Aims
Radioactive phosphorus (32P) is an innovative therapy for locally advanced pancreatic cancer that is implanted through endoscopic ultrasound (EUS). One of the most innovative therapies is the implantation of radioactive phosphorus-32 which is a type of brachytherapy. It is indicated for the treatment of patients with Locally Advanced Pancreatic Cancer (LAPC) in combination with gemcitabine-based chemotherapy. The primary goal of this study is to determine the safety of the intra-tumoral implantation of radioactive phosphorus (32P) through EUS and the complications of the procedure of implantation. The secondary goals are to determine the Local Disease Control Rate (LDCR) at 16 weeks and the effectiveness of the implantation of radioactive phosphorus by measuring Overall Survival (OS), Progression Free Survival (PFS) and Local Progression Free Survival (LPFS). They receive gemcitabine-based chemotherapy in combination with an intra-tumoral therapy with radioactive phosphorus (32P) through a 22-gauge FNA needle guided by EUS.
Methods
The adverse events of the implantation are evaluated by the Common Terminology Criteria for Adverse Events (CTCAE) version 4.0. The LDCR is evaluated at 16 weeks and the alteration of Tumor Volume every two months for the first year after implantation and every three months the second year after implantation according to RECIST 1.1.
Results
We currently have made the implantation in seventeen patients (10 male and 7 female) with similar clinical and demographic features who suffer from locally advanced pancreatic cancer. All the procedures (median age of patients:67,9 years) were unremarkable and no complication during the procedures was noted. The patients did not have any major adverse events during the day of the procedure. 13 out of 17 patients (76,4%) revealed mild abdominal pain on the second day which recovered with typical pain killers. The LDCR, for all patients, at 16 weeks, was 100%. Two of the patients had a major reduction in the tumor and underwent surgery (resection rate 12%) - R0 100%. Three patients died after a median overall survival of 20,3 months. 12 patients showed stable disease (70,6%) and 5 showed partial response (29,4%) during the eight months of follow-up. During the first four months the median reduction of the tumor was 0,64cm.
Conclusions
We must include more patients to conduct more useful results, but the initial results look promising.