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Baohui Han
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MA 14 - Diagnostic Radiology, Staging and Screening for Lung Cancer I (ID 672)
- Event: WCLC 2017
- Type: Mini Oral
- Track: Radiology/Staging/Screening
- Presentations: 1
- Moderators:H. Kondo, Hong Kwan Kim
- Coordinates: 10/17/2017, 15:45 - 17:30, F205 + F206 (Annex Hall)
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MA 14.07 - Randomized Lung Cancer Screening with Low-Dose CT in China: A Specific Risk-Based Screening for Chinese Population (ID 8906)
16:25 - 16:30 | Presenting Author(s): Baohui Han
- Abstract
- Presentation
Background:
The purpose of the present study was to investigate whether low-dose computed tomography (LDCT) screening is capable of enhancing the detection rate of early-stage lung cancer and reducing lung cancer mortality rate in China, thus determining the appropriate duration of screening and identifying additional risk factors for lung cancers in Chinese population.
Method:
A randomized lung cancer screening study was performed with participants aged 45 to 70 years old who had at least one high-risk factor as follows: 1) a history of cigarette smoking ≥20 pack-years; former smokers who had quit within the past 15 years; 2) cancer history in immediate family members; 3) personal cancer history; 4) professional exposure to carcinogens (asbestos, dust or radiation); 5) long history of passive smoking; or 6) long-term exposure to cooking oil fumes. Participants were randomly assigned to a screening group with alternating years of LDCT screening (R1, R2) or a control group with biennial questionnaire inquiries.
Result:
A total of 6657 eligible participants were enrolled, 3145 participants were assigned to the control group and 3512 were assigned to the baseline LDCT screening (R1) group. 1516 participants (43.2%) underwent the second round of LDCT screening (R2) in the alternate year. At R1 and R2 rounds, 19.6% and 24.0% participants showed non-calcified nodules ≥4 mm on LDCT images. Among these, lung cancer was diagnosed in 44 participants (1.3%) at R1, 12 (0.8%) at R2, and 10 (0.3%) in the control group through either biopsy or cytologic analysis. The proportions of early-stage (0 to I) lung cancer were 97.7% at R1, 91.7% at R2 and 20% in the control group, respectively. At R1, the sensitivity of LDCT for lung cancer screening was 97.7%, the specificity was 76.8%, the positive predictive value was 5.1%, and the negative predictive value (NPV) was 99.9%; at R2, both the sensitivity and the negative predictive value increased to 100%. Two cases of lung cancer-specific deaths occurred in the control group, but no death occurred in the LDCT group.
Conclusion:
Compared to usual care, the two biennial screenings with LDCT led to a 77.7% increase at R1 and 71.7% at R2 in detecting early-stage lung cancer and a 20% decrease in lung cancer mortality. Biennial screening may be at least as efficient as annual screening in terms of detecting rate, sensitivity and NPV. This study provides insights about the non-smoking related risk factors of lung cancer in the Chinese population.
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P2.04 - Clinical Design, Statistics and Clinical Trials (ID 705)
- Event: WCLC 2017
- Type: Poster Session with Presenters Present
- Track: Clinical Design, Statistics and Clinical Trials
- Presentations: 1
- Moderators:
- Coordinates: 10/17/2017, 09:30 - 16:00, Exhibit Hall (Hall B + C)
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P2.04-011 - The Using of LungCare Electromagnetic Navigated Bronchoscopy System in Lung Lesions, a New Project in China (ID 8787)
09:30 - 09:30 | Presenting Author(s): Baohui Han
- Abstract
Background:
With the application of low dose computed tomography in screening lung cancer for high-risk population, more peripheral pulmonary lesions are found which need to be diagnosed or treated. Traditional methods include transthoracic needle aspiration (TTNA) or transbronchial lung biopsy (TBLB) are not recommended nowadays because of its low diagnostic rate, more complications and high radiation dose for patients. Moreover, they lack real-time navigation system for guiding bronchoscope to the distal lesion where traditional methods hardly reach and highly depends on operators with knowledge of CT scans. Electromagnetic navigated bronchoscopy (ENB) has proven to be a novel technology, including electromagnetic tracking, virtual bronchoscopic navigation and CT reconstruction technologies. Only two commercial ENB systems have been approved by FDA in the United States. And more than 1,000 medical institutions have been equipped with ENB in Europe and the United States. As of the end of June 2016, more than 10 imported ENB systems were installed in China.
