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K. Syrigos
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ORAL 20 - Chemoradiotherapy (ID 124)
- Event: WCLC 2015
- Type: Oral Session
- Track: Treatment of Locoregional Disease – NSCLC
- Presentations: 1
- Moderators:G. Blumenschein, J.Y. Chang
- Coordinates: 9/08/2015, 10:45 - 12:15, 201+203
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ORAL20.02 - Safety Results of the Consolidation Phase of a Phase III (PROCLAIM): Pemetrexed, Cisplatin or Etoposide, Cisplatin plus Thoracic Radiation Therapy followed by Consolidation Cytotoxic Chemotherapy in Locally Advanced Nonsquamous Non-Small Cell Lung Cancer (ID 645)
10:56 - 11:07 | Author(s): K. Syrigos
- Abstract
- Presentation
Background:
Standard treatment for inoperable stage III non-small cell lung cancer (NSCLC) is concurrent chemoradiotherapy. However, many patients die from recurrent disease, indicating that new treatment strategies are needed.
Methods:
PROCLAIM is a phase III trial comparing overall survival in patients with unresectable stage III nonsquamous NSCLC receiving pemetrexed+cisplatin (PemCis) and concurrent radiotherapy for 3 cycles followed by 4 cycles of pemetrexed consolidation (Arm A) versus etoposide+cisplatin (EtoCis) and concurrent radiotherapy for 2 cycles followed by consolidation with a platinum-based doublet of choice for up to 2 cycles (Arm B). Possible consolidation therapies in Arm B were EtoCis, vinorelbine+cisplatin (VinCis), and paclitaxel+carboplatin (PacCarb). Overall efficacy and safety results for the intent-to-treat population will be presented in a separate disclosure. Safety was a secondary objective. Interim safety results for the concurrent phase were previously presented. Here we present safety results for the consolidation phase. Treatment-emergent adverse events (TEAEs) were assessed according to the Common Terminology Criteria for Adverse Events (v3.0, CTCAE). TEAE incidences were compared using Fisher’s exact test (two-sided α=0.05).
Results:
Of 598 randomized patients, 555 were treated in the concurrent phase (Arm A: N=283; Arm B: N=272), most of whom (Arm A: n=229 [80.9%]; Arm B: n=202 [74.3%]) continued on to the consolidation phase (Arm B patients: EtoCis [33.5%], PacCarb [26.8%], VinCis [14.0%]). Baseline characteristics, including age, gender, performance status, smoking status, stage, and origin, were well-balanced across arms. Percentages of patients in Arm A completing ≥2, ≥3, and 4 consolidation cycles were 95.2%, 84.3%, and 73.4%, respectively. Percentages of patients in Arm B completing 2 consolidation cycles (maximum) were EtoCis (89.0%), PacCarb (93.2%), and VinCis (86.8%). Mean dose intensities for pemetrexed, etoposide, vinorelbine, cisplatin, paclitaxel, and carboplatin were 95.4%, 94.0%, 84.2%, 91.2%, 88.7%, and 92.7%, respectively. More patients in Arm B, compared to Arm A, experienced dose reductions, dose omissions, and cycle delays. Patients in Arm B reported more grade 3/4/5 drug-related TEAEs than Arm A (51.0% versus 31.0%, p<0.001; Table). Rates of drug-related serious AEs were similar between groups (Arm A: 14.4%; Arm B: 13.4%).Drug-related Grade 3/4/5 TEAEs Occurring in ≥2% of Patients (or of Clinical Relevance) in the Consolidation Phase
CTCAE Arm A (N=229) n (%) Arm B (N=202) n (%) Neutrophils 27 (11.8) 76 (37.6)* Leukocytes 19 (8.3) 29 (14.4) Hemoglobin 6 (2.6) 9 (4.5) Platelets 5 (2.2) 10 (5.0) Febrile neutropenia 7 (3.1) 7 (3.5) Lymphopenia 8 (3.5) 5 (2.5) Pneumonitis/pulmonary infiltrates 5 (2.2) 2 (1.0) Fatigue 2 (0.9) 4 (2.0) Pneumonia 5 (2.2) 0 Esophagitis 0 3 (1.5) *p<0.001, Fisher’s exact test. Note: Of the TEAEs listed here, only one case (0.4%, Arm A, pneumonia) was grade 5.
Conclusion:
During the PROCLAIM consolidation phase, most patients were able to complete the planned number of cycles in either arm, with the highest dose intensity corresponding to pemetrexed. Pemetrexed consolidation had a significantly lower incidence of drug-related grade 3/4/5 TEAEs than the platinum doublets in Arm B. A more detailed analysis of Arm B (by treatment regimen) is underway.
