Carbohydrate antigen 19-9 is a prognostic and predictive biomarker in patients with advanced pancreatic cancer who receive gemcitabine-containing chemotherapy: A pooled analysis of 6 prospective trials

Todd M. Bauer, Bassel F. El-Rayes, Xiaobai Li, Nazik Hammad, Philip A. Philip, Anthony F. Shields, Mark M. Zalupski, Tanios Bekaii-Saab

Research output: Contribution to journalReview article

66 Citations (Scopus)

Abstract

Background: Carbohydrate antigen 19-9 (CA19-9) is a widely used biomarker in pancreatic cancer. There is no consensus on the interpretation of the change in CA19-9 serum levels and its role in the clinical management of patients with pancreatic cancer. Methods: Individual patient data from 6 prospective trials evaluating gemcitabine-containing regimens from 3 different institutions were pooled. CA19-9 values were obtained at baseline and after successive cycles of treatment. The objective of this study was to correlate a decline in CA19-9 with outcomes while undergoing treatment. Results: A total of 212 patients with locally advanced (n = 50) or metastatic (n = 162) adenocarcinoma of the pancreas were included. Median baseline CA19-9 level was 1077 ng/mL (range, 15-492,241 ng/mL). Groups were divided into those levels below (low) or above (high) the median. Median overall survival (mOS) was 8.7 versus 5.2 months (P =.0018) and median time to progression (mTTP) was 5.8 versus 3.7 months (P =.082) in the low versus high groups, respectively. After 2 cycles of chemotherapy, up to a 5% increase versus ≥ 5% increase in CA19-9 levels conferred an improved mOS (10.3 vs 5.1 months, P =.0022) and mTTP (7.5 vs 3.5 months, P = 0.0005). Conclusions: In patients who have advanced pancreatic cancer treated with gemcitabine-containing regimens baseline CA19-9 is prognostic for outcome. A decline in CA19-9 after the second cycle of chemotherapy is not predictive of improved mOS or mTTP; thus, CA19-9 decline is not a useful surrogate endpoint in clinical trials. Clinically, a ≥ 5% rise in CA19-9 after 2 cycles of chemotherapy serves as a negative predictive marker.

Original languageEnglish (US)
Pages (from-to)285-292
Number of pages8
JournalCancer
Volume119
Issue number2
DOIs
StatePublished - Jan 15 2013
Externally publishedYes

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gemcitabine
Pancreatic Neoplasms
Biomarkers
Carbohydrates
Antigens
Drug Therapy
Survival

Keywords

  • carbohydrate antigen 19-9
  • gemcitabine
  • outcomes
  • pancreatic
  • predictive
  • prognostic

ASJC Scopus subject areas

  • Oncology
  • Cancer Research

Cite this

Carbohydrate antigen 19-9 is a prognostic and predictive biomarker in patients with advanced pancreatic cancer who receive gemcitabine-containing chemotherapy : A pooled analysis of 6 prospective trials. / Bauer, Todd M.; El-Rayes, Bassel F.; Li, Xiaobai; Hammad, Nazik; Philip, Philip A.; Shields, Anthony F.; Zalupski, Mark M.; Bekaii-Saab, Tanios.

In: Cancer, Vol. 119, No. 2, 15.01.2013, p. 285-292.

Research output: Contribution to journalReview article

Bauer, Todd M. ; El-Rayes, Bassel F. ; Li, Xiaobai ; Hammad, Nazik ; Philip, Philip A. ; Shields, Anthony F. ; Zalupski, Mark M. ; Bekaii-Saab, Tanios. / Carbohydrate antigen 19-9 is a prognostic and predictive biomarker in patients with advanced pancreatic cancer who receive gemcitabine-containing chemotherapy : A pooled analysis of 6 prospective trials. In: Cancer. 2013 ; Vol. 119, No. 2. pp. 285-292.
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title = "Carbohydrate antigen 19-9 is a prognostic and predictive biomarker in patients with advanced pancreatic cancer who receive gemcitabine-containing chemotherapy: A pooled analysis of 6 prospective trials",
abstract = "Background: Carbohydrate antigen 19-9 (CA19-9) is a widely used biomarker in pancreatic cancer. There is no consensus on the interpretation of the change in CA19-9 serum levels and its role in the clinical management of patients with pancreatic cancer. Methods: Individual patient data from 6 prospective trials evaluating gemcitabine-containing regimens from 3 different institutions were pooled. CA19-9 values were obtained at baseline and after successive cycles of treatment. The objective of this study was to correlate a decline in CA19-9 with outcomes while undergoing treatment. Results: A total of 212 patients with locally advanced (n = 50) or metastatic (n = 162) adenocarcinoma of the pancreas were included. Median baseline CA19-9 level was 1077 ng/mL (range, 15-492,241 ng/mL). Groups were divided into those levels below (low) or above (high) the median. Median overall survival (mOS) was 8.7 versus 5.2 months (P =.0018) and median time to progression (mTTP) was 5.8 versus 3.7 months (P =.082) in the low versus high groups, respectively. After 2 cycles of chemotherapy, up to a 5{\%} increase versus ≥ 5{\%} increase in CA19-9 levels conferred an improved mOS (10.3 vs 5.1 months, P =.0022) and mTTP (7.5 vs 3.5 months, P = 0.0005). Conclusions: In patients who have advanced pancreatic cancer treated with gemcitabine-containing regimens baseline CA19-9 is prognostic for outcome. A decline in CA19-9 after the second cycle of chemotherapy is not predictive of improved mOS or mTTP; thus, CA19-9 decline is not a useful surrogate endpoint in clinical trials. Clinically, a ≥ 5{\%} rise in CA19-9 after 2 cycles of chemotherapy serves as a negative predictive marker.",
keywords = "carbohydrate antigen 19-9, gemcitabine, outcomes, pancreatic, predictive, prognostic",
author = "Bauer, {Todd M.} and El-Rayes, {Bassel F.} and Xiaobai Li and Nazik Hammad and Philip, {Philip A.} and Shields, {Anthony F.} and Zalupski, {Mark M.} and Tanios Bekaii-Saab",
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T1 - Carbohydrate antigen 19-9 is a prognostic and predictive biomarker in patients with advanced pancreatic cancer who receive gemcitabine-containing chemotherapy

