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

Authors: Curioni-Fontecedro, Alessandra; Perentes, Jean Yannis; Gelpke, Hans; Xyrafas, Alexandros; Bouchaab, Hasna; Mach, Nicolas; Matzinger, Oscar; +10 Authors

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

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/m2 and docetaxel 85 mg/m2 d1, q3w) followed by RT (44 Gy in 22 fractions) with concomitant cetuximab (250 mg/m2, 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, Male, 10255 Clinic for Thoracic Surgery, Cetuximab, 610 Medicine & health, Docetaxel, Article, 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, Carcinoma, Non-Small-Cell Lung, 616, Humans, 1306 Cancer Research, Aged, Neoplasm Staging, Chemoradiotherapy, Middle Aged, Neoadjuvant Therapy, Progression-Free Survival, 10032 Clinic for Oncology and Hematology, 2730 Oncology, Female, Cisplatin, ddc: ddc:616

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    influence
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selected citations
These citations are derived from selected sources.
This is an alternative to the "Influence" indicator, which also reflects the overall/total impact of an article in the research community at large, based on the underlying citation network (diachronically).
BIP!Citations provided by BIP!
popularity
This indicator reflects the "current" impact/attention (the "hype") of an article in the research community at large, based on the underlying citation network.
BIP!Popularity provided by BIP!
influence
This indicator reflects the overall/total impact of an article in the research community at large, based on the underlying citation network (diachronically).
BIP!Influence provided by BIP!
impulse
This indicator reflects the initial momentum of an article directly after its publication, based on the underlying citation network.
BIP!Impulse provided by BIP!
8
Top 10%
Top 10%
Top 10%
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hybrid
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