ESMO Supporter 2018

Displaying One Session

ICM - Room 1 Poster Discussion session
Date
21.10.2018
Time
14:45 - 16:00
Location
ICM - Room 1
Chairs
  • Wilfried E. Eberhardt (Essen, DE)
  • Pieter E. Postmus (Leiden, NL)
  • Jean-Louis Pujol (Montpellier, FR)
  • Cécile Le Pechoux (Villejuif, FR)
Poster Discussion session - Non-metastatic NSCLC and other thoracic malignancies Poster Discussion session

Session DOI

Lecture Time
14:45 - 14:45
Location
ICM - Room 1, ICM München, Munich, Germany
Date
21.10.2018
Time
14:45 - 16:00
Poster Discussion session - Non-metastatic NSCLC and other thoracic malignancies Poster Discussion session

1348PD - Genomic landscape and its correlation with TMB, CD8 TILs and PD-L1 expression in Chinese lung squamous cell carcinoma

Presentation Number
1348PD
Lecture Time
14:45 - 14:45
Speakers
  • Caicun Zhou (Shanghai, CN)
Location
ICM - Room 1, ICM München, Munich, Germany
Date
21.10.2018
Time
14:45 - 16:00

Abstract

Background

To comprehensively depict the genomic landscape of Chinese lung squamous cell carcinoma (LSCC) and investigate its correlation with tumor mutation burden (TMB), CD8 tumor infiltrating lymphocytes (TILs) density and PD-L1 expression.

Methods

Whole-exome sequencing were performed on tumor tissue collected from 189 patients with surgically resected LSCC. TMB was defined as total number of nonsynonymous single nucleotide and indel variants. High TMB was defined as greater than 75th percentile. CD8+ TILs and PD-L1 expression were assessed by immunohistochemistry. The cut-off point was 5% for high/low CD8+ TIL or PD-L1 +/- expression.

Results

We found recurrent mutations (>5%) in 8 genes, including TP53, KMT2C, NFE2L2, KEAP1, CDKN2A, PTEN and FBXW7. FGFR1 and PIK3CA amplifications were found in 19% and 11% of samples. 24.9% of patients had high TMB. Baseline clinical variables were similar except for smoking status. Interestingly, FGFR1, PIK3CA or SOX2 amplification was independently associated with higher TMB (P = 0.020, P = 0.017, P = 0.029; respectively). Patients with copy number variations had significantly higher TMB than those without (P = 0.009). Positive PD-L1 and CD8+ TILs expression were identified in 24.3% and 78.8% of all cases. NFE2L2 mutation and PIK3CA amplification were associated with significantly higher PD-L1 expression (P = 0.003, P = 0.014; respectively). TP53 mutations were associated with higher CD8+ TILs expression (P = 0.008), but FGFR1 amplification was correlated with lower CD8+ TILs expression (P = 0.042). Of note, there is no association between TMB and PD-L1 expression (r = 0.052, P = 0.476), or CD8+ TILs expression (r = 0.026, P = 0.718). None of TMB, PD-L1 and CD8+ TIL expression could individually predict overall survival (OS). However, combination of TMB and PD-L1 could stratify total populations into two groups with distinct prognosis. Patients with negative PD-L1 expression and high TMB had the worst prognosis (P = 0.008).

Conclusions

This was the most large-scale study to comprehensively portray genomic landscape of Chinese LSCC and provides several meaningful and referential findings for the future design of clinical trials in LSCC, especially immunotherapy.

Legal entity responsible for the study

Caicun Zhou.

Funding

Has not received any funding.

Editorial Acknowledgement

No.

Disclosure

All authors have declared no conflicts of interest.

