nach oben

Investigational New Drugs

Erschienen in:

08.10.2018 | SHORT REPORT

Safety and efficacy of immune checkpoint inhibitors for end-stage renal disease patients undergoing dialysis: a retrospective case series and literature review

verfasst von: Hyeon Cheun, Miso Kim, Hajeong Lee, Kook-Hwan Oh, Bhumsuk Keam

Erschienen in: Investigational New Drugs | Ausgabe 3/2019

Einloggen, um Zugang zu erhalten

Summary

Despite the lack of safety and efficacy data regarding immune checkpoint inhibitors (ICIs) for renal dysfunction, they have been approved to treat even in the patients with end-stage renal disease (ESRD). We report our experience with ICI administration to three ESRD patients undergoing hemodialysis. One of the patients had a partial response for several months; however, the other patients had a stable disease while undergoing dialysis. The toxicity was tolerable; however, one patient developed grade 2 pneumonitis. A literature review of other rarely reported cases of hemodialysis revealed that 10 out of 13 patients had a partial response or complete response; in addition, grade 3 or grade 4 immune-related adverse events occurred in 3 patients. ESRD combined with dialysis may not be a contraindication for the use of ICIs. ICIs can be beneficial to ESRD patients undergoing dialysis. However, caution is needed regarding immune-related adverse events. Further prospective studies involving pharmacokinetic analyses are necessary to obtain reliable safety and efficacy data.

Motzer RJ, Escudier B, McDermott DF et al (2015) Nivolumab versus Everolimus in advanced renal-cell carcinoma. N Engl J Med 373:1803–1813. https://doi.org/10.1056/NEJMoa1510665 CrossRefPubMedPubMedCentral

Bellmunt J, de Wit R, Vaughn DJ, Fradet Y, Lee JL, Fong L, Vogelzang NJ, Climent MA, Petrylak DP, Choueiri TK, Necchi A, Gerritsen W, Gurney H, Quinn DI, Culine S, Sternberg CN, Mai Y, Poehlein CH, Perini RF, Bajorin DF (2017) Pembrolizumab as second-line therapy for advanced Urothelial carcinoma. N Engl J Med 376:1015–1026. https://doi.org/10.1056/NEJMoa1613683 CrossRefPubMedPubMedCentral

Reck M, Rodríguez-Abreu D, Robinson AG, Hui R, Csőszi T, Fülöp A, Gottfried M, Peled N, Tafreshi A, Cuffe S, O’Brien M, Rao S, Hotta K, Leiby MA, Lubiniecki GM, Shentu Y, Rangwala R, Brahmer JR (2016) Pembrolizumab versus chemotherapy for PD-L1-positive non-small-cell lung Cancer. N Engl J Med 375:1823–1833. https://doi.org/10.1056/NEJMoa1606774 CrossRefPubMed

Kim ES, Bruinooge SS, Roberts S, Ison G, Lin NU, Gore L, Uldrick TS, Lichtman SM, Roach N, Beaver JA, Sridhara R, Hesketh PJ, Denicoff AM, Garrett-Mayer E, Rubin E, Multani P, Prowell TM, Schenkel C, Kozak M, Allen J, Sigal E, Schilsky RL (2017) Broadening eligibility criteria to make clinical trials more representative: American Society of Clinical Oncology and friends of Cancer research joint research statement. J Clin Oncol Off J Am Soc Clin Oncol 35:3737–3744. https://doi.org/10.1200/JCO.2017.73.7916 CrossRef

Yoo SH, Keam B, Kim M, Kim TM, Kim DW, Heo DS (2018) Generalization and representativeness of phase III immune checkpoint blockade trials in non-small cell lung cancer. Thorac Cancer 9:736–744. https://doi.org/10.1111/1759-7714.12641 CrossRefPubMedPubMedCentral

Donia M, Kimper-Karl ML, Høyer KL, Bastholt L, Schmidt H, Svane IM (1990) (2017) the majority of patients with metastatic melanoma are not represented in pivotal phase III immunotherapy trials. Eur J Cancer Oxf Engl 74:89–95. https://doi.org/10.1016/j.ejca.2016.12.017 CrossRef

Janus N, Launay-Vacher V (2015) Anticancer drugs in end-stage kidney disease patients. Semin Dial 28:413–416. https://doi.org/10.1111/sdi.12371 CrossRefPubMed

