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Open Access 01-06-2014 | Original Article

Efficacy and tolerability of controlled-release oxycodone for oxaliplatin-induced peripheral neuropathy and the extension of FOLFOX therapy in advanced colorectal cancer patients

Authors: Makoto Nagashima, Mitsuru Ooshiro, Ayako Moriyama, Yui Sugishita, Kengo Kadoya, Ayami Sato, Tomoaki Kitahara, Ryuichi Takagi, Tasuku Urita, Yutaka Yoshida, Hiroshi Tanaka, Takashi Oshiro, Shinichi Okazumi, Ryoji Katoh

Published in: Supportive Care in Cancer | Issue 6/2014

Abstract

Background

The oxaliplatin-based regimen FOLFOX is widely used to treat patients with advanced colorectal cancer (CRC). However, dose-limiting toxicity after continuous oxaliplatin administration can lead to peripheral neuropathy. Several agents, including opioids, that have been employed to treat oxaliplatin-induced peripheral neuropathy (OIPN) have been examined in clinical settings regarding their protective and therapeutic effects. However, the pharmacotherapy of these agents has not yet been established. Therefore, we investigated the efficacy and tolerability of oxycodone for OIPN and subsequently with FOLFOX therapy in CRC patients.

Methods

This was a single-center retrospective study of 64 CRC patients who underwent FOLFOX therapy at the Toho University Sakura Medical Center (Sakura, Japan). Controlled-release (CR) oxycodone was concomitantly administered to 29 patients (OXY group), whereas the additional 35 patients (non-OXY group) were not given oxycodone during the FOLFOX treatment course. The incidence and severity of OIPN and the number of FOLFOX cycles were measured and compared between the two groups. Neurological toxicities were assessed according to the Common Terminology Criteria for Advanced Events, version 3.0.

Results

All study patients had OIPN. Most patients experienced grade 1 or 2 sensory neuropathy. Grade 3 sensory neuropathy was observed in two patients in the non-OXY group. All patients in the OXY group completed the scheduled FOLFOX therapy, whereas FOLFOX therapy was discontinued in ten patients in the non-OXY group due to severe peripheral neuropathy. The median numbers of FOLFOX cycles in the OXY and non-OXY groups were 13 (range, 6–46) and 7 (range, 2–18), respectively (P < 0.05). The median cumulative oxaliplatin doses were 1072.3 mg/m² (range, 408.7–3385.3 mg/m²) in the OXY group and 483.0 mg/m² (range 76.2–1414.1 mg/m²) in the non-OXY group (P < 0.05).

Conclusions

Our findings indicate that CR oxycodone might attenuate the severity of OIPN and extend the use of FOLFOX therapy.

Paice JA (2010) Chronic treatment-related pain in cancer survivors. Pain 152(3 suppl):S84–S89PubMed

Malik B, Stillman M (2008) Chemotherapy-induced peripheral neuropathy. Curr Pain Headache Rep 12:165–174PubMedCrossRef

Loprinzi CL, Reeves BN, Dakhil SR, Sloan JA, Wolf SL, Burger KN, Kamal A, Le-Lindqwister NA, Soori GS, Jaslowski AJ, Novotny PJ, Lachance DH (2011) Natural history of paclitaxel-associated acute pain syndrome: prospective cohort study NCCTG N08C1. J Clin Oncol 29:1472–1478PubMedCentralPubMedCrossRef

McWhinney SR, Goldberg RM, McLeod HL (2009) Platinum neurotoxicity pharmacogenetics. Mol Cancer Ther 8:10–16PubMedCentralPubMedCrossRef

Quasthoff S, Hartung HP (2002) Chemotherapy-induced peripheral neuropathy. J Neurol 249:9–17PubMedCrossRef

André T, Boni C, Mounedji-Boudiaf L, Navarro M, Tabernero J, Hickish T, Topham C, Zaninelli M, Clingan P, Bridgewater J, Tabah-Fisch I, de Gramont A (2004) Oxaliplatin, fluorouracil, and leucovorin as adjuvant treatment for colon cancer. N Engl J Med 350:2343–2351PubMedCrossRef

Kottschade LA, Sloan JA, Mazurczak MA, Johnson DB, Murphy BP, Rowland KM, Smith DA, Berg AR, Stella PJ, Loprinzi CL (2011) The use of vitamin E for the prevention of chemotherapy-induced peripheral neuropathy: results of a randomized phase III clinical trial. Support Care Cancer 19:1769–1777PubMedCentralPubMedCrossRef

Meyer L, Patte-Mensah C, Taleb O, Mensah-Nyagan AG (2011) Allopregnanolone prevents and suppresses oxaliplatin-evoked painful neuropathy: multi-parametric assessment and direct evidence. Pain 152:170–181PubMedCrossRef

Garg MB, Ackland SP (2011) Pyridoxine to protect from oxaliplatin-induced neurotoxicity without compromising antitumor effect. Cancer Chemother Pharmacol 67:963–966PubMedCrossRef

10.