Method:
This project has been supported by the ministry of science and technology of the People’s Republic of China in 2017(2017YFC0112700). This project will utilize the domestic LungCare ENB system and its improved version to carry out five innovative sub-projects. These projects will cover all the issues of ENB on the early peripheral lung cancers (Stage IA), including the diagnosis, localization and treatment.
Result:
First, the project will utilize the CFDA approved LungCare ENB system to perform a large, prospective, multicenter, randomized study, which aims to enroll up to total 1362 consecutive subjects presenting for evaluation (diagnosis, localization and treatment) of lung lesions utilizing the ENB procedure at up to 3 clinical sites. Second, LungCare ENB system will upgrade their products and develop two new navigation systems including the transthoracic electromagnetic navigation system(TTEN) and the video assisted thoracoscopic surgery electromagnetic navigation system (VATS-EN). Two clinical studies will be performed in 3 clinical sites individually.
Conclusion:
LungCare ENB total solution including ENB, TTEN and VATS-EN, will extend their electromagnetic navigation system of the single use from the bronchus to the thoracic wall, and even through the thoracoscope. The value of the project will form the whole-lung electromagnetic navigation system and focus on the accurate diagnose, localization and treatment of early peripheral lung cancer.
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P3.01 - Advanced NSCLC (ID 621)
- Event: WCLC 2017
- Type: Poster Session with Presenters Present
- Track: Advanced NSCLC
- Presentations: 1
- Moderators:
- Coordinates: 10/18/2017, 09:30 - 16:00, Exhibit Hall (Hall B + C)
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P3.01-087 - Impact Factor Analysis for Efficacy and Prognosis of Anlotinib in NSCLC as Third-Line Treatment: Data from Trial ALTER 0303 (ID 9129)
09:30 - 09:30 | Author(s): Baohui Han
- Abstract
Background:
Anlotinib hydrochloride is a novel TKI targeting the VEGFR, FGFR, PDGFR and c-Kit. With the capability of inhibiting the tumor angiogenesis and tumor cell itself, anlotinib had showed significantly improvement in OS (9.63 vs. 6.30 months, HR=0.68, 95%CI 0.54-0.87, p=0.0018) and PFS (5.37 vs. 1.40 months, HR=0.26, 95%CI 0.21-0.33, p<0.0001) in ALTER 0303 study for refractory cancer, a randomized, double-blind, placebo-controlled Phase Ⅲ trial in China. Here, we report the main impact factors affecting the efficacy and prognosis of anlotinib based on the data from ALTER0303 to elucidate the most benefit population.
Method:
Analyzed data were collected from 294 patients that were enrolled in ALTER0303 trial and received anlotinib treatment between 4[th] March 2015 and 15[th] August 2016. The statistical analysis was conducted using SPSS19.0 software, in which the measuring and enumeration materials were described with Mean±SD and frequency/percentage respectively, Kaplan-Meier method was used for survival curves in survival analysis. Independent impact factors of OS and PFS were identified by univariate and multivariate analysis in Cox proportional hazards regression model (Significant level, α=0.05).
