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Adjuvant gemcitabine improved survival after pancreatic cancer resection
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Patients who underwent complete macroscopic removal of pancreatic cancer experienced better overall and disease-free survival after treatment with adjuvant gemcitabine in a recent study.
In the multicenter, open-label, phase 3 CONKO-001 study, researchers randomly assigned 368 adult patients with completely resected pancreatic cancer in Austria and Germany to adjuvant chemotherapy with gemcitabine (n=186) or observation (n=182) between July 1998 and December 2004, with follow-up every 8 weeks for up to 5 years or until death. Treated patients received six gemcitabine cycles every 4 weeks, including three 1,000 mg/m2 infusions weekly with a 1-week break. Intent-to-treat survival analysis included 179 evaluable treated patients and 175 observation controls.
Upon database closure in September 2012, recurrence had occurred in 308 patients in the intent-to-treat cohort during a median follow-up of 136 months, including 81% of treated patients and 93% of controls. Gemcitabine recipients had a median disease-free survival duration of 13.4 months, compared with 6.7 months for controls (P<.001). Disease-free survival rates were 16.6% and 7%, respectively, at 5 years and 14.3% and 5.8% at 10 years. Similar results were observed regardless of tumor stage or resection or nodal status.
At database closure, 23 gemcitabine recipients and 15 in the observation group were alive. Overall survival duration was longer for treated patients (median 22.8 months vs. 20.2 months; P=.01), with 5-year survival rates of 20.7% among gemcitabine recipients and 10.4% among observation controls and 10-year rates of 12.2% and 7.7%, respectively.
Multivariate analysis indicated significant associations between gemcitabine use and disease-free (HR=0.54; 95% CI, 0.43-0.67) and overall survival (HR=0.78; 95% CI, 0.62-0.97). Primary tumor and nodal stages were the only other evaluated factors predictive of survival.
“The CONKO-001 data show that among patients with macroscopic complete removal of pancreatic cancer, the use of adjuvant gemcitabine for 6 months compared with observation resulted in increased overall survival as well as disease-free survival,” the researchers wrote. “These findings support the use of gemcitabine in this setting.”
Disclosure: See the study for a full list of relevant financial disclosures.
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