An Italian, multicenter, real-world, retrospective study of first-line pazopanib in unselected metastatic renal-cell carcinoma patients: the 'Pamerit' study

被引：1

作者：

Mosca, Alessandra ^{[1
,2
]}

De Giorgi, Ugo ^{[3
]}

Procopio, Giuseppe ^{[4
]}

Basso, Umberto ^{[5
]}

Carteni, Giacomo ^{[6
]}

Bersanelli, Melissa ^{[7
]}

Naglieri, Emanuele ^{[8
]}

Galli, Luca ^{[9
]}

Caffo, Orazio ^{[10
]}

Fornarini, Giuseppe ^{[11
]}

Boccardo, Francesco ^{[12
]}

Porta, Camillo ^{[13
,14
]}

机构：

[1] Univ Piemonte Orientale, Dept Translat Med, Med Oncol, I-28100 Novara, Italy

[2] FPO IRCCS, Candiolo Canc Inst, Multidisciplinary Outpatient Oncol Clin, I-10060 Turin, Italy

[3] IRCCS Ist Sci Romagnolo Studio & Cura Tumori IRST, Dept Oncol, Meldola, Italy

[4] Fdn IRCCS Ist Nazl Tumori, Med Oncol Dept, Milan, Italy

[5] Ist Oncol Veneto IOV IRCCS, Med Oncol Unit 1, Padua, Italy

[6] Azienda Osped Rilievo Nazl A Cardarelli, Div Oncol, Naples, Italy

[7] Univ Hosp Parma, Med Oncol Unit, Parma, Italy

[8] Ist Oncol Giovanni Paolo II, Div Med Oncol, Bari, Italy

[9] Univ Hosp Pisa, Oncol Unit 2, Pisa, Italy

[10] Santa Chiara Hosp, Dept Med Oncol, Trento, Italy

[11] Osped Policlin San Martino, Med Oncol Unit, Ist Ricovero & Cura Carattere Sci IRCCS, Genoa, Italy

[12] IRCCS San Martino Polyclin Hosp, Acad Unit Med Oncol, Genoa, Italy

[13] Univ Pavia, Dept Internal Med & Therapeut, Pavia, Italy

[14] IRCCS Ist Clin Sci Maugeri, Div Translat Oncol, Pavia, Italy

来源：

JAPANESE JOURNAL OF CLINICAL ONCOLOGY | 2021年 / 51卷 / 03期

关键词：

pazopanib; first-line therapy; metastatic renal cell carcinoma; real-world effectiveness; vascular endothelial growth factor receptor tyrosine kinase inhibitors; SUNITINIB; EFFICACY; CRITERIA; TRIAL;

D O I：

10.1093/jjco/hyaa193

中图分类号：

R73 [肿瘤学];

学科分类号：

100214 ;

摘要：

Objective: Despite the current immunotherapy era, VEGFR inhibitors maintain effectiveness in metastatic renal cell cancer. Real-world data concerning pazopanib are limited. The aim of this study is to add information about efficacy and safety of pazopanib as first-line treatment in metastatic renal cell cancer patients not enrolled into clinical trials. Methods: Retrospective analysis (the PAMERIT study) of first-line pazopanib in real-world metastatic renal cell cancer patients among 39 Centers in Italy. Outcomes were progression-free survival, overall survival, objective response rate and treatment-related adverse events. Kaplan-Meier curves, log-rank test and multivariable Cox's models were used and adjusted for age, histology, previous renal surgery, International Metastatic RCC Database Consortium score and pazopanib initial dose. Results: Among 474 patients, 87.3% had clear cell metastatic renal cell cancer histology. Most of them (84.6%) had upfront renal surgery. Median progression-free survival and overall survival were 15.8 and 34.4 months, respectively, significantly correlating with International Metastatic RCC Database Consortium's good prognosis (P < 0.001), ECOG PS 0 (P < 0.001), age (<75 years, P = 0.005), surgery (P < 0.001) and response to pazopanib (P < 0.001). After 3 months of pazopanib, overall disease control rate have been observed in 76.6% patients. Among International Metastatic RCC Database Consortium's favorable group patients, 57/121 (47%) showed complete/partial response. No unexpected AEs emerged. Conclusions: In this real-world study, metastatic renal cell cancer patients treated with first-line pazopanib reached greater progression-free survival and overall survival than in pivotal studies and had high response rates when belonging to International Metastatic RCC Database Consortium's favorable group, without new toxicities. Pazopanib has been confirmed a valid first-line option for International Metastatic RCC Database Consortium's good prognosis metastatic renal cell cancer patients who cannot be submitted to immunotherapy.

引用

页码：484 / 491

页数：8

共 27 条

[1]

Bhindi B, 2019, EUR UROL, V75, P111, DOI [10.1016/j.eururo.2018.09.016, 10.1016/j.eururo.2018.11.021]

[2] Hypertension and Cardiovascular Morbidity Following Surgery for Kidney Cancer [J].

Capitanio, Umberto ;

Larcher, Alessandro ;

Cianflone, Francesco ;

Trevisani, Francesco ;

Nini, Alessandro ;

Mottrie, Alexandre ;

Mari, Andrea ;

Campi, Riccardo ;

Tellini, Riccardo ;

Briganti, Alberto ;

Veccia, Alessandro ;

Van Poppel, Hendrik ;

Carini, Marco ;

Simeone, Claudio ;

Salonia, Andrea ;

Minervini, Andrea ;

Antonelli, Alessandro ;

Montorsi, Francesco ;

Bertini, Roberto .

