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Poster display session: Breast cancer - early stage, locally advanced & metastatic, CNS tumours, Developmental therapeutics, Genitourinary tumours - prostate & non-prostate, Palliative care, Psycho-oncology, Public health policy, Sarcoma, Supportive care

4492 - Real-world effectiveness of pazopanib in patients with intermediate prognostic risk advanced renal cell carcinoma (PRINCIPAL Study)


22 Oct 2018


Poster display session: Breast cancer - early stage, locally advanced & metastatic, CNS tumours, Developmental therapeutics, Genitourinary tumours - prostate & non-prostate, Palliative care, Psycho-oncology, Public health policy, Sarcoma, Supportive care


Tumour Site

Renal Cell Cancer


Giuseppe Procopio


Annals of Oncology (2018) 29 (suppl_8): viii303-viii331. 10.1093/annonc/mdy283


G. Procopio1, A. Bamias2, M. Schmidinger3, R. Hawkins4, A. Rodriguez Sanchez5, S. Vazquez6, N. Srihari7, H. Kalofonos8, P. Bono9, C. Pisal10, Y. Hirschberg11, L. Dezzani11, Q. Ahmad11, C. Suarez Rodriguez12, E. Jonasch13

Author affiliations

  • 1 Medical Oncology, Fondazione IRCCS - Istituto Nazionale dei Tumori, 20133 - Milan/IT
  • 2 Oncology Unit, Department Of Clinical Therapeutics, Alexandra Hospital, 11528 - Athens/GR
  • 3 Oncology, Medical University of Vienna, 1090 - Vienna/AT
  • 4 Medical Oncology, The Christie NHS Foundation Trust, M20 4BX - Manchester/GB
  • 5 Oncology, University Hospital of Leon, Leon/ES
  • 6 Medical Oncology, Hospital Lucus Augusti, 27003 - Lugo/ES
  • 7 Medical Oncology, Shrewsbury & Telford Hospitals NHS Trust, Shrewsbury/GB
  • 8 Medical Oncology, University of Patras, Patras/GR
  • 9 Comprehensive Cancer Center, Helsinki University Hospital, Helsinki/FI
  • 10 Clinical research, Novartis Healthcare Private Limited, Hyderabad/IN
  • 11 Clinical research, Novartis Pharmaceuticals Corporation, East Hanover/US
  • 12 Medical Oncology, Vall d'Hebron University Hospital and Institute of Oncology, Universitat Autònoma de Barcelona, 08035 - Barcelona/ES
  • 13 Gu Medical Oncology, The University of Texas MD Anderson Cancer Center, 77030-4095 - Houston/US

Abstract 4492


Stratification by prognostic risk informs efficacy for various treatments in patients (pts) with advanced renal cell carcinoma (RCC). Whether further stratification beyond prognostic risk aids in predicting treatment outcomes is unknown. We conducted a post-hoc analysis of the real-world PRINCIPAL study (NCT01649778) to assess the effectiveness of pazopanib (PAZ) in pts with intermediate risk advanced RCC.


In this prospective, observational study, pts with advanced and/or metastatic clear cell RCC were enrolled within 30 days of initiating PAZ. Data on progression, survival, and safety were collected approximately every 3 months (mos) until death, consent withdrawal, or loss to follow-up, for up to 30 mos. Primary efficacy end points included overall survival (OS), progression-free survival (PFS), and overall response rate (ORR). A post-hoc analysis of pts with intermediate risk per Memorial Sloan Kettering Cancer Center (MSKCC) and International Metastatic Renal Cell Carcinoma Database Consortium (IMDC) criteria was conducted to evaluate effectiveness by number or risk factors (1 vs 2), age (<65 vs ≥ 65 years), and Eastern Cooperative Oncology Group performance status (ECOG PS).


