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M. Perol
Moderator of
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Closing remarks (ID 53)
- Event: ELCC 2018
- Type: Closing remarks
- Track:
- Presentations: 1
- Moderators:M. Perol, L. Paz-Ares
- Coordinates: 4/14/2018, 12:50 - 13:00, Room A
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Save the date (ID 708)
12:50 - 13:00 | Presenting Author(s): M. Perol, L. Paz-Ares
- Abstract
Abstract not provided
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ESMO-IASLC Best Abstracts (ID 61)
- Event: ELCC 2018
- Type: Best Abstract session
- Track:
- Presentations: 7
- Moderators:M. Perol, L. Paz-Ares
- Coordinates: 4/13/2018, 16:45 - 18:30, Room B
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Invited Discussant 128O and 129O (ID 683)
16:45 - 18:30 | Presenting Author(s): T. Mitsudomi
- Abstract
- Presentation
Abstract not provided
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Invited Discussant 91O, 109O and 233O (ID 682)
16:45 - 18:30 | Presenting Author(s): N. Reguart
- Abstract
- Presentation
Abstract not provided
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109O - Health-related quality of life (QoL) after prophylactic cranial irradiation (PCI) vs no PCI for stage III NSCLC patients: Results from the NVALT-11/DLCRG-02 study (ID 273)
16:45 - 18:30 | Presenting Author(s): W. Witlox | Author(s): B. Ramaekers, H. Groen, A. Dingemans, J. Praag, J. Belderbos, V. Van Der Noort, H. Van Tinteren, M. Joore, D. De Ruysscher
- Abstract
- Presentation
Background:
The NVALT-11/DLCRG-02 randomized phase III study compared PCI to observation after chemo-radiotherapy for stage III NSCLC and showed a significant decrease in time to develop symptomatic brain metastases in the PCI arm at the expense of more low-grade mostly neurological toxicity (HR 0.25 95% CI 0.11–0.58). We here report on the QoL.
Methods:
EORTC QLQ-C30 and EuroQol 5D (EQ-5D) data measured before PCI and 3, 12, and 24 months thereafter were compared for both arms. Specifically, functional scales and global health status scores (QLQ-C30) as well as VAS and utility scores (EQ-5D) were analysed using non-parametric tests.
Results:
In total, 86 and 88 patients were included in the PCI and observational arm respectively, accumulating to 853 observations (five observations completely missing). Baseline QoL was similar between both arms, except for emotional (p = 0.025) and cognitive functioning (p = 0.039) which showed a significantly better score in the PCI arm. At three months, the observational arm scored significantly better on the EQ-VAS (median 70 vs 60, p = 0.017), while EQ-5D utility scores (Dutch tariff) were similar. At three months, QLQ-C30 showed that physical functioning, cognitive functioning, and global disease specific QoL were significantly better in the observational arm (median 83 vs 73, p = 0.003, median 100 vs 83, p = 0.006 and median 67 vs 67, p = 0.017). At later time-points, except for significantly better cognitive functioning at 24 months in the observational arm (median 83 vs 67, p = 0.017), no significantly different QoL (either QLQ-C30 or EQ-5D) was observed between the two arms.Table:Median scores of functional scales and global health status scores of QLQ-C30 and VAS and utility scores of EQ-5DMedian (PCI) Median (Observation) T0 T3 T12 T24 T0 T3 T12 T24 QLQ-C30 Physical 77 73 87 80 80 83 80 77 Role 67 67 67 67 67 67 67 67 Emotional 83 83 83 92 75 88 83 88 Cognitive 100 83 83 67 83 100 83 83 Social 83 83 100 83 83 83 83 92 Global QoL 67 67 67 67 67 67 67 67 EQ-5D Utility score 0.843 0.775 0.805 0.843 0.811 0.811 0.775 0.843 VAS score 65 60 70 75 70 70 69 70
Conclusions:
In conclusion, despite substantially reducing the incidence of brain metastases in NSCLC patients, PCI impairs short term generic QoL as well as disease specific QoL. The impact on long term QoL is limited to problems concerning cognitive functioning only.
Clinical trial identification:
Legal entity responsible for the study:
Nederlandse Vereniging van Artsen voor Longziekten en Tuberculose (NVALT)
Funding:
Has not received any funding
Disclosure:
All authors have declared no conflicts of interest.
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128O - Osimertinib vs standard of care (SoC) EGFR-TKI as first-line therapy in patients (pts) with untreated EGFRm advanced NSCLC: FLAURA post-progression outcomes (ID 570)
16:45 - 18:30 | Presenting Author(s): D. Planchard | Author(s): M. Boyer, J. Lee, A. Dechaphunkul, P. Cheema, T. Takahashi, A. Todd, A. McKeown, Y. Rukazenkov, Y. Ohe
- Abstract
- Presentation
Background:
In the FLAURA phase 3 study, the third-generation EGFR-TKI osimertinib significantly improved progression-free survival (PFS) vs SoC EGFR-TKIs (gefitinib or erlotinib) in pts with previously untreated Ex19del/L858R (EGFRm) advanced NSCLC (hazard ratio [HR] 0.46 [95% CI 0.37, 0.57]; p < 0.001). Interim overall survival (OS) data was encouraging but not formally statistically significant (HR 0.63 [95% CI 0.45, 0.88]; p = 0.007). Here we report exploratory post-progression outcomes.
