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Efficacy and Safety of Salvage-line Nivolumab Monotherapy for Advanced Esophageal Squamous Cell Carcinoma: Comparison of 240 mg Versus 480 mg Doses.
Murashima, Yuko; Yamamoto, Shun; Hirose, Toshiharu; Kadono, Toru; Ikeda, Go; Ohara, Akihiro; Itoyama, Mai; Yokoyama, Kazuki; Honma, Yoshitaka; Ishiyama, Koshiro; Oguma, Jyunya; Daiko, Hiroyuki; Kato, Ken.
Afiliação
  • Murashima Y; Department of Head and Neck, Esophageal Medical Oncology, National Cancer Center Hospital, 5-1-1 Tsukiji, Chuo-ku, Tokyo, 104-0045, Japan.
  • Yamamoto S; Department of Gastroenterology, St. Luke's International Hospital, Tokyo, Japan.
  • Hirose T; Department of Head and Neck, Esophageal Medical Oncology, National Cancer Center Hospital, 5-1-1 Tsukiji, Chuo-ku, Tokyo, 104-0045, Japan.
  • Kadono T; Department of Gastrointestinal Medical Oncology, National Cancer Center Hospital, Tokyo, Japan.
  • Ikeda G; Department of Gastrointestinal Medical Oncology, National Cancer Center Hospital, Tokyo, Japan.
  • Ohara A; Department of Head and Neck, Esophageal Medical Oncology, National Cancer Center Hospital, 5-1-1 Tsukiji, Chuo-ku, Tokyo, 104-0045, Japan.
  • Itoyama M; Cancer Chemotherapy Center, Osaka Medical and Pharmaceutical University, Takatsuki, Osaka, Japan.
  • Yokoyama K; Department of Head and Neck, Esophageal Medical Oncology, National Cancer Center Hospital, 5-1-1 Tsukiji, Chuo-ku, Tokyo, 104-0045, Japan.
  • Honma Y; Department of Gastroenterology, Nippon Medical School Graduate School of Medicine, Tokyo, Japan.
  • Ishiyama K; Department of Head and Neck, Esophageal Medical Oncology, National Cancer Center Hospital, 5-1-1 Tsukiji, Chuo-ku, Tokyo, 104-0045, Japan.
  • Oguma J; Department of Head and Neck, Esophageal Medical Oncology, National Cancer Center Hospital, 5-1-1 Tsukiji, Chuo-ku, Tokyo, 104-0045, Japan.
  • Daiko H; Department of Head and Neck, Esophageal Medical Oncology, National Cancer Center Hospital, 5-1-1 Tsukiji, Chuo-ku, Tokyo, 104-0045, Japan.
  • Kato K; Department of Head and Neck, Esophageal Medical Oncology, National Cancer Center Hospital, 5-1-1 Tsukiji, Chuo-ku, Tokyo, 104-0045, Japan.
J Gastrointest Cancer ; 55(3): 1345-1351, 2024 Sep.
Article em En | MEDLINE | ID: mdl-39007963
ABSTRACT

BACKGROUND:

Nivolumab monotherapy is the standard second-line treatment for advanced esophageal squamous cell carcinoma (ESCC) after failure of platinum-based chemotherapy without anti-PD-1 antibody. Fixed dosing with 240 mg every 2 weeks was approved initially, followed by fixed dosing with 480 mg every 4 weeks based on pharmacokinetics data. However, information on the comparative efficacy and safety of the two doses remains limited.

METHODS:

We compared progression-free survival (PFS), overall survival (OS), objective response rate (ORR), and the incidence of adverse events (AEs) between the two doses in 117 patients who received second-line (n = 85) or later-line (n = 32) nivolumab monotherapy at our institution between January 2016 and December 2021.

RESULTS:

In the second-line group, patient characteristics for the 240 mg and 480 mg groups were as follows (240 mg vs. 480 mg) performance status (PS) 0/1/2 was 34/61/5% vs. 54/42/4%, and prior fluoropyrimidine plus platinum therapy (FP) was 81.3% vs. 42.3%. In the later-line group, the characteristics were PS 0/1/2 was 28/60/12% vs. 14/86/0%, and prior FP was 60.0% vs. 42.8%. ORR was 11.9 vs. 24.0% in the second-line group (p = 0.19) and 0 vs. 14.3% in the later-line group (p = 0.22). Median PFS was 1.7 vs. 4.1 months on second-line (hazard ratio [HR] 0.60, 95% confidence interval [CI] 0.35-1.01, p = 0.056) and 1.4 vs. 1.8 months on later-line (HR 0.58, 95% CI 0.23-1.46, p = 0.25); AEs of any grade were observed in 58.3 vs. 69.7%, respectively.

CONCLUSIONS:

The efficacy and safety of the two doses of nivolumab monotherapy were comparable in patients with advanced ESCC.
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Texto completo: 1 Coleções: 01-internacional Base de dados: MEDLINE Assunto principal: Neoplasias Esofágicas / Terapia de Salvação / Carcinoma de Células Escamosas do Esôfago / Nivolumabe Limite: Adult / Aged / Aged80 / Female / Humans / Male / Middle aged Idioma: En Revista: J Gastrointest Cancer Ano de publicação: 2024 Tipo de documento: Article País de afiliação: Japão País de publicação: Estados Unidos
Texto completo
Adicionar na Minha BVS
Imprimir
XML
PubMed Links
Buscar no Google

Texto completo: 1 Coleções: 01-internacional Base de dados: MEDLINE Assunto principal: Neoplasias Esofágicas / Terapia de Salvação / Carcinoma de Células Escamosas do Esôfago / Nivolumabe Limite: Adult / Aged / Aged80 / Female / Humans / Male / Middle aged Idioma: En Revista: J Gastrointest Cancer Ano de publicação: 2024 Tipo de documento: Article País de afiliação: Japão País de publicação: Estados Unidos