Of the 657 enrolled pts who received ≥1 dose of PAZ, 363 (55.3%) and 343 (52.2%) had intermediate risk per MSKCC and IMDC criteria, respectively. Within the subgroup of pts with intermediate risk MSKCC and IMDC, median PFS (but not OS) was numerically longer in pts with 1 (vs 2) risk factors, and outcomes were poorer in pts with ECOG PS ≥ 2 (vs < 2) (Table). Median OS within each MSKCC and IMDC risk group was longer than anticipated based on previous clinical trial and real-world data.Table: 884P

Median progression-free survival

MSKCC intermediate risk (n = 363)IMDC intermediate risk (n = 343)
Disease progression or death/N (%)Median (95% CI) monthsDisease progression or death/N (%)Median (95% CI) months
Number of risk factors*
185/147 (57.8)13.8 (10.7-18.1)88/171 (51.5)13.1 (10.7-18.1)
285/141 (60.3)7.4 (6.2-10.3)88/133 (66.2)8.1 (6.4-10.7)
<65 years79/142 (55.6)12.3 (9.0-16.4)73/136 (53.7)13.1 (10.3-18.4)
≥65 years131/219 (59.8)10.7 (9.0-13.8)123/205 (60.0)10.7 (9.0-13.1)
<2189/333 (56.8)11.2 (9.5-14.1)177/316 (56.0)11.8 (9.9-15.4)
≥28/8 (100.0)5.6 (1.3-12.8)8/8 (100.0)2.3 (1.2-10.7)

Patients with 1 missing risk factor were excluded.

CI; confidence interval; ECOG PS, Eastern Cooperative Oncology Group performance status; IMDC, International Metastatic Renal Cell Carcinoma Database Consortium; MSKCC, Memorial Sloan Kettering Cancer Center.


The results of the PRINCIPAL study suggest pts with advanced RCC of intermediate prognostic risk can be further stratified to predict treatment outcomes.

Clinical trial identification


Legal entity responsible for the study

Novartis Pharmaceuticals Corporation.


Novartis Pharmaceuticals Corporation.

Editorial Acknowledgement

Editorial support was provided by Chris Ontiveros, PhD (ApotheCom, New York).


G. Procopio: Honoraria: Astellas Pharma, Ipsen Inc., Novartis, Pfizer Inc.; Consulting/advisory roles: Bayer, Bristol-Myers Squibb Company, Ipsen Inc., Novartis Pharma AG, Pfizer Inc. A. Bamias: Personal fees: Novartis Pharma AG, Bristol Meyers Squibb Company, Ipsen Inc. M. Schmidinger: Research funding: Roche Holding AG; Honororia as consulting/advisory role: Pfizer Inc., Roche Holding AG, Bristol-Myers Squibb Company, Ipsen Inc., Novartis Pharma AG, Exelixis; Travel accommodations/expenses: Pfizer Inc., Roche Holding AG, Ipsen Inc. R. Hawkins: Personal fees: BMS, Novartis, Ipsen, EUSA, outside the submitted work; Patent: MRC Phage Antibody with royalties paid. S. Vazquez: Honoraria: Roche Holding AG, Pfizer Inc., Astellas Pharma, AstraZeneca, Bristol-Myers Squibb Company, Sanofi, Eli Lilly and Company; Travel expenses/accommodations: Roche Holding AG, AstraZeneca. N. Srihari: Non-financial support: Janssen. P. Bono: Stockholder: TILT Biotherapeutics; Honoraria: Bristol-Myers Squibb Company, Merck Sharp & Dohme Corp., Orion Corporation, Pfizer Inc., Novartis Pharma AG, Ipsen, Oncorena Holding AB. C. Pisal, Q. Ahmad: Employee of Novartis Pharma AG. Y. Hirschberg: Employee: Novartis Pharma AG; Stockholder: Beckton Dickinson, Novartis Pharma AG. L. Dezzani: Employee and stockholder: Novartis Pharma AG. E. Jonasch: Grants and personal fees: Novartis. All other authors have declared no conflicts of interest.

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