Methods:
Pts were randomised 1:1 to receive osimertinib (80 mg orally [PO], once daily [QD]) or SoC (gefitinib 250 mg PO QD or erlotinib 150 mg PO QD). Treatment beyond disease progression was allowed if the investigator judged continued clinical benefit; investigators determined subsequent therapy. Pts receiving SoC could cross over to osimertinib after objective disease progression with documented post-progression T790M-positive mutation status.
Results:
At data cutoff, 12 June 2017, 138/279 (49%) and 213/277 (77%) pts discontinued osimertinib and SoC, respectively; 82 (29%) and 129 (47%) received a subsequent treatment: EGFR-TKI-containing, 29 (10%) and 97 (35%; 55 [20%] osimertinib); platinum chemotherapy-containing, 46 (16%) and 27 (10%). Median time (mths) to discontinuation of study treatment or death: osimertinib 20.8 (95% CI 17.2, 24.1) vs SoC 11.5 (10.3, 12.8). Median time (mths) to discontinuation of any EGFR-TKI (study treatment and subsequent EGFR-TKI, not interrupted by non-EGFR-TKI therapy) or death: osimertinib 23.0 (19.5, not calculable [NC]) vs SoC 16.0 (14.8, 18.6). Time-to-event post-progression endpoints all favoured osimertinib (Table).
aCalculated using the Kaplan-Meier method.bHR and CI were obtained directly from the U and V statistics. The analysis was performed using a log rank test stratified by race (Asian versus non-Asian) and mutation type (Ex19del vs L858R). 2-sided p-value. CI, confidence interval; FST, first subsequent therapy (second-line treatment); HR, hazard ratio; NC, not calculable; PFS2, second progression-free survival (or death) post initiation of second-line treatment (i.e. time from randomisation to second progression on subsequent treatment); TFST, time to first subsequent therapy or death; TSST, time to second subsequent therapy or death; SST, second subsequent therapy; RECIST, Response Evaluation Criteria In Solid Tumors version 1.1.Osimertinib(n = 279) SoC (n = 277) Disease progression or death, n (%) 136 (49) 206 (74) Remained on study treatment for at least 7 days post investigator assessed progression, n/N (%) 91/136 (67) 145/206 (70) Median duration on study treatment post-progression (95% CI), wks[a] 8.1 (6.3, 12.3) 7.0 (5.9, 8.1) TFST Pts who started FST or died, n (%) 115 (41) 175 (63) Started FST, n (%) 82 (29) 129 (47) Died, n (%) 33 (12) 46 (17) Median TFST or death (95% CI), mths[a] 23.5 (22.0, NC) 13.8 (12.3, 15.7) HR (95% CI)[b] 0.51 (0.40, 0.64), p < 0.0001 PFS2 (investigator assessed) Second progression or death, n (%) 73 (26) 106 (38) Median PFS2 (95% CI), mths[a] NC (23.7, NC) 20.0 (18.2, NC) HR (95% CI)[b] 0.58 (0.44, 0.78), p = 0.0004 TSST Pts who started SST or died, n (%) 74 (27) 110 (40) Started SST, n (%) 24 (9) 39 (14) Died, n (%) 50 (18) 71 (26) Median TSST or death (95% CI), mths[a] NC (NC, NC) 25.9 (20.0, NC) HR (95% CI)[b] 0.60 (0.45, 0.80), p = 0.0005
Conclusions:
PFS benefit with osimertinib was preserved throughout time-to-event post-progression endpoints. Step-wise increase of the statistically significant HRs (PFS 0.46, TFST 0.51, PFS2 0.58, TSST 0.60) provides confidence in the interim OS data.
Clinical trial identification:
ClinicalTrials.gov NCT02296125
Legal entity responsible for the study:
AstraZeneca
Funding:
AstraZeneca
Disclosure:
D. Planchard: Advisory boards: Astrazeneca, Boehringer, BMS, Pfizer, Novartis, MSD, Roche M. Boyer: Research funding and/or honoraria for advisory board work or talks, paid to my institution, from: AstraZeneca, Roche, Merck Sharpe and Dohme, Pfizer, Amgen, Bristol-Myers Squibb. P. Cheema: Advisory board/Honorarium: AstraZeneca Research grant: AstraZeneca T. Takahashi: Honoraria: AstraZeneca, Eli Lilly Japan, Chugai Pharmaceutical, Ono Pharmaceutical, Grants: AstraZeneca KK, Pfizer Japan Inc., Eli Lilly Japan K.K., Chugai Pharmaceutical Co., Ltd., Taiho Pharmaceutical Co., Ltd., MSD K.K. A. Todd: Employee of AstraZeneca but own no stocks or shares, and am not a member of any board. I am not aware of any other conflicts of interest or opportunities for financial gain. A. McKeown: Employee of, and shareholder in, AstraZeneca. Y. Rukazenkov: Employee of and shareholder in AstraZeneca. Y. Ohe: Grants and personal fees from AstraZeneca, during the conduct of the study; grants and personal fees from AstraZeneca, grants and personal fees from Ono, grants and personal fees from BMS, grants and personal fees from Chougai, grants and personal fees from Pfizer, grants and personal fees from MSD, grants and personal fees from Novartis, grants from Kyorin, grants from Dainippon- Sumitomo, personal fees from Daiichi-Sankyo, personal fees from Nipponkayaku, personal fees from Boehringer Ingelheim, personal fees from Bayer, grants and personal fees from Lilly, outside the submitted work. All personal fees were honoraria for consulting or lectures. All other authors have declared no conflicts of interest.
