Inmunoterapia en urología: principios e indicaciones

Rouprêt, 2020, Recommandations françaises du Comité de cancérologie de l’AFU – actualisation 2020-2022 9/17/2021: tumeurs de la vessie, Prog Urol, 30, S78, 10.1016/S1166-7087(20)30751-X Kantoff, 2010, Sipuleucel-T immunotherapy for castration-resistant prostate cancer, N Engl J Med, 363, 411, 10.1056/NEJMoa1001294 Carosella, 2015, A systematic review of immunotherapy in urologic cancer: evolving roles for targeting of CTLA-4, PD-1/PD-L1, and HLA-G, Eur Urol, 68, 267, 10.1016/j.eururo.2015.02.032 Alexandrov, 2013, Signatures of mutational processes in human cancer, Nature, 500, 415, 10.1038/nature12477 Motzer, 2018, Nivolumab plus ipilimumab versus sunitinib in advanced renal-cell carcinoma, N Engl J Med, 10.1056/NEJMoa1712126 Fyfe, 1995, Results of treatment of 255 patients with metastatic renal cell carcinoma who received high-dose recombinant interleukin-2 therapy, J Clin Oncol, 13, 688, 10.1200/JCO.1995.13.3.688 Klapper, 2008, High-dose interleukin-2 for the treatment of metastatic renal cell carcinoma: a retrospective analysis of response and survival in patients treated in the surgery branch at the National Cancer Institute between 1986 and 2006, Cancer, 113, 293, 10.1002/cncr.23552 Motzer, 2007, Sunitinib versus interferon alfa in metastatic renal-cell carcinoma, N Engl JMed, 356, 115, 10.1056/NEJMoa065044 Motzer, 2015, Nivolumab versus everolimus in advanced renal-cell carcinoma, N Engl J Med, 373, 1803, 10.1056/NEJMoa1510665 Albiges, 2020, Nivolumab plus ipilimumab versus sunitinib for first-line treatment of advanced renal cell carcinoma: extended 4-year follow-up of the phase III CheckMate 214 trial, ESMO Open, 5, e001079, 10.1136/esmoopen-2020-001079 Rini, 2019, Pembrolizumab plus axitinib versus sunitinib for advanced renal-cell carcinoma, N Engl J Med, 380, 1116, 10.1056/NEJMoa1816714 Rini, 2019, Atezolizumab plus bevacizumab versus sunitinib in patients with previously untreated metastatic renal cell carcinoma (IMmotion151): a multicentre, open-label, phase 3, randomised controlled trial, Lancet, 393, 2404, 10.1016/S0140-6736(19)30723-8 Choueiri, 2021, Nivolumab plus cabozantinib versus sunitinib for advanced renal-cell carcinoma, N Engl JMed, 384, 829, 10.1056/NEJMoa2026982 Motzer, 2021, Lenvatinib plus pembrolizumab or everolimus for advanced renal cell carcinoma, N Engl J Med, 10.1056/NEJMoa2035716 Powles, 2020, Pembrolizumab plus axitinib versus sunitinib monotherapy as first-line treatment of advanced renal cell carcinoma (KEYNOTE-426): extended follow-up from a randomised, open-label, phase 3 trial, Lancet Oncol, 21, 1563, 10.1016/S1470-2045(20)30436-8 Motzer, 2019, Nivolumab plus ipilimumab versus sunitinib in first-line treatment for advanced renal cell carcinoma: extended followup of efficacy and safety results from a randomised, controlled, phase 3 trial, Lancet Oncol, 20, 1370, 10.1016/S1470-2045(19)30413-9 Motzer, 2019, Avelumab plus axitinib versus sunitinib for advanced renal-cell carcinoma, N Engl J Med, 380, 1103, 10.1056/NEJMoa1816047 Choueiri, 2020, Updated efficacy results from the JAVELIN Renal 101 trial: first-line avelumab plus axitinib versus sunitinib in patients with advanced renal cell carcinoma, Ann Oncol, 31, 1030, 10.1016/j.annonc.2020.04.010 Choueiri, 2021, Adjuvant pembrolizumab after nephrectomy in renal-cell carcinoma, N Engl J Med, 385, 683, 10.1056/NEJMoa2106391 Choueiri, 2020, Updated efficacy results from the JAVELIN Renal 101 trial: first-line avelumab plus axitinib versus sunitinib in patients with advanced renal cell carcinoma, Ann Oncol [Internet], 393 Tannir, 2021, Efficacy