Journal of Clinical Oncology, Vol 18, Issue 17
(September), 2000: 3084-3092
© 2000 American Society for Clinical Oncology
Exploratory Phase III Study of Paclitaxel and Cisplatin Versus Paclitaxel and Carboplatin in Advanced Ovarian Cancer
By Jan P. Neijt,
Svend A. Engelholm,
Malgorzata K. Tuxen,
Peter G. Sørensen,
Mogens Hansen,
Cristiana Sessa,
Cees A. M. de Swart,
Fred R. Hirsch,
Birthe Lund,
Hans C. van Houwelingen
From the University Medical Center Utrecht, Utrecht; Spaarneziekenhuis, Haarlem; Department of Medical Statistics, Leiden University Medical Centre, Leiden, the Netherlands; Finsen Center, Copenhagen University Hospital; Herlev Amtssygehus, University of Copenhagen, Copenhagen; Roskilde Hospital, Roskilde; Hillerød Hospital, Hillerød; Bispebjerg Hospital and Bristol Myers-Squibb, København, Denmark; and Ospedale San Giovanni, Bellinzona, Switzerland.
Address reprint requests to J.P. Neijt, MD, Utrecht University Medical Center, locatie Academisch Ziekenhuis F02.126, PO Box 85500, 3508 GA Utrecht, the Netherlands; email j.p.neijt{at}digd.azu.nl
PURPOSE: To determine the side effects and feasibility of cisplatin and carboplatin each in combination with paclitaxel as front-line therapy in advanced epithelial ovarian cancer.
PATIENTS AND METHODS: Patients were randomly allocated to receive paclitaxel 175 mg/m2 intravenously as a 3-hour infusion followed by either cisplatin 75 mg/m2 or carboplatin (area under the plasma concentration-time curve of 5), both on day 1. The schedule was repeated every 3 weeks for at least six cycles. Women allocated to paclitaxel-cisplatin were admitted to the hospital, whereas the carboplatin regimen was administered to outpatients.
RESULTS: A total of 208 eligible patients were randomized. Both regimens could be delivered in an optimal dose and without significant delay. Paclitaxel-carboplatin produced significantly less nausea and vomiting (P < .01) and less peripheral neurotoxicity (P = .04) but more granulocytopenia and thrombocytopenia (P < .01). The overall response rate in 132 patients with measurable disease was 64% (84 of 132 patients), and in patients with elevated CA 125 levels at start, it was 74% (132 of 178 patients). With a median follow-up time of 37 months, the median progression-free survival time of all patients was 16 months and the median overall survival time was 31 months. The small number of patients entered onto the study caused wide confidence intervals (CIs) around the hazards ratio for progression-free survival of paclitaxel-carboplatin compared with paclitaxel-cisplatin (hazards ratio, 1.07; 95% CI, 0.78 to 1.48) and did not allow conclusions about efficacy.
CONCLUSION: Paclitaxel-carboplatin is a feasible regimen for outpatients with ovarian cancer and has a better toxicity profile than paclitaxel-cisplatin.
Presented in part at the Thirty-Third Annual Meeting of the American Society of Clinical Oncology, Denver, CO, May 17-20, 1997.
This article has been cited by other articles:
|
|
|
|
 
M. Joerger, A. D.R. Huitema, D. J. Richel, C. Dittrich, N. Pavlidis, E. Briasoulis, J. B. Vermorken, E. Strocchi, A. Martoni, R. Sorio, et al.
Population Pharmacokinetics and Pharmacodynamics of Paclitaxel and Carboplatin in Ovarian Cancer Patients: A Study by the European Organization for Research and Treatment of Cancer-Pharmacology and Molecular Mechanisms Group and New Drug Development Group
Clin. Cancer Res.,
November 1, 2007;
13(21):
6410 - 6418.
