Predicting real-world effectiveness using overall survival and progression-free survival-based clinical trial efficacy measures.

2016 ◽  
Vol 34 (15_suppl) ◽  
pp. 6564-6564
Author(s):  
Jason Shafrin ◽  
Ningqi Hou ◽  
Ron Brookmeyer ◽  
Desi Peneva ◽  
Seanna Vine ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Overall Survival ◽  
Real World ◽  
Progression Free Survival ◽  
Free Survival ◽  
Efficacy Measures

scholarly journals Effect of comorbidities/comedications on sunitinib outcomes for metastatic renal cell carcinoma: the STAR-TOR registry

2020 ◽  
Vol 16 (35) ◽  
pp. 2939-2948
Author(s):  
Martin Boegemann ◽  
Katrin Schlack ◽  
Michael Rink ◽  
Stephan Bernhardt ◽  
Michael Moran ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Renal Cell Carcinoma ◽  
Overall Survival ◽  
Treatment Outcomes ◽  
Real World ◽  
Progression Free Survival ◽  
Clinical Trial Registration ◽  
Free Survival ◽  
Sunitinib Treatment ◽  
Registry Entry

Aim: Examine the effects of baseline hypertension (HTN) and statin or proton pump inhibitor (PPI) use on sunitinib treatment outcomes in STAR-TOR, a real-world registry. Materials & methods: Presence or absence of HTN and use or nonuse of statins or PPIs were determined at registry entry. End points included overall survival (OS) and progression-free survival (PFS). Results: Data were from 557 patients. Presence or absence of HTN did not affect OS or PFS. PFS (median [95% CI]) was longer in statin users (9.4 [6.5–13.6] months) versus nonusers (6.9 [5.7–8.2] months) (p = 0.0442). OS was shorter in PPI users (20.2 [14.9–28.3] months) versus nonusers (25.7 [22.7–33.0] months) (p = 0.0212). Conclusion: Comorbidities and comedications may affect real-world sunitinib treatment outcomes. Clinical Trial Registration: NCT00700258 ( ClinicalTrials.gov )

Real-world effectiveness of nivolumab in patients with non-small-cell lung cancer: a systematic review and meta-analysis

2020 ◽  
Vol 16 (27) ◽  
pp. 2045-2058 ◽  
Author(s):  
Yong-Jin Kim ◽  
Mark Oremus ◽  
Helen H Chen ◽  
Thomas McFarlane ◽  
Devanshi Shah ◽  
...  
Keyword(s):  
Lung Cancer ◽  
Overall Survival ◽  
Small Cell Lung Cancer ◽  
Cell Lung Cancer ◽  
Real World ◽  
Meta Analysis ◽  
Progression Free Survival ◽  
Small Cell ◽  
Small Cell Lung ◽  
Free Survival

Background: The effectiveness of immunotherapies for non-small-cell lung cancer under real-world clinical settings remains uncertain. Materials & methods: Systematic searches of PubMed, EMBASE and Web of Science were conducted. Random-effects models were used to estimate pooled median overall survival and progression-free survival estimates. Results: 36 studies of nivolumab were included for narrative synthesis and 11 of these studies were included for meta-analysis. Age, sex, histology and prior lines of treatment did not affect survival outcomes, while Eastern Cooperative Oncology Group Performance Status and brain metastasis were inversely associated with survival. In the meta-analysis, nivolumab was associated with 9.6 months (95% CI: 8.4–10.9) of overall survival and 2.6 months (95% CI: 1.6–3.6) of progression-free survival. Conclusion: Very-low-certainty evidence suggested the real-world effectiveness of nivolumab was consistent with those observed in the clinical trials.

Standard versus personalized schedule of regorafenib in metastatic gastrointestinal stromal tumors (GIST): A retrospective, multicenter, real-world study.

2021 ◽  
Vol 39 (15_suppl) ◽  
pp. e23521-e23521
Author(s):  
Margherita Nannini ◽  
Alessandro Rizzo ◽  
Maria Concetta Nigro ◽  
Bruno Vincenzi ◽  
Alessandro Mazzocca ◽  
...  
Keyword(s):  
Overall Survival ◽  
Clinical Practice ◽  
Real World ◽  
Gastrointestinal Stromal Tumors ◽  
Treatment Plan ◽  
Progression Free Survival ◽  
Term Therapy ◽  
Free Survival ◽  
Stromal Tumors ◽  
The Impact

