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:
, identifier NCT01745302.
The aim was to evaluate the effects of traditional Chinese medicine (TCM) as a combination medication with adjuvant chemotherapy on postoperative early stage non-small cell lung cancer (NSCLC) patients. The 314 patients with completely resected stage IB, II or IIIA cancers were assigned into vinorelbine plus cisplatin/carboplatin (NP/NC) (control, n = 158) and NP/NC with additional TCM (intervention, n = 156) groups. The primary endpoint was QOL scores; secondary endpoints were the toxicity and safety of the regimens. The NP/NC regimen caused mild (grade 1 or 2) non-hematologic toxic effects in the patients comprising vomiting (43.6%), fatigue (36.9%), pain (23%), dry mouth (27.6%) and diarrhea (7.9%). The incidence of adverse events was significantly lower in the intervention group than in the control group (0.57% vs 4.02%, P = 0.037). Transient severe (grade 3 or 4) hematological toxic effects occurred less often (hemoglobin reduction (11.9 vs 22.5 percent) and total bilirubin increased (to 42.1 vs 46.2%) in the intervention compared to the control group during the 2nd chemotherapy cycle. When combined with adjuvant chemotherapy, TCM led to partial relief of symptoms in addition to a reduction of side-effects and adverse events caused by the NP/NC regimens.
An effective "on-off-on" photoelectrochemical (PEC)/visual sensing system based on cleaning-switchable lab-on-paper device was designed to achieve ultrasensitive detection of analytes. The first amplified "signal-on" PEC state was gained by CdS quantum dots sensitized leaf-shape ZnO (CdS QDs/leaf-shape ZnO) structure, which was assembled on reduced graphene oxide (rGO) modified paper electrode. Then Au-modified prism-anchored octahedral CeO nanoparticles (Au@PO-CeO NPs), as an efficient signal quencher, were immobilized on the CdS QDs/leaf-shape ZnO with the assistance of DNA hybridization, resulting in a noticeable photocurrent response decrement with the "signal-off" PEC state. With the addition of analytes, the quencher Au@PO-CeO NPs were immediately released from the sensing surface and robust PEC response was recovered to the signal-on state again. Meanwhile, the disengaged quencher in electrolyte solution flowed to the colorimetric detection area of lab-on-paper device and catalyzed oxidation of the chromogenic substrate 3,3',5,5'-tetramethylbenzidine in the presence of HO to form the colored product, making the analytes detection more convincing with the visual discrimination. Under optimal conditions, the proposed PEC/visual lab-on-paper device possessed the detection limits toward adenosine and potassium ion as low as 0.15 and 0.06 nM, respectively. With ingenious design of actuating conversion process between hydrophilicity and hydrophobicity by slipping paper tab to solve cleaning issue in the assay procedures, the cleaning-switchable lab-on-paper device was constructed for high-performance biosensing applications. It provides an unambiguous simplicity and portable operation for exploring high reliability and sensitivity of novel point-of-care diagnostic tool with dual-signal readout.
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