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Nong Yang
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P1.01 - Advanced NSCLC (Not CME Accredited Session) (ID 933)
- Event: WCLC 2018
- Type: Poster Viewing in the Exhibit Hall
- Track:
- Presentations: 2
- Moderators:
- Coordinates: 9/24/2018, 16:45 - 18:00, Exhibit Hall
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P1.01-59 - A Better Real World Practice for ROS1 Positive NSCLC Patients, Driven by the Targeted Next Generation Sequencing(NGS) and the Targeted TKI (ID 11766)
16:45 - 18:00 | Author(s): Nong Yang
- Abstract
Background
Methodologically, Targeted NGS had been shown comparable to classical testing methods in testing sensitivity and specificity in several driver genetic aberrations. However, Data of standard TKI treatment outcome in NGS identified ROS1-positive NSCLC was rare, especially in TKI confirmatory clinical trials, thus it is practical and necessary to evaluate it in the real world.
a9ded1e5ce5d75814730bb4caaf49419 Method
We carried out a real word retrospective study in our center. From September 2015 to December 2017, NSCLC in-patients with targeted NGS testing (Burning Rock Dx; 8 genes or 56 genes panel) results were included in our study. Data of NGS multiple genes testing, crizotinib efficacy and potential clinical and genetic influential factors, and safety were analyzed.
4c3880bb027f159e801041b1021e88e8 Result
1104 NSCLC patients with targeted NGS testing (Burning Rock Dx; 8 genes or 56 genes panel) results were included in our study. All testing was based on tumor biopsy and adenocarcinoma is the domain histology. The occurrence rate of ROS1 rearrangement was 1.5 %( N=17). Seven phenotypes of ROS1 rearrangement were detected and the most common one was CD74-ROS1, which accounted for 45% (9 of 20). Furthermore, three patients were found carrying two different ROS1 rearrangements. 41% (7 of 17) patients were discovered with other concomitant mutations: including TP53 &PIK3CA mutation(n=1), TP53&CDKN2A mutation(n=1), TP53 & BRCA2 mutation(n=1), PIK3CA &ALK missense mutation (p.R311H）（n=1), MET amplification(n=1) ,TP53 mutation(n=1), ERBB2 mutation(n=1), Among all NSCLC patients with ROS1 rearrangement, 13 patients were diagnosed at stage IV and 12 patients received crizotinib treatment. The average follow-up period since crizotinib initiation was 12.7 months (range from 1.5 to 28 months). The ORR and DCR of crizotinib were 75% and 83% (9 PR, 1 SD and 2 NA) respectively. The median progression-free survival (mPFS) of crizotinib treatment was 14 months. Of influential factors analysis, it was shown that NSCLC patients with exclusive ROS1 rearrangement had a longer PFS than those carrying concomitant mutations (mPFS 15.5months vs 8.5months; p=0.0213) and there was no significance impact on PFS considering brain metastasis, crizotinib treatment lines or rearrangement subtypes. No grade 3 and 4 adverse events were observed in this retrospective study.
8eea62084ca7e541d918e823422bd82e Conclusion
Crizotinib is highly effective and tolerant in NGS identified ROS1 rearrangement advanced NSCLC in real-word clinical practice and the data is consistent with that in the previous clinical trials applying IHC/FISH/RT-PCR as ROS1 companion diagnosis. NSCLC patients with exclusive ROS1 rearrangement had better PFS under Crizotinib treatment compared to those with concomitant mutations.
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P1.01-62 - The Third Generation Irreversible EGFR Inhibitor HS-10296 in Advanced Non-Small Cell Lung Cancer Patients (ID 13138)
16:45 - 18:00 | Author(s): Nong Yang
- Abstract
Background
The epidermal growth factor receptor (EGFR) T790M mutation is the most common mechanism of drug resistance to EGFR tyrosine kinase inhibitors (TKIs) in non-small cell lung cancer (NSCLC) patients with sensitizing EGFR mutations. The third generation irreversible EGFR inhibitor HS-10296 has been shown to be safe and effective against both EGFR TKI-sensitizing and T790M resistance mutations in preclinical studies.
a9ded1e5ce5d75814730bb4caaf49419 Method
A Phase I, open-label, multi-center clinical trial was conducted in patients with locally advanced or distant metastatic NSCLC who have progressed following prior therapy with EGFR TKIs. The study was consisted of dose-escalation cohorts (55, 110, 220 and 260 mg) and dose-expansion cohorts (55, 110 and 220 mg) with once daily oral administration of HS-10296. In each expansion cohort, tumor biopsies were collected for central determination of EGFR T790M status. Patients were assessed for safety, tolerability, pharmacokinetics and efficacy of HS-10296.
