Addition of epirubicin as a third drug to carboplatin-paclitaxel in first-line treatment of advanced ovarian cancer: A prospectively randomized gynecologic cancer intergroup trial by the Arbeitsgemeinschaft Gynaekologische Onkologie Ovarian Cancer Study Group and the Groupe d'Investigateurs Nationaux pour l'Etude des Cancers Ovariens

被引:154
作者
du Bois, A
Weber, B
Rochon, J
Meier, W
Goupil, A
Bricht, S
Barats, JC
Kuhn, W
Orfeuvre, H
Wagner, U
Richter, B
Lueck, HJ
Pfisterer, J
Costa, S
Schroeder, W
Kimmig, R
Pujade-Lauraine, E
机构
[1] HSK Dr Horst Schmidt Klin, Dept Gynecol & Gynecol Oncol, D-65199 Wiesbaden, Germany
[2] St Vincentius Khs Karlsruhe, Dept Gynecol, Karlsruhe, Germany
[3] KKS Marburg, Marburg, Germany
[4] Evangel Krankenhaus, Dept Gynecol & Obstet, Coordinat Ctr Clin Trials, Dusseldorf, Germany
[5] Med Akad, Dept Gynecol & Obstet, Magdeburg, Germany
[6] Univ Muenchen, Dept Gynecol & Obstet, Munich, Germany
[7] Univ Hosp, Dept Gynecol, Tubingen, Germany
[8] Univ Dresden, Dept Gynecol & Obstet, Dresden, Germany
[9] Hannover Med Sch, Dept Gynecol Oncol, Hannover, Germany
[10] Univ Hosp Schleswig Holstein, Dept Gynecol & Obstet, Kiel, Germany
[11] Goethe Univ Frankfurt, Dept Gynecol & Obstet, D-6000 Frankfurt, Germany
[12] Rhein Westfal TH Aachen, Dept Gynecol & Obstet, D-5100 Aachen, Germany
[13] Univ Muenchen, Dept Gynecol & Obstet, Grosshadern, Germany
[14] Ctr Alexis Vautrin, Dept Oncol, Vandoeuvre Les Nancy, France
[15] Ctr Rene Huguenin, Dept Oncol, St Cloud, France
[16] Hop Civils, Dept Hematol Oncol, Colmar, France
[17] Hop Fleyriat, Dept Hematol Oncol, Bourg En Bresse, France
[18] Hop Hotel Dieu, Dept Oncol, F-75181 Paris, France
关键词
D O I
10.1200/JCO.2005.03.2938
中图分类号
R73 [肿瘤学];
学科分类号
100214 ;
摘要
Purpose Despite the progress that has been achieved, long-term survival rates in patients with advanced ovarian cancer are still disappointing. One attempt to improve results could be the addition of non-cross-resistant drugs to platinum-paclitaxel combination regimens. Anthracyclines were among the candidates for incorporation as a third drug into first-line regimens. Patients and Methods We performed a prospectively randomized phase III study comparing carboplatin-paclitaxel (TC; area under the curve 5/175 mg/m(2), respectively) with epirubicin 60 mg/m(2) added to the same combination (TEC) in previously untreated patients with advanced epithelial ovarian cancer. All drugs were administered intravenously on day 1 of a 3-week schedule for a planned minimum of six courses. Results Between November 1997 and February 2000, 1,282 patients were randomly assigned to receive either TC (635 patients) or TEC (647 patients), respectively. Grade 3/4 hematologic and some nonhematologic toxicities (nausea/emesis, mucositis, and infections) occurred significantly more frequently in the TEC arm, Accordingly, quality-of-life analysis showed inferiority of TEC versus TIC. Median progression-free survival time was 18.4 months for the TEC arm and 17.9 months for the TC arm (hazard ratio [HR], 0.95; 95% CI, 0.83 to 1.07; P = .3342). Median overall survival time was 45.8 months for the TEC arm and 41.0 months for the TC arm (HR, 0.93; 95% CI, 0.81 to 1.08; P = .3652). Similar nonsignificant differences were observed when strata were analyzed separately. Conclusion Addition of epirubicin to TC did not improve survival or time to treatment failure in patients with advanced epithelial ovarian cancer; therefore, it cannot be recommended for clinical use in this population.
