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Annals of Oncology Advance Access originally published online on August 5, 2005
Annals of Oncology 2005 16(10):1654-1661; doi:10.1093/annonc/mdi324
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© 2005 European Society for Medical Oncology

PS-341 and gemcitabine in patients with metastatic pancreatic adenocarcinoma: a North Central Cancer Treatment Group (NCCTG) randomized phase II study

S. R. Alberts1,*, N. R. Foster1, R. F. Morton2, J. Kugler3, P. Schaefer4, M. Wiesenfeld5, T. R. Fitch6, P. Steen7, G. P. Kim8 and S. Gill9

1 Mayo Clinic and Mayo Foundation, Rochester, MN 55905; 2 Iowa Oncology Research Association CCOP, Des Moines, IA 50309; 3 Illinois Oncology Research Association, Peoria, IL 61615; 4 Toledo Community Hospital Oncology Program CCOP, Toledo, OH 43623; 5 Cedar Rapids Oncology Project CCOP, Cedar Rapids, IA 52403; 6 Scottsdale CCOP, Scottsdale, AZ 85259–5404; 7 Meritcare Hospital CCOP, Fargo, ND 58122; 8 Mayo Clinic Jacksonville, Jacksonville, FL 32224; 9 BC Cancer Agency, Vancouver, British Columbia, V6M 2C6, Canada

* Correspondence to: Dr S. R. Alberts, Mayo Clinic, 200 First Street SW, Rochester, MN 55905, USA. Tel: +1-507-284-8694; Fax: +1-507-284-1803; E-mail: alberts.steven{at}mayo.edu

Background: PS-341 is a proteasome inhibitor with preclinical activity in pancreatic cancer tumor models and synergistic activity with gemcitabine. This randomized phase II study determined the tumor response rate (RR) for PS-341 alone and the 6-month survival and RR for the combination of gemcitabine and PS-341 in patients with metastatic pancreatic adenocarcinoma.

Patients and methods: Patients were randomized to receive 3-week cycles of either arm A: PS-341 1.5 mg/m2 i.v. bolus (over 3–5 s) on days 1, 4, 8 and 11 or arm B: PS-341 1.0 mg/m2 (same as arm A otherwise) plus gemcitabine 1000 mg/m2 i.v. on days 1 and 8. Patients progressing on arm A were allowed to receive arm B treatment.

Results: Arm A: 42 evaluable patients were enrolled with a confirmed RR of 0% (95% CI 0% to 8%), median survival of 2.5 months (95% CI 2.0–3.3), and median time to progression (TTP) of 1.2 months (95% CI 1.1–1.3). Twelve of 43 evaluable patients (28%) experienced at least one grade 4+ AE. Arm B: 39 evaluable patients yielded a 6-month survival rate of 41% (16/39, 95% CI 29.8% to 67.0%), median survival of 4.8 months (95% CI 2.4–7.4), median TTP of 2.4 months (95% CI 1.5–3.1), and confirmed RR of 10% (4 partial responses/0 complete responses, 95% CI 3% to 24%). Eleven of 43 evaluable patients (26%) experienced at least one grade 4+ AE. One patient had grade 5 hypotension.

Conclusion: The use of PS-341 alone or in combination with gemcitabine did not result in an overall survival and RR better than that expected for gemcitabine alone. Based on the lack of efficacy and the toxicity seen in our trial, there does not appear to be a role for PS-341 in pancreatic adenocarcinoma with either of the schedules used in this trial.

Key words: chemotherapy, clinical trial, pancreatic cancer, Proteosome inhibitor


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