BACKGROUND/AIMS: A prospective randomized clinical trial combining adjuvant locoregional chemoimmunotherapy for pancreatic carcinoma in 512 patients was conducted from September 1991 to September 1998 at Athens Medical Center. METHODOLOGY: All patients were randomly assigned to (A) Resective Surgery (n=274), and (B) Palliative Surgery (n=238) groups. Each group was further subdivided into: (1) surgery alone, and (2) surgery plus 1-day bolus chemotherapy (Gemcitabine 1 gm/m2, Carboplatin 200 mg/m2 and Mitoxantrone 0.2 g/kg bw suspended in 10 ml of Lipiodol and 2 ml of 58% urografin), and immunotherapy (1 ml IL-2 and 0.5 ml gamma-IFN suspended in 5 ml of Lipiodol and 1 ml of 58% urografin) followed by a 5-day course of transplenic and another 5-day course of transtumoral immunotherapy using the same agents. This was repeated at 2-month intervals during the first post-operative year and every 3 months thereafter. RESULTS: Significant reduction in patient symptomatology and improvements in post-treatment quality of life were noted in patients receiving adjuvant chemoimmunotherapy. Moreover, the mean survival rate significantly improved in patients receiving the adjuvant treatment, both for the resective (32 months) and the palliative (16 months) groups. CONCLUSIONS: The treatment regimen employed was well tolerated and did not contribute to any clinical deterioration. Adjuvant targeted locoregional chemoimmunotherapy is therefore a promising avenue in the management of patients with pancreatic carcinoma.
RCT Entities:
BACKGROUND/AIMS: A prospective randomized clinical trial combining adjuvant locoregional chemoimmunotherapy for pancreatic carcinoma in 512 patients was conducted from September 1991 to September 1998 at Athens Medical Center. METHODOLOGY: All patients were randomly assigned to (A) Resective Surgery (n=274), and (B) Palliative Surgery (n=238) groups. Each group was further subdivided into: (1) surgery alone, and (2) surgery plus 1-day bolus chemotherapy (Gemcitabine 1 gm/m2, Carboplatin 200 mg/m2 and Mitoxantrone 0.2 g/kg bw suspended in 10 ml of Lipiodol and 2 ml of 58% urografin), and immunotherapy (1 ml IL-2 and 0.5 ml gamma-IFN suspended in 5 ml of Lipiodol and 1 ml of 58% urografin) followed by a 5-day course of transplenic and another 5-day course of transtumoral immunotherapy using the same agents. This was repeated at 2-month intervals during the first post-operative year and every 3 months thereafter. RESULTS: Significant reduction in patient symptomatology and improvements in post-treatment quality of life were noted in patients receiving adjuvant chemoimmunotherapy. Moreover, the mean survival rate significantly improved in patients receiving the adjuvant treatment, both for the resective (32 months) and the palliative (16 months) groups. CONCLUSIONS: The treatment regimen employed was well tolerated and did not contribute to any clinical deterioration. Adjuvant targeted locoregional chemoimmunotherapy is therefore a promising avenue in the management of patients with pancreatic carcinoma.