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M. Zemanová
Moderator of
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MA06 - Locally Advanced NSCLC: Risk Groups, Biological Factors and Treatment Choices (ID 379)
- Event: WCLC 2016
- Type: Mini Oral Session
- Track: Locally Advanced NSCLC
- Presentations: 12
- Moderators:P. Van Houtte, M. Zemanová
- Coordinates: 12/05/2016, 16:00 - 17:30, Strauss 2
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MA06.01 - Overall Survival Characterization of Incidental N2 Non-Small Cell Lung Cancer over 14 Years at a Single Canadian Institution (ID 4751)
16:00 - 16:06 | Author(s): C. Van Der Merwe, A. D'Silva, S. Otsuka, G. Gelfand, A. Graham, S. Grondin, S. McFadden, G. Bebb
- Abstract
- Presentation
Background:
Incidental stage IIIA non-small cell lung cancer (NSCLC) cases have positive N2 mediastinal lymph node involvement discovered at the time of surgery, resulting in stage reclassification. These patients represent a small group within the stage III patient spectrum with limited data regarding their outcome. This study’s aim is to characterize the survival of incidental stage IIIA disease and compare these outcomes to patients diagnosed with stage II and IIIA disease.
Methods:
Using the Glans-Look Lung Cancer database and electronic patient charts, a retrospective review identified patients consulted at the Tom Baker Cancer Center from 1999 to 2012 who were defined as incidental stage III NSCLC. Their outcome was compared with stage II patients who underwent resection and stage IIIA patients treated with concurrent chemotherapy and radiation (CCR). These groups were selected for comparison because they represent patients who received the recommended standard of care for their respective diagnosis. A Kaplan-Meier analysis was conducted to compare overall survival (OS) among the groups.
Results:
Fifty-eight incidental stage III NSCLC patients were identified: median age was 63 years (SE ±10.3), 46.6% male, and 63.8% received adjuvant therapy. There were 225 individuals treated with CCR; median age 64 years (SE ±9.0), 56.0% male. The stage II group contained 248 individuals, the median age was 64 years (SE ±10.2), 53.6% were males, and 30.6% received adjuvant therapy. The OS of the incidental group was 47.4 months (95% CI 20.0-74.7). The OS for patients treated with CCR only was 24.0 months (95% CI 20.8-27.2) and 55.3 months (95% CI 43.7-66.9) for stage II resected cases. There was a significant difference in OS between CCR-treated stage IIIA and incidental cases (p = .001) but not between stage II and incidental (p = .264). The five-year survival rates were 44.6% (SE ±6.5) for incidental IIIA, 21.0% (SE ±2.7) for CCR-treated IIIA, and 46.9% (SE ±3.2) for resected stage II.
Conclusion:
This study demonstrates that incidental stage IIIA-N2 patients are a distinct group whose median OS closely resembled stage II patients. The benefit of resection for stage IIIA patients suggests that the traditional influence of stage in dictating treatment is changing. Further investigation is needed to identify which stage IIIA patients benefit the most. Ongoing analysis will include a comparison of progression-free survival between the three groups, impact assessment of post-operative treatment on OS, and a description of the diagnostic process evolution over time leading to an incidental N2 diagnosis.
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MA06.02 - Does Pathological Staging Following Neoadjuvant Therapy (ypTNM) Reflect the Reality? (ID 3859)
16:06 - 16:12 | Author(s): H. Melek, H.V. Kara, A. Demir, M.M. Erol, A.S. Bayram, A. Turna, A. Toker, C. Gebitekin
- Abstract
- Presentation
Background:
Complete histopathological response or downstaging has been reported as a good prognostic factor for locally advanced non-small cell lung cancer (NSCLC) patients who received neoadjuvant therapy and underwent surgical resection. However, it is yet to be known if the prognosis of pStage I patients is similar to that of ypStage I cases. In this study we aimed to compare the long-term survival following surgical excision between locally advanced NSCLC that have been downstaged to stage I after neoadjuvant therapy versus stage I NSCLC treated by direct surgery.
