Assessment of eligibility criteria in renal cell carcinoma trials evaluating systemic therapy.
HBV/HCV infection
HIV infection
brain metastases
clinical trials
comorbidities
eligibility criteria
prior or concurrent malignancies
renal cell carcinoma
Journal
BJU international
ISSN: 1464-410X
Titre abrégé: BJU Int
Pays: England
ID NLM: 100886721
Informations de publication
Date de publication:
07 Aug 2023
07 Aug 2023
Historique:
pubmed:
7
8
2023
medline:
7
8
2023
entrez:
7
8
2023
Statut:
aheadofprint
Résumé
To characterise the restrictiveness of eligibility criteria in contemporary renal cell carcinoma (RCC) trials, using recommendations from the American Society of Clinical Oncology (ASCO)-Friends of Cancer Research (FCR) initiative. vPhase I-III trials assessing systemic therapies in patients with RCC starting between 30 June 2012 and 30 June 2022 were identified. Eligibility criteria regarding brain metastases, prior or concurrent malignancies, hepatitis B virus (HBV) or hepatitis C virus (HCV) infection, and human immunodeficiency virus (HIV) infection were identified and stratified into three groups: exclusion, conditional inclusion, and not reported. Descriptive statistics were used to determine the frequency of eligibility criteria. Fisher's exact test or chi-square test were used to calculate their associations with certain trial characteristics. A total of 423 RCC trials were initially identified of which 112 (26.5%) had sufficient accessible information. Exclusion of patients with HIV infection, HBV/HCV infection, brain metastases, and prior or concurrent malignancies were reported in 74.1%, 53.6%, 33.0%, and 8.0% of trials, respectively. In the context of HIV and HBV/HCV infection, patients were largely excluded from trials evaluating immunotherapy (94.4% and 77.8%, respectively). In addition, brain metastases were excluded in trials assessing targeted therapy (36.4%), combined therapy (33.3%), and immunotherapy (22.2%). Exclusion of patients with prior or concurrent malignancies was less frequently reported, accounting for 9.1%, 8.3%, and 5.6% targeted therapy, combined therapy and immunotherapy trials, respectively. A substantial proportion of RCC trials utilise restrictive eligibility criteria, excluding patients with fairly prevalent comorbidities. Implementing the ASCO-FCR recommendations will ensure resulting data are more inclusive and aligned with patient populations in the real-world.
Types de publication
Journal Article
Langues
eng
Sous-ensembles de citation
IM
Informations de copyright
© 2023 The Authors. BJU International published by John Wiley & Sons Ltd on behalf of BJU International.
Références
Sung H, Ferlay J, Siegel RL et al. Global cancer statistics 2020: GLOBOCAN estimates of incidence and mortality worldwide for 36 cancers in 185 countries. CA Cancer J Clin 2021; 71: 209-249
American Cancer Society, American Cancer Society | Cancer Facts & Statistics, American Cancer Society | Cancer Facts & Statistics, n.d. Available at: http://cancerstatisticscenter.cancer.org/. Accessed February 2023
Dizman N, Arslan ZE, Feng M, Pal SK. Sequencing therapies for metastatic renal cell carcinoma. Urol Clin N Am 2020; 47: 305-318
Lichtman SM, Harvey RD, Damiette Smit M-A et al. Modernizing clinical trial eligibility criteria: recommendations of the American Society of Clinical Oncology-Friends of Cancer Research organ dysfunction, prior or concurrent malignancy, and comorbidities working group. JCO 2017; 35: 3753-3759
Lin NU, Prowell T, Tan AR et al. Modernizing clinical trial eligibility criteria: recommendations of the American Society of Clinical Oncology-Friends of Cancer Research brain metastases working group. JCO 2017; 35: 3760-3773
Uldrick TS, Ison G, Rudek MA et al. Modernizing clinical trial eligibility criteria: recommendations of the American Society of Clinical Oncology-Friends of Cancer Research HIV working group. JCO 2017; 35: 3774-3780
Kim ES, Bruinooge SS, Roberts S et al. Broadening eligibility criteria to make clinical trials more representative: American Society of Clinical Oncology and Friends of Cancer Research Joint Research Statement. JCO 2017; 35: 3737-3744
Jin S, Pazdur R, Sridhara R. Re-evaluating eligibility criteria for oncology clinical trials: analysis of investigational new drug applications in 2015. JCO 2017; 35: 3745-3752
Motzer RJ, McDermott DF, Escudier B et al. Conditional survival and long-term efficacy with nivolumab plus ipilimumab versus sunitinib in patients with advanced renal cell carcinoma. Cancer 2022; 128: 2085-2097
