The standard chemotherapy agent for adjuvant treatment of pancreatic cancer typically has been Fluorouracil (5-FU) based. But there have been other adjuvant agents and modalities for pancreatic cancer under study including gemcitabine, combined chemotherapy (multiple drug agents), and chemoradiation.
On behalf of the German Study Group for Pancreatic Cancer (a branch of the German Cancer Society), Riess and colleagues from a widely based consortium of community oncologists and oncology centers in Germany and Austria studied patients enrolled from 1998 until 2004 in 88 hospitals. The result of this work was published in the October 9, 2013 issue of the Journal of the American Medical Association.
The authors followed 368 patients who received substantive surgery for pancreatic cancer according to the extent of the disease and the dictates of the local hospitals’ protocols. These patients were randomized 1:1 to the no adjuvant therapy arm of the trial OR to the adjuvant therapy with gemcitabine arm of the trial (six months of chemotherapy with a weekly dosage at 700 mg/m2). There were 186 patients in the gemcitabine arm; 111 of the patients were able to receive all six cycles; 90% of patients in this arm received at least one single dose; 87% received at least one full gemcitabine cycle.
The pancreatic cancer patients in both arms of this Phase III trial were followed until September 2012. The data collection and coordination was undertaken by the Charité–Universitätsmedizin Berlin. The researchers found that the median overall survival of the patients in the gemcitabine arm was 22.8 months, compared with 20.2 months in the observation alone arm. This was found to be significant on a statistical basis.
Additionally, the five-year survival in the gemcitabine arm was 20.7%, compared with 10.4% in the observation alone arm. And the ten-year survival in the gemcitabine arm was 12.2%, compared with 7.7% in the observation alone arm.
The researchers suggest that gemcitabine has acceptable toxicity levels and confers survival advantage as adjuvant chemotherapy post-pancreatic cancer surgery.
Dale O’Brien, MD