Phase II trial of pembrolizumab in patients with platinum refractory germ-cell tumors: A Hoosier Cancer Research Network Study GU14-206

Annals of Oncology

Volumn 29, Issue 1, 2018, Pages 209-214

  Adra, N ^a   Einhorn, L H ^a   Althouse, S K ^b   Ammakkanavar, N R ^a   Musapatika, D ^c   Albany, C ^a   Vaughn, D ^d   Hanna, N H ^a  

^a INDIANA UNIVERSITY SCHOOL OF MEDICINE   (United States)

^b INDIANA UNIVERSITY SCHOOL OF MEDICINE   (United States)

^c Hoosier Cancer Research Network   (United States)

^d UNIVERSITY OF PENNSYLVANIA   (United States)

Author keywords

Checkpoint inhibitors; Germ cell tumor; Immunotherapy; Pembrolizumab; Testicular cancer

Indexed keywords

ALPHA FETOPROTEIN; CHORIONIC GONADOTROPIN BETA SUBUNIT; PEMBROLIZUMAB; PROGRAMMED DEATH 1 LIGAND 1; ANTINEOPLASTIC AGENT; CISPLATIN; IMMUNOLOGICAL ANTINEOPLASTIC AGENT; MONOCLONAL ANTIBODY; TUMOR MARKER;

ABDOMINAL PAIN; ADULT; ANEMIA; ARTICLE; CANCER CHEMOTHERAPY; CANCER IMMUNOTHERAPY; CANCER RECURRENCE; CLINICAL ARTICLE; CONNECTIVE TISSUE DISEASE; CONSTIPATION; COUGHING; DIARRHEA; DISEASE SEVERITY; DRUG EFFICACY; DRUG RESPONSE; DRUG SAFETY; DRUG TOLERABILITY; DRUG WITHDRAWAL; DRY SKIN; DYSPNEA; FATIGUE; FLU LIKE SYNDROME; FOLLOW UP; HUMAN; HUMAN CELL; HUMAN TISSUE; HYPERGLYCEMIA; IMMUNOHISTOCHEMISTRY; LIVER METASTASIS; LUNG METASTASIS; LYMPH NODE METASTASIS; MALE; MEDIASTINUM; MEDIASTINUM TUMOR; MULTICENTER STUDY; MUSCULOSKELETAL DISEASE; NAUSEA; NON SEMINOMATOUS GERMINOMA; NONCARDIAC CHEST PAIN; OPEN STUDY; PARAAORTIC LYMPH NODE; PATIENT HISTORY OF CHEMOTHERAPY; PERIPHERAL EDEMA; PHASE 2 CLINICAL TRIAL; PRIORITY JOURNAL; SCIATICA; SOFT TISSUE DISEASE; TESTIS; TESTIS NONSEMINOMA CANCER; TUMOR CELL; TUMOR GROWTH; TUMOR LOCALIZATION; VOMITING; CLINICAL TRIAL; DRUG RESISTANCE; MIDDLE AGED; NEOPLASM; SALVAGE THERAPY; TESTIS TUMOR;

ADULT; ANTIBODIES, MONOCLONAL, HUMANIZED; ANTINEOPLASTIC AGENTS, IMMUNOLOGICAL; ANTINEOPLASTIC COMBINED CHEMOTHERAPY PROTOCOLS; BIOMARKERS, TUMOR; CISPLATIN; DRUG RESISTANCE, NEOPLASM; HUMANS; MALE; MIDDLE AGED; NEOPLASMS, GERM CELL AND EMBRYONAL; SALVAGE THERAPY; TESTICULAR NEOPLASMS;

EID: 85041191856     PISSN: 09237534     EISSN: 15698041     Source Type: Journal    
DOI: 10.1093/annonc/mdx680     Document Type: Article

References (28)

