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Afatinib vs Cisplatin + Gemcitabine in Patients with Epidermal Growth Factor Receptor Mutation-positive Advanced Non-small Cell Lung Cancer
A randomised, open-label, Phase III study of afatinib* vs chemotherapy as first-line treatment for patients with Stage IIIB or IV adenocarcinoma of the lung harbouring an epidermal growth factor receptor (EGFR) activating mutation.
Patients were recruited at centres in China, Thailand and South Korea.
Trial CT.gov-Identifier: NCT01121393
Stage IIIB/IV adenocarcinoma of the lung that is EGFR mutation-positive
No prior treatment with chemotherapy for advanced/metastatic disease
No prior treatment with EGFR inhibitors
Eastern Cooperative Oncology Group performance status of 0–1
Stable brain metastases at baseline permitted
Primary outcome measure:
Secondary outcome measures:
PFS by independent review:
In the overall population, median PFS was 11.0 months for afatinib and 5.6 months for cisplatin/gemcitabine (Cis/Gem).
In the overall population, there was no significant OS benefit with afatinib treatment. In a prespecified OS analysis by mutation subgroups, patients with del19 mutation treated with afatinib demonstrated >1 year OS benefit compared with del19 mutation patients treated with cisplatin/gemcitabine.
The most common treatment-related adverse events were diarrhoea, rash/acne and stomatitis/mucositis for afatinib, and vomiting, nausea and neutropenia for cisplatin/gemcitabine.
Compared with cisplatin/gemcitabine, afatinib showed significantly better control of cancer-related dyspnoea, cough and pain..
Afatinib also showed significant improvements in global health status (as an indicator of overall HRQoL).
First-line afatinib for treatment of patients with advanced adenocarcinoma significantly (p<0.0001) improved PFS, vs treatment with cisplatin/gemcitabine chemotherapy. In addition, patients with EGFR del19 mutation showed >1 year OS benefit.
Afatinib showed improved efficacy and clinical benefit compared with cisplatin/gemcitabine chemotherapy in patients with previously untreated advanced adenocarcinoma of the lung and EGFR mutations. Afatinib was also associated with better control of lung cancer-related symptoms and improvement in HRQoL.
Wu YL, et al. Lancet Oncol 2014;15(2):213–222.
Geater SL, et al. J Thorac Oncol. 2015;10(6):883–889.
Yang JC, et al. Lancet Oncol 2015;16(2):141–151.
Clinicaltrials.gov. https://clinicaltrials.gov/ct2/show/NCT01121393 (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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