Evidence map›Paper›PMID 30867244›Full record

Observational studyThe oncologist2019

Prospective Observational Study of Pazopanib in Patients with Advanced Renal Cell Carcinoma (PRINCIPAL Study).

Manuela Schmidinger, Aristotelis Bamias, Giuseppe Procopio, Robert Hawkins, Angel Rodriguez Sanchez, Sergio Vázquez, Narayanan Srihari, Haralabos Kalofonos, Petri Bono, Chaitali Babanrao Pisal and 5 more

Registry-linked trialAbstract readObservational Study
In one paragraph

Observational study in The oncologist, 2019. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT06093568 (Exploring Engagement Dynamics Among Individuals Impacted by Renal Cell Carcinoma), which is not on this map. Cited by 12 papers.

0numbers the graph read from it
0cells of the map it votes in
12citing papers in PubMed
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT06093568 not yet recruitingnot on this mapstarted 2024, after this paper: background citation

Exploring Engagement Dynamics Among Individuals Impacted by Renal Cell Carcinoma

TypeobservationalSponsorPower Life Sciences Inc.Ran2024 to 2026Enrolled500ConditionsRenal Cell Carcinoma
3 · Its place in the literature

Who cites it

12 citing papers in PubMed.

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4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

15 authors.

Manuela SchmidingerMedical University of Vienna, Vienna, Austria manuela.schmidinger@meduniwien.ac.at.
Aristotelis BamiasNational and Kapodistrian University of Athens Alexandra Hospital, Athens, Greece.
Giuseppe ProcopioFondazione IRCCS Istituto Nazionale dei Tumori, Milan, Italy.
Robert HawkinsThe Christie Hospital and University of Manchester, Manchester, United Kingdom.
Angel Rodriguez SanchezUniversity Hospital of Leon, Leon, Spain.
Sergio VázquezHospital Universitario Lucus Augusti, Lugo, Spain.
Narayanan SrihariShrewsbury & Telford Hospitals NHS Trust, Shrewsbury, United Kingdom.
Haralabos KalofonosUniversity of Patras, Patras, Greece.
Petri BonoHelsinki University Hospital and University of Helsinki, Helsinki, Finland.
Chaitali Babanrao PisalNovartis Healthcare Private Limited, Hyderabad, India.
Yulia HirschbergNovartis Pharmaceuticals Corporation, East Hanover, New Jersey, USA.
Luca DezzaniNovartis Pharmaceuticals Corporation, East Hanover, New Jersey, USA.
Qasim AhmadNovartis Pharmaceuticals Corporation, East Hanover, New Jersey, USA.
Eric JonaschThe University of Texas MD Anderson Cancer Center, Houston, Texas, USA.
PRINCIPAL Study Group

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundReal-world data are essential to accurately assessing efficacy and toxicity of approved agents in everyday practice. PRINCIPAL, a prospective, observational study, was designed to confirm the real-world safety and efficacy of pazopanib in patients with advanced renal cell carcinoma (RCC). SUBJECTS, MATERIALS, AND

methodsPatients with clear cell advanced/metastatic RCC and a clinical decision to initiate pazopanib treatment within 30 days of enrollment were eligible. Primary objectives included progression-free survival (PFS), overall survival (OS), objective response rate (ORR), relative dose intensity (RDI) and its effect on treatment outcomes, change in health-related quality of life (HRQoL), and safety. We also compared characteristics and outcomes of clinical-trial-eligible (CTE) patients, defined using COMPARZ trial eligibility criteria, with those of non-clinical-trial-eligible (NCTE) patients. Secondary study objectives were to evaluate clinical efficacy, safety, and RDI in patient subgroups.

resultsSix hundred fifty-seven patients were enrolled and received ≥1 dose of pazopanib. Median PFS and OS were 10.3 months (95% confidence interval [CI], 9.2-12.0) and 29.9 months (95% CI, 24.7 to not reached), respectively, and the ORR was 30.3%. HRQoL showed no or little deterioration over time. Treatment-related serious adverse events (AEs) and AEs of special interest occurred in 64 (9.7%), and 399 (60.7%) patients, respectively. More patients were classified NCTE than CTE (85.2% vs. 14.8%). Efficacy of pazopanib was similar between the two groups.

conclusionPRINCIPAL confirms the efficacy and safety of pazopanib in patients with advanced/metastatic RCC in a real-world clinical setting. IMPLICATIONS FOR PRACTICE: PRINCIPAL is the largest (

Indexed as

AdultAgedAged, 80 and overAngiogenesis InhibitorsCarcinoma, Renal CellFemaleFollow-Up StudiesHumansIndazolesKidney NeoplasmsMaleMiddle AgedPrognosisProspective StudiesPyrimidinesQuality of LifeAngiogenesis InhibitorsIndazolespazopanibPyrimidinesSulfonamidesObservationalPazopanibReal‐worldRenal cell carcinomaTyrosine kinase inhibitor

Identifiers

PMID30867244
PMCPMC6459236

What OpenQuestion holds

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Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.