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Studies of pancreatic cancer utilizing monoclonal antibodies
M Büchler1, H Friess, P Malfertheiner
1Department of General Surgery, University of Ulm, Federal Republic of Germany.
Abstract:
Since 1985, 150 patients with pancreatic ductal adenocarcinoma have been treated with the monoclonal antibody BW 494 in four different multicentric trials in Germany. The antibody recognizes a human pancreatic cancer associated antigen and mediates an antibody dependent cellular cytotoxicity (ADCC) in vitro, when human mononuclear cells are coincubated as effector cells. In patients with at advanced unresectable pancreatic cancer there where two phase-I-studies finished in 1987 and 1989, respectively, and one uncontrolled phase-II-study finished in 1988. In 1987, we started a controlled randomized trial in patients with resectable (Whipple) pancreatic cancer, which will be finished in 1990. There were no major side effects if the intravenous antibody application was restricted to a 10-d treatment protocol (up to 370 mg given in 10 different dosages). Human anti-mouse-antibodies could be demonstrated in all patients investigated for within 4 wk after immunotherapy. In patients with advanced pancreatic cancer (n = 87), monoclonal antibody treatment did not induce significant response rates. There was stable disease in 1/3 to 1/2 of the patients lasting three months or longer. Therapeutic success may be expected in patients with minor tumor burden.
Insights
Monoclonal antibody BW 494 therapy in pancreatic cancer patients showed no significant response rates but offered stable disease in some. Therapeutic success may be possible in patients with minimal tumor burden.
Area of Science:
- Oncology
- Immunotherapy
- Monoclonal Antibody Therapy
Background:
- Pancreatic ductal adenocarcinoma is a challenging cancer with limited treatment options.
- Monoclonal antibody BW 494 targets a human pancreatic cancer-associated antigen.
- The antibody mediates antibody-dependent cellular cytotoxicity (ADCC) in vitro.
Purpose of the Study:
- To evaluate the efficacy and safety of monoclonal antibody BW 494 in patients with pancreatic cancer.
- To assess treatment response rates and duration of stable disease.
- To explore potential for therapeutic success in specific patient subgroups.
Main Methods:
- Four multicentric trials involving 150 patients with pancreatic ductal adenocarcinoma.
- Phase I and II studies in advanced unresectable pancreatic cancer.
- A controlled randomized trial in resectable pancreatic cancer patients.
Main Results:
- No major side effects observed with a 10-day intravenous treatment protocol.
- Human anti-mouse antibodies developed in all patients within 4 weeks.
- Advanced pancreatic cancer patients (n=87) showed no significant response rates, with stable disease in 33-50% lasting ≥3 months.
Conclusions:
- Monoclonal antibody BW 494 treatment did not yield significant response rates in advanced pancreatic cancer.
- Stable disease was observed in a notable proportion of patients.
- Therapeutic success might be achievable in patients with a minor tumor burden.