A Phase II study of nab-paclitaxel and carboplatin chemotherapy plus necitumumab in the first-line treatment of patients with stage IV squamous non-small cell lung cancer
Mené sur 54 patients atteints d'un cancer épidermoïde du poumon non à petites cellules de stade IV, cet essai de phase II évalue l'efficacité, du point de vue du taux de réponse objective, et la toxicité d'un traitement de première ligne combinant nab-paclitaxel, carboplatine et nécitumumab (un anticorps monoclonal ciblant EGFR)
Résumé en anglais
Objectives : Necitumumab is a second-generation, recombinant, human IgG1-type monoclonal antibody directed against EGFR approved for adult patients with metastatic squamous non-small cell lung cancer (NSCLC) in combination with gemcitabine and cisplatin. This study assessed the efficacy and safety of albumin-bound paclitaxel (nab-paclitaxel) and carboplatin in combination with necitumumab as first-line therapy in patients with stage IV squamous NSCLC.
Materials and methods : The treatment regimen comprised triplet induction with necitumumab (800 mg) with nab-paclitaxel (100 mg/m2) and carboplatin (AUC 6 mg*min/mL) for 4 cycles, followed by doublet maintenance with necitumumab and nab-paclitaxel with a 3-weekly schedule until progressive disease or unacceptable toxicity. The primary endpoint of the study was objective response rate (ORR).
Results : Fifty-four patients were enrolled. Median age was 65 years (range, 47-80 years). The majority of the patients were male (n = 42 [77.8%]) with an ECOG PS of 1 (n = 42 [77.8%]). The ORR was 51% (n = 26/54), and the disease control rate was 78.4% (n = 40/54). Median overall survival (OS) was 15.5 months (95% confidence interval [CI]: 10.18–not calculable), and the OS rate at 12 months was 50.4% (95% CI: 29.0-68.4). Median progression-free survival was 5.6 months (95% CI: 4.24-7.69)]. The most frequently reported treatment-emergent adverse events were anemia (57.4%), fatigue (55.6%), neutrophil count decreased (55.6%), hypomagnesemia (44.4%), and rash (38.9%).
Conclusion : Necitumumab/nab-paclitaxel/carboplatin first-line therapy produced favorable efficacy outcomes with manageable toxicity in patients with stage IV squamous NSCLC. The safety profile was fairly comparable with previous necitumumab combination studies in lung cancer..
