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Title: 3D Radiotherapy Can Be Safely Combined With Sandwich Systemic Gemcitabine Chemotherapy in the Management of Pancreatic Cancer: Factors Influencing Outcome

Journal Article · · International Journal of Radiation Oncology, Biology and Physics
 [1];  [2];  [3];  [4];  [5];  [6];  [7];  [8];  [9];  [10]; ;  [11];  [12];  [13]
  1. Department of Radiation Oncology, Sir Charles Gairdner Hospital, Nedlands, WA (Australia)
  2. Department of Radiation Oncology, Princess Alexandra Hospital, Woolloongabba, Queensland (Australia)
  3. Department of Radiation Oncology, Murray Valley Private Hospital, Wodonga, Victoria (Australia)
  4. Adelaide Radiotherapy Centre, Adelaide, SA (Australia)
  5. Division of Radiation Oncology, Peter MacCallum Cancer Centre, East Melbourne, Victoria (Australia)
  6. Department of Radiation Oncology, The Alfred, Prahran, Victoria (Australia)
  7. Department of Radiation Oncology, St. George Hospital, Kogarah, NSW (Australia)
  8. Department of Radiation Oncology, Royal Perth Hospital, Perth, WA (Australia)
  9. Cancer Therapy Centre, Liverpool Hospital, Liverpool, NSW (Australia)
  10. Department of Radiation Oncology, Prince of Wales Hospital, Randwick, NSW (Australia)
  11. Eli Lilly Australia, West Ryde, NSW (Australia)
  12. School of Surgery and Pathology, University of Western Australia, Nedlands, WA (Australia)
  13. Department of Medical Oncology, Prince of Wales Hospital, Randwick, NSW (Australia)

Purpose: The aim of this Phase II study was to examine whether concurrent continuous infusion 5-fluorouracil (CI 5FU) plus three-dimensional conformal planning radiotherapy sandwiched between gemcitabine chemotherapy is effective, tolerable, and safe in the management of pancreatic cancer. Methods and Materials: Patients were enrolled in two strata: (1) resected pancreatic cancer at high risk of local relapse (postsurgery arm, n = 22) or (2) inoperable pancreatic cancer in head or body without metastases (locally advanced arm, n = 41). Gemcitabine was given at 1,000 mg/m{sup 2} weekly for 3 weeks followed by 1 week rest then 5-6 weeks of radiotherapy and concurrent CI 5FU (200 mg/m{sup 2}/day). After 4 weeks' rest, gemcitabine treatment was reinitiated for 12 weeks. Results: For the two arms combined, treatment-related Grade 3 and 4 toxicities were reported by 25 (39.7%) and 7 (11.1%) patients, respectively. No significant late renal or hepatic toxicity was observed. In the postsurgery arm (R1 54.5%), median time to progressive disease from surgery was 11.0 months, median time to failure of local control was 32.9 months, and median survival time was 15.6 months. The 1- and 2-year survival rates were 63.6% and 31.8%. No significant associations between outcome and mutations in K-ras or TP53 or microsatellite instability were identified. Post hoc investigation of cancer antigen 19-9 levels found baseline levels and increases postbaseline were associated with shorter survival (p = 0.0061 and p < 0.0001, respectively). Conclusions: This three-dimensional chemoradiotherapy regimen is safe and promising, with encouraging local control for a substantial proportion of patients, and merits testing in a randomized trial.

OSTI ID:
21124150
Journal Information:
International Journal of Radiation Oncology, Biology and Physics, Vol. 70, Issue 5; Other Information: DOI: 10.1016/j.ijrobp.2007.08.070; PII: S0360-3016(07)04234-4; Copyright (c) 2008 Elsevier Science B.V., Amsterdam, The Netherlands, All rights reserved; Country of input: International Atomic Energy Agency (IAEA); ISSN 0360-3016
Country of Publication:
United States
Language:
English

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