Choice of the study design (superiority vs non-inferiority design) for postregistration trials comparing different treatments for the same therapeutic.

Slides:

Advertisements

Similar presentations

(A) Programmed cell death ligand-1 (PD-L1) expression score was significantly higher in pulmonary adenocarcinomas with grade G2/G3 differentiation as compared.

Advertisements

The publication gap in years for the cumulative percent of cited research papers in the ESMO and the UK overall cancer clinical guidelines, with the difference.

Meta-analysis of randomised phase III clinical trials comparing EGFR tyrosine kinase inhibitor (TKI) shows that male patients with non-small cell lung.

The Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) flow chart summarising the process for the identification of eligible studies.

Comparison of the LL95%CI rule to PE rules with similar behaviour, when the true HR is different from the design HR: %acceptance of maximal relative benefit,

Male patients with non-small cell lung cancer (NSCLC) have a 24% reduction in the risk of disease progression (A). Male patients with non-small cell lung.

Impact of (A): metastatic sites (bone metastasis±lymph node metastasis vs visceral metastasis), (B): PSA response, (C): AA drug exposure duration on overall.

Clinical marker confirmation using centrally assessed progression-free survival data in patients with advanced non-small cell lung cancer with non-squamous.

(A) Frequency of synchronous diagnosis of primary tumour and BM according to primary tumour type (B) Frequency of patients with asymptomatic BM at first.

Progesterone receptor nuclear morphology patterns in breast cancer.

Invasion front (pushing margin) of the patient's tumour from the primary resection showing a high number of tumour-infiltrating leucocytes, which is characteristic.

Programmed cell death ligand-1 (PD-L1) expression of alveolar macrophages. Programmed cell death ligand-1 (PD-L1) expression of alveolar macrophages. (A)

Recurrence pattern after initial treatment of brain metastases and cause of death. Recurrence pattern after initial treatment of brain metastases and cause.

Meta-analysis of randomised phase III clinical trials with ALK inhibitors in non-small cell lung cancer (NSCLC) showing similar benefit in male patients.

Flow chart of the used methodology adapted from Moher et al

Kaplan-Meier curves comparing: (A) overall survival for patients treated on trial compared to those outside of a trial; (B) progression-free survival for.

PRISMA study flow diagram

Kaplan-Meier curves for overall survival (OS) probability.

Methods distribution among the three EQAs

Changes in haemoglobin over the course of the treatment in a patient with chronic myeloid leukaemia who developed pure red cell aplasia secondary to imatinib.

Plot with best overall response and study duration.

Patients represented by 441 physicians surveyed from 19 countries, depicted in the patient journey from diagnosis to ensuing treatment with ADT. ADT, androgen.

Comparison of the LL95%CI rule with PE rules with similar behaviour: %acceptance of maximal RB for power 80% and 90% over all trials, for LL95%CI ≤0.65 rule,

Clinical courses of patients.

Treatment and secondary prevention strategy diagram for VTE in patients with active cancer based on the treatment guidelines for cancer-associated VTE.

An inflammatory triple negative breast cancer of an African woman before (A) and after (B) treatment. An inflammatory triple negative breast cancer of.

Mean change from baseline in symptom scales and single-item assessments after 6 weeks of alectinib treatment according to (A) the QLQ-C30 and (B) the QLQ-LC13.

Molecular spectra of BTC

Awareness of respondents about the availability or development of specialised services for AYA where adult and paediatric cancer specialists work together.

Programmed cell death ligand-1 (PD-L1) immunohistochemistry for pulmonary adenocarcinoma tissues. Programmed cell death ligand-1 (PD-L1) immunohistochemistry.

PFS by dose of nivolumab for (A) all patients (n=47), (B) PD-L1-positive patients (n=13) and (C) PD-L1-negative or unknown patients (n=34). mPFS, median.

Forest plots for all drugs (OS and PFS HRs combined): excellent versus reduced PS comparison and ECOG PS levels comparison (see online supplementary 1). ECOG.

Kaplan-Meier curves of OS by dose of nivolumab for (A) all patients (n=47), (B) PD-L1-positive patients (n=13) and (C) PD-L1-negative or unknown patients.

Tumour types of patients whose cancers harboured actionable molecular alterations in our series. ACUP, adenocarcinoma with unknown primary. Other: appendix.

Patients’ most feared AEs reported to be intolerable when lasting more than 7 days at baseline, on study and at study completion (% patients); (A) grade.

Change in individual tolerability assessment between baseline and study completion. Change in individual tolerability assessment between baseline and study.

Gender representation of board members in all international societies (reference year: 2016). Gender representation of board members in all international.

Kaplan-Meier-estimated PFS and OS are presented, with PFS in c-Met high and low patients shown in (A), OS in c-Met high and low patients in (B), PFS in.