and safety of nivolumab plus ipilimumab versus sunitinib in first-line treatment of patients with advanced sarcomatoid renal cell carcinoma, Clin Cancer Res, 27, 78, 10.1158/1078-0432.CCR-20-2063 Rini, 2019, Pembrolizumab (pembro) plus axitinib (axi) versus sunitinib as first-line therapy for metastatic renal cell carcinoma (mRCC): outcomes in the combined IMDC intermediate/poor risk and sarcomatoid subgroups of the phase 3 KEYNOTE-426 study, J Clin Oncol, 37 Choueiri, 2021, Efficacy and correlative analyses of avelumab plus axitinib versus sunitinib in sarcomatoid renal cell carcinoma: post hoc analysis of a randomized clinical trial, ESMO Open, 6, 100101, 10.1016/j.esmoop.2021.100101 Vano, 2020 de Vries-Brilland, 2020, Are immune checkpoint inhibitors a valid option for papillary renal cell carcinoma?. A multicentre retrospective study, Eur J Cancer, 136, 76, 10.1016/j.ejca.2020.02.019 Vogelzang, 2020, Safety and efficacy of nivolumab in patients with advanced non-clear cell renal cell carcinoma: results from the phase IIIb/IV CheckMate 374 Study, Clin Genitourin Cancer, 18, 461, 10.1016/j.clgc.2020.05.006 McDermott, 2021, Open-label, single-arm, phase II study of pembrolizumab monotherapy as first-line therapy in patients with advanced non-clear cell renal cell carcinoma, J Clin Oncol, 39, 1029, 10.1200/JCO.20.02365 Bellmunt, 2017, Pembrolizumab as second-line therapy for advanced urothelial carcinoma, N Engl J Med, 376, 1015, 10.1056/NEJMoa1613683 Powles, 2020, Avelumab maintenance therapy for advanced or metastatic urothelial carcinoma, N Engl J Med, 383, 1218, 10.1056/NEJMoa2002788 Galsky, 2020, Atezolizumab with or without chemotherapy in metastatic urothelial cancer (IMvigor130): a multicentre, randomised, placebo–controlled phase 3 trial, Lancet, 395, 1547, 10.1016/S0140-6736(20)30230-0 Powles, 2021, Pembrolizumab alone or combined with chemotherapy versus chemotherapy as first-line therapy for advanced urothelial carcinoma (KEYNOTE-361): a randomised, open-label, phase 3 trial, Lancet Oncol, 22, 931, 10.1016/S1470-2045(21)00152-2 Powles, 2020, Durvalumab alone and durvalumab plus tremelimumab versus chemotherapy in previously untreated patients with unresectable, locally advanced or metastatic urothelial carcinoma (DANUBE): a randomised, open-label, multicentre, phase 3 trial, Lancet Oncol, 21, 1574, 10.1016/S1470-2045(20)30541-6 Powles, 2018, Atezolizumab versus chemotherapy in patients with platinum-treated locally advanced or metastatic urothelial carcinoma (IMvigor211): a multicentre, open-label, phase 3 randomised controlled trial, Lancet, 391, 748, 10.1016/S0140-6736(17)33297-X Fradet, 2019, Randomized phase III KEYNOTE-045 trial of pembrolizumab versus paclitaxel, docetaxel, or vinflunine in recurrent advanced urothelial cancer: results of >2 years of follow-up, Ann Oncol, 30, 970, 10.1093/annonc/mdz127 Rosenberg, 2016, Atezolizumab in patients with locally advanced and metastatic urothelial carcinoma who have progressed following treatment with platinum-based chemotherapy: a single-arm, multicentre, phase 2 trial, Lancet, 387, 1909, 10.1016/S0140-6736(16)00561-4 Robertson, 2017, Comprehensive molecular characterization of muscle-invasive bladder cancer, Cell, 171, 540, 10.1016/j.cell.2017.09.007 Kim, 2019, The Cancer Genome Atlas expression subtypes stratify response to checkpoint inhibition in advanced urothelial cancer and identify a subset of patients with high survival probability, Eur Urol, 75, 961, 10.1016/j.eururo.2019.02.017 Balar, 2017, Atezolizumab as first-line treatment in cisplatin-ineligible patients with locally advanced and metastatic