Comparative Effectiveness of Atezolizumab, Nivolumab, and Docetaxel in Patients With Previously Treated Non–Small Cell Lung Cancer

Ramagopalan, Sreeram V; Gupta, Alind; Arora, Paul; Thorlund, Kristian; Ray, Joshua; Subbiah, Vivek

doi:10.1001/jamanetworkopen.2021.34299

Cited by 14 publications

(19 citation statements)

References 34 publications

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“…Atezolizumab and nivolumab, PD-L1 and PD-1 antibodies, respectively, are proven to be effective and safe in clinical trials [ 3 , 4 , 6 ] and after approval by authorities in real-world studies ( Table 1 ) [ 9 , 10 , 12 , 13 , 14 , 15 , 16 , 17 ]. However, there is no head-to-head clinical trial that compares the results of each drug, and to our knowledge, there are only two real-world studies that have compared outcomes between the two ICIs [ 11 , 12 ]. However, they did not perform a head-to-head subgroup analysis between the two ICIs.…”

Section: Discussionmentioning

confidence: 99%

“…Concerning the real world, Mencoboni et al [ 8 ] performed a meta-analysis that enrolled 32 studies, most of which were treated with nivolumab, concluding that the efficacy and safety of ICIs in clinical practice are comparable to those in clinical trials. Recently, Ramagopalan et al [ 11 ], in a real-world study of a large cohort (3336 patients), did not find significant differences in OS between atezolizumab and nivolumab in the overall population or in any subgroup that was examined. Similar results were reported by Weis et al [ 12 ] in a smaller cohort.…”

Section: Discussionmentioning

confidence: 99%

“…To our knowledge, only two studies compared them. Ramagopalan et al [ 11 ] studied them in a large cohort that compared the effectiveness (OS), and Weis et al [ 12 ] compared survival, response and toxicity, concluding in both cases that there was no statistically significant difference between the two treatments. With this aim, the main objective of this work is to characterize and compare the results (survival, response and safety) between nivolumab and atezolizumab in pretreated (second- and third-line treatment) patients with advanced NSCLC.…”

Section: Introductionmentioning

confidence: 99%

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Real-World Analysis of Nivolumab and Atezolizumab Efficacy in Previously Treated Patients with Advanced Non-Small Cell Lung Cancer

et al. 2022

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Nivolumab (anti-PD-1 antibody) and atezolizumab (anti-PD-L1 antibody) have shown superior survival outcomes and improved adverse effects compared to standard chemotherapy in advanced non-small cell lung cancer (NSCLC) patients. However, the efficacy of both treatments has not been directly compared in clinical trials. This retrospective, single-centre study was performed from June 2015 to December 2020 and included a cohort of 158 previously treated patients with stage IV or recurrent NSCLC who received PD-1 (nivolumab) (n = 89) or PD-L1 (atezolizumab) (n = 69) inhibitors at the Virgen del Rocío Hospital in Seville. The objective response rate (ORR) was 22.5% in the nivolumab group and 14.5% in the atezolizumab group (p = 0.140). Multivariate analysis did not show significant differences between the two groups for PFS and OS (PFS hazard ratio (HR): 0.80, 95% confidence interval (CI): 0.55–1.17, p = 0.260; OS HR: 0.79, 95% CI: 0.52–1.21, p = 0.281). Adverse events of all grades occurred in 68 patients in the nivolumab group (76.4%) and in 34 patients in the atezolizumab group (49.3%) (p < 0.001). Atezolizumab and nivolumab did not show statistically significant differences in survival outcomes in patients with NSCLC, even when stratified by histological subtype (squamous versus nonsquamous). However, the safety analysis suggested a more favourable toxicity profile for atezolizumab.

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Section: Discussionmentioning

confidence: 99%

Section: Discussionmentioning

confidence: 99%

Section: Introductionmentioning

confidence: 99%

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Real-World Analysis of Nivolumab and Atezolizumab Efficacy in Previously Treated Patients with Advanced Non-Small Cell Lung Cancer

et al. 2022

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“…Multiple imputation using chained equations and delta-based tipping point analysis were used for sensitivity analyses of missing data assumptions as described previously. 12 Statistical analyses were performed using the R programming environment (version 3.6.3). Details are in the eMethods in the Supplement .…”