Wilson RH, Lehky T, Thomas RR (2002) Acute oxaliplatin-induced peripheral nerve hyperexcitability. J Clin Oncol 20:1767–1774PubMedCrossRef

11.

Park SB, Lin CS, Krishnan AV, Goldstein D, Friedlander ML, Kiernan MC (2011) Dose effects of oxaliplatin on persistent and transient Na+ conductances and the development of neurotoxicity. PLoS One 6:e18469PubMedCentralPubMedCrossRef

12.

Mols F, Beijers T, Lemmens V, van den Hurk CJ, Vreugdenhil G, van de Poll-Franse LV, Saif MW, Reardon J (2013) Chemotherapy-induced neuropathy and its association with quality of life among 2- to 11-year colorectal cancer survivors: results from the population-based PROFILES registry. J Clin Oncol 31:2699–2707PubMedCrossRef

13.

Tofthagen C, Donovan KA, Morgan MA, Shibata D, Yeh Y (2013) Oxaliplatin-induced peripheral neuropathy’s effects on health-related quality of life of colorectal cancer survivors. Support Care Cancer 21:3307–3313PubMedCrossRef

14.

Shimozuma K, Ohashi Y, Takeuchi A, Aranishi T, Morita S, Kuroi K, Ohsumi S, Makino H, Katsumata N, Kuranami M, Suemasu K, Watanabe T, Hausheer FH (2012) Taxane-induced peripheral neuropathy and health-related quality of life in postoperative breast cancer patients undergoing adjuvant chemotherapy: N-SAS BC02 A randomized clinical trial. Support Care Cancer 20:3355–3364PubMedCrossRef

15.

Tofthagen C (2010) Surviving chemotherapy for colon cancer and living with the consequences. J Palliat Med 13:1389–1391PubMedCrossRef

16.

Eisenberg E, McNicol ED, Carr DB (2005) Efficacy and safety of opioid agonists in the treatment of neuropathic pain of nonmalignant origin: systematic review and meta-analysis of randomized controlled trials. JAMA 293:3043–3052PubMedCrossRef

17.

Furlan AD, Sandoval JA, Mailis-Gagnon A, Tunks E (2006) Opioids for chronic noncancer pain: a meta-analysis of effectiveness and side effects. CMAJ 174:1589–1594PubMedCentralPubMedCrossRef

18.

Garassino MC, Piva S, La Verde N, Spagnoletti I, Iorno V, Carbone C, Febbraro A, Bianchi A, Bramati A, Moretti A, Ganzinelli M, Marabese M, Gentili M, Torri V, Farina G (2013) Randomised phase II trial (NCT00637975) evaluating activity and toxicity of two different escalating strategies for pregabalin and oxycodone combination therapy for neuropathic pain in cancer patients. PLoS One 8:e59981PubMedCentralPubMedCrossRef

19.

U.S. Department of Health and Human Services (2009) Common terminology criteria of adverse events (CTCAE) version 3.0

20.

Wen F, Zhou Y, Wang W, Hu QC, Liu YT, Zhang PF, Du ZD, Dai J, Li Q (2013) Ca/Mg infusions for the prevention of oxaliplatin-related neurotoxicity in patients with colorectal cancer : a meta-analysis. Ann Oncol 24:171–178PubMedCrossRef

21.

Loprinzi L, Qin R, Dakhil SR, Fehrenbacher K, Stella PJ, Atherton PJ, Seisler DK, Qamar R, Lewis GC, Grothey A (2013) Phase III randomized, placebo (PL)-controlled, double-blind study of intravenous calcium/magnesium (CaMg) to prevent oxaliplatin-induced sensory neurotoxicity (sNT), N08CB : an alliance for clinical trials in oncology study. J Clin Oncol 31(15 suppl):3501

22.

de Afonseca SO, Cruz FM, de Iracema Gomes Cubero D, Lera AT, Schindler F, Okawara M, de Souza LF, Rogrigues NP, del Giglio A (2013) Vitamin E for prevention of oxaliplatin-induced peripheral neuropathy : a pilot randomized clinical trial. Sao Paulo Med J 131:35–38PubMed

23.

Kautio A-L, Haanpaa M, Leminen A, Kalso E, Kautiainen H, Saarto T (2009) Amitriptyline in the prevention of chemotherapy-induced neuropathic symptoms. Anticancer Res 29:2601–2606PubMed

24.

Rao RD, Michalak JC, Sloan JA, Loprinzi CL, Soori GS, Nickcevich DA, Warner DO, Novotny P, Kutteh LA, Wong GY, the North Central Cancer Treatment Group (2007) Efficacy of gabapentin in the management of chemotherapy-induced peripheral neuropathy : A phase 3 randomized, double-blind, placebo-controlled, crossover trial (N00C3). Cancer 110:2110–2118PubMedCrossRef

25.