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- Abstract
Background:
Our previous study demonstrated that liver metastases (LM) were the negative predictive and prognostic factor in EGFR-mutant NSCLC patients (Pts) treated with EGFR-TKIs, suggesting that additional treatment is warranted. Recently, several studies reported that local therapy could significantly improve progression-free survival (PFS) in NSCLC Pts with oligometastatic or oligoprogressive disease. This study aimed to investigate whether addition of local therapy to EGFR-TKIs could provide survival benefit in EGFR-mutant NSCLC Pts with oligometastatic or oligoprogressive LM.
Methods:
Pts with EGFR-mutant NSCLC and LM were included. Oligometastatic LM was defined as <5 sites in liver without extrahepatic metastases at initial diagnosis. Oligoprogressive LM was defined as <5 sites in liver without extrahepatic metastases during TKIs therapy. For oligoprogressive cohort, PFS1 was calculated from time of initiation of TKI therapy to first RECIST 1.1 defined progress disease (PD) or death. PFS2 was calculated from time of initiation of TKI therapy to off-TKI PD.
Results:
289 Pts with LM were enrolled (55 with oligometastatic LM and 63 with oligoprogressive LM). In oligometastatic cohort, 18 Pts received EGFR-TKIs (E) and 21 Pts received TKIs plus local therapy (E + LT) as first-line treatment. Median PFS was significantly longer in E + LT group than in E group (12.2 vs. 7.9 m, P = 0.030). Median OS was numerically longer in E + LT group than in E group (31.7 vs. 21.3 m, P = 0.102). In oligoprogressive cohort, 19 Pts received continuation of TKIs plus local therapy (cE + LT) and 22 Pts received switch therapy (ST). Median PFS1 was comparable. Median PFS2 was dramatically longer in cE + LT group than in ST group (13.9 vs. 8.8 m, P = 0.050). Median OS was marginally significantly longer in cE + LT group than in ST group (24.7 vs. 15.7 m, P = 0.085). Multivariate analysis revealed that addition of local therapy was independently associated with prolonged PFS and OS in Pts with oligometastatic LM.
Conclusions:
The current study indicated that EGFR-TKIs plus local therapy demonstrated the prolonged survival benefit than TKIs alone in EGFR-mutant NSCLC Pts with oligometastatic or oligoprogressive LM.
Clinical trial identification:
Legal entity responsible for the study:
Shanghai Pulmonary Hospital
Funding:
Has not received any funding
Disclosure:
All authors have declared no conflicts of interest.
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233O - Time to deterioration of symptoms with durvalumab in stage III, locally advanced, unresectable NSCLC: Post-hoc analysis of PACIFIC patient-reported outcomes (ID 703)
16:45 - 18:30 | Presenting Author(s): S. Antonia | Author(s): R. Hui, M. Özgüroğlu, A. Villegas, D. Daniel, D. Vicente Baz, S. Murakami, A. Rydén, Y. Zhang, P. Dennis
- Abstract
- Presentation
Background:
Along with improving efficacy outcomes such as progression-free survival (PFS) after concurrent chemoradiotherapy (cCRT) in locally advanced, unresectable NSCLC, it is critical that new therapies are well tolerated in the curative intent setting. We studied the impact of 12 mo of durvalumab on disease symptoms in this setting using patient-reported outcomes (PROs). In a post-hoc analysis of time to deterioration, we adjusted for transient symptom changes by requiring two consecutive deterioration recordings.
Methods:
Patients whose disease did not progress after ≥2 cycles of platinum-based cCRT were randomised 2:1 1–42 days post-cCRT to durvalumab 10 mg/kg i.v. or placebo every 2 weeks for up to 12 mo/progression. Co-primary endpoints were PFS and overall survival. PROs were assessed using EORTC QLQ-C30 v3 and QLQ-LC13. Time to deterioration was defined as time from randomisation until the first clinically relevant deterioration (≥10 point change); in the post-hoc analysis, deterioration confirmation was required at the next time point. Hazard ratios (HR) and 95% confidence intervals (CIs) were estimated using a stratified Cox proportional-hazards model.
Results:
In the pre-specified analysis, there was no difference between treatment arms in time to deterioration besides other pain, which favoured durvalumab vs placebo (HR 0.72; 95% CI 0.58–0.89). Our post-hoc analysis indicated notable delays in deterioration of overall pain (HR 0.75; 95% CI 0.60–0.93), chest pain (HR 0.74; 95% CI 0.57–0.97), arm/shoulder pain (HR 0.74; 95% CI 0.58–0.95), nausea/vomiting (HR 0.72; 95% CI 0.54–0.97), insomnia (HR 0.75; 95% CI 0.58–0.97) and haemoptysis (HR 0.70; 95% CI 0.50–0.99) in favour of durvalumab, with no between-group differences for other items.
Conclusions:
PACIFIC primary analysis showed that durvalumab significantly improved PFS vs placebo (16.8 mo vs 5.6 mo, respectively) in the post-cCRT setting, and was well tolerated, largely without PRO deterioration. Our post-hoc analysis indicates a delay in several PROs with durvalumab not observed in the pre-specified analysis. Confirmation of worsening may provide a more precise picture of deterioration than one time point alone.
