Preoperative chemotherapy and radiotherapy concomitant to cetuximab in resectable stage IIIB NSCLC: a multicentre phase 2 trial (SAKK 16/08).
Details
Serval ID
serval:BIB_6DA91E6BDAAE
Type
Article: article from journal or magazin.
Collection
Publications
Institution
Title
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
Working group(s)
Swiss Group of Clinical Cancer Research (SAKK)
ISSN
1532-1827 (Electronic)
ISSN-L
0007-0920
Publication state
Published
Issued date
05/2019
Peer-reviewed
Oui
Volume
120
Number
10
Pages
968-974
Language
english
Notes
Publication types: Clinical Trial, Phase II ; Journal Article ; Multicenter Study ; Research Support, Non-U.S. Gov't
Publication Status: ppublish
Publication Status: ppublish
Abstract
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 <sup>2</sup> and docetaxel 85 mg/m <sup>2</sup> d1, q3w) followed by RT (44 Gy in 22 fractions) with concomitant cetuximab (250 mg/m <sup>2</sup> , q1w) and subsequent surgery. The primary endpoint was 1-year progression-free survival (PFS).
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.
Resectable stage IIIB NSCLC received three cycles of CT (cisplatin 100 mg/m <sup>2</sup> and docetaxel 85 mg/m <sup>2</sup> d1, q3w) followed by RT (44 Gy in 22 fractions) with concomitant cetuximab (250 mg/m <sup>2</sup> , q1w) and subsequent surgery. The primary endpoint was 1-year progression-free survival (PFS).
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.
Keywords
Adult, Aged, Carcinoma, Non-Small-Cell Lung/drug therapy, Carcinoma, Non-Small-Cell Lung/pathology, Carcinoma, Non-Small-Cell Lung/radiotherapy, Carcinoma, Non-Small-Cell Lung/surgery, Cetuximab/administration & dosage, Cetuximab/adverse effects, Chemoradiotherapy, Cisplatin/administration & dosage, Cisplatin/adverse effects, Docetaxel/administration & dosage, Docetaxel/adverse effects, Female, Humans, Male, Middle Aged, Neoadjuvant Therapy/adverse effects, Neoplasm Staging, Progression-Free Survival
Pubmed
Web of science
Open Access
Yes
Create date
28/04/2019 15:42
Last modification date
15/01/2021 8:09