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Quality of life (QoL) analyses from OPTIMAL (CTONG-0802), a phase III, randomised, open-label study of first-line erlotinib versus chemotherapy in patients with advanced EGFR mutation-positive non-small-cell lung cancer (NSCLC)
Open accessAbstract
Background The OPTIMAL study found that erlotinib improved progression-free survival (PFS) versus standard chemotherapy in Chinese patients with advanced EGFR mutation-positive non-small-cell lung cancer (NSCLC). This report describes the quality of life (QoL) and updated PFS analyses from this study.Patients and methods Chinese patients ≥ 18 years with histologically confirmed stage IIIB or IV NSCLC and a confirmed activating mutation of EGFR (exon 19 deletion or exon 21 L858R point mutation) received erlotinib (150 mg/day; n = 82) or gemcitabine-carboplatin (n = 72). The primary efficacy end point was PFS; QoL was assessed using the Functional Assessment of Cancer Therapy-Lung (FACT-L) questionnaire, Trial Outcome Index (TOI) and Lung Cancer Subscale (LCS).Results Patients receiving erlotinib experienced clinically relevant improvements in QoL compared with the chemotherapy group in total FACT-L, TOI and LCS (P < 0.0001 for all scales). Erlotinib scored better than chemotherapy for all FACT-L subscales from baseline to cycles 2 and 4 (non-significant). In the updated analysis, PFS was significantly longer for erlotinib than chemotherapy (median PFS 13.7 versus 4.6 months; HR = 0.164, 95% CI = 0.105-0.256; P < 0.0001), which was similar to the previously reported primary analysis.Conclusion Erlotinib improves QoL compared with standard chemotherapy in the first-line treatment of patients with EGFR mutation-positive advanced NSCLC.
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“In the second small study, which was a publication of an abstract in the provisional clinical opinion, there was a longer PFS (erlotinib: 13.7 months; 95% CI, 10.6 to 15.3; control: 4.6 months; 95% CI, 4.2 to 5.4; HR, 0.164; 95% CI, 0.11 to 0.26; P < .001); OS had not yet been reached.13,14”
From Systemic Therapy for Stage IV Non–Small-Cell Lung Cancer: American Society of Clinical Oncology Clinical Practice Guideline Update (2015) · cites this paper as [14]
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Metadata
- Authors
- Chen, G., Feng, J., Zhou, C., Wu, Y.-L., Liu, X.-Q., Wang, C., Zhang, S., Wang, J., Zhou, S., Ren, S., Lu, S., Zhang, L., Hu, C.-P., Hu, C., Luo, Y., Chen, L., Ye, M., Huang, J., Zhi, X., Zhang, Y., Xiu, Q., Ma, J., Zhang, L., & You, C.
- Affiliations
- Harbin Medical University (CN)
- Jiangsu Cancer Hospital (CN)
- Tongji University (CN)
- Guangdong General Hospital (CN)
- Academy of Military Medical Sciences (CN)
- Tianjin Medical University Cancer Institute and Hospital (CN)
- Capital Medical University (CN)
- Peking University Cancer Hospital (CN)
- Shanghai Jiao Tong University (CN)
- Hunan Cancer Hospital (CN)
- Cancer Hospital of Shantou University Medical College (CN)
- First Affiliated Hospital of Soochow University (CN)
- Zhejiang Cancer Hospital (CN)
- Second Military Medical University (CN)
- Nanfang Hospital (CN)
- Corresponding author
- Zhou, C.
- ORCID
- Venue
- Annals of Oncology
- Publisher
- Elsevier BV
- Published
- 2013-06
- Volume
- 24
- Issue
- 6
- Pages
- 1615-1622
- ISSN
- 0923-7534 (ISSN-L)
- OpenAlex
- W2165771694
- Cited by
- 121
- References
- 21
- Citations by year
- 2026: 2 · 2025: 1 · 2024: 7 · 2023: 2 · 2022: 5 · 2021: 11 · 2020: 6 · 2019: 11 · 2018: 9 · 2017: 9 · 2016: 15 · 2015: 19 · 2014: 13 · 2013: 10
- FWCI
- 15.44
- Type
- journal article
- Language
- en
- Open access
- bronze
- doi.org
- Licence
- Locations
- Annals of Oncology (publishedVersion)
- PubMed (publishedVersion)
- HighWire Press Open Archive (submittedVersion)
- Funders
- the Shanghai Pulmonary Hospital and the Chinese Thoracic Oncology Group
- F. Hoffmann-La Roche
- the Science and Technology Commission of Shanghai Municipality (06DZ19502)
- Topics
- Health Sciences › Medicine › Pulmonary and Respiratory Medicine › Lung Cancer Treatments and Mutations
- Health Sciences › Medicine › Oncology › Cancer survivorship and care
- Social Sciences › Economics, Econometrics and Finance › Economics and Econometrics › Health Systems, Economic Evaluations, Quality of Life
- Keywords
- erlotinib, EGFR-mutant non-small cell lung cancer, quality of life, first-line therapy, progression-free survival, Chinese patients, exon 19 deletion, L858R mutation
- MeSH terms
- Erlotinib Hydrochloride, Adult, Aged, Antineoplastic Combined Chemotherapy Protocols, Carcinoma, Non-Small-Cell Lung, Female, Follow-Up Studies, Humans, Male, Middle Aged, Mutation, Quality of Life, Surveys and Questionnaires, Quinazolines, Disease-Free Survival, Protein Kinase Inhibitors, ErbB Receptors
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