Methods:
In this is multi-centered study we retrospectively analyzed the medical data of NSCLC patients undergoing surgery (segmentectomy or more) between January 1998 and December 2014. According to the histopathological results patients with Stage 1 (T1-2aN0) disease (n=427) were included into the study. Patients were divided into two groups Group 1: patients who underwent direct surgical resection without any preoperative therapy (n=291), Group 2: Patients who had locally advanced disease (T3-4N0-1 or T1-3N2) and received neoadjuvant treatment (chemotherapy or chemoradiation) for locally advanced NSCLC (n=136). The survival rates and effecting factors were analyzed.
Results:
All but 64 patients were male with a mean age of 60y (20-87y). According to tumor type; 192(45%) patients had squamous cell carcinoma, 158(37%) adenocarcinoma and 77 (18%) patients NSCLC. Neoadjuvant treatment consisted of chemotherapy in 89 (65,4%) and chemoradiation in 47(34,5%) patients. Histopathological investigation of the resected specimen revealed stage Ib (T2aN0) in 205 patients (group 1; n=140, group 2;n= 65, p=0,95). Overall morbidity rate for all patients was 30,9% (132/427) with 1.8% mortality. Five year survival rate in all patiens was 71% (77% in group I and 57% in group 2). The difference was statistically different between the groups, p<0,001.
Conclusion:
This study showed that survival of patients after surgical excision was different in ypStage 1 compared to pStage 1. Histopathological staging does not reflect to the survival figures. Our impression is that IASLC recommendations for staging of NSCLC should be subdivided or revised according to ypTNM staging following neoadjuvant treatment.
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MA06.03 - Recurrence Dynamics after Trimodality Therapy (Neoadjuvant Chemoradiotherapy and Surgery) in Stage IIIa(N2) Lung Cancer (ID 4963)
16:12 - 16:18 | Author(s): J.H. Lee, H.K. Kim, B.J. Park, Y.S. Choi, J.H. Cho, J.I. Zo, Y.M. Shim, S. Shin, H.R. Pyo, Y.C. Ahn, J.S. Ahn, M. Ahn, K. Park, J. Kim
- Abstract
- Presentation
Background:
In IIIa(N2) Non-small cell lung cancer (NSCLC), various strategies to cure have been tried but the major cause of mortality is still the recurrence. Therefore, understanding of the dynamics of recurrence is important to improve the treatment outcome. We investigated the timing and patterns of recurrence after treatment of IIIA(N2) NSCLC with trimodality treatment (neoadjuvant chemoradiotherapy and surgery).
Methods:
An institutional database of consecutive patients between 1997 and 2013 (N = 574) was reviewed retrospectively. Eligible patients had pathologically proven N2 disease of NSCLC and completion of a planned trimodality treatment. First events involving the development of loco-regional recurrence, distant metastases or both were considered. The hazard rate function was used to evaluate the dynamics of recurrence.
Results:
The 5-year overall survival rate was 47% and the 5-year recurrence free survival rate was 29%. Among the 299 patients (52.1% of total) who experienced recurrence, 26 (8.7%) had loco-regional recurrences, 248 (82.9%) had distant metastases, and 25 (8.4%) had both. The most frequent sites of distant metastases were lung (n=102, 41%), brain (n=63, 25%), and bone (n=63, 25%). The hazard rate function for the overall recurrence revealed the peak at approximately 8 months after surgery then the down-slope pattern before 38 months. A similar risk pattern was found in distant metastasis but low and steady risk pattern was detected in loco-regional recurrence. In distant metastases, similar patterns were found in individual organs, however, earlier peak at approximately 5 months presented in brain metastasis. A comparison of histology showed that adenocarcinoma exhibited higher recurrence hazard rate of distant metastasis than squamous cell carcinoma with similar pattern of recurrence (p=0.03). The status of nodal clearance after induction therapy exhibited that ypN2 patients (n= 229, 39.9%) had highest hazard rate (p=0.03). The recurrence hazard rate of ypN0 was the least, but the extent was not smaller, they showed approximately one of third of ypN2 at peak.
Conclusion:
The hazard rate of loco-regional failure after trimodality therapy was low. But the hazard rate of distant metastasis was considerably high yet and shifted to left with the peak within 12 moths after surgery. This study guides the intensive surveillance immediate after completion of trimodality therapy to identify risk groups of early recurrence and to develop therapeutic strategy.