Rao RD, Flynn PJ, Sloan JA, Wong GY, Novotny P, Johnson DB, Gross HM, Nashawaty M, Loprinzi CL (2008) Efficacy of lamotrigine in the management of chemotherapy-induced peripheral neuropathy : A phase 3 randomized, double-blind, placebo-controlled trial, N01C3. Cancer 112:2802–2808PubMedCrossRef

26.

Durand JP, Deplanque G, Montheil V, Gornet JM, Scotte F, Mir O, Cessot A, Coriat R, Raymond E, Mitry E, Herait P, Yataghene Y, Goldwasser F (2012) Efficacy of venlafaxine for the prevention and relief of oxaliplatin-induced acute neurotoxicity : results of EFFOX, a randomized, double-blind, placebo-controlled phase III trial. Ann Oncol 23:200–205PubMedCrossRef

27.

Smith EM, Pang H, Cirrincione C, Fleishman S, Paskett ED, Ahles T, Bressler LR, Fadul CE, Knox C, Le-Lindqwister N, Gilman PB, Shapiro CL (2013) Effect of duloxetine on pain, function, and quality of life among patients with chemotherapy-induced painful peripheral neuropathy: a randomized clinical trial. JAMA 309:1359–1367PubMedCentralPubMedCrossRef

28.

Urch CE, Dickenson AH (2008) Neuropathic pain in cancer. Eur J Pain 44:1091–1096

29.

Watson CPN, Babul N (1998) Efficacy of oxycodone in neuropathic pain: a randomized trial in postherpetic neuralgia. Neurology 50:1837–1841PubMedCrossRef

30.

Watson CP, Moulin D, Watt-Watson J, Gordon A, Eisenhoffer J (2003) Controlled-release oxycodone relieves neuropathic pain: a randomized controlled trial in painful diabetic neuropathy. Pain 105:71–78PubMedCrossRef

31.

Gimbel JS, Rochards P, Portenoy RK (2003) Controlled-release oxycodone for pain in diabetic neuropathy: a randomized controlled trial. Neurology 60:927–934PubMedCrossRef

32.

Hanna M, O’Brien C, Wilson MC (2008) Prolonged-release oxycodone enhances the effects of existing gabapentin therapy in painful diabetic neuropathy patients. Eur J Pain 12:804–813PubMedCrossRef

33.

Cartoni C, Brunetti GA, Federico V, Efficace F, Grammatico S, Tendas A, Scaramucci L, Cupelli L, D’Elia GM, Truini A, Niscola P, Petrucci MT (2012) Controlled-release oxycodone for the treatment of bortezomib-induced neuropathic pain in patients with multiple myeloma? Support Care Cancer 20:2621–2626PubMedCrossRef

34.

Narita M, Nakamura A, Ozaki M, Imai S, Miyoshi K, Suzuki M, Suzuki T (2008) Comparative pharmacological profiles of morphine and oxycodone under a neuropathic pain-like state in mice: evidence for less sensitivity to morphine. Neuropsychopharmacology 33:1097–1112PubMedCrossRef

35.

Minami K, Hasegawa M, Ito H, Nakamura A, Tomii T, Matsumoto M, Orita S, Matsushima S, Miyoshi T, Masuno K, Torii M, Koike K, Shimada S, Kanemasa T, Kihara T, Narita M, Suzuki T, Kato A (2009) Morphine, oxycodone, and fentanyl exhibit different analgesic profiles in mouse pain models. J Pharmacol Sci 111:60–72PubMedCrossRef

36.

Frigeni B, Piatti M, Lanzani F, Alberti P, Villa P, Zanna C, Ceracchi M, Ildebrando M, Cavaaletti G (2011) Chemotherapy-induced peripheral neurotoxicity can be misdiagnosed by the National Cancer Institute Common Toxicity scale. J Peripher Nerv Syst 16:228–236PubMedCrossRef

Title: Efficacy and tolerability of controlled-release oxycodone for oxaliplatin-induced peripheral neuropathy and the extension of FOLFOX therapy in advanced colorectal cancer patients
Authors: Makoto Nagashima
Mitsuru Ooshiro
Ayako Moriyama
Yui Sugishita
Kengo Kadoya
Ayami Sato
Tomoaki Kitahara
Ryuichi Takagi
Tasuku Urita
Yutaka Yoshida
Hiroshi Tanaka
Takashi Oshiro
Shinichi Okazumi
Ryoji Katoh
Publication date: 01-06-2014
Publisher: Springer Berlin Heidelberg
Published in: Supportive Care in Cancer / Issue 6/2014
Print ISSN: 0941-4355
Electronic ISSN: 1433-7339
DOI: https://doi.org/10.1007/s00520-014-2132-4

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