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Poster display session

1927 - SPAZO2 (SOGUG): Validation of the International Metastatic Database Consortium (IMDC) prognostic classification for targeted therapies as 2nd-line after 1st-line pazopanib (1stPz) in metastatic renal cell carcinoma (mRC).

Date

10 Sep 2017

Session

Poster display session

Presenters

Begoña Pérez-Valderrama

Citation

Annals of Oncology (2017) 28 (suppl_5): v295-v329. 10.1093/annonc/mdx371

Authors

B. Pérez-Valderrama1, J. Arranz Arija2, I. Chirivella González3, U. Anido Herranz4, J.M. Jurado García5, C. Suarez Rodriguez6, I. García Carbonero7, G. de Velasco8, R. García Domínguez9, R.D. García Marrero10, M.A. Gonzalez Del Alba Baamonde11, C. Molins Palau12, M.E. Lazaro13, J. Munoz-Langa14, E. Martinez Ortega15, A. Hernández Jorge16, M. Campayo Guillaumes17, M. Sereno Moyano18, R. Luque Caro19, Á. Rodríguez Sánchez20

Author affiliations

  • 1 Medical Oncology, HH Virgen del Rocío, 41013 - Sevilla/ES
  • 2 Medical Oncology, Hospital General Universitario Gregorio Marañon, 28007 - Madrid/ES
  • 3 Medical Oncology, Hospital Clinico Universitario de Valencia, 46010 - Valencia/ES
  • 4 Medical Oncology, Hospital Clinico Universitario de Santiago de Compostela, 15706 - Santiago de Compostela/ES
  • 5 Medical Oncology, Hospital Clinico San Cecilio, 18150 - Granada/ES
  • 6 Medical Oncology, Vall d'Hebron University Hospital, 08035 - Barcelona/ES
  • 7 Medical Oncology, Hospital Virgen de la Salud, 49004 - Toledo/ES
  • 8 Medical Oncology, Hospital 12 de Octubre, 28041 - Madrid/ES
  • 9 Medical Oncology, Hospital Universitario de Salamanca, 37007 - Salamanca/ES
  • 10 Medical Oncology, Hospital Universitario de Canarias, 38320 - Santa Cruz de Tenerife/ES
  • 11 Medical Oncology, Hospital Universitario Son Espases, 7010 - Palma de Mallorca/ES
  • 12 Medical Oncology, Hospital Universitario Dr Peset, 46017 - Valencia/ES
  • 13 Medical Oncology, Hospital Universitario Alvaro Cunqueiro, 36312 - Vigo/ES
  • 14 Medical Oncology, Hospital Universitari i Politècnic La Fe, 46026 - Valencia/ES
  • 15 Medical Oncology, Complejo Hospitalario de Jaen Universidad de Jaen, 23007 - Jaen/ES
  • 16 Medical Oncology, Onkologikoa, 20014 - Donostia/ES
  • 17 Medical Oncology, H. Mutua de Terrassa, 08221 - Terrassa/ES
  • 18 Medical Oncology, Hospital Infanta Sofia, 28702 - Madrid/ES
  • 19 Medical Oncology, HOSPITAL VIRGEN DE LAS NIEVES, Granada/ES
  • 20 Medical Oncology, Complejo Asistencial Universiario de Leon, 24071 - Leon/ES
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Resources

Abstract 1927

Background

Only 2% of pt included in the IMDC prognostic model for 2nd-line targeted agents in mRC had received 1stPz (Ko, Lancet Oncol 2015). We aimed to validate the IMDC model for this population of patients receiving 1stPz.

Methods

SPAZO2 (NCT03091465) was a retrospective real-world study to analyze the effectiveness of 1stPz and subsequent therapies in mRC in several settings in every day practice. Data from 530 pt treated with frontline pazopanib outside CT in 50 centers in Spain were collected by investigators, but monitored and entered in a database by an external CRO.

Results

A total of 285 pt received antiVEGF or mTOR inhibitor as 2nd line (37.6% everolimus, 2.5% temsirolimus, 36% axitinib, 9.9% sunitinib, 8.3% sorafenib, 2.9% cabozantinib, 2.1% pazopanib, 0.4% beva-Inf, 0.4% savolitinib), 242 after true progression and 43 due to other causes after 1stPz. Unlike in IMDC, no pt had received 1st-line immunotherapy. Mean age was 66 y, 67.7% were male, 74.4% nephrectomized, and 12.3% pure nonclear-cell. Metastatic sites were: lung 74%, lymph nodes 55%, bone 36%, soft tissue/skin 27%, liver 24.8%, CNS 7%, adrenal gland 5%, pleura/peritoneum 6%, pancreas 5%, kidney 3% and other organs 2%. Classification of pt into the IMDC risk groups were: favorable (FR, 14.4%), intermediate (IR: 64.2%), or poor (PR: 21.4%). Median follow-up since 2nd-line was 29 mo; 67% of pt has progressed, 64% had received or subsequent lines, and 73% had died. Response, PFS and OS (and 95%CI) since 2nd-line are showed in the table. Differences in PFS and OS were statistically significant among groups (FR vs IR and FR vs PR). The C-Index was 0.635 (95%CI: 0.627 – 0.642). We also provide an estimation of outcomes according to if pt received 2ndline after “true progression” or due to any cause.Table:

895P

SPAZO2IMDC
OverallFRIRPROverallFRIRPR
ORR14.6%22.5%15.8%5.5%Not reposted
Median PFS (1)*5.1 (4-6)11.5 (5-18)5 (4-6)3 (2-4)3.9Not reported
Median PFS (2)*4.7 (4-5)9.7 (4-15)4.8 (4-6)3 (2-4)
Median OS (1)*11.3 (9-13)24.4 (18-30)12.7 (10-15)6.5 (5-8)12.5 (11-14)35.3 (28-48)16.6 (15-18)5.4 (5-7)
Median OS (2)*11.1 (9-13)19.8 (12-27
*

Months; 1: 2nd-line due to any cause (N = 285); 2: 2nd-line due to progression to Pz (N = 242).

Conclusions

Our results validate the use of the IMDC prognostic classification as a discrimination tool, for predicting prognosis in pt receiving 2nd-line targeted therapies after pazopanib in mRC. Pt who received 2nd-line after true progression had a poorer prognostic than the predicted by the IMDC.

Clinical trial identification

NCT03091465

Legal entity responsible for the study

SOGUG

Funding

Novartis

Disclosure

B. Pérez-Valderrama: Consulting/Advisory role for Astellas Pharma, Novartis, Pfizer, Pierre Fabre, Bayer, Sanofi, Bristol-Myers Squib and Roche. J. Arranz Arija: AdBo from Novartis and Pfizer. G. de Velasco: Consulting and Advisory board for Pfizer, Novartis, Bayer, Roche. M.A. Gonzalez Del Alba Baamonde: Advisory boards for Novartis, Pfizer, Bristol-Myers Squib, Ipsen. All other authors have declared no conflicts of interest.

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