4c3880bb027f159e801041b1021e88e8 Result
A total of 117 patients (median age 60) received at least one dose of HS-10296 across multiple sites in China (43 patients), Taiwan (69 patients) and the United States (5 patients). Maximum tolerated dose（MTD）has not been reached in this study. The most common adverse events were grade1/2 rash, pyrexia, upper respiratory tract infection, constipation, diarrhoea and blood creatine phosphokinase elevation. Drug-related serious adverse events were anemia (0.8%), blood creatinine elevation (0.8%), anemiarhabdomyolysis (0.8%) and blood creatine phosphokinase elevation (0.8%) occurred mainly in the cohorts with higher doses at 220 mg or 260 mg, respectively. These data demonstrated favorable tolerability and safety of HS-10296 in patients enrolled. The pharmacokinetics of HS-10296 was dose proportional and the plasma half-life was 30.7~37.5 hours. Among 82 evaluable patients (18 in escalation cohorts and 64 in expansion cohorts) with the EGFR T790M mutation, the overall objective response rate (ORR) was 52.4% (43/82; 95% CI, 41.6 to 63.3), while disease control rate (DCR) was 91.5% (75/82; 95% CI, 85.4 to 97.5). 110mg cohort showed better DCR (97.2% VS. 86.1%) than 55mg cohort. Phase II study is ongoing with the dose at 110 mg.
8eea62084ca7e541d918e823422bd82e Conclusion
HS-10296 has the potential to provide clinical benefit to locally advanced or distant metastatic NSCLC patients with EGFR T790M mutation who had disease progression following prior therapy with EGFR TKIs.
(The study was sponsored by Jiangsu Hansoh Pharmaceutical Co., Ltd.; ClinicalTrials.gov number, NCT02981108)
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P1.15 - Treatment in the Real World - Support, Survivorship, Systems Research (Not CME Accredited Session) (ID 947)
- Event: WCLC 2018
- Type: Poster Viewing in the Exhibit Hall
- Track:
- Presentations: 2
- Moderators:
- Coordinates: 9/24/2018, 16:45 - 18:00, Exhibit Hall
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P1.15-35 - Real World Outcome of Different Administrations Endostar Combined With Chemotherapy in Driver Gene Mutation Negative Advanced NSCLC (ID 12320)
16:45 - 18:00 | Author(s): Nong Yang
- Abstract
Background
To compare the efficacy and safety of different administration endostar combined with platinum-based chemotherapy with first-line treatment of driver gene mutation negative advanced NSCLC patients, and provides real-world evidence for optimum administration of endostar.
a9ded1e5ce5d75814730bb4caaf49419 Method
From April 2014 to April 2017, 88 driver gene mutation negative patients who received platinum-based chemotherapy alone or combined with endostar were retrospectively enrolled in this project. All the patients were divided to three groups, including platinum-based chemotherapy alone (arm A), combined with 14 days endostar (7.5 mg/m2, d1-14, q21d, arm B) and 7 days endostar (15 mg/m2, d1-7, q21d, arm C). The primary endpoint was median overall survival (OS). The secondary endpoints were median progression-free survival (PFS), objective response rate (ORR), and disease control rate (DCR). The efficacy and safety was evaluated every 2 cycles.
4c3880bb027f159e801041b1021e88e8 Result
Of all the 88 enrolled patients, the median OS was 20 months in endostar groups (arm B and arm C) and 10 months in chemotherapy alone group (arm A, P<0.001). The median PFS was months and 4.5 months respectively (P=0.073). The median OS was 22 months (arm B) and 14 months (arm C, P = 0.01). The median PFS was 6 months in arm B, 6.5 months in arm C, and 4.5 months in arm A. The ORR were 44.4%, 22.2% and 20.6% for arm B (P=0.046), arm C (P=0.877) and arm A respectively. The DCR were 88.9%, 77.8% and 64.7% for arm B (P=0.046), arm C (P=0.266) and arm A respectively. There is no meaningful difference in OS between arm B and arm C (P=0.111), as well as ORR (P=0.074) and DCR (P=0.234), but a meaningful difference in PFS (P=0.044). The incidence of adverse event in the three groups was 22.2%, 3.7%, and 11.6%, respectively. There was no new occurring intolerant adverse event.
8eea62084ca7e541d918e823422bd82e Conclusion
Endostar plus platinum-based doublet chemotherapy can significantly improve short-term and long-term outcomes in driver gene mutation negative advanced NSCLC. The administration of 14 days endostar compared to 7 days has no significant improvement in efficacy, but results in a higher incidence of adverse events.
