scholarly journals Anti-angiogenic therapy in nonsquamous non-small cell lung cancer (NSCLC) with tyrosine kinase inhibition (TKI) that targets the VEGF receptor (VEGFR): perspective on phase III clinical trials

2018 ◽  
Vol 10 (2) ◽  
pp. 617-620 ◽  
Author(s):  
Sha’Shonda L. Revels ◽  
Jay M. Lee
Keyword(s):  
Lung Cancer ◽  
Clinical Trials ◽  
Tyrosine Kinase ◽  
Small Cell Lung Cancer ◽  
Small Cell ◽  
Phase Iii ◽  
Vegf Receptor ◽  
Small Cell Lung ◽  
Angiogenic Therapy ◽  
Phase Iii Clinical Trials

Review of end points of phase III clinical trials with combination chemotherapy regimens for non-small cell lung cancer evaluating importance of quality of life.

2013 ◽  
Vol 31 (15_suppl) ◽  
pp. e19119-e19119
Author(s):  
Kumar Prabhash ◽  
Ganesh Divekar ◽  
Minish Mahendra Jain ◽  
Bharatsinha Baburao Bhosale
Keyword(s):  
Quality Of Life ◽  
Lung Cancer ◽  
Clinical Trials ◽  
Small Cell Lung Cancer ◽  
Combination Chemotherapy ◽  
Small Cell ◽  
Phase Iii ◽  
Small Cell Lung ◽  
End Points

e19119 Background: Systemic combination chemotherapy is accepted as a standard of care for patients with advanced non-small cell lung cancer (NSCLC). Substantial similarities in terms of treatment efficacy and survival have emerged over the years between the different systemic chemotherapy regimens used. Quality of life (QOL) analysis will help to customize chemotherapy to improve outcome in NSCLC patients. Methods: Using PUBMED database, a review of randomized controlled phase III trials of advanced NSCLC published in last 5 years reporting comparative safety and efficacy between chemotherapeutic regimens as end points was conducted. An evaluation of end points, difference in efficacy endpoints, QOL analysis, and final conclusion was conducted. Results: The search criteria identified 51 trials (33,481 patients). Out of these 51 clinical trials, 16 trials showed difference in efficacy (13 survival endpoint, 1 ORR (objective response rate), 2 survival without grade 3/4 toxicity) and 11 trials used validated QOL instruments and were included for review. Two trials; one comparing pemetrexed/cisplatin with gemcitabine/cisplatin, and other comparing cisplatin/weekly vinoralbine with cisplatin/vinoralbine on day 1 and 8; showed difference with QOL; though not statistically significant. The QOL reporting/analysis techniques were heterogeneous. Two trials used QOL as primary endpoint. Safety reporting included percentage adverse events with treatment arms. Conclusions: Based on our review, it seems critical to have QOL as an endpoint while evaluating newer combination chemotherapeutic regimens for NSCLC. Secondly, it is unlikely that a major difference exists in the global QOL associated with standard chemotherapy regimens for NSCLC. An effort to have uniform QOL assessment across trials evaluating newer combination regimens for NSCLC will help to customize treatment.

scholarly journals CNS Efficacy of Osimertinib in Patients With T790M-Positive Advanced Non–Small-Cell Lung Cancer: Data From a Randomized Phase III Trial (AURA3)

2018 ◽  
Vol 36 (26) ◽  
pp. 2702-2709 ◽  
Author(s):  
Yi-Long Wu ◽  
Myung-Ju Ahn ◽  
Marina Chiara Garassino ◽  
Ji-Youn Han ◽  
Nobuyuki Katakami ◽  
...  
Keyword(s):  
Lung Cancer ◽  
Tyrosine Kinase ◽  
Small Cell Lung Cancer ◽  
Odds Ratio ◽  
Advanced Nsclc ◽  
Small Cell ◽  
Phase Iii ◽  
Small Cell Lung ◽  
Cns Metastases ◽  
Cns Lesions

Purpose In patients with epidermal growth factor receptor ( EGFR) mutation–positive advanced non–small-cell lung cancer (NSCLC), there is an unmet need for EGFR–tyrosine kinase inhibitors with improved CNS penetration and activity against CNS metastases, either at initial diagnosis or time of progression. We report the first comparative evidence of osimertinib CNS efficacy versus platinum-pemetrexed from a phase III study (AURA3; ClinicalTrials.gov identifier: NCT02151981) in patients with EGFR T790M–positive advanced NSCLC who experience disease progression with prior EGFR–tyrosine kinase inhibitor treatment. Methods Patients with asymptomatic, stable CNS metastases were eligible for enrollment and were randomly assigned 2:1 to osimertinib 80 mg once daily or platinum-pemetrexed. A preplanned subgroup analysis was conducted in patients with measurable and/or nonmeasurable CNS lesions on baseline brain scan by blinded independent central neuroradiological review. The CNS evaluable for response set included only patients with one or more measurable CNS lesions. The primary objective for this analysis was CNS objective response rate (ORR). Results Of 419 patients randomly assigned to treatment, 116 had measurable and/or nonmeasurable CNS lesions, including 46 patients with measurable CNS lesions. At data cutoff (April 15, 2016), CNS ORR in patients with one or more measurable CNS lesions was 70% (21 of 30; 95% CI, 51% to 85%) with osimertinib and 31% (5 of 16; 95% CI, 11% to 59%) with platinum-pemetrexed (odds ratio, 5.13; 95% CI, 1.44 to 20.64; P = .015); the ORR was 40% (30 of 75; 95% CI, 29% to 52%) and 17% (7 of 41; 95% CI, 7% to 32%), respectively, in patients with measurable and/or nonmeasurable CNS lesions (odds ratio, 3.24; 95% CI, 1.33 to 8.81; P = .014). Median CNS duration of response in patients with measurable and/or nonmeasurable CNS lesions was 8.9 months (95% CI, 4.3 months to not calculable) for osimertinib and 5.7 months (95% CI, 4.4 to 5.7 months) for platinum-pemetrexed; median CNS progression-free survival was 11.7 months and 5.6 months, respectively (hazard ratio, 0.32; 95% CI, 0.15 to 0.69; P = .004). Conclusion Osimertinib demonstrated superior CNS efficacy versus platinum-pemetrexed in T790M-positive advanced NSCLC.

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