SPAZO2 (SOGUG): Outcomes and prognostic significance of IMDC intermediate prognosis subclassification in metastatic renal cell carcinoma (mRCC) in...

Date 30 September 2019
Event ESMO 2019 Congress
Session Poster Display session 3
Topics Renal Cell Cancer
Presenter Begona P. Valderrama
Citation Annals of Oncology (2019) 30 (suppl_5): v356-v402. 10.1093/annonc/mdz249
Authors B. P. Valderrama1, S. Perez Ramirez2, A. Rodriguez-Vida3, A. González del Alba4, M.J. Mendez Vidal5, S. Vazquez Estevez6, E. Martinez Ortega7, J.A. Virizuela8, O. Fernández Calvo9, A. Hernández Jorge10, F.J. Vazquez Mazon11, M.B. Gonzalez Gragera12, M. Campayo13, O. Etxaniz Ulazia14, E. Almagro Casado15, M. Sereno Moyano16, M.T. Abad Villar17, C. Suarez Rodriguez18, E. Gallardo Diaz19, J.A. Arranz Arija2
  • 1Medical Oncology, Hospital Universitario Virgen del Rocio, 41013 - Sevilla/ES
  • 2Medical Oncology, Hospital General Universitario Gregorio Marañon, 28007 - Madrid/ES
  • 3Medical Oncology, Hospital del Mar, 08003 - Barcelona/ES
  • 4Medical Oncology, Hospital Universitario Puerta de Hierro-Majadahonda, 28222 - Madrid/ES
  • 5Medical Oncology, Reina Sofía University Hospital, Cordoba/ES
  • 6Medical Oncology, Hospital Universitario Lucus Augusti, 27004 - Lugo/ES
  • 7Medical Oncology, Complejo Hospitalario de Jaen Universidad de Jaen, 23007 - Jaen/ES
  • 8Medical Oncology, Hospital Universitario Virgen Macarena, 41007 - Sevilla/ES
  • 9Medical Oncology, Complejo Hospitalario de Orense, Ourense/ES
  • 10Medical Oncology, Onkologikoa, San Sebastian/ES
  • 11Medical Oncology, Hospital General Universitario de Elche, Elche/ES
  • 12Medical Oncology, Hospital de Son Llàtzer, Palma de Mallorca/ES
  • 13Medical Oncology, Hospital Mutua de Terrassa, 8221 - Terrassa/ES
  • 14Medical Oncology, Hospital Universitario Germans Trias i Pujol, Barcelona/ES
  • 15Medical Oncology, Hospital Universitario Quirón Salud, Madrid/ES
  • 16Medical Oncology, Hospital Infanta Sofia, 28702 - Madrid/ES
  • 17Medical Oncology, Hospital Universitario de Basurto, Bilbao/ES
  • 18Oncology, Vall d'Hebron University Hospital, 08035 - Barcelona/ES
  • 19Dept. Oncology, Hospital de Sabadell Corporacis Parc Tauli, 08208 - Sabadell/ES

Abstract

Background

IMDC classifies patients (pt) with mRCC in favorable, intermediate or poor-risk (FR, IR, PR). IR pt having 1 vs 2 unfavorable factors (IR1 vs IR2) treated with sunitinib in clinical trials, have different outcomes (Rini, ASCO 2017). Outcomes are also better foreligible vs ineligible pt for clinical trials (E vs I, Arranz, ESMO 2017).We compare IR1 vs IR2 in I vs E pt receiving 1stPz, and validate the IMDC-modified models.

Methods

SPAZO2 (NCT03091465) retrospectively analyzed the real-world effectiveness of 1stPz in mRCC in 530 pt from 50 centers in Spain. Data were externally monitored. Median follow-up was 39 months (mo). No pt received Nivo or Cabo as 2nd-line.

