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367

ICAR SINONASAL TUMORS

TABLE XXXII.4 (Continued)

Clinical endpoints

Study

Year LOE Study design Study groups

Conclusion

Ferris et al. 2182

1. There was a 13% rate of grade 3/4 AEs in the nivolumab group, most commonly fatigue, versus a 35% rate in the standard group, most commonly neutropenia 2. During therapy, QOL was stable in the nivolumab group but worse in the standard group 3. The most frequent AEs in the nivolumab group were fatigue, nausea, rash, decreased appetite, and pruritis 4. Two treatment-related deaths 1. AEs occurred in 62%, most commonly fatigue, hypothyroidism, and decreased appetite 2. Grade 3 + AEs occurred in 9%, most commonly decreased appetite, facial swelling, and pneumonitis 1. The most common grade 3 + toxicity during IC was neutropenia, followed by alopecia 2. There was no difference in toxicities during CRT between the IC and no-IC cohorts 1. The IV group had higher rates of renal toxicity 2. The IA group had higher rates of neurological toxicities 3. There was no difference between the groups in the rates of hematologic toxicities or other toxicities 1. Patients receiving TPF had higher rates of grade 3 + alopecia, leukopenia, and neutropenia 2. Patients receiving PF had higher rates of grade 3 + thrombocytopenia, nausea, vomiting, stomatitis, and hearing loss 3. There was a 2.3% death rate in the TPF group and 5.5% rate in the PF group occurred in the nivolumab group (pneumonitis and hypercalcemia)

1. Treatment related AEs 2. QOLas assessed by

2016 2

RCT

361 patients with

recurrent head and neck cancer failing platinum chemotherapy receiving either nivolumab ( n = 236) versus standard systemic chemotherapy (methotrexate, docetaxel, or cetuximab; n = 111)

the QLQ-C30 and QLQ-H&N35

Chowet al. 2185

2016 2

RCT

132 patients with

Treatment related AEs

recurrent/metastatic head and neck SCC receiving pembrolizumab

Paccagnella et al. 2166

Treatment toxicities

2010 2

RCT

101 patients with stage 3–4 head and neck cancer receiving CRT( n = 50) versus ICwithTPF followed by CRT ( n = 51) inoperable head and neck cancer treated with IA cisplatin plusRT( n = 118) versus IV cisplatin plusRT( n = 119) advanced head and neck cancer treated with either IC with TPF ( n = 177) versus ICwithPF ( n = 181) Patients with locally 237 patients with

Rasch et al. 2178

2010 2

RCT

Treatment toxicities

Vermorken et al. 2190

Toxicity of

2007 2

RCT

treatment

(Continues)