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Poster Discussion session - Non-metastatic NSCLC and other thoracic malignancies Poster Discussion session

1349PD - Gene expression signature of DNA damage response to predict the prognosis of early stage lung adenocarcinoma

Presentation Number
1349PD
Lecture Time
14:45 - 14:45
Speakers
  • Zhijie Wang (Beijing, CN)
Location
ICM - Room 1, ICM München, Munich, Germany
Date
21.10.2018
Time
14:45 - 16:00

Abstract

Background

For early-stage lung cancer, a clinically reliable prognostic biomarker is still in unmet needs. DNA damage response (DDR) system is necessary for genomic stability, whose alterations may affect prognosis via modulating immune response. We aimed to develop and validate a DDR expression signature to optimize prognostic stratification in stage I-II lung adenocarcinoma (LUAD).

Methods

A 254-patient training cohort including 4 Gene Expression Omnibus (GEO) data sets was used to develop prognostic algorithm. A 628-patient cohort from another 3 GEO data sets and a 387-patient cohort from The Cancer Genome Atlas (TCGA) data set were defined as validation cohort 1 and 2 respectively. Only resected LUAD of stage I-II with mRNA and survival data were included. Furthermore, we analyzed the associations of DDR genes signature and tumor mutation burden (TMB), copy number variations (CNVs) and tumor infiltrating lymphocytes (TILs).

Results

An 8-gene signature score was developed and stratified patients into high- and low-risk groups, including FNACA, NUDT1, CHEK1, RAD51, RAD51B, RAD54B, FAN1 and MBD4. In validation cohort 1, low-risk group showed longer disease-free survival (DFS, 102 vs 41.4 months, P = 0.008, Hazard ratio (HR) = 1.51(1.11-2.06)) and overall survival (OS, 128.8 vs 105.4 months, P = 0.003, HR = 1.53(1.15-2.02)) compared with high-risk group. For low-risk stage II patients, no significant difference was observed between patients with and without adjuvant therapy. For high-risk stage II patients, adjuvant therapy tended to improve DFS (31.0 vs 20.4months) and OS (95.0 vs 61.4months) compared with observation, but P values were not significant with limited sample size. In validation cohort 2, patients had similar gene expression pattern to that of training cohort and high-risk group showed worse survival outcomes. Analyses of TCGA cohort revealed that high-risk group had remarkably higher TMB and CNVs, and lower TILs (all P < 0.001).

Conclusions

The 8-gene DDR signature is a promising biomarker to optimize prognostic staging and personalize adjuvant therapy of early-stage LUAD. An independent multi-center study is underway to further validate the predictive value and clinical feasibility of this model.

Legal entity responsible for the study

Jie Wang.

Funding

This work was supported by the National Natural Sciences Foundation Key Program (81630071, 81330062), National Key R&D Program of China (2016YFC0902300), National High Technology Research and Development Program 863 (SS2015AA020403), CAMS Innovation Fund for Medical Sciences (CIFMS 2016-I2M-3-008), China National Natural Sciences Foundation (81472206), Beijing Novel Program Grants (Z141107001814051).

Disclosure

All authors have declared no conflicts of interest.

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Poster Discussion session - Non-metastatic NSCLC and other thoracic malignancies Poster Discussion session

1350PD_PR - Social and behavioral indicators of undergoing a screening test for lung cancer

Presentation Number
1350PD_PR
Lecture Time
14:45 - 14:45
Speakers
  • Sebastien Couraud (Pierre Bénite, FR)
Location
ICM - Room 1, ICM München, Munich, Germany
Date
21.10.2018
Time
14:45 - 16:00

Abstract

Background

The French health authorities are not in favor of systematic lung cancer (LC) screening and instead advocate boosting measures aimed at prohibiting smoking and controlling the use of tobacco. In this context, it appeared important to have a clear insight into the characteristics of individuals who have already undergone a screening test for LC.

Methods

The French nationwide observational survey, EDIFICE 6, was conducted online from 26 June-28 to July 2017 on a core sample of 12 046 individuals (age, 18-69 years). Representativeness was ensured by quota sampling on age, gender, profession, and stratification by geographical area and type of urban district. Multivariate stepwise logistic regression analysis was conducted to identify the characteristics of individuals likely to undergo LC screening. The present analysis included 3114 individuals (age, 55-69 years) with no history of cancer.

