Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Despite the clinical success of immune checkpoint blockade (ICB), in neoadjuvant setting, there is still a lack of valid data for operable NSCLC in the real world. This study aim to compare the clinical outcomes (pathologic response rate versus survival) of neoadjuvant immunochemotherapy with neoadjuvant chemotherapy in the real world, to explore the impact of clinicopathological factors on clinical outcomes in neoadjuvant immunochemotherapy setting, and to identify potential neoadjuvant immunochemotherapy beneficiaries.
Although the application of neoadjuvant immunotherapy in NSCLC has brought a new treatment option to many patients, most evidence is based on interventional clinical trials, in which the participants are highly selected and the therapeutic strategies are restricted, resulting in limited representation. There is still a lack of large-scale multicenter real-world data to further verify the benefits in long term overall survival, identify the potential beneficiaries and optimize the therapeutic strategies of neoadjuvant immunochemotherapy.
To meet the forementioned need, the investigators will perform a multi-center retrospective cohort to describe the patterns of neoadjuvant immunochemotherapy use in real world, compare the efficacy of neoadjuvant immunochemotherapy ,and evaluate prognosis of neoadjuvant immunochemotherapy.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Resectable stage I-III NSCLC | Patients with NSCLC patients receiving neoadjuvant therapy and undergoing surgeries. Resectability after neoadjuvant therapy is judged by the multidisciplinary team of thoracic surgeon, oncologist and radiation oncologist. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Neoadjuvant immunochemotherapy | Drug | Patients with operable stage I-III NSCLC who have previously undergone platinum drugs and immune checkpoint inhibitors(Anti PD-1) and then undergone radical surgery |
| Measure | Description | Time Frame |
|---|---|---|
| Disease-free survival(DFS) | Defined as the time from the date of randomization until the date of disease recurrence or death (by any cause in the absence of recurrence). | DFS was defined as the time from surgery to the appearance of metastasis, up to approximately 5 years. |
| Pathological Complete Response (pCR) | defined as 0% of viable tumor cells in primary tumor and lymph nodes | Within 2 weeks after surgery |
| Measure | Description | Time Frame |
|---|---|---|
| OS (overall survival) | OS is defined as the time from surgery tiem until death from any cause. | From date of surgery until date of death due to any cause, up to approximately 5 years. |
| Overall Survival (overall survival) Rate |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Stage I-III NSCLC patients undergo neoadjuvant treatment.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Jie He, Dr. | Contact | 010-87788863 | prof.jiehe@gmail.com |
| Name | Affiliation | Role |
|---|---|---|
| Jie He, Dr. | Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| National Cancer Center/Cancer Hospital,Chinese Academy of Medical Sciences and Peking Union Medical College | Recruiting | Beijing | Beijing Municipality | 100021 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 38342430 | Derived | Yang Z, Wang S, Yang H, Jiang Y, Zhu L, Zheng B, Fu H, Ma J, Xie H, Wang Z, He H, Xia C, Li R, Xu J, Han J, Huang X, Li Y, Zhao B, Ni C, Xing H, Chen Y, Wang J, Jiang Y, Song Y, Mao Y, Chen C, Yao F, Zhang G, Hu J, Xue Q, Gao S, He J; NeoR-World Research Group. Treatment patterns and clinical outcomes of patients with resectable non-small cell lung cancer receiving neoadjuvant immunochemotherapy: A large-scale, multicenter, real-world study (NeoR-World). J Thorac Cardiovasc Surg. 2024 Oct;168(4):1245-1258.e17. doi: 10.1016/j.jtcvs.2024.02.006. Epub 2024 Feb 10. |
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D002289 | Carcinoma, Non-Small-Cell Lung |
| ID | Term |
|---|---|
| D002283 | Carcinoma, Bronchogenic |
| D001984 | Bronchial Neoplasms |
| D008175 | Lung Neoplasms |
| D012142 | Respiratory Tract Neoplasms |
Not provided
Not provided
| ID | Term |
|---|---|
| D020360 | Neoadjuvant Therapy |
| ID | Term |
|---|---|
| D003131 | Combined Modality Therapy |
| D013812 | Therapeutics |
Not provided
Not provided
Not provided
Not provided
Not provided
|
| Neoadjuvant chemotherapy | Drug | Patients with operable stage I-III NSCLC who have previously undergone platinum-based chemotherapy regimens and then undergone radical surgery |
|
|
OS is defined as the time from surgery tiem until death from any cause, estimated from a Kaplan Meier plot of OS at the time of the primary analysis.
| From date of surgery until date of death due to any cause. Assessed at 1 years. |
| Overall Survival (overall survival) Rate | OS is defined as the time from surgery tiem until death from any cause, estimated from a Kaplan Meier plot of OS at the time of the primary analysis. | From date of surgery until date of death due to any cause. Assessed at 2 years. |
| Overall Survival (overall survival) Rate | OS is defined as the time from surgery tiem until death from any cause, estimated from a Kaplan Meier plot of OS at the time of the primary analysis. | From date of surgery until date of death due to any cause. Assessed at 5 years. |
| EFS (event-free survival) | EFS was defined as time from study inclusion (first dose date) to disease progression, death, or discontinuation of treatment. | Up to 5 years after first therapy. |
| Event Free Survival (event-free survival) Rate | EFS was defined as time from study inclusion (first dose date) to disease progression, death, or discontinuation of treatment. | From date of first received neoadjuvant therapy to 1 years after neoadjuvant. |
| Event Free Survival (event-free survival) Rate | EFS was defined as time from study inclusion (first dose date) to disease progression, death, or discontinuation of treatment. | From date of first received neoadjuvant therapy to 2 years after neoadjuvant. |
| Event Free Survival (event-free survival) Rate | EFS was defined as time from study inclusion (first dose date) to disease progression, death, or discontinuation of treatment. | From date of first received neoadjuvant therapy to 5 years after neoadjuvant. |
| Major Pathological Response (MPR) | defined as ≤10% of viable tumor cells | Within 2 weeks after surgery |
| Patterns of Relapse | Relapse was defined as disease recurrence at any site. | Within 5 years after surgery |
| D013899 |
| Thoracic Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |