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S.N. Waqar
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P2.03a - Poster Session with Presenters Present (ID 464)
- Event: WCLC 2016
- Type: Poster Presenters Present
- Track: Advanced NSCLC
- Presentations: 2
- Moderators:
- Coordinates: 12/06/2016, 14:30 - 15:45, Hall B (Poster Area)
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P2.03a-002 - Patterns of Chemotherapy Use and Overall Survival (OS) of Patients with Stage IV Squamous Lung Cancer (SCC) (ID 5216)
14:30 - 14:30 | Author(s): S.N. Waqar
- Abstract
Background:
Chemotherapy is standard of care for patients with metastatic SCC. There is limited information on the use and outcome of patients with metastatic SCC who receive chemotherapy. We used the National Cancer Data Base (NCDB) to investigate the use and survival of patients receiving chemotherapy for stage IV SCC.
Methods:
The NCDB was queried for patients≥ 18 years, diagnosed with stage IV SCC between 2004-2013 for whom chemotherapy data was available. The percentage of patients receiving chemotherapy within 2 months of diagnosis was calculated. Patients were stratified by age (<50, 50-70 and >70 years), Charlson-Deyo comorbidity score (0, 1 and 2), gender, and period of diagnosis (2004-2006, 2007-2009, 2010-2012) to evaluate patterns of chemotherapy use. Median, 1-year and 2-year OS were calculated for patients that received chemotherapy using Kaplan Meier method.
Results:
Among the 86,200 patients that met the eligibility criteria, 40,147 (46.6%) patients received chemotherapy, which included single agent (n=3,912; 9.7%) multiagent (n=32,737;81.5%) and number of agents unknown (n=3,498;8.7%). A total of 46,053 (53.43%) patients did not receive chemotherapy due to chemotherapy not recommended (n=5,397; 11.7%), patient refusal (n=6,119; 13.3%) and other/unknown reasons (n=34,537; 75%). Patients receiving multi-agent chemotherapy were younger than those receiving single agent chemotherapy (65.6 vs 71.5 years). Chemotherapy use declined with increase in comorbidity score (50.4% for score of 0, 44% for score of 1 and 36.2% for score of 2). The median, 1-year and 2-year OS for patients receiving chemotherapy were 7.5 months, 30.6% and 11.8% respectively (Table).OS for patients receiving chemotherapy by risk factor
Risk factor Median survival (months) 1 year OS 2 year OS Age <50 7.6 29.7% 11.5% 50-70 7.8 32.0% 12.4% >70 7.0 28.5% 10.8% Gender Male 7.3 29.0% 10.7% Female 7.9 33.7% 13.8% Year of diagnosis 2004-2006 7.3 28.8% 10.7% 2007-2009 7.5 31.0% 11.8% 2010-2013 7.7 31.6% 12.7% Charlson-Deyo comorbidity score 0 8.0 32.6% 12.7% 1 7.1 28.4% 10.6% 2 6.3 24.9% 9.2% All patients 7.5 30.6% 11.8%
Conclusion:
Most patients with metastatic SCC do not receive chemotherapy. The OS for patients with metastatic SCC remains poor, especially in patients over the age of 70, in men and those with multiple comorbidities.
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P2.03a-003 - Belinostat in Combination with Carboplatin and Paclitaxel in Patients with Chemotherapy-Naive Metastatic Lung Cancer (NSCLC) (ID 5996)
14:30 - 14:30 | Author(s): S.N. Waqar
- Abstract
Background:
Belinostat is a potent inhibitor of the enzyme histone deacetylase (HDAC), which influences chromatin accessibility through altering acetylation levels of histone and non-histone proteins. Belinostat may enhance the antitumor activity of carboplatin and paclitaxel. We conducted a phase 1 clinical trial of belinostat in combination with carboplatin and paclitaxel in chemotherapy-naive patients with stage IV NSCLC.
Methods:
This was a multicenter phase 1 open label study of belinostat in combination with carboplatin and paclitaxel in chemotherapy-naïve patients with histologically or cytologically confirmed Stage IV NSCLC, PS 0-1. A standard 3+3 dose escalation design was used to determine the primary endpoint of maximum tolerated dose (MTD) of belinostat administered intravenously on days 1-5 of a 21 day cycle in combination with carboplatin (AUC 6) and paclitaxel 200mg/m2 intravenously on day 3 of each cycle for up to 6 cycles. MTD was defined as the dose at which fewer than 2 of 6 patients experienced protocol defined dose-limiting toxicities (DLT) during cycle 1. Maintenance belinostat was allowed after sponsor approval. The starting dose of belinostat was 1000mg/m2. Secondary endpoints were safety and tolerability, progression free survival (PFS) and objective response rate (ORR) of the combination regimen.
