Virtual Library
Start Your Search
V. Kolek
Moderator of
-
+
OA07 - Lymph Node Metastases and Other Prognostic Factors for Local Spread (ID 376)
- Event: WCLC 2016
- Type: Oral Session
- Track: Surgery
- Presentations: 7
-
+
OA07.01 - Incidence, Local Distribution and Impact of pN2 Skip Metastasis in Patients Undergoing Curative Resection for NSCLC (ID 4177)
14:20 - 14:30 | Author(s): A. Steindl, S. Tahon, M. Nguyen, B. Dome, V. Laszlo, W. Klepetko, M.A. Hoda, T. Klikovits
- Abstract
- Presentation
Background:
Background: The presence of N2 lymph node (LN) involvement has strong impact on therapy and prognosis in non-small cell lung cancer (NSCLC). N2 LN metastasis may occur by skipping N1 LN stations (N2skip-met). We aim to analyze incidence, local distribution and impact of N2skip-mets in a large cohort of patients undergoing curative resection for NSCLC.
Methods:
Methods: A retrospective non-interventional singe-center cohort study was conducted, assessing all patients undergoing curative resection for NSCLC between 2006 and 2013 at our institution by reviewing medical charts. Incidence of N2skip-mets among these patients was the primary endpoint. Subsequent secondary correlation of clinical parameters was performed using uni- and multivariate logistic and cox regression models.
Results:
Results: In total, 1110 patients were enrolled, with the following pathological LN status: 789 (71%) pN0, 211 (19%) pN1, 105 (9.5%) pN2, 5 (0.5%) pN3. Histological subtype was: adenocarcinoma, n=675 (61%); squamous cell carcinoma, n=309 (28%); other, n=126 (11%). Incidence of N2skip was 55% (47/105). N2skip-mets occurred more frequently in right sided tumors (odds ratio (OR) 2.14, p=0.058) and patients with adenocarcinoma (vs. other, OR 1.54, p=0.19). Presence of N2skip-mets did not correlate with tumor size (ROC, area under curve (AUC) 0.44, p=0.32). Strikingly, presence of N2skip-mets was significantly increased in smokers (OR 3.5, 95% CI 1.38-8.83, p=0.006). Moreover, patients with N2skip-mets were more likely to develop subsequent brain mets (OR 4.13, p=0.06). Overall- and recurrence free survival will be presented at the conference.
Conclusion:
Conclusion: N2skip-mets occur in a high number of patients with N2 disease, with distinct differences in clinicopathologic features. Considering the results of this study, subclassification of N2 disease as recently proposed by the IASLC may have clinical impact in patients with resectable NSCLC.
Only Members that have purchased this event or have registered via an access code will be able to view this content. To view this presentation, please login, select "Add to Cart" and proceed to checkout. If you would like to become a member of IASLC, please click here.
-
+
- Abstract
- Presentation
Background:
Clinical practice involving segmental nodes (No.13) and subsegmental nodes (No.14) retrieval for pathological examination varies during lung cancer surgery. This study aims to evaluate whether omitting No.13 and No.14 node retrieval could lead to an inferior oncological outcome for pN0 non-small cell lung cancer（NSCLC）patients.
Methods:
This retrospective study analyzed 442 cases of NSCLC, both treating with R0 resection and systematic mediastinal lymphadenectomy and confirming as pN0 on postoperative pathology. Study group defined cases whose N1 nodes investigation involving from No.10 to No.14 in pathological report. In Control group, N1 nodes investigation only include No.10 to No.12. Clinical and pathological parameters of above two groups were balanced by propensity score matching based on surgical quality and the oncological outcomes between two groups were assessed by log-rank test.
