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

B. M. Wolpin, E. M. O'Reilly, Y. J. Ko, L. S. Blaszkowsky, M. Rarick, C. M. Rocha-Lima, P. Ritch, E. Chan, J. Spratlin, T. Macarulla, E. McWhirter, D. Pezet, M. Lichinitser, L. Roman, A. Hartford, K. Morrison, L. Jackson, M. Vincent, L. Reyno, M. Hidalgo

Research output: Contribution to journalArticle

21 Citations (Scopus)

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/m2 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.

Original languageEnglish
Article numbermdt066
Pages (from-to)1792-1801
Number of pages10
JournalAnnals of Oncology
Volume24
Issue number7
DOIs
StatePublished - Jul 1 2013

Fingerprint

gemcitabine
Pancreatic Neoplasms
Prostate
Stem Cells
Survival Rate
Antigens
Adenocarcinoma
AGS-1C4D4

Keywords

  • Chemotherapy
  • Clinical trial
  • Gemcitabine
  • Metastatic disease
  • Pancreatic cancer
  • Prostate stem cell antigen

ASJC Scopus subject areas

  • Oncology
  • Hematology

Cite this

Wolpin, B. M., O'Reilly, E. M., Ko, Y. J., Blaszkowsky, L. S., Rarick, M., Rocha-Lima, C. M., ... Hidalgo, M. (2013). Global, multicenter, randomized, phase ii trial of gemcitabine and gemcitabine plus AGS-1C4D4 in patients with previously untreated, metastatic pancreatic cancer. Annals of Oncology, 24(7), 1792-1801. [mdt066]. https://doi.org/10.1093/annonc/mdt066

Global, multicenter, randomized, phase ii trial of gemcitabine and gemcitabine plus AGS-1C4D4 in patients with previously untreated, metastatic pancreatic cancer. / Wolpin, B. M.; O'Reilly, E. M.; Ko, Y. J.; Blaszkowsky, L. S.; Rarick, M.; Rocha-Lima, C. M.; Ritch, P.; Chan, E.; Spratlin, J.; Macarulla, T.; McWhirter, E.; Pezet, D.; Lichinitser, M.; Roman, L.; Hartford, A.; Morrison, K.; Jackson, L.; Vincent, M.; Reyno, L.; Hidalgo, M.

In: Annals of Oncology, Vol. 24, No. 7, mdt066, 01.07.2013, p. 1792-1801.

Research output: Contribution to journalArticle

Wolpin, BM, O'Reilly, EM, Ko, YJ, Blaszkowsky, LS, Rarick, M, Rocha-Lima, CM, Ritch, P, Chan, E, Spratlin, J, Macarulla, T, McWhirter, E, Pezet, D, Lichinitser, M, Roman, L, Hartford, A, Morrison, K, Jackson, L, Vincent, M, Reyno, L & Hidalgo, M 2013, 'Global, multicenter, randomized, phase ii trial of gemcitabine and gemcitabine plus AGS-1C4D4 in patients with previously untreated, metastatic pancreatic cancer', Annals of Oncology, vol. 24, no. 7, mdt066, pp. 1792-1801. https://doi.org/10.1093/annonc/mdt066
Wolpin, B. M. ; O'Reilly, E. M. ; Ko, Y. J. ; Blaszkowsky, L. S. ; Rarick, M. ; Rocha-Lima, C. M. ; Ritch, P. ; Chan, E. ; Spratlin, J. ; Macarulla, T. ; McWhirter, E. ; Pezet, D. ; Lichinitser, M. ; Roman, L. ; Hartford, A. ; Morrison, K. ; Jackson, L. ; Vincent, M. ; Reyno, L. ; Hidalgo, M. / Global, multicenter, randomized, phase ii trial of gemcitabine and gemcitabine plus AGS-1C4D4 in patients with previously untreated, metastatic pancreatic cancer. In: Annals of Oncology. 2013 ; Vol. 24, No. 7. pp. 1792-1801.
@article{9dfc7516f990456dae33de74296881ba,
title = "Global, multicenter, randomized, phase ii trial of gemcitabine and gemcitabine plus AGS-1C4D4 in patients with previously untreated, metastatic pancreatic cancer",
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/m2 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.",
keywords = "Chemotherapy, Clinical trial, Gemcitabine, Metastatic disease, Pancreatic cancer, Prostate stem cell antigen",
author = "Wolpin, {B. M.} and O'Reilly, {E. M.} and Ko, {Y. J.} and Blaszkowsky, {L. S.} and M. Rarick and Rocha-Lima, {C. M.} and P. Ritch and E. Chan and J. Spratlin and T. Macarulla and E. McWhirter and D. Pezet and M. Lichinitser and L. Roman and A. Hartford and K. Morrison and L. Jackson and M. Vincent and L. Reyno and M. Hidalgo",
year = "2013",
month = "7",
day = "1",
doi = "10.1093/annonc/mdt066",
language = "English",
volume = "24",
pages = "1792--1801",
journal = "Annals of Oncology",
issn = "0923-7534",
publisher = "Oxford University Press",
number = "7",

}

TY - JOUR

T1 - Global, multicenter, randomized, phase ii trial of gemcitabine and gemcitabine plus AGS-1C4D4 in patients with previously untreated, metastatic pancreatic cancer

AU - Wolpin, B. M.

AU - O'Reilly, E. M.

AU - Ko, Y. J.

AU - Blaszkowsky, L. S.

AU - Rarick, M.

AU - Rocha-Lima, C. M.

AU - Ritch, P.

AU - Chan, E.

AU - Spratlin, J.

AU - Macarulla, T.

AU - McWhirter, E.

AU - Pezet, D.

AU - Lichinitser, M.

AU - Roman, L.

AU - Hartford, A.

AU - Morrison, K.

AU - Jackson, L.

AU - Vincent, M.

AU - Reyno, L.

AU - Hidalgo, M.

PY - 2013/7/1

Y1 - 2013/7/1

N2 - 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/m2 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.

AB - 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/m2 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.

KW - Chemotherapy

KW - Clinical trial

KW - Gemcitabine

KW - Metastatic disease

KW - Pancreatic cancer

KW - Prostate stem cell antigen

UR - http://www.scopus.com/inward/record.url?scp=84883811812&partnerID=8YFLogxK

UR - http://www.scopus.com/inward/citedby.url?scp=84883811812&partnerID=8YFLogxK

U2 - 10.1093/annonc/mdt066

DO - 10.1093/annonc/mdt066

M3 - Article

C2 - 23448807

AN - SCOPUS:84883811812

VL - 24

SP - 1792

EP - 1801

JO - Annals of Oncology

JF - Annals of Oncology

SN - 0923-7534

IS - 7

M1 - mdt066

ER -