CANCER AND LEUKEMIA GROUP B (CALGB) 89805: Phase II Chemoradiation Trial using Gemcitabine in Patients with Locoregional Adenocarcinoma of the Pancreas

Diana Stripp, MD
University of Pennsylvania Cancer Center
Last Modified: November 5, 2001

Presenter: A.W. Blackstock
Affiliation: CALGB
Type of Session: Scientific

Background

Pancreatic cancer has a high mortality without significant changes in life expectancy over the past several years

50% have distant disease at diagnosis and cure rates remain low even in locally advanced disease.

Gemcitabine administered twice-weekly produces radiation sensitization at low doses while gemcitabine as a single agent has activity in pancreatic cancer.

This study was performed to evaluate the combination of gemcitabine chemotherapy with radiation therapy

Materials and Methods

This was a phase II trial of 42 patients with non-metastatic, locally unresectable pancreatic cancer.

Patients received gemcitabine at a dose of 40 mg/m2 twice-weekly (80 mg/m2/wk) during 5 1/2 weeks of radiation therapy (50.4 Gy).

At the completion of the chemoradiation, patients without disease progression received weekly gemcitabine (1000 mg/m2) on days 1, 8 and 15 followed by a week rest and repeated for 5 cycles.

Results

The mean age of the patients was 59 years (range 39-84) with 20 males (48%) enrolled.

Overall, grade III - IV hematologic toxicity occurred in 38% and 12% of patients respectively. Grade III-IV gastrointestinal toxicities occurred in 33% and 2%, respectively. There was 1 death attributed to sepsis.

Chemoradiation portion of the study was completed without treatment delays in 60% of patients and without delays or dose reductions in 36%.

Median follow-up of ~ 16 months, 21% of patients remain alive. The median survival for PS=0 patients was 13.5 months versus 7.8 months in the PS=1 and 2 patients. The median survival for the entire group was 8.5 months. Local failure as a site of initial failure was observed in 4 patients.

28 patients had pre-treatment CA 19-9 levels above 75 U. 20/28 experienced a greater than 75% decrease during treatment. Median survival for the group who had a CA 19-9 decrease was 10.3 months compared to 7.8 months for the other patients.

Author's Conclusions

Concurrent gemcitabine and radiation to the upper abdomen produces manageable toxicity but with results not superior to the conventional 5FU based chemoradiation.

Utilizing this treatment strategy in concert with other cytotoxic/biologic agents is being considered.

Clinical/Scientific Implications

Better results are needed before gemcitabine based chemoradiation can be considered a standard therapeutic modality due to the potential side effects.

Utilization of gemcitabine as a XRT sensitizer for the treatment of pancreatic cancer should only be performed in clinical research trials.

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