Abstract
Docetaxel, a new semisynthetic taxoid that has demonstrated promising activity as an antineoplastic agent, was administered in combination with cisplatin to 63 patients in a dose-escalating study. As both drugs were known to be potentially neurotoxic, peripheral neurotoxicity was prospectively assessed in detail. Neuropathy was evaluated by clinical sum-score for signs and symptoms and by measurement of the vibration perception threshold (VPT). The severity of neuropathy was graded according to the National Cancer Institute's 'Common Toxicity Criteria'. The docetaxel-cisplatin combination chemotherapy induced a predominantly sensory neuropathy in 29 (53%) out of 55 evaluable patients. At cumulative doses of both cisplatin and docetaxel above 200 mg m(-2), 26 (74%) out of 35 patients developed a neuropathy which was mild in 15, moderate in ten and severe in one patient. Significant correlations were present between both the cumulative dose of docetaxel and cisplatin and the post-treatment sum-score of neuropathy (P < 0.01) as well as the post-treatment VPT (P < 0.01). The neurotoxic effects of this combination were more severe than either cisplatin or docetaxel as single agent at similar doses.
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- Aamdal S., Wolff I., Kaplan S., Paridaens R., Kerger J., Schachter J., Wanders J., Franklin H. R., Verweij J. Docetaxel (Taxotere) in advanced malignant melanoma: a phase II study of the EORTC Early Clinical Trials Group. Eur J Cancer. 1994;30A(8):1061–1064. doi: 10.1016/0959-8049(94)90456-1. [DOI] [PubMed] [Google Scholar]
- Apfel S. C., Arezzo J. C., Lipson L., Kessler J. A. Nerve growth factor prevents experimental cisplatin neuropathy. Ann Neurol. 1992 Jan;31(1):76–80. doi: 10.1002/ana.410310114. [DOI] [PubMed] [Google Scholar]
- Bissett D., Setanoians A., Cassidy J., Graham M. A., Chadwick G. A., Wilson P., Auzannet V., Le Bail N., Kaye S. B., Kerr D. J. Phase I and pharmacokinetic study of taxotere (RP 56976) administered as a 24-hour infusion. Cancer Res. 1993 Feb 1;53(3):523–527. [PubMed] [Google Scholar]
- Bruntsch U., Heinrich B., Kaye S. B., de Mulder P. H., van Oosterom A., Paridaens R., Vermorken J. B., Wanders J., Franklin H., Bayssas M. Docetaxel (Taxotere) in advanced renal cell cancer. A phase II trial of the EORTC Early Clinical Trials Group. Eur J Cancer. 1994;30A(8):1064–1067. doi: 10.1016/0959-8049(94)90457-x. [DOI] [PubMed] [Google Scholar]
- Cascinu S., Cordella L., Del Ferro E., Fronzoni M., Catalano G. Neuroprotective effect of reduced glutathione on cisplatin-based chemotherapy in advanced gastric cancer: a randomized double-blind placebo-controlled trial. J Clin Oncol. 1995 Jan;13(1):26–32. doi: 10.1200/JCO.1995.13.1.26. [DOI] [PubMed] [Google Scholar]
- Chaudhry V., Rowinsky E. K., Sartorius S. E., Donehower R. C., Cornblath D. R. Peripheral neuropathy from taxol and cisplatin combination chemotherapy: clinical and electrophysiological studies. Ann Neurol. 1994 Mar;35(3):304–311. doi: 10.1002/ana.410350310. [DOI] [PubMed] [Google Scholar]
- Chevallier B., Fumoleau P., Kerbrat P., Dieras V., Roche H., Krakowski I., Azli N., Bayssas M., Lentz M. A., Van Glabbeke M. Docetaxel is a major cytotoxic drug for the treatment of advanced breast cancer: a phase II trial of the Clinical Screening Cooperative Group of the European Organization for Research and Treatment of Cancer. J Clin Oncol. 1995 Feb;13(2):314–322. doi: 10.1200/JCO.1995.13.2.314. [DOI] [PubMed] [Google Scholar]
