251
Views
13
CrossRef citations to date
0
Altmetric
Review

Preventing oxaliplatin-induced neurotoxicity: rationale and design of phase Ib randomized, double-blind, placebo-controlled, cross-over trials for early clinical evaluation of investigational therapeutics

, , , &
Pages 1479-1490 | Received 03 Apr 2016, Accepted 09 Aug 2016, Published online: 23 Aug 2016

References

  • Andre T, Boni C, Navarro M, et al. Improved overall survival with oxaliplatin, fluorouracil, and leucovorin as adjuvant treatment in stage II or III colon Cancer in the MOSAIC trial. J Clin Oncol. 2009;27:3109–3116.
  • de Gramont A, Figer A, Seymour M, et al. Leucovorin and fluorouracil with or without oxaliplatin as first-line treatment in advanced colorectal cancer. J Clin Oncol. 2000;18:2938–2947.
  • Haller DG, Tabernero J, Maroun J, et al. Capecitabine plus oxaliplatin compared with fluorouracil and folinic acid as adjuvant therapy for stage III colon cancer. J Clin Oncol. 2011;29:1465–1471.
  • Kuebler JP, Wieand HS, O’Connell MJ, et al. Oxaliplatin combined with weekly bolus fluorouracil and leucovorin as surgical adjuvant chemotherapy for stage II and III colon cancer: results from NSABP C-07. J Clin Oncol. 2007;25:2198–2204.
  • Rothenberg ML, Oza AM, Bigelow RH, et al. Superiority of oxaliplatin and fluorouracil-leucovorin compared with either therapy alone in patients with progressive colorectal cancer after irinotecan and fluorouracil-leucovorin: interim results of a phase III trial. J Clin Oncol. 2003;21:2059–2069.
  • Conroy T, Desseigne F, Ychou M, et al. FOLFIRINOX versus gemcitabine for metastatic pancreatic cancer. New England J Med. 2011;364:1817–1825.
  • Cunningham D, Starling N, Rao S, et al. Capecitabine and oxaliplatin for advanced esophagogastric cancer. New England J Med. 2008;358:36–46.
  • Grothey A. Oxaliplatin-safety profile: neurotoxicity. Semin Oncol. 2003;30:5–13.
  • Argyriou AA, Cavaletti G, Briani C, et al. Clinical pattern and associations of oxaliplatin acute neurotoxicity: a prospective study in 170 patients with colorectal cancer. Cancer. 2013;119:438–444.
  • Mols F, Beijers T, Lemmens V, et al. 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. 2013;31:2699–2707.
  • Hershman DL, Lacchetti C, Dworkin RH, et al. Prevention and management of chemotherapy-induced peripheral neuropathy in survivors of adult cancers: American society of clinical oncology clinical practice guideline. J Clin Oncol. 2014;32:1941–1967.
  • Majithia N, Temkin SM, Ruddy KJ, et al. National Cancer Institute-supported chemotherapy-induced peripheral neuropathy trials: outcomes and lessons. Support Care Cancer. 2016;24:1439–1447.
  • Poupon L, Kerckhove N, Vein J, et al. Minimizing chemotherapy-induced peripheral neuropathy: preclinical and clinical development of new perspectives. Expert Opin Drug Saf. 2015;14:1269–1282.
  • Torre LA, Bray F, Siegel RL, et al. Global cancer statistics, 2012. CA Cancer J Clin. 2015;65:87–108.
  • Han CH, Khwaounjoo P, Kilfoyle DH, et al. Phase I drug-interaction study of effects of calcium and magnesium infusions on oxaliplatin pharmacokinetics and acute neurotoxicity in colorectal cancer patients. BMC Cancer. 2013;13:495.
  • Loprinzi CL, Qin R, Dakhil SR, et al. Phase III randomized, placebo-controlled, double-blind study of intravenous calcium and magnesium to prevent oxaliplatin-induced sensory neurotoxicity (N08CB/Alliance). J Clin Oncol. 2014;32:9997–1005.
  • Pachman DR, Qin R, Seisler DK, et al. clinical course of oxaliplatin-induced neuropathy: results from the randomized phase III trial N08CB (Alliance). J Clin Oncol. 2015;33:3416–3422.
  • Gamelin L, Boisdron-Celle M, Delva R, 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. Clin Cancer Res. 2004;10:4055–4061.
  • Pachman DR, Ruddy K, Sangaralingham LR, et al. Calcium and magnesium use for oxaliplatin-induced neuropathy: a case study to assess how quickly evidence translates into practice. J Natl Compr Cancer Netw. 2015;13:1097–1101.
  • Graham MA, Lockwood GF, Greenslade D, et al. Clinical pharmacokinetics of oxaliplatin: a critical review. Clin Cancer Res. 2000;6:1205–1218.
