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J Clin Oncol. 2013 Sep 20;31(27):3342-50. doi: 10.1200/JCO.2012.46.1764. Epub 2013 Jul 1.

Symptom control and quality of life in LUX-Lung 3: a phase III study of afatinib or cisplatin/pemetrexed in patients with advanced lung adenocarcinoma with EGFR mutations.

Author information

1
James Chih-Hsin Yang, National Taiwan University Hospital, Taipei, Taiwan; Vera Hirsh, McGill University, Montreal, Quebec, Canada; Martin Schuler, West German Cancer Center, University Duisburg-Essen, Essen; Juliane Lungershausen, Boehringer Ingelheim GmbH, Ingelheim, Germany; Nobuyuki Yamamoto, Shizuoka Cancer Center, Shizuoka, Japan; Kenneth J. O'Byrne, St James' Hospital, Dublin, Ireland; Tony S.K. Mok, State Key Laboratory of Southern China, Hong Kong Cancer Institute, The Chinese University of Hong Kong, Hong Kong; Victoria Zazulina, Mehdi Shahidi, and Dan Massey, Boehringer Ingelheim Limited, Bracknell; Michael Palmer, Keele University, Keele, United Kingdom; and Lecia V. Sequist, Massachusetts General Hospital and Harvard Medical School, Boston, MA.

Abstract

PURPOSE:

Patient-reported symptoms and health-related quality of life (QoL) benefits were investigated in a randomized, phase III trial of afatinib or cisplatin/pemetrexed.

PATIENTS AND METHODS:

Three hundred forty-five patients with advanced epidermal growth factor receptor (EGFR) mutation-positive lung adenocarcinoma were randomly assigned 2:1 to afatinib 40 mg per day or up to six cycles of cisplatin/pemetrexed. Lung cancer symptoms and health-related QoL were assessed every 21 days until progression using the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire C30 and Lung Cancer-13 questionnaires. Analyses of cough, dyspnea, and pain were preplanned, including percentage of patients who improved on therapy, time to deterioration of symptoms, and change in symptoms over time.

RESULTS:

Questionnaire compliance was high. Compared with chemotherapy, afatinib significantly delayed the time to deterioration for cough (hazard ratio [HR], 0.60; 95% CI, 0.41 to 0.87; P = .007) and dyspnea (HR, 0.68; 95% CI, 0.50 to 0.93; P = .015), but not pain (HR, 0.83; 95% CI, 0.62 to 1.10; P = .19). More patients on afatinib (64%) versus chemotherapy (50%) experienced improvements in dyspnea scores (P = .010). Differences in mean scores over time significantly favored afatinib over chemotherapy for cough (P < .001) and dyspnea (P < .001). Afatinib showed significantly better mean scores over time in global health status/QoL (P = .015) and physical (P < .001), role (P = .004), and cognitive (P = .007) functioning compared with chemotherapy. Fatigue and nausea were worse with chemotherapy, whereas diarrhea, dysphagia, and sore mouth were worse with afatinib (all P < .01).

CONCLUSION:

In patients with lung adenocarcinoma with EGFR mutations, first-line afatinib was associated with better control of cough and dyspnea compared with chemotherapy, although diarrhea, dysphagia, and sore mouth were worse. Global health status/QoL was also improved over time with afatinib compared with chemotherapy.

TRIAL REGISTRATION:

ClinicalTrials.gov NCT00949650.

PMID:
23816967
DOI:
10.1200/JCO.2012.46.1764
[Indexed for MEDLINE]

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