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MA06.04 - Discussant for MA06.01, MA06.02, MA06.03 (ID 7076)
16:18 - 16:30 | Author(s): F. Yang
- Abstract
- Presentation
Abstract not provided
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MA06.05 - Screening for Brain Metastases in Patients with Stage III NSCLC, MRI or CT? A Prospective Study (ID 5664)
16:30 - 16:36 | Author(s): J.J.A.O. Schoenmaekers, L. Hendriks, P. Hofman, G. Bootsma, M. Westenend, M. De Booij, W. Schreurs, R. Houben, D. De Ruysscher, A. Dingemans
- Abstract
- Presentation
Background:
In all current non-small cell lung cancer (NSCLC) guidelines it is advised to screen all stage III patients for brain metastases, preferably by magnetic resonance imaging (MRI), or otherwise a contrast-enhanced computed tomography (CE-CT). Access to MRI can be problematic and a dedicated brain CE-CT can be incorporated in the staging [18]Fluodeoxoglucose-positron-emission-tomography ([18]FDG-PET)-CT scan. The additive value of a brain MRI after a dedicated brain CE-CT scan is unknown.
Methods:
In this observational prospective multicentre study all consecutive stage III NSCLC patients scheduled for treatment with curative intent from three Dutch hospitals who underwent a dedicated brain CE-CT incorporated in the staging [18]FDG-PET and an additional brain MRI were included. Patients with another primary tumour within 2 years of NSCLC diagnosis were excluded. Data regarding patient characteristics and imaging results were collected. Primary endpoint was the percentage of patients diagnosed with brain metastases on MRI without suspect lesions on CE-CT. 118 patients were needed to show a clinically relevant considered difference of 2%.
Results:
Between December 14[th] 2012 and July 15[th] 2016, 264 consecutive patients had an extracranial stage III NSCLC based on [18]FDG-PET. 111 out of these 264 patients (42.0%) were excluded because of no dedicated brain CE-CT 57 (51.4%) had only a low dose CT for attenuation correction, 54 (48.6%) had a CE-CT but without dedicated brain imaging protocol). Fourty (26.1%) of the remaining 153 patients were excluded because of asymptomatic brain metastases on dedicated CE-CT brain (N=8), second primary (N=6) or no brain MRI (N=26). 113 stage III patients were included (updated results of 118 patients will be presented). 57.5% of the included patients were male; mean age was 67.0 years, 84.1% had WHO PS 0-1, 60.2% had stage IIIA (before MRI brain) and 42.5% had an adenocarcinoma. Median time (range) between [18]FDG-PET-CE-CT and MRI was 2.0 (0.0 -8.1) weeks. 5/113 (4.4%) patients had a solitary brain metastasis on MRI despite no suspect brain lesions on CE-CT. In retrospect, in one of these five patients a solitary brain metastasis could be identified on the [18]FDG-PET–CE-CT.
Conclusion:
Although asymptomatic brain metastasis were detected in staging CE-CT, MRI brain is in daily practice clinically relevant superior to a CE-CT in screening for brain metastases in stage III NSCLC
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- Abstract
- Presentation
Background:
Tumor-infiltrating lymphocytes (TILs) and tumor budding were all the markers of tumor microenvironment. This study aimed to explore the potential association of tumor microenvironment with brain metastases (BM) in patients with completely resected stage IIIA(N2) NSCLC.
Methods:
301 consecutive patients with pathological stage IIIA(N2) NSCLC who underwent complete surgery were reviewed between January 2005 and July 2012. Full-face hematoxylin and eosin-stained sections from surgical specimens for each case were evaluated for the density of TILs. Patients were stratified into TIL- and TIL+ groups based on pathologic evaluation. Tumor budding was defined as single cancer cells and clusters composed of up to four cancer cells. According to the number of tumor budding per field, the cases were classified into two groups: grade 1, up to five budding foci; and grade 2, six or more budding foci. The relationship between tumor microenvironment and BM at the initial presentation was analyzed.
Results:
Brain was the most common site of distant failure, and 92.5% BM developed in 3 years after the complete resection. 53 (17.6%) patients had BM as the first failure. Although, univariate analysis showed that TIL was not significantly associated with an increased risk of developing BM as the first site of failure in 3 years (P=0.196), a higher density of TILs was associated with improved postoperative survival time (P=0.058). Patients with the tumor budding >5 experienced increased BM in 3 years versus patients with the tumor budding ≤5 (P=0.068). Multivariate analysis showed that adenocarcinomas and multiple N2 stations were significantly associated with the high risk of BM as the initial site of failure in 3 years. Figure 1
Conclusion:
In patients with completely resected stage IIIA(N2) NSCLC, tumor budding >5 had a tendency to experience more BM. TIL seems to be a potential role in predicting survival of patients in completely resected stage IIIA(N2) NSCLC.
