Zie ook dit artikel: 

https://kanker-actueel.nl/aanbevolen-abstracten-van-asco-2019-over-longkanker-en-van-commentaar-voorzien-door-artsen-werkzaam-bij-asco-zelf.html

12 juni 2019: Bron: N Engl J Med. 2017 Jun 22; 376(25): 2415–2426.

Klik op de titel van de studie voor het volledige studierapport. Daaronder abstract plus referentielijst. Zie verder in gerelateerde artikelen.

First-Line Nivolumab in Stage IV or Recurrent Non-Small-Cell Lung Cancer

Geselecteerde subgroepen
Over de meeste geplande subgroepen (inclusief alle patiënten die randomisatie hadden ondergaan), waren de resultaten van de analyses van progressievrije overleving en algehele overleving consistent met de algehele onderzoeksresultaten (Fig. 2A and and2B).2B). 

De enige vooraf gespecificeerde subgroep waren patiënten gedefinieerd volgens histologische bevindingen (een stratificatiefactor); patiënten met histologische resultaten die plaveiselcel NSCLC vertoonden hadden een iets langere progressievrije overleving en totale overleving met nivolumab dan met chemotherapie, hoewel de resultaten niet significant waren (Fig. 2A and and2B2B).

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Exploratory Subgroup Analyses of Progression-free Survival and Overall Survival.

Panel A shows the subgroup analysis of progression-free survival involving all the patients who underwent random ization, and Panel B the subgroup analysis of overall survival. PD-L1 denotes programmed death ligand 1. The Eastern Cooperative Oncology Group (ECOG) per formance-status score is assessed on a 5-point scale, with higher numbers indicating greater disability. Panel C shows the analysis of progression-free survival among patients who could be evaluated for tumor-mutation burden and who had a high burden. NR denotes not reached. Panel D shows the analysis of progression-free survival among patients who could be evaluated for tumor-mutation burden and who had a low or medium burden. The data for patients with a low or medium tumor-mutation burden were pooled.

En hier het abstract van de studie:

2017 Jun 22;376(25):2415-2426. doi: 10.1056/NEJMoa1613493.

First-Line Nivolumab in Stage IV or Recurrent Non-Small-Cell Lung Cancer.

Abstract

BACKGROUND:

Nivolumab has been associated with longer overall survival than docetaxel among patients with previously treated non-small-cell lung cancer (NSCLC). In an open-label phase 3 trial, we compared first-line nivolumab with chemotherapy in patients with programmed death ligand 1 (PD-L1)-positive NSCLC.

METHODS:

We randomly assigned, in a 1:1 ratio, patients with untreated stage IV or recurrent NSCLC and a PD-L1 tumor-expression level of 1% or more to receive nivolumab (administered intravenously at a dose of 3 mg per kilogram of body weight once every 2 weeks) or platinum-based chemotherapy (administered once every 3 weeks for up to six cycles). Patients receiving chemotherapy could cross over to receive nivolumab at the time of disease progression. The primary end point was progression-free survival, as assessed by means of blinded independent central review, among patients with a PD-L1 expression level of 5% or more.

RESULTS:

Among the 423 patients with a PD-L1 expression level of 5% or more, the median progression-free survival was 4.2 months with nivolumab versus 5.9 months with chemotherapy (hazard ratio for disease progression or death, 1.15; 95% confidence interval , 0.91 to 1.45; P=0.25), and the median overall survival was 14.4 months versus 13.2 months (hazard ratio for death, 1.02; 95% CI, 0.80 to 1.30). A total of 128 of 212 patients (60%) in the chemotherapy group received nivolumab as subsequent therapy. Treatment-related adverse events of any grade occurred in 71% of the patients who received nivolumab and in 92% of those who received chemotherapy. Treatment-related adverse events of grade 3 or 4 occurred in 18% of the patients who received nivolumab and in 51% of those who received chemotherapy.

CONCLUSIONS:

Nivolumab was not associated with significantly longer progression-free survival than chemotherapy among patients with previously untreated stage IV or recurrent NSCLC with a PD-L1 expression level of 5% or more. Overall survival was similar between groups. Nivolumab had a favorable safety profile, as compared with chemotherapy, with no new or unexpected safety signals. (Funded by Bristol-Myers Squibb and others; CheckMate 026 ClinicalTrials.gov number, NCT02041533 .).

PMID:
28636851
PMCID:
PMC6487310
DOI:
10.1056/NEJMoa1613493

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