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Preoperative chemotherapy and radiotherapy concomitant to cetuximab in resectable stage IIIB NSCLC: a multicentre phase 2 trial (SAKK 16/08)


Curioni-Fontecedro, Alessandra; Perentes, Jean Yannis; Gelpke, Hans; Xyrafas, Alexandros; Bouchaab, Hasna; Mach, Nicolas; Matzinger, Oscar; Stojcheva, Nina; Frueh, Martin; Weder, Walter; Cathomas, Richard; Gargiulo, Piera; Bubendorf, Lukas; Pless, Miklos; Betticher, Daniel; Peters, Solange (2019). Preoperative chemotherapy and radiotherapy concomitant to cetuximab in resectable stage IIIB NSCLC: a multicentre phase 2 trial (SAKK 16/08). British Journal of Cancer, 120(10):968-974.

Abstract

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 and docetaxel 85 mg/m d1, q3w) followed by RT (44 Gy in 22 fractions) with concomitant cetuximab (250 mg/m, q1w) and subsequent surgery. The primary endpoint was 1-year progression-free survival (PFS).
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.

Abstract

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 and docetaxel 85 mg/m d1, q3w) followed by RT (44 Gy in 22 fractions) with concomitant cetuximab (250 mg/m, q1w) and subsequent surgery. The primary endpoint was 1-year progression-free survival (PFS).
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.

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Additional indexing

Contributors:Swiss Group of Clinical Cancer Research (SAKK)
Item Type:Journal Article, refereed, original work
Communities & Collections:04 Faculty of Medicine > University Hospital Zurich > Clinic for Oncology and Hematology
04 Faculty of Medicine > University Hospital Zurich > Clinic for Thoracic Surgery
Dewey Decimal Classification:610 Medicine & health
Language:English
Date:May 2019
Deposited On:15 Oct 2019 15:46
Last Modified:28 Feb 2020 08:32
Publisher:Nature Publishing Group
ISSN:0007-0920
OA Status:Green
Free access at:PubMed ID. An embargo period may apply.
Publisher DOI:https://doi.org/10.1038/s41416-019-0447-0
PubMed ID:30988393

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