Maintenance single-agent bevacizumab or observation after first-line chemotherapy in patients with metastatic colorectal cancer: A multicenter retrospective study

Luca Moscetti, Fabrizio Nelli, Maria A. Fabbri, Isabella Sperduti, Daniele Alesini, Enrico Cortesi, Donatello Gemma, Teresa Gamucci, Roberta Grande, Ida Pavese, Daniela Franco, Enzo M. Ruggeri

Research output: Contribution to journalArticle

Abstract

Summary: The addition of bevacizumab to standard chemotherapy has improved progression-free survival (PFS) and overall survival (OS) in patients with metastatic colorectal cancer (mCRC) in both first- and second line treatment, but the role of maintenance bevacizumab remains controversial. The association of various clinical factor and survival was examined in this retrospective cohort analysis. The clinical data from 220 previously untreated patients with mCRC, not progressive at the end of standard chemotherapy plus bevacizumab, were collected and analyzed. Patients were classified into two subgroups: those given with maintenance bevacizumab: "maintenance bevacizumab cohort (n = 118; MB)", and those discontinuing bevacizumab as a result of physician's or patient's decision: "no maintenance bevacizumab cohort (n = 102; noMB)". The baseline factors were well balanced between the study subgroups. Median PFS and OS for the general population was 10 months (range 7-15) and 22.5 months (range 18-26), respectively. Median PFS was 13 and 8 months in the BM and noBM cohorts, respectively (p <0.0001). In the multivariate analysis, maintenance therapy resulted independently associated with improved PFS (HR 1.73; p <0.001), but only objective response (OR) after first-line chemotherapy was associated with improved OS. Maintenance chemotherapy cannot be considered a standard of care after induction chemotherapy for mCRC, because the optimal balance between efficacy and safety of maintenance therapy remains a significant challenge. The results of our retrospective study suggest that maintenance therapy with bevacizumab is a safe and valuable option, particularly in those patients achieving an objective response after first-line chemotherapy.

Original languageEnglish
Pages (from-to)1035-1043
Number of pages9
JournalInvestigational New Drugs
Volume31
Issue number4
DOIs
Publication statusPublished - Aug 2013

Fingerprint

Multicenter Studies
Colorectal Neoplasms
Retrospective Studies
Maintenance
Observation
Drug Therapy
Disease-Free Survival
Survival
Maintenance Chemotherapy
Induction Chemotherapy
Bevacizumab
Therapeutics
Standard of Care
Cohort Studies
Multivariate Analysis
Physicians
Safety
Population

Keywords

  • Antiangiogenic therapy
  • Bevacizumab
  • Chemotherapy
  • Maintenance therapy
  • Metastatic colorectal cancer

ASJC Scopus subject areas

  • Pharmacology
  • Pharmacology (medical)
  • Oncology

Cite this

Maintenance single-agent bevacizumab or observation after first-line chemotherapy in patients with metastatic colorectal cancer : A multicenter retrospective study. / Moscetti, Luca; Nelli, Fabrizio; Fabbri, Maria A.; Sperduti, Isabella; Alesini, Daniele; Cortesi, Enrico; Gemma, Donatello; Gamucci, Teresa; Grande, Roberta; Pavese, Ida; Franco, Daniela; Ruggeri, Enzo M.

In: Investigational New Drugs, Vol. 31, No. 4, 08.2013, p. 1035-1043.

Research output: Contribution to journalArticle

Moscetti, L, Nelli, F, Fabbri, MA, Sperduti, I, Alesini, D, Cortesi, E, Gemma, D, Gamucci, T, Grande, R, Pavese, I, Franco, D & Ruggeri, EM 2013, 'Maintenance single-agent bevacizumab or observation after first-line chemotherapy in patients with metastatic colorectal cancer: A multicenter retrospective study', Investigational New Drugs, vol. 31, no. 4, pp. 1035-1043. https://doi.org/10.1007/s10637-013-9936-9
Moscetti, Luca ; Nelli, Fabrizio ; Fabbri, Maria A. ; Sperduti, Isabella ; Alesini, Daniele ; Cortesi, Enrico ; Gemma, Donatello ; Gamucci, Teresa ; Grande, Roberta ; Pavese, Ida ; Franco, Daniela ; Ruggeri, Enzo M. / Maintenance single-agent bevacizumab or observation after first-line chemotherapy in patients with metastatic colorectal cancer : A multicenter retrospective study. In: Investigational New Drugs. 2013 ; Vol. 31, No. 4. pp. 1035-1043.
@article{38435ab19139478b8c9bab86951691a7,
title = "Maintenance single-agent bevacizumab or observation after first-line chemotherapy in patients with metastatic colorectal cancer: A multicenter retrospective study",
abstract = "Summary: The addition of bevacizumab to standard chemotherapy has improved progression-free survival (PFS) and overall survival (OS) in patients with metastatic colorectal cancer (mCRC) in both first- and second line treatment, but the role of maintenance bevacizumab remains controversial. The association of various clinical factor and survival was examined in this retrospective cohort analysis. The clinical data from 220 previously untreated patients with mCRC, not progressive at the end of standard chemotherapy plus bevacizumab, were collected and analyzed. Patients were classified into two subgroups: those given with maintenance bevacizumab: {"}maintenance bevacizumab cohort (n = 118; MB){"}, and those discontinuing bevacizumab as a result of physician's or patient's decision: {"}no maintenance bevacizumab cohort (n = 102; noMB){"}. The baseline factors were well balanced between the study subgroups. Median PFS and OS for the general population was 10 months (range 7-15) and 22.5 months (range 18-26), respectively. Median PFS was 13 and 8 months in the BM and noBM cohorts, respectively (p <0.0001). In the multivariate analysis, maintenance therapy resulted independently associated with improved PFS (HR 1.73; p <0.001), but only objective response (OR) after first-line chemotherapy was associated with improved OS. Maintenance chemotherapy cannot be considered a standard of care after induction chemotherapy for mCRC, because the optimal balance between efficacy and safety of maintenance therapy remains a significant challenge. The results of our retrospective study suggest that maintenance therapy with bevacizumab is a safe and valuable option, particularly in those patients achieving an objective response after first-line chemotherapy.",
keywords = "Antiangiogenic therapy, Bevacizumab, Chemotherapy, Maintenance therapy, Metastatic colorectal cancer",
author = "Luca Moscetti and Fabrizio Nelli and Fabbri, {Maria A.} and Isabella Sperduti and Daniele Alesini and Enrico Cortesi and Donatello Gemma and Teresa Gamucci and Roberta Grande and Ida Pavese and Daniela Franco and Ruggeri, {Enzo M.}",
year = "2013",
month = "8",
doi = "10.1007/s10637-013-9936-9",
language = "English",
volume = "31",
pages = "1035--1043",
journal = "Investigational New Drugs",
issn = "0167-6997",
publisher = "Kluwer Academic Publishers",
number = "4",

