A randomised phase III trial comparing gemcitabine with surgery-only in patients with resected pancreatic cancer: Japanese Study Group of Adjuvant Therapy for Pancreatic Cancer.
BACKGROUND
This multicentre randomised phase III trial was designed to determine whether adjuvant chemotherapy with gemcitabine improves the outcomes of patients with resected pancreatic cancer.


METHODS
Eligibility criteria included macroscopically curative resection of invasive ductal carcinoma of the pancreas and no earlier radiation or chemotherapy. Patients were randomly assigned at a 1 : 1 ratio to either the gemcitabine group or the surgery-only group. Patients assigned to the gemcitabine group received gemcitabine at a dose of 1000 mg m(-2) over 30 min on days 1, 8 and 15, every 4 weeks for 3 cycles.


RESULTS
Between April 2002 and March 2005, 119 patients were enrolled in this study. Among them, 118 were eligible and analysable (58 in the gemcitabine group and 60 in the surgery-only group). Both groups were well balanced in terms of baseline characteristics. Although heamatological toxicity was frequently observed in the gemcitabine group, most toxicities were transient, and grade 3 or 4 non-heamatological toxicity was rare. Patients in the gemcitabine group showed significantly longer disease-free survival (DFS) than those in the surgery-only group (median DFS, 11.4 versus 5.0 months; hazard ratio=0.60 (95% confidence interval (CI): 0.40-0.89); P=0.01), although overall survival did not differ significantly between the gemcitabine and surgery-only groups (median overall survival, 22.3 versus 18.4 months; hazard ratio=0.77 (95% CI: 0.51-1.14); P=0.19).


CONCLUSIONS
The current results suggest that adjuvant gemcitabine contributes to prolonged DFS in patients undergoing macroscopically curative resection of pancreatic cancer.
Ueno
H
H
Hepatobiliary and Pancreatic Oncology Division, National Cancer Center Hospital, Tokyo, Japan. hiueno@ncc.go.jp
Kosuge
T
T
Matsuyama
Y
Y
Yamamoto
J
J
Nakao
A
A
Egawa
S
S
Doi
R
R
Monden
M
M
Hatori
T
T
Tanaka
M
M
Shimada
M
M
Kanemitsu
K
K
D000328:Adult; D000368:Aged; D000964:Antimetabolites, Antineoplastic / Q000627:therapeutic use*; D003841:Deoxycytidine / Q000009:adverse effects / Q000031:analogs & derivatives* / Q000627:therapeutic use; D018572:Disease-Free Survival; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D010190:Pancreatic Neoplasms / Q000401:mortality / Q000628:therapy*; D015996:Survival Rate; D000093542:Gemcitabine
D000964:Antimetabolites, Antineoplastic; D003841:Deoxycytidine; D000093542:Gemcitabine
Gastroenterology. 2009 Jan;136(1):187-95
18992248
J Clin Oncol. 2004 Sep 15;22(18):3776-83
15365074
Cancer Chemother Pharmacol. 2008 Apr;61(4):615-21
17520253
Br J Cancer. 2009 Jan 27;100(2):246-50
19127260
N Engl J Med. 2004 Mar 18;350(12):1200-10
15028824
Cancer Res. 2006 Apr 1;66(7):3928-35
16585222
JAMA. 2007 Jan 17;297(3):267-77
17227978
Int J Clin Oncol. 2004 Jun;9(3):174-8
15221601
Clin Cancer Res. 2009 Apr 15;15(8):2913-9
19318496
Cancer. 2008 Jan 15;112(2):243-9
18050292
Arch Surg. 1985 Aug;120(8):899-903
4015380
J Clin Oncol. 2002 Aug 1;20(15):3270-5
12149301
Jpn J Clin Oncol. 2011 Aug;41(8):953-8
21715364
Anticancer Drugs. 1998 Mar;9(3):191-201
9625429
J Clin Oncol. 2003 Sep 1;21(17):3296-302
12947065
J Clin Oncol. 1997 Jun;15(6):2403-13
9196156
Clin Cancer Res. 2004 Oct 15;10(20):6956-61
15501974
Cancer. 2007 Nov 15;110(10):2191-201
17918259
JAMA. 2008 Mar 5;299(9):1019-26
18319412
J Hepatobiliary Pancreat Surg. 2008;15(5):468-72
18836798
Br J Cancer. 2005 Apr 25;92(8):1372-81
15812554