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K. Fearon
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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): K. Fearon
- 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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P3.06 - 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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P3.06-004 - A Systematic Review of Outcome Reporting in Studies of Radical Radiotherapy and Chemoradiotherapy in Lung Cancer (ID 4420)
14:30 - 14:30 | Author(s): K. Fearon
- Abstract
Background:
Clinical decision making in lung oncology is informed by evidence about the risks and benefits of proposed treatments, alongside other important factors including clinician experience and patient preference. There is no consensus about which outcome measures are most meaningful to patients or informative for clinicians. Measures relating to disease response and survival are common, but it is not known which specific measures are most favoured, how consistently they are defined, and how frequently domains such as quality of life are represented.
Methods:
A systematic review of EMBASE, COCHRANE and MEDLINE was conducted. Prospective studies of radical radiotherapy or chemoradiotherapy for lung cancer published during 2013-2016 were included, where clinically-relevant outcomes (including patient-reported outcomes) were reported. Individual outcomes were recorded and categorised. Frequency of outcomes, reported definitions and consistency of reporting both within and between studies were examined. Study quality was assessed against UK national standards.
Results:
29 papers met the full inclusion criteria. 124 separate outcome measures were reported, within which, 68 distinct outcomes were identified. 47/124 outcome measures were defined or referenced. None were defined consistently between studies. 3 papers described an outcome measure in their Methods but did not report it in their Results. 24/29 papers reported outcomes not introduced in their Methods. One paper included patient-reported outcome measures. No short-term outcome measures (such as 30 or 90 day mortality) were reported.
Conclusion:
This systematic review has highlighted significant variation in practice in outcome measure reporting in studies of radical lung cancer treatments. A large number of different outcome measures were reported, the majority of which weren’t defined. Where apparently identical outcome measures were reported in more than one study, definitions were inconsistent. Outcome measures relating to short-term survival were not reported at all, despite the fact that long-term survival in this patient population was uncommon. Only one study included patient-reported outcome measures. If lung cancer research is to optimally inform clinical decision making, study endpoints should reflect outcomes that are most meaningful to patients and their clinicians. Variation in outcome-reporting practice, particularly where definitions are lacking and inconsistent, is a significant concern. It threatens the ability of clinicians to assimilate the findings from multiple studies and limits the extent to which the true benefits and burdens of proposed treatments can be understood. Consideration should be given as to whether a core outcome set, incorporating clinically meaningful and patient-reported outcomes, might be warranted in lung cancer. Further research is needed.