Result:
Several factors were discovered to be associated with the efficacy of Anlotinib treatment. The impact factors were presented in Tab1.Tab1. Impact factors for PFS and OS analyzed by Cox proportional hazards regression model Independent risk factor Independent protective factor PFS Ratio of granulocytes to lymphocytes at PD (HR=1.07, 95%CI 1.041-1.100, p<0.0001) Elevated ALP level (HR=1.553, 95%CI 1.142-2.112, p=0.005) Baseline sum of longest diameters of target lesions (HR=1.004, 95%CI 1.001-1.006, p=0.007) Elevated TSH level (HR= 0.555, 95%CI 0.422-0.730, p<0.0001) Hypercholesteremia (HR=0.720, 95%CI 0.534-0.971, p=0.031) Hypertension (HR=0.482, 95%CI 0.370-0.628, p<0.0001) Hand-foot skin reaction (HR=0.489, 95%CI 0.373- 0.643, p<0.0001) Elevated LDL level (HR=0.630, 95%CI 0.437-0.909, p=0.014) Age (HR=0.987, 95%CI 0.975-0.999, p=0.039) OS Ratio of granulocytes to lymphocytes at PD (HR=1.116, 95%CI 1.081-1.151, p<0.0001) Baseline sum of longest diameters of target lesions (HR=1.006, 95%CI 1.003-1.008, p<0.0001) ECOG PS≥2 at PD (HR=2.245, 95%CI 1.704- 3.508, p<0.0001) Elevated TSH level (HR=0.725, 95%CI 0.524- 1.005, p=0.053) Hypertriglyceridemia (HR=0.601, 95%CI 0.440-0.821, p<0.0001) Rash (HR=0.581, 95%CI 0.369-0.916, p=0.019) Female (HR=0.713, 95%CI 0.533-0.953, p=0.022)
Conclusion:
This analysis explored the possible impact factors of PFS and OS in Anlotinib treatment. Moreover, we provide real data for the prediction of Anlotinib efficacy and most benefit population through the baseline characteristics and variety of clinical index. However, further analysis in the larger scale study is still looking forward.
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P3.03 - Chemotherapy/Targeted Therapy (ID 719)
- Event: WCLC 2017
- Type: Poster Session with Presenters Present
- Track: Chemotherapy/Targeted Therapy
- Presentations: 2
- Moderators:
- Coordinates: 10/18/2017, 09:30 - 16:00, Exhibit Hall (Hall B + C)
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P3.03-006 - Efficiency of Anlotinib as 3rd Line Treatment in Patients with Different EGFR Gene Status, an Exploratory Subgroup Analysis of ALTER0303 Trial (ID 8306)
09:30 - 09:30 | Presenting Author(s): Baohui Han
- Abstract
Background:
Anlotinib hydrochloride is a novel TKI targeting the VEGFR, FGFR, PDGFR and c-Kit. ALTER0303 trial (NCT02388919), phase III study has demonstrated that Anlotinib significantly prolonged OS and PFS in advanced NSCLC patients as 3[rd] line treatment. Here we report the efficacy of anlotinib in patients with or without EGFR gene mutations from the ALTER0303 trial.
Method:
Eligible adult IIIB/IV NSCLC patients who progressed after at least 2 lines of prior therapies were randomized 2:1 to receive Anlotinib or placebo (12 mg QD from day 1 to 14 of a 21-day cycle) till progression. Patients harboring EGFR or ALK mutations must had received previous targeted therapies. Primary endpoint is OS.
Result:
Among patients with sensitive EGFR mutations, the PFS was 0.83 months for control arm and 5.57 months for anlotinib arm (p<0.0001, HR=0.15, 95%CI: 0.09-0.24). Accordingly, OS was found 4.43 months longer in anlotinib group (6.27 vs 10.70, p=0.0227, HR=0.59, 95%CI: 0.37-0.93). On the other hand, in the subgroup of patients with wild-type EGFR gene, remarkable advantages in PFS and OS were observed as well. Specifically, PFS in control arm was 1.57 months which is 3.80 months shorter than that in anlotinib group (1.57 vs 5.37, p<0.0001, HR=0.29, 95%CI: 0.22-0.39). As to OS, superiority of 2.40 months was found in anlotinib arm (6.47 vs 8.87, p=0.0282, HR=0.73, 95%CI: 0.55-0.97). In the patients treated with Anlotinib, the most common (≥ 3 grade) and significantly differ from placebo group AEs were hypertension (13.61%), dermal toxicity (3.74%) and hypertriglyceridemia (3.06%). These results indicate that either the patient with EGFR mutation or not, they can both benefit from Anlotinib treatment.
