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Corinne Faivre-Finn
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Mini Oral session II (ID 63)
- Event: ELCC 2019
- Type: Mini Oral session
- Track:
- Presentations: 1
- Moderators:
- Coordinates: 4/11/2019, 16:40 - 17:40, Room C
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85O - Prevalence of programmed death ligand-1 (PD-L1) by demographic, disease and sample characteristics in unresectable, stage III NSCLC (PACIFIC) (ID 305)
16:40 - 17:40 | Author(s): Corinne Faivre-Finn
- Abstract
- Presentation
Background
PACIFIC (NCT02125461) was a randomised, placebo-controlled, phase 3 trial evaluating the immune checkpoint inhibitor durvalumab in patients (pts) with unresectable, Stage III non-small cell lung cancer (NSCLC) who did not have disease progression after concurrent chemoradiotherapy (cCRT). Both primary endpoints of progression-free survival and overall survival were met and significantly improved with durvalumab, with similar safety, versus placebo (Antonia et al, NEJM 2017; 2018). We report exploratory analyses of the prevalence of tumour PD-L1 expression by baseline pt, disease and sample characteristics and by response to prior treatment for pts in PACIFIC.
a9ded1e5ce5d75814730bb4caaf49419 Methods
If available (provision of formalin-fixed paraffin-embedded tumour resection or biopsy samples was optional), archived pre-cCRT tumour tissue was tested retrospectively for PD-L1 tumour cell (TC) expression using the VENTANA PD-L1 (SP263) immunohistochemistry assay and scored at validated pre-specified (≥25%) and post-hoc (≥1%) cutoffs. Overall PD-L1 prevalence (regardless of treatment arm) was summarised by pt subgroups defined by various characteristics, and assessed using a Pearson’s chi-squared test for between-group differences.
20c51b5f4e9aeb5334c90ff072e6f928 Results
Of 713 randomized pts, 451 (63.2%) were evaluable for PD-L1 status. Among PD-L1-evaluable pts, 67.2% (303/451) had TC ≥ 1% and 35.3% (159/451) had TC ≥ 25% (similar to previous reports in metastatic NSCLC). PD-L1 prevalence by various characteristics at the TC ≥ 1% cut-off are reported in the table.
fd69c5cf902969e6fb71d043085ddee6 Conclusions
There were no important differences noted in PD-L1 prevalence between relevant subgroups at the TC ≥ 1% or TC ≥ 25% cut-offs (latter data to be presented). PD-L1 status was unaffected by sample type or age or biopsy location, suggesting expression is stable from pre-cCRT diagnostic biopsies, and supports the use of either primary tumour or lymph node biopsies for PD-L1 testing.
b651e8a99c4375feb982b7c2cad376e9 Clinical trial identification
NCT02125461.
7a6a3ffa2dadc03a6151ee2c4d6fa383 Editorial acknowledgement
Medical writing support, which was in accordance with Good Publication Practice (GPP3) guidelines, was provided by Andrew Gannon of Cirrus Communications, an Ashfield company, and was funded by AstraZeneca.
934ce5ff971f1ab29e840a35e3ca96e9 Legal entity responsible for the study
AstraZeneca.
213f68309caaa4ccc14d5f99789640ad Funding
AstraZeneca.
682889d0a1d3b50267a69346a750433d Disclosure
D. Planchard: Personal fees: AstraZeneca, Boehringer Ingelheim, BMS, MSD, Pfizer, Novartis, Roche, Celgene, outside the submitted work. M.C. Garassino: Personal fees: AstraZemeca, Roche, BMS, MSD outside the conduct of this study. L. Paz-Ares: Advisory board fees: BMS, Lilly, MSD, AstraZeneca, Roche, Pfizer, Novartis, Incyte, Merk, Boehringer Ingelheim. C. Faivre-Finn: Research funding:AstraZeneca, MSD. A. Spira: Advisory fees, institutional research support: AstraZeneca. Y. Gu, J. Whiteley, M. Scott, J. Walker: Employment, stock: AstraZeneca. C. Wadsworth, P.A. Dennis: Employment, stock: AstraZeneca, outside the conduct of the study. A-M. Boothman: Employment, stock options: AstraZeneca, outside the conduct of the study. M. Ratcliffe: Consultant fees: AstraZeneca, outside the conduct of the study. All other authors have declared no conflicts of interest.
cffcb1a185b2d7d5c44e9dc785b6bb25Only Members that have purchased this event or have registered via an access code will be able to view this content. To view this presentation, please login, select "Add to Cart" and proceed to checkout. If you would like to become a member of IASLC, please click here.
