Phase II Study of Consolidation Amrubicin After Concurrent Chemoradiotherapy in Patients With Limited-stage Small-cell Lung Cancer.


Journal

In vivo (Athens, Greece)
ISSN: 1791-7549
Titre abrégé: In Vivo
Pays: Greece
ID NLM: 8806809

Informations de publication

Date de publication:
Historique:
received: 11 11 2019
revised: 28 11 2019
accepted: 29 11 2019
entrez: 1 3 2020
pubmed: 1 3 2020
medline: 15 12 2020
Statut: ppublish

Résumé

Concurrent chemoradiotherapy (CCRT) is the gold standard for limited-stage small-cell lung cancer (LS-SCLC); however, most patients inevitably experience relapse. We hypothesized consolidation amrubicin following CCRT to be a potential treatment for LS-SCLC. All enrolled patients were treated using induction CCRT consisting of four cycles of etoposide and cisplatin plus concurrent thoracic radiotherapy. Eligible patients then received three cycles of amrubicin as consolidation therapy (consolidation population). The primary endpoint was the 2-year progression-free survival rate in the consolidation population. Of the 36 intention-to-treat patients, 28 (78%) received amrubicin and 24 (67%) completed all planned treatments. The 2-year progression-free survival rate and overall response rate were 35.7% and 86%, respectively. The median progression-free and overall survival were 14.3 and 60.9 months, respectively. There were no treatment-related deaths in the intention-to-treat population. This study was terminated due to slow patient accrual; however, this treatment strategy was feasible and demonstrated promising efficacy.

Sections du résumé

BACKGROUND BACKGROUND
Concurrent chemoradiotherapy (CCRT) is the gold standard for limited-stage small-cell lung cancer (LS-SCLC); however, most patients inevitably experience relapse. We hypothesized consolidation amrubicin following CCRT to be a potential treatment for LS-SCLC.
PATIENTS AND METHODS METHODS
All enrolled patients were treated using induction CCRT consisting of four cycles of etoposide and cisplatin plus concurrent thoracic radiotherapy. Eligible patients then received three cycles of amrubicin as consolidation therapy (consolidation population). The primary endpoint was the 2-year progression-free survival rate in the consolidation population.
RESULTS RESULTS
Of the 36 intention-to-treat patients, 28 (78%) received amrubicin and 24 (67%) completed all planned treatments. The 2-year progression-free survival rate and overall response rate were 35.7% and 86%, respectively. The median progression-free and overall survival were 14.3 and 60.9 months, respectively. There were no treatment-related deaths in the intention-to-treat population.
CONCLUSION CONCLUSIONS
This study was terminated due to slow patient accrual; however, this treatment strategy was feasible and demonstrated promising efficacy.

Identifiants

pubmed: 32111801
pii: 34/2/897
doi: 10.21873/invivo.11855
pmc: PMC7157837
doi:

Substances chimiques

Anthracyclines 0
Antineoplastic Agents 0
amrubicin 93N13LB4Z2

Types de publication

Clinical Trial, Phase II Journal Article

Langues

eng

Sous-ensembles de citation

IM

Pagination

897-902

Informations de copyright

Copyright© 2020, International Institute of Anticancer Research (Dr. George J. Delinasios), All rights reserved.

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Auteurs

Hironori Yoshida (H)

Department of Respiratory Medicine, Graduate School of Medicine, Kyoto University, Kyoto, Japan.

Hiroki Nagai (H)

Department of Therapeutic Oncology, Graduate School of Medicine, Kyoto University, Kyoto, Japan.

Yuichi Sakamori (Y)

Department of Therapeutic Oncology, Graduate School of Medicine, Kyoto University, Kyoto, Japan.

Hiroaki Ozasa (H)

Department of Respiratory Medicine, Graduate School of Medicine, Kyoto University, Kyoto, Japan.

Takashi Nishimura (T)

Department of Respiratory Medicine, Kyoto Katsura Hospital, Kyoto, Japan.

Keisuke Tomii (K)

Department of Respiratory Medicine, Kobe City Medical Center General Hospital, Kobe, Japan.

Toyohiro Hirai (T)

Department of Respiratory Medicine, Graduate School of Medicine, Kyoto University, Kyoto, Japan.

Yukinori Matsuo (Y)

Department of Radiation Oncology and Image-applied Therapy, Graduate School of Medicine, Kyoto University, Kyoto, Japan.

Yusuke Iizuka (Y)

Department of Radiation Oncology and Image-applied Therapy, Graduate School of Medicine, Kyoto University, Kyoto, Japan.

Takashi Mizowaki (T)

Department of Radiation Oncology and Image-applied Therapy, Graduate School of Medicine, Kyoto University, Kyoto, Japan.

Kenichi Yoshimura (K)

Center for Integrated Medical Research, Hiroshima University Hospital, Hiroshima University, Hiroshima, Japan.

Young Hak Kim (YH)

Department of Respiratory Medicine, Graduate School of Medicine, Kyoto University, Kyoto, Japan ekim@kuhp.kyoto-u.ac.jp.

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Classifications MeSH