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L. Hughes
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P3.02b - Poster Session with Presenters Present (ID 494)
- Event: WCLC 2016
- Type: Poster Presenters Present
- Track: Advanced NSCLC
- Presentations: 1
- Moderators:
- Coordinates: 12/07/2016, 14:30 - 15:45, Hall B (Poster Area)
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P3.02b-046 - Afatinib Benefits Patients with Confirmed/Suspected EGFR Mutant NSCLC, Unsuitable for Chemotherapy (TIMELY Phase II Trial) (ID 4195)
14:30 - 14:30 | Author(s): L. Hughes
- Abstract
Background:
Afatinib is licensed for EGFR-mutant NSCLC without prior TKI therapy, but its efficacy and toxicity in patients unsuitable for platinum-doublet chemotherapy is unknown. One previous study suggested that TKIs could benefit medically unfit EGFR-mutant East Asian patients. We conducted the first such study in a Western population.
Methods:
Single arm phase-II trial. Eligible patients with histologically confirmed NSCLC, comorbidities precluding chemotherapy, with either: (i) confirmed EGFR-mutation and PS 0-3, or (ii) suspected EGFR-mutation (no suitable tissue for genotyping or failed genotyping), but never/former-light smoker, adenocarcinoma and PS 0-2. Patients received oral afatinib (20-40mg daily) until disease progression/toxicity. CT scans performed 4 weeks after starting treatment then every 8 weeks in first year until progression, thereafter every 12 weeks. Primary endpoint was 6-month RECIST-defined progression-free-survival (target 30%).
Results:
39 patients were recruited across 14 UK centres (March 2013-August 2015). Median age 72 years (range 36-90); 30 females, 9 males; 20 confirmed and 19 suspected EGFR-mutant; 8 former and 11 never smokers (among suspected EGFR-positives); 1,1,7,30 in each stage IA,IIIA,IIIB,IV; and 27 PS 0-1, 12 PS 2-3. As of July 2016, 7 patients were still taking afatinib (median time on drug 11 months, range 10-16), and 11 stopped for toxicity. 23/39 patients had at least one grade ≥3 afatinib-related toxicity (all gd3, except two with gd4 [sepsis and hypokalemia], one fatal pneumonitis), mainly: n=13 diarrhoea; n=4 vomiting; n=3 dehydration; n=3 mouth ulcer, all expected for afatinib, and unsurprising in this unfit group. The table shows efficacy. 6-month PFS rate (58%) far exceeded the 30% target; similarly for patients with confirmed (74%) or suspected (41%) EGFR-mutation.Efficacy (26 PFS events, 21 deaths)
Rate (95%CI) at month Alive & progression-free Overall-survival All patients (n=39) 6 58% (43-74) 74% (60-88) 12 34% (18-50) 64% (48-80) Median, months (95%CI) 7.9 (4.6-10.2) 15.5 (10.9-25.1) Confirmed EGFR mutant (n=20) 6 74% (55-94) 85% (69-100) 12 47% (24-70) 85% (69-100) Median, months 10.2 (5.9-not estimable) Not reached Suspected EGFR mutant (n=19) 6 41% (19-64) 63% (41-85) 12 21% (0.1-41) 42% (18-66) Median, months 4.4 (2.6-8.0) 10.9 (3.9-21.0) Lower 95%CI for all 6-month PFS-rates exceed the pre-specified 15% minimum rate. 13% patients survived ≥18 months. 23% patients did not progress <12 months
Conclusion:
The toxicity rate was higher compared to that in fitter patients, but afatinib seems to improve PFS and OS in unfit EGFR-mutant NSCLC, and in suspected-positive patients who would otherwise only receive best supportive care.
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P3.06 - Poster Session with Presenters Present (ID 492)
- Event: WCLC 2016
- Type: Poster Presenters Present
- Track: Trial Design/Statistics
- Presentations: 1
- Moderators:
- Coordinates: 12/07/2016, 14:30 - 15:45, Hall B (Poster Area)
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P3.06-003 - SARON: Stereotactic Ablative Radiotherapy for Oligometastatic Non-Small Cell Lung Cancer (NSCLC). A UK Randomised Phase III Trial (ID 3814)
14:30 - 14:30 | Author(s): L. Hughes
- Abstract
Background:
It has been theorised that local ablative therapy such as stereotactic ablative radiotherapy (SABR) and stereotactic radiosurgery (SRS) could improve outcomes for patients with oligometastatic disease. There is now growing evidence to support the safety, local control effect and potential improvement in overall survival (OS) for SABR/SRS to warrant a randomised phase III trial. The SARON trial investigates the impact on OS of radiotherapy (RT) plus SABR/SRS following standard chemotherapy in patients with oligometastatic NSCLC and will undertake an early evaluation of feasibility and toxicity.
Methods:
SARON is a randomised, multicentre, phase III trial for patients with oligometastatic NSCLC (1-3 sites of synchronous metastatic disease). An early feasibility review will take place after 50 randomised patients. Patients requiring both conventional thoracic RT to the primary and SABR to a thoracic metastasis will be included in a sub-study to more thoroughly assess toxicity and planning issues. 340 patients will be recruited from 30 UK sites, to randomise 306 patients (1:1) to receive either platinum doublet chemotherapy alone (control arm) or platinum doublet chemotherapy followed by radical RT/SABR to their primary tumour and then SABR and/or SRS to all other metastatic sites (investigational arm). Figure 1
Results:
The primary endpoint is OS, and the study is powered to detect an improvement in median survival from 9.9 months in the control arm to 14.3 months in the investigational arm (85% power, 5% two-sided alpha). The secondary endpoints include progression free survival, toxicity, local control of primary and metastases, and quality of life.
Conclusion:
The study will open in Q3 2016 and is supported by Cancer Research UK (C13530/A18015).