T2 - A pooled analysis of 6 prospective trials

AU - Bauer, Todd M.

AU - El-Rayes, Bassel F.

AU - Li, Xiaobai

AU - Hammad, Nazik

AU - Philip, Philip A.

AU - Shields, Anthony F.

AU - Zalupski, Mark M.

AU - Bekaii-Saab, Tanios

PY - 2013/1/15

Y1 - 2013/1/15

N2 - Background: Carbohydrate antigen 19-9 (CA19-9) is a widely used biomarker in pancreatic cancer. There is no consensus on the interpretation of the change in CA19-9 serum levels and its role in the clinical management of patients with pancreatic cancer. Methods: Individual patient data from 6 prospective trials evaluating gemcitabine-containing regimens from 3 different institutions were pooled. CA19-9 values were obtained at baseline and after successive cycles of treatment. The objective of this study was to correlate a decline in CA19-9 with outcomes while undergoing treatment. Results: A total of 212 patients with locally advanced (n = 50) or metastatic (n = 162) adenocarcinoma of the pancreas were included. Median baseline CA19-9 level was 1077 ng/mL (range, 15-492,241 ng/mL). Groups were divided into those levels below (low) or above (high) the median. Median overall survival (mOS) was 8.7 versus 5.2 months (P =.0018) and median time to progression (mTTP) was 5.8 versus 3.7 months (P =.082) in the low versus high groups, respectively. After 2 cycles of chemotherapy, up to a 5% increase versus ≥ 5% increase in CA19-9 levels conferred an improved mOS (10.3 vs 5.1 months, P =.0022) and mTTP (7.5 vs 3.5 months, P = 0.0005). Conclusions: In patients who have advanced pancreatic cancer treated with gemcitabine-containing regimens baseline CA19-9 is prognostic for outcome. A decline in CA19-9 after the second cycle of chemotherapy is not predictive of improved mOS or mTTP; thus, CA19-9 decline is not a useful surrogate endpoint in clinical trials. Clinically, a ≥ 5% rise in CA19-9 after 2 cycles of chemotherapy serves as a negative predictive marker.

AB - Background: Carbohydrate antigen 19-9 (CA19-9) is a widely used biomarker in pancreatic cancer. There is no consensus on the interpretation of the change in CA19-9 serum levels and its role in the clinical management of patients with pancreatic cancer. Methods: Individual patient data from 6 prospective trials evaluating gemcitabine-containing regimens from 3 different institutions were pooled. CA19-9 values were obtained at baseline and after successive cycles of treatment. The objective of this study was to correlate a decline in CA19-9 with outcomes while undergoing treatment. Results: A total of 212 patients with locally advanced (n = 50) or metastatic (n = 162) adenocarcinoma of the pancreas were included. Median baseline CA19-9 level was 1077 ng/mL (range, 15-492,241 ng/mL). Groups were divided into those levels below (low) or above (high) the median. Median overall survival (mOS) was 8.7 versus 5.2 months (P =.0018) and median time to progression (mTTP) was 5.8 versus 3.7 months (P =.082) in the low versus high groups, respectively. After 2 cycles of chemotherapy, up to a 5% increase versus ≥ 5% increase in CA19-9 levels conferred an improved mOS (10.3 vs 5.1 months, P =.0022) and mTTP (7.5 vs 3.5 months, P = 0.0005). Conclusions: In patients who have advanced pancreatic cancer treated with gemcitabine-containing regimens baseline CA19-9 is prognostic for outcome. A decline in CA19-9 after the second cycle of chemotherapy is not predictive of improved mOS or mTTP; thus, CA19-9 decline is not a useful surrogate endpoint in clinical trials. Clinically, a ≥ 5% rise in CA19-9 after 2 cycles of chemotherapy serves as a negative predictive marker.

KW - carbohydrate antigen 19-9

KW - gemcitabine

KW - outcomes

KW - pancreatic

KW - predictive

KW - prognostic

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DO - 10.1002/cncr.27734

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