Results:
Seven cases were lost during follow up and 435 cases entered final analysis (Study group, n=170 vs. Control group, n=265). A total of 5.0±3.0 nodes per case were collected from No. 13 and No. 14 in Study group, which included 3.1±1.9 nodes of No. 13 and 2.0±2.2 of No. 14. Tumor-located segments harbored 2.8±2.2 lymph nodes, compared to 2.2±2.3 from non-tumor located segments (p=0.006). After propensity score matching, 143 cases remained in each group. Overall survival (OS) and disease-free survival (DFS) were improved in Study group compared with Control group (the 5-year OS rates, 89±3% vs. 77±4%, p=0.027; the 5-year DFS rates, 81±4% vs. 67±4%, p=0.021, Figure1A,1B). In multivariate analysis, T staging and performing intrapulmonary nodes collection were the prognostic factors for pN0 cases. For the whole cohort, patients with two intrapulmonary stations collected showed better survival than those with zero intrapulmonary station retrieved（Figure1C, 1D）.
Conclusion:
Inferior oncological outcomes of pN0 cases without intrapulmonary node retrieval suggests this procedure may play a role in outcome evaluation for pN0 NSCLC patients.
Only Members that have purchased this event or have registered via an access code will be able to view this content. To view this presentation, please login, select "Add to Cart" and proceed to checkout. If you would like to become a member of IASLC, please click here.
-
+
OA07.03 - Prognostic Significance of Micrometastases in Mediastinal Lymph Nodes of Patients With Radically Resected Non-Small Cell Lung Cancer (ID 5060)
14:40 - 14:50 | Author(s): P. Gwóźdź, M. Pasieka-Lis, K. Kołodziej, J. Pankowski, M. Zieliński
- Abstract
- Presentation
Background:
Recurrence occurs in 30-50 % of patients operated for early stage non-small cell lung cancer (NSCLC), what suggests the existence of occult metastases at the time of surgery. Preoperative detection of occult micrometastases in mediastinal lymph nodes could contribute to better selection of patients apropriate for surgery. This retrospective study was undertaken to determine the prognostic significance of preoperatively detected mediastinal lymph node (LN) micrometastases in patients treated with radical surgical resection for stage I and II NSCLC.
Methods:
From January 2007 to December 2010, 82 patients with stage I and 67 patients with stage II NSCLC underwent transcervical extended mediastinal lymphadenectomy (TEMLA) and subsequent radical pulmonary resection. A total of 4841 mediastinal lymph nodes resected during TEMLA procedure and determined as metastases-free by hematoxylin and eosin staining were labelled to detect occult micrometastases (dual immunohistochemical staining with AE1/AE3 and BerEP4 antibodies).
Results:
Micrometastases were detected in mediastinal LN of 16 patients (9,7%). 11 patients had only one LN station affected (68,8%). Subcarinal LN were most frequently affected station (11 patients, 68,8%). There was significant correlation between the presence of micrometastases and tumor size. 5-year total survival was significantly better for stage I (64,1%, p=0.0001) and stage II (44,4%, p<0.05) patients without micrometastases comparing to those with micrometastases (18,8%). By multivariate analysis, only the presence of micrometastases was demonstrated to be a significant prognostic factor for 5-year total survival.
Conclusion:
Presence of micrometastases in mediastinal LN of patients with radically resected stage I and II NSCL is associated with significantly reduced 5-year total survival. Preoprative detection of micrometastases with immunohistochemical staining of mediastinal LN resected during TEMLA procedure improves staging and may contribute to better patient selection for curative surgery.
Only Members that have purchased this event or have registered via an access code will be able to view this content. To view this presentation, please login, select "Add to Cart" and proceed to checkout. If you would like to become a member of IASLC, please click here.
-
+
OA07.04 - Discussant for OA07.01, OA07.02, OA07.03 (ID 7075)
14:50 - 15:05 | Author(s): Y.-. Wu
- Abstract
- Presentation
Abstract not provided
Only Members that have purchased this event or have registered via an access code will be able to view this content. To view this presentation, please login, select "Add to Cart" and proceed to checkout. If you would like to become a member of IASLC, please click here.
