Accelerated hypofractionated radiotherapy plus chemotherapy for inoperable locally advanced non-small-cell lung cancer: final results of a prospective phase-II trial with a long-term follow-up.
Adenocarcinoma
/ pathology
Adult
Aged
Antineoplastic Combined Chemotherapy Protocols
/ therapeutic use
Carcinoma, Non-Small-Cell Lung
/ pathology
Carcinoma, Squamous Cell
/ pathology
Chemoradiotherapy
/ mortality
Cisplatin
/ administration & dosage
Docetaxel
/ administration & dosage
Female
Humans
Lung Neoplasms
/ pathology
Male
Middle Aged
Prognosis
Prospective Studies
Radiation Dose Hypofractionation
Survival Rate
Accelerated hypofractionation
Inoperable locally advanced non-small-cell lung cancer
Intensity modulated arc therapy (IMAT)
Radiotherapy and chemotherapy
Journal
Radiation oncology (London, England)
ISSN: 1748-717X
Titre abrégé: Radiat Oncol
Pays: England
ID NLM: 101265111
Informations de publication
Date de publication:
24 Jun 2019
24 Jun 2019
Historique:
received:
24
12
2018
accepted:
06
06
2019
entrez:
26
6
2019
pubmed:
27
6
2019
medline:
21
12
2019
Statut:
epublish
Résumé
Concurrent chemotherapy and radiation using conventional fractionation is the standard treatment for inoperable, locally advanced non-small-cell lung cancer (NSCLC). We tested accelerated hypofractionated radiotherapy (AHR) and chemotherapy for the treatment of locally advanced NSCLC. Eligible patients with locally advanced NSCLC were treated with induction chemotherapy (cisplatin and docetaxel), followed by AHR using tomotherapy and consolidation chemotherapy. The prescribed doses were 30 Gy/5 daily fractions at the reference isodose (60-70%) to the tumor, and 25 Gy/5 daily fractions to the clinically involved lymph nodes. The primary end-point was response rate (RR); the secondary end-points were acute and late side-effects, local progression-free survival (PFS), metastasis-free survival (MFS) and overall survival (OS). This trial closed before the first planned interim analysis due to poor accrual. From January 2009 to January 2012, 17 of the 23 enrolled patients were evaluable. Treatment yielded an overall RR of 82%. Median follow-up was 87 months (range: 6-87), local PFS was 19.8 months (95% CI 9.7 - not reached), MFS was 9.7 months (95% CI 5.8-46.0) and OS was 23 months (95% CI 8.4-48.4). 70% of patients experienced acute G4 neutropenia, 24% G4 leukopenia, 24% G3 paresthesia, 4% G3 cardiac arrythmia, 4% underwent death after chemotherapy. Late toxicity was represented by 24% dyspnea G3. AHR combined with chemotherapy is feasible with no severe side-effects, and it appears highly acceptable by patients. This study is registered with the EudractCT registration 2008-006525-14 . Registered on 9 December 2008.
Sections du résumé
BACKGROUND
BACKGROUND
Concurrent chemotherapy and radiation using conventional fractionation is the standard treatment for inoperable, locally advanced non-small-cell lung cancer (NSCLC). We tested accelerated hypofractionated radiotherapy (AHR) and chemotherapy for the treatment of locally advanced NSCLC.
METHODS
METHODS
Eligible patients with locally advanced NSCLC were treated with induction chemotherapy (cisplatin and docetaxel), followed by AHR using tomotherapy and consolidation chemotherapy. The prescribed doses were 30 Gy/5 daily fractions at the reference isodose (60-70%) to the tumor, and 25 Gy/5 daily fractions to the clinically involved lymph nodes. The primary end-point was response rate (RR); the secondary end-points were acute and late side-effects, local progression-free survival (PFS), metastasis-free survival (MFS) and overall survival (OS). This trial closed before the first planned interim analysis due to poor accrual.
RESULTS
RESULTS
From January 2009 to January 2012, 17 of the 23 enrolled patients were evaluable. Treatment yielded an overall RR of 82%. Median follow-up was 87 months (range: 6-87), local PFS was 19.8 months (95% CI 9.7 - not reached), MFS was 9.7 months (95% CI 5.8-46.0) and OS was 23 months (95% CI 8.4-48.4). 70% of patients experienced acute G4 neutropenia, 24% G4 leukopenia, 24% G3 paresthesia, 4% G3 cardiac arrythmia, 4% underwent death after chemotherapy. Late toxicity was represented by 24% dyspnea G3.
CONCLUSIONS
CONCLUSIONS
AHR combined with chemotherapy is feasible with no severe side-effects, and it appears highly acceptable by patients.
TRIAL REGISTRATION
BACKGROUND
This study is registered with the EudractCT registration 2008-006525-14 . Registered on 9 December 2008.
Identifiants
pubmed: 31234868
doi: 10.1186/s13014-019-1317-x
pii: 10.1186/s13014-019-1317-x
pmc: PMC6591967
doi:
Substances chimiques
Docetaxel
15H5577CQD
Cisplatin
Q20Q21Q62J
Types de publication
Clinical Trial, Phase II
Journal Article
Langues
eng
Sous-ensembles de citation
IM
Pagination
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