引用
收藏
页码:1127 / 1135
页数:9
相关论文
共 22 条
[1]   THE EUROPEAN-ORGANIZATION-FOR-RESEARCH-AND-TREATMENT-OF-CANCER QLQ-C30 - A QUALITY-OF-LIFE INSTRUMENT FOR USE IN INTERNATIONAL CLINICAL-TRIALS IN ONCOLOGY [J].
AARONSON, NK ;
AHMEDZAI, S ;
BERGMAN, B ;
BULLINGER, M ;
CULL, A ;
DUEZ, NJ ;
FILIBERTI, A ;
FLECHTNER, H ;
FLEISHMAN, SB ;
DEHAES, JCJM ;
KAASA, S ;
KLEE, M ;
OSOBA, D ;
RAZAVI, D ;
ROFE, PB ;
SCHRAUB, S ;
SNEEUW, K ;
SULLIVAN, M ;
TAKEDA, F .
JOURNAL OF THE NATIONAL CANCER INSTITUTE, 1993, 85 (05) :365-376
[2]   IMPACT OF DOXORUBICIN ON SURVIVAL IN ADVANCED OVARIAN-CANCER [J].
AHERN, RP ;
GORE, ME .
JOURNAL OF CLINICAL ONCOLOGY, 1995, 13 (03) :726-732
[3]   Optimal therapy of advanced ovarian cancer: carboplatin and paclitaxel vs. cisplatin and paclitaxel (GOG158) and an update on GOG0 182-ICON5 [J].
Bookman, MA ;
Greer, BE ;
Ozols, RF .
INTERNATIONAL JOURNAL OF GYNECOLOGICAL CANCER, 2003, 13 (06) :735-740
[4]  
BUYSE M, 1991, J CLIN ONCOL, V9, P1668
[5]   CARBOPLATIN DOSAGE - PROSPECTIVE EVALUATION OF A SIMPLE FORMULA BASED ON RENAL-FUNCTION [J].
CALVERT, AH ;
NEWELL, DR ;
GUMBRELL, LA ;
OREILLY, S ;
BURNELL, M ;
BOXALL, FE ;
SIDDIK, ZH ;
JUDSON, IR ;
GORE, ME ;
WILTSHAW, E .
JOURNAL OF CLINICAL ONCOLOGY, 1989, 7 (11) :1748-1756
[6]  
du Bois A, 2004, J CLIN ONCOL, V22, p450S
[7]   A randomized clinical trial of cisplatin/paclitaxel versus carboplatin/paclitaxel as first-line treatment of ovarian cancer [J].
du Bois, A ;
Lück, HJ ;
Meier, W ;
Adams, HP ;
Möbus, V ;
Costa, S ;
Bauknecht, T ;
Richter, B ;
Warm, M ;
Schröder, W ;
Olbricht, S ;
Nitz, U ;
Jackisch, C ;
Emons, G ;
Wagner, U ;
Kuhn, W ;
Pfisterer, J .
JNCI-JOURNAL OF THE NATIONAL CANCER INSTITUTE, 2003, 95 (17) :1320-1330
[8]   First-line chemotherapy with epirubicin, paclitaxel, and carboplatin for advanced ovarian cancer:: A phase I/II study of the Arbeitsgemeinschaft Gynakologische Onkologie Ovarian Cancer Study Group [J].
du Bois, A ;
Lück, HJ ;
Bauknecht, T ;
Meier, W ;
Richter, B ;
Kuhn, W ;
Quaas, J ;
Pfisterer, J .
JOURNAL OF CLINICAL ONCOLOGY, 1999, 17 (01) :46-51
[9]  
FANNING J, 1992, OBSTET GYNECOL, V80, P954
[10]  
FAYERS PM, 1999, EORTC QLQC30 SCORING