Preoperative chemotherapy and radiotherapy concomitant to cetuximab in resectable stage IIIB NSCLC: a multicentre phase 2 trial (SAKK 16/08).
Journal
British journal of cancer
ISSN: 1532-1827
Titre abrégé: Br J Cancer
Pays: England
ID NLM: 0370635
Informations de publication
Date de publication:
05 2019
05 2019
Historique:
received:
28
11
2018
accepted:
20
03
2019
revised:
13
03
2019
pubmed:
17
4
2019
medline:
3
3
2020
entrez:
17
4
2019
Statut:
ppublish
Résumé
Neoadjuvant chemotherapy (CT) followed by radiotherapy (RT) and surgery showed a median survival of 28.7 months in resectable stage IIIB non-small-cell lung cancer (NSCLC) patients (pts). Here, we evaluate the impact of concomitant cetuximab to the same neoadjuvant chemo-radiotherapy (CRT) in selected patients (pts) with NSCLC, stage IIIB. Resectable stage IIIB NSCLC received three cycles of CT (cisplatin 100 mg/m Sixty-nine pts were included in the trial. Fifty-seven (83%) pts underwent surgery, with complete resection (R0) in 42 (74%) and postoperative 30 day mortality of 3.5%. Responses were: 57% after CT-cetuximab and 64% after CRT-cetuximab. One-year PFS was 50%. Median PFS was 12.0 months (95% CI: 9.0-15.6), median OS was 21.3 months, with a 2- and 3-yr survival of 41% and 30%, respectively. This is one of the largest prospective phase 2 trial to investigate the role of induction CRT and surgery in resectable stage IIIB disease, and the first adding cetuximab to the neoadjuvant strategy. This trial treatment is feasible with promising response and OS rates, supporting an aggressive approach in selected pts.
Sections du résumé
BACKGROUND
Neoadjuvant chemotherapy (CT) followed by radiotherapy (RT) and surgery showed a median survival of 28.7 months in resectable stage IIIB non-small-cell lung cancer (NSCLC) patients (pts). Here, we evaluate the impact of concomitant cetuximab to the same neoadjuvant chemo-radiotherapy (CRT) in selected patients (pts) with NSCLC, stage IIIB.
METHODS
Resectable stage IIIB NSCLC received three cycles of CT (cisplatin 100 mg/m
RESULTS
Sixty-nine pts were included in the trial. Fifty-seven (83%) pts underwent surgery, with complete resection (R0) in 42 (74%) and postoperative 30 day mortality of 3.5%. Responses were: 57% after CT-cetuximab and 64% after CRT-cetuximab. One-year PFS was 50%. Median PFS was 12.0 months (95% CI: 9.0-15.6), median OS was 21.3 months, with a 2- and 3-yr survival of 41% and 30%, respectively.
CONCLUSIONS
This is one of the largest prospective phase 2 trial to investigate the role of induction CRT and surgery in resectable stage IIIB disease, and the first adding cetuximab to the neoadjuvant strategy. This trial treatment is feasible with promising response and OS rates, supporting an aggressive approach in selected pts.
Identifiants
pubmed: 30988393
doi: 10.1038/s41416-019-0447-0
pii: 10.1038/s41416-019-0447-0
pmc: PMC6734655
doi:
Substances chimiques
Docetaxel
15H5577CQD
Cetuximab
PQX0D8J21J
Cisplatin
Q20Q21Q62J
Types de publication
Clinical Trial, Phase II
Journal Article
Multicenter Study
Research Support, Non-U.S. Gov't
Langues
eng
Sous-ensembles de citation
IM
Pagination
968-974Références
Cancer Res. 1999 Apr 15;59(8):1935-40
pubmed: 10213503
J Clin Oncol. 2011 Aug 10;29(23):3120-5
pubmed: 21747084
Chest. 2007 Sep;132(3 Suppl):161S-77S
pubmed: 17873167
Lancet. 2015 Sep 12;386(9998):1049-56
pubmed: 26275735
J Clin Oncol. 2015 Dec 10;33(35):4194-201
pubmed: 26527789
Lancet. 2009 Aug 1;374(9687):379-86
pubmed: 19632716
Radiother Oncol. 2005 Aug;76(2):151-6
pubmed: 16026875
Ann Thorac Surg. 2003 Dec;76(6):1810-4; discussion 1815
pubmed: 14667588
Eur Respir J. 2009 Jul;34(1):17-41
pubmed: 19567600
Eur J Cardiothorac Surg. 2007 Jul;32(1):1-8
pubmed: 17448671
N Engl J Med. 2018 Dec 13;379(24):2342-2350
pubmed: 30280658
J Clin Oncol. 2011 Jun 10;29(17):2312-8
pubmed: 21555682
Ann Thorac Surg. 2005 Oct;80(4):1224-30; discussion 1230
pubmed: 16181844
J Thorac Cardiovasc Surg. 2001 Oct;122(4):796-802
pubmed: 11581616
Int J Radiat Oncol Biol Phys. 1994 Jul 1;29(4):813-9
pubmed: 8040028
J Natl Cancer Inst. 2001 Jun 20;93(12):921-9
pubmed: 11416113
Lancet. 2009 May 2;373(9674):1525-31
pubmed: 19410716
J Thorac Cardiovasc Surg. 2007 Jul;134(1):188-93
pubmed: 17599507
N Engl J Med. 2017 Nov 16;377(20):1919-1929
pubmed: 28885881
Chest Surg Clin N Am. 1995 May;5(2):189-203
pubmed: 7613960
Lancet Oncol. 2015 Jul;16(7):763-74
pubmed: 26045340
J Thorac Cardiovasc Surg. 2010 Jun;139(6):1424-30
pubmed: 20416887
N Engl J Med. 2009 Jul 2;361(1):32-9
pubmed: 19571281
Lung Cancer. 2011 Feb;71(2):166-72
pubmed: 20541833
Ann Thorac Surg. 1994 Aug;58(2):290-4; discussion 294-5
pubmed: 8067822
Circulation. 2007 Oct 23;116(17):e418-99
pubmed: 17901357
J Thorac Oncol. 2016 Jan;11(1):39-51
pubmed: 26762738
Acta Oncol. 1988;27(2):131-46
pubmed: 3390344
J Clin Oncol. 2003 May 1;21(9):1752-9
pubmed: 12721251
Lancet Oncol. 2009 Aug;10(8):785-93
pubmed: 19604722
J Clin Oncol. 1995 Aug;13(8):1880-92
pubmed: 7636530
Eur J Cardiothorac Surg. 2009 Jul;36(1):181-4
pubmed: 19477657
J Thorac Oncol. 2014 Nov;9(11):1675-84
pubmed: 25436801
Lancet Oncol. 2015 Feb;16(2):187-99
pubmed: 25601342