Conclusion:
In ALTER0303 trial, significant advances in OS and PFS were found in anlotinib treated patients from both subgroups (sensitive EGFR mutations and wild EGFR gene type), indicating that, independent of the EGFR gene status, anlotinb treatment led to a consistent improvement in OS and PFS for advanced NSCLC patients and may be an appropriate option for this difficult-to-treat population as 3[rd] line treatment.
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P3.03-017 - Blood Samples NGS for Baseline Molecular Signature of Anotinib Treated Advanced NSCLC Patients in ALTER0303 Trial (ID 9670)
09:30 - 09:30 | Presenting Author(s): Baohui Han
- Abstract
Background:
Anlotinib hydrochloride, an oral multi-target TKI targeting VEGFR, FGFR, PDGFR and c-Kit, have demonstrated noticeable effects for advanced NSCLC as 3[rd] line treatment in phase III trial (ALTER0303). Anlotinib significantly improved OS (9.63 vs. 6.30 months, p=0.0018, HR=0.68) and PFS (5.37 vs 1.40 months, p<0.0001, HR=0.26) comparing to placebo. Here, we applied ctDNA-based NGS to investigate the association between baseline molecular signature and clinical parameters.
Method:
Blood samples were collected from patients who enrolled in Anlotinib arm in ALTER0303 trial. Total of 92 samples were analyzed by capture-based targeted ultra-deep sequencing using a panel consisting of critical exons and introns of 168 NSCLC-related genes for the baseline genetic profiling.
Result:
At baseline, ctDNA was detected in 85% samples (78/92), driver mutation was found in 58% (53/92) samples. POM121L12 and CDKN2A mutations showed a tendency of co-occurrence with TP53, and mutually exclusivity was found between KEAP1 and TP53. The correlation between baseline molecular signature and treatment efficacy measured by PFS or best response was also investigated. Maximum mutation allele frequency (MAF) at baseline was inversely correlated with PFS (P=0.006, HR=0.612, 95%CI: 0.402-0.932). Patients achieving SD or PR had a significantly lower MAF comparing to patients having PD as their best response (p=0.018). Tumor mutation burden (TMB) is positively correlated with age (p=0.016) and gender (p=0.01). POM121L12, TP53 and MYC statuses are correlated with metastases burden. Moreover, as an important drive gene, EGFR mutation and/or EGFR amplification was found in 36 patients at baseline. In 27 patients with sensitizing EGFR mutation (L858R or 19 del), no significant differences was found in PFS compare to those without this mutation (n=65) (5.53 vs 5.53 months, p=0.495, HR=1.16, 95%CI: 0.73-1.85). As well, no significant difference was found in PFS between the patients with (n=17) or without EGFR T790M mutation (5.53 vs 5.53 months, p=0.253, HR=1.35, 95%CI: 0.75-2.41). Interestingly, in patients with EGFR amplification (n=10), the PFS is significantly shorter than those with normal EGFR copy number (2.12 vs 5.57 months, p=0.002, HR=2.70, 95%CI: 0.99-7.36). However, a tendency of PFS benefit is still observed in patients with EGFR amplification treated by Anlotinib comparing placebo arm in ALTER0303 (1.40 months).
Conclusion:
According to available data, no correlation was found between PFS and EGFR sensitizing mutations or T790M in anlotinib treatment. The negative correlation of EGFR amplification and PFS is still need verification to eliminate the bias caused by the disparity and limitation of samples. A larger scale analysis is ongoing.
