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Clinical Trial
. 2015 Jun;102(7):746-54.
doi: 10.1002/bjs.9775. Epub 2015 Apr 2.

Randomized clinical trial of adjuvant chemotherapy with S-1 versus gemcitabine after pancreatic cancer resection

M Shimoda  1 , K Kubota, T Shimizu, M Katoh
Affiliations
Clinical Trial

Randomized clinical trial of adjuvant chemotherapy with S-1 versus gemcitabine after pancreatic cancer resection

M Shimoda et al. Br J Surg. 2015 Jun.

Abstract

Background: Randomized studies of adjuvant chemotherapy using gemcitabine suggest a survival benefit after resection of pancreatic cancer. S-1 has also been shown to prolong survival in patients with unresectable pancreatic cancer. This study compared the effects of adjuvant chemotherapy with S-1 or gemcitabine after resection of pancreatic cancer in a randomized trial.

Methods: Patients who had undergone resection of pancreatic cancer were registered in this randomized clinical trial. The primary endpoint was disease-free survival (DFS). Expression levels of thymidylate synthase (TS) and dihydropyrimidine dehydrogenase (DPD) mRNAs in cancer tissues were measured as indicators of fluoropyrimidine sensitivity.

Results: Of 57 patients registered, 29 were allocated to the S-1 group and 28 to gemcitabine. DFS tended to be better with S-1 (median 14·6 (90 per cent c.i. 8·8 to 28·4) months versus 10·5 (7·0 to 28·4) months in the gemcitabine group; P = 0·188), with a similar pattern for overall survival: 21·5 (95 per cent c.i. 14·4 to 42·3) and 18·0 (13·3 to 42·8) months respectively (P = 0·293). When patients were divided into subgroups based on high or low DPD and TS expression, those with a DPD level below the median of 0·88 or a TS level of at least 2·00 had a significant prolongation of DFS after S-1 treatment compared with gemcitabine (P = 0·008 and P = 0·035 respectively).

Conclusion: Overall, S-1 did not improve DFS compared with gemcitabine after pancreatic cancer resection, but there seemed to be a DFS advantage in patients with low expression of DPD or high expression of TS. Reference number: UMIN000009118 (http://www.umin.ac.jp/ctr/).

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