Interventions for preventing neuropathy caused by cisplatin and related compounds

James W Albers, Vinay Chaudhry, Guido Cavaletti, Ross C Donehower, James W Albers, Vinay Chaudhry, Guido Cavaletti, Ross C Donehower

Abstract

Background: Cisplatin and several related antineoplastic drugs used to treat many types of solid tumours are neurotoxic, and most patients completing a full course of cisplatin chemotherapy develop a clinically detectable sensory neuropathy. Effective neuroprotective therapies have been sought.

Objectives: To examine the efficacy and safety of purported chemoprotective agents to prevent or limit the neurotoxicity of cisplatin and related drugs.

Search methods: On 4 March 2013, we searched the Cochrane Neuromuscular Disease Group Specialized Register, CENTRAL, MEDLINE, EMBASE, LILACS, and CINAHL Plus for randomised trials designed to evaluate neuroprotective agents used to prevent or limit neurotoxicity of cisplatin and related drugs among human patients.

Selection criteria: We included randomised controlled trials (RCTs) or quasi-RCTs in which the participants received chemotherapy with cisplatin or related compounds, with a potential chemoprotectant (acetylcysteine, amifostine, adrenocorticotrophic hormone (ACTH), BNP7787, calcium and magnesium (Ca/Mg), diethyldithiocarbamate (DDTC), glutathione, Org 2766, oxcarbazepine, or vitamin E) compared to placebo, no treatment, or other treatments. We considered trials in which participants underwent evaluation zero to six months after completing chemotherapy using quantitative sensory testing (the primary outcome) or other measures including nerve conduction studies or neurological impairment rating using validated scales (secondary outcomes).

Data collection and analysis: Two review authors assessed each study, extracted the data and reached consensus, according to standard Cochrane methodology.

Main results: As of 2013, the review includes 29 studies describing nine possible chemoprotective agents, as well as description of two published meta-analyses. Among these trials, there were sufficient data in some instances to combine the results from different studies, most often using data from secondary non-quantitative measures. Nine of the studies were newly included at this update. Few of the included studies were at a high risk of bias overall, although often there was too little information to make an assessment. At least two review authors performed a formal review of an additional 44 articles but we did not include them in the final review for a variety of reasons.Of seven eligible amifostine trials (743 participants in total), one used quantitative sensory testing (vibration perception threshold) and demonstrated a favourable outcome in terms of amifostine neuroprotection, but the vibration perception threshold result was based on data from only 14 participants receiving amifostine who completed the post-treatment evaluation and should be regarded with caution. Furthermore the change measured was subclinical. None of the three eligible Ca/Mg trials (or four trials if a single retrospective study was included) described our primary outcome measures. The four Ca/Mg trials included a total of 886 participants. Of the seven eligible glutathione trials (387 participants), one used quantitative sensory testing but reported only qualitative analyses. Four eligible Org 2766 trials (311 participants) employed quantitative sensory testing but reported disparate results; meta-analyses of three of these trials using comparable measures showed no significant vibration perception threshold neuroprotection. The remaining trial reported only descriptive analyses. Similarly, none of the three eligible vitamin E trials (246 participants) reported quantitative sensory testing. The eligible single trials involving acetylcysteine (14 participants), diethyldithiocarbamate (195 participants), oxcarbazepine (32 participants), and retinoic acid (92 participants) did not perform quantitative sensory testing. In all, this review includes data from 2906 participants. However, only seven trials reported data for the primary outcome measure of this review, (quantitative sensory testing) and only nine trials reported our objective secondary measure, nerve conduction test results. Additionally, methodological heterogeneity precluded pooling of the results in most cases. Nonetheless, a larger number of trials reported the results of secondary (non-quantitative and subjective) measures such as the National Cancer Institute Common Toxicity Criteria (NCI-CTC) for neuropathy (15 trials), and these results we pooled and reported as meta-analysis. Amifostine showed a significantly reduced risk of developing neurotoxicity NCI-CTC (or equivalent) ≥ 2 compared to placebo (RR 0.26, 95% CI 0.11 to 0.61). Glutathione was also efficacious with an RR of 0.29 (95% CI 0.10 to 0.85). In three vitamin E studies subjective measures not suitable for combination in meta analysis each favoured vitamin E. For other interventions the qualitative toxicity measures were either negative (N-acetyl cysteine, Ca/Mg, DDTC and retinoic acid) or not evaluated (oxcarbazepine and Org 2766).Adverse events were infrequent or not reported for most interventions. Amifostine was associated with transient hypotension in 8% to 62% of participants, retinoic acid with hypocalcaemia in 11%, and approximately 20% of participantss withdrew from treatment with DDTC because of toxicity.

Authors' conclusions: At present, the data are insufficient to conclude that any of the purported chemoprotective agents (acetylcysteine, amifostine, calcium and magnesium, diethyldithiocarbamate, glutathione, Org 2766, oxcarbazepine, retinoic acid, or vitamin E) prevent or limit the neurotoxicity of platin drugs among human patients, as determined using quantitative, objective measures of neuropathy. Amifostine, calcium and magnesium, glutathione, and vitamin E showed modest but promising (borderline statistically significant) results favouring their ability to reduce the neurotoxicity of cisplatin and related chemotherapies, as measured using secondary, non-quantitative and subjective measures such as the NCI-CTC neuropathy grading scale. Among these interventions, the efficacy of only vitamin E was evaluated using quantitative nerve conduction studies; the results were negative and did not support the positive findings based on the qualitative measures. In summary, the present studies are limited by the small number of participants receiving any particular agent, a lack of objective measures of neuropathy, and differing results among similar trials, which make it impossible to conclude that any of the neuroprotective agents tested prevent or limit the neurotoxicity of platinum drugs.