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MA06.07 - Impact of Type 2 Diabetes Mellitus and Its Metabolic Control on Prognosis of Unresectable Non-Small Cell Lung Cancer Patients (ID 4314)
16:42 - 16:48 | Author(s): M.A. Bergamino Sirvén, A. Rullan, M. Saigi, I. Peiró, E. Montanya, R. Palmero, J.C. Ruffinelli, A. Navarro-Martin, M. Domenech Viñolas, A. Ortega Franco, S. Padrones, S. Aso, I. Brao, E. Nadal, F. Cardenal
- Abstract
- Presentation
Background:
Type 2 Diabetes Mellitus (T2DM) has been associated with an increased risk of relapse and mortality in several cancer locations, but the prognostic value of T2DM or its metabolic control (MC) in patients (pts) with stage III non-small cell lung cancer (NSCLC) have not been studied yet. The purpose of this study is to evaluate the influence of T2DM and its MC on the prognosis of pts with NSCLC treated with concurrent chemoradiotherapy (cCT-RT).
Methods:
170 pts with NSCLC stage III treated with cCT-RT at the Catalan Institute of Oncology from 2010-2014 were retrospectively reviewed. The overall survival (OS) and progression free survival (PFS) were calculated using Kaplan-Meier method and multivariate Cox model was adjusted by: age, histology, stage, ECOG PS and smoking history.
Results:
Patient characteristics: median age 64y (37-87), male 87%; ECOG≤1 92%; smoking history: current 49%, former 46%, never 5%; histology: adenocarcinoma 34%, squamous 43%, NOS 23%. Platinum doublet CT: Cisplatin 64%, Carboplatin 36%. RT between 60-70 Gys: 94%. At a median follow-up of 38 months (m), 108 patients relapsed (63%), mPFS; 13m (95% CI 10-16) and mOS: 28m (95% CI 22-34). 54 pts (32%) had been diagnosed with T2DM before NSCLC diagnosis. In the overall population mean baseline glycemia was 6.75 mmol/L (3-17). OS and PFS were significantly shorter in patients with T2DM (mOS 17m vs 31m, p=0,005; mPFS 10m vs 16m; p =0,003). T2DM pts were classified into 3 groups of MC based on glycated hemoglobin (HbAc1) before treatment: good MC (HbAc1 <7%), n=26pts; moderate MC (HbAc1 between 7.1-8.5%), n=18pts and poor MC (HbAc1 >8.6%), n=10pts. Poor MC was significantly associated with shorter mOS (11m) as compared with moderate MC (20m) and good MC (28m; p=0.029). T2DM pts treated with insulin had shorter mOS (8m vs 20m; p=0.002) and mPFS (7m vs 12m; p=0.002) than non-insulin treated pts. However there were no differences based on whether pts were taking metformin or not. T2DM was not associated with higher risk of treatment toxicity (pneumonitis or esophagitis). In the multivariate analysis, baseline glycemia and T2DM were both independent prognostic factors for OS (HR 1.2; IC95%1.17-1.3 and HR 1.51; IC95% 1.02 -2.27, respectively).
Conclusion:
Our data suggest that T2DM and poor MC is associated with worse prognosis in pts with stage III NSCLC treated with cCT-RT. Optimal control of T2DM and prevention of hyperglicaemia might benefit those pts, and further studies are warranted.
