1. Patients with resected pancreatic cancer treated with adjuvant gemcitabine for 6 months had improvements in 5-year and 10-year disease-free survival rates compared to patients without adjuvant therapy.
2. The overall survival rate improved by 24% in patients with resected pancreatic cancer treated with adjuvant gemcitabine compared to patients without adjuvant therapy.
Evidence Rating Level: 1 (Excellent)
Study Rundown: Patients with pancreatic cancer have poor survival rates due to late detection of disease and cancer poorly responsive to chemotherapy or radiation. Currently no expert consensus exits on adjuvant therapy after pancreatic cancer resection. In this randomized phase 3 trial, patients with macroscopically resected pancreatic cancer were treated with adjuvant gemcitabine therapy for 6 months or observed without therapy. Patients treated with gemcitabine showed an improvement in disease-free survival of 13.4 months (95% CI, 11.6-15.3) compared to 6.7 months (95% CI, 6.0-7.5) in patients who were observed. Overall survival rate improved by 24% with adjuvant therapy, with 10.3% improvement in 5-year survival rate (20.7% vs.10.4%) and 4.5% improvement in 10-year survival (12.2% vs. 7.7%) in gemcitabine vs. control groups respectively The study informs clinical practice by creating a standard for adjuvant therapy for resected pancreatic cancer. Strengths of the study include balanced baseline characteristics between experimental and control groups, as well as broad applicability to both community and academic oncology practices.
In-Depth [multi-center, randomized, phase 3 trial]: The study was performed in Germany and Austria between July 1998 and December 2004 with follow-up ending in September 2012. Three-hundred and sixty eight patients with stage T1-4N0-1M0 resected pancreatic cancer were randomized between adjuvant therapy with gemcitabine for 6 months or observation groups. Patients received follow-up every 8 weeks for 5 years to assess for adverse events, disease status, and survival. The primary endpoint of the study was disease-free survival, defined as time from randomization to the first symptoms indicating relapse or tumor detection by diagnostic imaging. A median follow-up of 11 years was established for all patients. Median disease-free survival in patients treated with gemcitabine was 13.4 months (95% CI, 11.6-15.3) compared to 6.7 months (95% CI 6.0-7.5) in controls (HR 0.55, 95% CI 0.44-0.69, p<0.001). Survival rates were also increased with 5-year survival rates of 20.7% vs 10.4%, and 10-year survival rates of 12.2% vs. 7.7% in gemcitabine vs control groups respectively. Adjuvant gemcitabine led to a 24% improvement in overall survival. Besides gemcitabine, other prognostic factors for survival were T and N stage, with the majority of patients in both groups in stage T3N1 before surgical resection.
By Gayatri Boddupalli and Brittany Hasty
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