Clinical trial identification:
NCT02125461 (April 25, 2014)
Legal entity responsible for the study:
AstraZeneca PLC
Funding:
AstraZeneca
Disclosure:
R. Hui: Personal fees from the following: AstraZeneca, Merck Sharp and Dohme: Advisory Board Member and Speaker Honorarium; Novartis, Pfizer: Advisory Board Member; BMS, Boehringer Ingelheim: Speaker Honorarium. A. Villegas: Celgene, Alexion, BMS: Speaker's Bureau. A. Ryden, Y. Zhang, P. Dennis: AstraZeneca: full-time employment and stock ownership. S. Antonia: Moffitt Cancer Center: Full-time employment, Grants/research support; Novartis: Grants/research support, Advisory board, Honorarium recipient; BMS, Merck, Boehringer Ingelheim, AstraZeneca, Memgen: Advisory board, Honorarium recipient; CBMG: Advisory board, Stock/shareholder, Honorarium recipient. All other authors have declared no conflicts of interest.
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91O - Adjuvant chemotherapy candidates in stage I lung adenocarcinomas following complete lobectomy: What does an analysis based on recurrence risk stratification tell us? (ID 435)
16:45 - 18:30 | Presenting Author(s): J. Qian | Author(s): J. Xu, S. Wang, F. Qian, W. Yang, B. Zhang, Y. Zhang, X. Zhang, B. Han
- Abstract
- Presentation
Background:
The study aimed to (i) develop a recurrence risk-scoring model in stage I lung adenocarcinoma (LAD) after complete lobectormy; (ii) explore the high-risk population that would benefit from adjuvant chemotherapy (ACT).
Methods:
A retrospective study was performed on 4606 patients with pathologically confirmed stage I LAD who underwent complete lobectomy at Shanghai Chest Hospital from 2008 to 2014. Patients were categorized into the non-ACT group (n = 3514) and ACT group (n = 1092). The nomogram was developed in the non-ACT group using Cox proportional hazards regression to predict 5-year recurrence-free survival (RFS). The predictive value was compared between the nomogram and the 8[th] edition of TNM system. The population that benefited from ACT was determined by comparing RFS between the non-ACT and the ACT group as stratified by the TNM stage, risk score quartiles and 5-year recurrence probability, respectively. The optimal cut-off scores were determined using X-tile software.
Results:
Six independent predictors including age, gender, tumor size, pathological subtype, visceral pleural invasion (VPI), and lymphovascular invasion (LVI) were associated with recurrence. The nomogram showed a better accuracy in predicting RFS than the TNM staging [C-index: 0.784 (95% CI: 0.756–0.812) vs 0.719 (95% CI: 0.689–0.749), P = 0.0017]. A trend in ACT benefit was observed along with the increasing risk scores. An improved RFS was exhibited after ACT for patients having a 50% recurrence probability (P = 0.0286). The optimal cut-off of the risk score was set at 203 and 244. ACT was detrimental in patients with risk scores below 203 (P < 0.0001) and beneficial in those with risk scores above 245 (P = 0.0416). Patients with score ≥ 245 accounted for 0.4% of stage IA patients and 7.5% of stage IB patients, respectively. In stage IB, patients with predominant solid/micropapillary subtype (62.8%) was the subgroup with the most percentage of score ≥ 245.
Conclusions:
The nomogram provided a more accurate RFS prediction for lobectomized stage I LAD. High-risk population, determined as recurrence risk score ≥ 245, may benefit from postoperative ACT.
Clinical trial identification:
Legal entity responsible for the study:
Shanghai Chest Hospital, Shanghai Jiao Tong University, China
Funding:
Has not received any funding
Disclosure:
All authors have declared no conflicts of interest.
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New approaches in rare thoracic tumors (ID 60)
- Event: ELCC 2018
- Type: Proffered Paper session
- Track:
- Presentations: 6
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Invited Discussant 112O, 213O and 214O (ID 695)
11:00 - 12:30 | Presenting Author(s): N. Girard
- Abstract
- Presentation
Abstract not provided
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Invited Discussant 135O (ID 696)
11:00 - 12:30 | Presenting Author(s): M. Perol
- Abstract
- Presentation
Abstract not provided
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112O - Primary result of an investigator-initiated phase II trial of nivolumab for unresectable or recurrent thymic carcinoma: PRIMER study (NCCH1505) (ID 349)
11:00 - 12:30 | Presenting Author(s): T. Seto | Author(s): Y. Katsuya, H. Horinouchi, S. Umemura, Y. Hosomi, M. Satouchi, A. Kuchiba, Y. Ohe
- Abstract
- Presentation
Background:
Thymic carcinoma (TC) is a rare cancer with a poor prognosis. Treatment options are limited, especially after relapse. We previously reported that PD-L1 positivity was observed in 70% of TCs by immunohistochemistry suggesting anti PD-1/PD-L1 agents could be a promising treatment.
