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KUANetal.

TABLE XXIV.D.3 Evidence surrounding impact of PD-L1 and immunotherapy in sinonasal mucosal melanoma treatment.

Clinical endpoints

Study

Year LOE Study design Study groups

Conclusion

1. 53% ORR for nivolumab monotherapy with PD-L1

1. Complete or partial response (ORR) 2. Duration of response (median PFS) 3. Rate of Grade 3or 4 complications

D’Angelo et al. 1550

2017 2

RCT

Nivolumab or

nivolumab plus ipilimumab in advanced (stage III or IV) melanoma patients ( n = 121 mucosal melanoma patients; mucosal site not specified)

expression ≥ 5%; 12.2% ORR if PD-L1 ≤ 5%

2. 14% ORR for ipilimumab monotherapy with PD-L1

expression ≥ 5%; 9.5% ORR if PD-L1 ≤ 5% 3. 60% ORR for combination nivolumab/ipilimumab with PD-L1 expression ≥ 5%; 33%ORR if PD-L1 ≤ 5% 4. PFS for combination nivolumab/ipilimumab was 5.9 months for mucosal melanoma 5. Nivolumab monotherapy 8.1% complication rate 6. Combination nivolumab/ipilimumab 40% complication rate 1. Immunotherapy independent predictor of improved survival 2. SI and SRI improved survival over SR 3. Immunotherapy confers survival benefit in SNMM, when subgrouped 4. No survival benefit in SI relative toSRI 1. 15.2% received biochemotherapy (e.g., interferon, interleukin), 27.3% received immune checkpoint inhibitors (ipilimumab, pembrolizumab, nivolumab) 2. In recurrent/persistent SNMM, OS was superior for immune checkpoint blockade versus no treatment, which was in turn superior to biochemotherapy Immunotherapy associated with improved survival in metastatic disease (HR 0.14)

Abiri et al. 1565

2022 4

Retrospective database study (NCDB)

Head and neck

OS

mucosal melanoma patients from the NCDB 2004–2017 ( n = 1910 total patients, of which 1371 were SNMM subsite) SNMM patients across 11 institutions (four United States, seven Europe) ( n = 505)

Lechner

1. OS 2. DFS

2022 4

Retrospective cohort

et al. 1564

Ganti et al. 366

2020 4

Retrospective database study (NCDB) Retrospective database study (NCDB)

SNMM patients in

OS

NCDB 2004–2015 ( n , SNMM = 1874)

OS

Immunotherapy was not associated with OS in metastatic SNMM

SNMM patients in

Klebaner et al. 1563

2020 4

NCDB 2012–2015 ( n , SNMM = 794)

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