SCOTROC 2B: feasibility of carboplatin followed by docetaxel or docetaxel–irinotecan as first-line therapy for ovarian cancer

作者: A R Clamp , , J Mäenpää , D Cruickshank , J Ledermann

DOI: 10.1038/SJ.BJC.6602910

关键词: Internal medicineChemotherapyTaxaneArea under the curveTopotecanMedicineDocetaxelSurgeryIrinotecanEvaluable DiseaseCarboplatinGastroenterology

摘要: The feasibility of combination irinotecan, carboplatin and docetaxel chemotherapy as first-line treatment for advanced epithelial ovarian carcinoma was assessed. One hundred patients were randomised to receive four 3-weekly cycles (area under the curve (AUC) 7) followed by 100 mg m(-2) (arm A, n=51) or 60 with irinotecan 200 B, n=49). Neither arm met formal criterion an eight-cycle completion rate that statistically greater than 60% A 71% (90% confidence interval (CI) 58-81%; P=0.079; B 67% CI 55-78%; P=0.184)). Median-dose intensities >85% planned dose all agents. In arms 15.6 12.2% patients, respectively, withdrew owing treatment-related toxicity. Grade 3-4 sensory neurotoxicity more common in (1.9 vs 0%) grade diarrhoea (0.6 3.5%). Of radiologically evaluable disease at baseline, 50 48% responded therapy respectively; median 17.1 months' follow-up, progression-free survival 15.9 months, respectively. Although both just failed meet statistical criteria, observed rates around 70% reasonable. addition generally well tolerated although associated increased gastrointestinal Further exploratory studies topoisomerase-I inhibitors this setting may be warranted.

参考文章(29)
Kenji Shibuya, Colin D Mathers, Cynthia Boschi-Pinto, Alan D Lopez, Christopher JL Murray, None, Global and regional estimates of cancer mortality and incidence by site: II. results for the global burden of disease 2000 BMC Cancer. ,vol. 2, pp. 37- 37 ,(2002) , 10.1186/1471-2407-2-37
Virginie M.M. Herben, Vinodh R. Nannan Panday, Dick J. Richel, Jan H.M. Schellens, Nine van der Vange, Hilde Rosing, Fred D. Beusenberg, Solange Hearn, Edward Doyle, Jos H. Beijnen, Wim W. ten Bokkel Huinink, Phase I and Pharmacologic Study of the Combination of Paclitaxel, Cisplatin, and Topotecan Administered Intravenously Every 21 Days as First-Line Therapy in Patients With Advanced Ovarian Cancer Journal of Clinical Oncology. ,vol. 17, pp. 747- 747 ,(1999) , 10.1200/JCO.1999.17.3.747
Franco M. Muggia, Patricia S. Braly, Mark F. Brady, Gregory Sutton, Theodore H. Niemann, Samuel L. Lentz, Ronald D. Alvarez, Paul R. Kucera, James M. Small, Phase III Randomized Study of Cisplatin Versus Paclitaxel Versus Cisplatin and Paclitaxel in Patients With Suboptimal Stage III or IV Ovarian Cancer: A Gynecologic Oncology Group Study Journal of Clinical Oncology. ,vol. 18, pp. 106- 115 ,(2000) , 10.1200/JCO.2000.18.1.106
Alan N. Gordon, John T. Fleagle, David Guthrie, David E. Parkin, Martin E. Gore, Angel J. Lacave, Recurrent Epithelial Ovarian Carcinoma: A Randomized Phase III Study of Pegylated Liposomal Doxorubicin Versus Topotecan Journal of Clinical Oncology. ,vol. 19, pp. 3312- 3322 ,(2001) , 10.1200/JCO.2001.19.14.3312
Diane C. Bodurka, Charles Levenback, Judith K. Wolf, Jacalyn Gano, J. Taylor Wharton, John J. Kavanagh, David M. Gershenson, Phase II Trial of Irinotecan in Patients With Metastatic Epithelial Ovarian Cancer or Peritoneal Cancer Journal of Clinical Oncology. ,vol. 21, pp. 291- 297 ,(2003) , 10.1200/JCO.2003.02.091
Alan F. Wahl, Karen L. Donaldson, Craig Faircnild, Frank Y.F. Lee, Scott A. Foster, G. William Demers, Denise A. Galloway, Loss of normal p53 function confers sensitization to Taxol by increasing G2/M arrest and apoptosis Nature Medicine. ,vol. 2, pp. 72- 79 ,(1996) , 10.1038/NM0196-72
Thomas R. Fleming, One-Sample Multiple Testing Procedure for Phase II Clinical Trials Biometrics. ,vol. 38, pp. 143- 151 ,(1982) , 10.2307/2530297
J P Guastalla III, V Diéras, The taxanes: toxicity and quality of life considerations in advanced ovarian cancer. British Journal of Cancer. ,vol. 89, ,(2003) , 10.1038/SJ.BJC.6601496
F M Wachters, H J M Groen, B Biesma, F M N H Schramel, P E Postmus, J A Stigt, E F Smit, A randomised phase II trial of docetaxel vs docetaxel and irinotecan in patients with stage IIIb–IV non-small-cell lung cancer who failed first-line treatment British Journal of Cancer. ,vol. 92, pp. 15- 20 ,(2005) , 10.1038/SJ.BJC.6602268
A E Guppy, A E Nelstrop, T Foster, R Agarwal, M J Seckl, G J S Rustin, A phase II study of sequential carboplatin, paclitaxel and topotecan in patients with previously untreated advanced ovarian cancer. British Journal of Cancer. ,vol. 90, pp. 810- 814 ,(2004) , 10.1038/SJ.BJC.6601618