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Poster display session

1922 - SPAZO2 (SOGUG): Comparative effectiveness of everolimus (Ev) vs axitinib (Ax) as second-line after first-line pazopanib (1stPz) in metastatic renal carcinoma (mRC).

Date

10 Sep 2017

Session

Poster display session

Topics

Cytotoxic Therapy;  Renal Cell Cancer

Presenters

Jose Arranz Arija

Citation

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

Authors

J. Arranz Arija1, B. Pérez-Valderrama2, A. Rodriguez Sanchez3, J. Puertas Alvarez4, A. Pinto Marin5, C. Maximiano Alonso6, J.C. Villa Guzman7, E.M. Fernandez Parra8, E. Gallardo Diaz9, J. Gonzalez-Larriba10, J. Tafalla García11, J. Lambea12, M. Constenla Figueiras13, M.J. Mendez Vidal14, J.A. Virizuela Echaburu15, F.J. Vazquez Mazon16, O. Etxaniz Ulazia17, M.T. Abad Villar18, J. Cassinello19, J.M. Jurado García20

Author affiliations

  • 1 Medical Oncology, Hospital General Universitario Gregorio Marañon, 28007 - Madrid/ES
  • 2 Medical Oncology, HH Virgen del Rocío, Sevilla/ES
  • 3 Medical Oncology, Hospital Universitario de León, 7005 - Leon/ES
  • 4 Medical Oncology, Hospital Universitario Rio Hortega, 47012 - Valladolid/ES
  • 5 Medical Oncology, Hospital Universitario La Paz, 28046 - Madrid/ES
  • 6 Medical Oncology, Hospital Universitario Puerta de Hierro, 28222 - Majadahonda/ES
  • 7 Medical Oncology, Hospital General Ciudad Real, 13005 - Ciudad Real/ES
  • 8 Medical Oncology, Hospital Nuestra Señora de Valme, 41014 - Sevilla/ES
  • 9 Medical Oncology, Hospital de Sabadell Corporacio Parc Tauli, 08208 - Sabadell/ES
  • 10 Medical Oncology, Hospital Clinico Universitario San Carlos, 28040 - Madrid/ES
  • 11 Medical Oncology, Hospital Central de la Defensa Gomez Ulla, 28047 - Madrid/ES
  • 12 Medical Oncology, Hospital Clinico Universitario Lozano Blesa, 50009 - Zaragoza/ES
  • 13 Medical Oncology, Hospital Provincial de Pontevedra, 36001 - Pontevedra/ES
  • 14 Medical Oncology, University Hospital Reina Sofia, 14004 - Cordoba/ES
  • 15 Medical Oncology, Hospital Universitario Virgen Macarena, 41003 - Sevilla/ES
  • 16 Medical Oncology, Hospital General Universitario de Elche, 3203 - Elche/ES
  • 17 Medical Oncology, Catalan Institute of Oncology (ICO Badalona), Hospital Germans Trias i Pujol, 08916 - Badalona/ES
  • 18 Medical Oncology, Hospital de Basurto, Bilbao/ES
  • 19 Medical Oncology, University General Hospital, 19002 - Guadalajara/ES
  • 20 Medical Oncology, Hospital Clinico San Cecilio, 18150 - Granada/ES
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Resources

Abstract 1922

Background

Pivotal studies of axitinib and everolimus in 2nd-line mRC did not include pt treated with 1stPz. In addition, E vs A have not been directly compared in clinical trials in this setting. We aimed to compare the effectiveness of E vs A in real life, as second-line after pazopanib in mRC.

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

Out of 285 pt receiving 2nd-line targeted therapies after 1stPz, 189 received either Ax (88, 46.6%) or Ev (101, 53.4%). There were no significant differences (Ax vs Ev), in age (63 y vs 66 y), sex (68% vs 64% males), nephrectomy (76% vs 67%), metastases in lymph nodes (58% vs 52%), liver (21% vs 28%), bone (45% vs 41%), CNS (6%), adrenal (4% vs 5%), pleura/peritoneum (4% vs 6%), or pancreas (4% vs 6%), but there were in age >75 (14% vs 25%), nonclear cell component (1 vs 16%), and lung (85 vs 72%) and skin/soft-tissue (20 vs 28%) metastases. According to the IMDC for 2nd-line targeted therapies, 17% vs 9% of pt were in the favorable risk group, 65% vs 69% in the intermediate risk, and 18% vs 22% in the poor risk. All-grades hypertension (32.6% vs 3.6%) and hypothyroidism (16% vs 6%) were significantly higher with Ax, whereas anemia (21.4% vs 55%), and mucositis (12.3% vs 39%) were more frequent with Ev. Subsequent therapies were given in 56% in Ax vs 46% in Eve. After median follow-up of 28 mo, 74.6 of pt have died. Outcomes and 95%CI are summarized in the table.Table:

886P

ResponsePFSOS
ORRSDMedian6 montsMedian1 year
Axitinib13.1%42.9%5.3 (3-7)47%11.6 (7-16)49%
Everolimus9.3%43%4.6 (3-6)39%9.5 (7-12)43%
Overall11.2%42.9%5.0 (4-6)43%10.7 (8-13)46%
p nsHR*: 0.76 (0.5-1.1)HR*: 0.81 (0.6-1.2)
*

Adjusted by IMDC, metastases, age, histology and subsequent therapies.

Conclusions

In this real world study in pt with mRC, we could not find statistically significant differences in effectiveness between axitinib and everolimus as 2nd-line after 1st line pazopanib. These results validate the use of both drugs in terms of clinical benefit, PFS and OS.

Clinical trial identification

NCT03091465

Legal entity responsible for the study

SOGUG

Funding

Novartis

Disclosure

J. Arranz Arija: AdBo from Novartis and Pfizer. B. Pérez-Valderrama: Consulting/Advisory role for Astellas Pharma, Novartis, Pfizer, Pierre Fabre, Bayer, Sanofi, Bristol-Myers Squib and Roche. J. Puertas Alvarez: Participation in advisory board meetings from Pfizer, Astellas, Novartis, Sanofi, GlaxoSmithKline, AstraZeneca, Pharmamar, Hospira, Janssen, Eisai, Roche, Lilly, and Bayer. All other authors have declared no conflicts of interest.

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