Abstract 1512
Background
In light of results of pivotal phase III randomized controlled trials (RCTs) concerning the effect of first-line tyrosine kinase inhibitor (TKIs) in first-line for advanced non-small cell lung cancer (NSCLC) with activating epidermal growth factor receptor (EGFR)-mutations, it might be interesting to examine the magnitude of the clinical benefit from TKIs in this setting of patients.
Methods
European Society for Medical Oncology Magnitude of Clinical Benefit Scale (ESMO-MCBS) was applied to pivotal phase III RCTs in first-line for advanced NSCLC with activating EGFR-mutations, to derive a relative ranking (from grade 1 to grade 5) of the magnitude of clinically meaningful benefit that can be expected from TKIs (erlotinib, gefitinib and afatinib) in this subset of patients.
Results
Our study evaluated 8 phase III RCTs (including 1710 patients). The main reported outcomes of the considered pivotal phase III RCTs in first-line for advanced NSCLC with activating EGFR-mutations and the corresponding ESMO-MCBS score are reported in Table 1.
Main outcomes of the considered pivotal phase III RCTs in first-line for advanced NSCLC with activating EGFR-mutations and the corresponding ESMO-MCBS score
| Authors/Trial | Comparative Regimens | N° of patients | Primary endpoint | OS (months) | PFS (months) | p-Value* | PFS/OS gain (months)** | PFS/OS HR (95% C.I.)** | ESMO-MCBS |
|---|---|---|---|---|---|---|---|---|---|
| Zhou et al, 2011 OPTIMAL | carboplatin + gemcitabine erlotinib | 7282 | PFS | NRNR | 4.613.1 | ConclusionsThe ESMO-MCBS reached high grade (grade 4) for all TKIs treatments with at least a phase III RCT. Combining pharmacological costs of drugs with the measure of efficacy represented by the PFS, it is evident that afatinib is the most cost-effective, with the lowest difference in costs per month-PFS gained (1682.3 €, data derived from literature) and a comparable high grade of magnitude of clinical benefit. Clinical trial identificationNot required. This is a review article. Legal entity responsible for the studyN/A FundingN/A DisclosureAll authors have declared no conflicts of interest. Resources from the same session2354 - The clinicopathologic features and treatment of 607 hindgut neuroendocrine tumor (NET) patients at a single institutionPresenter: Seung Tae Kim Session: Poster Display Resources: Abstract 2594 - Neuroendocrine carcinomas of the colorectal origin - Polish experiencePresenter: Agnieszka Kolasińska-Ćwikła Session: Poster Display Resources: Abstract 2539 - Neuroendocrine neoplasms of the appendix including goblet cell carcinoidsPresenter: Agnieszka Kolasinska-Cwikla Session: Poster Display Resources: Abstract 1245 - Prognostic validity of AJCC staging system in neuroendocrine tumors of the appendixPresenter: Amir Mehrvarz Sarshekeh Session: Poster Display Resources: Abstract 3902 - Enhancer of zest homolog 2 (EZH2) expression in well and moderately differentiated pancreatic neuroendocrine tumor (pNET)Presenter: Riccardo Marconcini Session: Poster Display Resources: Abstract 3882 - Differential clinical and pathological characteristics of hereditary neuroendocrine pancreatic tumours (NEPT)Presenter: Gema Marín Zafra Session: Poster Display Resources: Abstract 2296 - Natural course of thyroid cancer nodules compared with benign thyroid nodulesPresenter: Kyung-Jin Yun Session: Poster Display Resources: Abstract 4083 - Reassessment of proliferative activity at disease progression in neuroendocrine neoplasmsPresenter: Noemi Cicchese Session: Poster Display Resources: Abstract 3866 - 18F-FDG-PET to predict disease progression in advanced digestive neuroendocrine neoplasmsPresenter: Maria Rinzivillo Session: Poster Display Resources: Abstract 3651 - UK phase IV, observational study to assess quality of life in patients (pts) with pancreatic neuroendocrine tumours (pNETS) receiving treatment with everolimus: The “real-world” OBLIQUE studyPresenter: John Ramage Session: Poster Display Resources: Abstract This site uses cookies. Some of these cookies are essential, while others help us improve your experience by providing insights into how the site is being used. For more detailed information on the cookies we use, please check our Privacy Policy.
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