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Hansang Lee
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OA 03 - Mediastinal and Esophageal Tumor: Insight and New Treatment (ID 654)
- Event: WCLC 2017
- Type: Oral
- Track: Thymic Malignancies/Esophageal Cancer/Other Thoracic Malignancies
- Presentations: 1
- Moderators:M. Chida, Jhingook Kim
- Coordinates: 10/16/2017, 11:00 - 12:30, Room 311 + 312
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OA 03.04 - A Phase II Study of Pembrolizumab for Patients with Refractory or Relapsed Thymic Epithelial Tumor (ID 9689)
11:30 - 11:40 | Author(s): Hansang Lee
- Abstract
- Presentation
Background:
No standard treatment exists for patients with thymic epithelial tumor (TET) who progress after platinum-containing chemotherapy. We conducted a phase II study of pembrolizumab in patients with refractory or relapsed TET to evaluate the efficacy and safety.
Method:
Between March 2016 and June 2017, patients with histologically confirmed TET who progressed after at least one platinum-containing chemotherapy were eligible. Patients were excluded if they had an active autoimmune disease requiring systemic treatment within the past one year or documented history of clinically severe autoimmune disease. Patients received 200mg of pembrolizumab intravenously every 3 weeks until tumor progression or unacceptable toxicity. Response was assessed every 9 weeks by investigator. The trial was registered with ClinicalTrials.gov, number NCT02607631.
Result:
Thirty-three patients were enrolled, 26 with thymic carcinoma and 7 with thymoma. 19 (57.3%) patients received two or more prior lines of systemic chemotherapy. Median number of cycles was 8 (ranges, 1-22) and median follow-up was 11.8 months (ranges, 1.6-14.9 months). Of 33 patients, eight (24.2%) achieved partial responses, 17 (51.5%) stable disease, and 8 (24.2%) progressive disease as best response, resulting in overall response rate of 24.2% (7 confirmed PR). The median progression-free survival was 6.1 months for both of thymoma and thymic carcinoma. The most common adverse events of any grade include dyspnea (11 [33.3%] of 33 patients), chest wall pain (10 [30.3%]), anorexia (7 [21.2%]) and fatigue (7 [21.2%]). Treatment-related adverse events ≥ grade 3 associated with immune related adverse events (irAE) include hepatitis (4 [12.1%]), myocarditis (3 [9.1%]), myasthenia gravis (2 [6.1%]), thyroiditis (1 [3.0%]), ANCA-associated rapidly progressive glomerulonephritis (1 [3.0%]), colitis (1 [3.0%]), and subacute myoclonus (1 [3.0%]) except anemia (1 [3.0%]). Eight (24.2%) patients (5 thymoma, 3 thymic carcinoma) discontinued study treatment due to irAE, whereas irAEs were manageable with immediate administration of high dose corticosteroid and other immunosuppressive agents in most of patients (7 of 8 [87.5%]). In 18 (54.5%) patients who had tumor specimens available for correlative biomarker analysis, all of four patients achieved partial response had 50% or more proportion score of PD-L1 immunostaining and higher PD-L1 RNA expression compared with non-responders (p=0.0471).
Conclusion:
Pembrolizumab showed promising antitumor activity in patients with refractory or relapsed TET. Given the relatively high incidence of irAEs especially in thymoma, early detection and management of autoimmune toxicity is essential to ensure feasibility of pembrolizumab treatment in patients with TET.
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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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P3.01-029 - Transient Asymptomatic Pulmonary Opacities (TAPOs) during Osimertinib Treatment and Its Clinical Implication (ID 9117)
09:30 - 09:30 | Presenting Author(s): Hansang Lee
- Abstract
Background:
Osimertinib is an oral, potent, irreversible 3[rd] generation EGFR tyrosine kinase inhibitor(TKI) approved for the treatment of T790M positive non-small cell lung cancer (NSCLC) patients who failed 1[st] or 2[nd] generation EGFR TKIs. Interstitial lung disease (ILD) is a rare complication with osimertinib, accounting for 1-3%. Recently, relatively high incidence of transient asymptomatic pulmonary opacities (TAPOs) which are different from ILD has been described (Noonan et al, JTO 2016). However, its clinical implication has not been fully determined yet.
Method:
We retrospectively analyzed 75 EGFR mutant NSCLC patients treated with osimertinib at Samsung Medical Center. Serial CT findings were reviewed by radiologist (Dr. HY Lee) and TAPO was classified according to its radiologic pattern. We also analyzed the correlation of TAPO with clinical outcomes.
Result:
Among 74 patients, TAPO was found in 15 (20.3%). The median time to TAPOs development was 23.5 weeks (1 – 72 weeks) and the median duration of TAPOs was 6.0 weeks (5 – 24 weeks) during continued osimertinib treatment. The most common radiological patterns of TAPO include cryptogenic organizing pneumonia and/or simple eosinophilic pneumonia (SEP). There was no significant difference in patient characteristics between TAPO positive and negative group. The duration of exposure to osimertinib is longer in TAPO positive than negative group (25.2 months vs 14.0 months, p=0.016 ). The progression free survival (PFS) and overall survival (OS) was numerically longer in patients with TAPO positive than negative group (PFS : 15.0 m vs 12.5 m, p= 0.201/ OS : 37.0 m vs 24 m, p=0.155)
Conclusion:
TAPOs are frequently observed with osimertinib treatment and may be mistaken for isolated pulmonary progression or ILD. Given the lack of serious clinical deterioration, it is reasonable to continue osimertinib with regular CT scan follow-up. For further clinical validation of TAPOs, long-term and large studies are warranted.
