Multicriteria Decision Analysis (MCDA) comprises a set of methods that support decision making in Health Technology Assessment (HTA). MCDA studies that support the incorporation of new treatments for non-metastatic HER2-positive breast cancer are still rare.
Objective
To elaborate a MCDA comparing 8 treatments alternatives for women with non-metastatic, HER2+, hormone receptor positive (HR+), postmenopausal breast cancer, who did not achieve a pathological complete response (PCR) after neoadjuvant chemotherapy with taxane plus anti-HER2 therapy.
Methods
An MCDA approach specifically built for application in oncology was used. The study was developed at the Cancer Institute of the State of São Paulo (ICESP) according to the International Society for Pharmacoeconomics and Outcomes Research (ISPOR) recommendations.
Results
It was possible to obtain a ranking of the 8 alternatives: the first, second and third position were respectively: neoadjuvant treatment without anthracycline and anti-HER2 therapy with only trastuzumab followed by adjuvant trastuzumab (global value 0.739); neoadjuvant treatment with anthracycline and anti-HER2 trastuzumab alone followed by adjuvant trastuzumab (global value 0.717) and neoadjuvant treament with anthracycline plus trastuzumab alone or double anti-HER2 blockade with trastuzumab and pertuzumab, followed by adjuvant T-DM1 (global value 0.697). The criteria that received the greatest weight from stakeholders were in descending order: disease-free survival, cost, severity of the disease, adverse reactions and overall survival.
Conclusion
MCDA made it possible to compare treatment alternatives for non-metastatic, HER2+, HR + breast cancer, with the most innovative technology T-DM1 appearing fourth.
RosaDDAssadDXBinesJ, et al.Mama: doença localizada – neoadjuvância. Diretrizes de tratamentos oncológicos recomendados pela Sociedade Brasileira de Oncologia Clínica. 2022.
2.
HoffPMGDizMDPETestaL. Manual de Condutas em Oncologia. São Paulo: Atheneu, 2019.
3.
Von MinckwitzGHuangCSManoMS, et al.Trastuzumab Emtansine for Residual Invasive HER2-Positive Breast Cancer. N Engl J Med2019; 380: 617–628.
4.
RosaDDAssadDXBinesJ, et al.Mama: doença localizada adjuvância. Diretrizes de tratamentos oncológicos recomendados pela Sociedade Brasileira de Oncologia Clínica. 2022.
5.
PaimJTravassosCAlmeidaC, et al.The Brazilian health system: history, advances, and challenges. Lancet2011; 9779: 1778–1797.
6.
Ministério da Saúde (Brasil). Entendendo a incorporação de tecnologias em saúde no SUS: como se envolver, vol. 1. Brasília: Ministério da Saúde, Secretaria de Ciência, Tecnologia e Insumos Estratégicos; 2016. p. 34.
7.
Magalhães FilhoMAAguiarPNJr, et al.Cost-effectiveness analysis of Ado-trastuzumab emtansine for the treatment of residual invasive HER2-positive breast cancer. Einstein (São Paulo)2022; 20: 1–6.
8.
Comissão Nacional de Incorporação de Tecnologias no Sistema Único de Saúde - CONITEC. Trastuzumabe entansina no tratamento adjuvante do câncer de mama HER2-positivo operado em estádio III com doença residual na peça cirúrgica após tratamento neoadjuvante. Relatório 751. 2022.
9.
MarshKGoetghebeurMThokalaP, et al.Multi-Criteria Decision Analysis to Support Healthcare Decisions. Cham: Springer, 2017.
10.
ThokalaPDuenasA. Multiple criteria decision analysis for health technology assessment. Value Heal2012; 15: 1172–1181.
11.
CampolinaAGEstevez-DinizMDPAbeJM, et al.Multiple criteria decision analysis (MCDA) for evaluating cancer treatments in hospital based health technology assessment: the paraconsistent value framework. PLoS One2022; 17: e0268584.
12.
YoungkongSBaltussenRTantivessS, et al.Multicriteria decision analysis for including health interventions in the universal health coverage benefit package in Thailand. Value Heal2012; 15: 961–970.
13.