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MA06.08 - Discussant for MA06.05, MA06.06, MA06.07 (ID 7077)
16:48 - 17:00 | Author(s): T. Klikovits
- Abstract
- Presentation
Abstract not provided
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MA06.09 - Efficacy RENO Study Results of Oral Vinorelbine or Etoposide with Cisplatin & Chemo-Radiation in Stage III NSCLC. SLCG 10/02 (ID 4238)
17:00 - 17:06 | Author(s): D. Isla, R. De Las Peñas, R. Marsé, A. Insa Molla, N. Martínez-Banaclocha, T. Morán, P. Mut, M.Á. Sala, B. Massuti, A.L. Ortega Granados, J.M. Jurado, M.Á. Artal Cortés, M.F. Vázquez, V. Gutiérrez, P. Diz Taín, J. Gómez-Codina, I. Maestu Maiques, C. Camps, N. Viñolas Segarra, S. Ponce Aix, M. Álvarez De Mon Soto, R. García Gómez, M. Provencio
- Abstract
- Presentation
Background:
This study aims to compare efficacy and safety of two widely used combinations of cisplatin (P) in this setting: as etoposide (E) and vinorelbine. This last, in its oral formulation (oV) which has achieved comparable results as the IV formulation and patients (pts) prefer it.
Methods:
Pts between 18-75years, with histologically proven untreated and unresectable locally-advanced NSCLC (LA-NSCLC), adequate respiratory function, V20≤35% and ECOG-PS 0-1, were randomized 1:1 to oV-P arm: 2 induction cycles (cy) of oV-P followed by 2 cy more with RT; or to E-P arm: 2 cy of E-P concomitants to RT. Both arms with a total radiation dose of 66Gy administered 2 Gys daily. Primary endpoint was progression free survival (PFS) by RECIST 1.1. Secondary endpoints: overall response rate (ORR), overall survival (OS) and safety. With α-error of 0.05 (one-tailed test) and 0.1 β-error, median PFS unacceptable for the oV-P arm of 10 months (m) (p0) and a very acceptable of 15 m (p1), 122 eligible pts were required.
Results:
140 pts from 23 institutions of SLCG were randomized between 08/2011-12/2014. 134 pts were treated (66 in oV-P and 68 in E-P arms). Results based on this 134 pts are presented. Median age 62 years [39-76]; PS 0/1, 45%/55%; current smoker 51%; squamous cell 51%; stage IIIB 54%. 244 and 131 cy were given in the oV-P and E-P arms, respectively. All irradiated pts in oV-P arm received at least 60Gy, 7 pts in the E-P arm received less than 60Gy (4 due to toxicity). 1 pt (1.5%) in oV-P arm and 12 pts (17.6%) in E-P arm presented esophagitis G3/4 (p=0.002). 121 confirmed eligibility for efficacy analysis. ORR were 39 (64%) and 40 pts (67%) in the oV-P and E-P arms, respectively (p=0.889). After 16 m [1-43] of follow-up, 66% pts progressed and 43% pts died. Median PFS is 11.4 m (IC95%; 6-17) in oV-P arm and 11.8 m (IC95%; 7-16) in E-P arm (p=0.374).
Conclusion:
Both regimens achieve similar efficacy however oV-P has less toxicity, especially esophagitis G3/4. Further follow-up is needed for the survival analysis.
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MA06.10 - A Pooled Analysis Comparing the Outcomes of Elderly to Younger Patients on NCTN Trials of Concurrent CCRT for Stage 3 NSCLC (ID 4219)
17:06 - 17:12 | Author(s): T.E. Stinchcombe, Y. Zhang, E.E. Vokes, J. Schiller, J. Bradley, K. Kelly, W. Curran, S. Schild, B. Movsas, G. Clamon, R. Govindan, G. Blumenschein, M.A. Socinski, N. Ready, W.L. Akerley, H. Cohen, H. Pang, X. Wang
- Abstract
- Presentation
Background:
Concurrent chemoradiotherapy (CCRT) is the standard treatment (TRT) for stage 3 NSCLC. Elderly patients (pts) are common, may have increased toxicity,& poorer results from CCRT
Methods:
Individual patient data (IPD) from NCTN phase 2/3 trials of CCRT for stage 3 NSCLC from 1990-2012 was collected. We compared the overall survival (OS), progression-free survival (PFS), & adverse events (AE’s) for pts age ≥70 years (yrs) (elderly) vs. <70 yrs (younger). Unadjusted & adjusted Hazard Ratios (HRs) for survival time & their confidence intervals (CIs) were estimated by single-predictor & multivariable Cox models. Unadjusted & adjusted Odds Ratio (OR) for AE’s & their CIs were obtained from single-predictor & multivariable logistic regression models
Results:
IPD from 16 trials were analyzed; 2,768 pts were younger & 832 were elderly. Median OS & PFS for elderly & younger pts are in the table. In the unadjusted & multivariable models elderly pts had worse OS (HR=1.23; 95%CI =1.13-1.35, and 1.20; 95%CI=1.10-1.32, respectively). In the unadjusted & multivariable models, elderly & younger pts had a similar PFS (HR=1.02; 95% CI=0.94-1.11 and 1.01, 95% CI=0.92-1.10, respectively). Elderly pts had a higher rate of grade ≥3 AE’s in the unadjusted & multivariable models (OR=1.25; 95% CI=1.00-1.57 and 1.30; 95%CI=1.03-1.62, respectively). A lower percentage of elderly pts compared to younger completed TRT (47% and 57%, respectively; P<0.0001) & higher percentage stopped due to AE’s (20% and 13%; P<0.0001). Grade ≥ 3 AE’s (occurring at a rate ≥ 2.5%) with a higher rate in the elderly: neutropenia, dyspnea, fatigue, anorexia, vomiting, dehydration, hypoxia, hypotension, & pneumonitis (P<0.05).
