卡铂加每周紫杉醇与贝伐珠单抗治疗伴有特发性间质性肺炎的非鳞状非小细胞肺癌的 II 期研究(阪神癌症小组 IP002)。

IF 1.9 4区 医学 Q3 ONCOLOGY Japanese journal of clinical oncology Pub Date : 2024-09-23 DOI:10.1093/jjco/hyae132
Nobuyuki Katakami, Kazuma Nagata, Akiyoshi Nakakura, Tadashi Okamoto, Toshihiko Kaneda, Masahide Oki, Kana Watanabe, Takaaki Tokito, Yoshihiro Amano, Motohiro Tamiya, Satoshi Morita, Yukimasa Hatachi
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引用次数: 0

摘要

背景:治疗晚期非小细胞肺癌合并特发性间质性肺炎患者时,特发性间质性肺炎急性加重的风险会增加。目前还没有针对肺癌并发特发性间质性肺炎患者的标准最佳治疗方案。我们旨在评估卡铂(CBDCA)、贝伐单抗(Bmab)和每周紫杉醇(PXT)对特发性间质性肺炎患者的疗效和安全性:这项2期研究涉及化疗无效的特发性间质性肺炎晚期非小细胞肺癌患者。患者接受 CBDCA(曲线下面积:第 1 天 5)、PXT(第 1、8 和 15 天 70 mg/m2)和 Bmab(第 1 天 15 mg/kg)治疗,每 4 周一次。主要终点是总体反应率:21名患者于2013年1月至2018年10月期间入组,接受了至少一个疗程的方案治疗。由于应征人数不足,研究在达到计划人数前终止。患者年龄中位数为 69 岁(范围:62-79),19 名(90.5%)患者为男性。总体反应率为 61.9%(95% 置信区间 [CI],38.4-81.9),达到了主要终点。无进展生存期、治疗失败时间和总生存期的中位数分别为9.69个月(95% CI,5.78-11.63)、8.21个月(95% CI,3.75-11.63)和20.93个月(95% CI,13.17-29.83)。在方案治疗期间,没有出现急性加重或与治疗相关的死亡:结果表明,晚期非鳞状非小细胞肺癌合并特发性间质性肺炎的患者可以通过联合使用CBDCA、PXT和Bmab得到有效、安全的治疗。
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Phase II study of carboplatin plus weekly paclitaxel with bevacizumab for non-squamous, non-small cell lung cancer with idiopathic interstitial pneumonia (Hanshin Cancer Group IP002).

Background: There is an increased risk of acute exacerbation of idiopathic interstitial pneumonia when treating patients with advanced non-small cell lung cancer with idiopathic interstitial pneumonia. There is no standard optimal treatment regimen for patients with lung cancer complicated with idiopathic interstitial pneumonia. We aimed to evaluate the efficacy and safety of carboplatin (CBDCA), bevacizumab (Bmab) and weekly paclitaxel (PXT) in patients with idiopathic interstitial pneumonia.

Methods: This phase 2 study involved chemotherapy-naïve patients with advanced non-small cell lung cancer with idiopathic interstitial pneumonia. Patients received CBDCA (area under the curve: 5 on day 1), PXT (70 mg/m2 on days 1, 8 and 15) and Bmab (15 mg/kg on day 1) every 4 weeks. The primary endpoint was the overall response rate.

Results: Twenty-one patients were enrolled between January 2013 and October 2018 and received at least one course of the protocol treatment. The study was terminated before enrolling the planned number of patients because of poor accrual. The median patient age was 69 (range: 62-79) years, and 19 (90.5%) patients were men. The overall response rate was 61.9% (95% confidence interval [CI], 38.4-81.9), meeting the primary endpoint. The median progression-free survival, time to treatment failure, and overall survival were 9.69 (95% CI, 5.78-11.63), 8.21 (95% CI, 3.75-11.63) and 20.93 (95% CI, 13.17-29.83) months, respectively. There was no acute exacerbation or treatment-related death during protocol treatment.

Conclusion: The results indicate that patients with advanced non-squamous, non-small cell lung cancer with idiopathic interstitial pneumonia could be effectively and safely treated using a combination of CBDCA, PXT and Bmab.

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来源期刊
CiteScore
3.70
自引率
8.30%
发文量
177
审稿时长
3-8 weeks
期刊介绍: Japanese Journal of Clinical Oncology is a multidisciplinary journal for clinical oncologists which strives to publish high quality manuscripts addressing medical oncology, clinical trials, radiology, surgery, basic research, and palliative care. The journal aims to contribute to the world"s scientific community with special attention to the area of clinical oncology and the Asian region. JJCO publishes various articles types including: ・Original Articles ・Case Reports ・Clinical Trial Notes ・Cancer Genetics Reports ・Epidemiology Notes ・Technical Notes ・Short Communications ・Letters to the Editors ・Solicited Reviews
期刊最新文献
Awareness and implementation of comprehensive genomic profiling and cancer support for adolescents and young adults among healthcare professionals in Osaka, Japan. Identifying physicians' needs in community-based palliative care consultation for cancer patients in palliative care specialist-deficient settings: a qualitative study. Low-dose add-on methadone for cancer pain management: a retrospective analysis of 102 Japanese patients. Study protocol: randomized phase III trial of neo-adjuvant and adjuvant chemotherapy vs. immediate surgery and adjuvant chemotherapy for localized soft tissue sarcoma: Japan Clinical Oncology Group study JCOG2102 (NACLESS). The role of external-beam radiotherapy for differentiated thyroid cancer.
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