Suppr超能文献

新辅助吉西他滨-顺铂治疗肌层浸润性膀胱癌的总剂量和剂量强度对疗效及安全性的影响:三周与四周方案对比

Implications for Efficacy and Safety of Total Dose and Dose-Intensity of Neoadjuvant Gemcitabine-Cisplatin in Muscle-Invasive Bladder Cancer: Three-Week Versus Four-Week Regimen.

作者信息

Holmsten Karin, Omland Lise Høj, Als Anne Birgitte, Agerbæk Mads, Dohn Line Hammer, Lindberg Henriette, Jensen Niels Viggo, Carus Andreas, Moe Mette, Hosseini Abolfazl, Radkiewicz Cecilia, Pappot Helle, Ullén Anders

机构信息

Department of Oncology-Pathology, Karolinska Institute, Stockholm, Sweden.

Department of Oncology, Capio Sankt Görans Hospital, Stockholm, Sweden.

出版信息

Bladder Cancer. 2022 Mar 11;8(1):71-80. doi: 10.3233/BLC-211556. eCollection 2022.

Abstract

BACKGROUND

Neoadjuvant cisplatin-based chemotherapy is standard care prior to radical cystectomy in patients with muscle-invasive bladder cancer (MIBC).

OBJECTIVE

To assess efficacy and safety of two commonly used neoadjuvant schedules with different total doses and dose-intensities of gemcitabine and cisplatin (GC).

METHODS

Data were collected retrospectively from all patients treated between 2010 and 2018 with neoadjuvant chemotherapy according to clinical routine at seven centres in Sweden and Denmark. Patients in Sweden received three cycles of a 4-week schedule (GC-4w: cisplatin 70 mg/m day 1, gemcitabine 1000 mg/m days 1, 8, 15, q 28 days) and in Denmark four cycles of a 3-week schedule (GC-3w: cisplatin 70 mg/m day 1, gemcitabine 1000 mg/m days 1, 8, q 21 days). Primary endpoint was pathological response at cystectomy (pT0N0 and < pT2N0).

RESULTS

A total of 251 patients were treated with GC-4w and 455 with GC-3w. pT0N0 was significantly higher for patients treated with GC-3w compared to GC-4w, 46% versus 32% (adjusted odds ratio [aOR] 1.80; 95% confidence interval [CI] 1.16-2.80;  = 0.009); and for < pT2N0 60% versus 47% (aOR 1.08; 95% CI 0.70-1.66;  = 0.743). There were no significant differences between GC-4w and GC-3w regarding survival parameters. GC-3w patients discontinued treatment more frequently and showed a higher degree of neutropenia.

CONCLUSIONS

A significantly higher complete response-rate was observed in the patient group treated with the more cisplatin-dose-intense 3-week schedule. The side-effect profile was in favor of the 4-week approach while relapse-free and overall survival were similar.

摘要

背景

对于肌层浸润性膀胱癌(MIBC)患者,基于顺铂的新辅助化疗是根治性膀胱切除术之前的标准治疗方法。

目的

评估吉西他滨和顺铂(GC)两种常用新辅助化疗方案在不同总剂量和剂量强度下的疗效和安全性。

方法

回顾性收集2010年至2018年间在瑞典和丹麦七个中心按照临床常规接受新辅助化疗的所有患者的数据。瑞典的患者接受为期4周的三个周期化疗方案(GC-4w:顺铂70mg/m²第1天,吉西他滨1000mg/m²第1、8、15天,每28天一次),丹麦的患者接受为期3周的四个周期化疗方案(GC-3w:顺铂70mg/m²第1天,吉西他滨1000mg/m²第1、8天,每21天一次)。主要终点是膀胱切除术后的病理反应(pT0N0和<pT2N0)。

