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Genitourinary tumours, non-prostate

3772 - Immediate versus deferred cytoreductive nephrectomy (CN) in patients with synchronous metastatic renal cell carcinoma (mRCC) receiving sunitinib (EORTC 30073 SURTIME).

Date

09 Sep 2017

Session

Genitourinary tumours, non-prostate

Presenters

Axel Bex

Citation

Annals of Oncology (2017) 28 (suppl_5): v605-v649. 10.1093/annonc/mdx440

Authors

A. Bex1, P. Mulders2, M.A.S. Jewett3, J. Wagstaff4, R. van Velthoven5, P.M. Laguna Pes6, L. Wood7, H.H.E. van Melick8, P. Soetekouw9, J.B. Lattouf10, T. Powles11, E. Boleti12, I. de Jong13, S. Rottey14, B. Tombal15, S. Marreaud16, L. Collette16, S. Collette16, C.U. Blank17, J.B. Haanen18

Author affiliations

  • 1 Surgical Oncology-urology, The Netherlands Cancer Institute, 1066CX - Amsterdam/NL
  • 2 Urology, Radboud University Medical Centre Nijmegen, 6500 HB - Nijmegen/NL
  • 3 Department Of Surgery, Princess Margaret Cancer Center, Toronto/CA
  • 4 Oncology, South West Wales Cancer Institute Singleton Hospital, Sketty, SA2 8QA - Swansea/GB
  • 5 Urology, Hopital Jules Bordet, 1000 - Brussels/BE
  • 6 Urology, Amsterdam Medical Center, 1105AZ - Amsterdam/NL
  • 7 Division Of Medical Oncology, Queen Elizabeth II Health Sciences Centre, B3H2Y9 - Halifax/CA
  • 8 Urology, Antonius Hospital, 3435CM - Nieuwegein/NL
  • 9 Oncology, Academisch Ziekenhuis Maastricht (AZM), 6229 HX - Maastricht/NL
  • 10 Oncology, Cliniques Universitaires St. Luc, 1200 - Brussels/BE
  • 11 Oncology, St. Bartholomew's Hospital, EC1A 7BE - London/GB
  • 12 Medical Oncology, Royal Free Hospital School of Medicine, NW3 2QG - London/GB
  • 13 Urology, UMC Groningen, 9713GZ - Groningen/NL
  • 14 Oncology, Belgium Society of Medical Oncology, 1090 - Brussels/BE
  • 15 Urology, Cliniques Universitaires St. Luc, 1200 - Brussels/BE
  • 16 Statistics, EORTC - European Organisation for Research and Treatment of Cancer, 1200 - Brussels/BE
  • 17 Medical Oncology, The Netherlands Cancer Institute Antoni van Leeuwenhoek Hospital, 1066 CX - Amsterdam/NL
  • 18 Department Of Medical Oncology, The Netherlands Cancer Institute, 1066 CX - Amsterdam/NL
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Abstract 3772

Background

In clinical practice, mRCC patients with the primary tumour in situ are offered CN followed by targeted therapy. This randomized trial explored a period of targeted therapy (sunitinib) prior to CN as an alternative approach.

Methods

Patients with mRCC were randomized 1:1 to immediate CN followed by sunitinib versus 3 cycles sunitinib followed by CN and sunitinib. Inclusion required histologically confirmed clear-cell subtype, resectable asymptomatic primary tumour and 

Results

The study closed after 5.7 years with 99 patients entered by 19 institutions. As of May 5, 2017, median follow-up is 3.3 years. In the immediate CN arm, 46 of 50 patients had CN, 40 of 46 had post-CN sunitinib. In the deferred CN arm, 48 of 49 patients had sunitinib, 40 of 48 had CN and 26 of 40 had post-CN sunitinib (Table). PFR was 42.0% (CI: 28.2 – 56.8) and 42.9% (28.8 – 57.8) in the immediate and deferred arms, resp (p > 0.99). The OS HR (stratified by WHO PS) of intention to treat (ITT) with deferred versus immediate CN in all patients was 0.57 (CI: 0.34 – 0.95, p = 0.032) with a median OS of 32.4 (14.5-65.3) and 15.1 months (CI: 9.3, 29.5), respectively.

Table:

LBA35

Immediate CN N = 50Deferred CN N = 49
Median age (years)60.058.0
Male:/Female:82.0%/18.0%79.6%/20.4%
WHO PS 0:/1:72.0%/28.0%63.3%/36.7%
MSKCC intermediate risk86.0%87.7%
≥ 2 measurable metastatic sites86.0%93.9%
Mean (SD) primary tumor size (mm)93.1 (37.8)96.8 (31.3)
Progression at week 16* (*before planned CN in the deferred arm)46%32.7%*
CN performedN = 46N = 40
Surgical complications43.5%27.5%
Progression 4 weeks after CN19.6%23.5%

Conclusions

The sequence of CN and sunitinib did not affect the PFR at 28 weeks. The sample size precludes definitive conclusions from other endpoints, although an OS signal was seen for deferred CN. CN after sunitinib appears safe.

Clinical trial identification

NCT01099423

Legal entity responsible for the study

EORTC

Funding

Pfizer

Disclosure

A. Bex: Participation in Advisory boards of Pfizer, BMS, Roche, Eisai and Ipsen. M.A.S. Jewett: Honorarium: Ipsen, Pfizer. Consultant: Pfizer, Theralase Therapeutics Inc. Ownership: Stock Theralase Therapeutics Inc. J. Wagstaff: Advisory boards for Pfizer. T. Powles: Research funds: Pfizer, Novartis, Roche, AZ. Honoraria: Pfizer, Novartis, Roche, BMS, MSD, Ipsen, Eisei.E. Boleti: Advisory board for Pfizer, Eisai, Ipsen. S. Rottey: Speaker fee from BMS, Pfizer, Roche, Bayer. C.U. Blank: Advisory board for Pfizer, BMS and Roche. J.B. Haanen: Advisory role for Pfizer. All other authors have declared no conflicts of interest.

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