Results

Fifteen percent of the study population declared having already undergone a screening test for LC. Compared to individuals who had never been screened for LC, these 15% were characterized by a higher proportion of men (64% vs 54%, P<0.05), of retired individuals (59% vs 54%, P<0.05), and of current and former smokers (34% vs 21%, P<0.05, and 47% vs 38%, P<0.05, respectively). Mean age and social vulnerability did not differ significantly between the screened/unscreened populations. In multivariate analysis, items associated with undergoing screening included current smoking (OR=1.92, 95% CI=1.54-2.38), low body mass index (OR=1.92, 95% CI=0.97-3.57), male gender (OR=1.61, 95% CI=1.31-1.99), and higher education (OR=1.29, 95% CI=1.06-1.58). In contrast, belonging to the socioprofessional category of unskilled workers was associated with the likelihood of non-uptake of a LC screening exam (OR=0.38, 95% CI=0.16 – 0.78).

Conclusions

Individuals with a history of smoking or who currently smoke are the most likely to undergo screening for LC. The social criteria most frequently related to either uptake of or resistance to LC screening were higher education and belonging to lower socioprofessional categories, respectively.

Editorial Acknowledgement

edical writing assistance was provided by Isabelle Lawrence, Potentiel d’Action (France)

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Poster Discussion session - Non-metastatic NSCLC and other thoracic malignancies Poster Discussion session

Invited Discussant 1348PD, 1349PD and 1350PD_PR

Lecture Time
14:45 - 15:00
Speakers
  • Wilfried E. Eberhardt (Essen, DE)
Location
ICM - Room 1, ICM München, Munich, Germany
Date
21.10.2018
Time
14:45 - 16:00
Poster Discussion session - Non-metastatic NSCLC and other thoracic malignancies Poster Discussion session

Q&A led by Discussant

Lecture Time
15:00 - 15:10
Location
ICM - Room 1, ICM München, Munich, Germany
Date
21.10.2018
Time
14:45 - 16:00
Poster Discussion session - Non-metastatic NSCLC and other thoracic malignancies Poster Discussion session

1364PD - Cardiac events in stage III non-small cell lung cancer (NSCLC) treated in daily clinical practice: is it time for cardiovascular screening and follow-up?

Presentation Number
1364PD
Lecture Time
15:10 - 15:10
Speakers
  • Juliette Degens (Maastricht, NL)
Location
ICM - Room 1, ICM München, Munich, Germany
Date
21.10.2018
Time
14:45 - 16:00

Abstract

Background

Concurrent chemo-radiotherapy (cCRT) is the preferred treatment for most stage III NSCLC, with 5 year survival of 25-35%. Recent dose-escalated radiotherapy (RT) trials report a high incidence of cardiac events (CTCAE ≥ 3 of 11 – 23%) in NSCLC. However, real world data on the incidence of cardiac events are lacking.

Methods

In this multicenter retrospective cohort study a thorough patient file search was carried out in all consecutive pts treated with (C)RT for stage III NSCLC between 2006 - 2013. The primary endpoint of this study was incidence of new cardiac event (CTCAE ≥ 2) within five years after (C)RT. Secondary we evaluated risk factors for cardiac events.

Results

474 pts with stage III NSCLC were eligible. 391 were treated with cCRT, 69 with sequential CRT, 8 with lobectomy and/or RT and 6 are unknown. 30% of the pts had a cardiac history; mostly consisting of coronary artery disease (13.1%), atrial arrhythmia (7.4%) and chronic heart failure (4.2%). In 5 years of follow-up 151 pts (31.9%) developed a new cardiac events with a median time to event of 8 months (range 0 - 59). The most common cardiac events were arrhythmia (14.6%), heart failure (7.6%) and symptomatic coronary artery disease (6.8%). On multivariate analysis pre-existent cardiac comorbidity (hazard ratio [HR] 1.72; 95% CI 1.07 – 2.78; P = 0.02), WHO-PS ≥ 2 (HR 1.72; 95% CI 1.07 – 2.78; P = 0.03), male gender (HR 1.43; 95% CI 1.01 – 2.02; P = 0.04) and age ≥ 70 (HR 1.42; 95% CI 1.018 – 1.98; P = 0.03) were significantly associated with a cardiac event. Within the subgroup of pts without pre-existent cardiac comorbidity (N = 311), 27.1% developed a cardiac event and only age ≥ 70 was a significant predictor (HR 1.78; 95% CI 1.15 – 2.75; P = 0.01).