e23521 Background: Regorafenib (REG) is a multikinase inhibitor approved as third-line treatment in gastrointestinal stromal tumors (GIST). Although its proven activity, REG can present a relevant adverse profile which often leads to treatment modifications and transient or permanent discontinuation; thus, in clinical practice physicians usually adopt various dosing and interval schedules to counteract REG-related adverse events (AEs) and avoid treatment interruption. The aim of this real-world study was to investigate the efficacy and safety of personalized schedules of REG in metastatic GIST patients, in comparison with the standard schedule (160 mg daily, 3-weeks-on, 1-week-off schedule). Methods: Institutional registries across seven Italian reference centers were retrospectively reviewed and data of interest retrieved to identify GIST patients who had received REG from February 2013 to January 2021. The primary endpoint was Progression-Free Survival (PFS), with Overall Survival (OS) also assessed as secondary endpoint. The Kaplan-Meier method was used to estimate survival and the log-rank test to make comparisons. The impact of variables on survival was assessed through univariate and multivariate analysis. Results: A total of 152 GIST patients (82 male and 70 female) were included and split in two groups on the basis of the REG treatment plan received (standard vs personalized). Among the 103 patients for whom the treatment was personalized (38 since the beginning and 65 during the treatment course), the main strategies adopted were the following: 120 mg/day d1-21 e28 (n = 56; 54.4%); 80 mg/day d1-21 e28 (n = 22; 21.4%); 160 mg/day d1-5 e7 (n = 13; 12.6%). At a median follow-up of 36.5 months, median Overall Survival (OS) was 16.6 months (95% CI 14.1-21.8) and 20.5 months (95% CI 15.0-25.4) in the standard-dose and the personalized schedule groups, respectively (HR 0.75; 95% CI 0.49-1.22; p = 0.16). Median Progression-Free Survival (PFS) was 5.6 months (95% CI 3.3-not reached) and 9.7 months (95% CI 7.9-14.5) in the same groups (HR 0.51; 95% CI 0.34-0.75; p = 0.00052). Conclusions: Despite the expected limits of a retrospective analysis, we confirm that REG personalized schedules are commonly adopted in everyday clinical practice of high-volume GIST expert centers and correlate with significant improvement of therapeutic outcomes. Based on these results, REG treatment optimization in GIST patients may represent the best strategy to maximize long-term therapy, preserving tolerability and quality of life.

scholarly journals Real-World Data for Lenvatinib in Hepatocellular Carcinoma (ELEVATOR): A retrospective multicenter study

Liver Cancer ◽  
2022 ◽  
Author(s):  
Sabrina Welland ◽  
Catherine Leyh ◽  
Fabian Finkelmeier ◽  
André Jefremow ◽  
Kateryna Shmanko ◽  
...  
Keyword(s):  
Overall Survival ◽  
Real World ◽  
Median Overall Survival ◽  
Performance Status ◽  
Progression Free Survival ◽  
Inclusion Criteria ◽  
First Line ◽  
Ecog Performance Status ◽  
Free Survival ◽  
First Line Treatment

Background Lenvatinib is approved as first-line treatment for patients with advanced hepatocellular carcinoma (HCC). The efficacy of lenvatinib in Caucasian real-world patients is insufficiently defined. The purpose of this study was to evaluate the efficacy of lenvatinib in a multi-center cohort (ELEVATOR) from Germany and Austria. Methods A retrospective data analysis of 205 patients treated with first-line systemic lenvatinib at 14 different sites was conducted. Overall survival, progression free survival, overall response rate and adverse event rates were assessed and analyzed. Results Patients receiving lenvatinib in the real-world setting reached a median overall survival of 12.8 months, which was comparable to the results reported from the REFLECT study. Median overall survival (mOS) and progression free survival (mPFS) was superior in those patients who met the inclusion criteria of the REFLECT study compared to patients who failed to meet the inclusion criteria (mOS 15.6 vs 10.2 months, HR 0.55, 95% CI 0.38-0.81, p=0.002; mPFS 8.1 vs 4.8 months HR 0.65, 95% CI 0.46-0.91, p=0.0015). For patients with an impaired liver function according to the Albumin-Bilirubin (ALBI) grade, or reduced ECOG performance status ≥2, survival was significantly shorter compared to patients with sustained liver function (ALBI grade 1) and good performance status (ECOG performance status 0), respectively (HR 1.69, 95% CI 1.07-2.66, p=0.023; HR 2.25, 95% CI 1.19-4.23, p=0.012). Additionally, macrovascular invasion (HR 1.55, 95% CI 1.02-2.37, p=0.041) and an AFP ≥200 ng/mL (HR 1.56, 95% CI 1.03-2.34, p=0.034) were confirmed as independent negative prognostic factors in our cohort of patients with advanced HCC. Conclusion Overall, our data confirm the efficacy of lenvatinib as first-line treatment and did not reveal new or unexpected side effects in a large retrospective Caucasian real-world cohort, supporting the use of lenvatinib as meaningful alternative for patients that cannot be treated with IO-based combinations in first-line HCC.

Clinical effectiveness outcomes and healthcare resource utilization of patients diagnosed with small-cell lung cancer

2020 ◽  
Author(s):  
Junji Lin ◽  
Santosh Gautam ◽  
Nan Hu ◽  
Gboyega Adeboyeje ◽  
Sumesh Kachroo
Keyword(s):  
Lung Cancer ◽  
Overall Survival ◽  
Small Cell Lung Cancer ◽  
Cell Lung Cancer ◽  
Real World ◽  
Progression Free Survival ◽  
Small Cell ◽  
Small Cell Lung ◽  
Free Survival ◽  
Study Results

Background: Real-world data are lacking on patients with small-cell lung cancer (SCLC) with extensive-stage SCLC (eSCLC) and poor performance status (PS). Patients & methods: Eligible patients diagnosed with eSCLC between 1 January 2008 and 31 December 2017 were included in this retrospective, observational study. Results: The study included 406 patients, with 14.3% impaired PS. Progression-free survival and overall survival were not significantly different between impaired (Eastern Cooperative Oncology Group ≥2) and not impaired patients (median, 4.5 vs 5.3 months, and 7.2 vs 8.4 months, respectively). Impaired patients used more supportive care drugs (mean, 3.0 vs 2.0; p = 0.033). Conclusion: Effectiveness outcomes among patients with and without impaired PS did not differ in the real-world setting. Progression-free survival and overall survival were similar to data from clinical trials.

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