DataSheet_3_Chinese Herbal Medicine Combined With EGFR-TKI in EGFR Mutation-Positive Advanced Pulmonary Adenocarcinoma (CATLA): A Multicenter, Randomized, Double-Blind, Placebo-Controlled Trial.doc
Background: To determine the clinical activity and safety of Chinese herbal medicine (CHM) combined with epidermal growth factor receptor tyrosine kinase inhibitors (EGFR-TKI) in patients with advanced pulmonary adenocarcinoma (ADC) and the ability of CHM combined with EGFR-TKI to activate EGFR mutations.
Methods: Three hundred and fifty-four patients were randomly assigned to EGFR-TKI (erlotinib 150 mg/d, gefitinib 250 mg/d, or icotinib 125 mg tid/d) plus CHM (TKI+CHM, N = 185) or EGFR-TKI plus placebo (TKI+placebo, N = 169). Progression-free survival (PFS) was the primary end point; the secondary end points were overall survival (OS), objective response rate (ORR), disease control rate (DCR), quality of life [Functional Assessment of Cancer Therapy-Lung (FACT-L) and Lung Cancer Symptom Scale (LCSS)], and safety.
Results: The median PFS was significantly longer for the TKI+CHM group (13.50 months; 95% CI, 11.20–16.46 months) than with the EGFR-TKI group (10.94 months; 95% CI, 8.97–12.45 months; hazard ratio, 0.68; 95% CI, 0.51–0.90; P = 0.0064). The subgroup analyses favored TKI+CHM as a first-line treatment (15.97 vs. 10.97 months, P = 0.0447) rather than as a second-line treatment (11.43 vs. 9.23 months, P = 0.0530). Patients with exon 19 deletion had a significantly longer PFS than with 21 L858R. The addition of CHM to TKI significantly improved the ORR (64.32% vs. 52.66%, P = 0.026) and QoL. Drug-related grade 1–2 adverse events were less common with TKI+CHM.
Conclusions: TKI+CHM improved PFS when compared with TKI alone in patients with EGFR mutation-positive advanced non-small-cell lung cancer (NSCLC).
Clinical Trial Registration: www.ClinicalTrials.gov, identifier NCT01745302.
History
References
- https://doi.org//10.1007/s40265-015-0434-6
- https://doi.org//10.1016/S0895-4356(01)00477-2
- https://doi.org//10.1200/JCO.2016.66.9218
- https://doi.org//10.1111/cas.12125
- https://doi.org//10.1016/j.ctim.2015.12.008
- https://doi.org//10.1007/s005200050244
- https://doi.org//10.1177/1534735416645181
- https://doi.org//10.1038/srep46524
- https://doi.org//10.1016/j.jtho.2017.05.018
- https://doi.org//10.1016/S0140-6736(08)61758-4
- https://doi.org//10.1093/jnci/djw279
- https://doi.org//10.1016/j.jep.2016.10.077
- https://doi.org//10.1371/journal.pone.0057604
- https://doi.org//10.1371/journal.pone.0085245
- https://doi.org//10.3389/fonc.2014.00238
- https://doi.org//10.1016/S1470-2045(09)70364-X
- https://doi.org//10.1056/NEJMoa1612674
- https://doi.org//10.1056/NEJMoa0810699
- https://doi.org//10.1200/JCO.2017.74.7576
- https://doi.org//10.1158/1078-0432.CCR-05-1846
- https://doi.org//10.1016/S1470-2045(11)70393-X
- https://doi.org//10.1056/NEJMoa0904554
- https://doi.org//10.1016/S1470-2045(13)70355-3
- https://doi.org//10.1093/annonc/mdx359
- https://doi.org//10.1097/JTO.0b013e31822adaf7
- https://doi.org//10.1038/nm.3854
- https://doi.org//10.3389/fphar.2018.01233
- https://doi.org//10.5582/bst.2017.01259
- https://doi.org//10.1038/s41419-018-0314-6
- https://doi.org//10.1016/j.ctim.2014.10.001
- https://doi.org//10.1007/s11655-017-2819-8
- https://doi.org//10.1200/JCO.2015.63.3628
- https://doi.org//10.1158/1078-0432.CCR-12-2246
- https://doi.org//10.1371/journal.pone.0107161
- https://doi.org//10.1016/S1470-2045(11)70184-X
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