Conclusions

Approximately one third of stage III NSCLC pts treated in daily clinical practice develop a new cardiac event within 5 years after (C)RT. Pre-existent cardiac comorbidity, WHO-PS ≥ 2, age ≥ 70 and male gender are absolute risk factors for the development of a cardiac event. Because cardiac events cause a high burden of morbidity and can influence quality of life, screening for cardiac comorbidity and events, especially in the first year after treatment should be considered.

Legal entity responsible for the study

Maastricht University Medical Center (MUMC+).

Funding

Has not received any funding.

Disclosure

A-M.C. Dingemans: Other from Roche/Genentech, MSD Oncology, AstraZeneca, Pfizer, Lilly, other from Boehringer Ingelheim, Bristol-Myers Squibb, Clovis Oncology, outside the submitted work. All other authors have declared no conflicts of interest.

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Poster Discussion session - Non-metastatic NSCLC and other thoracic malignancies Poster Discussion session

1806PD - Multiple primary cancers (MPC) in a series of lung cancer (LC) patient: incidence and outcome

Presentation Number
1806PD
Lecture Time
15:10 - 15:10
Speakers
  • Susana Cedres Perez (Barcelona, ES)
Location
ICM - Room 1, ICM München, Munich, Germany
Date
21.10.2018
Time
14:45 - 16:00

Abstract

Background

The number of cancer survivors has increased as a result of significant progress in prevention, diagnosis and treatment of malignant tumors and the incidence of MPC in surviving cancer patients (p) is also rising. This study investigates the co-occurrence of MPC among p diagnosed with lung cancer (LC).

Methods

Review of clinical data of all consecutive patients with histologically confirmed LC visited at our institution between October 2017 and January 2018.

Results

Out of 933 p, two primary cancers occurred in 115 cases (12%), including 25 p (3%) with three primary cancers. Patients with MPC were predominantly males (69%), smokers (85%) and 20% had known family history. Median age at the first tumor was 61 years (44-85). LC occurred as first neoplasm in 21% of the cases, as subsequent neoplasm in 64% and as two consecutive primary neoplasm in 15%. Most common cancer previous to LC diagnosis was colorectal in 23%, breast in 22%, prostate in 19%, head and neck in 12% and bladder in 11%. Treatment received for first cancer included surgery in 79%, chemotherapy in 50% and radiotherapy in 30%. Second tumor was prostate in 22%, bladder in 22%, colorectal in 19%, breast in 19% and head and neck in 8%. Surgery was performed in 66% of the cases with second cancer. Overall, median time from diagnosis of first to second neoplasm was 4 years (2.9 -5.2), without significant differences if primary tumor was LC or another neoplasm (p = 0.39). Of note, 25% had diagnosis of second primary cancer within 1 year. Smoking was significantly associated with shorter time to diagnosis of a second neoplasm (3.4 years vs 4.7 years for non-smokers, p = 0.03). With a median follow up of 2 years after diagnosis of second neoplasm, the 2-year survival rate was 93.7% (88.8-98.7%). Having a second cancer within 3 years significantly increased the risk of death (HR = 7.7, p = 0.02).

Conclusions

In our series, the frequency of the co-occurrence of MPC among LC p is 12%, indicating that surveillance strategies are recommended. Many p are treated with curative intent. Smoking increased risk of second primary, and diagnosis within 3 years of follow-up associates with poor outcome.

Legal entity responsible for the study

Vall d'Hebron Institute Oncology.

Funding

Has not received any funding.

