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251

ICAR SINONASAL TUMORS

TABLE XXIV.A.7 (Continued)

Clinical endpoints

Study

Year LOE Study design Study groups

Conclusions

Miller et al. 1389

2019 4

Retrospective case series

N = 38 patients with ONB

OS

Patients who received platinum-based CRT did not exhibit improved survival compared to surgery/RT alone 5-year OS was 85% versus 53% versus 29% for primary surgery, RT, and chemotherapy

Orton et al. 1365

2018 4

Retrospective database study (NCDB) Retrospective database study (NCDB) Retrospective case series

N = 931 patients with ONB

OS

Carey et al. 1383

N = 1225 patients with ONB

OS

Adjuvant chemotherapy did not offer survival advantage

2017 4

Suet al. 1357

2017 4

N = 15 Advanced ONB with induction chemotherapy

1. DFS 2. OS

5-year DFS and OS were 71% and 78%, respectively

Abbreviations: CRT, chemoradiation therapy; DFS, disease-free survival; DSS, disease-specific survival; LRC, locoregional control; NCDB, National Cancer DataBase; ONB, olfactory neuroblastoma (esthesioneuroblastoma); OS, overall survival; PFS, progression-free survival; RT, radiation therapy; SEER, Surveillance, Epidemiology, and End Results.

Role of systemic therapy in ONB

vant/IC may play a beneficial role for patients who present with extensive locally invasive or unresectable disease. The effectiveness of immunotherapy in ONB has not yet been reported. However, PD-L1 expression, a key immune checkpoint pathway, has been reported in ONB, suggest ing a potential role for immune checkpoint blockade. 112 A recent study of 32 ONB patients found that poorer DFS was associated with high transforming growth factor beta (TGF- β ) signaling and postulated that given its immuno suppressive function that concomitant TGF- β andimmune checkpoint blockade may be beneficial in restoring an ONB tumor immune response. 1374 An active immunother apy clinical trial at the National Institutes of Health using bifunctional PD-L1/TGF- β blockade is currently available for patients with recurrent or metastatic ONB (NCT05012098). Somatostatin receptor 2 ( SSTR2 )hasbeen reported to be highly expressed in ONB and is potentially amenable to targeting with peptide receptor radionu clide therapy such as 177 Lu-DOTA-TATE. 15,1375 Indeed, several small studies have reported efficacy in recurrent or metastatic ONB, necessitating further investigation. 453 Table XXIV.8 includes additional studies relevant to survival outcomes in ONB during the updated review period.

Aggregate grade of evidence

C (Level 2: three studies; Level 4: 10 studies)

Benefit

Potential benefit for neoadjuvant chemotherapy in locally advanced or unresectable cases. Possible side effects from systemic therapy. Etoposide may be associated with bone marrow suppression leading to pancytopenia, while platinum-based agents may lead to renal, neurological, and otologic impairment.

Harm

Cost

Not evaluated in current studies. Balance of benefits and harms.

Benefits–Harms Assessment

Value

There are some data to suggest that neoadjuvant chemotherapy may be of value in select cases. No current ability to select for possible responders before treatment.

judgments

Policy level Option. Intervention Consider neoadjuvant chemotherapy for

locally advanced cases. Further studies are necessary to determine the benefit of other systemic treatment approaches for ONB.