EUROPEAN UROLOGY ONCOLOGY, 2020, 3 (02) :209-215

[3] Cost-effectiveness of Pazopanib Versus Sunitinib as First-line Treatment for Locally Advanced or Metastatic Renal Cell Carcinoma from an Italian National Health Service Perspective [J].

Capri, Stefano ;

Porta, Camillo ;

Delea, Thomas E. .

CLINICAL THERAPEUTICS, 2017, 39 (03) :567-+

[4] New response evaluation criteria in solid tumours: Revised RECIST guideline (version 1.1) [J].

Eisenhauer, E. A. ;

Therasse, P. ;

Bogaerts, J. ;

Schwartz, L. H. ;

Sargent, D. ;

Ford, R. ;

Dancey, J. ;

Arbuck, S. ;

Gwyther, S. ;

Mooney, M. ;

Rubinstein, L. ;

Shankar, L. ;

Dodd, L. ;

Kaplan, R. ;

Lacombe, D. ;

Verweij, J. .

EUROPEAN JOURNAL OF CANCER, 2009, 45 (02) :228-247

[5] Renal cell carcinoma: ESMO Clinical Practice Guidelines for diagnosis, treatment and follow-up [J].

Escudier, B. ;

Porta, C. ;

Schmidinger, M. ;

Rioux-Leclercq, N. ;

Bex, A. ;

Khoo, V. ;

Grunwald, V. ;

Gillessen, S. ;

Horwich, A. .

ANNALS OF ONCOLOGY, 2019, 30 (05) :706-720

[6] Randomized, Controlled, Double-Blind, Cross-Over Trial Assessing Treatment Preference for Pazopanib Versus Sunitinib in Patients With Metastatic Renal Cell Carcinoma: PISCES Study [J].

Escudier, Bernard ;

Porta, Camillo ;

Bono, Petri ;

Powles, Thomas ;

Eisen, Tim ;

Sternberg, Cora N. ;

Gschwend, Juergen E. ;

De Giorgi, Ugo ;

Parikh, Omi ;

Hawkins, Robert ;

Sevin, Emmanuel ;

Negrier, Sylvie ;

Khan, Sadya ;

Diaz, Jose ;

Redhu, Suman ;

Mehmud, Faisal ;

Cella, David .

JOURNAL OF CLINICAL ONCOLOGY, 2014, 32 (14) :1412-+

[7] Final results from the large sunitinib global expanded-access trial in metastatic renal cell carcinoma [J].

Gore, M. E. ;

Szczylik, C. ;

Porta, C. ;

Bracarda, S. ;

Bjarnason, G. A. ;

Oudard, S. ;

Lee, S-H ;

Haanen, J. ;

Castellano, D. ;

Vrdoljak, E. ;

Schoeffski, P. ;

Mainwaring, P. ;

Hawkins, R. E. ;

Crino, L. ;

Kim, T. M. ;

Carteni, G. ;

Eberhardt, W. E. E. ;

Zhang, K. ;

Fly, K. ;

Matczak, E. ;

Lechuga, M. J. ;

Hariharan, S. ;

Bukowski, R. .

BRITISH JOURNAL OF CANCER, 2015, 113 (01) :12-19

[8] Safety and efficacy of sunitinib for metastatic renal-cell carcinoma: an expanded-access trial [J].

Gore, Martin E. ;

Szczylik, Cezary ;

Porta, Camillo ;

Bracarda, Sergio ;

Bjarnason, Georg A. ;

Oudard, Stephane ;

Hariharan, Subramanian ;

Lee, Se-Hoon ;

Haanen, John ;

Castellano, Daniel ;

Vrdoljak, Eduard ;

Schoffski, Patrick ;

Mainwaring, Paul ;

Nieto, Alejandra ;

Yuan, Jinyu ;

Bukowski, Ronald .

LANCET ONCOLOGY, 2009, 10 (08) :757-763

[9] Outcomes of patients with metastatic renal cell carcinoma that do not meet eligibility criteria for clinical trials [J].

Heng, D. Y. C. ;

Choueiri, T. K. ;

Rini, B. I. ;

Lee, J. ;

Yuasa, T. ;

Pal, S. K. ;

Srinivas, S. ;

Bjarnason, G. A. ;

Knox, J. J. ;

MacKenzie, M. ;

Vaishampayan, U. N. ;

Tan, M. H. ;

Rha, S. Y. ;

Donskov, F. ;

Agarwal, N. ;

Kollmannsberger, C. ;

North, S. ;

Wood, L. A. .

ANNALS OF ONCOLOGY, 2014, 25 (01) :149-154

[10] Cytoreductive Nephrectomy in Patients with Synchronous Metastases from Renal Cell Carcinoma: Results from the International Metastatic Renal Cell Carcinoma Database Consortium [J].

Heng, Daniel Y. C. ;

Wells, J. Connor ;

Rini, Brian I. ;

Beuselinck, Benoit ;

Lee, Jae-Lyun ;

Knox, Jennifer J. ;

Bjarnason, Georg A. ;

Pal, Sumanta Kumar ;

Kollmannsberger, Christian K. ;

Yuasa, Takeshi ;

Srinivas, Sandy ;

Donskov, Frede ;

Bamias, Aristotelis ;

Wood, Lori A. ;

Ernst, D. Scott ;

Agarwal, Neeraj ;

Vaishampayan, Ulka N. ;

Rha, Sun Young ;

Kim, Jenny J. ;

Choueiri, Toni K. .

EUROPEAN UROLOGY, 2014, 66 (04) :704-710

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