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P2.07 - Poster Session/ Small Cell Lung Cancer (ID 222)
- Event: WCLC 2015
- Type: Poster
- Track: Small Cell Lung Cancer
- Presentations: 1
- Moderators:
- Coordinates: 9/08/2015, 09:30 - 17:00, Exhibit Hall (Hall B+C)
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P2.07-016 - Prognostic Impact of Bone Metastases in Small Cell Lung Carcinoma (ID 110)
09:30 - 09:30 | Author(s): K. Syrigos
- Abstract
Background:
Metastatic bone disease is associated with increased morbidity as it may cause disabling pain and lead to other skeletal-related events (SREs), such as pathologic fractures, spinal cord compression or hypercalcemia of malignancy, with significant consequences on quality of life and overall functioning of patients, potentially affecting survival as well. The aim of the present study was to further explore the potential impact of bone metastases (BMs) and their therapeutic management on the overall prognosis of patients with small cell lung carcinoma (SCLC).
Methods:
A retrospective analysis of medical records of 363 patients with SCLC was performed. Clinicopathological features and survival data were correlated with the presence of BMs, their time point of development (early versus late onset) and their treatment modality (radiotherapy, bisphosphonates or both), in the entire study population and in the subgroups of patients with limited or extensive-stage disease (LD or ED-SCLC, respectively) at diagnosis.
Results:
Overall, 35.8% of our patients were diagnosed with BMs, either at diagnosis (early onset BMs, 26.7%) or at a subsequent time point (late onset BMs, 9.1%). Patients with early onset BMs had a worse survival time compared to those with late-onset BMs or those without BMs (log rank test, p=0.020; figure 1). No statistically significant associations were observed between OS and the presence of BMs in the ED and LD subgroups of patients (p=0.926 and p=0.144, respectively). Treatment modality of BMs had no impact on OS either (p>0.05). Multiple Cox regression analysis showed that increased age, poor performance status, presence of BMs and early onset BMs were independently associated with reduced OS. Figure 1
Conclusion:
The presence of early-onset BMs may represent an independent prognostic factor in patients with SCLC. In contrast, the type of modality employed for treatment of BMs had no statistically significant impact on survival in our study population.
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P2.08 - Poster Session/ Thymoma, Mesothelioma and Other Thoracic Malignancies (ID 225)
- Event: WCLC 2015
- Type: Poster
- Track: Thymoma, Mesothelioma and Other Thoracic Malignancies
- Presentations: 1
- Moderators:
- Coordinates: 9/08/2015, 09:30 - 17:00, Exhibit Hall (Hall B+C)
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P2.08-031 - Usefullness of Positron Emission Tomography in Thymic Lesions' Surgery (ID 2368)
09:30 - 09:30 | Author(s): K. Syrigos
- Abstract
Background:
To evaluate the utilization of positron emission tomography (PET) scan with fluorine-18 fluorodeoxyglucose (FDG) in the selection of the surgical approach for thymic lesions.
Methods:
Twenty-two consecutive patients with thymic pathology, underwent PET-FDG after being evaluated by computed tomography (CT), since 2011. The Standard Uptake Value (SUV) max of the lesion, as well as the SUV of the mediastinum, were estimated. The ratio SUVmax Lesion/Mediastinum was the caliber for selecting thoracoscopic thymectomy (TT) or thymectomy via median sternotomy (TMS), as the therapeutic procedure. If the ratio SUVmax L/M < 1, thoracocscopic thymectomy was preferable. If the ratio was, 1 < SUVmax L/M < 2, the selection was depended on the lesion’s dimensions (TT was preferred for lesions < 4 cm). If the ratio was SUVmax L/M > 2, a median sternotomy was the approach of choice.
Results:
There were 14 male and 8 female patients, with a mean age of 41.1 y.o. In 13 patients the ratio SUVmax L/M showed up > 1, while in 4 patients was higher than 2. The histopathology revealed 7 thymomas, 2 thymolipomas, 8 true thymic hyperplasias, 1 non seminomatous tumour, 1 silicone indused lemphadenopathy while 1 patient is waiting for TT and another one (type C thymoma by fine needle biopsy), for TMS. The mean SUVmax for thymomas was 3.02+-1.67, for thymolipomas was 1.48+-0.26, for true thymic hyperplasias was 1.82+-0.42, while the non seminomatous’ tumour SUVmax was 12.4. There have been performed 7 TTs, 1 Transcervical approach and 13 TMSs. R0 resection was achieved in all 21 patients, have undergone operation, so far. All patients had an uneventful postoperative course and the mean duration of hospital stay was 4 days for TTs and 7 days for TMSs.
Conclusion:
There is no imaging modality sufficient by itself to identify the nature of thymic lesions. The intensity of FDG uptake is useful for predicting the grade of malignancy, and high FDG uptake may reflect the invasiveness of the malignant nature in thymic epithelial tumors. The creation of a scale of “metabolic biopsy” with the use of the ratio SUVmax L/M, will allow the use of TT to a larger patient population, following of course, the surgical oncology guidelines for the removal of thymic lesions.
