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Pembrolizumab + cisplatin-based chemo (NSCLC neoadjuvant; KEYNOTE-671)

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Contenu clinique provisoire : il ne s'agit pas d'une ordonnance. Un oncologue doit vérifier les sources originales, l'applicabilité et le statut de révision.

Source YAML: dossier complet

Notes

KEYNOTE-671 (Wakelee NEJM 2023, Spicer NEJM 2024 OS update): neoadjuvant pembrolizumab 200 mg q3w + cisplatin-based doublet × 4 cycles followed by surgery and adjuvant pembrolizumab × 13 cycles, in resectable stage II/IIIA/IIIB (T3-T4N2) NSCLC. 24-mo EFS 62.4% vs 40.6% (HR 0.58, p<0.001); pCR 18.1% vs 4.0%; mPR 30.2% vs 11.0%; OS update mOS not reached vs 52.4 mo (HR 0.72, p=0.005). FDA approval Oct 2023; NCCN v3.2025 category 1. Trial protocol used cisplatin-based doublet specifically: * Non-squamous: cisplatin 75 mg/m² + pemetrexed 500 mg/m² q3w * Squamous: cisplatin 75 mg/m² + gemcitabine 1000 mg/m² days 1+8 q3w Carboplatin (AUC 5) substitution for cisplatin is NCCN-allowed as a real-world tolerability variant in patients with renal impairment, ototoxicity, neuropathy, or other cisplatin-contraindications, but is NOT the trial protocol — note this in the plan rationale when carbo is substituted. Pembrolizumab is administered concurrently with chemo cycles 1-4 (neoadjuvant), then continues post-resection as adjuvant monotherapy × 13 cycles (REG-PEMBRO-ADJUVANT-NSCLC) for total ~17 cycles pembrolizumab over the perioperative course. Excludes patients with EGFR-activating mutation...

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Indication

• IND-NSCLC-PERIOPERATIVE-PEMBRO - IND-NSCLC-PERIOPERATIVE-PEMBRO

Protocole thérapeutique

• REG-PEMBRO-ADJUVANT-NSCLC - Pembrolizumab adjuvant (resected NSCLC; KEYNOTE-671)