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Mini Oral session III (ID 65)
- Event: ELCC 2019
- Type: Mini Oral session
- Track:
- Presentations: 1
- Moderators:
- Coordinates: 4/12/2019, 17:45 - 18:45, Room C
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72O - Multi-centre analysis of cardiac events following radical radiotherapy for lung cancer (ID 235)
17:45 - 18:45 | Author(s): Corinne Faivre-Finn
- Abstract
- Presentation
Background
Radical radiotherapy (RRT) plays an essential role in the management of early and locally advanced lung cancer. Recent studies suggest cardiac events post radiotherapy worsen survival outcome for patients. This study aims to identify risk factors which predispose patients to cardiac events post radiotherapy.
a9ded1e5ce5d75814730bb4caaf49419 Methods
All patients who received RRT (including Stereotactic Body Radiotherapy (SBRT), radical fractionated radiotherapy and chemoradiotherapy) for lung cancer between 01/01/2010 to 30/12/2016 at 2 UK institutions have been included. Patients were excluded if they had multiple courses of radiotherapy to the chest. Individual patient clinical information has been retrieved from hospital electronic database. Patient and cancer demographics have been collected. Pre-existing cardiac conditions, Charlsons’ Co-morbidity index and Qrisk 3 scores were calculated. Post radiotherapy cardiac events were identified rom electronic patient records and time to cardiac events were calculated.
20c51b5f4e9aeb5334c90ff072e6f928 Results
600 patients have been identified so far and processed. Median follow up is 31 months. Of all patients, 29% had pre-existing cardiac conditions. 52 patients experienced cardiac events following radiotherapy, of which 37% were ischaemic events. Of patients who experienced an ischaemic event, 58% did not have a known pre-existing cardiac condition. 71% of cardiac events post RRT occurred in the first 2 years following RT. Proportionally, patients who underwent radical fractionated radiotherapy and concurrent chemoradiotherapy had the highest incidence of cardiac events. Patient characteristics of those who experienced cardiac toxicity are summarized in the table below
fd69c5cf902969e6fb71d043085ddee6 ConclusionsTotal = 52 (10%) Ischaemic events 19 (7 events lead to death – Grade 5) Pericardial(effusion) events 8 Arrhythmic events 13 Cardiac failure events 12 Pre-existing cardiac diagnosis Patients who had ischaemic events 8/19 (4 previous MI, 2 IHD, 1 arrythmia and 1 valve abnormality Patients who had pericardial events 1/8 (arrhythmia) Patients who had arrhythmic events 6/13 (2 previous MI, 2 IHD, 1 CCF, 1 CCF and arrhythmia) Patients who had CCF events 9/12 (2 previous MI, 5 IHD, 2 valvular abnormality) Sex Male = 33 Female = 19 Age Median = 73 Smoking Never smoked 0 Ex-Smoker <10 PY 0 Ex-smoker <20 PY 9 Ex-Smoker 20-40PY 15 Ex-Smoker >40 PY 9 Current Smoker 19 Charlson Score Median = 6 RT indication Adjuvant RT 4 (12.5% of all Adjuvant RT) SBRT 19 (8.7% of all SBRT) Concurrent ChemoRT 10 (14.5% of all Concurrent ChemoRT) Sequential ChemoRT 0 Radical Fractionated RT 19 (15.6% of all Radical Fractionated RT) Tumour Location Left Upper Lobe(LUL) 12 (8% of all LUL tumours) Left Lower Lobe(LLL) 11 (17% of LLL tumours) Right Upper Lobe(RUL) 16 (9% of RUL tumours) Right Middle Lobe(RML) 1 (3% of RML tumours) Right Lower Lobe(RLL) 12 (17% of RLL tumours)
A clinically significant proportion of patients developed cardiac toxicity following radical radiotherapy for lung cancer. Cardiac events occur much sooner after lung cancer radiotherapy than radiotherapy for breast cancer or lymphoma. Work is ongoing to identify greater number of patients and combine local data with data from national registry to aid analysis.
b651e8a99c4375feb982b7c2cad376e9 Legal entity responsible for the study
The authors.
