CHICAGO—Compared with observation, adjuvant gemcitabine (Gemzar) reduces the risk of recurrence by 45% and the risk of death by 28% in patients with resected pancreatic cancer, according to final results of the CONKO-001 trial.
In the phase III trial, patients who had undergone a complete resection of pancreatic cancer were randomized to adjuvant gemcitabine or observation. The final analysis, which had a cutoff of March 2008, was based on 179 patients in the gemcitabine group and 175 patients in the observation group. Lead investigator Ulf P. Neumann, MD, PhD, of the Charit School of Medicine in Berlin noted that the majority of patients had T3 or T4 tumors (86%) and node-positive disease (72%).
Median disease-free survival, previously reported last year (Oettle H et al: JAMA 297:267-277, 2007), remained significantly longer in the gemcitabine group relative to the observation group in the final analysis (13.4 vs 6.9 months), with a significant 45% reduction in the risk of recurrence (hazard ratio, 0.55).
Moreover, this benefit was also significant in subgroups of patients stratified by resection type (R0 vs R1), nodal status (positive vs negative), and T stage (T 1/2 vs T 3/4).
Median overall survival, which did not differ by treatment in the earlier analysis, was now significantly longer with gemcitabine (22.8 vs 20.2 months), with a significant 28% reduction in the risk of death (hazard ratio, 0.72).
“The curves for the observation arm and the treatment arm separate about 2 years after the operation,” Dr. Neumann noted during his talk at ASCO 2008 (abstract 4504).
The absolute survival advantage of gemcitabine increased with time and resulted in long-term survival for about one-fifth of patients (see Table).
“Adjuvant treatment with gemcitabine doubles the long-term survival rate after 5 years compared with observation,” he pointed out.
Analyses of this outcome in subgroups, which Dr. Neumann cautioned were too small to produce definitive conclusions, suggested that gemcitabine conferred a significant survival benefit relative to observation after R0 resection (22.8 vs 20.3 months) and a trend toward one after R1 resection (22.1 vs 14.1 months).
Also, there was a trend toward better survival among patients with T1 or T2 tumors (40.6 vs 27.0 months) as well as significantly better survival among those with T3 or T4 tumors (21.0 vs 19.0 months).
Summing up the findings, Dr. Neumann asserted that treatment with gemcitabine improves both disease-free and overall survival in this population.
“Gemcitabine should be the standard of care for adjuvant treatment of pancreatic cancer,” he concluded.