Results

Among the 323 pt classified as IR1 (53%) or IR2 (47%), we found differences (p < 0.05) in mean age (64 vs 68 y), prior nephrectomy (80 vs 65%), ECOG 0-1 (98 vs 93%), HbUNL (8 vs 35%), interval to metastases < 1y (59 vs 84%), E v I (29 vs 40%) and bone metastases (18% vs 28%), but not in gender (61 vs 70% males), non-clear cell histology (14%), platelets>UNL (0 vs 1%), corrected Ca >UNL (18 vs 22%), or lymph nodes (44%), soft tissue (15 vs 14%), adrenal (5%) or CNS metastases (4 v s3%). Outcomes were superior for IR1 vs IR2 (p < 0.05, Table) in ORR, and OS (HR adjusted by E/I: 0.58, 95%CI: 0.44-0.76), but not in PFS (HR adjusted by E/I: 0.85, 95%CI: 0.65-1.11). The C-index of the IMDC model improved from 0.651 to 0.677 including IR1/IR2, and to 0.686 adding also E/I.Table:

954P

ORR (%)Median PFS (mo)Median OS (mo)
EIEIEI
FR634723.513.542.329.0
IR145.937.511.014.726.424.1
IR221.614.310.07.918.014.8
PR33167.55.214.25.9

Conclusions

In our real-world study before Nivo/Cabo approval for 2nd-line, pt with IR1 had statistically significant better ORR and longer OS than IR2. The discrimination power of the IMDC model can be improved by subclassifying patients of the intermediate group and eligibility for clinical trials.

Clinical trial identification

NCT03091465.

Editorial acknowledgement

Legal entity responsible for the study

SOGUG: Spanish Oncology Genito-Urinary Group.

Funding

Novartis.

