gms | German Medical Science

27. Deutscher Krebskongress

Deutsche Krebsgesellschaft e. V.

22. - 26.03.2006, Berlin

Paclitaxel-carboplatin-gemcitabine (TCG) versus paclitaxel-carboplatin (TC) as first line treatment in women with ovarian cancer: A randomized phase III GCIG Intergroup study (AGO-OVAR 9, GINECO-TCG, NSGO-OC-0102)

Meeting Abstract

  • corresponding author presenting/speaker Antje Kristina Belau - Horst-Schmidt-Kliniken, Wiesbaden, Greifswald, Deutschland
  • Jens Huober - Universitätsklinikum, Tuebingen
  • Volker Heilmann - Universitätsklinikum, Ulm
  • Hans-Helge Mueller - KKS Marburg
  • Alexander Burges - Universitätsklinikum, Muenchen
  • Jakobus Pfisterer - Universitätsklinikum, Kiel
  • Martina Gropp - Ev. Krankenhaus Duesseldorf
  • Willibald Schröder - Zentralkrankenhaus Bremen Mitte
  • Pauline Wimberger - Universitätsklinikum, Essen
  • Andreas du Bois - Horst-Schmidt-Kliniken, Wiesbaden

27. Deutscher Krebskongress. Berlin, 22.-26.03.2006. Düsseldorf, Köln: German Medical Science; 2006. DocOP341

Die elektronische Version dieses Artikels ist vollständig und ist verfügbar unter: http://www.egms.de/de/meetings/dkk2006/06dkk451.shtml

Veröffentlicht: 20. März 2006

© 2006 Belau et al.
Dieser Artikel ist ein Open Access-Artikel und steht unter den Creative Commons Lizenzbedingungen (http://creativecommons.org/licenses/by-nc-nd/3.0/deed.de). Er darf vervielf&aauml;ltigt, verbreitet und &oauml;ffentlich zug&aauml;nglich gemacht werden, vorausgesetzt dass Autor und Quelle genannt werden.


Gliederung

Text

Background: Despite major progress achieved in the last decades, epithelial ovarian Cancer is still not curable in the majority of patients. Addition of non cross-resistant drugs to standard TC is a potential option for improvement of efficacy. In phase II trials the addition of gemcitabine to TC resulted in high compliance and manageable toxicity. Therefore, a prospectively randomized phase III Intergroup study comparing TCG to standard TC was initiated within the GCIG network.

Patients and Methods: This protocol started in8/02 and recruitment was completed in04/04. Patients were 18 years or older, had epithelial ovarian cancer FIGO stages IC-IV, and were randomized within 6 weeks after primary surgery. Two-fold stratification was based on centre and disease characteristics: stratum I = FIGO stages IC-IIA, stratum II = FIGO stages IIB-IIC and residual tumor 0-1 cm, and stratum III = FIGO stage IV or residual tumor > 1 cm. Patients were randomized to either TC (T 175 mg/m2 3h iv d1 + C AUC 5 d1) or TCG (TC as above + G 800 mg /m2 iv d1 + 8) for at least 6 cycles every 21 days.

Results: This first interim analysis was based on data from 1,724 patients receiving at least one cycle of study medication, 5,257 cycles of TC and 5,111 cycles of TGC. The strata distribution showed 175, 891, and 676 patients in strata I, II, and III respectively. Most patients received 6+ cycles (87.5% TC, 87.1% TCG). Dose reductions on d1 occurred in < 10% in both arms and G d8 was omitted in 37% of cycles. Hematologic toxicity and need for support with G-CSF, blood products and antibiotics occurred significantly more frequent in the TCG arm, but neutropenic fever was rare with 2.1% and 6.5% (p < 0.0001). Fatigue was the only non-hematological toxicity showing a significant difference favouring TC (Grade 3/4: 6.6% versus 10.4%, p = 0.005). Until 04/05 166 deaths were observed of whom 142 were related to ovarian cancer. The other 24 deaths were equally distributed among patients in both arms and included 5 events possible related to study medication.

Conclusion: TCG was feasible but induced more haematological toxicity. Further follow-up will show if addition of G to TC will provide a meaningful benefit in women with ovarian cancer.