PMID- 27571499
OWN - NLM
STAT- MEDLINE
DCOM- 20171013
LR  - 20181202
IS  - 2171-8695 (Electronic)
IS  - 1130-6343 (Linking)
VI  - 40
IP  - 4
DP  - 2016 Jun 1
TI  - Nintedanib in combination with docetaxel for second-line treatment of advanced 
      non-small-cell lung cancer; GENESIS-SEFH drug evaluation report.
PG  - 316-27
LID - 10.7399/fh.2016.40.4.10455 [doi]
AB  - Nintedanib is a triple angiokinase inhibitor that has been approved by the 
      European Agency Medicines (EMA) in combination with docetaxel for the treatment 
      of adult patients with locally advanced, metastatic or locally recurrent non 
      small cell lung cancer (NSCLC) of adenocarcinoma tumour histology, after 
      first-line chemotherapy. In LUME-Lung 1 clinical trial, the combination of 
      nintedanib plus docetaxel vs. placebo plus docetaxel improved progression free 
      survival (PFS) in NSCLC patients, and improved overall survival in the population 
      of adenocarcinoma patients, particularly in those with progression within 9 
      months after first line treatment initiation, median 10.9 months ( [95% CI 
      8.5-12.6] vs. 7.9 months [6.7-9.1]; HR 0.75 [95% CI 0.60-0.92], p=0.0073). The 
      toxicity profile of the combination included a higher incidence of neutropenia, 
      gastro-intestinal (GI) disorders, and liver enzyme elevations; however, this did 
      not cause a detrimental effect on patient quality of life. According to data from 
      the clinical trial mentioned, the addition of nintedanib to docetaxel would lead 
      to an estimated incremental cost-effectiveness ratio (ICER) per year of life with 
      PFS in the overall population of 134,274.47 euro (notified price). In the 
      adenocarcinoma population per each life of year gained (LYG), the ICER of adding 
      nintedanib to docetaxel would be 40,886.14 euro; while by implementing a sensitivity 
      analysis with a 25% discount in the drug price, the cost per LYG would be 
      32,364.05 euro, and would place it close to the threshold of cost-effectiveness 
      usually considered acceptable in our setting. In view of efficacy and safety 
      results the proposed positioning is to recommend its inclusion in the Hospital 
      Formulary only for adult patients with metastatic or locally recurrent NSCLC with 
      adenocarcinoma histology after first line chemotherapy, with progression < 9 
      months from the initiation of first line treatment, taking into account the 
      inclusion and exclusion criteria in the pivotal clinical trial.
CI  - Copyright AULA MEDICA EDICIONES 2014. Published by AULA MEDICA. All rights 
      reserved.
FAU - Espinosa Bosch, Maria
AU  - Espinosa Bosch M
AD  - Hospital Regional de Malaga, Malaga.. maria.espinosa.sspa@juntadeandalucia.es.
FAU - Asensi Diez, Rocio
AU  - Asensi Diez R
AD  - Hospital Regional de Malaga, Malaga.. maria.espinosa.sspa@juntadeandalucia.es.
FAU - Garcia Agudo, Sara
AU  - Garcia Agudo S
AD  - Hospital Regional de Malaga, Malaga.. maria.espinosa.sspa@juntadeandalucia.es.
FAU - Clopes Estela, Ana
AU  - Clopes Estela A
AD  - Hospital Duran I Reynals. Institut Catala d'Oncologia. Hospitalet, Barcelona. 
      Spain.. maria.espinosa.sspa@juntadeandalucia.es.
LA  - eng
PT  - Journal Article
PT  - Randomized Controlled Trial
TT  - Nintedanib en combinacion con docetaxel como segunda linea de tratamiento del 
      cancer de pulmon no microcitico localmente avanzado; informe de evaluacion 
      GENESIS-SEFH.
DEP - 20160601
PL  - Spain
TA  - Farm Hosp
JT  - Farmacia hospitalaria : organo oficial de expresion cientifica de la Sociedad 
      Espanola de Farmacia Hospitalaria
JID - 9440679
RN  - 0 (Antineoplastic Agents)
RN  - 0 (Antineoplastic Agents, Phytogenic)
RN  - 0 (Indoles)
RN  - 0 (Taxoids)
RN  - 15H5577CQD (Docetaxel)
RN  - G6HRD2P839 (nintedanib)
SB  - IM
MH  - Antineoplastic Agents/administration & dosage
MH  - Antineoplastic Agents, Phytogenic/administration & dosage
MH  - Antineoplastic Combined Chemotherapy Protocols/administration & 
      dosage/economics/*therapeutic use
MH  - Carcinoma, Non-Small-Cell Lung/*drug therapy/economics
MH  - Cost-Benefit Analysis
MH  - Disease-Free Survival
MH  - Docetaxel
MH  - Humans
MH  - Indoles/administration & dosage
MH  - Lung Neoplasms/*drug therapy/economics
MH  - Taxoids/administration & dosage
MH  - Treatment Outcome
EDAT- 2016/08/30 06:00
MHDA- 2017/10/14 06:00
CRDT- 2016/08/30 06:00
PHST- 2016/08/30 06:00 [entrez]
PHST- 2016/08/30 06:00 [pubmed]
PHST- 2017/10/14 06:00 [medline]
AID - 10.7399/fh.2016.40.4.10455 [doi]
PST - epublish
SO  - Farm Hosp. 2016 Jun 1;40(4):316-27. doi: 10.7399/fh.2016.40.4.10455.