Conflict of interest statement

Dr Albers has the following conflict of interest statement.

"None of the potential conflicts of interest noted below relates directly to any of the material discussed in the current review. In the interest of erring on the side of full disclosure, however, I include the following:

Within the time of this review, Dr. Albers has received personal compensation for activities with Amylin Pharmaceuticals, Dow Chemical Co., Dow AgroSciences, Eli Lilly & Company, Lilly Research Laboratories, Periphagen (formerly Diamyd), Polymedix, Veristat, Wyeth Pharmaceuticals, or by firms representing companies in litigation. These activities have been as a consultant, advisory board member, data monitoring committee member, mortality and morbidity review committee member, participating study investigator, or expert witness. He also has received funding support for clinical research from government agencies, foundations, and private industry. Two immediate family members hold stock and/or stock options in companies whose products relate to the practice of medicine. These relationships are unrelated to the chemotherapy agents or chemo‐neuroprotectants discussed in the review."

Dr Cavaletti has acted in the past as a paid consultant to Sigma‐Tau IFR, Serono International SA, Rinat Neuroscience Co., Guilford Pharmaceuticals, and Eisai Pharmaceuticals, which manufacture different neuroprotective agents, and to Debiopharm SA which manufactures oxaliplatin. In the 36 months prior to submission of this updated review he has no known conflicts of interest.

Dr Chaudhry has served as a medical record reviewer and provided expert witness testimony for the Department of Justice Injury Compensation Program. Dr. Chaudhry has served as a consultant for clinical trials for Novartis. He receives compensation for serving on the editoria board of Neurologist. Dr. Chaudhry also receives royalities from Johns Hopkins University for use of Total Neuropathy Score (TNS).

Dr Donehower serves on the scientific advisory board of two companies involved in the development of new anticancer drugs.

