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A. Papachristofilou
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P1.08 - Poster Session with Presenters Present (ID 460)
- Event: WCLC 2016
- Type: Poster Presenters Present
- Track: Surgery
- Presentations: 1
- Moderators:
- Coordinates: 12/05/2016, 14:30 - 15:45, Hall B (Poster Area)
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P1.08-065 - Resection of Isolated Brain Metastasis Improves Outcome of Non Small-Cell Lung Cancer (NSCLC) Patients: A Retrospective Multicenter Study (ID 6132)
14:30 - 14:30 | Author(s): A. Papachristofilou
- Abstract
Background:
Metastatic non-small cell lung cancer (NSCLC) is an incurable disease. Selected patients with solitary brain metastasis from NSCLC can achieve long-term survival following metastasectomy. We analyzed the outcome of all consecutive and unselected patients undergoing resection of brain metastases in two cancer centers in Switzerland to assess safety and efficacy of brain metastasis resection in NSCLC.
Methods:
119 consecutive NSCLC patients undergoing surgical resection of brain metastases from two centers in Switzerland (University Hospital Basel, Cantonal Hospital St. Gallen) between 2000 and 2014 were analyzed. Measured outcomes were extent of resection, resection status, postoperative complications and overall survival (OS). We used the log-rank test to compare unadjusted survival probabilities and multivariable Cox regression to investigate potential prognostic factors with respect to OS.
Results:
Median age was 60.5 years, 56% were male, 74% were smokers, 55% had adenocarcinoma. Median OS of the whole cohort was 18.0 months. 1-year survival rate was 63%, 12% of patients were alive after 5 years. In total, 146 brain metastases were resected; the maximum number of resected metastases was 4 (median: 1). Median diameter of resected metastases was 25 millimeters (range, 6-70 mm). About half of metastases were localized in the frontal cortex or the cerebellum. 86% of patients received postoperative radiotherapy. 63% of patients were treated with whole brain radiation, 12.6% received stereotactic radiotherapy. Median dose of postoperative radiotherapy was 30 Gy. Patients not receiving adjuvant radiotherapy (n=11) had a significantly worse outcome (median OS 9.0 vs. 20.2 months, p=0.002). Patients with more than one brain metastasis (n=21) had a significantly worse outcome compared to those with a solitary metastasis (median OS 13.5 vs. 19.5 months, p=0.006). Also patients with extracerebral metastases (n=33) had a significantly poorer outcome (median OS 14.0 vs. 23.1 months, p=0.005). Patients with non-squamous histology (n=98) had a better outcome than patients with squamous cell carcinoma (median OS 22.6 vs. 12.0 months, p=0.019). 21% of patients experienced postoperative complications, including need for surgical reintervention (5.8%), neurological deficits (4.2%), infection (4.2%), stroke (3.4%) and others (11.8%). The occurrence of postoperative complications was not associated with outcome. In the multivariate analysis existence of extracerebral metastases and resection of more than one brain metastasis were independent negative prognostic factors.
Conclusion:
Patients with isolated brain metastasis from NSCLC in the absence of extracranial metastasis should be evaluated for metastasectomy. Prospective trials are needed to characterize the patient population experiencing the greatest benefit from a surgical procedure.
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P3.02c - Poster Session with Presenters Present (ID 472)
- 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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P3.02c-091 - Final Phase Ib Results of RNActive® Cancer Vaccine BI 1361849 and Local Radiation as Maintenance Therapy for Stage IV NSCLC (ID 4735)
14:30 - 14:30 | Author(s): A. Papachristofilou
- Abstract
Background:
Preclinical studies demonstrated that local radiotherapy (RT) acts synergistically with RNActive[® ]vaccines to increase tumor-infiltrating immune cells and enhance anti-tumor effects. BI 1361849 (CV9202) is an immunotherapeutic cancer vaccine comprising optimized mRNA constituents (RNActive[®]) encoding six NSCLC-associated antigens. Here we report clinical outcomes and immune response data of a phase Ib study, employing local RT and BI 1361849 in advanced NSCLC.
Methods:
Patients (Pts) with stage IV NSCLC and a response or stable disease after first-line chemotherapy or therapy with an epidermal growth factor receptor tyrosine kinase inhibitor (EGFR-TKI) were enrolled in three cohorts based on histological and molecular NSCLC subtypes (non-squamous vs. squamous vs. EGFR-mutated NSCLC). Pts received two initial vaccinations with BI 1361849 prior to local RT to the primary tumor or a metastatic lesion (four consecutive daily fractions of 5 Gy), followed by further vaccinations until start of another treatment. Maintenance Pemetrexed (mP) and EGFR-TKIs were continued according to the label. Primary endpoint was safety; secondary endpoints included objective response, PFS and OS. Cellular and humoral immune responses were measured ex vivo by multifunctional intracellular cytokine staining, IFN-γ ELISpot, and ELISA in pre- and post-treatment blood samples.
Results:
26 pts were enrolled. 15 pts received mP, two received EGFR TKIs. Most frequent AEs were mild to moderate injection-site reactions and flu-like symptoms. Two pts experienced BI 1361849-related grade 3 AEs (fatigue, pyrexia). No BI 1361849-related SAE or grade 4 AE was reported. Interim results indicate one confirmed PR in a patient receiving mP and SD in 13/25 evaluable pts (52%, 8 pts on mP, 3 pts without maintenance therapy, 2 pts on EGFR-TKI), with two pts showing remarkably long-lasting disease stabilization of up to 72 and 54 weeks, respectively. Shrinkage of lesions outside the irradiated field of ≥15% occurred in 7 pts, all but one receiving mP. Longitudinal assessment of tumor response allows for further insight into patterns of progression. BI 1361849 was capable of eliciting antigen-specific immune responses in the majority of the patients including both cellular and humoral immune responses.
Conclusion:
BI 1361849 elicits antigen-specific immune responses and can be safely combined with local RT and mP treatment. Shrinkage of non-irradiated lesions and prolonged disease stabilization was observed in a subset of pts, mainly in combination with mP. Final clinical outcomes and analyses of cellular and humoral immune responses will be presented.