Seymour L, Bogaerts J, Perrone A, Ford R, Schwartz LH, Mandrekar S, Lin NU, Litière S, Dancey J, Chen A, Hodi FS, Therasse P, Hoekstra OS, Shankar LK, Wolchok JD, Ballinger M, Caramella C, de Vries EGE (2017) iRECIST: guidelines for response criteria for use in trials testing immunotherapeutics. Lancet Oncol 18:e143–e152. https://doi.org/10.1016/S1470-2045(17)30074-8 CrossRefPubMedPubMedCentral

Kato S, Chmielewski M, Honda H, Pecoits-Filho R, Matsuo S, Yuzawa Y, Tranaeus A, Stenvinkel P, Lindholm B (2008) Aspects of immune dysfunction in end-stage renal disease. Clin J Am Soc Nephrol CJASN 3:1526–1533. https://doi.org/10.2215/CJN.00950208 CrossRefPubMed

10.

Naidoo J, Wang X, Woo KM, Iyriboz T, Halpenny D, Cunningham J, Chaft JE, Segal NH, Callahan MK, Lesokhin AM, Rosenberg J, Voss MH, Rudin CM, Rizvi H, Hou X, Rodriguez K, Albano M, Gordon RA, Leduc C, Rekhtman N, Harris B, Menzies AM, Guminski AD, Carlino MS, Kong BY, Wolchok JD, Postow MA, Long GV, Hellmann MD (2017) Pneumonitis in patients treated with anti-programmed Death-1/programmed death ligand 1 therapy. J Clin Oncol Off J Am Soc Clin Oncol 35:709–717. https://doi.org/10.1200/JCO.2016.68.2005 CrossRef

11.

Opdivo (nivolumab) injection label by FDA (available at https://www.accessdata.fda.gov)

12.

Yervoy (ipilimumab) injection label by FDA (available at https://www.accessdata.fda.gov)

13.

Keytruda (pembrolizumab) injection label by FDA (available at https://www.accessdata.fda.gov)

14.

Tecentriq (atezolizumab) injection label by FDA (available at https://www.accessdata.fda.gov)

15.

2013-Dialysis-Drugs.pdf (available at https://homedialyzorsunited.org)

16.

Nakauchi H, Okumura K, Tango T (1981) Immunoglobulin levels in patients on long-term hemodialysis. N Engl J Med 305:172–173. https://doi.org/10.1056/NEJM198107163050320 CrossRefPubMed

17.

Jillella AP, Dainer PM, Kallab AM, Ustun C (2002) Treatment of a patient with end-stage renal disease with rituximab: pharmacokinetic evaluation suggests rituximab is not eliminated by hemodialysis. Am J Hematol 71:219–222. https://doi.org/10.1002/ajh.10213 CrossRefPubMed

18.

Postel-Vinay S, Aspeslagh S, Lanoy E, Robert C, Soria JC, Marabelle A (2016) Challenges of phase 1 clinical trials evaluating immune checkpoint-targeted antibodies. Ann Oncol Off J Eur Soc Med Oncol 27:214–224. https://doi.org/10.1093/annonc/mdv550 CrossRef

19.

Balar AV, Galsky MD, Rosenberg JE, Powles T, Petrylak DP, Bellmunt J, Loriot Y, Necchi A, Hoffman-Censits J, Perez-Gracia JL, Dawson NA, van der Heijden MS, Dreicer R, Srinivas S, Retz MM, Joseph RW, Drakaki A, Vaishampayan UN, Sridhar SS, Quinn DI, Durán I, Shaffer DR, Eigl BJ, Grivas PD, Yu EY, Li S, Kadel EE III, Boyd Z, Bourgon R, Hegde PS, Mariathasan S, Thåström AC, Abidoye OO, Fine GD, Bajorin DF (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 Lond Engl 389:67–76. https://doi.org/10.1016/S0140-6736(16)32455-2 CrossRef

20.

Bajaj G, Wang X, Agrawal S, Gupta M, Roy A, Feng Y (2017) Model-based population pharmacokinetic analysis of Nivolumab in patients with solid tumors. CPT Pharmacomet Syst Pharmacol 6:58–66. https://doi.org/10.1002/psp4.12143 CrossRef

21.