-
+
OA07.05 - Prognostic Impact of Pleural Lavage Cytology (PLC): Significance of PLC after Lung Resection (ID 5801)
15:05 - 15:15 | Author(s): S. Katsumata, J. Yoshida, G. Ishii, K. Sekihara, T. Miyoshi, K. Aokage, T. Hishida, M. Tsuboi
- Abstract
- Presentation
Background:
We previously reported the prognostic significance of pleural lavage cytology (PLC) in patients undergoing surgery for non-small-cell lung cancer (NSCLC). Based on a larger cohort of more than 3500 NSCLC patients, which is the largest ever reported from a single institution in the literature, we evaluated the prognostic impact of PLC on survival and recurrence.
Methods:
From January 1993 to July 2015, 3671 patients underwent R0 surgical resection for NSCLC at our institution and PLC results before (pre-) and after (post-) lung resection were both available. The cytological evaluation was classified into 3 categories: negative (-), suggestive (±), positive (+). We excluded 77 patients whose PLC results were suggestive, and 3594 patients were analyzed. The impact of PLC results on survival and recurrence was evaluated with conventional clinicopathological factors.
Results:
The overall survival (OS) of pre-PLC (+) patients was significantly inferior to that of pre-PLC (-) patients. However, the 5-year OS rate of pre-PLC (+) patients was 43%, which was significantly better than that of patients with pleural dissemination (11%). In the following analyses, we divided the patients into 3 groups according to pre/post- PLC results as follows: Pre (-)/ post (-), Group A (n=3461); pre (+)/ post (-), Group B (n=43); and post (+), Group C (n=87). Statistically significant difference was not observed between Groups A and B in OS or in recurrence-free survival (RFS) (p=1.00, 0.28, respectively). However, there were significant differences in OS and RFS between Groups B and C (p=0.01 and p=0.02), and between Groups A and C (p<0.01 and p<0.01), respectively. In univariate and multivariate analyses of clinicopathological factors including post-PLC results to identify prognosticators for OS, post-PLC(+) (hazard ratio (HR) =2.20, p<0.01), older age (≥65 years; HR=1.95, p<0.01), smoking history (+) (HR=1.48, p<0.01), elevated serum CEA level (>5.0 mg/dL; HR=1.28, p<0.01), pathological(p)T≥2 (HR=1.28, p<0.01), pN≥1 (HR=1.48, p<0.01), pStage≥II (HR=1.51, p<0.01), pl(+) (HR=1.43, p<0.01), ly(+) (HR=1.32, p<0.01), and v(+) (HR=1.53, p<0.01) were found to be significant independent unfavorable prognosticators.
Conclusion:
The prognostic impact of pre-PLC was moderate and not prohibiting lung resection. Post-PLC was shown to be a strong independent prognostic factor. Its impact on survival of NSCLC patients was very strong, and therefore should be incorporated in the future TNM classification.
Only Members that have purchased this event or have registered via an access code will be able to view this content. To view this presentation, please login, select "Add to Cart" and proceed to checkout. If you would like to become a member of IASLC, please click here.
-
+
OA07.06 - In Early-Stage Lung Adenocarcinomas, Survival by Tumor Size (T) is Further Stratified by Tumor Spread through Air Spaces (ID 5905)
15:15 - 15:25 | Author(s): T. Eguchi, K. Kameda, S. Lu, M. Bott, K.S. Tan, D. Jones, W.D. Travis, P.S. Adusumilli
- Abstract
- Presentation
Background:
We investigated whether tumor spread through air spaces (STAS) further stratifies survival beyond tumor size, T-descriptor independent of resection type (lobectomy or limited resection) and surgical margin.
Methods:
In patients with pT1a-T2bN0M0 lung adenocarcinomas (LADC, n=1399), tumor size, distance of STAS from the tumor, type of resection, surgical margin were evaluated. The patients with small (≤2cm) tumors were divided into STAS(-) (n=561) and STAS(+) (n=307) and their cumulative incidence of recurrence (CIR), and lung cancer-specific death (CID) were compared with patients with larger tumors (2-3cm, n=299) by use of competing risk analysis.
