Comparative effectiveness and safety of monoclonal antibodies for mCRC

Wânia Cristina da Silva, Francisco de Assis Acurcio, Brian Godman, Vânia Eloisa de Araújo, Ellias Magalhães Abreu Lima, Jéssica Barreto dos Santos, Michael Ruberson Silva, Paulo Henrique Ribeiro Fernandes Almeida, Amanj Kurdi, Mariângela Leal Cherchiglia, Eli Iola Gurgel Andrade

Research output: Contribution to conferenceAbstract

Abstract

Introduction: Biological medicines are increasingly used in combination with chemotherapy for patients with metastatic colorectal cancer (mCRC), resulting in increased progression-free survival (PFS). However, concerns remain over the extent of their effect on overall survival (OS) given the high costs of these monoclonal antibodies (MoAbs) (bevacizumab, cetuximab and panitumumab) and their safety. Published studies suggest no major differences in effectiveness and safety between the MoAbs; however, differences in costs with cetuximab more expensive than bevacizumab by 127% in Brazil and more expensive than panitumumab by 112%, with panitumumab more expensive than bevacizumab by 6%. Since there is rising litigation in Brazil in order to access these 3 MoAbs as they are not currently reimbursed, we wanted to compare their effectiveness and safety associated with chemotherapy or chemotherapy alone in patients with mCRC to provide future guidance to the judiciary and the healthcare system. Method: A systematic review and meta-analysis based on cohort studies published in databases up to November 2017. Effectiveness measures include PFS, post-progression survival (PPS), RECIST (Response Evaluation Criteria In Solid Tumors), response rates, metastasectomy rates, OS and safety. We also evaluated the methodological quality of the studies. Results: Overall, 21 observational cohort studies were included in the review. There were statistically significant and clinically relevant benefits in patients treated with bevacizumab versus those not treated with bevacizumab (no bevacizumab arm) mainly around PFS, PPS, metastasectomy rates and OS, but not for disease control rates. However, bevacizumab increased toxicities and there were concerns with the heterogeneity of the studies. Conclusion: The results suggested an advantage in favour of bevacizumab for a number of outcome measures and costs in patients with mCRC. However, this advantage may be only clinically modest for bevacizumab. This though has to be weighed against the serious adverse events associated with bevacizumab, especially severe hypertension and gastrointestinal perforations
LanguageEnglish
Number of pages1
Publication statusAccepted/In press - 1 Feb 2019
EventHTAi Cologne, Germany - Cologne, Germany
Duration: 15 Jun 201919 Jun 2019
http://www.htai2019.org/

Conference

ConferenceHTAi Cologne, Germany
CountryGermany
CityCologne
Period15/06/1919/06/19
Internet address

Fingerprint

Colorectal Neoplasms
Monoclonal Antibodies
Safety
Metastasectomy
Disease-Free Survival
Costs and Cost Analysis
Brazil
Survival
Cohort Studies
Survival Rate
Bevacizumab
Drug Therapy
Jurisprudence
Combination Drug Therapy
Observational Studies
Meta-Analysis
Outcome Assessment (Health Care)
Databases
Hypertension
Delivery of Health Care