Disclosure

All authors have declared no conflicts of interest.

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Poster Discussion session - Non-metastatic NSCLC and other thoracic malignancies Poster Discussion session

Invited Discussant 1364PD and 1806PD

Lecture Time
15:10 - 15:20
Speakers
  • Pieter E. Postmus (Leiden, NL)
Location
ICM - Room 1, ICM München, Munich, Germany
Date
21.10.2018
Time
14:45 - 16:00
Poster Discussion session - Non-metastatic NSCLC and other thoracic malignancies Poster Discussion session

Q&A led by Discussant

Lecture Time
15:20 - 15:25
Location
ICM - Room 1, ICM München, Munich, Germany
Date
21.10.2018
Time
14:45 - 16:00
Poster Discussion session - Non-metastatic NSCLC and other thoracic malignancies Poster Discussion session

1665PD - Preliminary efficacy of durvalumab plus tremelimumab in platinum-refractory/resistant ED-SCLC from Arm A of the Phase II BALTIC study

Presentation Number
1665PD
Lecture Time
15:25 - 15:25
Speakers
  • Igor Bondarenko (Dnipropetrovsk, UA)
Location
ICM - Room 1, ICM München, Munich, Germany
Date
21.10.2018
Time
14:45 - 16:00

Abstract

Background

Prognosis in extensive-stage disease small cell lung cancer (ED-SCLC) is poor and patients (pts) commonly relapse within months of completing first-line platinum-based chemotherapy (CT). Investigation into a potential role for immune checkpoint inhibitors in SCLC treatment is supported by good scientific rationale, principally the high mutational burden associated with the disease. We report preliminary efficacy of anti-PD-L1 mAb durvalumab (D) plus anti-CTL4 mAb tremelimumab (T) in pts with platinum-refractory/resistant ED-SCLC, as assessed in Arm A of BALTIC (NCT02937818), a Phase II, multi-arm, signal-searching study.

Methods

Eligible pts had ED-SCLC, disease progression (PD) during or within 90 days of completing first-line platinum-based CT, WHO/ECOG performance status 0 or 1, and a life expectancy ≥8 weeks. Pts enrolled in Arm A received D 1500 mg + T 75 mg IV q4w for up to 4 months, followed by D 1500 mg IV q4w monotherapy from Week 16 until PD or discontinuation. The primary endpoint was objective response rate (ORR; investigator assessment, RECIST v1.1). Secondary endpoints included disease control rate (DCR), progression free survival (PFS), overall survival (OS), and safety and tolerability.

Results

25 pts were enrolled between November 2016 and September 2017, and 21 pts received study treatment (mean age 59.6 years; 71.4% male). As of 02 Feb 2018 (data cut off), median duration of treatment was approximately 14 weeks, with D treatment ongoing in 3 pts and T treatment ongoing in 2 pts. ORR was 9.5% (2 pts; 95% CI 1.17, 30.38). Both were partial responses. 5 pts (23.8%) had stable disease and 1 pt (4.8%) had an unconfirmed partial response. DCR at 12 weeks was 8/21 (38.1%). Grade 3 or higher adverse events (AEs; all cause) occurred in 10 pts (48%), of which 4 pts (19%) experienced an event deemed possibly causally related to treatment by the investigator. 1 pt (4.8%) discontinued due to a possibly causally related AE. Updated ORR, DCR and safety data will be presented, as well as PFS and OS data.

Conclusions

D in combination with T demonstrated a tolerable safety profile and encouraging anti-tumour activity in pts with platinum-refractory/resistant ED-SCLC, a difficult-to-treat patient population.

Clinical trial identification

NCT02937818 (October 5, 2016).

Legal entity responsible for the study

AstraZeneca.

Funding

AstraZeneca.

Editorial Acknowledgement

Medical writing support, which was in accordance with Good Publication Practice (GPP3) guidelines, was provided by Paul Glacken, MSc, and Elizabeth Andrew, PhD, of Cirrus Communications (Macclesfield, UK), an Ashfield company, and was funded by AstraZeneca.