Results:
Twenty three patients were enrolled and treated at the following belinostat levels: 1000 mg/m2 (n=5), 1200 mg/m2 (n=6), 1400 mg/m2 (n=6), 1600 mg/m2 (n=6). At the dose of 1600 mg/m2, 2 of 6 patients experienced DLTS (grade 3 syncope and grade 3 hypotension) and 1400 mg/m2 was determined as the belinostat MTD. Median cycles of belinostat: 10, 7, 5.5 and 4, median cycles of chemotherapy 6, 6, 5.5 and 4 in each of the four cohorts respectively. The most frequent adverse events (all grades) were fatigue (91%), nausea (78%), constipation (74%) anemia and diarrhea (65%) alopecia, arthralgia, decreased appetite, insomnia and neutropenia (61%) dizziness and vomiting (57%) and headache (52%). Median PFS was 5.7 months (95% CI: 2.8, 8.8). 13/23 patients had available response data at the end of cycle 6 with ORR of 35%. The responses observed were partial response in 8 patients (35%), stable disease in 4 patients (17%) and progressive disease in 1 patient (4%). Two patients with partial response at cycle 6 continued on belinostat maintenance and later achieved a complete response.
Conclusion:
The combination of belinostat and carboplatin and paclitaxel is feasible with observed toxicities consistent with expected side effect profile. Preliminary antitumor activity of this combination was also demonstrated.
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P3.02a - Poster Session with Presenters Present (ID 470)
- Event: WCLC 2016
- Type: Poster Presenters Present
- Track: Advanced NSCLC
- Presentations: 1
- Moderators:
- Coordinates: 12/07/2016, 14:30 - 15:45, Hall B (Poster Area)
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P3.02a-001 - Response and Plasma Genotyping from Phase I/II Trial of Ensartinib (X-396) in Patients (Pts) with ALK+ NSCLC (ID 6090)
14:30 - 14:30 | Author(s): S.N. Waqar
- Abstract
Background:
Ensartinib (X-396) is a novel, potent anaplastic lymphoma kinase (ALK) small molecule tyrosine kinase inhibitor (TKI) with additional activity against MET, ABL, Axl, EPHA2, LTK, ROS1 and SLK. We report data on the ALK TKI-naïve and crizotinib (C)-resistant NSCLC pts treated with ensartinib. Clinical trial information: NCT01625234
Methods:
In this multicenter expansion study, pts with ALK+ NSCLC were treated with ensartinib 225 mg daily on a 28-day schedule. Pts had measurable disease, ECOG PS 0-1, and adequate organ function. Untreated brain metastases (CNS) and leptomeningeal disease were allowed. Next Generation Sequencing (NGS) was performed on plasma samples collected at baseline and on study and compared with central tissue results (FISH/IHC). All pts were assessed for response to therapy using RECIST 1.1 and for adverse events (AEs) using CTCAE version 4.03.
Results:
80 pts (51% female) have been enrolled. Median age 54 (20-79) years, 64% ECOG PS 1. Of 40 ALK+ NSCLC pts evaluable for response; partial response (PR) was achieved in 23 pts (58%) and stable disease (SD) in 8 pts (20%). In the C-naïve pts (n = 8), PRs were observed in 7 pts (88%). In the 22 pts with prior C but no other ALK TKI, 14 pts (64%) achieved PR and 6 (27%) SD. In the 10 pts who had received two or more prior ALK TKIs, there was 2 PR, 2 SD (40% DCR). CNS responses (50% PR) have been observed in both C-naïve and C-resistant pts. Plasma and tissue genotyping were available on 27 pts (26 ALK+ and 1 ALK-). ALK was detected in plasma in 16 pts, all of whom had a response to therapy. 2 pts with PD were tissue +ve and plasma -ve. 9 plasma samples were unevaluable. Serial sequencing demonstrated a decrease in ALK in pts responding and an increase at the time of progression. The most common drug-related AEs (≥ 20% of pts) included rash (53%), nausea (32%), vomiting (26%), fatigue (23%), and pruritus (21%). Most AEs were Grade (G) 1-2. The G3 treatment-related AEs were rash (8 pts), fatigue (2 pts), pruritus (2 pts), edema (2 pts), decreased appetite (1 pt), nausea (1pt), and vomiting (1pt).
Conclusion:
Ensartinib is well-tolerated with response in both C-naïve and C-resistant ALK+ NSCLC pts, as well as pts with CNS disease. Plasma sequencing appears to be promising to select pts for therapy and monitor for response and development of acquired resistance.