Keywords

  • chemotherapy
  • overall survival
  • monoclonal antibodies

Cite this

da Silva, W. C., de Assis Acurcio, F., Godman, B., de Araújo, V. E., Lima, E. M. A., dos Santos, J. B., ... Gurgel Andrade, E. I. (Accepted/In press). Comparative effectiveness and safety of monoclonal antibodies for mCRC. Abstract from HTAi Cologne, Germany, Cologne, Germany.
da Silva, Wânia Cristina ; de Assis Acurcio, Francisco ; Godman, Brian ; de Araújo, Vânia Eloisa ; Lima, Ellias Magalhães Abreu ; dos Santos, Jéssica Barreto ; Silva, Michael Ruberson ; Almeida, Paulo Henrique Ribeiro Fernandes ; Kurdi, Amanj ; Cherchiglia, Mariângela Leal ; Gurgel Andrade, Eli Iola. / Comparative effectiveness and safety of monoclonal antibodies for mCRC. Abstract from HTAi Cologne, Germany, Cologne, Germany.1 p.
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title = "Comparative effectiveness and safety of monoclonal antibodies for mCRC",
abstract = "Introduction: Biological medicines are increasingly used in combination with chemotherapy for patients with metastatic colorectal cancer (mCRC), resulting in increased progression-free survival (PFS). However, concerns remain over the extent of their effect on overall survival (OS) given the high costs of these monoclonal antibodies (MoAbs) (bevacizumab, cetuximab and panitumumab) and their safety. Published studies suggest no major differences in effectiveness and safety between the MoAbs; however, differences in costs with cetuximab more expensive than bevacizumab by 127{\%} in Brazil and more expensive than panitumumab by 112{\%}, with panitumumab more expensive than bevacizumab by 6{\%}. Since there is rising litigation in Brazil in order to access these 3 MoAbs as they are not currently reimbursed, we wanted to compare their effectiveness and safety associated with chemotherapy or chemotherapy alone in patients with mCRC to provide future guidance to the judiciary and the healthcare system. Method: A systematic review and meta-analysis based on cohort studies published in databases up to November 2017. Effectiveness measures include PFS, post-progression survival (PPS), RECIST (Response Evaluation Criteria In Solid Tumors), response rates, metastasectomy rates, OS and safety. We also evaluated the methodological quality of the studies. Results: Overall, 21 observational cohort studies were included in the review. There were statistically significant and clinically relevant benefits in patients treated with bevacizumab versus those not treated with bevacizumab (no bevacizumab arm) mainly around PFS, PPS, metastasectomy rates and OS, but not for disease control rates. However, bevacizumab increased toxicities and there were concerns with the heterogeneity of the studies. Conclusion: The results suggested an advantage in favour of bevacizumab for a number of outcome measures and costs in patients with mCRC. However, this advantage may be only clinically modest for bevacizumab. This though has to be weighed against the serious adverse events associated with bevacizumab, especially severe hypertension and gastrointestinal perforations",
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da Silva, WC, de Assis Acurcio, F, Godman, B, de Araújo, VE, Lima, EMA, dos Santos, JB, Silva, MR, Almeida, PHRF, Kurdi, A, Cherchiglia, ML & Gurgel Andrade, EI 2019, 'Comparative effectiveness and safety of monoclonal antibodies for mCRC' HTAi Cologne, Germany, Cologne, Germany, 15/06/19 - 19/06/19, .

Comparative effectiveness and safety of monoclonal antibodies for mCRC. / da Silva, Wânia Cristina ; de Assis Acurcio, Francisco; Godman, Brian; de Araújo, Vânia Eloisa; Lima, Ellias Magalhães Abreu; dos Santos, Jéssica Barreto; Silva, Michael Ruberson; Almeida, Paulo Henrique Ribeiro Fernandes; Kurdi, Amanj; Cherchiglia, Mariângela Leal; Gurgel Andrade, Eli Iola.

