Shinomiya Hirotaka, Matsuura Kazuto, Onimaru Rikiya, Ohkoshi Akira, Saito Yuki, Tachibana Hiroyuki, Shiga Kiyoto, Ueda Tsutomu, Asada Yukinori, Uemura Hirokazu, Beppu Takeshi, Seto Akira, Yasumatsu Ryuji, Nakahira Mitsuhiko, Omura Go, Asakage Takahiro, Minami Shujiro, Fujii Takashi, Hirayama Yuji, Yoshida Daisuke, Nakamura Kenichi, Sasaki Keita, Mizusawa Junki, Fukuda Haruhiko, Homma Akihiro
Department of Otolaryngology-Head and Neck Surgery, Kobe University Graduate School of Medicine, 7-5-2 Kusunoki-Cho Chuo-Ku, Kobe, Hyogo, 650-0017, Japan.
Department of Head and Neck Surgery, National Cancer Center Hospital East, Kashiwa, Japan.
Int J Clin Oncol. 2025 Mar;30(3):489-496. doi: 10.1007/s10147-025-02702-8. Epub 2025 Feb 6.
JCOG1212 is a dose-finding and efficacy confirmatory study of concurrent superselective intra-arterial infusion of cisplatin and radiotherapy (RADPLAT) for locally advanced primary squamous cell carcinoma of the maxillary sinus (cT4a,bN0M0). In this study, we report the results of the final analysis of the efficacy confirmation phase for the T4a cohort with 5-year follow-up data to evaluate the late adverse events and long-term efficacy.
Based on the results of the dose-finding phase, the efficacy confirmation phase consisted of seven weekly intra-arterial infusions of cisplatin 100 mg/m combined with radiotherapy (70 Gy). The 5-year prognosis and late adverse events were evaluated.
Between April 2014 and August 2018, 64 patients were included in the analysis (one ineligible patient was excluded); 31 patients were treated with three-dimensional conformal radiation therapy (3D-CRT) and 33 with intensity modulated radiation therapy (IMRT). The 5-year overall survival, event-free survival, and local event-free survival was 71.9, 54.7, and 57.5%, respectively. In terms of late adverse events, grade 3 or higher non-hematologic toxicity was observed in 42.9% of 63 patients (retinopathy: 12, cataract: 10, osteonecrosis of mandible: 4, etc.). Grade 3 and 4 cataracts of affected side appeared in 22.6% (7/31) of the 3D-CRT group compared to 3.1% (1/32) in the IMRT group. Twenty-one patients had died, with 15 from the primary disease, 5 from other causes, and 1 from treatment-related cause.
The prognosis of RADPLAT was favorable after 5-year follow-up with acceptable late adverse events and low proportion of treatment related death.
JCOG1212是一项关于顺铂超选择性动脉内灌注与放疗同步进行（RADPLAT）治疗上颌窦局部晚期原发性鳞状细胞癌（cT4a,bN0M0）的剂量探索及疗效验证研究。在本研究中，我们报告了T4a队列疗效验证阶段的最终分析结果，该队列具有5年随访数据，以评估晚期不良事件和长期疗效。
基于剂量探索阶段的结果，疗效验证阶段包括每周一次动脉内输注100mg/m顺铂共7次，并联合放疗（70Gy）。评估了5年预后和晚期不良事件。
2014年4月至2018年8月期间，64例患者纳入分析（排除1例不符合条件的患者）；31例患者接受三维适形放疗（3D-CRT），33例接受调强放疗（IMRT）。5年总生存率、无事件生存率和局部无事件生存率分别为71.9%、54.7%和57.5%。在晚期不良事件方面，63例患者中有42.9%出现3级或更高等级的非血液学毒性（视网膜病变：12例，白内障：10例，下颌骨坏死：4例等）。3D-CRT组患侧3级和4级白内障发生率为22.6%（7/31），而IMRT组为3.1%（1/32）。21例患者死亡，其中15例死于原发性疾病，5例死于其他原因，1例死于治疗相关原因。
RADPLAT治疗5年随访后的预后良好，晚期不良事件可接受，治疗相关死亡比例低。
