| Autor: |
Zoran Andric, MD, Gabriella Gálffy, MD, Manuel Cobo Dols, MD, Barna Szima, MD, Goran Stojanovic, MD, Marina Petrovic, MD, Enriqueta Felip, MD, David Vicente Baz, MD, Santiago Ponce Aix, MD, Oscar Juan-Vidal, MD, Zsuzsanna Szalai, MD, Gyorgy Losonczy, MD, Antonio Calles Blanco, MD, Reyes Bernabe, MD, Gema García Ledo, MD, Andrés Aguilar Hernández, MD, Klaus Duecker, PhD, Dongli Zhou, PhD, Andreas Schroeder, MD, Guelseren Guezel, MD, Fortunato Ciardiello, MD, PhD |
| Jazyk: |
angličtina |
| Rok vydání: |
2023 |
| Předmět: |
|
| Zdroj: |
JTO Clinical and Research Reports, Vol 4, Iss 2, Pp 100461- (2023) |
| Druh dokumentu: |
article |
| ISSN: |
2666-3643 |
| DOI: |
10.1016/j.jtocrr.2022.100461 |
| Popis: |
Introduction: We present the results of a phase 2a trial of first-line avelumab (anti–programmed death-ligand 1 antibody) plus cetuximab (anti–EGFR antibody) in patients with advanced squamous NSCLC. Methods: Patients with recurrent or metastatic squamous NSCLC received avelumab 800 mg (d 1 and 8), cetuximab 250 mg/m2 (d 1) and 500 mg/m2 (d 8), cisplatin 75 mg/m2 (d 1), and gemcitabine 1250 mg/m2 (d 1 and 8) for four 3-week cycles, followed by avelumab 800 mg and cetuximab 500 mg/m2 every 2 weeks. The primary end point was the best overall response; the secondary end points were progression-free survival, duration of response, overall survival, and safety. Efficacy analyses were reported from an updated data cutoff. Results: A total of 43 patients were enrolled. The median follow-up was 6.6 months for the primary analyses and 9.2 months for the efficacy analyses. In the efficacy analyses, 15 patients had a confirmed partial response (objective response rate, 34.9% [95% confidence interval: 21.0%–50.9%]), and the median duration of response was 7.1 months (95% confidence interval: 4.2–12.5 mo). The median progression-free survival and overall survival were 6.1 months and 10.0 months, respectively. In the safety analyses (primary analysis), 38 patients (88.4%) had a treatment-related adverse event, of whom 24 (55.8%) had a grade 3 or higher treatment-related adverse event. Conclusions: The combination of avelumab + cetuximab and chemotherapy showed antitumor activity and tolerable safety; however, the ORR was not improved compared with those reported for current standards of care (NCT03717155). |
| Databáze: |
Directory of Open Access Journals |
| Externí odkaz: |
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