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ICAR SINONASAL TUMORS

TABLE XXIV.D.3 (Continued)

Clinical endpoints

Study

Year LOE Study design Study groups

Conclusion

PD-L1 expression analysis of TIL

1. Mucosal melanoma (sinus, oropharynx, anogenital)—16 out of 36 (44%) expressed PD-L1 (similar to cutaneous melanoma expression, 35%) 2. Higher expression of PD-L1 in spindle cell subtypes of mucosal melanoma 3. 15 out of 16 PD-L1-positive mucosal melanoma cases had high rate of TIL 1. Expression: PD-1 (48%), PD-L1 (54%), and IDO-1 (58%) 2. No significant association between PD-L1 expression and prognosis 3. In stage III, IVA, and IVB patients, PD-1 expression was associated with better outcome, but PD-L1-negative and IDO-1-positive patients had worse outcome

Kaunitz

2017 4

Retrospective case series

IHC analysis of

et al. 1543

melanoma from acral, mucosal, uveal, and sun-damaged sites ( n ,mucosal melanoma = 36)

Liuet al. 1584

2017 4

Retrospective case series

IHC analysis of SNMM PD-L1 ( n = 86)

1. PD-1, PD-L1, IDO-1, expression 2. OS based on PD-1, PD-L1, and IDO-1

Thierauf

1. 13% PD-L1 expression 2. Mean OS 42.5 months for PD-L1-negative versus

1. PD-L1

2015 4

Retrospective case series

IHC analysis and

et al. 1585

expression 2. OS by PD-L1 3. RFS

clinical outcome study on patients with head and neck mucosal melanoma ( n = 23)

121 months for PD-L1-positive tumors. 3. PD-L1 positivity associated with improved RFS

Abbreviations: DFS, disease-free survival; DSS, disease-specific survival; IDO-1, indoleamine 2,3-dioxygenase; NCDB, National Cancer DataBase; OS, overall survival; PD-L1, programmed death-ligand 1; RFS, recurrence-free survival; SEER, Surveillance, Epidemiology, and End Results; SI, surgery + immunotherapy; SNMM, sinonasal mucosal melanoma; SR, surgery + radiation; SRI, surgery + RT + immunotherapy; TIL, tumor-infiltrating lymphocytes.

6 Role of neck treatment The role of neck treatment in SNMM is not well defined (Table XXIV.D.4). The presence of cervical lymph node metastases at the time of SNMM diagnosis occurs in 7%–8% of patients. 1477,1483 When present at diagnosis, the presence of regional nodal metastases adversely affects survival; the 5-year OS rates in N + patients are reported to be 0%–4%. 1482,1483 In a systematic review of regional disease control in SNMM, the cumulative regional recurrence rate after treatment was 18.4%. In patients who were clinically N0 at presentation, the cumulative regional recurrence rate was 17% (median follow-up 22 months). 1482 However, END has not historically been performed for SNMM in clinically N0 necks due to the relatively low rate of occult nodal metastases. 1483 A recent systematic review and meta-analysis found that END is performed in only 0.4% of SNMM cases. 1482 The recent UK national guidelines on the management of head and neck mucosal

Cost

Immunotherapy is expensive; however, cost comparison analyses have not been undertaken.

Benefits–harm assessment

Balance of benefits and harms.

Value

OS is likely improved in advanced and metastatic SNMM with adjuvant

judgments

immunotherapy, but the duration and clinical significance are not well defined. In addition, the cost and adverse events associated with immunotherapy must be considered.

Policy level Option. Intervention Adjuvant immunotherapy should be considered as a treatment option in advanced or metastatic SNMM.