urothelial carcinoma: a single-arm, multicentre, phase 2 trial, Lancet, 389, 67, 10.1016/S0140-6736(16)32455-2 Balar, 2017, First-line pembrolizumab in cisplatin-ineligible patients with locally advanced and unresectable or metastatic urothelial cancer (KEYNOTE-052): a multicentre, single-arm, phase 2 study, Lancet Oncol, 18, 1483, 10.1016/S1470-2045(17)30616-2 Sharma, 2020, Efficacy and tolerability of tremelimumab in locally advanced or metastatic urothelial carcinoma patients who have failed first-line platinum-based chemotherapy, Clin Cancer Res, 26, 61, 10.1158/1078-0432.CCR-19-1635 Sharma, 2019, Nivolumab alone and with ipilimumab in previously treated metastatic urothelial carcinoma: Checkmate 032 nivolumab 1 mg/kg plus ipilimumab 3 mg/kg expansion cohort results, JCO, 37, 1608, 10.1200/JCO.19.00538 Harper, 2017, Upper tract urothelial carcinomas: frequency of association with mismatch repair protein loss and lynch syndrome, Mod Pathol, 30, 146, 10.1038/modpathol.2016.171 Necchi, 2020, Comprehensive genomic profiling of upper-tract and bladder urothelial carcinoma, Eur Urol Focus, S2405–4569, 30214 Necchi, 2020, Comprehensive assessment of immuno-oncology biomarkers in adenocarcinoma, urothelial carcinoma, and squamous-cell carcinoma of the bladder, Eur Urol, 77, 548, 10.1016/j.eururo.2020.01.003 Le, 2015, PD-1 blockade in tumors with mismatch-repair deficiency, N Engl J Med, 372, 2509, 10.1056/NEJMoa1500596 Iyer, 2017, Mismatch repair (MMR) detection in urothelial carcinoma (UC) and correlation with immune checkpoint blockade (ICB) response, JCO, 35, 4511, 10.1200/JCO.2017.35.15_suppl.4511 Necchi, 2018, Pembrolizumab as neoadjuvant therapy before radical cystectomy in patients with muscle-invasive urothelial bladder carcinoma (PURE-01): an open-label, single-arm, phase II study, JCO, 36, 3353, 10.1200/JCO.18.01148 Powles, 2019, Clinical efficacy and biomarker analysis of neoadjuvant atezolizumab in operable urothelial carcinoma in the ABACUS trial, Nat Med, 25, 1706, 10.1038/s41591-019-0628-7 van Dijk, 2020, Preoperative ipilimumab plus nivolumab in locoregionally advanced urothelial cancer: the NABUCCO trial, Nat Med, 26, 1839, 10.1038/s41591-020-1085-z Gao, 2020, Neoadjuvant PD-L1 plus CTLA-4 blockade in patients with cisplatin-ineligible operable high-risk urothelial carcinoma, Nat Med, 26, 1845, 10.1038/s41591-020-1086-y Bandini, 2020, Does the administration of preoperative pembrolizumab lead to sustained remission post-cystectomy? First survival outcomes from the PURE-01 study, Ann Oncol, 31, 1755, 10.1016/j.annonc.2020.09.011 Necchi, 2020, Updated results of PURE-01 with preliminary activity of neoadjuvant pembrolizumab in patients with muscle-invasive bladder carcinoma with variant histologies, Eur Urol, 77, 439, 10.1016/j.eururo.2019.10.026 Pfister, 2021, Eur Urol, 79, 214, 10.1016/j.eururo.2020.08.024 Kaimakliotis, 2019, Pd52-03 a multicenter phase 1b/2 study of neoadjuvant pembrolizumab and cisplatin chemotherapy for muscle invasive urothelial cancer, J Urol, 201, e924 Cathomas, 2020, Perioperative chemoimmunotherapy with durvalumab (Durva) in combination with cisplatin/gemcitabine (Cis/Gem) for operable muscle-invasive urothelial carcinoma (MIUC): Preplanned interim analysis of a single-arm phase II trial (SAKK 06/17), JCO, 38, 499, 10.1200/JCO.2020.38.6_suppl.499 Gupta, 2020, Results from BLASST-1 (Bladder Cancer Signal Seeking Trial) of nivolumab, gemcitabine, and cisplatin in muscle invasive bladder cancer (MIBC) undergoing cystectomy, JCO, 38, 439, 10.1200/JCO.2020.38.6_suppl.439 Bajorin, 2021, Adjuvant nivolumab versus placebo in muscle-invasive urothelial