a: Log-rank test for survival times, chi-square test for AE’s, and Fisher’s exact test for deaths. The P-values from these tests are unadjusted. b: Data available on 2,091 patientsAge ≥ 70yrs Age < 70 yrs P-value[a] Median OS (months) 17.0 20.7 < 0.01 Median PFS (months) 8.7 9.1 0.68 All toxicities grade ≥3 86% 84% 0.04 Hematologic AE’s grade ≥3 65% 61% 0.04 Non-hematologic AE’s ≥3 68% 62% <0.01 Grade 5 AE’s 9.0% 4.4% <0.01 TRT related deaths[b] 3.2% 2.0% 0.12
Conclusion:
Elderly pts in CCRT trials had worse OS, similar PFS, & a higher rate of severe AE's.
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MA06.11 - Phase II Study of Nimotuzumab + Concurrent Chemoradiotherapy (CRT) for Stage III Non-Small Cell Lung Cancer (NSCLC): 5-Year Follow-Up Results (ID 3868)
17:12 - 17:18 | Author(s): K. Hayakawa, Y. Nishimura, H. Harada, T. Soejima, K. Tsujino, T. Kozuka, M. Tanaka, T. Sasaki, N. Yamamoto, K. Nakagawa
- Abstract
- Presentation
Background:
Nimotuzumab, a humanized IgG~1~ monoclonal anti-EGFR antibody, is approved and widely used in patients (pts) with head and neck cancer or malignant glioma in combination with radiotherapy (RT) in several countries. On in-vitro and in-vivo experiments using NSCLC cell lines, nimotuzumab showed a radio-sensitizing effect.
Methods:
This phase II study evaluated the tolerability and efficacy of nimotuzumab in combination with concurrent CRT in pts with unresectable locally advanced NSCLC. All eligible pts received concurrent thoracic RT (60 Gy, 2 Gy/day, 6 weeks from day 1) and 4 cycles of chemotherapy (cisplatin 80 mg/m[2] on day 1, vinorelbine 20 mg/m[2] on days 1 and 8) once every 4 weeks as scheduled. Nimotuzumab (200 mg) was administrated once a week from cycle 1 to 4. The primary endpoint was tolerability in combination with concurrent CRT, which was measured by the percentage of pts who completed 60 Gy of RT within 8 weeks, completed 2 cycles of chemotherapy and received more than 75% of nimotuzumab.
Results:
Of 40 pts enrolled between June 2009 and May 2010, 39 eligible pts received the study treatment. The pts characteristics were as follows: 62 years (median); male/female, 34/5; stage IIIA/B, 21/18; PS0/1, 25/14. Thirty-four pts met the criteria for treatment tolerability, and 38 pts completed 60 Gy of RT within 8 weeks. Infusion reaction, >grade 3 skin rash, >grade 3 radiation pneumonitis, or >grade 4 nonhematological toxicity were not observed. The 3-year and 5-year overall survival rates for the 39 pts were 66.4% and 58.4%, respectively. The median PFS was 16.9 months, and the 5-year PFS rate for pts with squamous cell carcinoma (Sq; n = 16) was 50%, while that for pts with non-squamous cell carcinoma (non-Sq; n = 23) was 13.7%. In terms of the first relapse site, in-field relapse rates were low for both Sq (4/16; 25%) and non-Sq (4/23; 17%). However, the distant relapse rate was significantly higher for non-Sq (15/23; 65%) than that for Sq (4/16; 25%). Cytologic or histologic specimens were examined for the expression of EGFR protein/mutations using the EGFR IHC/FISH methods in 20 pts. EGFR 2+/3+ expression was shown more frequently in sq (8/10) than non-sq (4/10). EGFR mutation was observed in only 2 pts with non-sq.
