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D. Ardron
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MINI 28 - Psychological Impact of Lung Cancer and its Treatment (ID 150)
- Event: WCLC 2015
- Type: Mini Oral
- Track: Palliative and Supportive Care
- Presentations: 1
- Moderators:A. Oton
- Coordinates: 9/09/2015, 16:45 - 18:15, 102+104+106
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MINI28.09 - Can WBRT Be Omitted in NSCLC Patients with Inoperable Brain Metastases? Results from the UK MRC QUARTZ Randomised Clinical Trial (ID 2914)
17:35 - 17:40 | Author(s): D. Ardron
- Abstract
- Presentation
Background:
Brain metastases affect up to 40% of patients with non-small cell lung cancer (NSCLC), and for patients not suitable for surgical resection or stereotactic radiosurgery, whole brain radiotherapy (WBRT) and dexamethasone is standard treatment. However there are no randomised clinical trials showing whether WBRT improves either quality of life (QoL) or survival.
Methods:
A phase III randomised non-inferiority trial with a primary outcome measure of quality adjusted life years (QALYs). Patients with brain metastases from NSCLC who were not suitable for resection or stereotactic radiotherapy, irrespective of any other clinical characteristics, were randomly allocated to either optimal supportive care, including dexamethasone, plus WBRT 20 Gy/5f (OSC+WBRT) or OSC alone. QALYs were generated from overall survival and patients’ weekly completion of the EQ-5D questionnaire. OSC alone was considered non-inferior if not greater than 7 QALY days worse than OSC+WBRT (80% power and a one sided significance level of 5% requiring 534 patients). Secondary outcome measures include sub-group analyses to identify/validate predictive classifications.
Results:
From 2007-2014 538 patients were recruited from 69 UK and 3 Australian centres. Summary trial information is presented in table 1, with baseline characteristics well balanced between trial arms. Median survival was 65 days (OSC+WBRT) vs 57 days (OSC), hazard ratio 1.05 (95% CI 0.89 – 1.26). The mean QALY was 43.3 days (OSC+WBRT) vs 41.4 days (OSC), difference -1.9 days (90% CI -9.1 – +6.6). More OSC patients received additional anti-cancer treatment (39% vs 25%, p-value=0.0004), particularly radiotherapy (22% vs 13%, p-value=0.0067), with palliative thoracic irradiation in the two weeks following randomisation accounting for most of the difference. At 4 weeks post-randomisation, 36% of patients in each arm were alive with maintained or improved QoL compared to baseline. This fell to 17% in each arm at 8 weeks. The most commonly reported problems at 4 weeks concerned mobility (73% WBRT vs 79% OSC) and the ability to perform usual activities (68% vs 67%). Table 1. Summary of main trial dataOSC+WBRT (N=269) OSC (N=269) Sex Male 157 (58%) 157 (58%) Age Median 66 67 IQR 60 – 72 62 – 72 Range 38 – 84 45 – 85 KPS <70 101 (38%) 102 (38%) ≥70 168 (62%) 167 (62%) Extra-cranial mets No 122 (45%) 124 (46%) Number of brain mets Solitary 80 (30%) 82 (30%) Time since brain mets diagnosis <= 4 weeks 165 (61%) 153 (57%) > 4 weeks 104 (39%) 116 (43%) Median (days) 23 26 Range (days) 2 – 235 0 – 196 Survival (weeks) Deaths 260 262 One-year (95% CI) 2.6% (1.1%, 5.1%) 2.7% (1.2%, 5.3%)
Conclusion:
This is the only large randomised trial evaluating the utility of WBRT in this disease. Although the results include the pre-specified non-inferiority margin, the estimate of the difference in QALYs suggests WBRT provides no additional clinically significant benefit for this group of patients. Additionally there were no significant differences in overall survival or quality of life. .
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