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Clinical Trial
. 2013 Jul;24(7):1792-1801.
doi: 10.1093/annonc/mdt066. Epub 2013 Feb 28.

Global, multicenter, randomized, phase II trial of gemcitabine and gemcitabine plus AGS-1C4D4 in patients with previously untreated, metastatic pancreatic cancer

B M Wolpin  1 , E M O'Reilly  2 , Y J Ko  3 , L S Blaszkowsky  4 , M Rarick  5 , C M Rocha-Lima  6 , P Ritch  7 , E Chan  8 , J Spratlin  9 , T Macarulla  10 , E McWhirter  11 , D Pezet  12 , M Lichinitser  13 , L Roman  14 , A Hartford  15 , K Morrison  15 , L Jackson  15 , M Vincent  15 , L Reyno  15 , M Hidalgo  16
Affiliations
Clinical Trial

Global, multicenter, randomized, phase II trial of gemcitabine and gemcitabine plus AGS-1C4D4 in patients with previously untreated, metastatic pancreatic cancer

B M Wolpin et al. Ann Oncol. 2013 Jul.

Abstract

Background: We evaluated AGS-1C4D4, a fully human monoclonal antibody to prostate stem cell antigen (PSCA), with gemcitabine in a randomized, phase II study of metastatic pancreatic cancer.

Patients and methods: Patients with Eastern Cooperative Oncology Group (ECOG) performance status 0/1 and previously untreated, metastatic pancreatic adenocarcinoma were randomly assigned 1:2 to gemcitabine (1000 mg/m(2) weekly seven times, 1 week rest, weekly three times q4weeks) or gemcitabine plus AGS-1C4D4 (48 mg/kg loading dose, then 24 mg/kg q3weeks IV). The primary end point was 6-month survival rate (SR). Archived tumor samples were collected for pre-planned analyses by PSCA expression.

Results: Between April 2009 and May 2010, 196 patients were randomly assigned to gemcitabine (n = 63) or gemcitabine plus AGS-1C4D4 (n = 133). The 6-month SR was 44.4% (95% CI, 31.9-57.5) in the gemcitabine arm and 60.9% (95% CI, 52.1-69.2) in the gemcitabine plus AGS-1C4D4 arm (P = 0.03), while the median survival was 5.5 versus 7.6 months and the response rate was 13.1% versus 21.6% in the two arms, respectively. The 6-month SR was 57.1% in the gemcitabine arm versus 79.5% in the gemcitabine plus AGS-1C4D4 arm among the PSCA-positive subgroup and 31.6% versus 46.2% among the PSCA-negative subgroup.

Conclusions: This randomized, phase II study achieved its primary end point, demonstrating an improved 6-month SR with addition of AGS-1C4D4 to gemcitabine among patients with previously untreated, metastatic pancreatic adenocarcinoma. ClinicalTrials.gov identifier: NCT00902291.

Keywords: chemotherapy; clinical trial; gemcitabine; metastatic disease; pancreatic cancer; prostate stem cell antigen.

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Figures

Figure 1.
Figure 1.
Duration of (A) overall survival (OS) and (B) progression-free survival (PFS) by treatment arm. (A) OS. (B) PFS.
Figure 2.
Figure 2.
Overall survival (OS) of patients receiving (A) gemcitabine and (B) gemcitabine versus gemcitabine plus AGS-1C4D4 by tumor PSCA staining. (A) Gemcitabine arm only. (B) Gemcitabine arm and gemcitabine plus AGS-1C4D4 arm.
See this image and copyright information in PMC

References

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