Retrospective Study
Copyright ©The Author(s) 2021. Published by Baishideng Publishing Group Inc. All rights reserved.
World J Clin Oncol. Nov 24, 2021; 12(11): 1037-1046
Published online Nov 24, 2021. doi: 10.5306/wjco.v12.i11.1037
First-line pazopanib in patients with advanced non-clear cell renal carcinoma: An Italian case series
Sebastiano Buti, Melissa Bersanelli, Francesco Massari, Ugo De Giorgi, Orazio Caffo, Gaetano Aurilio, Umberto Basso, Giacomo Carteni, Claudia Caserta, Luca Galli, Francesco Boccardo, Giuseppe Procopio, Gaetano Facchini, Giuseppe Fornarini, Alfredo Berruti, Elena Fea, Emanuele Naglieri, Fausto Petrelli, Roberto Iacovelli, Camillo Porta, Alessandra Mosca
Sebastiano Buti, Melissa Bersanelli, Medical Oncology Unit, University Hospital of Parma, Parma 43126, Italy
Melissa Bersanelli, Medicine and Surgery Department, University of Parma, Parma 43126, Italy
Francesco Massari, Division of Oncology, Policlinico Sant’Orsola-Malpighi Hospital, Bologna 40138, Italy
Ugo De Giorgi, Department of Oncology, IRCCS Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori (I.R.S.T.), Meldola 47014, Italy
Orazio Caffo, Department of Medical Oncology, Santa Chiara Hospital, Trento 38122, Italy
Gaetano Aurilio, Department of Medical Oncology, Division of Urogenital and Head and Neck Tumours, European Institute of Oncology IRCCS, Milan 20141, Italy
Umberto Basso, Medical Oncology Unit 3, Istituto Oncologico Veneto IOV IRCCS, Castelfranco Veneto, Padova 31033, Italy
Giacomo Carteni, Division of Oncology, Azienda Ospedaliera di Rilievo Nazionale A. Cardarelli, Napoli 80131, Italy
Claudia Caserta, Medical Oncology Unit, Azienda Ospedaliera S. Maria, Terni 05100, Italy
Luca Galli, Oncology Unit 2, University Hospital of Pisa, Pisa 56126, Italy
Francesco Boccardo, Academic Unit of Medical Oncology, IRCCS San Martino Polyclinic Hospital, Genova 16132, Italy
Giuseppe Procopio, Medical Oncology Genitourinary Section, Fondazione IRCCS Istituto Nazionale Dei Tumori, Milan 20133, Italy
Gaetano Facchini, Departmental Unit of Clinical and Experimental Uro-Andrologic Oncology, Istituto Nazionale Tumori IRCCS Fondazione G. Pascale, Napoli 80131, Italy
Giuseppe Fornarini, Medical Oncology Unit, Istituto di Ricovero e Cura a Carattere Scientifico (IRCCS) Ospedale Policlinico San Martino, Genova 16132, Italy
Alfredo Berruti, University of Brescia, ASST-Spedali Civili, Brescia, Brescia 25123, Italy
Elena Fea, Medical Oncology Unit, S Croce and Carle Teaching Hospital, Cuneo 12100, Italy
Emanuele Naglieri, Division of Medical Oncology, Istituto Tumori G Paolo II, IRCCS, Bari 70124, Italy
Fausto Petrelli, Medical Oncology Unit, ASST Bergamo Ovest, Treviglio, Bergamo 24047, Italy
Roberto Iacovelli, Medical Oncology Unit, Fondazione Policlinico Universitario Agostino Gemelli IRCCS, Rome 00161, Italy
Camillo Porta, Division of Oncology, AOU Consorziale Policlinico di Bari, Bari 70124, Italy
Camillo Porta, Department of Biomedical Sciences and Human Oncology, University of Bari "A.Moro", Bari 70124, Italy
Alessandra Mosca, Multidisciplinary Outpatient Oncology Clinic, Candiolo Cancer Institute, FPO-IRCCS, Candiolo, Turin 10060, Italy
Author contributions: All authors contributed to the data collection and manuscript revision.
Institutional review board statement: The study was reviewed and approved by the Local Ethics Committee of Parma (Italy).
Informed consent statement: All study participants provided informed written consent prior to study enrollment.
Conflict-of-interest statement: Melissa Bersanelli received honoraria as a speaker at scientific events by Bristol-Myers Squibb (BMS), Novartis, Astra Zeneca, Pierre Fabre, and Pfizer and as a consultant for advisory role by Novartis, BMS, IPSEN, and Pfizer; she also received fees for copyright transfer by Sciclone Pharmaceuticals and research funding by Roche S.p.A., Seqirus UK, Pfizer, Novartis, BMS, Astra Zeneca, and Sanofi Genzyme. Sebastiano Buti received honoraria as a speaker at scientific events and advisory role by Bristol-Myers Squibb (BMS), Pfizer; MSD, Ipsen, Roche, Eli-Lilly, AstraZeneca, and Novartis; he also received research funding from Novartis. Orazio Caffo received honoraria as a speaker by Astellas, Bayer, Astra Zeneca, Janssen, Pfizer, Sanofi, and a consultant for advisory role by Astellas, Janssen, MSD. Camillo Porta received honoraria a Consultant or Speaker for Angelini, Astra Zeneca, BMS, Eisai, EUSA, General Electric, Ipsen, Janssen, Merck, MSD, Novartis and Pfizer, acted as an Expert Testimony for EUSA and Pfizer and was a Protocol Steering Committee Member ofr BMS, Eisai, and EUSA. Finally, he did receive travel support from Roche. All other authors have no conflict of interest to declare.
Data sharing statement: Data will be made available upon reasonable request by the corresponding author.
Open-Access: This article is an open-access article that was selected by an in-house editor and fully peer-reviewed by external reviewers. It is distributed in accordance with the Creative Commons Attribution NonCommercial (CC BY-NC 4.0) license, which permits others to distribute, remix, adapt, build upon this work non-commercially, and license their derivative works on different terms, provided the original work is properly cited and the use is non-commercial. See:
Corresponding author: Melissa Bersanelli, MD, Adjunct Professor, Postdoctoral Fellow, Staff Physician, Medical Oncology Unit, University Hospital of Parma, Via Gramsci 14, Parma 43126, Italy.
Received: February 27, 2021
Peer-review started: February 27, 2021
First decision: May 4, 2021
Revised: May 18, 2021
Accepted: September 3, 2021
Article in press: September 3, 2021
Published online: November 24, 2021

