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Characteristics of Real‐World Metastatic Non‐Small Cell Lung Cancer Patients Treated with Nivolumab and Pembrolizumab During the Year Following Approval
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Martin Reck Fiona Taylor John R. Penrod Michael DeRosa Laura Morrissey Homa Dastani Lucinda Orsini Richard J. Gralla 《Journal of thoracic oncology》2018,13(2):194-204
Introduction
In the phase III CheckMate 017 study, nivolumab prolonged overall survival versus docetaxel in previously treated patients with advanced squamous NSCLC. Study objectives included health-related quality of life (HRQoL) and symptom assessments.Methods
Patients serially completed the Lung Cancer Symptom Scale (LCSS) and European Quality of Life Five Dimensions (EQ-5D) questionnaires. The LCSS average symptom burden index (ASBI) (mean score for six lung cancer–specific symptoms; range 0–100), LCSS three-item global index, EQ-5D utility index, and EQ-5D visual analog scale scores were analyzed. The proportion of patients exhibiting clinically meaningful improvement (a ≥10-point decrease) in ASBI scores by week 12 was a secondary end point. Mixed-effect model repeated measures analysis of HRQoL changes from baseline and analyses of time to HRQoL deterioration were conducted.Results
Baseline mean plus or minus SD LCSS ASBI scores were similar in the nivolumab (29.6 ± 16.4) and docetaxel (29.6 ± 14.7) groups. By week 12, the proportions of patients (95% confidence interval) with clinically meaningful improvement in ASBI scores were 20.0% (13.6–27.7) with nivolumab and 21.9% (15.3–29.8) with docetaxel. At weeks 16 to 54, significant improvements in ASBI scores from baseline were seen with nivolumab; clinically meaningful improvements were observed at weeks 42 to 84. No significant changes in ASBI scores from baseline were observed with docetaxel; at week 36, a clinically meaningful deterioration was seen. Improvements in HRQoL with nivolumab versus with docetaxel were supported by other measures, and time to first HRQoL deterioration was longer.Conclusion
Nivolumab alleviates symptom burden and improves health status versus docetaxel as second-line squamous NSCLC treatment. 相似文献94.
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《Journal of thoracic oncology》2022,17(1):130-140
IntroductionPrevious studies have evaluated stereotactic body radiotherapy (SBRT) in oligometastatic patients with NSCLC, including multimodality treatment with anti–programmed cell death protein-1 monotherapy. Questions remain regarding the timing of SBRT and immunotherapy, safety with dual checkpoint blockade, and the utility in widely metastatic patients. This randomized phase 1 trial combined nivolumab and ipilimumab with sequential or concurrent multisite SBRT in patients with stage IV NSCLC to evaluate safety and obtain preliminary activity data.MethodsTreatment-naive patients with metastatic NSCLC were randomized to concurrent (SBRT with immunotherapy) or sequential (SBRT followed by immunotherapy) treatment. A maximum of four treatment fields received SBRT. Nivolumab and ipilimumab were continued until clinical progression, development of toxicity, or after 2 years. Dose-limiting toxicity was defined as greater than or equal to grade 3 toxicity to the relevant organ system attributed to SBRT and immunotherapy occuring within 3 months.ResultsA total of 37 patients were assessable. No dose-limiting toxicity occurred in the concurrent cohort (n = 18). The sequential cohort required a dose reduction in the central lung group owing to two grade 4 pneumonitis events (2 of 19). Overall best response was as follows: 5.4% (2 of 37) complete response, 40.5% (15 of 37) partial response, 16.2% (6 of 37) stable disease, and 37.8% (14 of 37) progressive disease. Median progression-free survival was 5.8 months (95% confidence interval: 3.6–11.4 mo), with median follow-up of 17.0 months. Median overall survival was not reached.ConclusionsConcurrent nivolumab, ipilimumab, and SBRT were not more toxic than sequential therapy, and multisite SBRT was well tolerated in widely metastatic patients. Multimodality therapy resulted in durable metastasis control and encouraging early overall survival. 相似文献
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