Disclosure

S. Jones: Former employment: AstraZeneca; Consultant, equity owner: AstraZeneca. H. Jiang: Employment, equity ownership: AstraZeneca. N. Reinmuth: Personal fees: BMS, Roche, AstraZeneca, Takeda, Novartis, MSD, Lilly, Boehringer-Ingelheim outside the submitted work. All other authors have declared no conflicts of interest.

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Poster Discussion session - Non-metastatic NSCLC and other thoracic malignancies Poster Discussion session

1666PD - Trilaciclib (T) decreases multi-lineage myelosuppression in extensive-stage small cell lung cancer (ES-SCLC) patients receiving 1st line chemotherapy

Presentation Number
1666PD
Lecture Time
15:25 - 15:25
Speakers
  • Konstantin H. Dragnev (Lebanon, US)
Location
ICM - Room 1, ICM München, Munich, Germany
Date
21.10.2018
Time
14:45 - 16:00

Abstract

Background

Chemotherapy (chemo)-induced damage of hematopoietic stem and progenitor cells (HSPC) causes multi-lineage myelosuppression. T is an iv CDK4/6i in development to preserve HSPC and immune system function during chemo (myelopreservation). Preclinically, transient T-induced G1 arrest renders HSPCs resistant to chemo cytotoxicity, leading to faster hematopoietic recovery and enhanced anti-tumor immunity.

Methods

This Phase 2, randomized, placebo (P)-controlled, double-blind study dosed 75 chemo-naïve ES-SCLC pts with adequate organ function, ECOG 0-2, and no symptomatic brain metastases (NCT02499770). Pts received T or P iv prior to etoposide/carboplatin (EP) on days 1 to 3 of each cycle. Growth factors were prohibited in cycle 1; otherwise supportive care was allowed as needed. Lineage-specific endpoints were prespecified to assess the effect of T on myelosuppression. Tumor response was assessed using RECIST v1.1.

Results

Key results are in the table. T + EP was well tolerated with fewer ≥ G3 AEs in T (50%) vs P (83.8%), primarily due to less hematological (heme) toxicity. No T-related ≥ G3 AEs occurred. Improvements were seen with T in neutrophil, RBC and lymphocyte measures in all pt subgroups. There was an increase in activated CD8+ T-cells and a decrease in regulatory T-cells in the peripheral blood (PB) with T. Tumor assessment showed: objective response rate (T 66.7%, P 62.2%); DOR (median T 5.7m, P 4.3m); and PFS (median T 6.2m, P 5.0m; HR 0.6, p = 0.06).

Parameter, nEP + P N = 37EP + T N = 38P-value (1)
G4 ANC1620.0001
G-CSF Administration244<0.0001
Febrile Neutropenia310.2773
RBC transfusion ≥ 5 weeks on study820.0781
Dose reductions due to heme toxicity1220.0029
Lymphocyte count at end of 6 cycles(2)1.608 x 109/L1.935 x 109/L0.0499

Significance testing at 2-sided α = 0.2 P, n = 22; T, n = 20

Conclusions

Trilaciclib demonstrated (1) myelopreservation across three hematopoietic lineages with fewer supportive care interventions and dose reductions, (2) encouraging DOR and PFS, and (3) changes in peripheral blood T-cell subsets indicating a more robust immune response. These data demonstrate strong proof-of-concept for the myelopreservation benefits of T.

Clinical trial identification

NCT02499770; EudraCT: 2016-001583-11.

Legal entity responsible for the study

G1 Therapeutics, Inc.

Funding

G1 Therapeutics, Inc.

Disclosure

Z. Yang, P.J. Roberts, J.M. Antal, R.K. Malik, S.R. Morris: Employee: G1 Therapeutics. J.M. Weiss: Financial support to institution: AstraZeneca, Celgene, Merck; Advisory board: AstraZeneca, Celgene, Boston Biomedical. All other authors have declared no conflicts of interest.

