Prospective observational study on pazopanib in patients treated for advanced/metastatic renal cell carcinoma (RCC): APOLON Study.

Authors

null

Philippe Barthelemy

Hôpitaux Universitaires de Strasbourg, Strasbourg, France

Philippe Barthelemy , Laurence Albiges , Bernard Escudier , Thierry Lebret , Pierre Bigot , Ulrich Stein , Louis-Marie Dourthe , Jeannine De La Cruz , Malka Tindel , Antoine Thiery-Vuillemin

Organizations

Hôpitaux Universitaires de Strasbourg, Strasbourg, France, Medical Oncology, Gustave Roussy, Université Paris-Saclay, Villejuif, France, Hôpital Foch, Suresnes, France, Service d’Urologie CHU Angers, Université d’Angers, Angers, France, Medical Oncology - CHRU Jean Minjoz, Besançon, France, Strasbourg Oncologie Libérale, Strasbourg, France, Novartis Oncology France, Rueil-Malmaison Cedex, France, Novartis, Rueil Malmaison, France, Medical Oncology CHRU Jean Minjoz, Besançon, France

Research Funding

Pharmaceutical/Biotech Company
novartis.

Background: Pazopanib (PZP), has been granted for advanced or metastatic RCC. In addition to pivotal clinical trials, real-world evidence (RWE) is required to evaluate effectiveness and safety in clinical routine practices. Methods: APOLON is a non-interventional, multicentric prospective study to assess PZP Progression-Free Survival (PFS) (8-month PFS rate as primary endpoint), Overall Survival (OS), Objective Response Rate (ORR), tolerability, subsequent post-pazopanib therapy sequences. It is conducted in France with 55 sites (hospital or private practitioners) in patients with mRCC, naïve to anti-VEGF therapy, who initiated PZP treatment. Data are collected at baseline and at 1, 2-3, 6, 9, 12, 18, 24, 30, 36 months (mo). Patients (n= 218) were recruited from Nov 2017 to Jan 2019. This interim analysis presents results 6 months after last patient was enrolled. Results: Patients were 71,1% males, with a median age of 69.6 years. They had clear-cell type RCC for 97.7% with a favourable (26.4%), intermediate (52.9%) or poor (20.7%) IMDC risk score. Comorbidities were: hypertension (75.1%), diabetes (26%), arterial disorders (20.1%), other pathologies (47.3%); 81.7% received co-medications. ECOG-PS was 0 (42.9%), 1 (40%), 2 (15.7%), Metastases were mainly located in lungs (62.8%), bones (28.9%), mediastinal (17.9%)/abdominal (17%) lymph nodes, glands (pancreas, thyroid, adrenals) (17.4%). Of them, 56% had an history of partial/total nephrectomy, 28.1% previous local treatments for metastases. Median PFS, assessed by investigator, was 11.3 mo (95%CI: 8.7-13), with an 8-mo PFS rate at 62.9%. ORR was 47.2% and 1-year OS rate was 71.2%. Treatment-related serious adverse events were reported in 17.3% of patients. No new safety signal was identified. After a median follow-up of 8.8 mo, of the 121 patients with discontinuation, 74 received post-PZP lines comprising firstly nivolumab (67.6%), cabozantinib (16.2%), sunitinib (10.8%), other (5.6%). Conclusions: APOLON study represents real-life population including elderly and frail patients with clinically meaningful ORR and PFS with PZP. Reported adverse events were consistent with known safety PZP profile.

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Abstract Details

Meeting

2020 Genitourinary Cancers Symposium

Session Type

Poster Session

Session Title

Poster Session C: Renal Cell Cancer

Track

Renal Cell Cancer

Sub Track

Patient-Reported Outcomes and Real-World Evidence

Citation

J Clin Oncol 38, 2020 (suppl 6; abstr 629)

Abstract #

629

Poster Bd #

D15

Abstract Disclosures

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