Real-world treatment model and comprehensive comparative efficacy of Endostar plus different chemotherapies in advanced patients with non-small cell lung cancer

The patients

A multicenter retrospective observational study was conducted based on electronic medical records (EMRs) from 7 cancer hospitals in China, registered in the Chinese Clinical Trial Registry (ChiCTR2000035129). This study has been approved and waived informed consent by all institutional and licensing committees. [Ethics committee of National Cancer Center/National Clinical Research Center for Cancer/Cancer Hospital & Shenzhen Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Shenzhen, China (14/01/2020), Ethics committee of The Third Clinical College of Xinjiang Medical University, Urumqi, China (22/06/2020), Ethics committee of Yunnan Cancer Hospital, Kunming, China (29/03/2021), Ethics committee of Anhui Provincial Hospital, Hefei, China (10/06/2020), Ethics committee of Hunan Cancer Hospital, Changsha, China (10/03/2021), Ethics committee of Chongqing Cancer Hospital, Chongqing, China (22/05/2020), and Ethics committee of Shaanxi Provincial Cancer Hospital, Xi’an, China (25/03/2021)]. All research was carried out in accordance with the Declaration of Helsinki. Patients over 18 years of age with a clinical diagnosis of NSCLC, pathological stage III or IV [defined by American Joint Committee on Cancer tumor, node, metastasis (TNM) staging system version 7.0], and treated with Endostar combined with chemotherapy between 2012 and 2019 were included. According to the combination chemotherapy, the patients were further divided into Endostar plus NP group, Endostar plus DP group, Endostar plus GP group, Endostar plus PP group and Endostar plus TP group. Treatment naïve patients and retreatment patients were defined separately as those who received Endostar administration during 1st line treatment and those who received Endostar administration during 2nd line treatment or after , and an exploratory subgroup analysis was then performed.

Basic covariates

The index date was defined as the date of first treatment with Endostar, and baseline data on covariates was collected, including date of birth, gender, smoking history, family history of lung cancer, date of admission and date of discharge, stage of tumor, pathologic feature and routes of administration. . Smoking history, family history of lung cancer, tumor stage, and pathologic features were extracted by natural language processing (NLP) from admission records and discharge note in the EMR.

Effectiveness evaluation

The Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 is used to assess tumor response. ORR was defined as the percentage of patients who achieved a complete response (CR) and/or a partial response (PR). DCR was defined as the percentage of patients who had CR and/or PR and/or stable disease (SD). PFS was defined as the interval (months) between the first date of Endostar administration and the date of disease progression or death. In patients with disease progression or death, the date of imaging progression or death was used as the assessment date, and if PD and death were not observed, the date of the last evaluation was taken as the censored date.

Statistical methods

SAS 9.4 (SAS Institute INC., Cary, NC) was used to describe patient characteristics and compare the effectiveness of different treatment regimens. The quantitative variables, age, were described using the mean ± standard deviation and the median (P25-P75), and the qualitative variables, gender, tumor stage, family history of lung cancer, smoking history, routes of administration and treatment regimen were described in terms of number and ratio of components. . Chi-square test or Fisher’s exact test was used to compare ORR and DCR. The Kaplan-Meier method was used to describe PFS and the log-rank test was used to compare differences between different groups. The HR (95% CI) of the different chemotherapy groups was estimated by the Cox regression model. A double sided P

Ethical declarations and consent to participate

This study is a retrospective, non-interventional study that does not interfere with routine diagnosis and treatment, does not affect any patient medical rights, or increase patient medical risk. At the same time, the study did not identify individual patients. In addition, most of the patients to be included in this study died or were lost to follow-up and their informed consent could not be obtained. For the above reasons, we have requested waiver of informed consent from all patients in this study and have been approved by the ethics committees of all centers. All research was carried out in accordance with the Declaration of Helsinki.

The full name of all ethics committees that approved this study:

  • Ethics Committee of the National Cancer Center/National Clinical Research Center for Cancer/Cancer Hospital & Shenzhen Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Shenzhen, China (01/14/2020).

  • Ethics Committee of the Third Clinical College of Xinjiang Medical University, Urumqi, China (06/22/2020).

  • Ethics Committee of Yunnan Cancer Hospital, Kunming, China (03/29/2021).

  • Ethics Committee of Anhui Provincial Hospital, Hefei, China (10/06/2020).

  • Ethics Committee of Hunan Cancer Hospital, Changsha, China (10/03/2021).

  • Ethics Committee of Chongqing Cancer Hospital, Chongqing, China (22/05/2020).

  • Ethics Committee of Shaanxi Provincial Cancer Hospital, Xi’an, China (03/25/2021).

Sara H. Byrd