Figures

1
1
Risk of bias summary: review authors' judgements about each risk of bias item for each included study. Red (‐) = high risk of bias; yellow (?) = unclear risk of bias; green (+) = low risk of bias.
2
2
Forest plot of comparison: 2 Amifostine ‐ neurotoxicity rating, outcome: 2.2 Neurotoxicity rating ≥ 2.
3
3
Forest plot of comparison: 2 Amifostine ‐ neurotoxicity rating, outcome: 2.3 Neurotoxicity rating ≥ 3.
4
4
Forest plot of comparison: 5 Ca/Mg ‐ sensory neuropathy (SNP), outcome: 5.1 Chronic NCI‐CTC ≥ grade 2.
5
5
Forest plot of comparison: 11 GSH ‐ NCI NT rating 2‐4 at treatment end, outcome: 11.1 Chronic NCI ≥ grade 2.
6
6
Forest plot of comparison: 20 Vitamin E ‐ SNAP amplitude, outcome: 20.1 Sural amplitude uv after 6 cycles.
7
7
Forest plot of comparison: 24 Vitamin E ‐ Clinical impairment, outcome: 24.1 Total neuropathy score after 6 cycles.
1.1. Analysis
1.1. Analysis
Comparison 1 Amifostine ‐ clinical impairment, Outcome 1 Clinical impairment at 3 months.
2.1. Analysis
2.1. Analysis
Comparison 2 Amifostine ‐ functional activities of daily living, Outcome 1 Functonal activities of daily living as measured at 3 months.
3.1. Analysis
3.1. Analysis
Comparison 3 Amifostine ‐ neurotoxicity rating, Outcome 1 Neurotoxicity rating ≥ 1.
3.2. Analysis
3.2. Analysis
Comparison 3 Amifostine ‐ neurotoxicity rating, Outcome 2 Neurotoxicity rating ≥ 2.
3.3. Analysis
3.3. Analysis
Comparison 3 Amifostine ‐ neurotoxicity rating, Outcome 3 Neurotoxicity rating ≥ 3.
4.1. Analysis
4.1. Analysis
Comparison 4 Calcium/magnesium ‐ nerve conduction study (NCS) results, Outcome 1 Abnormal sensory nerve action potential.
5.1. Analysis
5.1. Analysis
Comparison 5 Calcium/magnesium ‐ sensory neuropathy (SNP), Outcome 1 Oxaliplatin specific sensory neurotoxicity ≥ grade 2.
5.2. Analysis
5.2. Analysis
Comparison 5 Calcium/magnesium ‐ sensory neuropathy (SNP), Outcome 2 Chronic NCI‐CTC ≥ grade 2.
5.3. Analysis
5.3. Analysis
Comparison 5 Calcium/magnesium ‐ sensory neuropathy (SNP), Outcome 3 SNP grade 3.
6.1. Analysis
6.1. Analysis
Comparison 6 Diethyldithiocarbamate ‐ National Cancer Institute (NCI) neurotoxicity rating scale, Outcome 1 NCI toxicity for neuropathy.
7.1. Analysis
7.1. Analysis
Comparison 7 Glutathione ‐ nerve conduction study (NCS) results, Outcome 1 SSC amplitude.
8.1. Analysis
8.1. Analysis
Comparison 8 Glutathione ‐ clinical impairment, Outcome 1 Impairment at 3 months.
9.1. Analysis
9.1. Analysis
Comparison 9 Glutathione ‐ Neuropathy Symptom Score (NSS), Outcome 1 NSS symptoms of neuropathy at 3 months.
10.1. Analysis
10.1. Analysis
Comparison 10 Glutathione ‐ World Health Organization (WHO) evidence of neurotoxicity, Outcome 1 WHO neurotoxicity during trial.
11.1. Analysis
11.1. Analysis
Comparison 11 Glutathione ‐ chronic National Cancer Institute (NCI) toxicity rating, Outcome 1 NCI toxicity at 12 weeks.
12.1. Analysis
12.1. Analysis
Comparison 12 Glutathione ‐ National Cancer Institute (NCI) neurotoxicity rating 2‐4 at treatment end, Outcome 1 Chronic NCI ≥ grade 2.
13.1. Analysis
13.1. Analysis
Comparison 13 Glutathione ‐ other outcomes, Outcome 1 Oliguria.
14.1. Analysis
14.1. Analysis
Comparison 14 Org 2766 ‐ qualitative vibration position testing (VPT), Outcome 1 Abnormal VPT at 3 to 5 months.
15.1. Analysis
15.1. Analysis
Comparison 15 Org 2766 (1 or 2 mg)‐ vibration perception testing (VPT) finger or hand, Outcome 1 VPT hand 3 to 5 months post treatment.
16.1. Analysis
16.1. Analysis
Comparison 16 Oxcarbazepine ‐ sensory nerve action potential (SNAP) amplitude, Outcome 1 SNAP amplitude: sural.
16.2. Analysis
16.2. Analysis
Comparison 16 Oxcarbazepine ‐ sensory nerve action potential (SNAP) amplitude, Outcome 2 SNAP amplitude: superficial peroneal.
16.3. Analysis
16.3. Analysis
Comparison 16 Oxcarbazepine ‐ sensory nerve action potential (SNAP) amplitude, Outcome 3 SNAP amplitude: ulnar.
17.1. Analysis
17.1. Analysis
Comparison 17 Oxcarbazepine ‐ neurotoxicity rating, Outcome 1 Neuropathy after 12 cycles.
17.2. Analysis
17.2. Analysis
Comparison 17 Oxcarbazepine ‐ neurotoxicity rating, Outcome 2 Severity of neuropathy (TNS).
18.1. Analysis
18.1. Analysis
Comparison 18 Retinoic acid ‐ National Cancer Institute (NCI) neurotoxicity rating, Outcome 1 NCI‐CTC grade ≥ 2.
19.1. Analysis
19.1. Analysis
Comparison 19 Vitamin E ‐ qualitative sensory nerve conduction study (NCS) amplitudes, Outcome 1 Abnormal median or sural sensory amplitude.
20.1. Analysis
20.1. Analysis
Comparison 20 Vitamin E ‐ sensory nerve action potential amplitude, Outcome 1 Superficial peroneal amp 3 mos s/p treatment.
20.2. Analysis
20.2. Analysis
Comparison 20 Vitamin E ‐ sensory nerve action potential amplitude, Outcome 2 Ulnar SNAP amp 3 mos s/p treatment.
20.3. Analysis
20.3. Analysis
Comparison 20 Vitamin E ‐ sensory nerve action potential amplitude, Outcome 3 Sural amplitude uv after 6 cycles.
21.1. Analysis
21.1. Analysis
Comparison 21 Vitamin E ‐ incidence of neuropathy, Outcome 1 Incidence of peripheral neuropathy (completed trial).
21.2. Analysis
21.2. Analysis
Comparison 21 Vitamin E ‐ incidence of neuropathy, Outcome 2 Incidence of peripheral neuropathy (intention to treat).
22.1. Analysis
22.1. Analysis
Comparison 22 Vitamin E ‐ modified peripheral neuropathy (PNP) score, Outcome 1 Modified peripheral neuropathy (PNP) score.
23.1. Analysis
23.1. Analysis
Comparison 23 Vitamin E ‐ clinical impairment, Outcome 1 Total neuropathy score after 6 cycles.