结果

共有251例患者接受GC-4w治疗,455例接受GC-3w治疗。与GC-4w相比,接受GC-3w治疗的患者pT0N0显著更高,分别为46%和32%(调整优势比[aOR]1.80;95%置信区间[CI]1.16 - 2.80;P = 0.009);对于<pT2N0,分别为60%和47%(aOR 1.08;95%CI 0.70 - 1.66;P = 0.743)。在生存参数方面,GC-4w和GC-3w之间没有显著差异。GC-3w患者更频繁地中断治疗,且中性粒细胞减少程度更高。

结论

在接受顺铂剂量强度更高的3周方案治疗的患者组中观察到显著更高的完全缓解率。副作用方面更倾向于4周方案,而无复发生存期和总生存期相似。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/5afc/11181847/4f6324d117bd/blc-8-blc211556-g001.jpg

相似文献

3
Neoadjuvant Dose-dense Gemcitabine and Cisplatin in Muscle-invasive Bladder Cancer: Results of a Phase 2 Trial.
Eur Urol Oncol. 2018 May;1(1):54-60. doi: 10.1016/j.euo.2018.02.007. Epub 2018 Jun 6.
5
Cisplatin, Gemcitabine, and Lapatinib as Neoadjuvant Therapy for Muscle-Invasive Bladder Cancer.
Cancer Res Treat. 2016 Jul;48(3):1084-91. doi: 10.4143/crt.2015.405. Epub 2015 Dec 2.
6
Comparative analysis of three vs. four cycles of neoadjuvant gemcitabine and cisplatin for muscle invasive bladder cancer.
Urol Oncol. 2022 Oct;40(10):453.e19-453.e26. doi: 10.1016/j.urolonc.2022.05.023. Epub 2022 Jul 8.
7
Retrospective analysis of the efficacy and safety of neoadjuvant gemcitabine and cisplatin in muscle-invasive bladder cancer.
J Oncol Pharm Pract. 2020 Mar;26(2):330-337. doi: 10.1177/1078155219845434. Epub 2019 May 12.
8
Neoadjuvant Gemcitabine-Cisplatin Plus Radical Cystectomy-Pelvic Lymph Node Dissection for Muscle-invasive Bladder Cancer: A 12-year Experience.
Clin Genitourin Cancer. 2020 Oct;18(5):387-394. doi: 10.1016/j.clgc.2020.02.014. Epub 2020 Mar 6.
9
Multicenter assessment of neoadjuvant chemotherapy for muscle-invasive bladder cancer.
Eur Urol. 2015 Feb;67(2):241-9. doi: 10.1016/j.eururo.2014.09.007. Epub 2014 Sep 23.

本文引用的文献

2
Clinical efficacy and biomarker analysis of neoadjuvant atezolizumab in operable urothelial carcinoma in the ABACUS trial.
Nat Med. 2019 Nov;25(11):1706-1714. doi: 10.1038/s41591-019-0628-7. Epub 2019 Nov 4.
4
Erdafitinib in Locally Advanced or Metastatic Urothelial Carcinoma.
N Engl J Med. 2019 Jul 25;381(4):338-348. doi: 10.1056/NEJMoa1817323.
5
Role of gemcitabine and cisplatin as neoadjuvant chemotherapy in muscle invasive bladder cancer: Experience over the last decade.
Asian J Urol. 2019 Jul;6(3):222-229. doi: 10.1016/j.ajur.2018.06.006. Epub 2018 Jun 25.
6
Vinflunine in the treatment of relapsed metastatic urothelial cancer: A systematic review and meta-analysis of real-world series.
Crit Rev Oncol Hematol. 2019 Aug;140:80-87. doi: 10.1016/j.critrevonc.2019.05.006. Epub 2019 May 21.
10
Dose dense MVAC prior to radical cystectomy: a real-world experience.
World J Urol. 2017 Nov;35(11):1729-1736. doi: 10.1007/s00345-017-2065-x. Epub 2017 Jun 17.

文献AI研究员

20分钟写一篇综述,助力文献阅读效率提升50倍。

立即体验

用中文搜PubMed

大模型驱动的PubMed中文搜索引擎

马上搜索

文档翻译

学术文献翻译模型,支持多种主流文档格式。

立即体验