Abstract
Platinum-containing doublet chemotherapy regimens are generally considered the standard first-line systemic therapy for recurrent or metastatic (R/M) nasopharyngeal caner (NPC). Gemcitabine (GEM)+Cisplatin (CDDP) demonstrated significant improvement of both progression-free survival and overall survival over 5FU+CDDP for R/M NPC in a phase 3 study, leading to standard of care as first-line therapy for R/M NPC. Although the results of a phase 2 study of cetuximab (Cmab) in combination with carboplatin in patients with heavily pretreated NPC was reported, there was no available data for platinum-based chemotherapy plus Cmab as first-line therapy for R/M NPC. The objective of the currents study was to evaluate safety and efficacy of platinum-based chemotherapy plus Cmab in patients with R/M NPC. We conducted a retrospective review of patients with recurrent or metastatic NPC who were treated with platinum-based chemotherapy plus cetuximab during 2013 to 2017 at our institute. Treatment consisted of CDDP or carboplatin+5FU+Cmab(PFE) or paclitaxel+carboplatin+Cmab(PCE). Eleven patients were identified; patient characteristics were median age, 54.7 years (36-75); male /female 8/3; PS 0/1/2, 6/5/0; histology WHOI/II/III/ unknown, 2/3/3/3; number of prior chemotherapies 0/1/2/3 2/2/1; treatment regimen: PFE/PCE: 3/8. Of the 10 patients assessable for efficacy, 1 patient (10%) achieved complete response (CR), 3 patients (30%) with partial responses (PR), 5 patients (50%) with stable disease (SD), and 1 patient (10%) with progressive diseases (PD), in best response. Overall response rate (ORR) was 40% in all patients. The median progression-free survival (PFS) were 5.6 overall, 6.5 for patients treated with PFE, 5.4 months for patients treated with PCE, respectively. The median overall survival (OS) were 25.3 overall, 25.3 for patients treated with PFE, 25.8 months for patients treated with PCE, respectively. A patient who achieved CR has continued to receive Cmab maintenance for 42.3 months. Most common adverse events(AEs) were acne-like rash (81.8%), skin cracks (72.7%), and bone marrow suppression (54.5%). Most common grade 3 AEs were acne-like rash (1 patient) and althralgia (1 patient). Grade 4 AEs were infusion reaction (1 patient) and allergy due to carboplatin (1 patient). No treatment-related death was observed. Platinum-based chemotherapy plus Cmab demonstrated promising efficacy with ORR 40%, median PFS 5.6 months and OS of 25.3 months, with acceptable toxicities. Cmab in combination with gemcitabine plus CDDP, warrants further investigations.
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