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Poster Discussion session - Non-metastatic NSCLC and other thoracic malignancies Poster Discussion session

Invited Discussant 1665PD and 1666PD

Lecture Time
15:25 - 15:35
Speakers
  • Jean-Louis Pujol (Montpellier, FR)
Location
ICM - Room 1, ICM München, Munich, Germany
Date
21.10.2018
Time
14:45 - 16:00
Poster Discussion session - Non-metastatic NSCLC and other thoracic malignancies Poster Discussion session

Q&A led by Discussant

Lecture Time
15:35 - 15:40
Location
ICM - Room 1, ICM München, Munich, Germany
Date
21.10.2018
Time
14:45 - 16:00
Poster Discussion session - Non-metastatic NSCLC and other thoracic malignancies Poster Discussion session

1667PD - Impact of early prophylactic cranial irradiation with hippocampal avoidance on neurocognitive function in patients with limited disease small-cell lung cancer. A multicenter phase II trial (SAKK 15/12)

Presentation Number
1667PD
Lecture Time
15:40 - 15:40
Speakers
  • Hansjörg Vees (Zurich, CH)
Location
ICM - Room 1, ICM München, Munich, Germany
Date
21.10.2018
Time
14:45 - 16:00

Abstract

Background

In limited disease small-cell lung cancer (LD SCLC) prophylactic cranial irradiation (PCI) is the standard of care following chemotherapy (CHT) and thoracic radiotherapy (tRT) in patients with a good clinical response. It is unknown if PCI concomitant with CHT and tRT has an impact on neurocognitive function (NCF) and clinical outcome.

Methods

In a phase II trial, patients with LD SCLC received hippocampal avoidance (HA)-PCI concomitant to the 2nd cycle of CHT (cisplatin or carboplatin and etoposide) and tRT. All patients underwent objective NCF testing before starting HA-PCI (baseline), at 6 weeks, and at 6 and 12 months after HA-PCI. NCF tests included the Hopkins Verbal Learning Test Revised (HVLT-R) for verbal learning and memory, the Controlled Oral Word Association (COWAT) for verbal fluency, and Trail Making Tests A and B (TMT A&B) for visual search, scanning, speed of processing and executive function. The primary endpoint was NCF decline at 6 months after HA-PCI, defined as a decrease of one standard error of measurement in any of the tests. We assumed a rate of ≤ 30% of patients with no NCF decline as unpromising and a rate of ≥ 50% as promising. Secondary endpoints included overall survival (OS) and quality of life.

Results

Among the 44 patients enrolled in the trial, 37 had evaluable NCF assessment at 6 months after HA-PCI (2 had no CHT, 2 had no BL TMT B assessment, 1 died and 2 have pending NCF results). At the time of analysis, 13 patients (35%; 90% CI: 22-50%) showed no NCF decline. The median follow-up was 12 months with a 1-year OS rate of 84% (95% CI: 65-93%). Four patients died due to SCLC, 1 due to respiratory failure, 1 due to hemorrhage, and 1 for unknown reason. The most common acute adverse events grade ≥3 were anemia (21%), febrile neutropenia (19%) and fatigue (14%).

Conclusions

The rate of patients with no NCF decline 6 months after HA-PCI in LD SCLC does not seem to be better, but rather similar to that observed in patients receiving sequential PCI. Early HA-PCI appears feasible. OS was promising in this selected population. Updated and additional results will be presented.

Legal entity responsible for the study

SAKK (Swiss Group for Clinical Cancer Research).

Funding

Schweizerische Stiftung für Klinische Krebsforschung (SSKK); Hirslanden Klinik Zuerich; Krebsliga Zuerich Schweizerische Stiftung für Klinische Krebsforschung (SSKK).

Disclosure

All authors have declared no conflicts of interest.

