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Review

Toxicity of the topoisomerase I inhibitors

Pages 45-53 | Published online: 22 Apr 2005

Bibliographys

  • GUPTA M, FUJIMORI A, POMMIER Eukaryotic DNA topoisomerases I. Biochim. Biophys. Acta (1995) 1262:1–14.
  • ••An excellent review of the actions oftopoisomerase I.
  • KOHN KW, POMMIER Y: Molecular and biological determinants of the cytotoxic actions of camptothecins. Perspective for the development of new topoisomerase I inhibitors. Ann. NY Acad. Sci. (2000) 922:11–26.
  • SORDET 0, KHAN QA, KOHN KW, POMMIER Apoptosis induced by topoisomerase inhibitors. Cuff. Med. Chem. Anti-Cane. Agents (2003) 3:271–290.
  • WALL ME, WANT MC, COOK CE, PALMER KH: Plant antitumour agents, I: the isolation and structure of camptothecin, a novel alkaloidal leukaemia and tumour inhibitor from Camptotheca acuminata. J. Am. Chem. Soc. (1966) 88:3888–3890.
  • MOERTEL CG, SCHUTT AJ, REITEMEIER RJ, HAHN RG: Phase II study of camptothecin (NSC-100880) in the treatment of advanced gastrointestinal cancer. Cancer Chemother. Rep. (1972) 56:95–101.
  • HSIANG YH, HERTZBERG R, HECHT S, LIU LF: Camptothecin induces protein-linked DNA breaks via mammalian topoisomerase I. j Biol. Chem. (1985) 260:14873–14878.
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  • LAVERGNE 0, LESUER-GINOT L, PLA RODAS F et al.: Homocamptothecins: synthesis and antitumour activity of novel E-ring-modified camptothecin analogues. J. Med. Chem. (1998) 41:5410–5419.
  • GELDERBLOM H, SALAZAR R, VERWEIJ J et al.: Phase I pharmacological and bioavailability study of oral diflomotecan (BN80915), a novel E-ring-modified camptothecin analogue in adults with solid tumours. Clin. Cancer Res. (2003) 9:4101–4107.
  • ROUGIER P, BUGAT R, DOUILLARD JY et al.: Phase II study of irinotecan in the treatment of advanced colorectal cancer in chemotherapy-naive patients and patients pretreated with fluorouracil-based chemotherapy. Clin. Oncol. (1997) 15:251–260.
  • •The definitive French Phase II study using the every three week regimen of irinotecan.
  • ROTHENBERG ML, ECKARDT JR, KUHN JG et al.: Phase II trial of irinotecan in patients with progressive or rapidly recurrent colorectal cancer. J. Clin. Oncol. (1996) 14:1128–1135.
  • •The definitive US Phase II study using weekly irinotecan in metastatic colorectal cancer.
  • PITOT HC, WENDER DB, O'CONNELL MJ et al.: Phase II trial of irinotecan in patients with metastatic colorectal carcinoma. J. Clin. Oncol (1997) 15:2910–2919.
  • SHIMADA Y, YOSHINO M, WAKUI A et al.: Phase II study of CPT-11, a new camptothecin derivative, in metastatic colorectal cancer. CPT-11 Gastrointestinal Cancer Study Group. J. Clin. Oncol. (1993) 11:909–913.
  • •An early Japanese Phase II study.
  • FUKUOKA M, NIITANI H, SUZUKI A et al.: A Phase II study of CPT-11, a new derivative of camptothecin, for previously untreated non-small-cell lung cancer. Clin. Oncol. (1992) 10:16–20.
  • MASUDA N, FUKUOKA M, KUSUNOKI Y et ell.: CPT-11: anew derivative of camptothecin for the treatment of refractory or relapsed small-cell lung cancer. J. Clin. Oncol. (1992) 10:1225–1229.
  • OHNO R, OKADA K, MASAOKA T et al.: An early Phase II study of CPT-11: a new derivative of camptothecin, for the treatment of leukaemia and lymphoma. J. Clin. Oncol. (1990) 8:1907–1912.
  • SALIBA F, HAGIPANTELLI R, MISSET JL et al.: Pathophysiology and therapy of irinotecan-induced delayed-onset diarrhea in patients with advanced colorectal cancer: a prospective assessment. J. Clin. Oncol. (1998) 16:2745–2751.
  • ••A detailed analysis of the mechanismsof diarrhoea following treatment with irinotecan.
