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C.S. Baik
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OA05 - Treatment Advances in SCLC (ID 373)
- Event: WCLC 2016
- Type: Oral Session
- Track: SCLC/Neuroendocrine Tumors
- Presentations: 1
- Moderators:A. Ardizzoni, J. Pujol
- Coordinates: 12/05/2016, 14:20 - 15:50, Strauss 2
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OA05.05 - Randomized Phase 2 Study: Alisertib (MLN8237) or Placebo + Paclitaxel as Second-Line Therapy for Small-Cell Lung Cancer (SCLC) (ID 4855)
15:05 - 15:15 | Author(s): C.S. Baik
- Abstract
- Presentation
Background:
Alisertib, an investigational selective Aurora A kinase inhibitor, showed single-agent antitumor activity in preclinical in vivo SCLC models and was synergistic with paclitaxel in this setting. We report the efficacy, quality of life (QoL), and safety from this study.
Methods:
Patients ≥18 years with SCLC relapsed <180 days after standard first-line platinum-based chemotherapy were randomized 1:1 to alisertib 40 mg orally twice-daily on days 1–3, 8–10, 15–17 + paclitaxel 60 mg/m[2] IV on days 1, 8, 15 (Arm A) or matched placebo + paclitaxel 80 mg/m[2] (Arm B) in 28-day cycles. Patients were stratified using an interactive voice response system (IVRS) by type of relapse post-frontline platinum (sensitive vs resistant/refractory) and presence/absence of brain metastases at baseline. Protocol Amendment 2 corrected the definition for relapse per standard guidance; stratification factors were corrected accordingly. Primary endpoint was progression-free survival (PFS) per stratified log-rank test. QoL outcomes were assessed per EORTC QLQ-C30 and -LC13.
Results:
178 patients were randomized, 89/89 to Arm A/B (median age 62/62 years). Survival, response, QoL, and safety results are presented in the Table. The analysis of PFS using IVRS stratification favored Arm A, as did the analysis per corrected stratification factors. Mean EORTC QLQ-C30 QoL scores were similar between arms, as were mean change-from-baseline values at end of treatment (-5.7 in Arm A vs -4 in Arm B). Figure 1
Conclusion:
Alisertib + paclitaxel shows favorable PFS over placebo + paclitaxel with both initial and updated IVRS stratification. A similar favorable trend was also observed for OS and ORR although not statistically significant. Comparable changes in QoL scores were observed from baseline in both arms. The alisertib + paclitaxel arm showed higher rates of AEs and discontinuation due to AEs. Updated survival analyses are pending.
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P3.02b - Poster Session with Presenters Present (ID 494)
- 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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P3.02b-061 - A Phase II Study of Nab-Paclitaxel (Nab-P) in Patients with Advanced Non-Small Cell Lung Cancer (NSCLC) with EGFR Mutations (ID 4337)
14:30 - 14:30 | Author(s): C.S. Baik
- Abstract
Background:
Patients with NSCLC harboring a sensitizing EGFR mutation have effective targeted therapy options initially but most patients eventually need to receive cytotoxic chemotherapy. We previously reported our institutional experience with taxane based therapy in this patient population and this provided the rationale for the currently ongoing phase II study (NCT01620190).
Methods:
Patients with EGFR mutation positive NSCLC who were refractory to tyrosine kinase inhibitor (TKI) therapy and chemotherapy naive received nab-P at 125mg/m2 on days 1, 8 and 15 in a 28-day cycle. The primary endpoint was response rate which was assessed using RECIST v1.1.
Results:
As of data cut-off of March 14 2016, 22 patients were enrolled and received therapy (19 evaluable, 2 not yet evaluable, 1 patient excluded due to not being eligible). Median age was 65 (range 54-77), 75% of patients were women, 40% did not have a smoking history and majority (65%) of patients had an ECOG performance status of 1. Tumor histology consisted mostly of adenocarcinoma (90%); 55% of patients harbored exon 21 L858R and 45% harbored exon deletion 19 mutations. Confirmed partial response was documented in 8 of 19 (42%) patients with a median duration of response of 4.3 months (range 3.3-9.5) and stable disease was documented in 4 of 19 (21%) patients with a disease control rate of 63%. Median progression free survival was 4.4 months (95% CI 1.8-5.5 months). The most common grade 3 treatment-related adverse events (AE) were peripheral neuropathy (10%), fatigue (10%) and neutropenia (15%). There were no treatment-related grade 4 AEs.
Conclusion:
Single agent nab-P has promising activity in patients with EGFR mutation positive NSCLC. The AE profile was consistent with previously reported AEs in the literature. Accrual of patients continues and updated data will be presented Figure 1
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P3.07 - Poster Session with Presenters Present (ID 493)
- Event: WCLC 2016
- Type: Poster Presenters Present
- Track: Regional Aspects/Health Policy/Public Health
- Presentations: 1
- Moderators:
- Coordinates: 12/07/2016, 14:30 - 15:45, Hall B (Poster Area)
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P3.07-013 - Determining EGFR and ALK Status in a Population-Based Cancer Registry: A Natural Language Processing Validation Study (ID 5061)
14:30 - 14:30 | Author(s): C.S. Baik
- Abstract
Background:
Population-based data on Epidermal Growth Factor Receptor (EGFR) and Anaplastic Lymphoma Kinase (ALK) gene test status can inform about real-world molecular testing practices and their impact on treatment decisions and outcomes. Yet no efficient methods are available for population-based cancer registries to ascertain molecular testing data of non-squamous non-small cell lung cancer (NS-NSCLC) from electronic pathology (e-path) records. We sought to validate natural language processing (NLP) systems to accurately ascertain EGFR and ALK test use and results in patients with stage IV NS-NSCLC included in the Fred Hutchinson Cancer Research Center’s Cancer Surveillance System (CSS), a part of the U.S. Surveillance, Epidemiology, and End Results (SEER) program.
Methods:
We identified 4,279 e-path reports available in the CSS corresponding to 1,634 patients diagnosed with stage IV NS-NSCLC between 09/1/2011 and 12/31/2013. Using a random sample of 426 (10%) reports, we developed and trained an NLP system to detect EGFR mutation and ALK gene rearrangement test use (test result reported vs. not reported), and test results (positive vs. negative among reported tests). Two oncologists reviewed all e-path reports and resolved discrepancies by consensus to determine the gold-standard classification of test use and results. We report preliminary estimates of the NLP sensitivity, specificity, positive predictive value (PPV), and negative predictive value (NPV) for EGFR and ALK test use based on a second random sample of 426 reports (testing subsample).
Results:
Of 1,634 patients, mean age was 68 years, 815 (50%) were male, 1424 (87%) were white, and 1,347 (82%) had adenocarcinoma histology. Based on the gold-standard classification, in the training subsample, 126 (30%) and 103 (24%) reports contained information about EGFR and ALK test results, respectively. In the testing subsample, 139 (32%) and 115 (27%) had information about EGFR and ALK test results, respectively. In the testing subsample, the NLP system correctly detected 135 reports that contained EGFR test results and 285 that did not (sensitivity=97%; specificity=99%; PPV=99%; NPV=99%), respectively. The NLP system correctly detected 113 reports that contained ALK test results and 307 that did not (sensitivity=98%; specificity=99%; PPV=97%; NPV=99%), respectively.
Conclusion:
NLP is likely a valid method for capture of EGFR and ALK test use from e-path reports. Ongoing analyses include the NLP validity for ascertainment of test results among reported EGFR and ALK tests in this initial dataset and in a separate validation dataset of 3,427 pathology reports, all of which will be reported subsequently.