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Poster Discussion session - Non-metastatic NSCLC and other thoracic malignancies Poster Discussion session

1365PD - Screening for brain metastases (BM) in patients (pts) with stage III non-small cell lung cancer (NSCLC), magnetic resonance imaging (MRI) or dedicated contrast-enhanced computed tomography (dCE-CT)? A prospective observational study

Presentation Number
1365PD
Lecture Time
15:40 - 15:40
Speakers
  • Janna J. Schoenmaekers (Maastricht, NL)
Location
ICM - Room 1, ICM München, Munich, Germany
Date
21.10.2018
Time
14:45 - 16:00

Abstract

Background

In all NSCLC guidelines it is advised to screen stage III pts eligible for therapy (tx) with curative intent for BM, preferably by MRI, or otherwise a dCE-CT. However, MRI access can be problematic. dCE-CT brain is frequently incorporated in the staging 18Fluodeoxoglucose-positron-emission-tomography (18FDG-PET)-CE-CT scan. The additive value of a brain MRI after a dCE-CT brain is unknown.

Methods

Observational prospective multicentre study (3 Dutch centers, (NTR3628). Inclusion: all consecutive neurologically asymptomatic stage III (based on 18FDG-PET) NSCLC pts with a dCE-CT brain incorporated in the 18FDG-PET and an additional brain MRI. Demographics, brain imaging results and development of BM in follow-up (FU) were collected. Both MRI and 18FDG-PET-CE-CT were reviewed by an experienced neuroradiologist. Primary endpoint: % pts with BM on MRI without suspect lesions on dCE-CT. 118 pts were needed to show a clinically relevant considered difference of 2%. Secondary endpoints: % of pts with BM on dCE-CT, % of pts with BM ≤ 1 year of a negative staging MRI.

Results

118 pts were enrolled between 12-‘12 until 12-‘16, and were followed until 12-’17. During the year of FU 30 extra pts were included. In total 148 pts were included: 59% male; mean age 68 years, 84% WHO PS 0-1 and 44% adenocarcinoma. Median time (range) between 18FDG-PET-CE-CT and MRI was 13 (0 -57) days. 5 of the first 118 pts (4.2%) had a solitary BM on MRI despite no suspect brain lesions on dCE-CT. In total 7/154 pts (4.5%) had a BM on MRI without suspect lesions on dCE-CT. In retrospect, in one of these 7 pts a solitary BM could be identified on the 18FDG-PET–CE-CT. 16 (7%) of the screened pts with extracranial stage III were excluded because BM were already detected on dCE-CT brain. Of the 118 pts with a FU of 1 year, 10 (8.5%) developed BM ≤ 1 year after a negative staging brain MRI.

Conclusions

Although in 7% of stage III NSCLC pts BM were detected on staging dCE-CT, MRI brain detected BM in an additional 4.5% of pts which we consider clinically relevant in this pt population. Within 1 year after a negative staging MRI, 8.5% of pts developed BM.

Clinical trial identification

NTR3628.

Legal entity responsible for the study

Academic hospital Maastricht.

Funding

Has not received any funding.

Disclosure

L. Hendriks: Outside the current abstract: Research funding: Roche; Advisory board: Boehringer, BMS; Travel reimbursement: Roche, BMS. A-M.C. Dingemans: Advisory board: BMS, MSD, Roche. D. De Ruysscher: Outside the current abstract: Advisory board: BMS, Roche/Genentech, Merck/ Pfizer, Celgene, AstraZeneca, Noxxon, Mologen. All financial income is going to Maastro Clinic. All other authors have declared no conflicts of interest.

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Poster Discussion session - Non-metastatic NSCLC and other thoracic malignancies Poster Discussion session

Invited Discussant 1667PD and 1365PD

Lecture Time
15:40 - 15:50
Speakers
  • Cécile Le Pechoux (Villejuif, FR)
Location
ICM - Room 1, ICM München, Munich, Germany
Date
21.10.2018
Time
14:45 - 16:00
Poster Discussion session - Non-metastatic NSCLC and other thoracic malignancies Poster Discussion session

Q&A led by Discussant

Lecture Time
15:50 - 15:55
Location
ICM - Room 1, ICM München, Munich, Germany
Date
21.10.2018
Time
14:45 - 16:00