Results:
Of 1399 tumors, 521 (37%) were STAS(+). Compared to STAS(-), recurrence rates were higher with STAS(+) tumors even when the margin is ≥tumor size (Figure 1). In patients with ≤2cm STAS(+) tumors, CIR and CID are higher than in patients with larger (2-3cm) tumors (Figure 2). The poor prognostic influence of STAS(+) was evident even when analyzed by the procedure or recurrence pattern (Figure 2 table).
Conclusion:
STAS further stratifies survival beyond tumor size, T-descriptor in early-stage (pT1a-2b) lung adenocarcinoma based on the higher prognostic potential for recurrence and lung cancer-specific death independent of the type of resection or margin. Figure 1 Figure 2
Only Members that have purchased this event or have registered via an access code will be able to view this content. To view this presentation, please login, select "Add to Cart" and proceed to checkout. If you would like to become a member of IASLC, please click here.
-
+
OA07.07 - Discussant for OA07.05, OA07.06, OA07.07 (ID 7074)
15:25 - 15:40 | Author(s): M. Krasnik
- Abstract
- Presentation
Abstract not provided
Only Members that have purchased this event or have registered via an access code will be able to view this content. To view this presentation, please login, select "Add to Cart" and proceed to checkout. If you would like to become a member of IASLC, please click here.
Author of
-
+
MA05 - Innovative Techniques in Pulmonology and the Impact on Lung Cancer (ID 378)
- Event: WCLC 2016
- Type: Mini Oral Session
- Track: Pulmonology
- Presentations: 1
- Moderators:J. Eckmayr, P.R. Mohapatra
- Coordinates: 12/05/2016, 16:00 - 17:30, Strauss 1
-
+
MA05.04 - Discussant for MA05.01, MA05.02, MA05.03 (ID 7109)
16:18 - 16:30 | Author(s): V. Kolek
- Abstract
- Presentation
Abstract not provided
Only Members that have purchased this event or have registered via an access code will be able to view this content. To view this presentation, please login, select "Add to Cart" and proceed to checkout. If you would like to become a member of IASLC, please click here.
-
+
P1.04 - Poster Session with Presenters Present (ID 456)
- Event: WCLC 2016
- Type: Poster Presenters Present
- Track: Pulmonology
- Presentations: 1
- Moderators:
- Coordinates: 12/05/2016, 14:30 - 15:45, Hall B (Poster Area)
-
+
P1.04-007 - Y Stents in Malignant Tumours - Long Time Follow up and Survival (ID 4071)
14:30 - 14:30 | Author(s): V. Kolek
- Abstract
Background:
Stent insertion is one of the standard methods of therapeutic bronchology. Stents can be applied to trachea or bronchi. Y stents are inserted to the tracheobronchial area around tracheal bifurcation. The most frequent indications are the central malignant tumours, less frequently benign stenosis, phistulla or tracheomalatia. The prognosis of central stenosing tumours is usually unfavourable with no specific data available.
Methods:
464 stents were inserted in our institution, out of them 120 were of Y type. The results of Y stent insertion in malignant tumours during the period 2001- 2015 were evaluated. Survival of patients was compared according to sex, age, tumour origin, histology and stage.