213f68309caaa4ccc14d5f99789640ad Funding
Yorkshire Cancer Research.
682889d0a1d3b50267a69346a750433d Disclosure
All authors have declared no conflicts of interest.
cffcb1a185b2d7d5c44e9dc785b6bb25Only Members that have purchased this event or have registered via an access code will be able to view this content. To view this presentation, please login, select "Add to Cart" and proceed to checkout. If you would like to become a member of IASLC, please click here.
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Optimal management of brain metastases in NSCLC (ID 47)
- Event: ELCC 2019
- Type: Educational session
- Track:
- Presentations: 1
- Moderators:
- Coordinates: 4/13/2019, 09:40 - 11:10, Room C
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The role of brain irradiation (ID 118)
09:40 - 11:10 | Presenting Author(s): Corinne Faivre-Finn
- Abstract
- Presentation
Abstract not provided
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Proffered Paper session I (ID 57)
- Event: ELCC 2019
- Type: Proffered Paper session
- Track:
- Presentations: 1
- Moderators:
- Coordinates: 4/10/2019, 16:30 - 18:15, Room C
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LBA2 - Patient-reported outcomes (PROs) with durvalumab by PD-L1 expression in unresectable, stage III NSCLC (PACIFIC) (ID 308)
16:30 - 18:15 | Author(s): Corinne Faivre-Finn
- Abstract
- Presentation
Background
In the ph 3 PACIFIC study of Stage III NSCLC pts without progression after cCRT, PFS and OS were significantly improved with durva vs. pbo, with no detrimental effect on PROs. We retrospectively investigated the impact of tumour PD-L1 expression on PROs.
a9ded1e5ce5d75814730bb4caaf49419 Background
In the phase 3 PACIFIC study of unresectable, Stage III NSCLC pts without progression after platinum-based concurrent chemoradiotherapy (cCRT), the primary endpoints PFS and OS were significantly improved with durvalumab versus placebo with similar safety and no detrimental effect on PROs. We retrospectively investigated the impact of tumour PD-L1 expression on PROs to better understand the benefit/risk profile of durvalumab across all PD-L1 subgroups.
a9ded1e5ce5d75814730bb4caaf49419 Methods
After ≥2 cCRT cycles, pts were randomised (2:1) to durva 10 mg/kg or pbo IV q2w up to 12 mo. If available, optional pre-cCRT tumour tissue was tested for PD-L1 tumour cell (TC) expression using the VENTANA SP263 immunohistochemistry assay and scored at pre-specified (25% or unknown) and post-hoc (1%) cutoffs. PROs were assessed using EORTC QLQ-C30 and -LC13 with changes from BL analysed by a mixed model for repeated measures, HRs for time to deterioration (TTD) by a stratified Cox proportional-hazards model, and ORs for improvement rates by logistic regression.
20c51b5f4e9aeb5334c90ff072e6f928 Methods
After cCRT with ≥2 chemotherapy cycles, pts were randomised (2:1) to durvalumab 10 mg/kg or placebo IV q2w up to 12 months. If available, optional pre-cCRT tumour tissue was tested for PD-L1 tumour cell (TC) expression using the VENTANA SP263 immunohistochemistry assay and scored at pre-specified (25%) and post-hoc (1%) cutoffs. PROs were assessed using EORTC QLQ-C30 and -LC13 with changes from baseline (BL) analysed by a mixed model for repeated measures, hazard ratios (HRs) for time to deterioration (TTD) by a Cox proportional-hazards model, and odd ratios (ORs) for improvement rates by logistic regression.
20c51b5f4e9aeb5334c90ff072e6f928 Results
Of 713 pts, 63% had known PD-L1 status. Compliance was high (>80% at Wk 48) across all five PD-L1 subgroups (TC ≥25%, <25%, ≥1%, <1%, and unknown). Most PROs remained stable; however, similar to the ITT population, clinically relevant improvements from BL to Wk 48 were observed for dysphagia and alopecia across most subgroups (4/5 and 5/5, respectively) for durva (mean changes 10.1−20.9 and 15.5−26.9) and all for pbo (10.4−19.4 and 15.8−31.3); plus improvements with pbo for TC ≥25% (12.5 for chest pain and constipation) and TC <25% (10.0 for appetite loss and arm/shoulder pain). Across most subgroups, there were no TTD differences, except those favouring durva: for TC ≥25%, chest pain (HR=0.57), physical functioning (0.60), emotional functioning (0.47), pain (0.56), and haemoptysis (0.42); and, similar to ITT, for TC ≥25%, <25%, ≥1% and <1%, ‘other pain’ (0.60, 0.57, 0.67 and 0.39, respectively). Improvement rates were also similar, except as follows, favouring durva: for TC ≥25%, role functioning (OR=2.84) and, similar to ITT, appetite loss (4.33); for TC ≥1%, diarrhoea (4.50) and haemoptysis (19.34); and, for TC<1%, ‘other pain’ (7.25); for TC<25%, the rate favoured pbo for cough (0.51).
