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T4 期口腔鳞状细胞癌患者术前同步放化疗 S-1 的 II 期研究。

Phase II study of preoperative concurrent chemoradiation therapy with S-1 in patients with T4 oral squamous cell carcinoma.

机构信息

Department of Oral and Maxillofacial Surgery, Kumamoto University Hospital, Honjo, Kumamoto, Japan.

出版信息

Int J Radiat Oncol Biol Phys. 2010 Apr;76(5):1347-52. doi: 10.1016/j.ijrobp.2009.03.055. Epub 2009 Jul 21.

DOI:10.1016/j.ijrobp.2009.03.055
PMID:19628343
Abstract

PURPOSE

To determine the feasibility and efficacy of preoperative concurrent chemoradiation therapy (CCRT) with S-1, an oral fluoropyrimidine derivative, in patients with T4 oral squamous cell carcinoma (SCC).

METHODS AND MATERIALS

Only patients with histologically proven T4 oral SCC were included. Radiotherapy (total dose, 30 Gy) was delivered in 2-Gy daily fractions over a period of 3 weeks. Concurrently, S-1 (80 mg/m(2)/day) was administered orally twice daily for 14 consecutive days.

RESULTS

We enrolled 46 patients. All underwent radiotherapy as planned; however, oral S-1 was discontinued in 3 patients who manifested acute toxicity. Grade 3 toxicities were mucositis (20%), anorexia (9%), and neutropenia (4%). We encountered no Grade 4 adverse events or serious postoperative morbidity requiring surgical intervention. After CCRT, 32 of the 46 patients underwent radical resection; in 17 (53%) of the operated patients, the pathologic response was complete. During follow-up ranging from 7 to 58 months (median, 22 months), tumor control failed in 5 (16%) of the 32 operated patients; there were 3 local and 2 regional failures. Of the 14 non-operated patients, 8 (57%) manifested local (n = 7) or regional failure (n = 1). The 3-year overall survival rate for all 46 patients was 69%; it was significantly higher for operated than for non-operated patients (82% vs. 48%; p = 0.0288).

CONCLUSION

Preoperative CCRT with S-1 is feasible and effective in patients with T4 oral SCC. Even in inoperable cases, CCRT with S-1 provides adequate tumor control.

摘要

目的

评估替吉奥(S-1)联合术前放化疗治疗 T4 期口腔鳞状细胞癌(SCC)的可行性和疗效。

方法与材料

仅纳入经组织学证实的 T4 期口腔 SCC 患者。放疗(总剂量 30Gy)采用 2Gy 单次剂量,3 周内完成。同期给予 S-1(80mg/m2/天)口服,每日 2 次,连续 14 天。

结果

共纳入 46 例患者。所有患者均按计划接受放疗;然而,由于 3 例患者出现急性毒性,停止了口服 S-1 治疗。3 级毒性包括黏膜炎(20%)、食欲不振(9%)和中性粒细胞减少症(4%)。未发生 4 级不良事件或需要手术干预的严重术后并发症。在 CCRT 后,46 例患者中有 32 例接受了根治性切除术;在 17 例(53%)接受手术的患者中,病理反应完全。在 7-58 个月(中位 22 个月)的随访期间,32 例接受手术的患者中有 5 例(16%)肿瘤控制失败;其中 3 例为局部失败,2 例为区域失败。在 14 例未手术的患者中,8 例(57%)出现局部(n=7)或区域失败(n=1)。46 例患者的 3 年总生存率为 69%;手术组明显高于未手术组(82%比 48%;p=0.0288)。

结论

S-1 联合术前放化疗治疗 T4 期口腔 SCC 是可行和有效的。即使在不可手术的情况下,S-1 联合 CCRT 也能提供充分的肿瘤控制。

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