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卡铂联合每周一次紫杉醇治疗合并特发性间质性肺炎的晚期肺鳞状细胞癌的II期研究(阪神癌症组IP001)

Phase II study of carboplatin + weekly paclitaxel for advanced lung squamous cell carcinoma with idiopathic interstitial pneumonia (Hanshin Cancer Group IP001).

作者信息

Suzuki Hidekazu, Hata Akito, Tokito Takaaki, Watanabe Kana, Fukuhara Tatsuro, Zaizen Yoshiaki, Yokoyama Toshihide, Fukuda Yasushi, Shiroyama Takayuki, Amano Yoshihiro, Ishida Akane, Nakakura Akiyoshi, Morita Satoshi, Hatachi Yukimasa, Katakami Nobuyuki

机构信息

Department of Thoracic Oncology, Osaka Habikino Medical Center, 3-7-1 Habikino, Habikino city, Osaka, 583-8588, Japan.

Kobe Minimally Invasive Cancer Center, Kobe, Japan.

出版信息

Med Oncol. 2025 Jun 30;42(8):304. doi: 10.1007/s12032-025-02843-w.

DOI:10.1007/s12032-025-02843-w
PMID:40587012
Abstract

Advanced lung cancer complicated by idiopathic interstitial pneumonia (IIP) is difficult to treat because anticancer agents can worsen IIP. The efficacy and risks of treatment remain unknown and no standard chemotherapy regimen has been established for this condition. The central institutional review board approved this study. Radiologists and pulmonologists independently determined the sub-type of IIP. Eligibility criteria included age > 20 years, PS 0-1, adequate organ function, and written informed consent. Chemotherapy consisted of Carboplatin (CBDCA; area under the curve = 5), day 1 and Paclitaxel (PAC) 70 mg/m, days 1, 8, and 15. Participants received chemotherapy every 4 weeks, for 4-6 cycles. Between January 2013 and October 2018, 36 patients enrolled in the study and 35 patients underwent chemotherapy. Patient characteristics were as follows: median age 73 years (range: 66-80 years), male/female (31/4), stage IIIA/IIIB/IV/post-op recurrence = 7/8/16/4, smoking yes/no = 34/1. Subtypes of IIP included idiopathic pulmonary fibrosis in 11(31.4%), combined pulmonary fibrosis and emphysema in 7, unclassified in 16, and interstitial linear abnormality in one. The response rate was 45.7% [0.288-0.634] with Complete Response/Partial Response/Stable Disease/Progressive Disease = 0/16/15/3, progression-free survival of 5.75 [4.70-6.67] months, and median overall survival of 9.99 [7.92-17.45] months. The acute exacerbation rate of IIP was 8.6% (3/35). CBDCA + weekly PAC had an acceptable acute exacerbation rate with a reasonable response rate, suggesting that it is a promising therapy for advanced squamous cell lung cancer with IIP. The risk factors of acute exacerbation remain to be investigated.

摘要

晚期肺癌合并特发性间质性肺炎(IIP)难以治疗,因为抗癌药物会使IIP恶化。治疗的疗效和风险尚不清楚,且尚未针对这种情况确立标准的化疗方案。中心机构审查委员会批准了本研究。放射科医生和肺科医生独立确定IIP的亚型。纳入标准包括年龄>20岁、体能状态0 - 1、器官功能良好以及书面知情同意。化疗方案为卡铂(CBDCA;曲线下面积 = 5),第1天给药,紫杉醇(PAC)70mg/m²,第1、8和15天给药。参与者每4周接受一次化疗,共4 - 6个周期。2013年1月至2018年10月,36例患者纳入研究,35例患者接受了化疗。患者特征如下:年龄中位数73岁(范围:66 - 80岁),男性/女性(31/4),ⅢA/ⅢB/Ⅳ期/术后复发 = 7/8/16/4,吸烟/不吸烟 = 34/1。IIP的亚型包括11例(31.4%)特发性肺纤维化、7例合并肺纤维化和肺气肿、16例未分类以及1例间质线性异常。缓解率为45.7% [0.288 - 0.634],完全缓解/部分缓解/病情稳定/疾病进展 = 0/16/15/3,无进展生存期为5.75 [4.70 - 6.67]个月,总生存期中位数为9.99 [7.92 - 17.45]个月。IIP的急性加重率为8.6%(3/35)。CBDCA + 每周一次的PAC急性加重率可接受,缓解率合理,表明它是治疗合并IIP的晚期鳞状细胞肺癌的一种有前景的疗法。急性加重的危险因素仍有待研究。

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