A Phase III Intergroup Trial (RTOG 97-04) of Adjuvant Pre- and Post-chemoradiation (CRT) 5-FU vs. Gemcitabine (G) for Resected Pancreatic Adenocarcionma
Locally advanced squamous cell head and neck cancer is often treated with a combination of cisplatin chemotherapy and radiation therapy. The dose of cisplatin is limited by the side effects it causes. By giving chemotherapy into an artery near the tumor (carotid artery), and giving a drug to counteract the cisplatin's effects in other areas of the body, the cisplatin dose that can be safely given is significantly higher, and thus perhaps more drug will reach the tumor. Two- hundred and forty patients with T3 or T4 tumors were randomly assigned to receive chemotherapy either intravenously (traditional IV) or intra-arterially (via carotid artery in the neck). The results revealed no difference in the development of metastatic disease or in overall survival.
This study was conducted in the Netherlands and used an intra-arterial technique that was different from the technique used in the US, namely there was less bilateral artery infusion, which may mean not enough chemotherapy drug was given. The moderator of the presentation felt this may have resulted in the lack of improvement in outcome with the intra-arterial technique.
This trial was done to determine whether the addition of gemcitabine to postoperative 5-FU, along with radiation, would improve outcomes in patients with resected pancreatic adenocarcinomas. Numerous studies have shown that there are considerable differences in the way radiation is planned and delivered for pancreatic cancer. Previous studies have suggested that the quality of the radiation given directly impacts patient outcomes. This analysis of the previous study's data was performed to see if a correlation exists between the quality of radiation therapy and patient survival.
Patients had non-metastatic disease with 0 or 1 lymph node involved, and had all undergone surgical resection. Radiation was scored by the investigators as: 1) per protocol, 2) variation acceptable, 3) variation unacceptable, or 4) data incomplete to analyze. Patients who were considered to have received radiation per protocol had significantly improved survival compared to patients who did not. In this study, radiation quality significantly impacted the outcomes for patients with pancreatic cancer.