Results:
80 Y stents were inserted in 50 men and 30 women, mean age in the time of diagnosis was 61.6 year, in the time of stent insertion 62.8 year. There were 53 bronchial cancers, 6 tracheal cancers, 12 oesophageal cancers, 3 laryngeal cancer, 2 thyroid cancers, and 1 breast cancer, 2 lymphomas, and 1 thymoma. Since diagnosis the mean survival (MS) was 26.39 months, median of overall survival (mOS) was 10.89 (95% CI 8.10- 13.67) months. Since stent insertion MS was 18.09 m and mOS was 3.48 (95% CI 2.72-4.23) m. There were no statistically significant differences according to sex, age and type of tumour (p >0.05): tracheal cancer - mOS 6.07 m, lung cancer - mOS 3.64 m, oesophageal cancer - mOS 2.49 m, other tumours - mOS 3.54 m. Among lung cancers squamous cancer was the most frequent type (34 pts, mOS 4.20 m) and had better prognosis than adenocarcinoma (8 pts, mOS 3.64 m), small cell lung cancer (4 pts, mOS 1.18 m) and NOS (3 pts, mOS 1.80 m). Squamous cancer stage IIIB (22 pts, mOS 5.18 m) had better prognosis than stage IV (10 pts, 3.47 m), all differences were not significant.
Conclusion:
Y stent insertion is an effective palliative procedure in malignant stenosis of central airways. Tumours in this localisation have generally bad prognosis. In present study, squamous lung cancer was the most frequent one and had longer survival than other types of cancers. Study was supported by grant AZV 16-32318A
-
+
P1.05 - Poster Session with Presenters Present (ID 457)
- Event: WCLC 2016
- Type: Poster Presenters Present
- Track: Early Stage NSCLC
- Presentations: 1
- Moderators:
- Coordinates: 12/05/2016, 14:30 - 15:45, Hall B (Poster Area)
-
+
P1.05-054 - Adjuvant Chemotherapy Uptake in Patients with NSCLC after Complete Resection: Single Institution/Single Area Experience (ID 3914)
14:30 - 14:30 | Author(s): V. Kolek
- Abstract
Background:
Adjuvant chemotherapy (AC) is recommended in patients (pts) with stages IB (tumour of ≥4 cm in diameter), IIA, IIB, and IIIA of non-small cell lung cancer (NSCLC) after complete resection. According to metaanalyses it prolongs survival of pts in good PS and age less than 75 years. The selection of patients is influenced by the limited profit of AC, possible toxicity and the lack of predictive biomarkers. There are only few retrospective studies describing routine utilization of AC in specified areas. Presented AC uptake in stages II and III varies from 20 % to 24% in Canada and USA. .
Methods:
A retrospective study of AC uptake in pts with NSCLC from a Moravian region with 600.000 inhabitants was conducted, evaluation period was 2006-2013. Treatment strategy of all patients was discussed by surgeons and pneumo-oncologists on the interdisciplinary tumour boards before and after surgery. Uptake and compliance of AC was evaluated according to age, sex, TNM stages, type of surgery and other cofactors. AC was given in regimens using doublets of platinum with vinorelbine (rarely gemcitabine or paclitaxel). Vinorelbine was applied both intravenously (25 mg/m[2]) and orally (60 - 80 mg/m[2]). The choice of cisplatinum (80mg/m[2]) or carboplatinum (AUC 5) was based on patient preference, PS and comorbidities. .
Results:
Out of all 1557 pts with lung cancer, NSCLC was present in 1293 pts. 308 pts underwent curative-intent surgery and complete resection was achieved in 295 pts. 226 pts were pts with stages IB, II and IIIA and AC was applied in 183 pts (80.1%), in 34 (18.6 %) pts together with neoadjuvant chemotherapy. AC was not applied in 43 (19.9 %) pts after radical surgery due to worse PS, comorbidities, complications after surgery or patient´s refusal. The mean age of pts with AC was 65 years, 66,7% were men, 48,9 % women, 49,9 % were current smokers, 40,0% ex-smokers and 10,1 % non-smokers. Age, sex and smoking habits were not statistically different between pts with and without AC. Compliance with AC was very good, 82% of pts accomplished planned therapy.