Definition of health states

Partitioned survival plots for the (A) trifluridine/tipiracil group and (B) placebo group in RECOURSE. REL, relapse state (from progression until death); TOX,

Application of 5-aminolevulinic acid (5-ALA) induced fluorescence during resection of a brain metastasis. Application of 5-aminolevulinic acid (5-ALA)

(A) Progression-free survival in the hormone receptor-negative cohort patients treated with PARPi versus those treated with mono chemotherapy (controls).

Objective response rate in patients with BRCA-mutated HER2-negative breast cancer treated with PARPi versus those treated with monochemotherapy (controls).

Gender representation in all international congresses (reference year 2016). Gender representation in all international congresses (reference year 2016).

Concentration-time profiles of repeated weekly infusions of (A) 720 mg and (B) 990 mg tomuzotuximab measured in individual patients before and at the end.

Health-related quality of life (HRQOL) results.

Proportion of continuous, intermittent, and limited (

Overview of cancer genetics in the SMP1 cohort: lung cancer (A), breast cancer (B), colorectal adenocarcinoma (except mucinous subtype) (C), prostate cancer.

(A) The stratified analysis for DFS because of the uncertain status of HER2, 132 patients could be calculated the recurrence risk score. (A) The stratified.

The 22 study patients: overall survival (first patient enrolled 9 May 2014, last patient enrolled 26 August 2015, censoring date 9 May 2016); primary tumour.

Comparison of the ESMO-MCBS dual rule and the dual rule with PE thresholds exhibiting similar behaviour: %acceptance of maximal RB (solid line: RB rule)

Immunochemical staining for HMBG3 in normal cervix, CIN III and invasive carcinomas and could show absent staining in normal cervix (A), absent to weak.

Kaplan-Meier plot of overall survival from the time of first dose of intrathecal interleukin-2 (IT IL-2) for all patients (A, n=43) and based on the extent.

Kaplan-Meier plot presenting PFS for patients with BRAFV600-mutated ctDNA at first visit (

Efficacy of nivolumab in Japanese patients with advanced non-squamous non-small cell lung cancer (A) Kaplan-Meier curve for PFS, (B) Kaplan-Meier curve.

Kaplan-Meier curves for PFS (panel A) and OS (panel B) of patients with mTCC receiving an anti-EGFR based therapy. mTCC, metastatic transverse colon cancer;

Kaplan-Meier plots of (A) time to first improvement and (B) time to first deterioration in pain in the chest, cough and dyspnoea, according to the 13-Item Quality.

Heterogeneity in the natural history of triple negative breast cancer.

Threshold utility plot: Quality-adjusted Time WIthout Symptoms of disease or Toxicity difference (trifluridine/tipiracil vs placebo) after a median follow-up.

Progression-free (a) and overall (b) survival by age subgroup, Kaplan-Meier plots. Progression-free (a) and overall (b) survival by age subgroup, Kaplan-Meier.

Kaplan–Meier analysis of PFS and OS in patients with advanced non-small cell lung cancer with adenocarcinoma histology with time since start of first-line.

Dot plots comparing changes in renal function at pretreatment and after the first and last cycles in both hydration groups. Dot plots comparing changes.

(A) Survival curves according to clinical response.

Total number of KRAS variants identified and discussed by the Genomics Review Board from all Sarah Cannon Molecular Diagnostics reports. Total number of.

Kaplan-Meier estimates for survival in metastatic disease for the whole patient cohort (A) and in patients with or without history of adjuvant trastuzumab.

Time to progression and overall survival for patients who had dose-dense chemotherapy, according to two factors (in order, top to bottom): type of dose-dense.

Prescribers’ responses rating their level of comfort on a scale of 1–5

Prescribers’ responses rating their level of knowledge/understanding on a scale of 1–5. Prescribers’ responses rating their level of knowledge/understanding.

Meta-analysis of the effect of gender in the overall survival, comparing HRs and 95% CI obtained from multivariate analysis in hospital databases. Meta-analysis.

Kaplan-Meier (K-M) curves of progression-free survival (PFS) in 54 patients with metastatic gastric cancer treated with RAD001. Kaplan-Meier (K-M) curves.

Presentation transcript:

Choice of the study design (superiority vs non-inferiority design) for postregistration trials comparing different treatments for the same therapeutic indication, based on the presumed difference in efficacy and on the toxicity profiles. Choice of the study design (superiority vs non-inferiority design) for postregistration trials comparing different treatments for the same therapeutic indication, based on the presumed difference in efficacy and on the toxicity profiles. Massimo Di Maio et al. ESMO Open 2016;1:e000109 Copyright © European Society for Medical Oncology. All rights reserved.