tumor volume plus a 1-cm margin starting with the first dose of gemcitabine, Dr. Robertson reported. Seven patients entered the trial at the starting dose of 30 gray, three were treated at 34 gray, and five patients received 38 gray; however, two of those patients withdrew from the study due to disease progression, leaving 13 patients.

The treatment was well tolerated with no patient reporting any grade 3 toxicities other than pain. Five of the patients reported pain -- but four of them had pain prior to starting treatment.

"We are planning to use the results of this trial to plan a phase 2 evaluation of the combination," Dr. Robertson said.

[Presentation title: Progress Report on a Phase I Trial of Conformal Radiation Therapy with Concurrent Full Dose Gemcitabine and Erlotinib for Unresected Pancreas Cancer. Abstract 247]