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Afatinib and Best Supportive Care vs Placebo and Best Supportive Care in Non-Small Cell Lung Cancer Patients Failing Erlotinib or Gefitinib
Phase IIb/III, randomised, double-blind trial of afatinib* plus best supportive care (BSC) vs placebo plus BSC in patients with non-small cell lung cancer after failure of erlotinib or gefitinib.
Trial CT.gov-Identifier: NCT00656136
Stage IIIB/IV adenocarcinoma of the lung
Progressed after one or two lines of chemotherapy (including one platinum-based regimen) and ≥12 weeks of treatment with erlotinib or gefitinib
Eastern Cooperative Oncology Group performance status of 0–2
Primary outcome measure:
Secondary outcome measures:
Median OS was 10.8 months with afatinib and 12.0 months with placebo; the difference was not statistically significant.
Median PFS was significantly longer with afatinib (3.3 months) than with placebo (1.1 months). Twenty-nine patients (7%) had a confirmed objective response to afatinib by independent review, compared with one partial response in the placebo group.
The most common adverse events for afatinib were diarrhoea and rash/acne.
Although there was no benefit in terms of OS, patients on afatinib showed improvement in PFS and response rate relative to placebo, suggesting that afatinib might be of some benefit to patients with advanced lung adenocarcinoma that has progressed after one or two lines of chemotherapy and ≥12 weeks of treatment with either erlotinib and/or gefitinib.
Miller VA, et al. Lancet Oncol 2012;13(5):528–538.
Clinicaltrials.gov. https://clinicaltrials.gov/ct2/show/NCT00656136 (Accessed: July 2017).
*Afatinib is approved in more than 70 markets including the EU, Japan, Taiwan, and Canada under the brand name GIOTRIF®, in the US under the brand name GILOTRIF® and in India under the brand name Xovoltib®; for the full list please see here. Registration conditions differ internationally; please refer to locally approved prescribing information.
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