OBJECTIVE: As 30% of non-seminomas in clinical stage I will progress during active surveillance, alternative adjuvant strategies of 2 cycles of bleomycin, etoposid, cisplatin (BEP) or nerve sparing retroperitoneal lymphadenectomy (RPLND) can be offered. The risk of relapse is reduced to 2% and 10%, respectively. Without prognostic markers and with lowered toxicity it is postulated that only one cycle of BEP could significantly reduce the recurrence rate in comparison to RPLND. MATERIALS AND METHODS:Between 1996 and 2005, 382 patients were randomly assigned to receive either RPLND (n=191) or 1 cycle of BEP (n=191). In accordance with the protocol, 174 patients were treated with 1 cycle of BEP and 173 underwent RPLND. The primary study end-point was a reduction of recurrence from 10% after RPLND to a maximum of 3% after 1 cycle of BEP. RESULTS: After a mean follow-up of 4.7 years, there were 2 and 13 recurrences in the according-to-protocol population with chemotherapy and surgery, respectively. The difference between chemotherapy (1.15%) and surgery (7.5%) was statistically significant (p=0.0033). The tumor-specific survival was 100%. CONCLUSION: This largest randomized trial investigating treatment strategies in clinical stage I non-seminomas (AUO AH 01/94) showed the superiority of one cycle BEP over RPLND. The data obtained represent the basis for a reduced chemotherapy.
RCT Entities:
OBJECTIVE: As 30% of non-seminomas in clinical stage I will progress during active surveillance, alternative adjuvant strategies of 2 cycles of bleomycin, etoposid, cisplatin (BEP) or nerve sparing retroperitoneal lymphadenectomy (RPLND) can be offered. The risk of relapse is reduced to 2% and 10%, respectively. Without prognostic markers and with lowered toxicity it is postulated that only one cycle of BEP could significantly reduce the recurrence rate in comparison to RPLND. MATERIALS AND METHODS: Between 1996 and 2005, 382 patients were randomly assigned to receive either RPLND (n=191) or 1 cycle of BEP (n=191). In accordance with the protocol, 174 patients were treated with 1 cycle of BEP and 173 underwent RPLND. The primary study end-point was a reduction of recurrence from 10% after RPLND to a maximum of 3% after 1 cycle of BEP. RESULTS: After a mean follow-up of 4.7 years, there were 2 and 13 recurrences in the according-to-protocol population with chemotherapy and surgery, respectively. The difference between chemotherapy (1.15%) and surgery (7.5%) was statistically significant (p=0.0033). The tumor-specific survival was 100%. CONCLUSION: This largest randomized trial investigating treatment strategies in clinical stage I non-seminomas (AUO AH 01/94) showed the superiority of one cycle BEP over RPLND. The data obtained represent the basis for a reduced chemotherapy.
Authors: Janine Nuver; Andries J Smit; Jan van der Meer; Maarten P van den Berg; Winette T A van der Graaf; Martin T Meinardi; Dirk Th Sleijfer; Harald J Hoekstra; Anne I van Gessel; Arie M van Roon; Jourik A Gietema Journal: J Clin Oncol Date: 2005-11-21 Impact factor: 44.544
Authors: L S Freedman; M C Parkinson; W G Jones; R T Oliver; M J Peckham; G Read; E S Newlands; C J Williams Journal: Lancet Date: 1987-08-08 Impact factor: 79.321
Authors: Duncan C Gilbert; Andrew R Norman; Judith Nicholl; David P Dearnaley; Alan Horwich; Robert A Huddart Journal: BJU Int Date: 2006-07 Impact factor: 5.588
Authors: M H Cullen; S P Stenning; M C Parkinson; S D Fossa; S B Kaye; A H Horwich; S J Harland; M V Williams; R Jakes Journal: J Clin Oncol Date: 1996-04 Impact factor: 44.544
Authors: Susanne Krege; Jörg Beyer; Rainer Souchon; Peter Albers; Walter Albrecht; Ferran Algaba; Michael Bamberg; István Bodrogi; Carsten Bokemeyer; Eva Cavallin-Ståhl; Johannes Classen; Christoph Clemm; Gabriella Cohn-Cedermark; Stéphane Culine; Gedske Daugaard; Pieter H M De Mulder; Maria De Santis; Maike de Wit; Ronald de Wit; Hans Günter Derigs; Klaus-Peter Dieckmann; Annette Dieing; Jean-Pierre Droz; Martin Fenner; Karim Fizazi; Aude Flechon; Sophie D Fosså; Xavier Garcia del Muro; Thomas Gauler; Lajos Geczi; Arthur Gerl; Jose Ramon Germa-Lluch; Silke Gillessen; Jörg T Hartmann; Michael Hartmann; Axel Heidenreich; Wolfgang Hoeltl; Alan Horwich; Robert Huddart; Michael Jewett; Johnathan Joffe; William G Jones; László Kisbenedek; Olbjørn Klepp; Sabine Kliesch; Kai Uwe Koehrmann; Christian Kollmannsberger; Markus Kuczyk; Pilar Laguna; Oscar Leiva Galvis; Volker Loy; Malcolm D Mason; Graham M Mead; Rolf Mueller; Craig Nichols; Nicola Nicolai; Tim Oliver; Dalibor Ondrus; Gosse O N Oosterhof; Luis Paz Ares; Giorgio Pizzocaro; Jörg Pont; Tobias Pottek; Tom Powles; Oliver Rick; Giovanni Rosti; Roberto Salvioni; Jutta Scheiderbauer; Hans-Ulrich Schmelz; Heinz Schmidberger; Hans-Joachim Schmoll; Mark Schrader; Felix Sedlmayer; Niels E Skakkebaek; Aslam Sohaib; Sergei Tjulandin; Padraig Warde; Stefan Weinknecht; Lothar Weissbach; Christian Wittekind; Eva Winter; Lori Wood; Hans von der Maase Journal: Eur Urol Date: 2007-12-26 Impact factor: 20.096
Authors: R T D Oliver; J Ong; J Shamash; R Ravi; V Nagund; P Harper; M J Ostrowski; B Sizer; J Levay; A Robinson; D E Neal; M Williams Journal: Urology Date: 2004-03 Impact factor: 2.649