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369

ICAR SINONASAL TUMORS

TABLE XXXII.4 (Continued)

Clinical endpoints Treatment toxicities

Study

Year LOE Study design Study groups

Conclusion

Ye et al. 2175

1. There was equivalent grade 3 + mucositis, enteral feeding, and weight loss in both groups 2. Higher rates of nausea/emesis and unplanned or prolonged hospitalization were seen in the cisplatin group 3. Higher rates of RT dermatitis and acneiform rash were seen in the cetuximab group 4. Two patients in each group died of treatment-related complications 1. In the IC cohort, the most common grade 3/4 toxicities were nausea/vomiting, anemia, and neutropenia 2. In the CRT cohort, the most common grade 3/4 toxicities were nausea/vomiting, dermatitis, dysphagia, mucositis, andpain 3. In the RT only cohort, the most common grade 3/4 toxicity was dermatitis 1. 75% of patients experienced acute grade 3/4 toxicity, most commonly leukopenia, mucositis, and fevers 2. Late AEs included ORN, brain necrosis, and ocular/visual problems 1. Six patients had cetuximab infusion reactions, and one patient died of an infusion reaction to cetuximab 2. Median pretreatment KPS was 80 and declined during treatment 3. 46% of patients receiving single-agent cetuximab had grade 3/4 AEs, most commonly dyspnea, vomiting, and asthenia 4. No skin reactions were grade 3 orhigher

2013 3

Prospective cohort

349 adults with locally advanced head and neck cancer treated with CRT with

cisplatin ( n = 262) versus cetuximab ( n = 87)

Nishimura et al. 2173

2009 3

Retrospective cohort

Patients with

Treatment toxicities

untreated stage 3/4 maxillary sinus SCC treated with IC with 5FU, methotrexate, and leucovorin with IA cisplatin ( n = 16) versus CRT with 5FU, methotrexate, and leucovorin with IA cisplatin ( n = 15) versus RT only ( n = 9) 47 patients with T3 + nasal and SNM treated with IA cisplatin and EBRT

Homma

Treatment toxicities

2009 3

Prospective cohort

et al. 2191

Vermorken et al. 2164

2007 3

Prospective cohort

103 patients with

1. Treatment related AEs 2. KPS

recurrent and/or metastatic head and neck cancer that failed platinum-based therapy and then received cetuximab, with or without platinum

Abbreviations: AE, adverse events; CRT, chemoradiation therapy; 5FU, 5-fluorouracil; HNSCC, head and neck squamous cell carcinoma; IA, intra-arterial; IC, induction chemotherapy; PF, cisplatin and 5-fluorouracil; QLQ-C30, EORTC Core QOL Questionnaire; QLQ-H&N35, EORTC QOL Questionnaire: Head and Neck Module; FACT-HN, Functional Assessment of Cancer Therapy: Head and Neck; HHI, Herth Hope Index; KPS, Karnofsky Performance Scale; MDASI, MD Anderson Symptom Inventory; ORN, osteoradionecrosis; RT, radiation therapy; TPF, docetaxel, cisplatin, and 5-fluorouracil.