Methods:
In this open-label, two-stage, multi-center, single-arm, phase II trial, the main eligibility criteria were: unresectable or recurrent TC, an ECOG-PS of 0 or 1, the presence of measurable disease, progression after at least one previous platinum-based chemo(radio)therapy treatment, and no history of autoimmune disease. Nivolumab was administered at a dose of 3 mg/kg every 2 weeks. The primary endpoint was the response rate (RR) as evaluated by central review using the RECIST v1.1; secondary endpoints include progression-free survival (PFS), overall survival, disease control rate, and safety. The planned sample size was 15 for the first stage and 15 for the second stage, with a threshold RR of 5%, an expected RR of 20%, one-sided alpha of 5% and power of 80%. This trial was registered with UMIN000022007.
Results:
Between July 1 and August 16, 2016, 15 patients were accrued in the first stage; at the data cutoff (August 31, 2017), all were assessable for a response. Median follow-up time was 3.8 months (range 1.4–12.0). All were Japanese, 12 were male, median age was 55 (range 34–70), 13 had squamous histology. The median number of nivolumab cycles received was 8 (range 3–29). RR by central review was 0% (no patient with complete or partial response; 95% confidence interval [CI]: 0–21.8). Eleven patients had stable disease and four had progressive disease. Median PFS was 3.8 months (95% CI: 1.9–5.6), and 12-month PFS rate was 13.3% (95% CI: 2.2–34.6). Two patients experienced a treatment-related serious adverse events (grade 3 AST increase and grade 2 adrenal insufficiency). Because the early termination criteria at the first stage (less than one responder) was fulfilled, the patient accrual was terminated.
Conclusions:
Despite of the small number of patients, our results suggested further development of nivolumab is not recommended in previously treated unresectable or recurrent TC.
Clinical trial identification:
Legal entity responsible for the study:
None
Funding:
Japan Agency for Medical Research and Development
Disclosure:
T. Seto: Consulting and advisory services, speaking or writing engagements, public presentations; AstraZeneca, Bristol-Myers Squibb, Chugai, Eli Lilly, MSD, Nippon Boehringer Ingelheim, Ono, Pfizer, Taiho, Takeda. Direct research support to the responsible project lead (e.g., Principal Investigator); Eisai, MSD, Nippon Boehringer Ingelheim, AstraZeneca, Astellas, Chugai, Daiichi Sankyo, Eli Lilly, Merck Serono, Novartis, Pfizer. H. Horinouchi: Research Grant; Ono pharmaceutical, BMS, MSD, Taiho, Chugai, Novartis, Astellas, Merck Serono. Honoraria; Ono pharmaceutical, BMS, Taiho, Chugai, Novartis, Lilly, AstraZeneca. S. Umemura: Corporate-sponsored research; MSD, AstraZeneca. Honoraria; AstraZeneca, Chugai pharmaceutical, Ono, Boehringer ingelheim. Y. Hosomi: Honoraria; Lilly, Ono pharmaceutical, BMS, Chugai, AstraZeneca. Corporate-sponsored research; Lilly, Ono pharmaceutical, Chugai, AstraZeneca, Taiho, MSD. M. Satouchi: Corporate-sponsored research; Astellas Pharma, AstraZeneca, Boehringer Ingelheim, Bristol-Myers Squibb, Chugai Pharmaceutical, Eli Lilly Japan, Novartis, Ono Pharmaceutical, Pfizer Japan. Lecture fees and/or honoraria; AstraZeneca, Boehringer Ingelheim, Bristol-Myers Squibb, Chugai Pharmaceutical, Eli Lilly Japan, Merck, Novartis, Ono Pharmaceutical, Pfizer Japan, Taiho Pharmaceutical. Y. Ohe: Corporate-sponsored research; Taiho, AstraZeneca, Chugai, Lilly, Pfizer, MSD, Novartis, Kyorin, Dainippon-Sumitomo, Ignyta. Membership on an advisory board or board of directors or other substantive relationships; Taiho, AstraZeneca, Chugai, Lilly, Pfizer, MSD, Novartis, Daiichi-Sankyo, Nipponkayaku, Boehringer Ingelheim, Bayer. All other authors have declared no conflicts of interest.
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135O - A phase 1b study of necitumumab in combination with abemaciclib in patients with stage IV non-small cell lung cancer (ID 592)
11:00 - 12:30 | Presenting Author(s): B. Besse | Author(s): F. Barlesi, I. Demedts, J. Fuentes Pradera, A. Renault, G. Robinet, B. Frimodt-Moller, M. Gil, J. Vansteenkiste
- Abstract
- Presentation
Background:
Necitumumab and abemaciclib inhibit tumor progression by different, independent mechanisms, and both have shown activity in patients with non-small cell lung cancer (NSCLC).
Methods:
This Phase 1b study was a single arm, multicenter trial to explore the safety and efficacy of necitumumab plus abemaciclib in adults with confirmed Stage IV NSCLC, who had received a maximum of 1 other prior chemotherapy for advanced and/or metastatic disease. Part A was a dose escalation study for abemaciclib in combination with necitumumab 800 mg D1D8 Q3W in up to 18 patients to determine the recommended dose for the expansion cohort (Part B, planned for 50 patients). The primary endpoint was progression-free survival (PFS) rate at 3 months compared to the historical PFS rate with single agent epidermal growth factor receptor inhibitors (50%). Secondary efficacy endpoints included PFS, overall response rate (ORR), disease control rate (DCR), and overall survival (OS).
