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300

KUANetal.

TABLE XXV.9 (Continued)

Clinical endpoints

Study

Year LOE Study design Study groups

Conclusions

Mai et al. 1713

1. Significant improvement in median PFS was detected in toripalimab arm compared with placebo arm, and this improvement was observed across key subgroups, including PD-L1 expression 2. Risk of progression or death was decreased in toripalimab group by 59% when compared with placebo 3. ORR was significantly higher in toripalimab arm than in placebo arm, and DoR was significantly longer in toripalimab arm 4. Incidence of grade ≥ 3 AEs was similar 1. Camrelizumab group had significantly longer PFS than placebo group 2. 87.3% of the camrelizumab group and duration of response was longer with camrelizumab group than in placebo 3. No significant differences in grade 3 or worse AEs in camrelizumab versus placebo groups, with the most common events being leukopenia, neutropenia, anemia, and thrombocytopenia 1. Chemotherapy + RT improved 2-year OS and PFS compared with chemotherapy alone group 2. ORR was comparable between the two groups at the end of six cycles of chemotherapy 3. No significant differences in acute hematological or GI toxic effects were observed in both arms 1. ORR was 20.5% with median DoR 12.8 months an DCR of 40.0% 2. Median PFS was 1.9 months and median OS was 17.4 months 3. ORR was higher in PD-L1-positive patients at 27.1% compared to 19.4% in PD-L1-negative patients, though was not statistically significant 4. Grade 3–5 AEs occurred in 14.2% of patients (Continues) 80.6% of placebo group achieved objective response and median between the two arms, except for immune-related AEs, which were more frequent in toripalimab arm compared with placebo arm

1. PFS 2. ORR 3. DoR 4. Grade ≥ 3AE

289 treatment-naive

2021 2

Multicenter phase III RCT

recurrent/metastatic NPC patients treated with toripalimab + GC versus placebo + GC

Yanget al. 1714

2021 2

Multicenter,

263 patients with treatment-naive

1. PFS 2. ORR, DCR, DoR 3. AEs

randomized, double-blind phase III trial

recurrent/metastatic NPCfrom28 hospitals treated with camrelizumab + GC versus placebo + GC

Youet al. 1704

1. 2-year OS 2. PFS,ORR

126 patients with

2020 2

Multicenter phase III RCT

metastatic NPC who demonstrated complete or partial response following three cycles of PF, then treated with CRTversus chemotherapy alone recurrent/metastatic NPC refractory to standard chemotherapy treated with toripalimab until PD

Wanget al. 1709

2021 2

Single-arm,

190 patients with

1. ORR 2. DoR, PFS, OS,DCR 3. Toxicity

multicenter, phase II clinical trial