By prospectively observing the time to the best therapeutic effect of non-small cell lung cancer after ICI treatment, the characteristics of lesion distribution when the best therapeutic effect is reached, and the phenotype of disease progression after ICI treatment response, the investigators intended to explore the failure pattern of NSCLC after the once effective ICI treatment. The investigators also aim to evaluate the feasibility and clinical value of radiotherapy for the treatment of oligo-progressive lesions after ICI.
Study Type
OBSERVATIONAL
Enrollment
320
Fudan University Shanghai Cancer Center
Shanghai, Shanghai Municipality, China
Oligo-progression disease rate in NSCLC patients developing acquired resistance to ICI treatment.
Acquired resistance (AR) was defined as disease progression after partial or complete response (PR or CR) to ICI treatment. (by RECIST standard v1.1) When observing disease progression in ICI treatment, the number and distribution of progression lesions were recorded. Oligo-progression disease (OPD) was defined as 1-3 progression lesions in 1-2 organs. The OPD rate in all AR cases will be calculated.
Time frame: at least 2 months after ICI treatment.
Overall objective response rate to radiotherapy.
When radiotherapy to at least one of the OPD lesions is indicated in the opinion of the investigator. Overall objective response rate (ORR) to radiotherapy will be recorded. ORR was defined as the proportion of participants with partial response (PR) or complete response (CR) to treatment as defined by Response Evaluation Criteria in Solid Tumors (RECIST) 1.1.
Time frame: at least 4 weeks after radiotherapy.
Objective response rate in non-irradiated lesion
Objective response rate (ORR) in Non-irradiated Lesion was defined as the proportion of patients with at least 30% reduction from baseline in the longest diameter of any of non-irradiated target lesions defined by Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 at any time-point from the date of treatment initiation to the date of last follow-up.
Time frame: at least 4 weeks after radiotherapy.
Percentage of Participants With Adverse Events
Treatment-related adverse events were assessed and graded according to CTCAE v. 5.0.
Time frame: Two years
Overall Survival since AR development.
OS was defined as the time from the date of enrollment until death by any cause. Participants still alive at the time of data analysis were censored at the date of last follow-up.
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Time frame: Two years