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P1.15-36 - A Better Real World Practice for Pemetrexed in First-Line Treatment of Advanced Mon-Squamous Non-Small Cell Lung Cancer (ID 13250)
16:45 - 18:00 | Author(s): Nong Yang
- Abstract
Background
To investigate the real world practice of first-line pemetrexed combined with different drugs in patients with advanced Non-squamous non-small cell lung cancer.
a9ded1e5ce5d75814730bb4caaf49419 Method
A total number of 164 patients from February 2012 to August 2017 in Hunan Cancer Hospital in the combination of pemetrexed with cisplatin were enrolled in this study. All the patients were divided into 5 groups: PC-P (pemetrexed combined with platinum for 4 cycles and pemetrexed maintenance, arm A), PCA-PA (Pemetrexed plus platinum and bevacizumab 4cycles, pemetrexed combined with bevacizumab maintenance, arm B), PC (pemetrexed combined with platinum chemotherapy 4 cycles, arm C), PCA (pemetrexed with platinum chemotherapy, plus bevacizumab 4 cycles without maintenance, arm D), PC-EGFR TKI (pemetrexed plus platinum chemotherapy 4 cycles, and then EGFR TKI as maintenance treatment, arm E). Efficacy and safety of pemetrexed was performed in each group comparing with each major clinical data.
4c3880bb027f159e801041b1021e88e8 Result
According to retrospective study , the median PFS for arm A, B, C, D and E were 13 months, 12 months, 5 months, 5 months, 15.8 months respectively; the median OS was 27 month, 21 months, 15 months, 11 months and 31 months respectively. Arm A and Arm C, Arm B and Arm D achieved statistically different on PFS (p<0.05). And Arm A and Arm C, Arm B and Arm D also achieved statistical differences between OS (p<0.05). In the multivariate regression analysis of all patients, we found that the ECOG PS score may be an independent prognostic factor for death from lung cancer patients. Among all the patients, 35 (21.4%) patients presented with non-hematologic serious adverse event (grade 3 and 4). There was no new occurring intolerant adverse event comparing with other clinical trials.
8eea62084ca7e541d918e823422bd82e Conclusion
In this real world study, pemetrexed proved to be high efficacy and well tolerant in advanced NSCLC. The efficiency of maintenance pemetrexed treatment group achieved significantly better outcome than the non-maintenance treatment group. In addition, ECOG PS score may be an independent prognostic factor for the death of patients in lung cancer. There was no new occurring intolerant adverse event comparing with previous clinical trials, the main adverse events in this study were also focused on non-hematologic toxicity. This is consistent with clinical trials.
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P2.01 - Advanced NSCLC (Not CME Accredited Session) (ID 950)
- Event: WCLC 2018
- Type: Poster Viewing in the Exhibit Hall
- Track:
- Presentations: 2
- Moderators:
- Coordinates: 9/25/2018, 16:45 - 18:00, Exhibit Hall
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P2.01-119 - Phase III Randomized Trial of Palonosetron and Dexamethasone with Aprepitant to Prevent Full Dose Single-Day Cisplatin-Based CINV in Lung Cancer (ID 12316)
16:45 - 18:00 | Author(s): Nong Yang
- Abstract
Background
This study aimed to determine the efficacy and safety of aprepitant, palonosetron and dexamethasone to prevent chemotherapy-induced nausea and vomiting (CINV) in patients with locally advanced or metastatic lung cancer receiving full dose single-day cisplatin-based combination chemotherapy.
a9ded1e5ce5d75814730bb4caaf49419 Method
Patients diagnosed with locally advanced or metastatic lung cancer received full dose single-day cisplatin-based chemotherapy were randomized (1:1) to aprepitant plus palonosetron and dexamethasone, or placebo plus palonosetron and dexamethasone. Primary endpoint was complete response (CR; no vomiting/retching and no use of rescue medication) of nausea and vomiting in the overall period (0-120 h) in first cycle. The secondary endpoints were the proportion of nausea and vomiting, who received rescue antiemetic medication with metoclopramide, the response of cross over patients and safety were also evaluated.
4c3880bb027f159e801041b1021e88e8 Result
244 patients were randomized. There was no difference between two groups with personal characteristics. The aprepitant significantly improved CR for vomiting in the overall period (92.6% vs. 79.93%, p<0.01), rather than nausea-free (75.4% vs.71.3%, p＞0.05) in first cycle. The percentage of patients who received rescue antiemetic medication was decreased for aprepitant group (14.8% vs. 37.1%, p<0.001). Patients without using aprepitant suffered with nausea and vomiting in cycle 1 were crossed over to aprepitant group (N=32), the rate of nausea and vomiting in cycle 2 were decreased to 37.5% (p<0.05) and 25% (p<0.05) respectively. There was no drug related i ntolerance side effects.