1. Hanna NH, Einhorn LH. Testicular cancer-discoveries and updates. N Engl J Med 2014; 371(21): 2005-2016.
2. Einhorn LH, Williams SD, Chamness A. High-dose chemotherapy and stem-cell rescue for metastatic germ-cell tumors. N Engl J Med 2007; 357(4): 340-348.
3. Feldman DR, Sheinfeld J, Bajorin DF et al. TI-CE high-dose chemotherapy for patients with previously treated germ cell tumors: results and prognostic factor analysis. J Clin Oncol 2010; 28: 1706-1713.
4. Kondagunta GV, Bacik J, Donadio A et al. Combination of paclitaxel, ifosfamide, and cisplatin is an effective second-line therapy for patients with relapsed testicular germ cell tumors. J Clin Oncol 2005; 23(27): 6549-6555.
5. Loehrer PJ Sr, Einhorn LH, Williams SD. VP-16 plus ifosfamide plus cisplatin as salvage therapy in refractory germ cell cancer. J Clin Oncol 1986; 4(4): 528-536.
6. Loehrer PJ Sr, Gonin R, Nichols CR et al. Vinblastine plus ifosfamide plus cisplatin as initial salvage therapy in recurrent germ cell tumor. J Clin Oncol 1998; 16(7): 2500-2504.
7. Murphy BR, Breeden ES, Donohue JP et al. Surgical salvage of chemorefractory germ cell tumors. J Clin Oncol 1993; 11(2): 324-329.
8. Bellmunt J, de Wit R, Vaughn DJ et al. Pembrolizumab as second-line therapy for advanced urothelial carcinoma. New England Journal of Medicine 2017; 376: 1015-1026.
9. Motzer RJ, Escudier B, McDermott DF et al. Nivolumab versus everolimus in advanced renal-cell carcinoma. N Engl J Med 2015; 373(19): 1803-1813.
10. Reck M, Rodriguez-Abreu D, Robinson AG et al. Pembrolizumab versus chemotherapy for PD-L1-positive non-small-cell lung cancer. N Engl J Med 2016; 375(19): 1823-1833.
11. Robert C, Long GV, Brady B et al. Nivolumab in previously untreatedmelanoma without BRAFmutation. N Engl JMed 2015; 372(4): 320-330.
12. Fankhauser CD, Curioni-Fontecedro A, Allmann V et al. Frequent PD-L1 expression in testicular germ cell tumors. Br J Cancer 2015; 113(3): 411-413.
13. Cierna Z, Mego M, Miskovska V et al. Prognostic value of programmeddeath-1 receptor (PD-1) and its ligand 1 (PD-L1) in testicular germ cell tumors. Ann Oncol 2016; 27(2): 300-305.
14. Zschäbitz S, Lasitschka F, Jäger D, Grüllich C. Activity of immune checkpoint inhibition in platinum refractory germ-cell tumors. Ann Oncol 2016; 27(7): 1356-1360.
15. Eisenhauer EA, Therasse P, Bogaerts J et al. New response evaluation criteria in solid tumours: revised RECIST guideline (version 1.1). Eur J Cancer 2009; 45(2): 228-247.
16. Wolchok JD, Hoos A, O'Day S et al. Guidelines for the evaluation of immune therapy activity in solid tumors: immune-related response criteria. Clin Cancer Res 2009; 15(23): 7412-7420.
17. Simon R. Optimal two-stage designs for phase II clinical trials. Control Clin Trials 1989; 10(1): 1-10.
18. Ko JJ, Bernard B, Tran B et al. Conditional survival of patients with metastatic testicular germ cell tumors treated with first-line curative therapy. J Clin Oncol 2016; 34(7): 714-720.
19. Adra N, Ku K, Kalra M et al. Survival outcomes of patients with metastatic germ cell tumor (mGCT) treated from 1998 to 2012: the Indiana University (IU) experience. J Clin Oncol 2016; 34(Suppl 2S; abstr): 491.
20. Adra N, Abonour R, Althouse SK et al. High-dose chemotherapy and autologous peripheral-blood stem-cell transplantation for relapsed metastatic germ cell tumors: the Indiana University experience. J Clin Oncol 2016; 35: 1096-1102.
21. Cary C, Pedrosa JA, Jacob J et al. Outcomes of postchemotherapy retroperitoneal lymph node dissection following high-dose chemotherapy with stem cell transplantation. Cancer 2015; 121(24): 4369-4375.
22. Kollmannsberger C, Preßler H, Mayer F et al. Cisplatin-refractory, HER2/ neu-expressing germ-cell cancer: induction of remission by the monoclonal antibody Trastuzumab. Ann Oncol 1999; 10(11): 1393-1394.
23. Rick O, Braun T, Siegert W, Beyer J. Activity of thalidomide in patients with platinum-refractory germ-cell tumours. Eur J Cancer 2006; 42(12): 1775-1779.
24. Feldman DR, Turkula S, Ginsberg MS et al. Phase II trial of sunitinib in patients with relapsed or refractory germ cell tumors. Invest New Drugs 2010; 28(4): 523-528.
25. Einhorn LH, Brames MJ, Heinrich MC et al. Phase II study of imatinib mesylate in chemotherapy refractory germ cell tumors expressing KIT. Am J Clin Oncol 2006; 29(1): 12-13.
26. Necchi A, Lo Vullo S, Giannatempo P et al. Pazopanib in advanced germ cell tumors after chemotherapy failure: results of the openlabel, single-arm, phase 2 Pazotest trial. Ann Oncol 2017; 28(6): 1346-1351.
27. Song M, Chen D, Lu B et al. PTEN loss increases PD-L1 protein expression and affects the correlation between PD-L1 expression and clinical parameters in colorectal cancer. PLoS One 2013; 8(6): e65821.
28. Lastwika KJ, Wilson W III, Li QK et al. Control of PD-L1 expression by oncogenic activation of the AKT-mTOR pathway in non-small cell lung cancer. Cancer Res 2016; 76(2): 227-238.