  • BENSON AB, AJANI JA, CATALANO RB et al.: Recommended guidelines for the treatment of cancer treatment-induced diarrhea./ Clin. Oncol. (2004) 22:2918–2926.
  • ••An excellent summary of the treatmentof irinotecan-induced diarrhoea. This article contains a very practical treatment algorithm.
  • FUCHS CS, MOORE MR, HARKER G et al.: Phase III comparison of two irinotecan dosing regimens in second-line therapy of metastatic colorectal cancer. J. Clin. Oncol. (2003) 21:807–814.
  • TSAVARIS N, ZIRAS N, KOSMAS C et al.: Two different schedules of irinotecan (CPT-11) in patients with advanced colorectal carcinoma relapsing after a 5-fluorouracil and leucovorin combination. A randomized study. Cancer Chemother. PharmacoL (2003) 52:514–519.
  • CUNNINGHAM D, PYRHONEN S, JAMES RD et al.: Randomised trial of irinotecan plus supportive care versus supportive care alone after fluorouracil failure for patients with metastatic colorectal cancer. Lancet (1998) 352:1413–1418.
  • •An important study showing a survival advantage for patients treated with irinotecan after failing FU-based therapy.
  • ROUGIER P, VAN CUTSEM E, BAJETTA E et al.: Randomised trial of irinotecan versus fluorouracil by continuous infusion after fluorouracil failure in patients with metastatic colorectal cancer. Lancet (1998) 352:1407–1412.
  • DOUILLARD JY, CUNNINGHAM D, ROTH AD et al.: Irinotecan combined with fluorouracil compared with fluorouracil alone as first-line treatment for metastatic colorectal cancer: a multi-centre randomised trial. Lancet (2000) 355:1041–1047.
  • SALTZ LB, KANOWITZ J, KEMENY NE et al.: Phase I clinical and pharmacokinetic study of irinotecan, fluorouracil, and leucovorin in patients with advanced solid tumours./ Clin. Oncol. (1996) 14:2959–2967.
  • SALTZ LB, COX JV, BLANKE C et aL: Irinotecan plus fluorouracil and leucovorin for metastatic colorectal cancer. Irinotecan Study Group. N EngL J. Med. (2000) 343:905–914.
  • •The definitive report of the IFL regimen.
  • ROTHENBERG ML, MEROPOL NJ, POPLIN EA et aL: Mortality associated with irinotecan plus bolus fluorouracil/leucovorin: summary findings of an independent panel. J. Clin. Oncol. (2001) 19:3801–3807.
  • ••A detailed analysis of the toxicity of theIFL regimen.
  • ANDRE T, LOUVET C, MAINDRAULT-GOEBEL F et aL: CPT-11 (irinotecan) addition to bimonthly, high-dose leucovorin and bolus and continuous-infusion 5-fluorouracil (FOLFIRI) for pretreated metastatic colorectal cancer. GERCOR. Eur. J. Cancer (1999) 35:1343–1347.
  • •The alternative FOLFIRI regimen.
  • MABRO M, LOUVET C, ANDRE T et al.: Bimonthly leucovorin, infusion 5-fluorouracil, hydroxyurea, and irinotecan (FOLFIRI-2) for pretreated metastatic colorectal cancer. Am. J. Clin. Oncol. (2003) 26:254–258.
  • GOLDBERG RM, SARGENT DJ, MORTON RF et aL: A randomized controlled trial of fluorouracil plus leucovorin, irinotecan, and oxaliplatin combinations in patients with previously untreated metastatic colorectal cancer. Clin. Oncol. (2004) 22:23–30.
  • SATOH T, HOSOKAWA M, ATSUMI R et al.: Metabolic activation of CPT-11, 7-ethyl-1044-(1-piperidino)-1-piperidinolcarbonyloxycamptothecin, a novel antitumour agent, by carboxylesterase. Biol. Pharm. Bull (1994) 17:662–664.
  • KUDOH S, FUKUOKA M, MASUDA N et al.: Relationship between the pharmacokinetics of irinotecan and diarrhea during combination chemotherapy with cisplatin. Jpn. J. Cancer Res. (1995) 86:406–413.
  • BARILERO I, GANDIA D, ARMAND JP et al.: Simultaneous determination of the camptothecin analogue CPT-11 and its active metabolite SN-38 by high-performance liquid chromatography: application to plasma pharmacokinetic studies in cancer patients. J. Chromatogr. (1992) 575:275–280.
