What question did this study set out to answer?

To assess the extended safety, tolerability, and clinical efficacy of anamorelin over an additional 12 weeks in patients with advanced non-small-cell lung cancer cachexia.

May 2, 2017Annals of OncologyOpen Access

ROMANA 3: a phase 3 safety extension study of anamorelin in advanced non-small-cell lung cancer (NSCLC) patients with cachexia

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Authors

DCDavid C. CurrowFlinders University JTJennifer S. TemelMassachusetts General Hospital AAAmy P. AbernethyHighland Community College - Illinois

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Implication

Randomized double-blind trial reveals sustained weight gain and safety with anamorelin in non-small-cell lung cancer cachexia, indicating tolerable long-term symptom management.

Key Points

To assess the extended safety, tolerability, and clinical efficacy of anamorelin over an additional 12 weeks in patients with advanced non-small-cell lung cancer cachexia.
Conducted a double-blind safety extension trial (ROMANA 3; NCT01395914) of two phase 3 trials in 513 patients with advanced NSCLC and cachexia (anamorelin 100 mg daily, N=345; placebo, N=168) who had completed 12 weeks of treatment with ECOG ≤2.
Assessed primary safety and tolerability outcomes across weeks 12 to 24, along with secondary endpoints measuring changes in body weight, handgrip strength, and symptom burden from baseline to week 24.
Treatment-emergent adverse events occurred in 52.2% of the anamorelin group versus 55.7% in the placebo group, with grade ≥3 events in 22.4% versus 21.6%, serious events in 12.8% versus 12.6%, and non-drug-related deaths in 10.5% (n=36) versus 13.8% (n=23).
Anamorelin significantly increased body weight from original baseline across all evaluation points compared to placebo (P < 0.0001) and improved anorexia-cachexia symptoms at weeks 3, 6, 9, 12, and 16 (P < 0.05).
Handgrip strength demonstrated no significant improvement in either treatment group throughout the duration of the trial.

Cite This Study

Currow et al. (2017) studied this question.

synapsesocial.com/papers/6aace085defaaedc0aaab5e0 https://doi.org/10.1093/annonc/mdx192

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Implication

Randomized double-blind trial reveals sustained weight gain and safety with anamorelin in non-small-cell lung cancer cachexia, indicating tolerable long-term symptom management.

ROMANA 3: a phase 3 safety extension study of anamorelin in advanced non-small-cell lung cancer (NSCLC) patients with cachexia

Discussion

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Implication

Key Points

Cite This Study

ROMANA 3: a phase 3 safety extension study of anamorelin in advanced non-small-cell lung cancer (NSCLC) patients with cachexia

Discussion

Member takes

Implication

Key Points

Cite This Study

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