References

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    1. Argyriou AA, Chroni E, Koutras A, Iconomou G, Papapetropoulos S, Polychronopoulos P, et al. A randomized controlled trial evaluating the efficacy and safety of vitamin E supplementation for protection against cisplatin‐induced peripheral neuropathy: final results. Support Care Cancer 2006;14(11):1134‐40. [PUBMED: 16622646]
Argyriou 2006a {published data only}
    1. Argyriou AA, Chroni E, Polychronopoulos P, Iconomou G, Koutras A, Makatsoris T, Gerolymos MK, et al. Efficacy of oxcarbazepine for prophylaxis against cumulative oxaliplatin‐induced neuropathy. Neurology 2006;67(12):2253‐5. [PUBMED: 17190958]
Arrieta 2011 {published data only}
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Bogliun 1996 {published data only}
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Cascinu 1995 {published data only}
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Cascinu 2002 {published data only}
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Chay 2010 {published data only}
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Colombo 1995 {published data only}
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DeVos 2005 {published data only}
    1. Vos FY, Bos AM, Schaapveld M, Swart CA, Graaf H, et al. A randomized phase II study of paclitaxel with carboplatin +/‐ amifostine as first line treatment in advanced ovarian carcinoma. Gynecologic Oncology 2005;97(1):60‐7. [PUBMED: 15790438]
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    1. Gandara DR, Nahhas WA, Adelson MD, Lichtman SM, Podczaski ES, Yanovich S, et al. Randomized placebo‐controlled multicenter evaluation of diethyldithiocarbamate for chemoprotection against cisplatin‐induced toxicities. Journal of Clinical Oncology 1995;13(2):490‐6. [PUBMED: 7844610]
Grothey 2011 {published data only}
    1. Grothey A, Nikcevich DA, Sloan JA, Kugler JW, Silberstein PT, Dentchev T, et al. Intravenous calcium and magnesium for oxaliplatin‐induced sensory neurotoxicity in adjuvant colon cancer: NCCTG N04C7. Journal of Clinical Oncology 2011;29(4):421‐7. [PUBMED: 21189381]
Hovestadt 1992 {published data only}
    1. Hovestadt A, Burg ME, Verbiest HB, Putten WL, Vecht CJ. The course of neuropathy after cessation of cisplatin treatment, combined with Org 2766 or placebo. Journal of Neurology 1992;239(3):143‐6. [PUBMED: 1315383]
Ishibashi 2010 {published data only}
    1. Ishibashi K, Okada N, Miyazaki T, Sano M, Ishida H. Effect of calcium and magnesium on neurotoxicity and blood platinum concentrations in patients receiving mFOLFOX6 therapy: a prospective randomized study. International Journal of Clinical Oncology 2010;15(1):82‐7. [PUBMED: 20108160]
Kanat 2003 {published data only}
    1. Kanat O, Evrensel T, Baran I, Coskun H, Zarifoglu M, Turan OF, et al. Protective effect of amifostine against toxicity of paclitaxel and carboplatin in non‐small cell lung cancer: a single center randomized study. Medical Oncology 2003;20(3):237‐45. [PUBMED: 14514973]
Kemp 1996 {published data only}
    1. Kemp G, Rose P, Lurain J, Berman M, Manetta A, Roullet B, et al. Amifostine pretreatment for protection against cyclophosphamide‐induced and cisplatin‐induced toxicities: results of a randomized control trial in patients with advanced ovarian cancer. Journal of Clinical Oncology 1996;14(7):2101‐12. [PUBMED: 8683243]
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Knijn 2011 {published data only}
    1. Knijn N, Tol J, Koopman M, Werter MJ, Imholz AL, Valster FA, et al. The effect of prophylactic calcium and magnesium infusions on the incidence of neurotoxicity and clinical outcome of oxaliplatin‐based systemic treatment in advanced colorectal cancer patients. European Journal of Cancer 2011;47(3):369‐74. [PUBMED: 21067912]
Kottschade 2011 {published data only}
    1. Kottschade LA, Sloan JA, Mazurczak MA, Johnson DB, Murphy BP, Rowland KM, et al. The use of vitamin E for the prevention of chemotherapy‐induced peripheral neuropathy: results of a randomized phase III clinical trial. Supportive Care in Cancer 2011;19(11):1769‐77. [PUBMED: 20936417]
Lin 2006 {published data only}
    1. Lin PC, Lee MY, Wang WS, Yen CC, Chao TC, Hsiao LT, et al. N‐acetylcysteine has neuroprotective effects against oxaliplatin‐based adjuvant chemotherapy in colon cancer patients: preliminary data. Supportive Care in Cancer 2006;14(5):484‐7. [PUBMED: 16450089]
Lorusso 2003 {published data only}
    1. Lorusso D, Ferrandina G, Greggi S, Gadducci A, Pignata S, Tateo S, et al. Phase III multicenter randomized trial of amifostine as cytoprotectant in first‐line chemotherapy in ovarian cancer patients. Annals of Oncology 2003;14(7):1086‐93. [PUBMED: 12853351]
Lu 2008 {published data only}
