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 sessionZUMA-3: A phase 1/2 multi-center study evaluation the safety and efficacy of KTE-C19 anti-CD19 CAR T cells in adult patients with relapsed/refractory B precursor acute lymphoblastic leukemia (R/R ALL)Presenter: Bijal Shah Session: Poster display Resources: Abstract ZUMA-2: A phase 2 multi-center study evaluating the efficacy of KTE-C19 (Anti-CD19 CAR T cells) in patients with relapsed/refractory Mantle cell lymphoma (R/R MCL)Presenter: Michael Wang Session: Poster Display Resources: Abstract ZUMA-1: A phase 2 multi-center study evaluating anti-CD19 chimeric antigen receptor (CAR) T cells in patients with refractory aggressive non-Hodgkin lymphoma (NHL)Presenter: Sattva Neelapu Session: Poster Display Resources: Abstract Younger age as a prognostic indicator in breast cancer: Correlation between clinical-pathologic factors and miRNAs and long-term follow-upPresenter: Maria Teresa Martinez Session: Poster display Resources: Abstract Window study of the PARP inhibitor rucaparib in patients with primary triple negative or BRCA1/2 related breast cancer (RIO)Presenter: Christy Toms Session: Poster display Resources: Abstract Whole exome sequencing (WES) and RNA sequencing (RNA-seq) in routine clinical practice for colorectal cancer (CRC) and non-small cell lung cancer (NSCLC) patients (pts)Presenter: Géraldine Perkins Session: Poster display Resources: Abstract What is the optimal annual interpretive volume for a radiologist reading screening mammograms?Presenter: Asli Uluturk Session: Poster display Resources: Abstract What decides breast conservation versus mastectomy in the background of diverse sociocultural environment, an Indian studyPresenter: Poonamalle Padmanabhan Bapsy Session: Poster display Resources: Abstract Waiting time to diagnosis and treatment of the head and neck cancer in four institutions in PortugalPresenter: Ana Castro Session: Poster display Resources: Abstract Wait times for diagnosis and treatment of lung cancer: a single centre experiencePresenter: Catherine Labbe 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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