Regorafenib indicated as monotherapy for the treatment of adult patients with hepatocellular carcinoma who have been previously treated with sorafenib. EUnetHTA adopted HTA report.
AETSA
Record ID 32018000387
English, Spanish
Original Title:
Regorafenib en monoterapia en pacientes con carcinoma hepatocelular previamente tratados con sorafenib
Authors' results and conclusions:
This extension of indication is based on a single randomised pivotal trial (the RESORCE study), which demonstrated that regorafenib plus BSC is more effective than placebo plus BSC in terms of OS in a selected population that tolerated sorafenib treatment and with a preserved general state (ECOG 0-1; Child-Pugh A). However, the addition of regorafenib to BSC induced a modest gain in terms of median OS (+2.8 months) that must be seen in view of the worsened safety profile, notably in terms of Grade ≥3 AEs, SAEs and AEs leading to dose modification or reduction.
Given the poor prognosis of these patients and their general health status observed in clinical practice, HRQoL is also considered as a critical clinical endpoint. In view of the exploratory design of this endpoint, the conclusion on quality of life is greatly limited, which is regrettable.
The stringent eligibility criteria of the RESORCE study result in the non-inclusion of a subset of patients, such as those who did not tolerate sorafenib or those with a deteriorated general health status (ECOG >1) or a Child-Pugh score of B or C, or a combination of these. Therefore, patients included in the RESORCE trial only partially reflect patients seen in clinical practice and the benefit of regorafenib cannot be assessed in these fragile populations.
Authors' identified further research:
Further research or data collection are deemed necessary to evaluate the use of regorafenib in these specific subgroups.
Details
Project Status:
Completed
Year Published:
2018
URL for published report:
https://www.aetsa.org/publicacion/regorafenib-en-monoterapia-en-pacientes-con-carcinoma-hepatocelular-previamente-tratados-con-sorafenib/
Requestor:
Consejería de Salud. Junta de Andalucía
English language abstract:
An English language summary is available
Publication Type:
Other
Country:
Spain
MeSH Terms
- Carcinoma, Hepatocellular
- Drug Therapy
- Quality of Life
Contact
Organisation Name:
Andalusian Health Technology Assessment Area
Contact Address:
Area de Evaluacion de Tecnologias Sanitarias Sanitarias de Andalucia (AETSA) Avda. Innovación, s/n Edificio Arena 1. Sevilla (Spain) Tel. +34 955 006 309
Contact Name:
aetsa.csalud@juntadeandalucia.es
Contact Email:
aetsa.csalud@juntadeandalucia.es
Copyright:
AETSA, Andalusian Health Technology Assessment Area
This is a bibliographic record of a published health technology assessment from a member of INAHTA or other HTA producer. No evaluation of the quality of this assessment has been made for the HTA database.