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E. Szabo
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OA18 - New Insights in the Treatment of Thymic Malignancies (ID 408)
- Event: WCLC 2016
- Type: Oral Session
- Track: Mesothelioma/Thymic Malignancies/Esophageal Cancer/Other Thoracic Malignancies
- Presentations: 1
- Moderators:N. Girard, S.B. Watzka
- Coordinates: 12/07/2016, 11:00 - 12:30, Schubert 2
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OA18.02 - Evaluation of a Modified Dosing Regimen (2-Weeks on/1-Week off) of Sunitinib as Part of a Phase II Trial in Thymic Carcinoma (ID 6289)
11:10 - 11:20 | Author(s): E. Szabo
- Abstract
- Presentation
Background:
Sunitinib is active in patients with recurrent thymic carcinoma (TC). We have previously reported an objective response rate of 26% and disease control rate (partial response and stable disease) of 91% in patients with TC when sunitinib is administered at a dose of 50 mg once daily for 4 weeks followed by 2 weeks off (4/2 dosing schedule). Grade 3 or 4 treatment-related adverse events (TEAEs) occurring in more than 10% of patients included fatigue, oral mucositis and lymphocytopenia (20% each), and hypertension (13%). Grade 3 decrease in left ventricular ejection fraction (LVEF) was observed in 8% of patients. Alternative dosing schedules have been evaluated in solid tumors to improve tolerability. As part of an ongoing phase II study (NCT01621568), we evaluated the clinical activity and tolerability of sunitinib in patients with TC using a 2-weeks-on/1-week-off (2/1) dosing regimen.
Methods:
Patients with progressive TC after at least one prior platinum-containing chemotherapy regimen, measurable disease, and adequate end organ function were enrolled and received sunitinib at a dose of 50 mg orally once daily using a 2/1 schedule until disease progression or development of intolerable adverse events. The primary objective was evaluation of response rate. Tumor assessments were performed every 6 weeks using RECIST version 1.1 and toxicity was assessed every 3 weeks using CTCAE version 4.0. Exploratory correlative studies including evaluation of immune cell subsets will be reported separately.
Results:
Between July 8, 2014 and January 14, 2016, 15 patients were enrolled. Median age was 62 years (range, 41-76), and 33% were male. A median of 4 (range, 1 – 33+) cycles of sunitinib was administered. Among 13 evaluable patients, there was 1 (8%) partial response, 11 (85%) stable disease and 1 (8%) progressive disease. After a median follow-up of 16 months, the median progression-free survival was 5 months and median overall survival was 16 months. Grade 3 or 4 TEAEs occurring in more than 10% of patients included lymphocytopenia (40%), neutropenia and leucopenia (20% each), thrombocytopenia and oral mucositis (13% each). Grade 3 decrease in LVEF was observed in 1 (7%) patient.
Conclusion:
Sunitinib, administered using a 2/1 dosing schedule, has clinical activity in patients with TC, and the frequency of clinically significant TEAEs (fatigue, mucositis, hypertension) is acceptable. Studies are ongoing to identify novel immunological biomarkers of activity.
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P1.01 - Poster Session with Presenters Present (ID 453)
- Event: WCLC 2016
- Type: Poster Presenters Present
- Track: Epidemiology/Tobacco Control and Cessation/Prevention
- Presentations: 1
- Moderators:
- Coordinates: 12/05/2016, 14:30 - 15:45, Hall B (Poster Area)
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P1.01-040 - Long-Term Survival in Metastatic Non-Small-Cell Lung Cancer: An Investigation Using Surveillance, Epidemiology and End Results Data (ID 4466)
14:30 - 14:30 | Author(s): E. Szabo
- Abstract
Background:
The introduction of new effective modalities for the treatment of metastatic non-small cell lung cancer (NSCLC), such as targeted therapies and immunotherapy, has resulted in reports of long-term survival in small sub-groups of patients treated with these therapies. It is therefore important to understand the frequency and characteristics of long-term survivors in large cohorts of advanced-stage lung cancer patients who were diagnosed and treated prior to the advent of these new therapies.
Methods:
A survival analysis of data from the Surveillance Epidemiology and End Results database was performed. The cohort was limited to patients diagnosed with stage IV NSCLC, squamous and adenocarcinoma histology only, between 1991 and 2007, with follow-up through 2012. Outcomes and factors associated with extended survival were evaluated in the 10% of patients with longest survival (long-term survivors, ≥21 months) vs. 90% short-survival patients (< 21 months). Patients surviving ≥ 5 years were compared with those surviving <5 years and ≥21 months. Demographic, tumor characteristic, and treatment differences between long-term and short-survival patients were compared using chi-square and Student’s T-test for categorical and continuous variables, respectively. For descriptive analyses unadjusted for confounders, Kaplan Meier curves and log-rank tests were used to compare survival by histology and long-term survival status.
Results:
Among the 44,387 patients diagnosed at stage IV, long-term survivors (4,544) are distinguishable from short-survival patients (39,843) by younger age, female sex, Asian/ Pacific Islander race, lower tumor grade, adenocarcinoma histology, upper lobe site, and treatment with surgery. Among only long-term survivors (≥ 21 months), predictors of longest survival are younger age, lower tumor grade, and treatment by surgery and radiation. Median survival increased over time from 3 to 4 months for short-survival patients versus 30 to 36 months for long-term survivors. Notably, 1.5% of patients survived >5 years even prior to modern combination chemotherapy regimens, targeted therapies, and immunotherapy.
Conclusion:
Despite the poor overall survival of patients diagnosed with stage IV NSCLC, the top 10% of survivors have significantly longer survival than the rest and a sub-population of individuals with extraordinary survival is identifiable. The discrepancy in median survival between long-term survivors and the rest suggests that long-term survivors comprise a disproportionate percentage of clinical trial participants and provides a rationale for more detailed clinical and molecular analyses in order to improve therapeutic targeting and future study design.