Primary and secondary endpoints aprepitant placebo CR for vomiting 92.60% 79.93% nausea-free 75.40% 71.30% received rescue antiemetic medication 14.80% 37.10%
8eea62084ca7e541d918e823422bd82e Conclusion
Aprepitant plus palonosetron and dexamethasone proved to be effective and well-tolerated in preventing CINV for full dose single-day cisplatin-based combination chemotherapy.
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P2.01-120 - First Study to Evaluate the Efficacy of SB Oral Solution to Prevent Neutropenia and FN Induced by Platinum-Based Chemotherapy in Lung Cancer (ID 13272)
16:45 - 18:00 | Author(s): Nong Yang
- Abstract
Background
The aim of this study is to investigate the efficiency of Shengbai Oral Solution to Neutropenia and Febrile Neutropenia induced by platinum-based chemotherapy in lung cancer.
a9ded1e5ce5d75814730bb4caaf49419 Method
A total of 295 lung cancer patients from January 2014 through December 2016 were treated with platinum-based chemotherapy including etoposide or paclitaxel liposome combined with cisplatin (75mg/m2, one day finished) or carboplatin (AUC=6.25, one day finished), and 91 of them were treated with Shengbai Oral Solution. Using the ratio 1:2 with propensity score matching (PSM), the control group of 169 patients was matched to the experimental group of 91 patients, and the remaining 35 patients were excluded. The primary end point was to evaluate the effectiveness of Shengbai Oral Solution in preventing grade 2/3/4 drug-related toxicities of neutropenia. And the secondary outcome was to evaluate the rate of Febrile Neutropeniathe, cost and toxicity. All the patients were from this clinical trials with the NCT number of NCT01980212.
4c3880bb027f159e801041b1021e88e8 Result
There were no difference between two groups, with gender, age, smoking status, histologic grade, and histologic type included. The study revealed that compared with the control group, the ratio of neutropenia in the experimental group was significantly lower (34.07% vs 64.50%, HR 0.53, p<0.05), as expected, the grade 2/3/4, 3/4 neutropenia had similar results (30.77% vs 55.62%, HR 0.55, p<0.01), (14.29% vs 23.67%, HR 0.60, p<0.05), respectively. And the secondary endpoint showed that Shengbai Oral Solution can signifcantly reduce the rate of Febrile Neutropenia and did not significantly increase the additional medical expenses. There was no intolerance drug related toxicity.
8eea62084ca7e541d918e823422bd82e Conclusion
This study suggested that Shengbai Oral Solution was effective on reducing neutropenia and Febrile Neutropenia caused by chemotherapy in patients with lung cancer and was worth promoting in clinical.
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P3.15 - Treatment in the Real World - Support, Survivorship, Systems Research (Not CME Accredited Session) (ID 981)
- Event: WCLC 2018
- Type: Poster Viewing in the Exhibit Hall
- Track:
- Presentations: 1
- Moderators:
- Coordinates: 9/26/2018, 12:00 - 13:30, Exhibit Hall
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P3.15-31 - Better Clinical Outcomes and Resistance Mechanisms of Crizotinib in ALK-Positive Non-Small Cell Lung Cancer (ID 14455)
12:00 - 13:30 | Author(s): Nong Yang
- Abstract
Background
Advanced anaplastic lymphoma kinase (ALK) fusion-positive non-small cell lung cancers (NSCLCs) are effectively treated with ALK tyrosine kinase inhibitors (TKIs). However, clinical outcomes and acquired resistance were unclear. This study was to show the clinical outcomes and resistance mechanisms of crizotinib in ALK-Positive Non-Small Cell Lung Cancer (NSCLC)
a9ded1e5ce5d75814730bb4caaf49419 Method
From Fab 2, 2013 to Mar 10, 2018, 2360 patients in Hunan Cancer Hospital were enrolled in this project. We identified 90 ALK-positive NSCLC patients which were detected by Ventana (Roche) and Nex-generation sequencing with known ALK variants were selected for target patients. ALK resistance mutations and clinical outcomes on Crizotinib were retrospectively evaluated according to ALK variant and detection methods. Subgroups of brain metastasis, multiple gene mutation, uncommon rearrangement and concomitant mutation and dual rearrangement were also been evaluated. Nomograms for predicting survival in ALK-Positive NSCLC was also been built.
4c3880bb027f159e801041b1021e88e8 Result
Section not applicable
8eea62084ca7e541d918e823422bd82e Conclusion
Section not applicable
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