奈达铂与5-氟尿嘧啶联合放疗治疗晚期食管癌的疗效与毒性

Efficacy and toxicity of nedaplatin and 5-FU with radiation treatment for advanced esophageal carcinomas.

作者信息

Kato Hiroyuki, Fukuchi Minoru, Manda Ryokuhei, Nakajima Masanobu, Miyazaki Tatsuya, Sohda Makoto, Masuda Norihiro, Fukai Yasuyuki, Tsukada Katsuhiko, Kuwano Hiroyuki

机构信息

Department of Surgery I, Gunma University Faculty of Medicine, 3-39-22, Showamachi, Maebashi, Gunma, 371-8511, Japan.

出版信息

Anticancer Res. 2003 Jul-Aug;23(4):3493-8.

PMID:12926096

Abstract

BACKGROUND

Nedaplatin, a new analog of cisplatin, has been developed and marketed in recent years in Japan. In this study, we evaluated the efficacy and toxicity of a regimen of nedaplatin and 5-FU with radiation in patients with advanced esophageal carcinomas.

MATERIALS AND METHODS

Between June 1999 and December 2002, 42 patients with advanced and unresectable thoracic esophageal squamous cell carcinomas (SCCs) were enrolled into this study. Twenty-five of these 42 patients were considered to have inoperable tumors due to distant organ metastasis, distant lymph node metastasis, severe organ dysfunction and rejection of surgery by the patients. The remaining 17 patients received neoadjuvant treatment followed by surgery. The clinical responses of the primary tumors were evaluated.

RESULTS

Response and toxicity could be assessed in 22 of the 25 patients with unresectable esophageal SCCs. Two of these 22 achieved a complete response (CR), 15 had a partial response (PR) and 5 showed no change (NC). The overall response rate (CR + PR) was 77%. The one- and 2-year survival rates were 30.7% and 10.2%, respectively, with a median survival time (MST) of 10.1 months. Of the 17 patients who received neoadjuvant treatment, 14 underwent subsequent surgery. Preoperatively, 2 of these 17 patients achieved a CR, 10 had a PR and 5 showed NC. The overall response rate for all 39 patients was 74%. The pathological complete response (pCR) rate of the 14 patients who underwent surgery was 28.6%. Their one- and 2-year survival rates were 48.2% and 12.1%, respectively, with an MST of 12.2 months. Toxicity was evaluated in the 39 patients whose responses were assessed. Toxicity higher than grade 3 occurred in 8 out of 39 (20.5%) patients, and 6 (15.4%), 3 (7.7%) and one (2.6%) had grade 3 leukopenia, thrombocytopenia and anemia, respectively.

CONCLUSION

In conclusion, this study indicates that combination chemoradiotherapy with nedaplatin and 5-FU is safe and efficacious for patients with advanced esophageal carcinomas. We recommend further evaluation of this treatment regimen in such patients.

摘要

背景

奈达铂是顺铂的一种新类似物，近年来已在日本研发并上市。在本研究中，我们评估了奈达铂和5-氟尿嘧啶联合放疗方案对晚期食管癌患者的疗效和毒性。

材料与方法

1999年6月至2002年12月期间，42例晚期且不可切除的胸段食管鳞状细胞癌（SCC）患者纳入本研究。这42例患者中，25例因远处器官转移、远处淋巴结转移、严重器官功能障碍及患者拒绝手术而被认为肿瘤无法切除。其余17例患者接受新辅助治疗后行手术。评估原发肿瘤的临床反应。

结果

25例不可切除食管SCC患者中有22例可评估反应和毒性。这22例患者中，2例达到完全缓解（CR），15例部分缓解（PR），5例无变化（NC）。总缓解率（CR + PR）为77%。1年和2年生存率分别为30.7%和10.2%，中位生存时间（MST）为10.1个月。17例接受新辅助治疗的患者中，14例随后接受了手术。术前，这17例患者中2例达到CR，10例PR，5例NC。39例患者的总缓解率为74%。14例接受手术患者的病理完全缓解（pCR）率为28.6%。他们的1年和2年生存率分别为48.2%和12.1%，MST为12.2个月。对39例评估了反应的患者进行毒性评估。39例患者中有8例（20.5%）出现高于3级的毒性，6例（15.4%）、3例（7.7%）和1例（2.6%）分别出现3级白细胞减少、血小板减少和贫血。