1356P - Efficacy and safety of oxycodone/naloxone in the management of chemotherapy-induced peripheral neuropathy in Korea

Date 28 September 2014
Event ESMO 2014
Session Poster Display session
Topics Complications of Treatment
Palliative Care
Presenter Jin-Hyoung Kang
Citation Annals of Oncology (2014) 25 (suppl_4): iv471-iv477. 10.1093/annonc/mdu350
Authors J. Kang1, B.S. Kim2, J. Jin3, J.H. Kwon4, I. Woo5, Y. Ko6, S. Park7, H.Y. Kim8
  • 1Division Of Medical Oncology, Seoul St. Mary’s Hospital, the Catholic University of Korea, 137701 - Seoul/KR
  • 2Internal Medicine, VHS Medical Center, 134-791 - Seoul/KR
  • 3Division Of Hemato-oncology, Bucheon St. Mary’s Hospital, The Catholic University of Korea, Bucheon/KR
  • 4Department Of Internal Medicine, Kangdong Sacred Heart Hospital, Hallym University College of Medicine, 134-701 - Seoul/KR
  • 5Department Of Internal Medicine, Yeouido ST.Mary,s hospital, The catholic university of Korea, Seoul/KR
  • 6Division Of Oncology, Uijeongbu St. Mary’s Hospital, the Catholic University of Korea, Uijeongbu/KR
  • 7Division Of Oncology, Daejeon St. Mary’s Hospital, the Catholic University of Korea, Daejeon/KR
  • 8Medical Affairs, Mundipharma Korea, Seoul/KR

Abstract

Aim

The pharmacologic treatment options for chemotherapy-induced peripheral neuropathy (CIPN) including topical agents, tricyclic antidepressants, and anticonvulsants have shown limited efficacy. Opioids are highly effective against cancer-related pain. Among opioids, oxycodone has favorable analgesic potency against neuropathic pain because of its high affinity to kappa receptor. Therefore, we investigated the efficacy and safety of oxycodone/naloxone in CIPN patients not adequately controlled with anticonvulsants in Korea.

Methods

The patients with CIPN not adequately controlled with pregabalin or gabapentin were enrolled (Numeric Rating Scale 0-10; NRS score ≥4 at baseline). The use of weak opioids, NSAIDs or acetaminophen was also permitted before and during the study. In addition to pregabalin or gabapentin of the existing dosages, oxycodone/naloxone was started with 20/10 mg/day, then up-titrated to 80/40 mg/day at the discretion of investigators. The primary outcome was the difference in NRS score at 4 weeks from baseline. Patient-reported neuropathic symptoms were evaluated with the Functional Assessment of Cancer Therapy/Gynaecologic Oncology Group/Neurotoxicity (FACT/GOG-Ntx) questionnaire as the secondary outcome.

Results

Total 73 patients were enrolled and 72 were included in the safety set and 66 in full analysis set. The mean daily dose of pregabalin and gabapentin was 304.1 ± 24.7 mg (n = 37) and 1091.6 ± 337.3 mg (n = 37), respectively. The mean daily dose of oxycodone was 23.3 ± 7.5 mg. The baseline mean NRS score was 6.0 ± 1.3 which was reduced to 4.7 ± 2.1 at 4 weeks (difference; -1.3 ± 1.8, p < 0.0001). 43.9% of patients reported a drop in NRS ≥2 after addition of oxycodone/naloxone. The results of FACT/GOG-Ntx showed that the numbness or tingling of hands (Ntx 1) and that of feet (Ntx 2) were improved at 4 weeks (p = 0.0427, p < 0.0001, respectively). Total 48 adverse drug reactions (ADRs) were reported in 25 patients (34.7%) and common ADRs were dizziness (20.8%) and nausea (9.7%).

Conclusions

The addition of oxycodone/naloxone in CIPN patients not adequately controlled with pregabalin or gabapentin provided additional pain relief and neuropathic symptom control.

Disclosure

S. Park: This study was sponsored by Mundipharma Korea Ltd.; K.H. Lee: This study was sponsored by Mundipharma Korea Ltd.; T.W. Kim: This study was sponsored by Mundipharma Korea Ltd.; J.H. Kang: This study was sponsored by Mundipharma Korea Ltd.; J. Kim: This study was sponsored by Mundipharma Korea Ltd.; J.S. Ahn: This study was sponsored by Mundipharma Korea Ltd.; S. Kim: This study was sponsored by Mundipharma Korea Ltd.; H.J. Yun: This study was sponsored by Mundipharma Korea Ltd.; H.Y. Kim: This study was sponsored by Mundipharma Korea Ltd. HY Kim, Medical Manager of the company, was involved in this study.