[Abstract]
[Full Text]
[PDF]
|
|
|
|
|
|
|
V. Mobus, H. Wandt, N. Frickhofen, C. Bengala, K. Champion, R. Kimmig, H. Ostermann, A. Hinke, and J. A. Ledermann
Phase III Trial of High-Dose Sequential Chemotherapy With Peripheral Blood Stem Cell Support Compared With Standard Dose Chemotherapy for First-Line Treatment of Advanced Ovarian Cancer: Intergroup Trial of the AGO-Ovar/AIO and EBMT
J. Clin. Oncol.,
September 20, 2007;
25(27):
4187 - 4193.
[Abstract]
[Full Text]
[PDF]
|
|
|
|
|
|
|
F Hilpert, A du Bois, E. Greimel, J Hedderich, G Krause, L Venhoff, S Loibl, and J Pfisterer
Feasibility, toxicity and quality of life of first-line chemotherapy with platinum/paclitaxel in elderly patients aged >=70 years with advanced ovarian cancer--a study by the AGO OVAR Germany
Ann. Onc.,
February 1, 2007;
18(2):
282 - 287.
[Abstract]
[Full Text]
[PDF]
|
|
|
|
|
|
|
J-M Ferrero, B Weber, J-F Geay, D Lepille, H Orfeuvre, M Combe, F Mayer, B Leduc, H Bourgeois, D Paraiso, et al.
Second-line chemotherapy with pegylated liposomal doxorubicin and carboplatin is highly effective in patients with advanced ovarian cancer in late relapse: a GINECO phase II trial
Ann. Onc.,
February 1, 2007;
18(2):
263 - 268.
[Abstract]
[Full Text]
[PDF]
|
|
|
|
|
|
|
M. Kyrgiou, G. Salanti, N. Pavlidis, E. Paraskevaidis, and J. P. A. Ioannidis
Survival Benefits With Diverse Chemotherapy Regimens for Ovarian Cancer: Meta-analysis of Multiple Treatments.
J Natl Cancer Inst,
November 15, 2006;
98(22):
1655 - 1663.
[Abstract]
[Full Text]
[PDF]
|
|
|
|
|
|
|
J. Pfisterer, B. Weber, A. Reuss, R. Kimmig, A. du Bois, U. Wagner, H. Bourgeois, W. Meier, S. Costa, J.-U. Blohmer, et al.
Randomized phase III trial of topotecan following carboplatin and paclitaxel in first-line treatment of advanced ovarian cancer: a gynecologic cancer intergroup trial of the AGO-OVAR and GINECO.
J Natl Cancer Inst,
August 2, 2006;
98(15):
1036 - 1045.
[Abstract]
[Full Text]
[PDF]
|
|
|
|
|
|
|
T. Wasil and S. M. Lichtman
Clinical Pharmacology Issues Relevant to the Dosing and Toxicity of Chemotherapy Drugs in the Elderly
Oncologist,
September 1, 2005;
10(8):
602 - 612.
[Abstract]
[Full Text]
[PDF]
|
|
|
|
|
|
|
G. Aravantinos, G. Fountzilas, P. Kosmidis, M. A. Dimopoulos, G. P. Stathopoulos, N. Pavlidis, D. Bafaloukos, C. Papadimitriou, S. Karpathios, V. Georgoulias, et al.
Paclitaxel plus carboplatin versus paclitaxel plus alternating carboplatin and cisplatin for initial treatment of advanced ovarian cancer: long-term efficacy results: a Hellenic Cooperative Oncology Group (HeCOG) study
Ann. Onc.,
July 1, 2005;
16(7):
1116 - 1122.
[Abstract]
[Full Text]
[PDF]
|
|
|
|
|
|
|
A. Gadducci, E. Sartori, F. Landoni, P. Zola, T. Maggino, A. Maggioni, S. Cosio, E. Frassi, M. T. LaPresa, L. Fuso, et al.
Relationship Between Time Interval From Primary Surgery to the Start of Taxane- Plus Platinum-Based Chemotherapy and Clinical Outcome of Patients With Advanced Epithelial Ovarian Cancer: Results of a Multicenter Retrospective Italian Study
J. Clin. Oncol.,
February 1, 2005;
23(4):
751 - 758.
