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B. Besse
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5th ESO Lung Cancer Observatory (ID 52)
- Event: ELCC 2018
- Type: Special session
- Track:
- Presentations: 1
- Moderators:M.S. Aapro, E. Felip
- Coordinates: 4/13/2018, 16:45 - 18:15, Room W
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Developments in immunotherapy: What practice changing studies will mature in 2019? (ID 289)
16:45 - 18:15 | Presenting Author(s): B. Besse
- 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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144PD - Leptomeningeal metastases in EGFR-mutated non-small cell lung carcinoma: Management after tyrosine kinase inhibitors (ID 611)
07:45 - 09:00 | Author(s): B. Besse
- Abstract
Background:
Leptomeningeal metastases (LM) in non-small-cell lung carcinoma (NSCLC) are associated with poor outcome. Tyrosine kinase inhibitors (TKIs) are active in LM+ EGFR mutated (EGFRm) patients (pts), but optimal patient's management after failure of TKIs is unknown.
Methods:
We included consecutive pts with EGFRm NSCLC who had LM progression during first-line EGFR TKI, defined as diagnosis of LM during TKI treatment or progression of known LM after first-line TKI, treated in our institution. Clinical and pathological data were retrospectively collected. We evaluated overall survival (OS), progression-free survival (PFS), clinical response rate (CRR), and disease control rate (DCR) defined as clinical response or stable disease >2 months.
Results:
We included 66 pts treated between Apr. 2003 and Sept. 2016, with a median age of 54 years [26–79]; 51 (77%) were females; 56 (85%) non-smokers. Twenty-three tumors (35%) had exon 19 deletion, 23 (35%) L858R exon 21 mutation, 10 (15%) T790M mutation. Median number of previous lines was 2 [1–7], and 19 pts (29%) had additional intrathecal treatment. 2[nd] line TKI was given to 36 pts (55%): 19 (53%) received erlotinib, 10 (28%) high dose (HD) erlotinib (300 mg daily), 3 osimertinib, 4 other 1[st]/2[nd] generation TKI (3 gefitinib, 1 afatinib). Median PFS and OS from LM progression were 3 months (m) [CI95% 2–3] and 7 m [CI95% 3–16], respectively. CRR and DCR for 2nd-line TKI were 43% and 77%. Nine pts (25%) were alive at 10 m (6 erlotinib, 1 HD erlotinib, 2 osimertinib). Median OS for erlotinib, HD erlotinib, osimertinib and other 1[st]/2[nd] generation TKI were 8 m (CI 95% 7–16), 3 m (CI 95% 2-not reached (NR)), NR (CI 95% NR-NR), and 2.5 m (CI 95% 0-NR), respectively. Patients treated with erlotinib, of whom 79% received prior afatinib or gefitinib, had better OS compared to patients treated with other 1[st]/2[nd] generation TKI (8 m vs. 2.5 m, P = 0.04). CRR and DCR in patients with HD erlotinib were 40% and 60%, respectively, of whom 80% received prior erlotinib.
Conclusions:
2[nd]-line TKI can increase survival in LM+ EGFRm NSCLC previously treated with TKI. Sequential erlotinib after prior gefitinib or afatinib seems to be a suitable strategy. Increasing erlotinib dose has demonstrated clinical benefit.
Clinical trial identification:
Legal entity responsible for the study:
Gustave Roussy
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: 1
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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
- 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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Poster Display session (Friday) (ID 65)
- Event: ELCC 2018
- Type: Poster Display session
- Track:
- Presentations: 1
- Moderators:
- Coordinates: 4/13/2018, 12:30 - 13:00, Hall 1
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182P - Real world anti-PD-L1 treatment (tx) outcomes in a multinational European non-small cell lung cancer (NSCLC) cohort with focus on toxicity (tox) and brain metastases (BM): Preliminary data from an EORTC young investigators lung cancer group collaborative analysis (ID 432)
12:30 - 13:00 | Author(s): B. Besse
- Abstract
Background:
Anti-PD-(L)1 (IO) tx has been approved for treating incurable NSCLC patients (pts) in 1st line and beyond. Outcome of pts with BM is not well known as these pts were often excluded from clinical trials. Similarly, there are limited data in pts that discontinue tx due to tox (TOX+). We evaluated outcome of pts with BM at baseline IO (BM+) and IO tox pts in a real world European cohort.
Methods:
Retrospective multicenter data collection (1 NL, 1 UK, 2 IT) including all consecutive IO treated NSCLC pts. Primary outcomes: progression free and overall survival (PFS/OS) from start IO to progression (PD) or death, respectively of BM+ pts and TOX+ pts (≥gr 2 IO related tox). Secondary: BM development during IO.
Results:
Between 05-′15 and 10-′17 150 pts received IO: 26% pembro, 74% nivo. 5.3%, 60.7% and 34% received IO as 1st, 2nd or ≥2 line, respectively. 60.7% male, median age 65.7 years, WHO PS 0-1/2-3/unknown: 89.3/9.3%/1.3%, respectively, 87% current/former smoker, 65% non-squamous histology, 4% EGFR/ALK driver mutation (pretreated with TKI). 25 pts (16.7%) BM+ (1 leptomeningeal (LM), 81% of whom pretreated with radiation), baseline characteristics did not significantly differ between BM+ and BM−. 12.6% of all pts developed/had PD of BM during IO. Median FU was 7.8 months (mo). Median PFS was 11.7 vs 4.6 mo (p < 0.001) for BM+ vs BM-, median PFS of the LM pt was 0.3 mo. Median OS was not reached for BM+ pts and was 9.4 mo for BM- pts (p < 0.001). 46 pts (30.6%) had grade ≥ 2 IO related tox, 13 pts (8.7%) discontinued IO without having PD (76.9% grade ≥3). Median time on IO for TOX+ discontinuing pts was 4.8 mo. 38.5% of the TOX+ pts had PD after discontinuation. Median PFS and OS of TOX+ vs TOX- pts was 16.3 vs 10.2 and 17.7 vs 15.0 mo respectively with a trend towards longer survival for TOX+ pts (both p ns).
Conclusions:
With limited FU, (irradiated) BM+ is not a negative prognostic marker in IO treated pts, as PFS/OS are significantly longer compared to BM-. Development/PD of BM during IO is low. Discontinuation because of tox while responding does not negatively impact on survival in most pts.
Clinical trial identification:
Legal entity responsible for the study:
Authors
Funding:
Has not received any funding
Disclosure:
All authors have declared no conflicts of interest.
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Second line in non-oncogene addiction (ID 8)
- Event: ELCC 2018
- Type: Educational session
- Track:
- Presentations: 1
- Moderators:E. Garon, S. Novello
- Coordinates: 4/12/2018, 09:00 - 10:30, Room B
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Hyperprogressive disease in second-line (ID 30)
09:00 - 10:30 | Presenting Author(s): B. Besse
- Abstract
- Presentation
Abstract not provided
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