Survival and Quality of Life of Patients with Resected Pancreatic Adenocarcinoma Treated with Adjuvant Interferon-Based Chemoradiation: A Phase II Trial
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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.
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.
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.
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.
- 1.Kalser MH, Ellenberg SS. Pancreatic cancer. Adjuvant combined radiation and chemotherapy following curative resection. Arch Surg. 1985;120:899–903.Google Scholar
- 13.Marten A, Schmidt J, Debus J, et al. CapRI: final results of the open-label, multicenter, randomized phase III trial of adjuvant chemoradiation plus interferon-a2b (CRI) versus 5-FU alone for patients with resected pancreatic adenocarcinoma (PAC). J Clin Oncol. 2010;28(Suppl):LBA4012.Google Scholar
- 15.Common terminology criteria for adverse events (CTCAE), version 3. Washington, DC: U.S. Department of Health and Human Services, National Institutes of Health, National Cancer Institute; 2003.Google Scholar
- 18.Fitzsimmons D, Johnson CD, George S, et al. Development of a disease specific quality of life (QoL) questionnaire module to supplement the EORTC core cancer QoL questionnaire, the QLQ-C30 in patients with pancreatic cancer. EORTC Study Group on Quality of Life. Eur J Cancer. 1999;35:939–41.PubMedCrossRefGoogle Scholar