    1. Lu P, Fan QX, Wang LX, Wang X, Zong H, Wang RL. Prophylactic effect of amifostine on oxaliplatin‐related neurotoxicity in patients with digestive tract tumors. Ai Zheng [Chinese Journal of Cancer] 2008;27(10):1117‐20.
Milla 2009 {published data only}
    1. Milla P, Airoldi M, Weber G, Drescher A, Jaehde U, Cattel L. Administration of reduced glutathione in FOLFOX4 adjuvant treatment for colorectal cancer: effect on oxaliplatin pharmacokinetics, Pt‐DNA adduct formation, and neurotoxicity. Anticancer Drugs 2009;20(5):396‐402. [PUBMED: 19287306]
Pace 2003 {published data only}
    1. Pace A, Savarese A, Picardo M, Maresca V, Pacetti U, Del MG, et al. Neuroprotective effect of vitamin E supplementation in patients treated with cisplatin chemotherapy. Journal of Clinical Oncology 2003;21(5):927‐31. [PUBMED: 12610195]
Planting 1999 {published data only}
    1. Planting AS, Catimel G, Mulder PH, Graeff A, Höppener F, Verweij J, et al. Randomized study of a short course of weekly cisplatin with or without amifostine in advanced head and neck cancer. EORTC Head and Neck Cooperative Group. Annals of Oncology 1999;10(6):693‐700. [PUBMED: 10442192]
Roberts 1997 {published data only}
    1. Roberts JA, Jenison EL, Kim K, Clarke‐Pearson D, Langleben A. A randomized, multicenter, double‐blind, placebo‐controlled, dose‐finding study of ORG 2766 in the prevention or delay of cisplatin‐induced neuropathies in women with ovarian cancer. Gynecologic Oncology 1997;67(2):172‐7. [PUBMED: 9367703]
Schmidinger 2000 {published data only}
    1. Schmidinger M, Budinsky AC, Wenzel C, Piribauer M, Brix R, Kautzky M, et al. Glutathione in the prevention of cisplatin induced toxicities: a prospectively randomized pilot trial in patients with head and neck cancer and non small cell lung cancer. Wiener Klinische Wochenschrift 2000;112(14):617‐23. [PUBMED: 11008323]
Smyth 1997 {published data only}
    1. Smyth JF, Bowman A, Perren T, Wilkinson P, Prescott RJ, Quinn KJ, et al. 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. Annals of Oncology 1997;8(6):569‐73. [PUBMED: 9261526]
van der Hoop 1990 {published data only}
    1. Gerritsen van der Hoop R, Vecht CJ, Burg ME, Elderson A, Boogerd W, Heimans JJ, et al. Prevention of cisplatin neurotoxicity with an ACTH(4‐9) analogue in patients with ovarian cancer. New England Journal of Medicine 1990;322(2):89‐94. [PUBMED: 2152972]
van Gerven 1994 {published data only}
    1. Gerven JMA, Hovestadt A, Moll JW, Rodenburg CJ, Splinter TA, Oosterom AT, et al. The effects of an ACTH (4‐9) analogue on development of cisplatin neuropathy in testicular cancer: a randomized trial. Journal of Neurology 1994;241(7):432‐5. [PUBMED: 7931444]
References to studies excluded from this review Ali 2009 {published data only}
    1. Ali BH. Amelioration of oxaliplatin neurotoxicity by drugs in humans and experimental animals: a minireview of recent literature. Basic & Clinical Pharmacology & Toxicology 2009;106:272‐9.
Ao 2012 {published data only}
    1. Ao R, Wang Y‐H, Li R‐W, Wang Z‐R. Effects of calcium and magnesium on acute and chronic neurotoxicity caused by oxaliplatin: a meta‐analysis. Experimental and Therapeutic Medicine 2012;4(5):933‐7.
Argyriou 2005 {published data only}
    1. Argyriou AA, Chroni E, Koutras A, Ellul J, Papapetropoulos S, Katsoulas G, et al. Vitamin E for prophylaxis against chemotherapy‐induced neuropathy: a randomized controlled trial. Neurology 2005;64(1):26‐31.
Block 2005 {published data only}
    1. Block KI, Gyllenhaal C. Commentary: the pharmacological antioxidant amifostine ‐‐ implications of recent research for integrative cancer care. Integrative Cancer Therapies 2005;4(4):329‐51.
Bogliun 1992 {published data only}
    1. Bogliun G, Marzorati L, Cavaletti G, Frattola L. Evaluation by somatosensory evoked potentials of the neurotoxicity of cisplatin alone or in combination with glutathione. Italian Journal of Neurological Sciences 1992;13(8):643‐7.
Cancer Care Ontario 2012 {published data only}
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Capizzi 1995 {published data only}
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Cassidy 1998 {published data only}
    1. Cassidy J, Paul J, Soukop M, Habeshaw T, Reed NS, Parkin D, et al. Clinical trials of nimodipine as a potential neuroprotector in ovarian cancer patients treated with cisplatin. Cancer Chemotherapy & Pharmacology 1998;41(2):161‐6.
Catalano 1999 {published data only}
    1. Catalano V. An evaluation of potential neuroprotective effect of reduced‐glutathione (GSH) on oxaliplatin (OXA) based chemotherapy in advanced colorectal cancer patients [abstract no: 1529]. European Journal of Cancer 1999;35:S375.
Chen 2012 {published data only}
    1. Chen XF, Wang R, Yin YM, Roe OD, Li J, Zhu LJ, et al. The effect of monosialotetrahexosylganglioside (GM1) in prevention of oxaliplatin induced neurotoxicity: a retrospective study. Biomedicine & Pharmacotherapy 2012;66(4):279‐84.