AngelisAKanavosP. Multiple criteria decision analysis (MCDA) for evaluating new medicines in health technology assessment and beyond: the advance value framework. Soc. Sci. Med2017; 188: 137–156.
14.
MarshKIjzermanMThokalaP, et al.Multiple criteria decision analysis for health care decision making - emerging good practices: report 2 of the ISPOR MCDA emerging good practices task force. Value Heal2016; 19: 125–137.
15.
ThokalaPDevlinNMarshK, et al.Multiple criteria decision analysis for health care decision making - an introduction: report 1 of the ISPOR MCDA emerging good practices task force. Value Heal2016; 19: 1–13.
16.
JoensuuHBonoPKellokumpu-LehtinenP, et al.Fluorouracil, epirubicin, and cyclophosphamide with either docetaxel or vinorelbine, with or without trastuzumab, as adjuvant treatments of breast cancer: final results of the FinHer Trial. J Clin Oncol2019; 27: 5685–5692.
17.
RomondEHPerez EdithABryantJ, et al.Trastuzumab plus adjuvant chemotherapy for operable HER2-positive breast cancer. N Engl J Med2005. 353: 1673–1684.
18.
SpielmannMRochéHDelozierT, et al.Trastuzumab for patients with axillary-node-positive breast cancer: results of the FNCLCC-PACS 04 trial. J Clin Oncol2009; 27: 6129–6134.
19.
SallesGSeymourJFOffnerF, et al.Rituximab maintenance for 2 years in patients with high tumour burden follicular lymphoma responding to rituximab plus chemotherapy (PRIMA): a phase 3, randomised controlled trial. Lancet2011; 377: 42–51.
20.
Van OersMHKlasaRMarcus RobertE, et al.Rituximab maintenance improves clinical outcome of relapsed/resistant follicular non-hodgkin lymphoma in patients both with and without rituximab during induction: results of a prospective randomized phase 3 intergroup trial. Blood2006; 108: 3295–3301.
21.
ForstpointnerRMichaelUMartinD, et al. Maintenance therapy with rituximab leads to a significant prolongation of response duration after salvage therapy with a combination of rituximab, fludarabine, cyclophosphamide, and mitoxantrone (R-FCM) in patients with recurring and refractory follicular and mantle cell lymphomas: results of aprospective randomized study of the German low grade lymphoma study group (GLSG).Blood2006; 108: 4003–4008.
22.
ArdeshnaKM, et al.An intergroup randomised trial of rituximab versus a watch and wait strategy in patients with stage II, III, IV, asymptomatic, non-bulky follicular lymphoma (grades 1, 2 and 3a).rituximab versus a watch-and-wait approach in patients with advanced-stage, asymptomatic, non-bulky follicular lymphoma: an open-label randomised phase 3 trial. Lancet Oncol2014; 15: 424–435.
23.
HainsworthJD, et al.Maximizing therapeutic benefit of rituximab: maintenance therapy versus re-treatment at progression in patients with indolent non hodgkin’s lymphoma—a randomized phase II trial of the minnie pearl cancer research network. J Clin Oncol2005; 23: 1088–1095.
24.
HochsterH, et al.Maintenance rituximab after cyclophosphamide, vincristine, and prednisone prolongs progression-free survival in advanced indolent lymphoma: results of the randomized phase III ECOG1496 study. J Clin Oncol2009; 27: 1607–1614.
25.
GrobJJ, et al.Randomised trial of interferon alpha-2a as adjuvant therapy in resected primary melanoma thicker than 1.5 mm without clinically detectable node metastases. French cooperative group on melanoma. Lancet1998; 351: 1905–1910.
26.
SemiglazovV, et al.Anastrazole vs tamoxifen vs combination as neoadjuvant endocrine therapy of postmenopausal breast cancer patients. J Clin Oncol2003; 22: 880. abstract 3538.
27.
StuppRHegiMEMasonWP, et al.Effects of radiotherapy with concomitant and adjuvant temozolomide versus radiotherapy alone on survival in glioblastoma in a randomised phase III study: 5-year analysis of the EORTC-NCIC trial. Lancet Oncol2009; 10: 459–466.
28.
RobertC, et al.Ipilimumab plus dacarbazine for previously untreated metastatic melanoma. N Engl J Med2011; 364: 2517–2526.
