Baseline serum albumin is a predictive biomarker for patients with advanced pancreatic cancer treated with bevacizumab: A pooled analysis of 7 prospective trials of gemcitabine-based therapy with or without bevacizumab

Shubham Pant, Ludmila K. Martin, Susan Geyer, Lai Wei, Katherine Van Loon, Nilli Sommovilla, Mark Zalupski, Renuka Iyer, David Fogelman, Andrew H. Ko, Tanios Bekaii-Saab

Research output: Contribution to journalArticle

14 Citations (Scopus)

Abstract

BACKGROUND Phase 3 studies of bevacizumab in patients with advanced pancreatic cancer (APCA) demonstrated no improvement in outcome. To the authors' knowledge, no validated predictive biomarkers for bevacizumab exist, although emerging data suggest that subsets of patients with APCA may benefit from treatment with bevacizumab. The authors evaluated baseline serum albumin (b-alb) as a predictive biomarker in a pooled analysis from 7 prospective clinical trials of gemcitabine-based therapy with or without bevacizumab. METHODS Data were collected from individual databases from 7 prospective clinical trials. Patients were grouped by exposure to bevacizumab and by b-alb level (≥ 3.4 g/L or < 3.4 g/dL). Overall survival (OS), time to disease progression (TTP), overall response rate, and disease control rate (overall response rate plus stable disease lasting ≥ 16 weeks) were compared between groups. Univariate and multivariable analyses of prognostic factors were performed. RESULTS A total of 264 patients were included. The median age was 59 years (range, 31 years-85 years) and all patients had stage IV disease per TNM staging. Normal b-alb was associated with significantly improved median OS (10.2 months vs 4.1 months; P = .0001), median TTP (6.2 months vs 3.7 months; P = 0.0488), and disease control rate (71% vs 46%; P = .007) for patients receiving bevacizumab, but not for those treated without bevacizumab. Multivariable analysis revealed a significant influence of normal b-alb on OS (P = .0008) and TTP (P = .033). CONCLUSIONS Patients with APCA with normal b-alb derive benefit from treatment with bevacizumab. Future prospective investigations of bevacizumab in patients with APCA should consider selecting patients with normal b-alb to maximize potential benefit.

Original languageEnglish (US)
Pages (from-to)1780-1786
Number of pages7
JournalCancer
Volume120
Issue number12
DOIs
StatePublished - Jun 15 2014
Externally publishedYes

Fingerprint

gemcitabine
Pancreatic Neoplasms
Serum Albumin
Biomarkers
Disease Progression
Therapeutics
Survival
Clinical Trials
Bevacizumab
Neoplasm Staging

Keywords

  • albumin
  • bevacizumab
  • pancreatic cancer
  • predictive biomarker

ASJC Scopus subject areas

  • Oncology
  • Cancer Research

Cite this

Baseline serum albumin is a predictive biomarker for patients with advanced pancreatic cancer treated with bevacizumab : A pooled analysis of 7 prospective trials of gemcitabine-based therapy with or without bevacizumab. / Pant, Shubham; Martin, Ludmila K.; Geyer, Susan; Wei, Lai; Van Loon, Katherine; Sommovilla, Nilli; Zalupski, Mark; Iyer, Renuka; Fogelman, David; Ko, Andrew H.; Bekaii-Saab, Tanios.

In: Cancer, Vol. 120, No. 12, 15.06.2014, p. 1780-1786.

Research output: Contribution to journalArticle

Pant, Shubham ; Martin, Ludmila K. ; Geyer, Susan ; Wei, Lai ; Van Loon, Katherine ; Sommovilla, Nilli ; Zalupski, Mark ; Iyer, Renuka ; Fogelman, David ; Ko, Andrew H. ; Bekaii-Saab, Tanios. / Baseline serum albumin is a predictive biomarker for patients with advanced pancreatic cancer treated with bevacizumab : A pooled analysis of 7 prospective trials of gemcitabine-based therapy with or without bevacizumab. In: Cancer. 2014 ; Vol. 120, No. 12. pp. 1780-1786.
@article{841d0a69afb2465f9089f2ab5b73e64b,
title = "Baseline serum albumin is a predictive biomarker for patients with advanced pancreatic cancer treated with bevacizumab: A pooled analysis of 7 prospective trials of gemcitabine-based therapy with or without bevacizumab",
abstract = "BACKGROUND Phase 3 studies of bevacizumab in patients with advanced pancreatic cancer (APCA) demonstrated no improvement in outcome. To the authors' knowledge, no validated predictive biomarkers for bevacizumab exist, although emerging data suggest that subsets of patients with APCA may benefit from treatment with bevacizumab. The authors evaluated baseline serum albumin (b-alb) as a predictive biomarker in a pooled analysis from 7 prospective clinical trials of gemcitabine-based therapy with or without bevacizumab. METHODS Data were collected from individual databases from 7 prospective clinical trials. Patients were grouped by exposure to bevacizumab and by b-alb level (≥ 3.4 g/L or < 3.4 g/dL). Overall survival (OS), time to disease progression (TTP), overall response rate, and disease control rate (overall response rate plus stable disease lasting ≥ 16 weeks) were compared between groups. Univariate and multivariable analyses of prognostic factors were performed. RESULTS A total of 264 patients were included. The median age was 59 years (range, 31 years-85 years) and all patients had stage IV disease per TNM staging. Normal b-alb was associated with significantly improved median OS (10.2 months vs 4.1 months; P = .0001), median TTP (6.2 months vs 3.7 months; P = 0.0488), and disease control rate (71{\%} vs 46{\%}; P = .007) for patients receiving bevacizumab, but not for those treated without bevacizumab. Multivariable analysis revealed a significant influence of normal b-alb on OS (P = .0008) and TTP (P = .033). CONCLUSIONS Patients with APCA with normal b-alb derive benefit from treatment with bevacizumab. Future prospective investigations of bevacizumab in patients with APCA should consider selecting patients with normal b-alb to maximize potential benefit.",
keywords = "albumin, bevacizumab, pancreatic cancer, predictive biomarker",
author = "Shubham Pant and Martin, {Ludmila K.} and Susan Geyer and Lai Wei and {Van Loon}, Katherine and Nilli Sommovilla and Mark Zalupski and Renuka Iyer and David Fogelman and Ko, {Andrew H.} and Tanios Bekaii-Saab",
year = "2014",
month = "6",
day = "15",
doi = "10.1002/cncr.28648",
language = "English (US)",
volume = "120",
pages = "1780--1786",
journal = "Cancer",
issn = "0008-543X",
publisher = "John Wiley and Sons Inc.",
number = "12",