Culy 2001 {published data only}
    1. Culy CR, Spencer CM. Amifostine: an update on its clinical status as a cytoprotectant in patients with cancer receiving chemotherapy or radiotherapy and its potential therapeutic application in myelodysplastic syndrome. Drugs 2001;61(5):641‐84.
De Grandis 2007 {published data only}
    1. Grandis D. Acetyl‐L‐carnitine for the treatment of chemotherapy‐induced peripheral neuropathy: a short review. CNS Drugs 2007;21(Suppl 1):39‐43.
De Vos 2005 {published data only}
    1. Vos FY, Bos AM, Schaapveld M, Swart CA, Graaf H, Zee AG, et al. A randomized phase II study of paclitaxel with carboplatin +/‐ amifostine as first line treatment in advanced ovarian carcinoma. Gynecologic Oncology 2005;97(1):60‐7.
Durand 2003 {published data only}
    1. Durand JP, Brezault C, Goldwasser F. Protection against oxaliplatin acute neurosensory toxicity by venlafaxine. Anticancer Drugs 2003;14(6):423‐5.
Gamelin 2004 {published data only}
    1. Gamelin L, Boisdron‐Celle M, Delva R, Guerin‐Meyer V, Ifrah N, Morel A, et al. 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. Clinical Cancer Research 2004;10(12 Pt 1):4055‐61.
Gamelin 2008 {published data only}
    1. Gamelin L, Boisdron‐Celle M, Morel A, Poirier AL, Berger V, Gamelin E, et al. Oxaliplatin‐related neurotoxicity: interest of calcium‐magnesium infusion and no impact on its efficacy (letter). Journal of Clinical Oncology 2008;26(7):1188‐9.
Gedlicka 2003 {published data only}
    1. Gedlicka C, Kornek GV, Schmid K, Scheithauer W. Amelioration of docetaxel/cisplatin induced polyneuropathy by alpha‐lipoic acid (letter). Annals of Oncology 2003;14(2):339‐40.
Gispen 1992 {published data only}
    1. Gispen WH, Hamers FP, Vecht CJ, Jennekens FG, Neyt JP. ACTH/MSH like peptides in the treatment of cisplatin neuropathy. Journal of Steroid Biochemistry & Molecular Biology 1992;43(1‐3):179‐83.
Glover 1987 {published data only}
    1. Glover D, Glick JH, Weiler C. WR‐2721 and high‐dose cisplatin: An active combination in the treatment of metastatic melanoma. Journal of Clinical Oncology 1987;5(4):574‐8.
Glover 1989 {published data only}
    1. Glover D, Grabelsky S, Fox K, Weiler C, Cannon L, Glick J. Clinical trials of WR‐2721 and cis‐platinum. International Journal of Radiation Oncology, Biology, Physics 1989;16(5):1201‐4.
Glover 2003 {published data only}
    1. Glover D, Ibrahim J, Kirkwood J, Glick J, Karp D, Stewart J, et al. Phase II randomized trial of cisplatin and WR‐2721 versus cisplatin alone for metastatic melanoma: An Eastern Cooperative Oncology Group Study (E1686). Melanoma Research 2003;13(6):619‐26.
Gradishar 2001 {published data only}
    1. Gradishar WJ, Stephenson P, Glover DJ, Neuberg DS, Moore MR, Windschitl HE, et al. A phase II trial of cisplatin plus WR‐2721 (amifostine) for metastatic breast carcinoma: an Eastern Cooperative Oncology Group Study (E8188). Cancer 2001;92(10):2517‐22.
Grothey 2005 {published data only}
    1. Grothey A. Clinical management of oxaliplatin‐associated neurotoxicity. Clinical Colorectal Cancer 2005;5(Suppl 1):S38‐S46.
Haigentz 2003 {published data only}
    1. Haigentz JM, Kim M, Sorich J, Lee J, Hochster H, Macapinlac M, et al. Phase I study of amifostine as a cytoprotector of the gemcitabine/cisplatin combination in patients with advanced solid malignancies. Anti‐Cancer Drugs 2003;14(4):321‐6.
Heidenreich 1999 {published data only}
    1. Heidenreich A, Marx FJ, Peters HJ, Engelmann UH, Hannappel J, Leusmann D. Amifostine as protective agent in cisplatin‐based chemotherapy of advanced bladder cancer. [German]. Urologe 1999;38(6):586‐91.
Hensley 2009 {published data only}
    1. Hensley ML, Hagerty KL, Kewalramani T, Green DM, Meropol NJ, Wasserman TH, et al. American Society of Clinical Oncology 2008 clinical practice guideline update: use of chemotherapy and radiation therapy protectants. Journal of Clinical Oncology 2009;27(1):127‐45.
Hilkens 1995 {published data only}
    1. Hilkens PH, van‐der‐Burg ME, Moll JW, Planting AS, van‐Putten WL, Vecht CJ, et al. Neurotoxicity is not enhanced by increased dose intensities of cisplatin administration. European Journal of Cancer 1995;31A(5):678‐81.
Hilpert 2005 {published data only}
    1. Hilpert F, Stahle A, Tome O, Burges A, Rossner D, Spathe K, et al. Neuroprotection with amifostine in the first‐line treatment of advanced ovarian cancer with carboplatin/paclitaxel‐based chemotherapy‐‐a double‐blind, placebo‐controlled, randomized phase II study from the Arbeitsgemeinschaft Gynakologische Onkologoie (AGO) Ovarian Cancer Study Group. Supportive Care in Cancer 2005;13(10):797‐805.
Hochster 2007 {published data only}
    1. Hochster HS, Grothey A, Childs BH. Use of calcium and magnesium salts to reduce oxaliplatin‐related neurotoxicity. Journal of Clinical Oncology 2007;25(25):4028‐9.