- Di Re F., Bohm S., Oriana S., Spatti G. B., Pirovano C., Tedeschi M., Zunino F. High-dose cisplatin and cyclophosphamide with glutathione in the treatment of advanced ovarian cancer. Ann Oncol. 1993 Jan;4(1):55–61. doi: 10.1093/oxfordjournals.annonc.a058362. [DOI] [PubMed] [Google Scholar]
- Elderson A., Gerritsen van der Hoop R., Haanstra W., Neijt J. P., Gispen W. H., Jennekens F. G. Vibration perception and thermoperception as quantitative measurements in the monitoring of cisplatin induced neurotoxicity. J Neurol Sci. 1989 Nov;93(2-3):167–174. doi: 10.1016/0022-510x(89)90187-1. [DOI] [PubMed] [Google Scholar]
- Extra J. M., Rousseau F., Bruno R., Clavel M., Le Bail N., Marty M. Phase I and pharmacokinetic study of Taxotere (RP 56976; NSC 628503) given as a short intravenous infusion. Cancer Res. 1993 Mar 1;53(5):1037–1042. [PubMed] [Google Scholar]
- Fossella F. V., Lee J. S., Murphy W. K., Lippman S. M., Calayag M., Pang A., Chasen M., Shin D. M., Glisson B., Benner S. Phase II study of docetaxel for recurrent or metastatic non-small-cell lung cancer. J Clin Oncol. 1994 Jun;12(6):1238–1244. doi: 10.1200/JCO.1994.12.6.1238. [DOI] [PubMed] [Google Scholar]
- Francis P. A., Rigas J. R., Kris M. G., Pisters K. M., Orazem J. P., Woolley K. J., Heelan R. T. Phase II trial of docetaxel in patients with stage III and IV non-small-cell lung cancer. J Clin Oncol. 1994 Jun;12(6):1232–1237. doi: 10.1200/JCO.1994.12.6.1232. [DOI] [PubMed] [Google Scholar]
- Francis P., Schneider J., Hann L., Balmaceda C., Barakat R., Phillips M., Hakes T. Phase II trial of docetaxel in patients with platinum-refractory advanced ovarian cancer. J Clin Oncol. 1994 Nov;12(11):2301–2308. doi: 10.1200/JCO.1994.12.11.2301. [DOI] [PubMed] [Google Scholar]
- Gandara D. R., Perez E. A., Weibe V., De Gregorio M. W. Cisplatin chemoprotection and rescue: pharmacologic modulation of toxicity. Semin Oncol. 1991 Feb;18(1 Suppl 3):49–55. [PubMed] [Google Scholar]
- Goldberg J. M., Lindblom U. Standardised method of determining vibratory perception thresholds for diagnosis and screening in neurological investigation. J Neurol Neurosurg Psychiatry. 1979 Sep;42(9):793–803. doi: 10.1136/jnnp.42.9.793. [DOI] [PMC free article] [PubMed] [Google Scholar]
- Hilkens P. H., Verweij J., Stoter G., Vecht C. J., van Putten W. L., van den Bent M. J. Peripheral neurotoxicity induced by docetaxel. Neurology. 1996 Jan;46(1):104–108. doi: 10.1212/wnl.46.1.104. [DOI] [PubMed] [Google Scholar]
- Hovestadt A., van der Burg M. E., Verbiest H. B., van Putten W. L., Vecht C. J. The course of neuropathy after cessation of cisplatin treatment, combined with Org 2766 or placebo. J Neurol. 1992 Mar;239(3):143–146. doi: 10.1007/BF00833914. [DOI] [PubMed] [Google Scholar]
- Lipton R. B., Apfel S. C., Dutcher J. P., Rosenberg R., Kaplan J., Berger A., Einzig A. I., Wiernik P., Schaumburg H. H. Taxol produces a predominantly sensory neuropathy. Neurology. 1989 Mar;39(3):368–373. doi: 10.1212/wnl.39.3.368. [DOI] [PubMed] [Google Scholar]
- Mollman J. E., Glover D. J., Hogan W. M., Furman R. E. Cisplatin neuropathy. Risk factors, prognosis, and protection by WR-2721. Cancer. 1988 Jun 1;61(11):2192–2195. doi: 10.1002/1097-0142(19880601)61:11<2192::aid-cncr2820611110>3.0.co;2-a. [DOI] [PubMed] [Google Scholar]