[Abstract]
[Full Text]
[PDF]
|
|
|
|
|
|
|
P. A. Vasey, G. C. Jayson, A. Gordon, H. Gabra, R. Coleman, R. Atkinson, D. Parkin, J. Paul, A. Hay, S. B. Kaye, et al.
Phase III Randomized Trial of Docetaxel-Carboplatin Versus Paclitaxel-Carboplatin as First-line Chemotherapy for Ovarian Carcinoma
J Natl Cancer Inst,
November 17, 2004;
96(22):
1682 - 1691.
[Abstract]
[Full Text]
[PDF]
|
|
|
|
|
|
|
A. Bezjak, D. Tu, M. Bacon, D. Osoba, B. Zee, G. Stuart, J.-A. Roy, M. Piccart, and E. Eisenhauer
Quality of Life in Ovarian Cancer Patients: Comparison of Paclitaxel Plus Cisplatin, With Cyclophosphamide Plus Cisplatin in a Randomized Study
J. Clin. Oncol.,
November 15, 2004;
22(22):
4595 - 4603.
[Abstract]
[Full Text]
[PDF]
|
|
|
|
|
|
|
B. Gronlund, C. Hogdall, J. Hilden, S. A. Engelholm, E. V.S. Hogdall, and H. H. Hansen
Should CA-125 Response Criteria Be Preferred to Response Evaluation Criteria in Solid Tumors (RECIST) for Prognostication During Second-Line Chemotherapy of Ovarian Carcinoma?
J. Clin. Oncol.,
October 15, 2004;
22(20):
4051 - 4058.
[Abstract]
[Full Text]
[PDF]
|
|
|
|
|
|
|
S. De Placido, G. Scambia, G. Di Vagno, E. Naglieri, A. V. Lombardi, R. Biamonte, M. Marinaccio, G. Carteni, L. Manzione, A. Febbraro, et al.
Topotecan Compared With No Therapy After Response to Surgery and Carboplatin/Paclitaxel in Patients With Ovarian Cancer: Multicenter Italian Trials in Ovarian Cancer (MITO-1) Randomized Study
J. Clin. Oncol.,
July 1, 2004;
22(13):
2635 - 2642.
[Abstract]
[Full Text]
[PDF]
|
|
|
|
|
|
|
G. J. S. Rustin, R. C. Bast Jr., G. J. Kelloff, J. C. Barrett, S. K. Carter, P. D. Nisen, C. C. Sigman, D. R. Parkinson, and R. W. Ruddon
Use of CA-125 in Clinical Trial Evaluation of New Therapeutic Drugs for Ovarian Cancer
Clin. Cancer Res.,
June 1, 2004;
10(11):
3919 - 3926.
[Full Text]
[PDF]
|
|
|
|
|
|
|
V. Hess, R. A'Hern, N. Nasiri, D. M. King, P. R. Blake, D. P.J. Barton, J. H. Shepherd, T. Ind, J. Bridges, K. Harrington, et al.
Mucinous Epithelial Ovarian Cancer: A Separate Entity Requiring Specific Treatment
J. Clin. Oncol.,
March 15, 2004;
22(6):
1040 - 1044.
[Abstract]
[Full Text]
[PDF]
|
|
|
|
|
|
|
A. du Bois, H.-J. Luck, W. Meier, H.-P. Adams, V. Mobus, S. Costa, T. Bauknecht, B. Richter, M. Warm, W. Schroder, et al.
A Randomized Clinical Trial of Cisplatin/Paclitaxel Versus Carboplatin/Paclitaxel as First-Line Treatment of Ovarian Cancer
J Natl Cancer Inst,
September 3, 2003;
95(17):
1320 - 1329.