2019. Abstract from HTAi Cologne, Germany, Cologne, Germany.

Research output: Contribution to conferenceAbstract

TY - CONF

T1 - Comparative effectiveness and safety of monoclonal antibodies for mCRC

AU - da Silva, Wânia Cristina

AU - de Assis Acurcio, Francisco

AU - Godman, Brian

AU - de Araújo, Vânia Eloisa

AU - Lima, Ellias Magalhães Abreu

AU - dos Santos, Jéssica Barreto

AU - Silva, Michael Ruberson

AU - Almeida, Paulo Henrique Ribeiro Fernandes

AU - Kurdi, Amanj

AU - Cherchiglia, Mariângela Leal

AU - Gurgel Andrade, Eli Iola

PY - 2019/2/1

Y1 - 2019/2/1

N2 - Introduction: Biological medicines are increasingly used in combination with chemotherapy for patients with metastatic colorectal cancer (mCRC), resulting in increased progression-free survival (PFS). However, concerns remain over the extent of their effect on overall survival (OS) given the high costs of these monoclonal antibodies (MoAbs) (bevacizumab, cetuximab and panitumumab) and their safety. Published studies suggest no major differences in effectiveness and safety between the MoAbs; however, differences in costs with cetuximab more expensive than bevacizumab by 127% in Brazil and more expensive than panitumumab by 112%, with panitumumab more expensive than bevacizumab by 6%. Since there is rising litigation in Brazil in order to access these 3 MoAbs as they are not currently reimbursed, we wanted to compare their effectiveness and safety associated with chemotherapy or chemotherapy alone in patients with mCRC to provide future guidance to the judiciary and the healthcare system. Method: A systematic review and meta-analysis based on cohort studies published in databases up to November 2017. Effectiveness measures include PFS, post-progression survival (PPS), RECIST (Response Evaluation Criteria In Solid Tumors), response rates, metastasectomy rates, OS and safety. We also evaluated the methodological quality of the studies. Results: Overall, 21 observational cohort studies were included in the review. There were statistically significant and clinically relevant benefits in patients treated with bevacizumab versus those not treated with bevacizumab (no bevacizumab arm) mainly around PFS, PPS, metastasectomy rates and OS, but not for disease control rates. However, bevacizumab increased toxicities and there were concerns with the heterogeneity of the studies. Conclusion: The results suggested an advantage in favour of bevacizumab for a number of outcome measures and costs in patients with mCRC. However, this advantage may be only clinically modest for bevacizumab. This though has to be weighed against the serious adverse events associated with bevacizumab, especially severe hypertension and gastrointestinal perforations

AB - Introduction: Biological medicines are increasingly used in combination with chemotherapy for patients with metastatic colorectal cancer (mCRC), resulting in increased progression-free survival (PFS). However, concerns remain over the extent of their effect on overall survival (OS) given the high costs of these monoclonal antibodies (MoAbs) (bevacizumab, cetuximab and panitumumab) and their safety. Published studies suggest no major differences in effectiveness and safety between the MoAbs; however, differences in costs with cetuximab more expensive than bevacizumab by 127% in Brazil and more expensive than panitumumab by 112%, with panitumumab more expensive than bevacizumab by 6%. Since there is rising litigation in Brazil in order to access these 3 MoAbs as they are not currently reimbursed, we wanted to compare their effectiveness and safety associated with chemotherapy or chemotherapy alone in patients with mCRC to provide future guidance to the judiciary and the healthcare system. Method: A systematic review and meta-analysis based on cohort studies published in databases up to November 2017. Effectiveness measures include PFS, post-progression survival (PPS), RECIST (Response Evaluation Criteria In Solid Tumors), response rates, metastasectomy rates, OS and safety. We also evaluated the methodological quality of the studies. Results: Overall, 21 observational cohort studies were included in the review. There were statistically significant and clinically relevant benefits in patients treated with bevacizumab versus those not treated with bevacizumab (no bevacizumab arm) mainly around PFS, PPS, metastasectomy rates and OS, but not for disease control rates. However, bevacizumab increased toxicities and there were concerns with the heterogeneity of the studies. Conclusion: The results suggested an advantage in favour of bevacizumab for a number of outcome measures and costs in patients with mCRC. However, this advantage may be only clinically modest for bevacizumab. This though has to be weighed against the serious adverse events associated with bevacizumab, especially severe hypertension and gastrointestinal perforations

KW - chemotherapy

KW - overall survival

KW - monoclonal antibodies

UR - http://htai2019.org/

M3 - Abstract

ER -

da Silva WC, de Assis Acurcio F, Godman B, de Araújo VE, Lima EMA, dos Santos JB et al. Comparative effectiveness and safety of monoclonal antibodies for mCRC. 2019. Abstract from HTAi Cologne, Germany, Cologne, Germany.