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Clinical Trial
. 2014 Feb;16(2):131-9.
doi: 10.1111/hpb.12086. Epub 2013 Mar 19.

Neoadjuvant interferon-based chemoradiation for borderline resectable and locally advanced pancreas cancer: a Phase II pilot study

Eric H Jensen  1 , Leonard Armstrong, Chung Lee, Todd M Tuttle, Selwyn M Vickers, Timothy Sielaff, Edward W Greeno
Affiliations
Clinical Trial

Neoadjuvant interferon-based chemoradiation for borderline resectable and locally advanced pancreas cancer: a Phase II pilot study

Eric H Jensen et al. HPB (Oxford). 2014 Feb.

Abstract

Objectives: Neoadjuvant chemoradiotherapy (CRT) is a viable treatment strategy for patients with pancreatic cancer. This study was conducted to evaluate the Virginia Mason Protocol (5-fluorouracil, cisplatin, interferon-α and radiation) given in the neoadjuvant setting for the treatment of locally advanced pancreatic cancer.

Methods: A Phase II pilot study evaluating interferon-based neoadjuvant CRT in patients with locally advanced pancreatic cancer was performed.

Results: A total of 23 patients were enrolled. The mean age of the patients was 58.6 years. Of the 23 patients, seven (30.4%) completed all treatments. In the remaining 16 (69.6%) patients, treatment was interrupted as a result of toxicity. The most commonly reported effects of toxicity were leucopoenia/cytopoenia (n = 19, 82.6%) and gastrointestinal effects (n = 19, 82.6%). Surgical resection was successful in seven (30.4%) patients. Margins were negative in six (85.7%) of these seven patients. Positive lymph nodes were identified in three (42.9%) of seven patients. Overall survival was 11.5 months. Surgery provided improved survival (22.6 months) compared with CRT alone (8.8 months). Disease-free survival in resected patients was 17.2 months.

Conclusions: Interferon-based neoadjuvant CRT may allow for resection of locally advanced pancreatic cancer, but with significant toxicity. In the absence of surgical resection, survival remains dismal.

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Figures

Figure 1
Figure 1
Treatment protocol in the current Phase II trial of neoadjuvant chemoradiotherapy (CRT) in patients with unresectable pancreatic cancers. RT, radiotherapy; 5-FU, 5-fluorouracil; CI, continuous infusion
Figure 2
Figure 2
Microphotograph of infiltrative malignant glands within the muscularis propria. The duodenal lumen is on the left; benign pancreatic parenchyma with features of chronic pancreatitis is on the right. (Magnification ×1)
Figure 3
Figure 3
Overall survival across the study cohort (n = 23) in patients treated with chemoradiotherapy and submitted for resection (n = 7) or not submitted for resection (n = 16). 95% CI, 95% confidence interval
See this image and copyright information in PMC

References

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