Rini BI, Plimack ER, Stus V et al. Pembrolizumab (pembro) plus axitinib (axi) versus sunitinib as first-line therapy for advanced clear cell renal cell carcinoma (ccRCC): results from 42-month follow-up of KEYNOTE-426. JCO 2021; 39: 4500
Motzer RJ, Powles T, Burotto M et al. Nivolumab plus cabozantinib versus sunitinib in first-line treatment for advanced renal cell carcinoma (CheckMate 9ER): long-term follow-up results from an open-label, randomised, phase 3 trial. Lancet Oncol 2022; 23: 888-898
Choueiri TK, Eto M, Motzer R et al. Lenvatinib plus pembrolizumab versus sunitinib as first-line treatment of patients with advanced renal cell carcinoma (CLEAR): extended follow-up from the phase 3, randomised, open-label study. Lancet Oncol 2023; 24: 228-238
Zhu Z, Zhang Y, Wang H et al. Renal cell carcinoma associated with HIV/AIDS: a review of the epidemiology, risk factors, diagnosis, and treatment. Front Oncol 2022; 12: 872438
D'Jaen GA, Pantanowitz L, Bower M et al. Human immunodeficiency virus-associated primary lung cancer in the era of highly active antiretroviral therapy: a multi-institutional collaboration. Clin Lung Cancer 2010; 11: 396-404
Montoto S, Shaw K, Okosun J et al. HIV status does not influence outcome in patients with classical Hodgkin lymphoma treated with chemotherapy using doxorubicin, bleomycin, vinblastine, and dacarbazine in the highly active antiretroviral therapy era. J Clin Oncol 2012; 30: 4111-4116
Cook MR, Kim C. Safety and efficacy of immune checkpoint inhibitor therapy in patients with HIV infection and advanced-stage cancer: a systematic review. JAMA Oncol 2019; 5: 1049-1054
Uldrick TS, Gonçalves PH, Abdul-Hay M et al. Assessment of the safety of pembrolizumab in patients with HIV and advanced cancer-a phase 1 study. JAMA Oncol 2019; 5: 1332-1339
Kusumoto S, Arcaini L, Hong X et al. Risk of HBV reactivation in patients with B-cell lymphomas receiving obinutuzumab or rituximab immunochemotherapy. Blood 2019; 133: 137-146
Yoo S, Lee D, Shim JH et al. Risk of hepatitis B virus reactivation in patients treated with immunotherapy for anti-cancer treatment. Clin Gastroenterol Hepatol 2022; 20: 898-907
Zhang X, Zhou Y, Chen C et al. Hepatitis B virus reactivation in cancer patients with positive hepatitis B surface antigen undergoing PD-1 inhibition. J Immunother Cancer 2019; 7: 322
Shah NJ, Al-Shbool G, Blackburn M et al. Safety and efficacy of immune checkpoint inhibitors (ICIs) in cancer patients with HIV, hepatitis B, or hepatitis C viral infection. J Immunother Cancer 2019; 7: 353
Li B, Yan C, Zhu J et al. Anti-PD-1/PD-L1 blockade immunotherapy employed in treating hepatitis B virus infection-related advanced hepatocellular carcinoma: a literature review. Front Immunol 2020; 11: 1037
Arvanitis CD, Ferraro GB, Jain RK. The blood-brain barrier and blood-tumour barrier in brain tumours and metastases. Nat Rev Cancer 2020; 20: 26-41
Besse B, Lasserre SF, Compton P, Huang J, Augustus S, Rohr U-P. Bevacizumab safety in patients with central nervous system metastases. Clin Cancer Res 2010; 16: 269-278
Gore ME, Hariharan S, Porta C et al. Sunitinib in metastatic renal cell carcinoma patients with brain metastases. Cancer 2011; 117: 501-509
Tawbi HA, Forsyth PA, Hodi FS et al. Long-term outcomes of patients with active melanoma brain metastases treated with combination nivolumab plus ipilimumab (CheckMate 204): final results of an open-label, multicentre, phase 2 study. Lancet Oncol 2021; 22: 1692-1704
Long GV, Atkinson V, Lo S et al. Combination nivolumab and ipilimumab or nivolumab alone in melanoma brain metastases: a multicentre randomised phase 2 study. Lancet Oncol 2018; 19: 672-681
Tran TT, Jilaveanu LB, Omuro A, Chiang VL, Huttner A, Kluger HM. Complications associated with immunotherapy for brain metastases. Curr Opin Neurol 2019; 32: 907-916
Ebrahimi H, Castro DV, Feng MI et al. Examining exclusion criteria in advanced prostate cancer clinical trials: an assessment of recommendations from the American Society of Clinical Oncology and Friends of Cancer Research. Clin Genitourin Cancer 2023. https://doi.org/10.1016/j.clgc.2023.05.013
Zarif TE, Nassar AH, Adib E et al. Safety and activity of immune checkpoint inhibitors in people living with HIV and cancer: a real-world report from the Cancer Therapy using Checkpoint inhibitors in people living with HIV-International (CATCH-IT) consortium. JCO 2023; 41: 3712-3723