2019 ASCO Annual Meeting!
Session: Genitourinary (Nonprostate) Cancer
Type: Oral Abstract Session
Time: Monday June 3, 8:00 AM to 11:00 AM
Location: Arie Crown Theater
Cytoreductive nephrectomy (CN) in metastatic renal cancer (mRCC): Update on Carmena trial with focus on intermediate IMDC-risk population.
Genitourinary (Nonprostate) Cancer
2019 ASCO Annual Meeting
J Clin Oncol 37, 2019 (suppl; abstr 4508)
Author(s): Arnaud Mejean, Simon Thezenas, Christine Chevreau, Karim Bensalah, Lionnel Geoffrois, Antoine Thiery-Vuillemin, Luc Cormier, Herve Lang, Laurent Guy, Gwenaelle Gravis, Frederic Rolland, Claude Linassier, Marc-Olivier Timsit, Laurence Albiges, Stephane Oudard, Thierry Lebret, jean-Marc Treluyer, Sandra Colas, Bernard Escudier, Alain Ravaud; Department of Urology, Hôpital Européen Georges-Pompidou - Paris Descartes University, Paris, France; Institut du Cancer de Montpellier (ICM), Univ Montpellier, Montpellier, France; IUCT-Oncopôle Institut Claudius Regaud, Toulouse, France; University Hospital Pontchaillou Service d’urologie CHU Rennes, Université de Rennes, Rennes, France; Centre Alexis Vautrin, Vandoeuvre-Lès-Nancy, France; CU-PH Medical Oncology, Besançon, France; Centre Hospitalier Universitaire de Dijon, Dijon, France; Department of Urology, CHU Strasbourg, Strasbourg University, Strasbourg, France; Hopital Gabriel Montpied CHU, Clermont-Ferrand, France; Medical Oncology, Institut Paoli-Calmettes, Marseille, France; Institut de Cancérologie de l'Ouest, Department of Medical Oncology, St Herblain, France; CHU Tours, Tours Cedex 9, France; Hopital Europeen Georges Pompidou, Paris, France; Medical Oncology, Gustave Roussy, Université Paris-Saclay, Villejuif, France; Hôpital Foch, Suresnes, France; URC/CIC Paris Descartes Necker Cochin, Paris, France; Gustave Roussy, Villejuif, France; CHU Hopitaux de Bordeaux-Hôpital Saint-André, Bordeaux, France
Background: Carmena was a randomized phase III trial, testing the benefit of CN followed by sunitinib (arm A) vs sunitinib alone (arm B), with stratification by MSKCC risk groups in 450 mRCC patients. Based on this trial, CN is not anymore recommended in mRCC (NEJM, Mejean et al, 2018). However there are questions about which patients could still benefit from CN, especially in intermediate risk group. In the present study, we investigated different subgroups from the Carmena trial to answer these questions. Methods: Carmena trial was initially stratified according to MSKCC risk groups. For the purpose of this analysis, we reclassified the patients based on IMDC risk groups. We also analyzed patients with one metastatic site vs more than one, as well as patients with secondary nephrectomy in arm B. Overall survival (OS) was the primary endpoint. Results: With a updated median FU of 61.5 months (mo), the median OS by ITT analysis was 15.6 vs 19.8 mo in arm A and B respectively stratified on MSKCC (HR 0.933 ; 95% CI [0.76- 1.15]) / stratified on IMDC (HR 0.957 ; 95% CI [0.78- 1.18]). Using IMDC risk group factors, 58.6% patients were intermediate and 41.4 % were poor risk. When looking at intermediate risk group only, 48.1% had only one risk factor (interval between diagnosis and treatment < 1y), with a median OS of 30.5 and 25.2 mo in arm A and B respectively (HR 1.24 [0.81 – 1.90]). By contrast, 51.9 % had two risk factors (mostly low hemoglobin, high corrected calcium or neutrophils), with a median OS of 16.6 and 31.2 mo in arm A and B respectively (HR 0.61 [0.41 – 0.91] p = 0.015). Regarding number of metastatic sites, 33% had only one metastatic site. Median OS was 23.6 and 22.7 mo in arm A and B respectively (HR 1.08 [0.75 – 1.57]. Finally, 40 patients had a secondary nephrectomy in arm B, with median OS of 48.5 mo [CI 95%: 27.9-64.4] vs 15.7 mo [CI 95%: 13.3-20.5] in patients who never had surgery. Conclusions: With longer FU, Carmena trial confirms that CN is not superior to sunitinib alone in ITT population, both with MSKCC and IMDC risk groups. However for patients with only one IMDC risk factor, CN might be beneficial. Number of metastatic site is not helpful to define good candidates for surgery. Finally, patients with secondary nephrectomy have very long OS, supporting this strategy. Clinical trial information: NCT00930033