AttalM, et al.Lenalidomide maintenance after stem-cell transplantation for multiple myeloma. N Engl J Med2012 May 10; 366: 1782–1791.
31.
PalumboA, et al.Autologous transplantation and maintenance therapy in multiple myeloma. N Engl J Med2014; 371: 895–905.
32.
JacksonGDaviesFEPawlynC, et al.Lenalidomide Maintenance Significantly Improves Outcomes Compared to Observation Irrespective of Cytogenetic Risk: Results of the Myeloma XI Trial. Blood2017; 130: 436.
33.
JacksonGH, et al.Lenalidomide before and after autologous stem cell transplantation for transplant-eligible patients of all ages in the randomized, phase III, myeloma XI trial. Haematologica2021; 106: 1957–1967.
34.
HallekM, et al.Addition of rituximab to fludarabine and cyclophosphamide in patients with chronic lymphocytic leukaemia: a randomised, open-label, phase 3 trial. Lancet2010; 376: 1164–1174.
35.
Comissão Nacional de Incorporação de Tecnologias no Sistema Único de Saúde - CONITEC. Trastuzumabe para tratamento do câncer de mama inicial. Relatório 7. 2012.
36.
Comissão Nacional de Incorporação de Tecnologias no Sistema Único de Saúde - CONITEC. Rituximabe para o tratamento de Linfoma não Hodgkin de células B, folicular, CD20 positivo, em 1ª e 2ª linha. Relatório 81. 2013.
37.
Comissão Nacional de Incorporação de Tecnologias no Sistema Único de Saúde - CONITEC. Quimioterapia adjuvante com alfainterferona no tratamento do melanoma cutâneo. N° 17. 2013.
38.
Comissão Nacional de Incorporação de Tecnologias no Sistema Único de Saúde - CONITEC. Hormonioterapia prévia (neoadjuvante, pré-operatória) no câncer de mama. N° 116. 2014.
39.
Comissão Nacional de Incorporação de Tecnologias no Sistema Único de Saúde - CONITEC. Temozolomida para o tratamento adjuvante de pacientes portadores de Gliomas de Alto Grau. N° 104. 2014.
40.
Comissão Nacional de Incorporação de Tecnologias no Sistema Único de Saúde - CONITEC. Ipilimumabe para tratamento de pacientes com melanoma metastático. N° 391. 2018.
41.
Comissão Nacional de Incorporação de Tecnologias no Sistema Único de Saúde - CONITEC. Lenalidomida para terapia de manutenção em pacientes com mieloma múltiplo submetidos ao transplante de células-tronco hematopoiéticas. N° 700.
42.
Comissão Nacional de Incorporação de Tecnologias no Sistema Único de Saúde - CONITEC. Rituximabe associado à quimioterapia com fludarabina e ciclofosfamida para o tratamento de primeira linha da leucemia linfocítica crônica. N° 838. 2023.
43.
KyuHH, et al.Global, regional, and national disability-adjusted life-years (DALYs) for 359 diseases and injuries and healthy life expectancy (HALE) for 195 countries and territories, 1990–2017: a systematic analysis for the global burden of disease study 2017. Lancet2018; 392: 1859–1922. pmid:30415748.
44.
MamounasEP, et al.Adjuvant T-DM1 versus trastuzumab in patients with residual invasive disease after neoadjuvant therapy for HER2-positive breast cancer: subgroup analyses from KATHERINE. Ann Oncol2021; 32: 1005–1014.
45.
LoiblS, et al.Phase III study of adjuvant Ado-trastuzumab emtansine vs trastuzumab for residual invasive HER2-positive early breast cancer after neoadjuvant chemotherapy and HER2-targeted therapy: KATHERINE final IDFS and updated OS analysis. In Presented at: 2023 San Antonio Breast Cancer Symposium. December 5-9, 2023; San Antonio, TX. Abstract GS03-12.
46.
YauC, et al.Residual cancer burden after neoadjuvant chemotherapy and long-term survival outcomes in breast cancer: a multicentre pooled analysis of 5161 patients. Lancet Oncol.2022. 23 , 149–160. Jan 1.
