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M. Patel
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OA13 - Immunotherapy in Malignant Pleural Mesothelioma: Current Status of Trials and New Approaches (ID 392)
- Event: WCLC 2016
- Type: Oral Session
- Track: Mesothelioma/Thymic Malignancies/Esophageal Cancer/Other Thoracic Malignancies
- Presentations: 1
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OA13.07 - Intrapleural Modified Vaccine Strain Measles Virus Therapy for Patients with Malignant Pleural Mesothelioma (ID 5655)
15:25 - 15:35 | Author(s): M. Patel
- Abstract
- Presentation
Background:
Malignant pleural mesothelioma (MM) remains an almost universally fatal disease with limited treatment options. Preclinical models indicate the preferential oncolytic activity of the modified vaccine strain measles virus carrying the gene for the human sodium-iodine symporter (NIS) – MV-NIS. Intraperitoneal and intravenous administration of MV-NIS was recently found to be potentially effective in patients with refractory ovarian cancer and multiple myeloma. However, whether MV-NIS is directly oncolytic or triggers an anti-tumor immune response remains unclear.
Methods:
We conducted a phase I dose escalation study with 3+3 design and ongoing maximal tolerated dose (MTD) expansion cohort. MV-NIS was administered as first or second line therapy via a tunneled intrapleural catheter to patients with MM. MV-NIS dose ranged from 10[8] TICID~50~ to 9 x 10[9] TICID~50~. In the absence of dose limiting toxicity and disease progression, patients received up to 6 cycles of MV-NIS therapy (Phase I). Currently additional patients are being randomized between a single and multiple cycles. MV-NIS infection and replication are monitored by Iodine[123] SPECT/CT (Phase I only) as well as by RT-PCR and/or plaque-assay. Anti-tumor immunity is monitored in the blood and pleural fluid and patients are followed clinically by chest CT using the modified RECIST criteria.
Results:
Twelve patients (3/dose level) received MV-NIS therapy. There were no dose limiting adverse events and therapy was well tolerated. The best therapeutic response was stable disease, which was achieved at 1 month by 8/12 evaluable patients (67%). Median overall survival was 449 days (95%CI: 221, 484) (~15 months) (4/12 patients remain alive), and median progression free survival was 63 days (95% CI: 33, 174) (~2 months). MV infection and replication were detectable by RT-PCR and plaque assay in the pleural fluid between 24-72 hours after treatment. I[123] SPECT-CT demonstrated only marginal viral gene expression in a single patient treated with the highest dose level. MV-NIS therapy effectively boosted pre-existing anti-MV neutralizing antibody responses in the plasma and pleural fluid of most patients. We observed a transient inflammatory response in the pleural space after MV-NIS administration. In addition, induction or boosting of anti-tumor antibody responses was observed.
Conclusion:
The intrapleural administration of MV-NIS is safe, resulted in stable disease for 67% of patients and may be associated with favorable overall survival in MM. While there was only transient infection and viral replication, we observed the induction of anti-tumor immune responses supportive of potential long-term therapeutic impact. The study continues with the MTD expansion cohort.
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P1.06 - Poster Session with Presenters Present (ID 458)
- Event: WCLC 2016
- Type: Poster Presenters Present
- Track: Advanced NSCLC
- Presentations: 1
- Moderators:
- Coordinates: 12/05/2016, 14:30 - 15:45, Hall B (Poster Area)
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P1.06-013 - Patient Characteristics and Survival: A Real-World Analysis of US Veterans With Stage IV Adenocarcinoma vs Squamous NSCLC (ID 4737)
14:30 - 14:30 | Author(s): M. Patel
- Abstract
Background:
5-year survival rate in patients with stage IV NSCLC was 1%. Stage IV adenocarcinoma (ADENO) and squamous (SCC) account for 44% and 18% of stage IV NSCLC diagnoses, respectively. Patient characteristics and survival in US veterans with stage IV ADENO vs SCC NSCLC were examined.
Methods:
Patients with a unique diagnosis of stage IV NSCLC between 1/1/2010 and 12/31/2015 from the US Veterans Affairs (VA) health system database were included. Lung cancer diagnoses were confirmed by VA Central Cancer Registry and Veterans Health Administration National Patient Care Database. Patients were excluded if they did not have 1 VA visit within 1 year before diagnosis.
Results:
13,956 patients with stage IV NSCLC were included (ADENO: n=6525 [47%]; SCC: n=3421 [25%]). Baseline characteristics were similar for ADENO vs SCC, including age at diagnosis (mean, 68.8 vs 69.2 y), married at diagnosis (43.9% vs 42.2%), had known Agent Orange exposure (17.4% vs 16.3%), and the majority were white (60.8% vs 63.8%). For ADENO vs SCC, more patients were former smokers (39.5% vs 34.3%), but fewer were current smokers (53.9% vs 61.1%). For ADENO vs SCC, occurrence of brain or bone metastases were higher and incidence of chronic obstructive pulmonary disease or chronic pulmonary disease were lower (Table); age at death (mean, 69.3 vs 69.7 y) and time from diagnosis to death (TDD; mean, 0.56 vs 0.55 y) were similar. More ADENO vs SCC patients received chemotherapy (48.5% vs 44.1%). Mean TDD was longer in patients treated with chemotherapy vs not (ADENO: 0.86 vs 0.31 y; SCC: 0.84 vs 0.35 y).Figure 1
Conclusion:
ADENO was more prevalent than SCC in veterans with stage IV NSCLC, similar to the overall population; stage IV SCC prevalence was higher in the veterans than in the overall population. Mean TDD was longer in chemotherapy-treated patients regardless of histology.