}

TY - JOUR

T1 - Maintenance single-agent bevacizumab or observation after first-line chemotherapy in patients with metastatic colorectal cancer

T2 - A multicenter retrospective study

AU - Moscetti, Luca

AU - Nelli, Fabrizio

AU - Fabbri, Maria A.

AU - Sperduti, Isabella

AU - Alesini, Daniele

AU - Cortesi, Enrico

AU - Gemma, Donatello

AU - Gamucci, Teresa

AU - Grande, Roberta

AU - Pavese, Ida

AU - Franco, Daniela

AU - Ruggeri, Enzo M.

PY - 2013/8

Y1 - 2013/8

N2 - Summary: The addition of bevacizumab to standard chemotherapy has improved progression-free survival (PFS) and overall survival (OS) in patients with metastatic colorectal cancer (mCRC) in both first- and second line treatment, but the role of maintenance bevacizumab remains controversial. The association of various clinical factor and survival was examined in this retrospective cohort analysis. The clinical data from 220 previously untreated patients with mCRC, not progressive at the end of standard chemotherapy plus bevacizumab, were collected and analyzed. Patients were classified into two subgroups: those given with maintenance bevacizumab: "maintenance bevacizumab cohort (n = 118; MB)", and those discontinuing bevacizumab as a result of physician's or patient's decision: "no maintenance bevacizumab cohort (n = 102; noMB)". The baseline factors were well balanced between the study subgroups. Median PFS and OS for the general population was 10 months (range 7-15) and 22.5 months (range 18-26), respectively. Median PFS was 13 and 8 months in the BM and noBM cohorts, respectively (p <0.0001). In the multivariate analysis, maintenance therapy resulted independently associated with improved PFS (HR 1.73; p <0.001), but only objective response (OR) after first-line chemotherapy was associated with improved OS. Maintenance chemotherapy cannot be considered a standard of care after induction chemotherapy for mCRC, because the optimal balance between efficacy and safety of maintenance therapy remains a significant challenge. The results of our retrospective study suggest that maintenance therapy with bevacizumab is a safe and valuable option, particularly in those patients achieving an objective response after first-line chemotherapy.

AB - Summary: The addition of bevacizumab to standard chemotherapy has improved progression-free survival (PFS) and overall survival (OS) in patients with metastatic colorectal cancer (mCRC) in both first- and second line treatment, but the role of maintenance bevacizumab remains controversial. The association of various clinical factor and survival was examined in this retrospective cohort analysis. The clinical data from 220 previously untreated patients with mCRC, not progressive at the end of standard chemotherapy plus bevacizumab, were collected and analyzed. Patients were classified into two subgroups: those given with maintenance bevacizumab: "maintenance bevacizumab cohort (n = 118; MB)", and those discontinuing bevacizumab as a result of physician's or patient's decision: "no maintenance bevacizumab cohort (n = 102; noMB)". The baseline factors were well balanced between the study subgroups. Median PFS and OS for the general population was 10 months (range 7-15) and 22.5 months (range 18-26), respectively. Median PFS was 13 and 8 months in the BM and noBM cohorts, respectively (p <0.0001). In the multivariate analysis, maintenance therapy resulted independently associated with improved PFS (HR 1.73; p <0.001), but only objective response (OR) after first-line chemotherapy was associated with improved OS. Maintenance chemotherapy cannot be considered a standard of care after induction chemotherapy for mCRC, because the optimal balance between efficacy and safety of maintenance therapy remains a significant challenge. The results of our retrospective study suggest that maintenance therapy with bevacizumab is a safe and valuable option, particularly in those patients achieving an objective response after first-line chemotherapy.

KW - Antiangiogenic therapy

KW - Bevacizumab

KW - Chemotherapy

KW - Maintenance therapy

KW - Metastatic colorectal cancer

UR - http://www.scopus.com/inward/record.url?scp=84880918721&partnerID=8YFLogxK

UR - http://www.scopus.com/inward/citedby.url?scp=84880918721&partnerID=8YFLogxK

U2 - 10.1007/s10637-013-9936-9

DO - 10.1007/s10637-013-9936-9

M3 - Article

C2 - 23417697

AN - SCOPUS:84880918721

VL - 31

SP - 1035

EP - 1043

JO - Investigational New Drugs

JF - Investigational New Drugs

SN - 0167-6997

IS - 4

ER -