Dataset Information

Effectiveness of First-line Immune Checkpoint Blockade Versus Carboplatin-based Chemotherapy for Metastatic Urothelial Cancer.

ABSTRACT: BACKGROUND:Limited data compare first-line carboplatin-based chemotherapy and immune checkpoint blockade in cisplatin-ineligible metastatic urothelial carcinoma (mUC) patients. The primary evidence guiding treatment decisions was a recent Food and Drug Administration/European Medicines Agency safety alert based on emerging data from two ongoing phase III trials, reporting shorter survival in programmed death-ligand 1 (PD-L1)-negative patients receiving immunotherapy. Final results from these trials are unknown. OBJECTIVE:To compare survival in cisplatin-ineligible mUC patients receiving first-line immunotherapy versus those receiving carboplatin-based chemotherapy. DESIGN, SETTING, AND PARTICIPANTS:We conducted a retrospective cohort study of 2017 mUC patients receiving first-line carboplatin-based chemotherapy (n?=?1530) or immunotherapy (n?=?487) from January 1, 2011 to May 18, 2018 using the Flatiron Health electronic health record-derived database. OUTCOME MEASUREMENTS AND STATISTICAL ANALYSIS:The primary outcomes were overall survival (OS), comparing 12- and 36-mo OS, and hazard ratios before and after 12 mo. Propensity score-based inverse probability of treatment weighting (IPTW) was used to address confounding in Kaplan-Meier and Cox regression model estimates of comparative effectiveness. RESULTS AND LIMITATIONS:IPTW-adjusted OS rates in the immunotherapy group were lower at 12 mo (39.6% [95% confidence interval {CI} 34.0-45.3%] vs 46.1% [95% CI 43.4-48.8%]) but higher at 36 mo (28.3% [95% CI 21.8-34.7%] vs 13.3% [95% CI 11.1-15.5%]) relative to the chemotherapy group. Immunotherapy treatment demonstrated inferior OS during the first 12 mo relative to carboplatin-based chemotherapy (IPTW-adjusted hazard ratio [HR] 1.37, 95% CI 1.15-1.62), but superior OS beyond 12 mo (IPTW-adjusted HR 0.50, 95% CI 0.30-0.85). Limitations include retrospective design and potential unmeasured confounding. CONCLUSIONS:In the setting of mUC, clinicians and patients should carefully consider how to balance the short-term benefit of chemotherapy against the long-term benefit of immunotherapy. PATIENT SUMMARY:To determine the optimal first-line therapy for metastatic bladder cancer patients who are unfit for cisplatin, we compared carboplatin-based chemotherapy versus immunotherapy using real-world data. Survival in the 1st year of treatment was lower with immunotherapy relative to chemotherapy, but for patients surviving beyond the 1st year, immunotherapy was superior.

SUBMITTER: Feld E

PROVIDER: S-EPMC6822167 | biostudies-literature | 2019 Oct

REPOSITORIES: biostudies-literature

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Effectiveness of First-line Immune Checkpoint Blockade Versus Carboplatin-based Chemotherapy for Metastatic Urothelial Cancer.

Feld Emily E Harton Joanna J Meropol Neal J NJ Adamson Blythe J S BJS Cohen Aaron A Parikh Ravi B RB Galsky Matthew D MD Narayan Vivek V Christodouleas John J Vaughn David J DJ Hubbard Rebecca A RA Mamtani Ronac R

European urology 20190728 4

<h4>Background</h4>Limited data compare first-line carboplatin-based chemotherapy and immune checkpoint blockade in cisplatin-ineligible metastatic urothelial carcinoma (mUC) patients. The primary evidence guiding treatment decisions was a recent Food and Drug Administration/European Medicines Agency safety alert based on emerging data from two ongoing phase III trials, reporting shorter survival in programmed death-ligand 1 (PD-L1)-negative patients receiving immunotherapy. Final results from t ...[more]

PMID: 31362898

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Project description:BackgroundAtezolizumab could significantly improve clinical outcomes and was associated with less toxicity compared with chemotherapy as the first-line treatment of PD-L1-selected patients with EGFR and ALK wild-type metastatic non-small-cell lung cancer (NSCLC). However, the economic outcomes remain unclear yet in China. This study aimed to investigate the cost-effectiveness of atezolizumab versus chemotherapy as first-line therapy for metastatic NSCLC with different PD-L1 expression status from the Chinese health sector perspective.MethodsA decision-analytic model was conducted to evaluate the economic outcomes for the first-line treatment of EGFR and ALK wild-type metastatic NSCLC with atezolizumab and chemotherapy in high PD-L1 expression, high or intermediate PD-L1 expression and any PD-L1 expression populations, respectively. The efficacy and safety data were obtained from the IMpower110 trial. Cost and utility values were gathered from the local charges and published literatures. Incremental cost-effectiveness ratio (ICER) was estimated. A scenario analysis for a patient assistance program (PAP) was conducted. One-way and probabilistic sensitivity analyses were performed to explore the robustness of the model results.ResultsAtezolizumab yielded additional 0.91 QALYs, 0.57 QALYs, 0.42 QALYs in comparison with chemotherapy, and the ICERs were $123,778.60/QALY, $142,827.19/QALY, $168,902.66/QALY in the high PD-L1 expression, high or intermediate PD-L1 expression, and any PD-L1 expression populations, respectively. When PAP was available, the ICERs were $52,414.63/QALY, $52,329.73/QALY, $61,189.66/QALY in the three categories of PD-L1 expression status populations, respectively. The ICERs were exceed the willingness-to-pay (WTP) threshold of $30,828/QALY (three times of per capita gross domestic product of China in 2019) in China. One-way sensitivity analyses suggested that the cost of atezolizumab played a vital role in the model outcomes, and the probabilistic sensitivity analyses showed atezolizumab was unlikely to be cost-effective at the WTP threshold regardless of PD-L1 expression status and whether the PAP was available or not.ConclusionsAtezolizumab as first-line treatment for PD-L1-selected metastatic NSCLC patients without EGFR mutations or ALK translocations is unlikely to be cost-effective compared with chemotherapy regardless of PD-L1 expression status in the Chinese context.

Dataset Information

Effectiveness of First-line Immune Checkpoint Blockade Versus Carboplatin-based Chemotherapy for Metastatic Urothelial Cancer.

Publications

Effectiveness of First-line Immune Checkpoint Blockade Versus Carboplatin-based Chemotherapy for Metastatic Urothelial Cancer.

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