Non-clear cell (ncc) metastatic renal-cell carcinoma (RCC) has dismal results with standard systemic therapies and a generally worse prognosis when compared to its clear-cell counterpart. New systemic combination therapies have emerged for metastatic RCC (mRCC), but the pivotal phase III trials excluded patients with nccRCC, which constitute about 30% of metastatic RCC cases.


To provide a piece of real-life evidence on the use of pazopanib in this patient subgroup.


The present study is a multicenter retrospective observational analysis aiming to assess the activity, efficacy, and safety of pazopanib as first-line therapy for advanced nccRCC patients treated in a real-life setting.


Overall, 48 patients were included. At the median follow-up of 40.6 mo, the objective response rate was 27.1%, the disease control rate was 83.3%, and the median progression-free survival and overall survival were 12.3 (95% confidence interval [CI]: 3.6-20.9) and 27.7 (95%CI: 18.2-37.1) mo, respectively. Grade 3 adverse events occurred in 20% of patients, and no grade 4 or 5 toxicities were found.


Pazopanib should be considered as a good first-line option for metastatic RCC with variant histology.

Keywords: Pazopanib, Non-clear cell, Kidney cancer, Renal-cell carcinoma, Variant histology, Tyrosine kinase inhibitors

Core Tip: Non-clear cell metastatic renal-cell carcinoma (nccRCC) has dismal results with standard systemic therapies and a poor prognosis. Few therapeutic molecules have been explicitly tested in nccRCC patients. We retrospectively collected 48 advanced nccRCC patients treated with pazopanib in the first-line setting, offering promising findings of quite good response rate (27%), progression-free survival around 12 mo, and overall survival around 28 mo. In light of these results, we suggest that pazopanib can be a good treatment choice in this subgroup of patients, pending the results of ongoing clinical trials with new therapeutic combinations.