- A systematic review of 14 randomized clinical trials (RCTs) has clarified features of NSCLC that are influential in the failure of first-line treatments.
Why this matters
- Refractory NSCLC remains a treatment challenge.
- There is an unmet need for treatment of patients with aggressive NSCLC.
- Development of treatment has been hampered by lack of characterization of aggressive NSCLC.
- Systematic literature review of RCTs to explore clinical trial definitions of aggressive NSCLC.
- Predefined literature review protocol in line with Cochrane methodology and following Preferred Reporting Items for Systematic Reviews and Meta-Analyses recommendations.
- Searches of Medline, Embase, BioSciences Information Service, Cochrane Library (to October 17, 2017), conference abstracts through October 2017, and recent systematic literature reviews and meta-analyses.
- Eligible studies were RCTs reporting efficacy and safety of selected second-line antiangiogenic therapy, immune checkpoint inhibitor therapy, or chemotherapy for advanced NSCLC with characteristics associated with aggressive disease.
- Funded by Eli Lilly and Company.
- 14 RCTs included.
- Features of aggressive NSCLC: refractory and/or progressive disease after treatment, rapid progression, short duration of prior treatment, high tumor burden or "bulky disease," short time since start of prior treatment, high symptom burden.
- Baseline characteristics of subgroups of patients with aggressive disease often not reported.
- Safety and efficacy data for subgroups of patients with aggressive disease often not reported.
- Similar outcome data seldom reported, limiting ability to compare outcomes across trials.
- "With the emerging clinical importance of aggressive disease, more standard use of aggressive disease definitions within randomized clinical trials may allow for greater comparison across second-line treatments and will enable indirect treatment comparisons of the results," said presenter Cliff Molife, PhD, Eli Lilly and Company.