Rationale and protocol design for the TORG1835/NEXT-SHIP study: a phase II study of carboplatin, etoposide and nintedanib for unresectable limited/extensive disease small cell lung cancer with idiopathic pulmonary fibrosis.
carboplatin
etoposide
idiopathic pulmonary fibrosis
nintedanib
small cell lung cancer
Journal
Therapeutic advances in medical oncology
ISSN: 1758-8340
Titre abrégé: Ther Adv Med Oncol
Pays: England
ID NLM: 101510808
Informations de publication
Date de publication:
2020
2020
Historique:
received:
09
03
2020
accepted:
10
04
2020
entrez:
4
6
2020
pubmed:
4
6
2020
medline:
4
6
2020
Statut:
epublish
Résumé
Interstitial pneumonia (IP) is one of the most common and poor prognostic comorbidities in patients with small cell lung cancer (SCLC). The pharmacotherapy for SCLC occasionally induces fatal acute exacerbation of comorbid IP, especially in patients with idiopathic pulmonary fibrosis (IPF). Safe and effective pharmacotherapy is of greater importance in patients with SCLC and IPF, because SCLC presents a poor prognosis without systemic treatment. Nintedanib is expected to restrain acute exacerbation and present angiogenesis-inhibiting effects. The TORG1835/NEXT-SHIP study is the world's first multi-center, single-arm, phase II trial for unresectable limited or extensive disease SCLC with IPF. The patients receive carboplatin (area under the curve 5, day 1), etoposide (<75 years old: 100 mg/m Because there is no clinical trial for unresectable SCLC with IPF, our study would provide a major impact on clinical practice. Japan Registry of Clinical Trials, jRCTs031190119, registered date: October 18, 2019 - Retrospectively registered, https://jrct.niph.go.jp/en-latest-detail/jRCTs031190119.
Sections du résumé
BACKGROUND
BACKGROUND
Interstitial pneumonia (IP) is one of the most common and poor prognostic comorbidities in patients with small cell lung cancer (SCLC). The pharmacotherapy for SCLC occasionally induces fatal acute exacerbation of comorbid IP, especially in patients with idiopathic pulmonary fibrosis (IPF). Safe and effective pharmacotherapy is of greater importance in patients with SCLC and IPF, because SCLC presents a poor prognosis without systemic treatment. Nintedanib is expected to restrain acute exacerbation and present angiogenesis-inhibiting effects.
METHODS
METHODS
The TORG1835/NEXT-SHIP study is the world's first multi-center, single-arm, phase II trial for unresectable limited or extensive disease SCLC with IPF. The patients receive carboplatin (area under the curve 5, day 1), etoposide (<75 years old: 100 mg/m
DISCUSSION
CONCLUSIONS
Because there is no clinical trial for unresectable SCLC with IPF, our study would provide a major impact on clinical practice.
TRIAL REGISTRATION
BACKGROUND
Japan Registry of Clinical Trials, jRCTs031190119, registered date: October 18, 2019 - Retrospectively registered, https://jrct.niph.go.jp/en-latest-detail/jRCTs031190119.
Identifiants
pubmed: 32489433
doi: 10.1177/1758835920923431
pii: 10.1177_1758835920923431
pmc: PMC7238300
doi:
Types de publication
Journal Article
Langues
eng
Pagination
1758835920923431Informations de copyright
© The Author(s), 2020.
Déclaration de conflit d'intérêts
Conflict of interest: SI received honoraria from Boehringer Ingelheim. TO received honoraria and research funding from Boehringer Ingelheim. TK received honoraria from Boehringer Ingelheim, Takeda Pharmaceutical, Pfizer, and Bristol-Myers Squibb; and research funding from Pfizer and Bristol-Myers Squibb. HK received honoraria from Boehringer Ingelheim and Bristol-Myers Squibb; and research funding from Boehringer Ingelheim. TI received honoraria from Boehringer Ingelheim. TY received honoraria from Boehringer Ingelheim, Takeda Pharmaceutical, and Pfizer; and research funding from Boehringer Ingelheim and Takeda Pharmaceutical. HO received research funding from Bristol-Myers Squibb and Takeda Pharmaceutical. TM declared no potential conflicts of interest with any companies or organizations whose products or services might be discussed in this article.
Références
Lung Cancer. 2013 Nov;82(2):260-5
pubmed: 24054547
Clin Lung Cancer. 2018 Jan;19(1):e5-e9
pubmed: 28687482
J Thorac Oncol. 2011 Jul;6(7):1242-6
pubmed: 21623239
J Thorac Oncol. 2011 Apr;6(4):801-7
pubmed: 21336181
Oncology. 2012;82(1):19-24
pubmed: 22269348
N Engl J Med. 2014 May 29;370(22):2071-82
pubmed: 24836310
Lancet Oncol. 2014 Feb;15(2):143-55
pubmed: 24411639
Cochrane Database Syst Rev. 2003;(4):CD001990
pubmed: 14583943
J Thorac Oncol. 2009 Sep;4(9):1049-59
pubmed: 19652623
Lung Cancer. 2016 Jun;96:108-12
pubmed: 27133759
Int J Clin Oncol. 2014 Apr;19(2):260-5
pubmed: 23592279
Br J Cancer. 2004 Aug;91 Suppl 2:S3-10
pubmed: 15340372