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Superselective intra-arterial chemoradiotherapy for maxillary sinus squamous-cell carcinoma: results from the T4bN0M0 cohort of JCOG1212.
СтатьяМногоцентровое исследованиеНазвание и аннотация: Перевод в очереди
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Tachibana H, Matsuura K, Onimaru R, Yoshida D, Kobayashi T, Ueda T, Nakahira M, Ohkoshi A, Omura G, Mukaigawa T, Katagiri K, Asakage T, Shinomiya H, Ito F, Asada Y, Beppu T, Fujii T, Hirayama Y, Tsukahara K, Saito Y, Ichikawa K, Uemura H, Tahara M, Hanai N, Kiyota N, Iwamoto S, Sasaki K, Mizusawa J, Fukuda H, Homma A, JCOG Head and Neck Cancer Study Group of the Japan Clinical Oncology Group (JCOG-HNCSG)
Аннотация
BACKGROUND: JCOG1212 is a multi-institutional prospective single-arm trial evaluating the efficacy and safety of superselective intra-arterial cisplatin infusion with concomitant radiotherapy (RADPLAT) for locally advanced maxillary sinus squamous-cell carcinoma (MS-SCC). We previously reported the results for the T4aN0M0 cohort (n = 64), in which RADPLAT was shown to be feasible and to provide favorable survival outcomes. This report presents the results for the T4bN0M0 cohort.
PATIENTS AND METHODS: Patients with previously untreated T4bN0M0 MS-SCC received weekly intra-arterial cisplatin (100 mg/m2) for seven cycles in combination with radiotherapy (70 Gy in 35 fractions). The primary endpoint was 3-year overall survival (OS), with a predefined efficacy threshold of 35% and a one-sided alpha of 5%. Secondary endpoints included event-free survival (EFS), local EFS (LEFS), clinical response, and toxicity.
RESULTS: Sixty-four patients were enrolled from 20 institutions. The 3-year OS was 68.8% [90% confidence interval (CI) 58.1% to 77.2%], exceeding the efficacy threshold. The clinical complete response rate was 54.7%. The 3-year EFS and LEFS was 51.6% (95% CI 38.8% to 63.0%) and 57.8% (95% CI 44.8% to 68.8%), respectively. With regard to acute adverse events, neutropenia ≥ grade 3 (18.0%), mucositis ≥ grade 3 (23.0%), hearing impairment ≥ grade 2 (3.3%), and stroke ≥ grade 2 (1.6%) were observed. No grade 2 ≥ creatinine increase was observed. There were no treatment-related deaths.
CONCLUSIONS: RADPLAT achieved favorable survival outcomes with acceptable toxicity in patients with T4bN0M0 MS-SCC. These results establish RADPLAT as a feasible and effective organ-preserving treatment and demonstrate the potential of intra-arterial chemoradiotherapy for unresectable MS-SCC.
PATIENTS AND METHODS: Patients with previously untreated T4bN0M0 MS-SCC received weekly intra-arterial cisplatin (100 mg/m2) for seven cycles in combination with radiotherapy (70 Gy in 35 fractions). The primary endpoint was 3-year overall survival (OS), with a predefined efficacy threshold of 35% and a one-sided alpha of 5%. Secondary endpoints included event-free survival (EFS), local EFS (LEFS), clinical response, and toxicity.
RESULTS: Sixty-four patients were enrolled from 20 institutions. The 3-year OS was 68.8% [90% confidence interval (CI) 58.1% to 77.2%], exceeding the efficacy threshold. The clinical complete response rate was 54.7%. The 3-year EFS and LEFS was 51.6% (95% CI 38.8% to 63.0%) and 57.8% (95% CI 44.8% to 68.8%), respectively. With regard to acute adverse events, neutropenia ≥ grade 3 (18.0%), mucositis ≥ grade 3 (23.0%), hearing impairment ≥ grade 2 (3.3%), and stroke ≥ grade 2 (1.6%) were observed. No grade 2 ≥ creatinine increase was observed. There were no treatment-related deaths.
CONCLUSIONS: RADPLAT achieved favorable survival outcomes with acceptable toxicity in patients with T4bN0M0 MS-SCC. These results establish RADPLAT as a feasible and effective organ-preserving treatment and demonstrate the potential of intra-arterial chemoradiotherapy for unresectable MS-SCC.