Annals of Surgical Oncology

, Volume 18, Issue 13, pp 3615–3622

Survival and Quality of Life of Patients with Resected Pancreatic Adenocarcinoma Treated with Adjuvant Interferon-Based Chemoradiation: A Phase II Trial

Authors

  • Matthew H. G. Katz
    • Department of Surgical OncologyThe University of Texas M. D. Anderson Cancer Center
  • Robert Wolff
    • Department of Gastrointestinal Medical OncologyThe University of Texas M. D. Anderson Cancer Center
  • Christopher H. Crane
    • Department of Radiation OncologyThe University of Texas M. D. Anderson Cancer Center
  • Gauri Varadhachary
    • Department of Gastrointestinal Medical OncologyThe University of Texas M. D. Anderson Cancer Center
  • Milind Javle
    • Department of Gastrointestinal Medical OncologyThe University of Texas M. D. Anderson Cancer Center
  • E. Lin
    • Department of BiostatisticsThe University of Texas M. D. Anderson Cancer Center
  • Douglas B. Evans
    • Department of SurgeryThe Medical College of Wisconsin
  • Jeffrey E. Lee
    • Department of Surgical OncologyThe University of Texas M. D. Anderson Cancer Center
  • Jason B. Fleming
    • Department of Surgical OncologyThe University of Texas M. D. Anderson Cancer Center
    • Department of Surgical OncologyThe University of Texas M. D. Anderson Cancer Center
Pancreatic Tumors

DOI: 10.1245/s10434-011-1847-4

Cite this article as:
Katz, M.H.G., Wolff, R., Crane, C.H. et al. Ann Surg Oncol (2011) 18: 3615. doi:10.1245/s10434-011-1847-4

Abstract

Purpose

We conducted a phase II trial to assess the survival duration and quality of life of patients who received adjuvant interferon-based chemoradiation for pancreatic adenocarcinoma after pancreaticoduodenectomy.

Methods

Patients with a performance status of 0 or 1 were enrolled to receive interferon-alfa-2b (3 million units MWF), cisplatin (30 mg/m2, 6 doses) and 5-fluorouracil (5-FU; 175 mg/m2/day), concurrent with external-beam radiation (50.4 Gy) and followed by 2 courses of systemic 5-FU. The protocol was modified to include an optional 9 day break in the middle of chemoradiation. Quality of life was assessed by use of validated instruments.

Results

Twenty-eight patients were eligible for analysis. The operation of 15 (54%) patients was performed at other institutions. All patients had T3 tumors, 22 (79%) had positive lymph nodes and 4 (14%) had positive (R1) margins. 24 (86%) patients completed therapy. In all, 25 (89%) patients experienced grade 3 toxicity and 3 (11%) patients were hospitalized. The most common grade 3 events were leukopenia (15, 54%) and neutropenia (12, 43%). No grade 4 toxicity occurred. Overall quality of life decreased during chemoradiation but returned to baseline thereafter and was stable throughout surveillance. 19 patients have died; the median follow-up of the 9 survivors is 62 months. The median OS duration of treated patients was 42.3 (95% confidence interval 30.5–54.2) months.

Conclusions

Adjuvant interferon-based chemoradiation can be delivered safely and tolerably—though with substantial reversible toxicity—to patients of good performance status at an experienced cancer center. Therapy may be associated with an improvement in overall survival.

Supplementary material

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Supplementary Fig. 1b Treatment scheme after institution of an optional 9-day treatment break in the middle of chemoradiation (EPS 739 kb)
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Supplementary Fig. 2b Kaplan–Meier survival curve for disease-free survival (DFS) (EPS 729 kb)
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Supplementary Fig. 3c Responses over time to specific questions in the QOL surveys. c “To what extent have you been troubled by side effects from your treatment over past week?” (Quality of Life Questionnaire-Pancreas 26). Responses were converted to a discrete numerical scale; points represent mean (bars represent SD) of all patients’ responses to the query at each time point. Mid CXRT midpoint of chemoradiation, Post CXRT after chemoradiation, Pre CTX1 before chemotherapy cycle 1; Pre CTX 2 before chemotherapy cycle 2. Numbers refer to months after completion of therapy (EPS 758 kb)
10434_2011_1847_MOESM4_ESM.eps (756 kb)
Supplementary Fig. 3d Responses over time to specific questions in the QOL surveys. d “How many times have you felt sad over past week?” (Center for Epidemiologic Studies-Depression). Responses were converted to a discrete numerical scale; points represent mean (bars represent SD) of all patients’ responses to the query at each time point. Mid CXRT midpoint of chemoradiation, Post CXRT after chemoradiation, Pre CTX1 before chemotherapy cycle 1; Pre CTX 2 before chemotherapy cycle 2. Numbers refer to months after completion of therapy (EPS 757 kb)

Copyright information

© Society of Surgical Oncology 2011