carcinoma, N Engl J Med, 384, 2102, 10.1056/NEJMoa2034442 Chou, 2017, Intravesical therapy for the treatment of nonmuscle invasive bladder cancer: a systematic review and meta-analysis, J Urol, 197, 1189, 10.1016/j.juro.2016.12.090 Pettenati, 2018, Mechanisms of BCG immunotherapy and its outlook for bladder cancer, Nat Rev Urol, 15, 615, 10.1038/s41585-018-0055-4 Balar, 2020, Pembrolizumab (pembro) for the treatment of patients with Bacillus Calmette-Guérin (BCG) unresponsive, high-risk (HR) nonmuscle-invasive bladder cancer (NMIBC): over two years follow-up of KEYNOTE-057, JCO, 38, 5041, 10.1200/JCO.2020.38.15_suppl.5041 Beer, 2016, Randomized, double-blind, phase III trial of ipilimumab versus placebo in asymptomatic or minimally symptomatic patients with metastatic chemotherapy-naive castration-resistant prostate cancer, JCO, 35, 40, 10.1200/JCO.2016.69.1584 Kwon, 2014, Ipilimumab versus placebo after radiotherapy in patients with metastatic castration-resistant prostate cancer that had progressed after docetaxel chemotherapy (CA184-043): a multicentre, randomised, double-blind, phase 3 trial, Lancet Oncol, 15, 700, 10.1016/S1470-2045(14)70189-5 Cabel, 2017, Long-term complete remission with ipilimumab in metastatic castrateresistant prostate cancer: case report of two patients, J Immunother Cancer, 5, 31, 10.1186/s40425-017-0232-7 Fizazi, 2020, Final analysis of the ipilimumab versus placebo following radiotherapy phase III trial in postdocetaxel metastatic castration-resistant prostate cancer identifies an excess of long-term survivors, Eur Urol, 78, 822, 10.1016/j.eururo.2020.07.032 Antonarakis, 2019, Pembrolizumab for treatment-refractory metastatic castration-resistant prostate cancer: multicohort, open-label phase II KEYNOTE-199 Study, JCO, 38, 395, 10.1200/JCO.19.01638 Hansen, 2018, Pembrolizumab for advanced prostate adenocarcinoma: findings of the KEYNOTE-028 study, Ann Oncol, 29, 1807, 10.1093/annonc/mdy232 Sharma, 2020, Nivolumab plus ipilimumab for metastatic castration-resistant prostate cancer: preliminary analysis of patients in the CheckMate 650 Trial, Cancer Cell, 38, 489, 10.1016/j.ccell.2020.08.007 Ritch, 2020, Identification of hypermutation and defective mismatch repair in ctDNA from metastatic prostate cancer, Clin Cancer Res, 26, 1114, 10.1158/1078-0432.CCR-19-1623 Abida, 2019, Analysis of the prevalence of microsatellite instability in prostate cancer and response to immune checkpoint blockade, JAMA Oncol, 5, 471, 10.1001/jamaoncol.2018.5801 Barata, 2020, Clinical activity of pembrolizumab in metastatic prostate cancer with microsatellite instability high (MSI-H) detected by circulating tumor DNA, J Immunother Cancer, 8, e001065, 10.1136/jitc-2020-001065 Antonarakis, 2019, Clinical features and therapeutic outcomes in men with advanced prostate cancer and DNA mismatch repair gene mutations, Eur Urol, 75, 378, 10.1016/j.eururo.2018.10.009 Graham, 2020, Mismatch repair deficiency in metastatic prostate cancer: response to PD-1 blockade and standard therapies, PLoS One, 15, e0233260, 10.1371/journal.pone.0233260 Wu, 2018, Inactivation of CDK12 delineates a distinct immunogenic class of advanced prostate cancer, Cell, 173, 1770, 10.1016/j.cell.2018.04.034 Schweizer, 2020, CDK12-mutated prostate cancer: clinical outcomes with standard therapies and immune checkpoint blockade, JCO Precis Oncol, 4, 382, 10.1200/PO.19.00383 Antonarakis, 2020, CDK12-altered prostate cancer: clinical features and therapeutic outcomes to standard systemic therapies, poly (ADP-Ribose) polymerase inhibitors, and PD-1 inhibitors, JCO Precis Oncol, 4, 370, 10.1200/PO.19.00399