National Cancer Institute-supported chemotherapy-induced peripheral neuropathy trials: outcomes and lessons

Supportive Care in Cancer

Volumn 24, Issue 3, 2016, Pages 1439-1447

  Majithia, Neil ^a   Temkin, Sarah M ^b   Ruddy, Kathryn J ^a   Beutler, Andreas S ^a   Hershman, Dawn L ^c   Loprinzi, Charles L ^a  

^a MAYO CLINIC   (United States)

^b NATIONAL CANCER INSTITUTE   (United States)

^c Department of Medicine   (United States)

Author keywords

Cancer; Chemotherapy; Clinical trials; Peripheral neuropathy

Indexed keywords

AMIFOSTINE; ANTINEOPLASTIC AGENT; BACLOFEN; DULOXETINE; GABAPENTIN; LAMOTRIGINE; LEVACECARNINE; NORTRIPTYLINE; THIOCTIC ACID;

CANCER GRADING; CANCER INCIDENCE; CHEMOTHERAPY INDUCED PERIPHERAL NEUROPATHY; DISEASE COURSE; DRUG EFFICACY; HUMAN; NATIONAL HEALTH ORGANIZATION; PERIPHERAL NEUROPATHY; PRIORITY JOURNAL; RANDOMIZED CONTROLLED TRIAL (TOPIC); REVIEW; TREATMENT OUTCOME; CHEMICALLY INDUCED; UNITED STATES;

ANTINEOPLASTIC AGENTS; HUMANS; NATIONAL CANCER INSTITUTE (U.S.); PERIPHERAL NERVOUS SYSTEM DISEASES; TREATMENT OUTCOME; UNITED STATES;

EID: 84955632359     PISSN: 09414355     EISSN: 14337339     Source Type: Journal    
DOI: 10.1007/s00520-015-3063-4     Document Type: Review

References (52)

