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局部晚期鼻咽癌吉西他滨和顺铂化疗联合调强放疗的 II 期研究的长期结果。

Long-term results of a phase II study of gemcitabine and cisplatin chemotherapy combined with intensity-modulated radiotherapy in locoregionally advanced nasopharyngeal carcinoma.

机构信息

Department of Radiation Oncology, Fudan University Shanghai Cancer Center, Shanghai, China; Department of Oncology, Shanghai Medical College, Shanghai, China.

Department of Radiation Oncology, Fudan University Shanghai Cancer Center, Shanghai, China; Department of Oncology, Shanghai Medical College, Shanghai, China.

出版信息

Oral Oncol. 2017 Oct;73:118-123. doi: 10.1016/j.oraloncology.2017.08.016. Epub 2017 Sep 1.

Abstract

OBJECTIVES

To evaluate long-term results of a phase II study of induction and adjuvant gemcitabine and cisplatin (GP) chemotherapy with intensity-modulated radiotherapy (IMRT) in locoregionally advanced nasopharyngeal carcinoma (NPC).

MATERIALS AND METHODS

One hundred and twelve patients (Stage III: 65, IVA-B: 47) with locoregionally advanced NPC were enrolled in this study. All patients received induction chemotherapy consisting of 1000 mg/m2 gemcitabine on day 1 and 8, and cisplatin 25 mg/m2 on day 1–3, every 3 weeks for 2 cycles. Adjuvant chemotherapy for 2 cycles of the same regime was given 28 days after the end of IMRT. The IMRT technique was utilized for all patients.

RESULTS

In total, 97.3% patients completed 2 cycles of induction chemotherapy. The overall response rate (RR) of cervical lymph nodes was 89.0%. Acute toxicities were mainly grade 1–2 myleosuppression and vomiting. And 83.9% patients completed 2 cycles of adjuvant chemotherapy. All patients finished IMRT with RR at the end of IMRT for nasopharynx, lymph nodes of neck and retropharyngeal area being 99.1%, 97.9% and 97.7%, respectively. The 5-year local control, regional control, distant metastasis-free and overall survival rates were 93.2%, 92.3%, 89.0% and 82.1%, respectively. The 5-year overall survival of stage III and IVA-B were 87.0%, and 75.5%, respectively. The incidence of grade 3–4 acute radiotherapy-related mucositis was 28.6%. Severe late toxicities were uncommon.

CONCLUSION

IMRT combined with GP for locoregionally advanced NPC is well tolerated, effective, and convenient, and warrants further studies.

摘要

目的

评估局部晚期鼻咽癌患者接受诱导和辅助吉西他滨和顺铂(GP)化疗联合强度调制放疗(IMRT)的 II 期研究的长期结果。

材料和方法

本研究纳入了 112 例局部晚期鼻咽癌患者(III 期:65 例,IVA-B 期:47 例)。所有患者接受诱导化疗,方案为吉西他滨 1000mg/m2,第 1 天和第 8 天;顺铂 25mg/m2,第 1-3 天,每 3 周为 1 个周期,共 2 个周期。IMRT 结束后 28 天给予 2 个周期的辅助化疗,方案同诱导化疗。所有患者均接受 IMRT 治疗。

结果

共有 97.3%的患者完成了 2 个周期的诱导化疗。颈淋巴结的总缓解率(RR)为 89.0%。急性毒性主要为 1-2 级骨髓抑制和呕吐。83.9%的患者完成了 2 个周期的辅助化疗。所有患者均完成了 IMRT 治疗,结束时鼻咽部、颈部淋巴结和咽后区的 RR 分别为 99.1%、97.9%和 97.7%。局部控制、区域控制、无远处转移和总生存率分别为 93.2%、92.3%、89.0%和 82.1%。III 期和 IVA-B 期的 5 年总生存率分别为 87.0%和 75.5%。3-4 级急性放疗相关黏膜炎的发生率为 28.6%。严重的晚期毒性并不常见。

结论

IMRT 联合 GP 治疗局部晚期鼻咽癌具有良好的耐受性、有效性和便利性,值得进一步研究。

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