A Phase II Study of External Irradiation and Weekly Paclitaxel for Non-Metastatic, Unresectable Pancreatic Cancer: A Preliminary Report of RTOG Protocol 98-12

Ryan Smith, MD
University of Pennsylvania Cancer Center
Ultima Vez Modificado: 5 de noviembre del 2001

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Presenter: T. Rich
Affiliation: University of Virginia
Type of Session: Scientific

Background

  • Unresectable/locally advanced pancreatic cancer remains a difficult disease to treat, with median survival of less than 1 year
  • This is a new approach to the management of pancreatic cancer, using paclitaxel (Taxol) and radiation therapy to improve palliation and extend life.

    Materials and Methods

  • 122 patients with adenocarcinoma of the pancreas were entered into the study at multiple institutions. A total of 110 were eligible for analysis
  • All were unresectable based on CT/MRI, though patients with residual disease were also eligible.
  • Paclitaxel (50 mg/m2) was delivered weekly x 6 cycles
  • Radiation was delivered concurrently. Initial fields included the primary tumor plus regional nodes to 45 Gy, followed by a conedown to the primary tumor to a total tumor dose of 50.4 Gy
  • KPS >80 in 81% of patients
  • 80% had T3 or T4 disease, 66% had N0 disease, while 22% had N1 disease
  • Median followup was 280 days

    Results

  • 85% of patients received all cycles of paclitaxel and 89% received >48 Gy. An additional 3% received >53 Gy
  • 37% of patients experienced acute grade 3 toxicity (though 43% of these were asymptomatic neutropenia). 4% experienced grade 4 toxicity, and 1 patient died of infection during treatment.
  • Local-Regional response was assessed via CT 6 weeks after radiation. 26% had PR, 7% had CR, and 59% had no response
  • Median survival was 11.9 months with 1 year survival of 43%

    Author's Conclusions

  • This regimen of concurrent paclitaxel with radiation is well tolerated, with a fairly low incidence of severe toxicity.
  • Median survival of 1 year is better than historical results with concurrent 5-FU chemoradiation
  • The newly opened RTOG PA-0020 builds onto this: paclitaxel, gemcitabine, FTI, and XRT to 50.4 Gy

    Clinical/Scientific Implications
    Unresectable or locally advanced pancreatic carcinoma has an extremely poor prognosis of approximately 9 months with traditional treatment using concurrent 5-FU and radiation therapy. This represents a new approach to the treatment of this disease using paclitaxel in place of 5-FU. It was well tolerated with 37% having grade 3 toxicity (and 43% of these being asymptomatic neutropenia). With this taken into account, approximately 20% had clinically evident grade 3 toxicity with this regimen. Median survival was approximately 1 year in a somewhat selected group of partients. Whether this represents an increase in efficacy over standard treatments is unknown, though the results presented here are not substantially better. Further investigations are warranted.

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

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

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