1. Mols F, Beijers T, Vreugdenhil G, van de Poll-Franse L (2014) Chemotherapy-induced peripheral neuropathy and its association with quality of life: a systematic review. Support Care Cancer 22:2261–2269. doi:10.1007/s00520-014-2255-7
2. Siegal T, Haim N (1990) Cisplatin-induced peripheral neuropathy. Frequent off-therapy deterioration, demyelinating syndromes, and muscle cramps. Cancer 66:1117–1123. doi:10.1002/1097-0142(19900915)66:6<1117::AID-CNCR2820660607>3.0.CO;2-O
3. Bennett BK, Park SB, Lin CS, Friedlander ML, Kiernan MC, Goldstein D (2012) Impact of oxaliplatin-induced neuropathy: a patient perspective. Support Care Cancer 20:2959–2967. doi:10.1007/s00520-012-1428-5
4. 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 29:1472–1478. doi:10.1200/jco.2010.33.0308
5. Reeves BN, Dakhil SR, Sloan JA, Wolf SL, Burger KN, Kamal A, Le-Lindqwister NA, Soori GS, Jaslowski AJ, Kelaghan J, Novotny PJ, Lachance DH, Loprinzi CL (2012) Further data supporting that paclitaxel-associated acute pain syndrome is associated with development of peripheral neuropathy: North Central Cancer Treatment Group trial N08C1. Cancer 118:5171–5178. doi:10.1002/cncr.27489
6. Hershman DL, Weimer LH, Wang A, Kranwinkel G, Brafman L, Fuentes D, Awad D, Crew KD (2011) Association between patient reported outcomes and quantitative sensory tests for measuring long-term neurotoxicity in breast cancer survivors treated with adjuvant paclitaxel chemotherapy. Breast Cancer Res Treat 125:767–774. doi:10.1007/s10549-010-1278-0
7. Ibrahimpasic K (2013) Alpha lipoic acid and glycaemic control in diabetic neuropathies at type 2 diabetes treatment. Med Arch 67:7–9. doi:10.5455/medarh.2013.67.7-9
8. Gedlicka C, Scheithauer W, Schull B, Kornek GV (2002) Effective treatment of oxaliplatin-induced cumulative polyneuropathy with alpha-lipoic acid. J Clin Oncol 20:3359–3361. doi:10.1200/JCO.2002.99.502
9. Guo Y, Jones D, Palmer JL, Forman A, Dakhil SR, Velasco MR, Weiss M, Gilman P, Mills GM, Noga SJ, Eng C, Overman MJ, Fisch MJ (2014) Oral alpha-lipoic acid to prevent chemotherapy-induced peripheral neuropathy: a randomized, double-blind, placebo-controlled trial. Support Care Cancer 22:1223–1231. doi:10.1007/s00520-013-2075-1
10. Grothey A, Nikcevich DA, Sloan JA, Kugler JW, Silberstein PT, Dentchev T, Wender DB, Novotny PJ, Chitaley U, Alberts SR, Loprinzi CL (2011) Intravenous calcium and magnesium for oxaliplatin-induced sensory neurotoxicity in adjuvant colon cancer: NCCTG N04C7. J Clin Oncol 29:421–427. doi:10.1200/JCO.2010.31.5911
11. 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 19:1769–1777. doi:10.1007/s00520-010-1018-3
12. Hershman DL, Unger JM, Crew KD, Minasian LM, Awad D, Moinpour CM, Hansen L, Lew DL, Greenlee H, Fehrenbacher L, Wade JL, Wong S-F, Hortobagyi GN, Meyskens FL, Albain KS (2013) Randomized double-blind placebo-controlled trial of acetyl-L-carnitine for the prevention of taxane-induced neuropathy in women undergoing adjuvant breast cancer therapy. J Clin Oncol 31:2627–2633. doi:10.1200/jco.2012.44.8738
13. Leal AD, Qin R, Atherton PJ, Haluska P, Behrens RJ, Tiber CH, Watanaboonyakhet P, Weiss M, Adams PT, Dockter TJ, Loprinzi CL (2014) North Central Cancer Treatment Group/Alliance trial N08CA-the use of glutathione for prevention of paclitaxel/carboplatin-induced peripheral neuropathy: a phase 3 randomized, double-blind, placebo-controlled study. Cancer 120:1890–1897. doi:10.1002/cncr.28654