Conclusion:
The optimal uptake of AC in routine practice depends on the intensive communication between the patient, surgeons and pneumoocologists. The individual decision is important in a context to the patients´ health status, tumour parameters and the potential risk/ benefit of therapy. Study was supported by grant AZV 16-32318A
-
+
P2.03a - Poster Session with Presenters Present (ID 464)
- Event: WCLC 2016
- Type: Poster Presenters Present
- Track: Advanced NSCLC
- Presentations: 1
- Moderators:
- Coordinates: 12/06/2016, 14:30 - 15:45, Hall B (Poster Area)
-
+
P2.03a-026 - Pemetrexed (Alimta) in Maintenance Therapy of 194 Patients with Advanced Non-Small-Cell Lung Cancer (NSCLC) (ID 4206)
14:30 - 14:30 | Author(s): V. Kolek
- Abstract
Background:
The effectiveness and safety of continuation maintenance therapy with pemetrexed versus the watch-and-wait approach was proved by a large randomised phase III trial (Paz-Ares et al., 2013). We focused on continuance maintenance therapy with pemetrexed (Alimta) in routine clinical practice in the Czech Republic.
Methods:
The primary objective of our analysis was to evaluate the overall survival, defined as the length of time from the start of maintenance therapy to the date of death. Data was summarised using the standard descriptive statistics, absolute and relative rates for categorial variables, averages for continuous variables, 95% confidence intervals, as well as median, minimum and maximum values. Kaplan-Meier survival curves were used to display the patient survival. All analyses and graphical outputs were performed in the SAS 9.4 Software.
Results:
The analysed cohort of NSCLC patients treated with pemetrexed maintenance therapy in the Czech Republic as on March 2016 involved 194 patients. The median age was 64,0 years; stage IV was the predominant clinical stage (84,5%), 52.6% of patients were men, and 47,4% women. Adenocarcinoma was in 190 patients. From a total of 194 patients, treatment response was assessed in 173 patients. Among the assessed patients one showed complete regression (CR), 34 of them (19.7%) showed partial regression (PR), stable disease (SD) was the most frequent response, reported in 95 patients (54,9%); progression occurred in 36 patients (20.8%). Adverse events led to the termination of treatment in only 6 (3.5%) patients. The median number of cycles of maintenance therapy in our study was 5.0 (1.0; 24.0), and the median duration of maintenance therapy was 13.0 weeks. In the registration trial, the median number of cycles was 4.0 (1.0; 44.0). Median overall survival (median OS), was 15.4 months (95% CI: (12,7-18.18).
Conclusion:
The continuation maintenance therapy with pemetrexed (Alimta) has been shown to be effective and well tolerated in the Czech population. Treatment had to be terminated only in 6 (3.5%) patients due to adverse events. In the registration trial involving 359 patients (Paz-Ares et al., 2013), the continuation maintenance therapy with pemetrexed led to the median OS of 13.9 months, whereas in the Czech Republic, the median OS has been 15,4 months so far. However, a lower number of patients treated in the Czech Republic must be taken into account, and therefore this result is considered as preliminary.
-
+
P3.02b - Poster Session with Presenters Present (ID 494)
- 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)
-
+
P3.02b-082 - Gefitinib in First-Line Treatment of Caucasian Patients with NSCLC and EGFR Mutations in Exons 19 or 21 (ID 4207)
14:30 - 14:30 | Author(s): V. Kolek
- Abstract
Background:
This study evaluates treatment outcomes in 182 NSCLC of Caucasian patients from Czech Republic according to activated mutations located in exons 19 (Del19) and 21 (L858R).
Methods:
NSCLC patients with EGFR activated mutations were treated with gefitinib in first line between 02/2010 and 3/2016 in 10 institutions. Retrospective analyses were carried out to assess the effectiveness and safety of gefitinib treatment according to activated mutations located in exons 19 (Del 19) and 21 (L858R).