Kesari 2005 {published data only}
    1. Kesari S, Wen PY. Neuroprotective effect of vitamin E supplementation (commentary). Neurology 2005;64(1):1.
Leong 2003 {published data only}
    1. Leong SS, Tan EH, Fong KW, Wilder‐Smith E, Ong YK, Tai BC, et al. Randomized double‐blind trial of combined modality treatment with or without amifostine in unresectable stage III non‐small‐cell lung cancer. Journal of Clinical Oncology 2003;21(9):1767‐74.
Lissoni 1997 {published data only}
    1. Lissoni P, Tancini G, Barni S, Paolorossi F, Ardizzoia A, Conti A, et al. Treatment of cancer chemotherapy‐induced toxicity with the pineal hormone melatonin. Supportive Care in Cancer 1997;5(2):126‐9.
Lissoni 1999 {published data only}
    1. Lissoni P, Barni S, Mandala M, Ardizzoia A, Paolorossi F, Vaghi M, et al. Decreased toxicity and increased efficacy of cancer chemotherapy using the pineal hormone melatonin in metastatic solid tumor patients with poor clinical status. European Journal of Cancer 1999;35(12):1688‐92.
Lissoni 2002 {published data only}
    1. Lissoni P, Vaghi M, Ardizzoia A, Malugani F, Fumagalli E, Bordin V, et al. A phase II study of chemoneuroimmunotherapy with platinum, subcutaneous low‐dose interleukin‐2 and the pineal neurohormone melatonin (P.I.M.) as a second‐line therapy in metastatic melanoma patients progressing on dacarbazine plus interferon‐alpha. In Vivo 2002;16(2):93‐6.
Miller 2008 {published data only}
    1. Miller AA, Wang XF, Gu L, Hoffman P, Khatri J, Dunphy F, et al. Phase II randomized study of dose‐dense docetaxel and cisplatin every 2 weeks with pegfilgrastim and darbepoetin alfa with and without the chemoprotector BNP7787 in patients with advanced non‐small cell lung cancer (CALGB 30303). Journal of Thoracic Oncology 2008;3(10):1159‐65.
Mollman 1988 {published data only}
    1. Mollman JE, Glover DJ, Hogan WM, Furman RE. Cisplatin neuropathy. Risk factors, prognosis, and protection by WR‐2721. Cancer 1988;61(11):2192‐5.
Moore 2003 {published data only}
    1. Moore DH, Donnelly J, McGuire WP, Almadrones L, Cella DF, Herzog TJ, et al. Limited access trial using amifostine for protection against cisplatin‐ and three‐hour paclitaxel‐induced neurotoxicity: a phase II study of the Gynecologic Oncology Group. Journal of Clinical Oncology 2003;21(22):4207‐13. [PUBMED: 14615449]
Pace 2005 {published data only}
    1. Pace A, Bove L, Jandolo B. Vitamin E for prophylaxis against chemotherapy‐induced neuropathy: a randomized controlled trial. Neurology 2005;65(3):501‐2.
Pace 2010 {published data only}
    1. Pace A, Giannarelli D, Galie E, Savarese A, Carpano S, Della GM, et al. Vitamin E neuroprotection for cisplatin neuropathy: a randomized, placebo‐controlled trial. Neurology 2010;74(9):762‐6.
Penz 2001 {published data only}
    1. Penz M, Kornek GV, Raderer M, Ulrich‐Pur H, Fiebiger W, Scheithauer W. Subcutaneous administration of amifostine: a promising therapeutic option in patients with oxaliplatin‐related peripheral sensitive neuropathy. Annals of Oncology 2001;12(3):421‐2.
Rick 2001 {published data only}
    1. Rick O, Beyer J, Schwella N, Schubart H, Schleicher J, Siegert W. Assessment of amifostine as protection from chemotherapy‐induced toxicities after conventional‐dose and high‐dose chemotherapy in patients with germ cell tumor. Annals of Oncology 2001;12(8):1151‐5.
Wang 2007 {published data only}
    1. Wang WS, Lin JK, Lin TC, Chen WS, Jiang JK, Wang HS, et al. Oral glutamine is effective for preventing oxaliplatin‐induced neuropathy in colorectal cancer patients. Oncologist 2007;12(3):312‐9.
Wen 2013 {published data only}
    1. Wen F, Zhou Y, Wang W, Hu QC, Liu YT, Zhang PF, et al. Ca/Mg infusions for the prevention of oxaliplatin‐related neurotoxicity in patients with colorectal cancer: a meta‐analysis. Annals of Oncology 2013;24(1):171‐8. [PUBMED: 22898039]
Wilkes 2007 {published data only}
    1. Wilkes G. Peripheral neuropathy related to chemotherapy. Seminars in Oncology Nursing 2007;23(3):162‐73.
References to studies awaiting assessment Dong 2010 {published data only}
    1. Dong M, Xing PY, Liu P, Feng FY, Shi YK. [Assessment of the protective effect of calcium‐magnesium infusion and glutathione on oxaliplatin‐induced neurotoxicity]. Zhonghua Zhong Liu Za Zhi [Chinese Journal of Oncology] 2010;32(3):208‐11. [PUBMED: 20450590]
Pang 2010 {published data only}
    1. Pang DM, Deng YM, Lan XS, Feng WN, Liang JM, Xu YH. Efficacy of reduced glutathione in preventing and reducing neurotoxicity of oxaliplatin [Chinese]. Chinese Journal of Cancer Prevention and Treatment 2010;17:2059.
Romano 2011 {published data only}
    1. Romano LM. Vitamin E neuroprotection for cisplatin neuropathy: a randomized, placebo‐controlled trial. [Spanish]. Neurologia Argentina 2011;3:146.