14. Loprinzi CL, Qin R, Dakhil SR, Fehrenbacher L, Flynn KA, Atherton P, Seisler D, Qamar R, Lewis GC, Grothey A (2014) Phase III randomized, placebo-controlled, double-blind study of intravenous calcium and magnesium to prevent oxaliplatin-induced sensory neurotoxicity (N08CB/Alliance). J Clin Oncol 32:997–1005. doi:10.1200/JCO.2013.52.0536
15. Hammack JE, Michalak JC, Loprinzi CL, Sloan JA, Novotny PJ, Soori GS, Tirona MT, Rowland KM Jr, Stella PJ, Johnson JA (2002) Phase III evaluation of nortriptyline for alleviation of symptoms of cis-platinum-induced peripheral neuropathy. Pain 98:195–203. doi:10.1016/S0304-3959(02)00047-7
16. Rao RD, Michalak JC, Sloan JA, Loprinzi CL, Soori GS, Nikcevich DA, Warner DO, Novotny P, Kutteh LA, Wong GY (2007) Efficacy of gabapentin in the management of chemotherapy-induced peripheral neuropathy: a phase 3 randomized, double-blind, placebo-controlled, crossover trial (N00C3). Cancer 110:2110–2118. doi:10.1002/cncr.23008
17. Rao RD, Flynn PJ, Sloan JA, Wong GY, Novotny P, Johnson DB, Gross HM, Renno SI, Nashawaty M, Loprinzi CL (2008) Efficacy of lamotrigine in the management of chemotherapy-induced peripheral neuropathy. Cancer 112:2802–2808. doi:10.1002/cncr.23482
18. Gewandter JS, Mohile SG, Heckler CE, Ryan JL, Kirshner JJ, Flynn PJ, Hopkins JO, Morrow GR (2014) A phase III randomized, placebo-controlled study of topical amitriptyline and ketamine for chemotherapy-induced peripheral neuropathy (CIPN): a University of Rochester CCOP study of 462 cancer survivors. Support Care Cancer 22:1807–1814. doi:10.1007/s00520-014-2158-7
19. Barton DL, Wos EJ, Qin R, Mattar BI, Green NB, Lanier KS, Bearden JD 3rd, Kugler JW, Hoff KL, Reddy PS, Rowland KM Jr, Riepl M, Christensen B, Loprinzi CL (2011) A double-blind, placebo-controlled trial of a topical treatment for chemotherapy-induced peripheral neuropathy: NCCTG trial N06CA. Support Care Cancer 19:833–841. doi:10.1007/s00520-010-0911-0
20. Lavoie Smith EM, Pang H, Cirrincione C, Fleishman SB, 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 309:1359–1367. doi:10.1001/jama.2013.2813
21. Gamelin L, Boisdron-Celle M, Delva R, Guerin-Meyer V, Ifrah N, Morel A, Gamelin E (2004) Prevention of oxaliplatin-related neurotoxicity by calcium and magnesium infusions: a retrospective study of 161 patients receiving oxaliplatin combined with 5-Fluorouracil and leucovorin for advanced colorectal cancer. Clin Cancer Res 10:4055–4061. doi:10.1158/1078-0432.CCR-03-0666
22. Bove L, Picardo M, Maresca V, Jandolo B, Pace A (2001) A pilot study on the relation between cisplatin neuropathy and vitamin E. J Exp Clin Cancer Res 20:277–280
23. Pace A, Savarese A, Picardo M, Maresca V, Pacetti U, Del Monte G, Biroccio A, Leonetti C, Jandolo B, Cognetti F, Bove L (2003) Neuroprotective effect of vitamin E supplementation in patients treated with cisplatin chemotherapy. J Clin Oncol 21:927–931. doi:10.1200/JCO.2003.05.139
24. Argyriou AA, Chroni E, Koutras A, Ellul J, Papapetropoulos S, Katsoulas G, Iconomou G, Kalofonos HP (2005) Vitamin E for prophylaxis against chemotherapy-induced neuropathy: a randomized controlled trial. Neurology 64:26–31. doi:10.1212/01.WNL.0000148609.35718.7D
25. Argyriou AA, Chroni E, Koutras A, Iconomou G, Papapetropoulos S, Polychronopoulos P, Kalofonos HP (2006) Preventing paclitaxel-induced peripheral neuropathy: a phase II trial of vitamin E supplementation. J Pain Symptom Manag 32:237–244. doi:10.1016/j.jpainsymman.2006.03.013
26. Pisano C, Pratesi G, Laccabue D, Zunino F, Lo Giudice P, Bellucci A, Pacifici L, Camerini B, Vesci L, Castorina M, Cicuzza S, Tredici G, Marmiroli P, Nicolini G, Galbiati S, Calvani M, Carminati P, Cavaletti G (2003) Paclitaxel and cisplatin-induced neurotoxicity: a protective role of acetyl-L-carnitine. Clin Cancer Res 9:5756–5767