Results:
Sixty-six patients entered the study: 71% male, 61% <65 years of age, 77% ECOG performance status 1, 41% squamous histology, and 15% never smokers. In Part A (n = 15), the maximum tolerated abemaciclib dose was determined to be 150 mg every 12 hours; overall 57 patients received this treatment. The 3-month PFS rate was 32.3% (95% CI: 20.4, 44.8); median PFS was 2.14 months (1.41, 2.76). ORR was 5.3% (1.1, 14.6), and DCR was 47.4% (34.0, 61.0). The median OS was 6.93 months (4.96, 12.85). Treatment-emergent adverse events occurring in ≥30% of all patients (n [%]) included fatigue (34 [51.5]), diarrhea (33 [50.0]), dermatitis acneiform (31 [47.0]), decreased appetite (26 [39.4]), nausea (26 [39.4]), anemia (24 [36.4]), dyspnea (22 [33.3]), hypomagnesemia (21 [31.8]), vomiting (21 [31.8]), and dry skin (20 [30.3]).
Conclusions:
In patients with Stage IV NSCLC, the combination of abemaciclib with necitumumab did not meaningfully impact the PFS rate at 3 months. The safety profile was consistent with the individual study drugs, and no new significant safety concerns emerged.
Clinical trial identification:
ClinicalTrials.gov NCT02411591
Legal entity responsible for the study:
Eli Lilly and Company
Funding:
Eli Lilly and Company
Disclosure:
B. Besse: Research support from Eli Lilly and Company. B. Frimodt-Moller, M. Gil: Employee and stockholder of Eli Lilly and Company. All other authors have declared no conflicts of interest.
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213O - Nintedanib + pemetrexed/cisplatin in malignant pleural mesothelioma (MPM): Phase II biomarker data from the LUME Meso study (ID 206)
11:00 - 12:30 | Presenting Author(s): N. Pavlakis | Author(s): F. Grosso, N. Steele, A. Nowak, S. Novello, S. Popat, L. Greillier, M. Reck, T. Kitzing, G. Scagliotti
- Abstract
- Presentation
Background:
The randomised Phase II/III LUME-Meso study is evaluating nintedanib + pemetrexed/cisplatin versus placebo + pemetrexed/cisplatin (≤6 cycles), followed by nintedanib or placebo maintenance, in chemo-naïve MPM. In the Phase II part, nintedanib treatment led to improved progression-free survival (PFS; hazard ratio [HR] = 0.54; p = 0.010) and a trend for longer overall survival (OS; HR = 0.77; p = 0.319) compared with placebo. Patients with epithelioid tumours derived greatest benefit. Plasma angiogenic factors and genomic markers were explored for potential associations with treatment outcome in the Phase II epithelioid population.
Methods:
Baseline plasma levels of 58 angiogenic factors were analysed by multiplex immunoassay (Human AngiogenesisMAP®, Myriad RBM). Genes implicated in the nintedanib mode of action and/or mesothelioma pathophysiology (VEGFR1, VEGFR3 and mesothelin) were evaluated for known single-nucleotide polymorphisms (SNPs). Biomarker associations with PFS/OS treatment effects were analysed by Cox regression and interaction tests with false-discovery rate (FDR) adjustment. Analyses were exploratory and hypothesis generating.
Results:
Angiogenic factor and genomic data were available for 71 and 67 patients, respectively, in the epithelioid population (n = 77). Of the angiogenic factors evaluated, only endoglin showed a possible trend for association with both PFS and OS improvement, with potentially greater benefit in patients with low plasma levels. Major homozygous genotypes for two VEGFR3 SNPs (rs307821 G/G and rs307826 A/A) showed weak association with OS effect, while the VEGFR1 SNP rs9582036 A/A genotype was potentially correlated with PFS benefit. However, all biomarker treatment associations were limited by small subgroup size (especially for minor genotypes) and FDR-adjusted interaction tests were not significant.
Conclusions:
These first biomarker results for nintedanib-treated MPM showed potential signals for greater PFS/OS benefits in patients with low plasma endoglin and major homozygous VEGFR1/3 genotypes, but no biomarkers showed clear and significant association with nintedanib efficacy.
