Virtual Library
Start Your Search
Y. Zhao
Author of
-
+
P1.03 - Poster Session with Presenters Present (ID 455)
- Event: WCLC 2016
- Type: Poster Presenters Present
- Track: Radiology/Staging/Screening
- Presentations: 1
- Moderators:
- Coordinates: 12/05/2016, 14:30 - 15:45, Hall B (Poster Area)
-
+
P1.03-062 - Lung Cancer Screening with Low-Dose CT in China: Study Design and Baseline Results from the First Round Screening Arm (ID 5639)
14:30 - 14:30 | Author(s): Y. Zhao
- Abstract
Background:
Lung cancer screening with low-dose CT (LDCT) was shown to reduce lung cancer mortality by 20% in the National Lung Screening Trial. However, several other trails have reported that there was no reduction in lung cancer mortality with a LDCT screening strategy. Meanwhile, whether LDCT screens could decrease healthcare costs is yet insufficiently explored. The objectives of the present study was to investigate whether LDCT screening is capable to reduce the lung cancer mortality by at least 20% and analyze the healthcare costs of the lung cancer LDCT screening in China.
Methods:
The present study is a randomized controlled trial of LDCT screening for lung cancer versus usual care. Eligible participants were those aged 45–70 years, and with either of the following risk factors: 1) history of cigarette smoking ≥ 20 pack-years, and, if former smokers, had quit within the previous 15 years; 2) malignant tumors history in immediate family members; 3) personal cancer history; 4) professional exposure to carcinogens; 5) long term exposure to second-hand smoke; 6) long term exposure to cooking oil fumes. All the participants were randomized into a screening arm with three rounds of alternate years LDCT screens and a control arm with three rounds of alternate years questionnaire inquiries. Management of positive screening test was carried out by a prespecified protocol.
Results:
From November 2013 to November 2014, 5933 participants were enrolled in our trail, of which 2933 were assigned to LDCT screening arm, and 3000 to control arm. In the first screening round, 2892 participants (98.6%) undergo LDCT after randomization. At baseline 742 subjects (25.7%) showed noncalcified nodules (NCN) larger than 4 mm. 69 cases were highly suspected of lung cancer according to the suggestion of three experienced experts. The highly suspected cases were accounting for 9.30% of all NCN subjects and 2.39% of all the screening arm participants. By March 2016, 26 cases underwent surgical resections, including 23 lung adenocarcinoma, 1 lung squamous cell carcinoma and 2 benign lesions, representing a positive lung cancer detection rate with low-dose CT screening of 0.83%(24/2892). Among all the lung cancer cases, 23/24 (95.8%) had stage I disease, and 1/24 (4.2%) had stage II disease. The second round screening was still ongoing since May 2016.
Conclusion:
Screening with LDCT increases the detection rate of early stage lung cancers (stage I and II) in a high risk population.
-
+
P2.03a - Poster Session with Presenters Present (ID 464)
- Event: WCLC 2016
- Type: Poster Presenters Present
- Track: Advanced NSCLC
- Presentations: 1
- Moderators:
- Coordinates: 12/06/2016, 14:30 - 15:45, Hall B (Poster Area)
-
+
P2.03a-001 - A Randomized Phase III Clinical Trial of Anlotinib Hydrochloride in Patients with Advanced Non-Small Cell Lung Cancer (NSCLC) (ID 4722)
14:30 - 14:30 | Author(s): Y. Zhao
- Abstract
Background:
Anlotinib hydrochloride, a novel multi-targeted tyrosine kinase inhibitor (TKI) was found to exhibit excellent inhibitory efficiency on a variety of receptor tyrosine kinases (RTK) involved in tumor progression, especially the vascular endothelial growth factor receptor (VEGFR), fibroblast growth factor receptor (FGFR), platelet-derived growth factor receptor (PDGFR) and stem cell-factor receptor (c-Kit). This ongoing trial aimed at evaluating the efficacy and safety of anlotinib hydrochloride comparing with placebo in advanced NSCLC patients who had received at least two previous chemotherapy and EGFR/ALK targeted therapy regimens.
Methods:
This Phase III, randomized, double-blind, placebo-controlled study (NCT 02388919) is ongoing in 31 centers in China under the supervision of Independent Data Monitoring Committee (IDMC). Pathological stage IIIB/IV adult advanced NSCLC patients (Pts) who had failed with at least two previous chemotherapy and EGFR/ALK targeted therapy regimens were eligible. The status of EGFR and ALK genes should be clear in all enrolled pts. Pts with sensitive EGFR or ALK mutations must had received and appeared intolerance to pervious targeted therapies. Pts were randomized (2:1) to receive Anlotinib hydrochloride or placebo once daily (12 mg) from day 1 to 14 of a 21-day cycle until progression. Dose reduction to 8 or 10 mg/day could be applied when grade 3 or 4 treatment-related toxicities were observed. The minimal sample size was estimated to 450 patients. The primary endpoint is overall survival (OS) and second endpoints are progression-free survival (PFS), overall response rate (ORR), disease control rate (DCR) and quality of life (QoL). Quality of life was assessed via EORTC QLQ-C30, safety is determined using standard NCI-CTCAE v4.02, and responses are evaluated according to RECIST v1.1.
Results:
This study started in February 2015, up to early July 2016, a total of 420 pts have been enrolled (93.3 % of 450 pts). Among enrolled pts, about 80 % were diagnosed as adenocarcinoma, EGFR mutation or ALK rearrangement was found in 1/3 of the pts. The overall analyses will start after 300 OS events.
Conclusion:
Anti-angiogenesis is the main mechanism of Anlotinib hydrochloride for preventing the tumor progression. Results of randomized, placebo-controlled Phase II trial (NCT01924195) has been reported in WCLC 2015, however, advantages in PFS (4.8 vs. 1.2 months) and OS (9.3 vs. 6.3 months) were observed in Anlotinib arm from the renewed data. Based on these exciting data, we are looking forward for the results of the Phase III trial