Cavalcante L, Amin A, Lutzky J (2015) Ipilimumab was safe and effective in two patients with metastatic melanoma and end-stage renal disease. Cancer Manag Res 7:47–50. https://doi.org/10.2147/CMAR.S73389 CrossRefPubMedPubMedCentral

22.

Chang R, Shirai K (2016) Safety and efficacy of pembrolizumab in a patient with advanced melanoma on haemodialysis. BMJ Case Rep 2016: pii: bcr2016216426. doi: https://doi.org/10.1136/bcr-2016-216426

23.

Carlo MI, Feldman DR (2016) Response to Nivolumab in a patient with metastatic clear cell renal cell carcinoma and end-stage renal disease on Dialysis. Eur Urol 70:1082–1083. https://doi.org/10.1016/j.eururo.2016.05.040 CrossRefPubMedPubMedCentral

24.

Tabei T, Natsume I, Kobayashi K (2017) Successful treatment of metastatic clear cell carcinoma with nivolumab in a patient receiving dialysis treatment. Int J Urol Off J Jpn Urol Assoc 24:708–710. https://doi.org/10.1111/iju.13420 CrossRef

25.

Ansari J, Ali M, Farrag A, Ali AM, Alhamad A (2018) Efficacy of Nivolumab in a patient with metastatic renal cell carcinoma and end-stage renal disease on Dialysis: case report and literature review. Case Rep Immunol 2018:1623957–1623954. https://doi.org/10.1155/2018/1623957 CrossRef

26.

Park S, Daniels GA (2017) Anti-PD-1 therapy in patients with end-stage renal disease on dialysis: a single-center case series. J Clin Oncol 35:e14553–e14553. https://doi.org/10.1200/JCO.2017.35.15_suppl.e14553 CrossRef

Titel: Safety and efficacy of immune checkpoint inhibitors for end-stage renal disease patients undergoing dialysis: a retrospective case series and literature review
verfasst von: Hyeon Cheun
Miso Kim
Hajeong Lee
Kook-Hwan Oh
Bhumsuk Keam
Publikationsdatum: 08.10.2018
Verlag: Springer US
Erschienen in: Investigational New Drugs / Ausgabe 3/2019
Print ISSN: 0167-6997
Elektronische ISSN: 1573-0646
DOI: https://doi.org/10.1007/s10637-018-0673-y

Neu im Fachgebiet Onkologie

16.04.2024 | Maligne primäre ZNS-Tumoren | Nachrichten

Springer Medizin

Safety and efficacy of immune checkpoint inhibitors for end-stage renal disease patients undergoing dialysis: a retrospective case series and literature review

Summary

Neu im Fachgebiet Onkologie

Manche Gestagene können das Risiko für Meningeome erhöhen

Einladung zum PSA-Screening senkt die Krebssterblichkeit

Chemotherapie mit Hindernissen

Das Ende der vollständigen axillären Lymphknotendissektion

Update Onkologie

Springer Medizin

Summary

Bitte loggen Sie sich ein, um Zugang zu diesem Inhalt zu erhalten

Weitere Artikel der Ausgabe 3/2019

The metronomic all-oral DEVEC is an effective schedule in elderly patients with diffuse large b-cell lymphoma

Chemosensitivity of various peritoneal cancer cell lines to HIPEC and PIPAC: comparison of an experimental duplex drug to standard drug regimens in vitro

Hand-foot-skin reaction of grade ≥ 2 within sixty days as the optimal clinical marker best help predict survival in sorafenib therapy for HCC

A natural compound derivative P-13 inhibits STAT3 signaling by covalently inhibiting Janus kinase 2

Clinical outcomes of patients with G1/G2 neuroendocrine tumors arising from foregut or hindgut treated with somatostatin analogs: a retrospective study

Correction to: Eribulin, trastuzumab, and pertuzumab as first-line therapy for patients with HER2-positive metastatic breast cancer: a phase II, multicenter, collaborative, open-label, single-arm clinical trial

Neu im Fachgebiet Onkologie

Manche Gestagene können das Risiko für Meningeome erhöhen

Einladung zum PSA-Screening senkt die Krebssterblichkeit

Chemotherapie mit Hindernissen

Das Ende der vollständigen axillären Lymphknotendissektion

Update Onkologie