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

Authors:
Alessandra Curioni-Fontecedro
Alessandra Curioni-Fontecedro
University Hospital Zurich
Switzerland
Jean Yannis Perentes
Jean Yannis Perentes
Centre Hospitalier Universitaire Vaudois
Switzerland
Hans Gelpke
Hans Gelpke
State Hospital Winterthur
Alexandros Xyrafas
Alexandros Xyrafas
SAKK Coordinating Center
Hasna Bouchaab
Hasna Bouchaab
Hospital of Fribourg
Switzerland
Nicolas Mach
Nicolas Mach
University Hospital of Geneva
Switzerland
Oscar Matzinger
Oscar Matzinger
Centre Hospitalier Universitaire Vaudois
Switzerland
Nina Stojcheva
Nina Stojcheva
Laboratory of Molecular Neuro-Oncology

Br J Cancer 2019 May 16;120(10):968-974. Epub 2019 Apr 16.

University Hospitals of Vaud, Lausanne, Switzerland.

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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http://dx.doi.org/10.1038/s41416-019-0447-0DOI Listing
May 2019
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