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Efficacy and Tolerability of Oxycodone Hydrochloride Controlled-Release Tablets in Moderate to Severe Cancer Pain

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Abstract

Background and objective: Oxycodone is a semisynthetic opioid analgesic drug classed as a strong opioid. The controlled-release oxycodone tablet formulation (OCRT) was approved in China in 2004 for management of moderate to severe cancer pain. Few data about the efficacy of OCRT and clinical outcomes in Chinese patients taking this drug are available. The purpose of this study was to evaluate the efficacy and tolerability of this drug for relief of moderate to severe cancer pain in Chinese patients.

Methods: This was a prospective, open-label, multicentre clinical trial carried out in ten hospitals in Zhejiang Province, China. Patients with cancer pain with a score ≥4 (numerical rating scale) were enrolled. They received oral OCRT at an initial dosage of 5mg every 12 hours for patients scoring 4–6 and 10mg every 12 hours for patients scoring ≥7. Doses were then titrated on an individual basis. Onset of analgesic action, pain score and quality-of-life (QOL) scores —including items measuring family understanding and support, sleep, mental state, appetite, fatigue, and activities of daily life —were evaluated. Adverse effects were also documented.

Results: 216 patients (126 males and 90 females) aged 22–84 years were enrolled. The total mean OCRT dosage was 445.2 ± 361.6mg (range 130–2320mg). The daily dosages of the vast majority of cases (89%) were between 10mg and 30mg. Onset of analgesic action occurred within 1 hour in 198 cases (91.7%) following administration of OCRT. 82.4% of cases were titrated to a steady dosage level within 2 days following administration of the first dose of medication. Pain score decreased significantly (p < 0.01) from 7.1 ± 1.2 at baseline to 2.3 ± 1.2 one week after starting medication and 1.8 ± 0.9 four weeks after starting medication. Scores on all six QOL items increased significantly (p < 0.01) compared with baseline but showed varying rates of improvement. Adverse events included constipation, nausea, vomiting, drowsiness and dysuria. These were noted most frequently in the first week (25.5% of patients) and lessened over time. No severe adverse events were noted.

Conclusion: We conclude that OCRT is well tolerated and effective in controlling moderate to severe cancer pain in Chinese patients.

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  1. The use of trade names is for product identification purposes only and does not imply endorsement.

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Acknowledgements

This study was funded by Sir Run Run Shaw Hospital of Zhejiang University, China. No other sources of funding were used in conducting this study and preparing this manuscript. The authors have no conflicts of interest directly relevant to the content of this study.

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Authors and Affiliations

  1. Medical Oncology Department, Sir Run Run Shaw Hospital, Medical School of Zhejiang University, No. 3 Qingchun East Road, Hangzhou, China

    Hongming Pan

  2. Oncology Department, Sir Run Run Shaw Hospital, Medical School of Zhejiang University, Hangzhou, China

    Zaiyun Zhang

  3. Chemotherapy Department, Zhejiang Cancer Hospital, Hangzhou, China

    Yiping Zhang

  4. Chemotherapy Department, The First Hospital Affiliated to Medical School of Zhejiang University, Zhejiang, China

    Nong Xu

  5. Oncology Department, Zhejiang Provincial Hospital, Hangzhou, China

    Liqin Lu

  6. Oncology Department, Zhejiang Hospital, Hangzhou, China

    Chunfeng Dou

  7. Oncology Department, Zhejiang Provincial Traditional Chinese Medicine Hospital, Hangzhou, China

    Yong Guo

  8. Oncology Department, The First Hospital Affiliated to Wenzhou Medical College, Wenzhou, China

    Shixiu Wu

  9. Oncology Department, Hangzhou Armed Police Hospital, Hangzhou, China

    Jianhua Yue

  10. Oncology Department, The People’s Hospital of Shaoxing City, Shaoxing, China

    Dongping Wu

  11. Oncology Department, Central Hospital of Taizhou City, Taizhou, China

    Yuechu Dai

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  1. Hongming Pan
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Correspondence to Hongming Pan.

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Pan, H., Zhang, Z., Zhang, Y. et al. Efficacy and Tolerability of Oxycodone Hydrochloride Controlled-Release Tablets in Moderate to Severe Cancer Pain. Clin. Drug Investig. 27, 259–267 (2007). https://doi.org/10.2165/00044011-200727040-00005

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