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D. Currow
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P1.06 - Poster Session with Presenters Present (ID 458)
- Event: WCLC 2016
- Type: Poster Presenters Present
- Track: Advanced NSCLC
- Presentations: 1
- Moderators:
- Coordinates: 12/05/2016, 14:30 - 15:45, Hall B (Poster Area)
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P1.06-003 - Anamorelin in Cachectic Patients with Advanced NSCLC, a Post-Hoc Pooled Efficacy Data Analysis of Two Phase 3 Trials (ID 4878)
14:30 - 14:30 | Author(s): D. Currow
- Abstract
Background:
Anorexia-cachexia is a multifactorial syndrome frequently experienced by patients with non-small cell lung cancer (NSCLC). It is characterized by decreased body weight (mainly due to muscle loss) and is associated with worsen morbidity, poor tolerance of chemotherapy and reduced survival. The randomized, double-blind ROMANA 1 and ROMANA 2 phase 3 trials in cachectic NSCLC patients, demonstrated that the ghrelin receptor agonist anamorelin was well tolerated, improved body weight, lean body mass (LBM), fat mass (FM) and anorexia/cachexia symptoms and concerns, with no difference in handgrip strength compared to placebo. Here we assessed pooled efficacy and numbers needed to treat (NNT) from ROMANA 1 and ROMANA 2 studies.
Methods:
Stage III/IV NSCLC patients with cachexia (≥5% weight loss during prior 6 months or BMI<20 kg/m[2]) were randomized (2:1) to daily oral 100 mg anamorelin or placebo for 12 weeks. Endpoints included changes in LBM, FM, total body mass (TBM) and in self-reported anorexia/cachexia symptoms and concerns. We present the pooled efficacy data from a post-hoc analysis from both trials (anamorelin, N=552; placebo, N=277); treatment differences, 95% CI, NNT and nominal p values from baseline to end of study.
Results:
At the end of study, compared with placebo, anamorelin-treated patients significantly increased body composition parameters (LBM, appendicular LBM, FM and TBM), and a greater proportion of patients showed improvements in these parameters (Table). The anamorelin group also significantly improved anorexia/cachexia symptoms and concerns, and compared to placebo, more patients in the anamorelin arm achieved the minimally important difference of 4 points. Figure 1
Conclusion:
Anamorelin has anabolic activity while improving symptom burden in cachectic patients with NSCLC. A significantly greater proportion of patients increased lean mass, fat mass and improved anorexia/cachexia symptoms and concern score in the anamorelin arm versus the placebo arm, with favorable NNT.
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P3.07 - Poster Session with Presenters Present (ID 493)
- Event: WCLC 2016
- Type: Poster Presenters Present
- Track: Regional Aspects/Health Policy/Public Health
- Presentations: 1
- Moderators:
- Coordinates: 12/07/2016, 14:30 - 15:45, Hall B (Poster Area)
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P3.07-019 - AMDAT Lung, An Ideal Lung Cancer MDT Dataset (ID 5753)
14:30 - 14:30 | Author(s): D. Currow
- Abstract
Background:
The role of multidisciplinary teams (MDTs) is central to lung cancer care in Australia with support at policy level and with the development of a nation-wide lung cancer MDT directory from Lung Foundation Australia. In parallel, the importance of accessible, clinically relevant information from routine data collection in lung cancer (as well as other tumour streams) is receiving increased recognition. MDT meetings increasingly act as central hubs for the co-ordination of lung cancer care and therefore have the opportunity to focus on quality assurance as well as analyses of patterns of care and identification and targeting of evidence-practice gaps. MDT meetings can act as central sources of data collection and analysis and as such a standardized approach to lung cancer MDT data collection in Australia is warranted. This study will present the results of a modified Delphi study, surveying Australian lung cancer clinicians, aiming to finalize an ideal clinical dataset for collection through lung cancer multidisciplinary meetings.
Methods:
A 17-item survey has been circulated to a broad, representative sample of lung cancer clinicians, medical and allied health, in Australia. Clinicians were identified and contacted either as (1) part of a purposive sample or (2) through MDT lead clinicians identified through convenience or through the Lung Foundation Australia Lung Cancer MDT registry. Results of an initial survey will be analyzed and a second-round survey will be circulated to an expert panel drawn from the first-round participants prior to finalization of the dataset.
Results:
The first round of the survey is reaching completion at the time of abstract submission. A total of 98 responses have been received across the two sampling strategies in the 4 weeks since surveys were distributed. Initial data analysis showed a predominance of pulmonary physicians, attendance at MDT weekly more than fortnightly, support for inclusion of most of the variables presented in the survey and a leaning towards MDT presentation of complex/multimodality therapy and stage IIIA cases rather than all cases of lung cancer.
Conclusion:
The findings of the study will support the development of a standard dataset for collection at lung cancer MDT meetings. This dataset will be utilized in future planned studies across multiple sites for targeted data intervention and feedback strategies and analysis of effect on lung cancer outcomes.