}

TY - JOUR

T1 - Baseline serum albumin is a predictive biomarker for patients with advanced pancreatic cancer treated with bevacizumab

T2 - A pooled analysis of 7 prospective trials of gemcitabine-based therapy with or without bevacizumab

AU - Pant, Shubham

AU - Martin, Ludmila K.

AU - Geyer, Susan

AU - Wei, Lai

AU - Van Loon, Katherine

AU - Sommovilla, Nilli

AU - Zalupski, Mark

AU - Iyer, Renuka

AU - Fogelman, David

AU - Ko, Andrew H.

AU - Bekaii-Saab, Tanios

PY - 2014/6/15

Y1 - 2014/6/15

N2 - BACKGROUND Phase 3 studies of bevacizumab in patients with advanced pancreatic cancer (APCA) demonstrated no improvement in outcome. To the authors' knowledge, no validated predictive biomarkers for bevacizumab exist, although emerging data suggest that subsets of patients with APCA may benefit from treatment with bevacizumab. The authors evaluated baseline serum albumin (b-alb) as a predictive biomarker in a pooled analysis from 7 prospective clinical trials of gemcitabine-based therapy with or without bevacizumab. METHODS Data were collected from individual databases from 7 prospective clinical trials. Patients were grouped by exposure to bevacizumab and by b-alb level (≥ 3.4 g/L or < 3.4 g/dL). Overall survival (OS), time to disease progression (TTP), overall response rate, and disease control rate (overall response rate plus stable disease lasting ≥ 16 weeks) were compared between groups. Univariate and multivariable analyses of prognostic factors were performed. RESULTS A total of 264 patients were included. The median age was 59 years (range, 31 years-85 years) and all patients had stage IV disease per TNM staging. Normal b-alb was associated with significantly improved median OS (10.2 months vs 4.1 months; P = .0001), median TTP (6.2 months vs 3.7 months; P = 0.0488), and disease control rate (71% vs 46%; P = .007) for patients receiving bevacizumab, but not for those treated without bevacizumab. Multivariable analysis revealed a significant influence of normal b-alb on OS (P = .0008) and TTP (P = .033). CONCLUSIONS Patients with APCA with normal b-alb derive benefit from treatment with bevacizumab. Future prospective investigations of bevacizumab in patients with APCA should consider selecting patients with normal b-alb to maximize potential benefit.

AB - BACKGROUND Phase 3 studies of bevacizumab in patients with advanced pancreatic cancer (APCA) demonstrated no improvement in outcome. To the authors' knowledge, no validated predictive biomarkers for bevacizumab exist, although emerging data suggest that subsets of patients with APCA may benefit from treatment with bevacizumab. The authors evaluated baseline serum albumin (b-alb) as a predictive biomarker in a pooled analysis from 7 prospective clinical trials of gemcitabine-based therapy with or without bevacizumab. METHODS Data were collected from individual databases from 7 prospective clinical trials. Patients were grouped by exposure to bevacizumab and by b-alb level (≥ 3.4 g/L or < 3.4 g/dL). Overall survival (OS), time to disease progression (TTP), overall response rate, and disease control rate (overall response rate plus stable disease lasting ≥ 16 weeks) were compared between groups. Univariate and multivariable analyses of prognostic factors were performed. RESULTS A total of 264 patients were included. The median age was 59 years (range, 31 years-85 years) and all patients had stage IV disease per TNM staging. Normal b-alb was associated with significantly improved median OS (10.2 months vs 4.1 months; P = .0001), median TTP (6.2 months vs 3.7 months; P = 0.0488), and disease control rate (71% vs 46%; P = .007) for patients receiving bevacizumab, but not for those treated without bevacizumab. Multivariable analysis revealed a significant influence of normal b-alb on OS (P = .0008) and TTP (P = .033). CONCLUSIONS Patients with APCA with normal b-alb derive benefit from treatment with bevacizumab. Future prospective investigations of bevacizumab in patients with APCA should consider selecting patients with normal b-alb to maximize potential benefit.

KW - albumin

KW - bevacizumab

KW - pancreatic cancer

KW - predictive biomarker

UR - http://www.scopus.com/inward/record.url?scp=84902126251&partnerID=8YFLogxK

UR - http://www.scopus.com/inward/citedby.url?scp=84902126251&partnerID=8YFLogxK

U2 - 10.1002/cncr.28648

DO - 10.1002/cncr.28648

M3 - Article

C2 - 24633933

AN - SCOPUS:84902126251

VL - 120

SP - 1780

EP - 1786

JO - Cancer

JF - Cancer

SN - 0008-543X

IS - 12

ER -