This phase II trial studied the use of oxycodone to treat refractory dyspnea in 20 advanced breast cancer patients. The average age was 59.5 years. Common side effects were constipation and nausea/vomiting. No patients stopped treatment due to side effects. Oxycodone was given at an average starting dose of 10 mg/day increasing to 30 mg/day over 75.5 days on average. Dyspnea scores improved significantly from an average of 7.5 initially to 1.6, showing oxycodone effectively controlled dyspnea. The study concluded oxycodone is effective and safe for dyspnea in these patients and should be compared to morphine in a phase III trial.

1. Phase II trial of oxycodone in the treatment of refractory dyspnea in advanced breast cancer patients. Abst. ID: 115 (Temp. Abst. ID: 54857) Local/Regional Therapy Authors: R. Trujillo, C. Nuño, I. Fortes

2. Dyspnea is a frequent symptom in breast advanced cancer patients, and may seriously affect patient quality of life. Oxycodone (14-hydroxy-7 ,8-dihdrocodeinone) is a semisynthetic product derived from an alkaloid of opium, is a pure agonist of receptors mu and kappa. It is indicated for the treatment of severe pain, however its use for treatment of dyspnea has been little studied, when being an opioid similar to morphine, efficacy in the treatment of dyspnea should at least be similar to the morphine . BACKGROUND

3. METHODS We designed a phase II trial to evaluate the efficacy and safety of oxycodone in breast advanced cancer patients experiencing dyspnea. Eligible criteria were: patients older than 18 years of age with satisfactory baseline cognitive function diagnosed with end-stage breast cancer complaining of dyspnea. The study was conducted on a total of 20 breast cancer patients with dyspnea advanced disease refractory to treatment with corticosteroids and subsidiary of treatment with morphine. Visual analogue scale was used to score VAS 1 (less dyspnea) -10 (worst dyspnea) before treatment with oxycodone and one month after treatment.

4. RESULTS The average age of patients was 59.5 years. The most common side effects were constipation in 20%, nausea and vomiting in 10% of patients. There were no patient abandoned treatment because of side effects. The average time treated with oral oxycodone was 75.5 days. The average initial dose was 10 mg/day and the mean final dose of 30 mg/day. The average initial VAS was 7.5, and mean final VAS was 1.6, and this difference was statistically significant (p 0.005) in favor of improvement of dyspnea with oxycodone.

5. SIDE EFFECTS

6. Visual Analogue Scale

7. DOSE OF OXYCODONE mg/day

8. CONCLUSIONS The results obtained in this phase II study confirms that the oxycodone is effective and safe for control of dyspnea in breast cancer patients with advanced disease refractory dyspnea, and should be studied and compared in a phase III trial to morphine, which is currently the standard.