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P3.04 - Poster Session/ Biology, Pathology, and Molecular Testing (ID 235)
- Event: WCLC 2015
- Type: Poster
- Track: Biology, Pathology, and Molecular Testing
- Presentations: 1
- Moderators:
- Coordinates: 9/09/2015, 09:30 - 17:00, Exhibit Hall (Hall B+C)
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P3.04-123 - Serum and Pleural Fluid VEGF Levels in Advanced NSCLC (ID 89)
09:30 - 09:30 | Author(s): K. Syrigos
- Abstract
Background:
Although most previous studies have suggested that higher pretreatment serum vascular endothelial factor (VEGF) levels may be associated with reduced survival in patients with non-small cell lung cancer (NSCLC), the independent prognostic value of this biomarker remains largely controversial. The primary aim of this study was to evaluate the prognostic significance of pretreatment serum and pleural fluid VEGF levels in NSCLC patients presenting with malignant pleural effusion (MPE).
Methods:
Forty consecutive newly diagnosed NSCLC patients with MPE at presentation but without distant metastases were prospectively enrolled. Serum and pleural fluid VEGF levels were assayed by enzyme-linked immunoassay (ELISA). ROC curve analysis was used to determine the optimal cut-off value for serum VEGF to discriminate between patients and healthy subjects. Serum and pleural fluid VEGF levels were correlated with standard clinicopathological parameters, including gender, age, smoking history, performance status (PS), histological type of tumor and treatment response. The prognostic value of each variable for overall survival (OS) and progression-free survival (PFS) was assessed by Cox regression analysis.
Results:
The median serum VEGF levels were significantly higher in patients as compared to healthy controls (p<0.001), while the optimal cut-off of serum VEGF was 375 pg/ml, with a sensitivity and specificity of 76.9% and 98.0%, respectively. Serum VEGF more than 375 pg/ml, pleural fluid VEGF over the median value and the presence of progressive disease, were all significantly associated with reduced OS and PFS, both in univariate and multivariate analysis (Figures 1 and 2). A statistically significant correlation was also observed between serum and pleural fluid VEGF levels (p<0.001). Figure 1Figure 2
Conclusion:
Our results suggest that increased pretreatment serum and pleural fluid levels of VEGF may be independent predictors of a worse survival in advanced-stage NSCLC patients. Furthermore, pretreatment serum VEGF levels may be useful in discriminating between NSCLC patients and healthy subjects.
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P3.08 - Poster Session/ Thymoma, Mesothelioma and Other Thoracic Malignancies (ID 226)
- Event: WCLC 2015
- Type: Poster
- Track: Thymoma, Mesothelioma and Other Thoracic Malignancies
- Presentations: 1
- Moderators:
- Coordinates: 9/09/2015, 09:30 - 17:00, Exhibit Hall (Hall B+C)
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P3.08-027 - Teratoid Wilms' Tumor of the Mediastinum in an Adult (ID 111)
09:30 - 09:30 | Author(s): K. Syrigos
- Abstract
Background:
Teratoid Wilms’ tumor is an uncommon histologic variant of nephroblastoma, which is mainly characterized by a predominance of heterologous components within the tumor mass, and typically located in the kidney. Extrarenal forms of this neoplasm are extremely rare and have been previously described almost exclusively in pediatric patients.
Methods:
We herein describe the clinical, imaging, histological and immunohistochemical features of a mediastinal teratoid Wilms’ tumor in a 63-year old female. Diagnosis was established following surgical resection and histopathological evaluation of the tumor specimen, along with documentation of complete absence of a primary renal lesion.
Results:
Microscopic examination of representative tumor sections showed the typical WT architecture consisting of blastemal, mesenchymal and epithelial components (fig.1). More than 50% of the tumor’s volume was occupied by a variety of heterologous elements. Immunohistochemistry showed positive staining of the epithelial tumor cells for pankeratin (fig.2a), while the blastematous component stained positive for CD56 (fig.2b), CD99 (fig.2c) and WT1 (fig.2d). The patient received one preoperative course of carboplatin etoposide, as well as eight and four postoperative courses of carboplatin-etoposide and cyclophosphamide-doxorubicin, respectively. Disease progression was noted 15 months following administration of the first chemotherapy cycle, and the patient died 23 months after her initial presentation. Figure 1 Figure 2
Conclusion:
Identification of the typical triphasic WT histology along with a predominant heterologous differentiation –but without evidence of unequivocal heterotopic organogenesis- as well as documentation of complete absence of a primary renal neoplasm, are all required to establish the diagnosis of this extremely rare tumor.