  • ROWINSKY EK, GROCHOW LB, ETTINGER DS et aL: Phase I and pharmacological study of the novel topoisomerase I inhibitor 7-ethyl-10-l4-(1-piperidino)-1-piperidinolcarbonyloxycamptothecin (CPT-11) administered as a ninety-minute infusion every 3 weeks. Cancer Res. (1994) 54:427–436.
  • INNOCENTI F, UNDEVIA SD, IYER L et al.: Genetic variants in the UDP-glucuronosyltransferase 1A1 gene predict the risk of severe neutropaenia of irinotecan. j Clin. Oncol. (2004) 22:1382–1388.
  • ••Landmark study analysing the effect of UDP-glucuronosyltransferase polymorphisms on irinotecan toxicity.
  • MEYERHARDT JA, KWOK A, RATAIN MJ et al.: Relationship of baseline serum bilirubin to efficacy and toxicity of single-agent irinotecan in patients with metastatic colorectal cancer. J. Clin. Oncol. (2004) 22:1439–1446.
  • ••An important study that analyses therelationship between bilirubin level and irinotecan toxicity.
  • VENOOK AP, ENDERS KLEIN C, FLEMING G et al.: A Phase I and pharmacokinetic study of irinotecan in patients with hepatic or renal dysfunction or with prior pelvic radiation: CALGB 9863. Ann. Oncol. (2003) 14:1783–1790.
  • ••A guide to irinotecan dosing in patientswith organ dysfunction.
  • RAYMOND E, BOIGE V, FAIVRE S et aL: Dosage adjustment and pharmacokinetic profile of irinotecan in cancer patients with hepatic dysfunction. J. Clin. Oncol. (2002) 20:4303–4312.
  • ••A guide to irinotecan dosing in patientswith hepatic dysfunction.
  • CANAL P, GAY C, DEZEUZE A et al.: Pharmacokinetics and pharmacodynamics of irinotecan during a Phase II clinical trial in colorectal cancer. Pharmacology and Molecular Mechanisms Group of the European Organization for Research and Treatment of Cancer./ Clin. Oncol. (1996) 14:2688–2695.
  • GUPTA E, MICK R, RAMIREZ J et al: Pharmacokinetic and pharmacodynamic evaluation of the topoisomerase inhibitor irinotecan in cancer patients. J. Clin. Oncol (1997) 15:1502–1510.
  • VASSAL G, DOZ F, FRAPPAZ D et al.: A Phase I study of irinotecan as a 3-week schedule in children with refractory or recurrent solid tumours. J. Clin. Oncol. (2003) 21:3844–3852.
  • MUGISHIMA H, MATSUNAGA T, YAGI K et al.: Phase I study of irinotecan in pediatric patients with malignant solid tumours. J. Pediatr. Hematol Oncol (2002) 24:94–100.
  • GILBERT MR, SUPKO JG, BATCHELOR T et al.: Phase I clinical and pharmacokinetic study of irinotecan in adults with recurrent malignant glioma. Clin. Cancer Res. (2003) 9:2940–2949.
  • •This study emphasizes the importance of drug interactions on irinotecan efficacy and toxicity.
  • RIBRAG V KOSCIELNY S, VANTELON JM et al.: Phase II trial of irinotecan (CPT-11) in relapsed or refractory non-Hodgkin's lymphomas. Leuk. Lymphoma (2003) 44:1529–1533.
  • RIBRAG V, SUZAN F, RAVOET C et ell.: Phase II trial of CPT-11 in myelodysplastic syndromes with excess of marrow blasts. Leukaemia (2003) 17:319–322.
  • SARRIS AH, PHAN A. GOY A et al: Irinotecan in relapsed or refractory non-Hodgkin's lymphomas. Indications of activity in a Phase II trial. Oncology (2002) 16:27–31.
  • ROWINSKY EK, GROCHOW LB, SARTORIUS SE et al.: Phase I and pharmacologic study of high doses of the topoisomerase I inhibitor topotecan with granulocyte colony-stimulating factor in patients with solid tumours. J. Clin. Oncol (1996) 14:1224–1235.
  • CREEMERS GJ, BOLIS G, GORE M et al: Topotecan, an active drug in the second-line treatment of epithelial ovarian cancer: results of a large European Phase II study. J. Clin. Oncol (1996) 14:3056–3061.
  • •An important Phase II study of topotecan.
