Intravenous 5-Fluorouracil in Patients With Advanced Squamous Cell Carcinoma: A Retrospective Study

• Published in: Annals of Otology, Rhinology & Laryngology Rhinology & Laryngology, 2018-07, Vol.127 (7), p.456-462
• Main Authors: Buxó, Elvira, Sosa, Aaron, Reig, Oscar, Victoria, Ivan, Caballero, Miguel, Grau, Juan José, Garcia-Morillo, Marcial
• Format: Article
• Language: English
• Subjects: Aged; Carcinoma, Squamous Cell - diagnosis; Carcinoma, Squamous Cell - drug therapy; Carcinoma, Squamous Cell - mortality; Disease-Free Survival; Dose-Response Relationship, Drug; Female; Fluorouracil - administration & dosage; Follow-Up Studies; Head and Neck Neoplasms - diagnosis; Head and Neck Neoplasms - drug therapy; Head and Neck Neoplasms - mortality; Humans; Immunosuppressive Agents - administration & dosage; Infusions, Intravenous; Male; Middle Aged; Neoplasm Staging; Retrospective Studies; Spain - epidemiology; Squamous Cell Carcinoma of Head and Neck; Survival Rate - trends; Treatment Outcome
• ISSN: 0003-4894; 1943-572X
• DOI: 10.1177/0003489418778066

Objectives: In the EXTREME trial, a combination of cisplatin or carboplatin plus 5-fluorouracil (5-FU) and cetuximab was superior to cisplatin/carboplatin plus 5-FU for first-line treatment of recurrent or metastatic head and neck squamous cell carcinoma (HNSCC). With the aim of improving fluoropyrimidine-related tolerance without decreasing its efficacy, the safety and efficacy of carboplatin plus the oral fluoropyrimidine tegafur and cetuximab were investigated. Methods: A retrospective analysis of 104 patients with recurrent or metastatic HNSCC was conducted. Patients were treated with carboplatin (area under the curve: 5 mg/mL/min) on day 1, oral tegafur (250 mg/m2 twice daily) for 21 consecutive days, and cetuximab (400 mg/m2 as an initial 2-hour intravenous infusion, then 250 mg/m2 as a 1-hour weekly infusion for 3 weeks) for ≤6 cycles. Patients who responded to the therapy then received weekly cetuximab maintenance therapy. Results: Treatment was well tolerated with a high level of compliance (relative dose intensity: 96%, 88%, and 81% for carboplatin, tegafur, and cetuximab, respectively). Grade 3-4 adverse events (AEs) were observed in 38% of patients (skin reactions in 17% of patients, anemia 4%, and neutropenia 3%). Grade 1-2 AEs included skin reactions (52% of patients), hypomagnesemia (20%), asthenia (19%), and anemia (13%). No venous thrombosis related to chemotherapy perfusion was observed. Over a median follow-up of 21 months, the median overall and progression-free survival were 11 and 6 months, respectively, and the overall response rate was 35%. Conclusions: Carboplatin plus oral tegafur and cetuximab is a safe, well-tolerated first-line therapy for recurrent or metastatic HNSCC.