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ICAR SINONASAL TUMORS
TABLE XXV.9 (Continued)
Clinical endpoints
Study
Year LOE Study design Study groups
Conclusions
Yanget al. 1707
1. ORR was 28.2%, DCR was 54.5%, TTR was 8.3 weeks 2. Median PFS was 17.4 months 3. 33% of patients had grade ≥ 3AEs
1. ORR 2. DCR 3. TTR 4. PFS 5. OS
156 patients from eight hospitals with stage IVb NPC, who failed first − line platinum-base chemotherapy and second-line single agent or combined chemotherapy treated with camrelizumab 536 patients with recurrent/metastatic NPC from seven trialsSix different treatment regimens - Pembrolizumab - Nivolumab - JS001 - Camrelizumab - Chemotherapy - Camrelizumab + chemotherapy
2021 2
Phase II
multicenter, open-label, single-arm
Lvet al. 1712
2019 2
Pooled analysis of trials
1. Grade 1–5 AEs and
1. Nivolumab (54.2%) and pembrolizumab (74.1%) exhibited the optimal safety regarding grade 1–5 AEs, whereas camrelizumab (16.1%) and nivolumab (17.4%) had the lowest grade 3–5 AEs 2. Treatment discontinuation due to AEs was most commonly recorded in pembrolizumab (18.5%), followed by camrelizumab + chemotherapy (13.0%) and JS001 (9.8%) and lowest in camrelizumab (2.2%) 3. As first-line therapy, camrelizumab + chemotherapy achieved higher ORR than with chemotherapy alone; when nivolumab was used as first-line therapy (in treatment-naïve patients), its ORR increased to 40.0% 4. As second- or later-line therapy, ORR was higher with camrelizumab (34.1%) followed by pembrolizumab (26.3%), JS001 (23.3%), and nivolumab (19.0%) 5. Pooled ORR was 28.4% for PD-L1-positive and 17.4% for PD-L1-negative patients 1. ORR was 20.5% (CR n = 1, PR n = 8), median DoR was 9.3 months, DCR was 54.5% 2. Median OS was 17.1 months and median PFS was 2.8 months 3. 1-year OS was 59% and PFS was 19.3% 4. No statistical correlation between ORR and biomarkers (Continues)
grade 3–5 AEs
2. ORR
Maet al. 1708
1. ORR 2. DoR, OS, PFS
44 patients with pretreated
2018 2
Multicenter phase II study
recurrent/metastatic NPC treated with nivolumab until PD
Two phase III studies on efficacy of different platinum based regimens done a few years later showed that GP had a significantly higher objective response rate (ORR), PFS, and OS compared with 5-FU 1702 or docetaxel 1703 plus platinum-based regimen.
There is no universal recommendation on the role of locoregional RT of the nasopharynx and neck in metastatic NPC patients. A multicenter phase III study on addi tion of locoregional RT to chemotherapy in patients with de novo metastatic NPC showed that chemotherapy plus
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