Section: Methodsmentioning

confidence: 99%

Association Between Smoking History and Overall Survival in Patients Receiving Pembrolizumab for First-Line Treatment of Advanced Non–Small Cell Lung Cancer

et al. 2022

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“…Because second-line PD-L1 immunotherapy has been associated with significant improvement in OS compared with second-line docetaxel in patients who experienced disease progression while receiving first-line chemotherapy, [18][19][20] we quantified the consequences of differences in the JAMA Network Open | Statistics and Research Methods prevalence of second-line immunotherapy between the US and Canada for OS in the first-line chemotherapy cohort. The US-standardized risks for the first-line chemotherapy cohort under these hypothetical treatment regimens are shown in Figure 3.…”

Section: Bias Analysismentioning

confidence: 99%

Transportability of Overall Survival Estimates From US to Canadian Patients With Advanced Non–Small Cell Lung Cancer With Implications for Regulatory and Health Technology Assessment

et al. 2022

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ImportanceThe external validity of survival outcomes derived from clinical practice data from US patients with advanced non–small cell lung cancer (NSCLC) is not known and is of potential importance because it may be used to support regulatory decision-making and health technology assessment outside of the US.ObjectiveTo evaluate whether overall survival (OS) estimates for a selected group of patients with advanced NSCLC from a large US clinical practice database are transportable to Canadian patients receiving the same systemic therapies.Design, Setting, and ParticipantsThis retrospective multicenter cohort study used transportability analysis to assess whether adjustment for pretreatment characteristics of eligible patient cohorts could reliably approximate OS estimated from US-based samples to Canadian populations. A total of 17 432 eligible adult patients who were diagnosed de novo with advanced NSCLC on or after January 1, 2011, were included in the analysis and followed up until September 30, 2020. Because data on race and ethnicity were available in the US database but not the Canadian database and because racial and ethnic distribution was likely to be similar between US and Canadian patients, these characteristics were not analyzed.ExposuresInitiation of platinum-doublet chemotherapy or pembrolizumab monotherapy as first-line systemic treatment for advanced NSCLC.Main Outcomes and MeasuresOS measured from the time of initiation of the respective treatment regimen.ResultsAmong 17 432 eligible patients, 15 669 patients from the US and 1763 patients from Canada were included in the analysis. Of those, 11 863 patients (sample size–weighted estimates of mean [SD] age, 68.0 [9.3] years; 6606 [55.7%] male; 10 100 from the US and 1763 from Canada) were included in the subset of patients with complete data for baseline covariates. A total of 13 532 US patients received first-line chemotherapy, and 2137 received first-line pembrolizumab monotherapy. Of those, 8447 patients (62.4%) in the first-line chemotherapy group and 1653 patients (77.3%) in the first-line pembrolizumab group had complete data on baseline covariates for outcome model estimation. A total of 1476 Canadian patients who received first-line chemotherapy and 287 patients who received first-line pembrolizumab monotherapy were identified from the target population. After standardization to baseline patient covariates in the Canadian cohorts, transported OS estimates revealed a less than 5% mean absolute difference from the observed OS in the target population (0.56% over 60 months of follow-up in the first-line chemotherapy group and 4.54% over 30 months of follow-up in the first-line pembrolizumab group). Negative control analysis using a mismatched outcome model revealed a 6.64% discrepancy and an incompatible survival curve shape. The results were robust to assumptions of random missingness for baseline covariates, to unadjusted differences in baseline metastases and comorbidities, and to differences in the standard of care between the US and Canada related to administration of second-line anti–programmed cell death 1 ligand 1 immunotherapy for patients who initiated first-line chemotherapy.Conclusions and RelevanceThe results of this cohort study suggest that, under specific circumstances, OS estimates from US clinical practice data can be adjusted using baseline clinical characteristics to closely approximate OS in selected groups of Canadian patients with advanced NSCLC. These results may have implications for regulatory decision-making and health technology assessment in target populations outside of the US.

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Comparative Effectiveness of Atezolizumab, Nivolumab, and Docetaxel in Patients With Previously Treated Non–Small Cell Lung Cancer

Cited by 14 publications

References 34 publications

Real-World Analysis of Nivolumab and Atezolizumab Efficacy in Previously Treated Patients with Advanced Non-Small Cell Lung Cancer

Real-World Analysis of Nivolumab and Atezolizumab Efficacy in Previously Treated Patients with Advanced Non-Small Cell Lung Cancer

Association Between Smoking History and Overall Survival in Patients Receiving Pembrolizumab for First-Line Treatment of Advanced Non–Small Cell Lung Cancer

Transportability of Overall Survival Estimates From US to Canadian Patients With Advanced Non–Small Cell Lung Cancer With Implications for Regulatory and Health Technology Assessment

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