  • Jerremalm E, Wallin I, Ehrsson H. New insights into the biotransformation and pharmacokinetics of oxaliplatin. J Pharm Sci. 2009;98:3879–3885.
  • Jerremalm E, Wallin I, Yachnin J, et al. Oxaliplatin degradation in the presence of important biological sulphur-containing compounds and plasma ultrafiltrate. Eur J Pharm Sci. 2006;28:278–283.
  • Spingler B, Whittington DA, Lippard SJ. 2.4 angstrom crystal structure of an oxaliplatin 1,2-d(GpG) intrastrand cross-link in a DNA dodecamer duplex. Inorg Chem. 2001;40:5596–5602.
  • Machin D, Campbell M, Fayers P, et al. Sample size tables for clinical studies. Blackwell Sci. 1997;102–104.
  • Balin-Gauthier D, Delord JP, Rochaix P, et al. In vivo and in vitro antitumor activity of oxaliplatin in combination with cetuximab in human colorectal tumor cell lines expressing different level of EGFR. Cancer Chemother Pharmacol. 2006;57:709–718.
  • Ip V, Liu JJ, McKeage MJ. Evaluation of effects of copper histidine on copper transporter 1-mediated accumulation of platinum and oxaliplatin-induced neurotoxicity in vitro and in vivo. Clin Exp Pharmacol Physiol. 2013;40:371–378.
  • Louvet C, Coudray AM, Tournigand C, et al. Synergistic antitumoral activity of combined UFT, folinic acid and oxaliplatin against human colorectal HT29 cell xenografts in athymic nude mice. Anti-Cancer Drugs. 2000;11:579–582.
  • Hui D, Zhukovsky DS, Bruera E. Which treatment is better? Ascertaining patient preferences with crossover randomized controlled trials. J Pain Symptom Manage. 2015;49:625–631.
  • Louis TA, Lavori PW, Bailar JC, et al. Crossover and self-controlled designs in clinical research. N Engl J Med. 1984;310:24–31.
  • Mills EJ, Chan AW, Wu P, et al. Design, analysis, and presentation of crossover trials. Trials. 2009;10:27.
  • U.S. Department of Health and Human Services Food and Drug Administration CfDEaRC. Statistical Approaches to Establishing Bioequivalence; 2001. Available from: http://www.fda.gov/downloads/Drugs/…/Guidances/ucm070244.pdf
  • U.S. Department of Health and Human Services Food and Drug Administration CfDEaRC. Drug Interaction Studies —Study Design, Data Analysis, Implications for Dosing, and Labeling Recommendations; 2012. Available from: http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/ucm292362.pdf
  • Gluud LL. Bias in clinical intervention research. Am J Epidemiol. 2006;163:493–501.
  • Ip V, McKeage MJ, Thompson P, et al. Platinum-specific detection and quantification of oxaliplatin and Pt(R, R-diaminocyclohexane)Cl(2) in the blood plasma of colorectal cancer patients. J Anal At Spectrom. 2008;23:881–884.
  • Hill A, Bergin P, Hanning F, et al. Detecting acute neurotoxicity during platinum chemotherapy by neurophysiological assessment of motor nerve hyperexcitability. BMC Cancer. 2010;10:451–459.
  • McDonald JH. Handbook of biological statistics. Baltimore (MD): Sparky House Publishing; 2008.
  • Zimmerman C, Atherton PJ, Pachman D, et al. MC11C4: a pilot randomized, placebo-controlled, double-blind study of venlafaxine to prevent oxaliplatin-induced neuropathy. Support Care Cancer. 2016;24:1071–1078.
  • Alejandro LM, Behrendt CE, Chen K, et al. Predicting acute and persistent neuropathy associated with oxaliplatin. Am J Clin Oncol. 2013;36:331–337.
  • Velasco R, Bruna J, Briani C, et al. Early predictors of oxaliplatin-induced cumulative neuropathy in colorectal cancer patients. J Neurol Neurosurg Psychiatry. 2014;85:392–398.

Reprints and Corporate Permissions

Please note: Selecting permissions does not provide access to the full text of the article, please see our help page How do I view content?

To request a reprint or corporate permissions for this article, please click on the relevant link below:

Academic Permissions

Please note: Selecting permissions does not provide access to the full text of the article, please see our help page How do I view content?

Obtain permissions instantly via Rightslink by clicking on the button below:

If you are unable to obtain permissions via Rightslink, please complete and submit this Permissions form. For more information, please visit our Permissions help page.