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

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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.

    Oncolink's ASTRO Coverage made possible by an unrestricted Educational Grant from Bristol-Myers Squibb Oncology and Pharmacia Oncology.