Clinical trial identification:
NCT01907100
Legal entity responsible for the study:
Boehringer Ingelheim
Funding:
Boehringer Ingelheim
Disclosure:
N. Pavlakis: Advisory Boards: Boehringer Ingelheim, MSD, Merck, BMS, Astra Zeneca, Takeda, Bayer, Novartis, Pfizer, Roche, Ipsen Speaking Honoraria: Boehringer Ingelheim, Bayer, Novartis, Pfizer, Roche Travel Support: BMS, Astra Zeneca, Roche. N. Steele: Honoraria: Pfizer, Novartis Consulting/advisory role: MSD, Boehringer Ingelheim, BMS Research funding: Merck Serono, AstraZeneca, Boehringer Ingelheim, BMS, Novartis, Roche Travel, accommodation, expenses: Pfizer, MSD Oncology, Boehringer Ingelheim. A. Nowak: Consulting/ Advisory Role: Aduro Biotech, Morphotek, Bayer, AstraZeneca, Sellas Life Sciences, Trizell, Boehringer Ingelheim, Epizyme, Roche Research Funding: Boehringer Ingelheim, AstraZeneca Travel and expenses: Amgen, AstraZeneca, Boehringer Ingelheim. S. Novello: Speakers’ Bureau: AstraZeneca, MSD, Bristol-Myers Squibb, Roche, Pfizer, Eli Lilly. S. Popat: Honoraria: Pfizer, Boehringer Ingelheim, Eli Lilly, AstraZeneca, Novartis, Roche Consulting/advisory role: Boehringer Ingelheim, Eli Lilly, Pfizer, Novartis, Roche Research funding: Boehringer Ingelheim, Epizyme, BMS, Clovis Oncology, Eli Lilly, Roche. L. Greillier: Honoraria: Boehringer Ingelheim, Bristol-Myers Squibb, Eli Lilly, Pfizer, AstraZeneca, Novartis Pharma, Roche Consulting/advisory role: Boehringer Ingelheim, Bristol-Myers Squibb, Roche Research funding: Roche. M. Reck: Honoraria: Boehringer Ingelheim, Proacta, BMS, MSD, Pfizer, Eli Lilly, AstraZeneca, Merck Inc., Celgene, Novartis Consulting/advisory role: Boehringer Ingelheim, Eli Lilly, BMS, MSD, Pfizer, AstraZeneca, Merck Inc., Celgene, Novartis, Roche Speaker's bureau: Roche, Eli Lilly, MSD Oncology, Merck, AstraZeneca, BMS, Boehringer Ingelheim, Celgene, Pfizer, Novartis. T. Kitzing: Employment: Boehringer Ingelheim. G. Scagliotti: Honoraria: Eli Lilly, Pfizer, MSD, AstraZeneca, Roche Consulting/Advisory role: Eli Lilly Speakers’ Bureau: Eli Lilly, MSD. All other authors have declared no conflicts of interest.
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214O - Multiplexed proteomics biomarkers for malignant pleural mesothelioma detection in blood (ID 385)
11:00 - 12:30 | Presenting Author(s): F. Cerciello | Author(s): M. Choi, S.L. Sinicropi-Yao, E. Felley-Bosco, R.A. Stahel, B. Robinson, J. Creaney, H.I. Pass, O. Vitek, D.P. Carbone
- Abstract
Background:
Blood biomarkers are not routinely applied for the diagnosis of malignant pleural mesothelioma (MPM). We investigated a multiplexed biomarkers signature composed of 6 glycopeptides for the diagnosis of MPM in blood using mass spectrometry based targeted proteomics.
Methods:
We applied the targeted proteomics technology selected reaction monitoring (SRM, also known as multiple reaction monitoring – MRM) to investigate more than 400 serum samples from early and advanced stages MPM patients and asbestos exposed donors. Samples were from biobanks in the USA, Australia and Europe. Samples were enriched for N-linked glycoproteins using hydrazide chemistry. After tryptic digestion, N-linked glycopeptides were separated by liquid chromatography before analysis on a triple quadrupole mass spectrometer (LC-MS/MS). Logistic regression was fitted on a training set of 212 samples followed by evaluation of predictive accuracy of the signature in a validation set of 193 samples.
Results:
The proteomics platform for serum processing on 96-well plates and LC-MS/MS analysis had coefficient of variation between 2.0 and 11.4% for peptide quantification over more than 700 measurements, and standard deviation of 0.42 for processing more than 400 replicates. The predictive accuracy for MPM discrimination was significantly higher using multiplexed biomarkers by mass spectrometry compared to using single biomarkers alone. The multiplexed proteomics signature separated MPM patients and asbestos exposed donors with an area under the receiver operating characteristic curve (AUC) of 0.72 in the validation set, and AUC for discriminating early stage MPM from asbestos exposed donors was 0.74. Predictive accuracy of the proteomics signature was not inferior to the currently best available MPM blood biomarker soluble-mesothelin related peptides (SMRP) measured in the samples of the validation set using an enzyme-linked immunosorbent assay (ELISA) approved by the US food and drug administration (FDA). Furthermore, signature was significantly associated with survival of MPM patients after treatment.
Conclusions:
Mass spectrometry based proteomics biomarkers have potential for MPM diagnosis in blood.
Clinical trial identification:
Legal entity responsible for the study:
The Ohio State University Medical Center
Funding:
Kathy and Jay Worly Lung Cancer Early Detection Fund Don Ward, President, Special Claims Services, Inc. at The Ohio State University Comprehensive Cancer Center (OSUCCC) The Swiss National Science Foundation (postdoc mobility fellowship)
Disclosure:
All authors have declared no conflicts of interest.
