A prospective, single-arm trial of PD-1 inhibitors plus chemoradiotherapy for solitary metachronous metastasis nasopharyngeal carcinoma.

Abstract

PURPOSE:

Initial treatment for Recurrent/Metastatic Nasopharyngeal Carcinoma (R/M NPC) often involves Gemcitabine plus cisplatin with or without PD-1 inhibitors. However, PD-1 inhibitors' effectiveness varies, prompting for better treatments. This study explores effect and safety of combining PD-1 inhibitors with chemoradiotherapy for oligometastatic NPC patients.

METHODS:

Oligometastatic NPC patients underwent radical treatment with PD-1 inhibitors and chemotherapy, followed by concurrent PD-1 inhibitors and chemoradiotherapy, and then maintenance PD-1 inhibitors. Objective response rate (ORR) and disease control rate (DCR) were calculated by irRECIST-1.1, and CTCAE-4.0 was used to evaluate the toxicity.

RESULTS:

The study enrolled 47 patients with a median age of 46. The median follow-up lasted 16.5 months, with metastatic lesions receiving a median radiation dose of 45 Gy. The median courses of PD-1 inhibitors and chemotherapy were 9.5 and 5 respectively. The metastasis sites included lung (40.8 %), liver (21.1 %), mediastinal lymph node (7.9 %), abdominal lymph nodes (3.9 %), bone (21.1 %), adrenal gland (3.9 %), and brain (1.3 %). ORR and DCR were 85.1 % and 100 % at 3 months after radiotherapy. The median survival was not reached yet, and 1 and 2-year OS rates were 93.1 % and 78.4 %. The median PFS was 18 months, with 1 and 2-year PFS rates of 70.2 % and 47.7 % respectively. PD-L1 expression showed a positive correlation for PFS. Twenty-five patients experienced grade 3 or 4 adverse events (AE) that were possibly related to chemotherapy. No grade 5 AE was observed.

CONCLUSIONS:

The synergy of concurrent PD-1 inhibitors and chemoradiotherapy shows promising efficacy and an acceptable toxicity for oligometastasis NPC patients.

• Authors: Lu Li, Lu Chen, Ming Fan, Yue Tian, Hangyu Ai, Lu Yan, Fang Li, Mei Lan, Xin Lai, Yecai Huang, Peng Xu, Mei Feng, Jinyi Lang
• Journal: Oral oncology (Oral Oncol) Vol. 150 Pg. 106695 (Mar 2024) ISSN: 1879-0593 [Electronic] England
• PMID: 38262250 (Publication Type: Clinical Trial, Journal Article)
• Copyright: Copyright © 2024 Elsevier Ltd. All rights reserved.

Chemical References

• Cisplatin
• Deoxycytidine
• Immune Checkpoint Inhibitors

Topics

• Humans
• Antineoplastic Combined Chemotherapy Protocols (therapeutic use)
• Chemoradiotherapy (adverse effects)
• Cisplatin
• Deoxycytidine (therapeutic use)
• Immune Checkpoint Inhibitors (therapeutic use)
• Nasopharyngeal Carcinoma (drug therapy)
• Nasopharyngeal Neoplasms (pathology)
• Neoplasm Recurrence, Local (pathology)
• Prospective Studies