Disclosure

B. P. Valderrama: Honoraria (self), Advisory / Consultancy: Pierre Fabre; Honoraria (self), Advisory / Consultancy: Astellas Pharma; Honoraria (self): Novartis; Honoraria (self), Advisory / Consultancy, Travel / Accommodation / Expenses: Bristol-Myers Squibb; Honoraria (self), Advisory / Consultancy: Ipsen; Honoraria (self), Advisory / Consultancy, Travel / Accommodation / Expenses: Roche; Honoraria (self), Advisory / Consultancy: Bayer; Advisory / Consultancy: Sanofi; Advisory / Consultancy: MSD Oncology; Travel / Accommodation / Expenses: Janssen-Cilag; Travel / Accommodation / Expenses: Pfizer; Advisory / Consultancy: EUSA Pharma. A. Rodriguez-Vida: Honoraria (self), Advisory / Consultancy: MSD Oncology; Honoraria (self), Advisory / Consultancy, Research grant / Funding (institution): Pfizer; Honoraria (self), Advisory / Consultancy, Research grant / Funding (institution): Bristol-Myers-Squibb; Honoraria (self), Advisory / Consultancy: Astellas Pharma; Honoraria (self), Advisory / Consultancy: Janssen-Cilag; Honoraria (self), Advisory / Consultancy: Bayer; Honoraria (self), Advisory / Consultancy: Roche; Honoraria (self): AstraZeneca; Honoraria (self): Sanofi-Aventis; Research grant / Funding (institution): Takeda. A. González del Alba: Honoraria (self), Advisory / Consultancy, Travel / Accommodation / Expenses: Sanofi-Aventis; Honoraria (self), Advisory / Consultancy, Research grant / Funding (self), Travel / Accommodation / Expenses: Astellas Pharma; Honoraria (self), Advisory / Consultancy, Speaker Bureau / Expert testimony, Travel / Accommodation / Expenses: Roche; Honoraria (self), Advisory / Consultancy, Speaker Bureau / Expert testimony, Travel / Accommodation / Expenses: Pfizer; Honoraria (self), Advisory / Consultancy, Travel / Accommodation / Expenses: Janssen-Cilag; Honoraria (self), Advisory / Consultancy: Novartis; Honoraria (self), Advisory / Consultancy, Speaker Bureau / Expert testimony: Ipsen; Advisory / Consultancy, Travel / Accommodation / Expenses: Bristol-Meyer-Squibb; Travel / Accommodation / Expenses: MSD Oncology; Advisory / Consultancy: Bayer; Advisory / Consultancy: Eisai; Advisory / Consultancy, Speaker Bureau / Expert testimony: Pierre-Fabre; Advisory / Consultancy: EUSA Pharma. M.J. Mendez Vidal: Honoraria (self), Advisory / Consultancy, Travel / Accommodation / Expenses: Janssen-Cilag; Advisory / Consultancy: Bayer Healthcare; Speaker Bureau / Expert testimony, Travel / Accommodation / Expenses: Sanofi-Aventis; Honoraria (self), Advisory / Consultancy: Astellas Pharma; Honoraria (self), Advisory / Consultancy, Travel / Accommodation / Expenses: Roche; Honoraria (self), Travel / Accommodation / Expenses: Bristol-Meyer-Squibb; Honoraria (self), Advisory / Consultancy: Novartis; Honoraria (self), Advisory / Consultancy, Travel / Accommodation / Expenses: Pfizer. S. Vazquez Estevez: Advisory / Consultancy, Travel / Accommodation / Expenses: Pfizer; Honoraria (self), Advisory / Consultancy: Astellas Pharma; Advisory / Consultancy: Janssen-Cilag; Advisory / Consultancy: MSD; Honoraria (self), Advisory / Consultancy: Bayer; Honoraria (self), Advisory / Consultancy, Travel / Accommodation / Expenses: Roche; Advisory / Consultancy: Bristol-Meyer-Squibb; Honoraria (self), Advisory / Consultancy: Boehringer; Honoraria (self), Advisory / Consultancy, Travel / Accommodation / Expenses: AstraZeneca; Honoraria (self), Advisory / Consultancy: Ipsen; Advisory / Consultancy: Novartis; Advisory / Consultancy: EUSA Pharma; Advisory / Consultancy: Eisai; Honoraria (self), Advisory / Consultancy: Sanofi; Honoraria (self): Lilly. O. Fernández Calvo: Advisory / Consultancy, Travel / Accommodation / Expenses: Pfizer; Honoraria (self), Advisory / Consultancy: Novartis; Honoraria (self), Advisory / Consultancy: Ipsen; Honoraria (self), Advisory / Consultancy, Travel / Accommodation / Expenses: Roche; Honoraria (self), Advisory / Consultancy: Bristol-Meyer-Squibb; Advisory / Consultancy, Travel / Accommodation / Expenses: Astellas Pharma; Honoraria (self), Advisory / Consultancy, Travel / Accommodation / Expenses: MSD; Advisory / Consultancy: Sanofi-Aventis. C. Suarez Rodriguez: Honoraria (self), Research grant / Funding (institution): Astellas Pharma; Advisory / Consultancy, Research grant / Funding (institution): AstraZeneca; Advisory / Consultancy: Bayer; Honoraria (self), Advisory / Consultancy, Travel / Accommodation / Expenses: Bristol-Myers-Squibb; Advisory / Consultancy: EUSA Pharma; Honoraria (self), Advisory / Consultancy: Ipsen; Honoraria (institution): Novartis; Honoraria (self), Advisory / Consultancy, Travel / Accommodation / Expenses: Pfizer; Advisory / Consultancy: Sanofi-Aventis; Advisory / Consultancy, Travel / Accommodation / Expenses: Roche; Research grant / Funding (institution): AB Science; Research grant / Funding (institution): Aragon Pharmaceuticals; Research grant / Funding (institution): Arog Pharmaceuticals INC; Research grant / Funding (institution): Bayer AG; Research grant / Funding (institution): Aveo Pharmaceuticals INC; Research grant / Funding (institution): Blueprint Medicines Corporation; Research grant / Funding (institution): BN Immunopharmaceutics INC; Research grant / Funding (institution): Boehringer Ingelheim España S.A.; Research grant / Funding (institution): Bristol-Myers-Squibb International Corporation; Research grant / Funding (institution): Clovis Oncology INC; Research grant / Funding (institution): Cougar Biotechnology INC; Research grant / Funding (institution): Deciphera Pharmaceuticals LLC; Research grant / Funding (institution): Exelixis INC; Research grant / Funding (institution): Hoffmann-La Roche LTD; Research grant / Funding (institution): Genentech INC; Research grant / Funding (institution): GlaxoSmithKline, S.A; Research grant / Funding (institution): Incyte Corporation; Research grant / Funding (institution): Janssen-Cilag International NV; Research grant / Funding (institution): Karyopharm Therapeutics INC; Research grant / Funding (institution): Laboratoires Leurquin Mediolanum SAS; Research grant / Funding (institution): Lilly S.A.; Research grant / Funding (institution): Medimmune; Research grant / Funding (institution): Millennium Pharmaceuticals INC; Research grant / Funding (institution): Nanobiotix S.A.; Research grant / Funding (institution): Novartis Farmacéutica S.A.; Research grant / Funding (institution): Pfizer SLU; Research grant / Funding (institution): Teva Pharma SLU; Research grant / Funding (institution): Puma Biotechnology INC; Research grant / Funding (institution): Sanofi-Aventis S.A.; Research grant / Funding (institution): SFJ Pharma LTD.II. E. Gallardo Diaz: Honoraria (self), Advisory / Consultancy, Travel / Accommodation / Expenses: Sanofi-Aventis; Honoraria (self), Advisory / Consultancy, Travel / Accommodation / Expenses: Janssen-Cilag; Honoraria (self), Advisory / Consultancy, Travel / Accommodation / Expenses: Astellas-Pharma; Honoraria (self), Advisory / Consultancy, Travel / Accommodation / Expenses: Pfizer; Honoraria (self), Advisory / Consultancy, Travel / Accommodation / Expenses: Bayer; Honoraria (self), Advisory / Consultancy, Travel / Accommodation / Expenses: Roche; Honoraria (self), Advisory / Consultancy, Travel / Accommodation / Expenses: Ipsen; Honoraria (self), Advisory / Consultancy, Travel / Accommodation / Expenses: Novartis; Honoraria (self), Advisory / Consultancy, Travel / Accommodation / Expenses: Eisai; Advisory / Consultancy: EUSA Pharma; Advisory / Consultancy: Bristol-Myers-Squibb; Honoraria (self), Advisory / Consultancy: Rovi; Travel / Accommodation / Expenses: Pierre-Fabre; Honoraria (self), Advisory / Consultancy: Daiichi; Honoraria (self), Advisory / Consultancy: Sankyo; Advisory / Consultancy: Techdow; Advisory / Consultancy: Leo Pharma; Advisory / Consultancy: Menarini; Travel / Accommodation / Expenses: Ferrer; Travel / Accommodation / Expenses: GSK. J.A. Arranz Arija: Honoraria (self), Advisory / Consultancy, Speaker Bureau / Expert testimony, Research grant / Funding (institution): Novartis; Honoraria (self), Advisory / Consultancy, Travel / Accommodation / Expenses: MSD Oncology; Honoraria (self), Advisory / Consultancy, Travel / Accommodation / Expenses: Janssen-Cilag; Honoraria (self), Advisory / Consultancy: EUSA Pharma; Honoraria (self), Advisory / Consultancy: Astellas Pharma; Honoraria (self), Advisory / Consultancy, Speaker Bureau / Expert testimony, Research grant / Funding (institution), Travel / Accommodation / Expenses: Bristol-Myers-Squibb; Advisory / Consultancy, Travel / Accommodation / Expenses: Pfizer; Advisory / Consultancy: Bayer; Advisory / Consultancy: Ipsen; Speaker Bureau / Expert testimony, Research grant / Funding (institution): Pierre-Fabre. All other authors have declared no conflicts of interest.