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Opening and welcome (ID 43)
- Event: ELCC 2018
- Type: Opening and welcome
- Track:
- Presentations: 4
- Moderators:L. Paz-Ares, M. Perol
- Coordinates: 4/11/2018, 13:30 - 13:45, Room B
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2018 HHH Award Winner Introduction (ID 705)
13:30 - 13:45 | Presenting Author(s): S. Peters
- Abstract
- Presentation
Abstract not provided
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Introduction to ESMO (ID 701)
13:30 - 13:45 | Presenting Author(s): S. Peters
- Abstract
- Presentation
Abstract not provided
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Introduction to IASLC (ID 702)
13:30 - 13:45 | Presenting Author(s): G. Scagliotti
- Abstract
Abstract not provided
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Welcome to the Congress (ID 700)
13:30 - 13:45 | Presenting Author(s): M. Perol, L. Paz-Ares
- Abstract
- Presentation
Abstract not provided
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Author of
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Closing remarks (ID 53)
- Event: ELCC 2018
- Type: Closing remarks
- Track:
- Presentations: 1
- Moderators:M. Perol, L. Paz-Ares
- Coordinates: 4/14/2018, 12:50 - 13:00, Room A
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Save the date (ID 708)
12:50 - 13:00 | Presenting Author(s): M. Perol
- Abstract
Abstract not provided
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Immunotherapy and next-generation TKIs: From second to frontline treatment (ID 55)
- Event: ELCC 2018
- Type: Poster Discussion session
- Track:
- Presentations: 1
- Moderators:P. Garrido Lopez, S. Ekman, S. Ortiz-Cuaran, E. Wauters
- Coordinates: 4/12/2018, 07:45 - 09:00, Room A
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138PD_PR - Patient-reported outcomes (PROs) in ALEX: A phase III study of alectinib (ALEC) vs crizotinib (CRIZ) in non-small-cell lung cancer (NSCLC) (ID 464)
07:45 - 09:00 | Presenting Author(s): M. Perol
- Abstract
Background:
ALEC showed superior efficacy versus CRIZ in patients (pts) with treatment-naïve ALK+ NSCLC in the phase III ALEX trial (NCT02075840). PRO data (disease burden, symptom tolerability and health-related quality of life [HRQoL]) are reported here.
Methods:
Pts (n = 303) were randomised 1:1 to receive ALEC (600 mg BID) or CRIZ (250 mg BID). Primary endpoint: investigator-assessed PFS. PROs were collected using EORTC QLQ-C30/QLQ-LC13 questionnaires. Pre-specified endpoints: time-to-deterioration (TTD) in lung cancer symptoms and HRQoL, longitudinal analyses of mean score changes from baseline, and proportion of pts with clinically meaningful change (≥10-point change from baseline) during treatment in the ITT population and patients with baseline CNS metastases.
Results:
Baseline completion rates and characteristics were balanced between arms in the PRO-evaluable population (ALEC n = 100, 65.8%; CRIZ n = 97, 64.2%). Median TTD in composite symptom endpoint (cough, dyspnoea, chest pain) was similar between arms (HR 1.10 [95% CI 0.72–1.68]). On average, ALEC pts reported a clinically meaningful improvement in baseline lung cancer symptoms for a longer duration of time versus CRIZ (cough, week 96 vs week 84; chest pain, week 96 vs week 80; fatigue, week 96 vs 68; pain in other parts, week 96 vs 68, respectively). Differences in lung symptoms between treatment arms tended to favour ALEC from 11.1 months (45 weeks), which was around the time of median PFS with CRIZ. ALEC pts reported a clinically meaningful improvement from baseline in HRQoL for a longer duration of time than CRIZ pts (week 88 vs 68, respectively). Fewer ALEC pts experienced a clinically meaningful worsening in treatment-related symptoms (nausea/vomiting, diarrhoea, appetite loss, dysphagia, peripheral neuropathy) than CRIZ pts.
Conclusions:
TTD for lung cancer symptoms was comparable between arms. Clinically meaningful improvement in lung cancer symptoms was maintained for longer with ALEC versus CRIZ, consistent with the improved PFS with ALEC versus CRIZ. HRQoL was improved with ALEC versus CRIZ. PRO data are consistent with ALEX safety data and confirm greater tolerability with ALEC versus CRIZ.
Clinical trial identification:
BO28984; 15 April 2016
Legal entity responsible for the study:
F. Hoffmann-La Roche Ltd
Funding:
F. Hoffmann-La Roche Ltd
Disclosure:
M. Perol: Advisory role for Roche and Pfizer. S. Peters: Education grants, provided consultation, attended advisory boards and/or provided lectures for the following organisations: Amgen, AstraZeneca, Boehringer-Ingelheim, Bristol-Myers Squibb, Clovis, Eli Lilly, F. Hoffmann-La Roche, Janssen, Merck Sharp and Dohme and Merck Serono, Pfizer, Regeneron and Takeda. N. Pavlakis: Advisory role for Novartis, Takeda, Roche and Pfizer. S. Novello: Speakers Bureau for: Eli Lilly, BMS, MSD, F. Hoffmann-La Roche Ltd and Astra Zeneca. T. Karagiannis: Employee of, owns stocks in and has taken part in company-sponsored research for Genentech. A. Zeaiter: Employee of F.Hoffman-La Roche Ltd. R. Dziadziuszko: Substantive relationships with Novartis, Pfizer and BMS. All other authors have declared no conflicts of interest.
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New approaches in rare thoracic tumors (ID 60)
- Event: ELCC 2018
- Type: Proffered Paper session
- Track:
- Presentations: 1
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Invited Discussant 135O (ID 696)
11:00 - 12:30 | Presenting Author(s): M. Perol
- Abstract
- Presentation
Abstract not provided
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Opening and welcome (ID 43)
- Event: ELCC 2018
- Type: Opening and welcome
- Track:
- Presentations: 1
- Moderators:L. Paz-Ares, M. Perol
- Coordinates: 4/11/2018, 13:30 - 13:45, Room B
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Welcome to the Congress (ID 700)
13:30 - 13:45 | Presenting Author(s): M. Perol
- Abstract
- Presentation
Abstract not provided
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