Additional references Carozzi 2010
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Cavaletti 1992
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Cavaletti 2004
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Cavaletti 2010a
    1. Cavaletti G, Frigeni B, Lanzani F, Mattavelli L, Susani E, Alberti P, et al. Chemotherapy‐induced peripheral neurotoxicity assessment: a critical revision of the currently available tools. European Journal of Cancer 2010;46(3):479‐94.
Cavaletti 2013
    1. Cavaletti G, Cornblath DR, Merkies IS, Postma TJ, Rossi E, Frigeni B, et al. The chemotherapy‐induced peripheral neuropathy outcome measures standardization study: from consensus to the first validity and reliability findings. Annals of Oncology 2013;24(2):454‐62.
Elderson 1989
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Gandara 1991
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Grothey 2003
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Grothey 2004
    1. Grothey A, Goldberg RM. A review of oxaliplatin and its clinical use in colorectal cancer. Expert Opinion on Pharmacotherapy 2004;5(10):2159‐70.
Higgins 2008
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Higgins 2011
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Krarup‐Hansen 1993
    1. Krarup‐Hansen A, Fugleholm K, Helweg‐Larsen S, Hauge EN, Schmalbruch H, Trojaborg W, et al. Examination of distal involvement in cisplatin‐induced neuropathy in man. An electrophysiological and histological study with particular reference to touch receptor function. Brain 1993;116(Pt 5):1017‐41.
Links 1999
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Mollman 1990
    1. Mollman JE. Cisplatin neurotoxicity. New England Journal of Medicine 1990;322(2):126‐7.
Molloy 2001
    1. Molloy FM, Floeter MK, Syed NA, Sandbrink F, Culcea E, Steinberg SM, et al. Thalidomide neuropathy in patients treated for metastatic prostate cancer. Muscle & Nerve 2001;24:1050‐7.
Pisano 2003
    1. Pisano C, Pratesi G, Laccabue D, Zunino F, Giudice PL, Bellucci A, et al. Paclitaxel and cisplatin‐induced neurotoxicity: a protective role of acetyl‐L‐carnitine. Clinical Cancer Research 2003;9(15):5756‐67.
Prestayko 1979
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Roelofs 1984
    1. Roelofs RI, Hrushesky W, Rogin J, Rosenberg L. Peripheral sensory neuropathy and cisplatin chemotherapy. Neurology (Minneap) 1984;34:934‐8.
Rose 1996
    1. Rose PG. Amifostine cytoprotection with chemotherapy for advanced ovarian carcinoma. Seminars in Oncology 1996;23(4 Suppl 8):83‐9.
Schmidt 1995
    1. Schmidt Y, Unger JW, Bartke I, Reiter R. Effect of nerve growth factor on peptide neurons in dorsal root ganglia after taxol or cisplatin treatment and in diabetic (db/db) mice. Experimental Neurology 1995;132(1):16‐23.
Thompson 1984
    1. Thompson SW, Davis LE, Kornfeld M, Hilgers RD, Standefer JC. Cisplatin neuropathy. Clinical, electrophysiologic, morphologic, and toxicologic studies. Cancer 1984;54(7):1269‐75.
Tomiwa 1986
    1. Tomiwa K, Nolan C, Cavanagh JB. The effects of cisplatin on rat spinal ganglia: a study by light and electron microscopy and by morphometry. Acta Neuropathologica 1986;69(3‐4):295‐308.
Von Hoff 1979
    1. Hoff DD, Schilsky R, Reichert CM, Reddick RL, Rozencweig M, Young RC, et al. Toxic effects of cis‐dichlorodiammineplatinum(II) in man. Cancer Treatment Report 1979;63(9‐10):1527‐31.
Wald 1994
    1. Wald JJ, Albers JW, Simmons Z, Roberts JA, Capo B. Cisplatin neuropathy: clinical and nerve conduction correlation (abstr). Muscle & Nerve 1994;17:1116‐7.
Wald 1995
    1. Wald JJ, Albers JW, Simmons Z, Roberts JA, Capo B. Cisplatin neuropathy not prevented by ACTH(4‐9) analog (abstr). Neurology 1995;45 (Suppl 4):A170.
Windebank 1994
    1. Windebank AJ, Smith AG, Russell JW. The effect of nerve growth factor, ciliary neurotrophic factor, and ACTH analogs on cisplatin neurotoxicity in vitro. Neurology 1994;44(3 Pt 1):488‐94.
References to other published versions of this review Albers 2005
    1. Albers J, Chaudhry V, Donehower R, Cavaletti G. Interventions for preventing neuropathy caused by cisplatin and related compounds. Cochrane Database of Systematic Reviews 2005, Issue 4. [DOI: 10.1002/14651858.CD005228]
Albers 2007
    1. Albers J, Chaudhry V, Cavaletti G, Donehower R. Interventions for preventing neuropathy caused by cisplatin and related compounds. Cochrane Database of Systematic Reviews 2007, Issue 1. [DOI: 10.1002/14651858.CD005228.pub2]
Albers 2011
    1. Albers JW, Chaudhry V, Cavaletti G, Donehower RC. Interventions for preventing neuropathy caused by cisplatin and related compounds. Cochrane Database of Systematic Reviews 2011, Issue 2. [DOI: 10.1002/14651858.CD005228.pub3]

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