[Abstract]
[Full Text]
[PDF]
|
|
|
|
|
|
|
R. F. Ozols, B. N. Bundy, B. E. Greer, J. M. Fowler, D. Clarke-Pearson, R. A. Burger, R. S. Mannel, K. DeGeest, E. M. Hartenbach, and R. Baergen
Phase III Trial of Carboplatin and Paclitaxel Compared With Cisplatin and Paclitaxel in Patients With Optimally Resected Stage III Ovarian Cancer: A Gynecologic Oncology Group Study
J. Clin. Oncol.,
September 1, 2003;
21(17):
3194 - 3200.
[Abstract]
[Full Text]
[PDF]
|
|
|
|
|
|
|
M. Gore
Carboplatin Equals Cisplatin: But How Do I Prescribe It?
J. Clin. Oncol.,
September 1, 2003;
21(17):
3183 - 3185.
[Full Text]
[PDF]
|
|
|
|
|
|
|
M. Markman, P.Y. Liu, S. Wilczynski, B. Monk, L. J. Copeland, R. D. Alvarez, C. Jiang, and D. Alberts
Phase III Randomized Trial of 12 Versus 3 Months of Maintenance Paclitaxel in Patients With Advanced Ovarian Cancer After Complete Response to Platinum and Paclitaxel-Based Chemotherapy: A Southwest Oncology Group and Gynecologic Oncology Group Trial
J. Clin. Oncol.,
July 1, 2003;
21(13):
2460 - 2465.
[Abstract]
[Full Text]
[PDF]
|
|
|
|
|
|
|
V. Hess, M. W. Verrill, C. C. Bomphray, M. M. Vaughan, M. Allen, and M. E. Gore
Phase I study of carboplatin, doxorubicin and weekly paclitaxel in patients with advanced ovarian carcinoma
Ann. Onc.,
April 1, 2003;
14(4):
638 - 642.
[Abstract]
[Full Text]
[PDF]
|
|
|
|
|
|
|
D. K. Armstrong
Relapsed Ovarian Cancer: Challenges and Management Strategies for a Chronic Disease
Oncologist,
October 1, 2002;
7(90005):
20 - 28.
[Abstract]
[Full Text]
[PDF]
|
|
|
|
|
|
|
D. S. Dizon, M. L. Hensley, E. A. Poynor, P. Sabbatini, C. Aghajanian, A. Hummer, E. Venkatraman, and D. R. Spriggs
Retrospective Analysis of Carboplatin and Paclitaxel as Initial Second-Line Therapy for Recurrent Epithelial Ovarian Carcinoma: Application Toward a Dynamic Disease State Model of Ovarian Cancer
J. Clin. Oncol.,
March 1, 2002;
20(5):
1238 - 1247.
[Abstract]
[Full Text]
[PDF]
|
|
|
|
|
|
|
A. du Bois, W. Meier, H. J. Luck, G. Emons, V. Moebus, W. Schroeder, S. Costa, T. Bauknecht, S. Olbricht, C. Jackisch, et al.
Chemotherapy versus hormonal treatment in platinum- and paclitaxel-refractory ovarian cancer: a randomised trial of the German Arbeitsgemeinschaft Gynaekologische Onkologie (AGO) Study Group Ovarian Cancer
Ann. Onc.,
February 20, 2002;
13(2):
251 - 257.
[Abstract]
[Full Text]
[PDF]
|
|
|
|
|
|
|
K. Hata, R. Fujiwaki, K. Nakayama, and K. Miyazaki
Expression of the Endostatin Gene in Epithelial Ovarian Cancer
Clin. Cancer Res.,
August 1, 2001;
7(8):
2405 - 2409.
[Abstract]
[Full Text]
[PDF]
|
|
|
|
|
|
|
V. Shridhar, K. C. Bible, J. Staub, R. Avula, Y. K. Lee, K. Kalli, H. Huang, L. C. Hartmann, S. H. Kaufmann, and D. I. Smith
Loss of Expression of a New Member of the DNAJ Protein Family Confers Resistance to Chemotherapeutic Agents Used in the Treatment of Ovarian Cancer
Cancer Res.,
May 1, 2001;
61(10):
4258 - 4265.
[Abstract]
[Full Text]
|
|
|
|