27. Di Giulio AM, Gorio A, Bertelli A, Mantegazza P, Ferraris L, Ramacci MT (1992) Acetyl-L-carnitine prevents substance P loss in the sciatic nerve and lumbar spinal cord of diabetic animals. Int J Clin Pharmacol Res 12:243–246
28. De Grandis D, Minardi C (2002) Acetyl-L-carnitine (levacecarnine) in the treatment of diabetic neuropathy. A long-term, randomised, double-blind, placebo-controlled study. Drugs R D 3:223–231
29. Famularo G, Moretti S, Marcellini S, Trinchieri V, Tzantzoglou S, Santini G, Longo A, De Simone C (1997) Acetyl-carnitine deficiency in AIDS patients with neurotoxicity on treatment with antiretroviral nucleoside analogues. AIDS 11:185–190
30. Bianchi G, Vitali G, Caraceni A, Ravaglia S, Capri G, Cundari S, Zanna C, Gianni L (2005) Symptomatic and neurophysiological responses of paclitaxel- or cisplatin-induced neuropathy to oral acetyl-L-carnitine. Eur J Cancer 41:1746–1750. doi:10.1016/j.ejca.2005.04.028
31. Colombo N, Bini S, Miceli D, Bogliun G, Marzorati L, Cavaletti G, Parmigiani F, Venturino P, Tedeschi M, Frattola L, Buratti C, Mangioni C (1995) Weekly cisplatin +/− glutathione in relapsed ovarian carcinoma. Int J Gynecol Cancer 5:81–86
32. Cascinu S, Cordella L, Del Ferro E, Fronzoni M, Catalano G (1995) Neuroprotective effect of reduced glutathione on cisplatin-based chemotherapy in advanced gastric cancer: a randomized double-blind placebo-controlled trial. J Clin Oncol 13:26–32
33. Cascinu S, Catalano V, Cordella L, Labianca R, Giordani P, Baldelli AM, Beretta GD, Ubiali E, Catalano G (2002) Neuroprotective effect of reduced glutathione on oxaliplatin-based chemotherapy in advanced colorectal cancer: a randomized, double-blind, placebo-controlled trial. J Clin Oncol 20:3478–3483. doi:10.1200/JCO.2002.07.061
34. Milla P, Airoldi M, Weber G, Drescher A, Jaehde U, Cattel L (2009) Administration of reduced glutathione in FOLFOX4 adjuvant treatment for colorectal cancer: effect on oxaliplatin pharmacokinetics, Pt-DNA adduct formation, and neurotoxicity. Anticancer Drugs 20:396–402. doi:10.1097/CAD.0b013e32832a2dc1
35. Smyth JF, Bowman A, Perren T, Wilkinson P, Prescott RJ, Quinn KJ, Tedeschi M (1997) Glutathione reduces the toxicity and improves quality of life of women diagnosed with ovarian cancer treated with cisplatin: results of a double-blind, randomised trial. Ann Oncol 8:569–573
36. Lin PC, Lee MY, Wang WS, Yen CC, Chao TC, Hsiao LT, Yang MH, Chen PM, Lin KP, Chiou TJ (2006) N-acetylcysteine has neuroprotective effects against oxaliplatin-based adjuvant chemotherapy in colon cancer patients: preliminary data. Support Care Cancer 14:484–487. doi:10.1007/s00520-006-0018-9
37. Loprinzi CL, Maddocks-Christianson K, Wolf SL, Rao RD, Dyck PJ, Mantyh P (2007) The Paclitaxel acute pain syndrome: sensitization of nociceptors as the putative mechanism. Cancer J 13:399–403. doi:10.1097/PPO.0b013e31815a999b
38. Gomez-Perez FJ, Rull JA, Dies H, Rodriquez-Rivera JG, Gonzalez-Barranco J, Lozano-Castaneda O (1985) Nortriptyline and fluphenazine in the symptomatic treatment of diabetic neuropathy. A double-blind cross-over study. Pain 23:395–400
39. Kvinesdal B, Molin J, Froland A, Gram LF (1984) Imipramine treatment of painful diabetic neuropathy. JAMA 251:1727–1730
40. Langohr HD, Stohr M, Petruch F (1982) An open and double-blind cross-over study on the efficacy of clomipramine (Anafranil) in patients with painful mono- and polyneuropathies. Eur Neurol 21:309–317