  • SCHILLER JH, KIM K, HUTSON Pet al: Phase II study of topotecan in patients with extensive-stage small-cell carcinoma of the lung: an Eastern Cooperative Oncology Group Trial. J. Clin. Oncol (1996) 14:2345–2352.
  • ARDIZZONI k HANSEN H, DOMBERNOWSKY P et al:Topotecan, a new active drug in the second-line treatment of small-cell lung cancer: a Phase II study in patients with refractory and sensitive disease. J. Clin. Oncol (1997) 15:2090–2096.
  • MACDONALD JS, BENEDETTI JK, MODIANO M, ALBERTS DS: Phase II evaluation of topotecan in patients with advanced colorectal cancer. A Southwest Oncology Group trial (SWOG 9241). Invest. New Drugs (1997) 15:357–359.
  • TEN BOKKEL HUININK W, GORE M, CARMICHAEL J et al: Topotecan versus paclitaxel for the treatment of recurrent epithelial ovarian cancer. J. Clin. Oncol (1997) 15:2183–2193.
  • ••An important study that demonstratedthat topotecan was as active as paclitaxel in ovarian cancer.
  • VON PAWEL J, SCHILLER JH, SHEPHERD FA et al: Topotecan versus cyclophosphamide, doxorubicin, and vincristine for the treatment of recurrent small-cell lung cancer. J. Clin. Oncol. (1999) 17:658–667.
  • HOCHSTER H, WADLER S, RUNOWICZ C et al: Activity and pharmacodynamics of 21-Day topotecan infusion in patients with ovarian cancer previously treated with platinum-based chemotherapy. J. Clin. Oncol (1999) 17:2553–2561.
  • HOCHSTER H, LIEBES L, SPEYER J et al.: Phase I trial of low-dose continuous topotecan infusion in patients with cancer: an active and well-tolerated regimen. J. Clin. Oncol (1994) 12:553–559.
  • KANTARJIAN HM, BERAN M, ELLIS A et al.: Phase I study of topotecan, a new topoisomerase I inhibitor, in patients with refractory or relapsed acute leukaemia. Blood (1993) 81:1146–1151.
  • BERAN M, KANTARJIAN H,O'BRIEN S et al: Topotecan, a topoisomerase I inhibitor, is active in the treatment of myelodysplastic syndrome and chronic myelomonocytic leukaemia. Blood (1996) 88:2473–2479.
  • BERAN M, ESTEY E, O'BRIEN S et al: Topotecan and cytarabine is an active combination regimen in myelodysplastic syndromes and chronic myelomonocytic leukaemia. J. Clin. Oncol (1999) 17:2819–2830.
  • ••Report of a commonly used topotecanbased regimen for patients with MDS.
  • SCHILDER RJ, GALLO JM, MILLENSON MM et al.: Phase I trial of multiple cycles of high-dose carboplatin, paclitaxel, and topotecan with peripheral-blood stem-cell support as front-line therapy. J. Clin. Oncol (2001) 19:1183–1194.
  • PRINCE HM, RISCHIN D, QUINN M et al.: Repetitive high-dose topotecan, carboplatin, and paclitaxel with peripheral blood progenitor cell support in previously untreated ovarian cancer: results of a Phase I study. Gynecol. Oncol (2001) 81:216–224.
  • KUSHNER BH, CHEUNG NK, KRAMER K et al.: Topotecan combined with myeloablative doses of thiotepa and carboplatin for neuroblastoma, brain tumours, and other poor-risk solid tumours in children and young adults. Bone Marrow Transplant (2001) 28:551–556.
  • DONATO ML, ALEMAN A, CHAMPLIN RE et al.: High-dose topotecan, melphalan and cyclophosphamide (TMC) with stem cell support: a new regimen for the treatment of multiple myeloma. Leuk. Lymphoma (2004) 45:755–759.
  • O'REILLY S, ROWINSKY EK, SLICHENMYER Wet al.: Phase I and pharmacologic study of topotecan in patients with impaired renal function. Clin. Oncol (1996) 14:3062–3073.
  • ••A detailed analysis of the use of topotecanin patients with renal dysfunction.
  • O'REILLY S, ROWINSKY E, SLICHENMYER Wet al.: Phase I and pharmacologic studies of topotecan in patients with impaired hepatic function. Natl Cancer Inst. (1996) 88:817–824.
  • ••A detailed analysis of the use of topotecanin patients with hepatic dysfunction.

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