Results:
Out of 182 patients, 119 (80 female, 39 male) had EGFR mutations in exon 19, and 63 (43 female, 20 male) in exon 21. Median age was 66 years in group with mutations in exon 19 and 69 years in group with mutations in exon 21. There was no statistically significant difference in gender ( p=0.999) and in age (p=0.093). No statistically significant difference was observed in the representation in smoking (p=0.0999). There was statistically significant difference in adenocarcinoma proportion (p=0.034). In the group with Del 19 were 97.56% patients with adenocarcinoma and in the grpup with L858R 88.9%. Between these two groups, there was no statistically significant difference according to performance status (p=0.999); according clinical stages (p=0.999). There was no statistically significant difference according to disease control (CR+PR+SD) (p=0.524); no statistically significant difference according the response to the treatment (CR + PR) (p=0.864). Statistically significant difference in the overall survival (OS) of patients was not proved on the chosen significance level of α=0.05. P-value of the Log-rank test: p=0.452. In the group of patients with Del19, the median OS was 21,4 months (CI 95%: 18.77- 24.28), in the group with L858R the median OS was 16.3 months (CI 95%: 10.1- 21.8). Median OS in both groups together was 20.2 months (CI 95%: 16.9- 23.5). There was no statistically significant difference (p=0.142) in progression free survival (PFS); in the group of patients with Del 19 it was 11,7 months (CI 95%:10.0-13.5), and in the group with L858R it was 8,8 months (CI 95% 6.9-10.6). Median PFS in both groups together was 10,6 months (CI 95%: 8.9-12.3). SimiIar numbers of adverse effects were observed in either group (33.6% and 33.3%).
Conclusion:
In both groups of patients, the treatment with gefitinib was very safe. PFS and median OS were satisfactory without statistically significant differences between the two groups; however, a better trend was observed in the group of patients with mutations in exon 19.
-
+
P3.06 - Poster Session with Presenters Present (ID 492)
- Event: WCLC 2016
- Type: Poster Presenters Present
- Track: Trial Design/Statistics
- Presentations: 1
- Moderators:
- Coordinates: 12/07/2016, 14:30 - 15:45, Hall B (Poster Area)
-
+
P3.06-001 - Phase I/II Study to Evaluate Safety and Efficacy DCVAC/LuCa with 1st Line Chemotherapy +/- Immune Enhancers vs Chemotherapy, Stage IV NSCLC (ID 4591)
14:30 - 14:30 | Author(s): V. Kolek
- Abstract
Background:
Lung cancer (LuCa) has been the most common cancer in the world for several decades and also the most common cause of death from cancer worldwide. Immunotherapy, for induction of tumor cell specific immune responses destroying tumor cells, has emerged as a promising treatment modality in solid malignant tumors. Studies have shown that chemotherapy can be combined with vaccine without impairing the immune response.
Methods:
SLU01 is a randomized, open, parallel-group, multicenter, international phase I/II study to evaluate the efficacy and safety of DCVAC/LuCa (active cellular immunotherapy based on dendritic cells) added to standard first line chemotherapy with carboplatin and paclitaxel +/- immune enhancers (interferon-α and hydroxychloroquine) vs chemotherapy alone in patients with Stage IV NSCLC. The study was initiated in December 2014 and plans to enroll 105 patients at approximately 12 sites in Czech and Slovak Republics. Eligible patients are required to present with metastatic NSCLC defined by histologically or cytologically confirmation and ECOG score 0-1. All patients will receive Standard of Care (SoC) carboplatin and paclitaxel, and will be randomized 1:1:1 to DCVAC/LuCa or DCVAC/LuCa + immune enhancers (pegylated IFN-α2b and hydroxychloroquine) or SoC only. Patients will be stratified by histology subtype adenomatous or squamous cell carcinoma and smoking history. The primary objective is to compare efficacy of DCVAC/LuCa + chemotherapy +/- immune enhancers vs. chemotherapy alone in patients with stage IV NSCLC, as measured by progression free survival (PFS). Secondary objectives include assessments of safety, objective response rate (ORR), duration of response (DoR) and overall survival (OS). Exploratory objectives include comparison of changes in immune responses and search for prognostic biomarkers. Clinical trial information: EudraCT number 2014-003084-37.
Results:
Section is not applicable
Conclusion:
Section is not applicable