41. Eisenberg E, Lurie Y, Braker C, Daoud D, Ishay A (2001) Lamotrigine reduces painful diabetic neuropathy: a randomized, controlled study. Neurology 57:505–509. doi:10.1212/WNL.57.3.505
42. Vestergaard K, Andersen G, Gottrup H, Kristensen BT, Jensen TS (2001) Lamotrigine for central poststroke pain: a randomized controlled trial. Neurology 56:184–190. doi:10.1212/WNL.56.2.184
43. Simpson DM, Olney R, McArthur JC, Khan A, Godbold J, Ebel-Frommer K (2000) A placebo-controlled trial of lamotrigine for painful HIV-associated neuropathy. Neurology 54:2115–2119. doi:10.1212/WNL.54.11.2115
44. Zakrzewska JM, Chaudhry Z, Nurmikko TJ, Patton DW, Mullens EL (1997) Lamotrigine (lamictal) in refractory trigeminal neuralgia: results from a double-blind placebo controlled crossover trial. Pain 73:223–230
45. Hershman DL, Lacchetti C, Dworkin RH, Lavoie Smith EM, Bleeker J, Cavaletti G, Chauhan C, Gavin P, Lavino A, Lustberg MB, Paice J, Schneider B, Smith ML, Smith T, Terstriep S, Wagner-Johnston N, Bak K, Loprinzi CL (2014) Prevention and management of chemotherapy-induced peripheral neuropathy in survivors of adult cancers: American Society of Clinical Oncology clinical practice guideline. J Clin Oncol 32:1941–1967. doi:10.1200/JCO.2013.54.0914
46. Postma TJ, Aaronson NK, Heimans JJ, Muller MJ, Hildebrand JG, Delattre JY, Hoang-Xuan K, Lanteri-Minet M, Grant R, Huddart R, Moynihan C, Maher J, Lucey R (2005) The development of an EORTC quality of life questionnaire to assess chemotherapy-induced peripheral neuropathy: the QLQ-CIPN20. Eur J Cancer 41:1135–1139. doi:10.1016/j.ejca.2005.02.012
47. Lavoie Smith EM, Barton DL, Qin R, Steen PD, Aaronson NK, Loprinzi CL (2013) Assessing patient-reported peripheral neuropathy: the reliability and validity of the European Organization for Research and Treatment of Cancer QLQ-CIPN20 Questionnaire. Qual Life Res 22:2787–2799. doi:10.1007/s11136-013-0379-8
48. Pachman DR, Ruddy K, Sangaralingham LR, Grothey A, Shah ND, Beutler AS, Hubbard JM, Loprinzi CL (2015) Calcium and magnesium use for oxaliplatin-induced neuropathy: a case study to assess how quickly evidence translates into practice. J Natl Compr Cancer Netw 13:1097–1101
49. Ruddy KJ, Pachman D, Qin R, Seisler DK, Lavoie Smith EM, Puttabasavaiah S, Novotny PJ, Ta LE, Beutler AS, Wagner-Johnston ND, Staff N, Grothey A, Dakhil SR, Loprinzi CL (2015) A comparison of the natural history of oxaliplatin- and paclitaxel-induced neuropathy (NCCTG N08C1, N08CB/Alliance). J Clin Oncol 33 (suppl; abstr 9564)
50. Beutler AS, Kulkarni AA, Kanwar R, Klein CJ, Therneau TM, Qin R, Banck MS, Boora GK, Ruddy KJ, Wu Y, Smalley RL, Cunningham JM, Le-Lindqwister NA, Beyerlein P, Schroth GP, Windebank AJ, Zuchner S, Loprinzi CL (2014) Sequencing of Charcot-Marie-Tooth disease genes in a toxic polyneuropathy. Ann Neurol 76:727–737. doi:10.1002/ana.24265
51. Boora GK, Kulkarni AA, Kanwar R, Beyerlein P, Qin R, Banck MS, Ruddy KJ, Pleticha J, Lynch CA, Behrens RJ, Zuchner S, Loprinzi CL, Beutler AS (2015) Association of the Charcot-Marie-Tooth disease gene ARHGEF10 with paclitaxel induced peripheral neuropathy in NCCTG N08CA (Alliance). J Neurol Sci. doi:10.1016/j.jns.2015.06.056
52. Baldwin RM, Owzar K, Zembutsu H, Chhibber A, Kubo M, Jiang C, Watson D, Eclov RJ, Mefford J, McLeod HL, Friedman PN, Hudis CA, Winer EP, Jorgenson EM, Witte JS, Shulman LN, Nakamura Y, Ratain MJ, Kroetz DL (2012) A genome-wide association study identifies novel loci for paclitaxel-induced sensory peripheral neuropathy in CALGB 40101. Clin Cancer Res 18:5099–5109. doi:10.1158/1078-0432.CCR-12-1590