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Predicting safety and efficacy of afatinib treatment of NSCLC

Predicting safety and efficacy of afatinib treatment of NSCLC

Assoc/Prof Michael Sorich

Flinders Centre for Innovation in Cancer, Flinders University, Adelaide, Australia

Partially supported by a Project Grant of the National Health and Medical Research Council of Australia.


8 Aug 2016

Lung cancer is one of the most common and difficult to treat forms of cancer. Afatinib is one of the main cancer medicines that may be used by individuals with lung cancer. It has been found to prolong survival but its use may also lead to patients experience adverse effects such as diarrhoea and skin reactions. There is also considerable inter-individual variability - that is, some people gain significant benefit and others appear to gain little or no benefit, some patients have severe adverse effects and others have little or no toxicity. Being able to predict, in advance, individuals at greatest risk of harms and greatest risk of treatment failure may allow doctors and patients to make better treatment decisions.

This project primarily aims to improve understanding of and the ability to predict the risk of benefits and harms from using afatinib for treatment of lung cancer. Using data from completed clinical trials, patient characteristics which are associated with benefit and harms from afatinib will be identified and where possible prediction models will be developed to make the best predictions possible for new patients being considered for treatment for afatinib and for patients early in the treatment with afatinib. Any improved understanding of risk factors (and prediction models) of benefit and harms with afatinib will be communicated internationally in medical publications to inform clinicians treating with afatinib so that they can better explain the risks to patients considering the use of afatinib.

[{ "PostingID": 1964, "Title": "BI-1200.23", "Description": "BIBW 2992 and BSC Versus Placebo and BSC in Non-small Cell Lung Cancer Patients Failing Erlotinib or Gefitinib (LUX-LUNG 1)" },{ "PostingID": 2381, "Title": "BI-1200.22", "Description": "LUX Lung 2 Phase II Single Arm BIBW 2992 \"Afatinib\" in NSCLC With EGFR Activating Mutations" },{ "PostingID": 2382, "Title": "BI-1200.32", "Description": "BIBW 2992 (Afatinib) Versus Chemotherapy as First Line Treatment in NSCLC With EGFR Mutation" },{ "PostingID": 2916, "Title": "BI-1200.34", "Description": "BIBW 2992 (Afatinib) vs Gemcitabine-cisplatin in 1st Line Non-small Cell Lung Cancer (NSCLC)" }]

Statistical Analysis Plan

Cancers 2018, 10, 384; doi:10.3390/cancers10100384