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)

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.

doi:10.1093/annonc/mdt012

Cited by 122Lung Cancer Treatments and MutationsCancer survivorship and careHealth Systems, Economic Evaluations, Quality of Life

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)

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Chen, G., Feng, J., Zhou, C., Wu, Y.-L., Liu, X.-Q., Wang, C., Zhang, S., Wang, J. +16 more·2013·Annals of Oncology

DOI 10.1093/annonc/mdt012

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Abstract

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 a second small study comparing first-line erlotinib with chemotherapy, 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).
“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”
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Updated efficacy and quality-of-life (QoL) analyses in OPTIMAL, a phase III, randomized, open-label study of first-line erlotinib versus gemcitabine/carboplatin in patients with EGFR-activating mutation-positive (EGFR Act Mut+) advanced non-small cell lung cancer (NSCLC).
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Reply to ‘Concern on quality-of-life analysis in the OPTIMAL study’ by Couraud et al
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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: Chen, G.
Feng, J.
Zhou, C.
Wu, Y.-L.
Zhang, S.
Wang, J.
Zhou, S.
Ren, S.
Lu, S.
Luo, Y.
Chen, L.
Ye, M.
Huang, J.
Zhang, Y.
You, C.
Venue: Annals of Oncology
Publisher: Elsevier BV
Published: 2013-06
Volume: 24
Issue: 6
Pages: 1615-1622
ISSN: 0923-7534 (ISSN-L)
DOI: 10.1093/annonc/mdt012
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 · 2012: 1
FWCI: 15.44
Type: journal article
Language: en
Open access: bronze
doi.org
Licence: www.elsevier.com/tdm/userlicense/1.0/ (tdm)
www.elsevier.com/open-access/userlicense/1.0/ (vor, 2411 d)
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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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)

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