fd69c5cf902969e6fb71d043085ddee6 Results
Of 713 pts, 63% had known PD-L1 status. Similar to the intent-to-treat (ITT) population, most PROs remained stable over time from BL across the PD-L1 subgroups (TC ≥25%, <25%, ≥1%, <1%, or unknown), with no clinically meaningful (CM) differences (≥10 points) for durvalumab compared to placebo. However, similar to the ITT population, CM improvements (decreases ≥10 points) from BL to Week 48 were observed for dysphagia and alopecia across most PD-L1 subgroups for both durvalumab (mean changes 8.1 [not CM]−20.9 and 15.5 − 26.9, respectively) and placebo (mean changes 10.4 − 19.4 and 15.8 − 31.3). Pre-specified and post hoc TTD analyses of PROs by PD-L1 subgroup were generally similar to those of the ITT population, with overlapping HR and 95% CIs. Similarly, PRO improvement rates by PD-L1 subgroup were generally similar to those of the ITT population, with overlapping OR and 95% CIs.
fd69c5cf902969e6fb71d043085ddee6 Conclusions
Similar to the ITT population, there were minimal between-Tx differences in PROs based on PD-L1 expression, supporting use of the PACIFIC regimen (durvalumab after cCRT) in all comers.
b651e8a99c4375feb982b7c2cad376e9 Conclusions
There were no CM differences in PROs between treatment arms across various PD-L1 subgroups. Results were generally consistent with those in the ITT population, suggesting that PD-L1 expression did not influence PROs in this study.
b651e8a99c4375feb982b7c2cad376e9 Clinical trial identification
NCT02125461
7a6a3ffa2dadc03a6151ee2c4d6fa383 Editorial acknowledgement
Medical writing support, which was in accordance with Good Publication Practice (GPP3) guidelines, was provided by Hashem Dbouk, PhD, of Cirrus Communications, an Ashfield company, and was funded by AstraZeneca.
934ce5ff971f1ab29e840a35e3ca96e9 Editorial acknowledgement
Medical writing support, which was in accordance with Good Publication Practice (GPP3) guidelines, was provided by Andrew Gannon of Cirrus Communications, an Ashfield company, and funded by AstraZeneca.
934ce5ff971f1ab29e840a35e3ca96e9 Legal entity responsible for the study
AstraZeneca.
213f68309caaa4ccc14d5f99789640ad Funding
AstraZeneca.
682889d0a1d3b50267a69346a750433d Disclosure
M.C. Garassino: Personal fees: AstraZeneca, Roche, BMS, MSD. L. Paz-Ares: Advisory fees: BMS, Lilly, MSD, AstraZeneca, Roche, Pfizer, Novartis, Incyte, Merck, Boehringer Ingelheim, outside the conduct of the study. C. Faivre-Finn: Research funding: AstraZeneca, MSD, outside the conduct of the study. A. Spira: Consultant fees, institutional research support: AstraZeneca, outside the conduct of the study. D. Planchard: Personal fees: AstraZeneca, Boehringer Ingelheim, BMS, MSD, Pfizer, Novartis, Roche, Celgene, outside the conduct of the study. M. Ozguroglu: Consultant fees: Astellas; Honoraria: Janssen, outside the conduct of the study. A. Rydén, P.A. Dennis: Employment, stock: AstraZeneca. Y. Zhang, C. O’Brien: Employment, stock: AstraZeneca, outside the conduct of the study. All other authors have declared no conflicts of interest.
cffcb1a185b2d7d5c44e9dc785b6bb25Only Members that have purchased this event or have registered via an access code will be able to view this content. To view this presentation, please login, select "Add to Cart" and proceed to checkout. If you would like to become a member of IASLC, please click here.