Conclusion:
Addition of nimotuzumab to the concurrent CRT in this setting was well tolerated with clinical benefit to the patients. The low in field relapse rates may be attributed to the radio-sensitizing effect of nimotuzumab.
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MA06.12 - Discussant for MA06.09, MA06.10, MA06.11 (ID 6976)
17:18 - 17:30 | Author(s): P. Bonomi
- Abstract
- Presentation
Abstract not provided
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Author of
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P2.02 - Poster Session with Presenters Present (ID 462)
- Event: WCLC 2016
- Type: Poster Presenters Present
- Track: Locally Advanced NSCLC
- Presentations: 1
- Moderators:
- Coordinates: 12/06/2016, 14:30 - 15:45, Hall B (Poster Area)
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P2.02-011 - Management of Non-Small-Cell Lung Cancer (NSCLC) Stage III Patients in Central European Countries (ID 4608)
14:30 - 14:30 | Author(s): M. Zemanová
- Abstract
Background:
The aim of the study is to determine the actual standard management of patients with stage III NSCLC in Central European centres/countries. The project is a multicentre, prospective, non-interventional registry.
Methods:
After ethical committee approval and signed informed consent, the data about diagnostic and therapeutic procedures of consecutive patients diagnosed with stage III NSCLC (UICC7) were collected in web-based registry organised by the IBA MUNI, Brno, Czech Republic.
Results:
With cut-off 30 June 2016, 509 patients from 7 countries/16 centres were enrolled, median number of patients per centre being 23 (range 6-99). There were 163 (32%) women and 37 (7%) never smokers. Performance status distribution was as follows: ECOG 0, 1, 2 and 3 in 29%, 56%, 12% and 3%, respectively. Squamous cancer was found in 52%, adenocarcinoma in 39%, not otherwise specified in 5% and others in 4% of cases. Genetic mutations were examined in 119 (23%) patients, predominantly EGFR in 111 subjects with 10 (8%) positive findings, while the ALK mutation in 64 patients with no positive finding. Regular staging procedures were X-Ray scan (97%), chest CT (96%) and bronchoscopy (89%). Staging was completed by abdominal CT in 66% of patients, abdominal US in 29%, PET/CT in 22%, bone scan in 17% and brain CT or MRI in 13%, respectively. Stage IIIA was found in 59% and stage IIIB in 41% of patients. N2/N3 nodes were diagnosed in 60%/22% of patients. Pathological mediastinal lymph-node positivity was confirmed in 109 (21%) patients (6% EBUS, 0.2% VATS, 1% mediastinoscopy, 1% transbronchial biopsy and 13% surgery). Median time from diagnosis to first treatment was 23 days (range 0–321). Treatment procedures were: surgery 138 (27%), chest radiotherapy 246 (48%) and chemotherapy 409 (80%) of subjects, respectively. Chemotherapy as only modality was given in 136 (27%) of patients. Surgery was combined with radiation in 6 cases, with chemotherapy in 79 (16%) cases and with both chemotherapy and radiotherapy in 37 (7%) patients. Chemotherapy plus radiotherapy was given in 159 (31%) patients including concurrent chemoradiotherapy in 67 (13%) cases. At the time of cut-off, 64% patients were alive, median survival time was not reached, and the 1-year estimated survival rate was 71%.
Conclusion:
The most prevalent histology was squamous cancer. Histopathological examination of mediastinal lymph-nodes was done in 21% of patients, mostly during surgery. Majority of patients (55%) were treated with combination therapy. Palliative chemotherapy only was given in 27% of patients. Survival data are not mature.
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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)
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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): M. Zemanová
- 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.
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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)
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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): M. Zemanová
- 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.
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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)
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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): M. Zemanová
- 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