- New P. Z., Jackson C. E., Rinaldi D., Burris H., Barohn R. J. Peripheral neuropathy secondary to docetaxel (Taxotere) Neurology. 1996 Jan;46(1):108–111. doi: 10.1212/wnl.46.1.108. [DOI] [PubMed] [Google Scholar]
- Pazdur R., Kudelka A. P., Kavanagh J. J., Cohen P. R., Raber M. N. The taxoids: paclitaxel (Taxol) and docetaxel (Taxotere). Cancer Treat Rev. 1993 Oct;19(4):351–386. doi: 10.1016/0305-7372(93)90010-o. [DOI] [PubMed] [Google Scholar]
- Rowinsky E. K., Chaudhry V., Forastiere A. A., Sartorius S. E., Ettinger D. S., Grochow L. B., Lubejko B. G., Cornblath D. R., Donehower R. C. Phase I and pharmacologic study of paclitaxel and cisplatin with granulocyte colony-stimulating factor: neuromuscular toxicity is dose-limiting. J Clin Oncol. 1993 Oct;11(10):2010–2020. doi: 10.1200/JCO.1993.11.10.2010. [DOI] [PubMed] [Google Scholar]
- Rowinsky E. K., Gilbert M. R., McGuire W. P., Noe D. A., Grochow L. B., Forastiere A. A., Ettinger D. S., Lubejko B. G., Clark B., Sartorius S. E. Sequences of taxol and cisplatin: a phase I and pharmacologic study. J Clin Oncol. 1991 Sep;9(9):1692–1703. doi: 10.1200/JCO.1991.9.9.1692. [DOI] [PubMed] [Google Scholar]
- Smyth J. F., Smith I. E., Sessa C., Schoffski P., Wanders J., Franklin H., Kaye S. B. Activity of docetaxel (Taxotere) in small cell lung cancer. The Early Clinical Trials Group of the EORTC. Eur J Cancer. 1994;30A(8):1058–1060. doi: 10.1016/0959-8049(94)90455-3. [DOI] [PubMed] [Google Scholar]
- Thompson S. W., Davis L. E., Kornfeld M., Hilgers R. D., Standefer J. C. Cisplatin neuropathy. Clinical, electrophysiologic, morphologic, and toxicologic studies. Cancer. 1984 Oct 1;54(7):1269–1275. doi: 10.1002/1097-0142(19841001)54:7<1269::aid-cncr2820540707>3.0.co;2-9. [DOI] [PubMed] [Google Scholar]
- Wadler S., Beitler J. J., Rubin J. S., Haynes H., McGill F., Rozenblit A., Goldberg G., Cohen C., Speyer J., Runowicz C. Pilot trial of cisplatin, radiation, and WR2721 in carcinoma of the uterine cervix: a New York Gynecologic Oncology Group study. J Clin Oncol. 1993 Aug;11(8):1511–1516. doi: 10.1200/JCO.1993.11.8.1511. [DOI] [PubMed] [Google Scholar]
- Windebank A. J., Smith A. G., Russell J. W. The effect of nerve growth factor, ciliary neurotrophic factor, and ACTH analogs on cisplatin neurotoxicity in vitro. Neurology. 1994 Mar;44(3 Pt 1):488–494. doi: 10.1212/wnl.44.3_part_1.488. [DOI] [PubMed] [Google Scholar]
- van Gerven J. M., Moll J. W., van den Bent M. J., Bontenbal M., van der Burg M. E., Verweij J., Vecht C. J. Paclitaxel (Taxol) induces cumulative mild neurotoxicity. Eur J Cancer. 1994;30A(8):1074–1077. doi: 10.1016/0959-8049(94)90459-6. [DOI] [PubMed] [Google Scholar]
- van der Hoop R. G., Vecht C. J., van der Burg M. E., Elderson A., Boogerd W., Heimans J. J., Vries E. P., van Houwelingen J. C., Jennekens F. G., Gispen W. H. Prevention of cisplatin neurotoxicity with an ACTH(4-9) analogue in patients with ovarian cancer. N Engl J Med. 1990 Jan 11;322(2):89–94. doi: 10.1056/NEJM199001113220204. [DOI] [PubMed] [Google Scholar]
- van der Hoop R. G., van der Burg M. E., ten Bokkel Huinink W. W., van Houwelingen C., Neijt J. P. Incidence of neuropathy in 395 patients with ovarian cancer treated with or without cisplatin. Cancer. 1990 Oct 15;66(8):1697–1702. doi: 10.1002/1097-0142(19901015)66:8<1697::aid-cncr2820660808>3.0.co;2-g. [DOI] [PubMed] [Google Scholar]