Immunotherapy with single agent nivolumab for advanced leiomyosarcoma of the uterus: Results of a phase 2 study

Cancer

Volumn 123, Issue 17, 2017, Pages 3285-3290

  Ben Ami, Eytan ^a   Barysauskas, Constance M ^a   Solomon, Sarah ^a   Tahlil, Kadija ^a   Malley, Rita ^a   Hohos, Melissa ^a   Polson, Kathleen ^a   Loucks, Margaret ^a   Severgnini, Mariano ^a   Patel, Tara ^a   Cunningham, Amy ^a   Rodig, Scott J ^a,b   Hodi, F Stephen ^a   Morgan, Jeffrey A ^a   Merriam, Priscilla ^a   Wagner, Andrew J ^a   Shapiro, Geoffrey I ^a,b   George, Suzanne ^a  

^a DANA FARBER CANCER INSTITUTE   (United States)

^b BRIGHAM AND WOMEN S HOSPITAL   (United States)

Author keywords

anti programmed death 1 (PD 1); immunotherapy; nivolumab; sarcoma; uterine leiomyosarcoma

Indexed keywords

AMYLASE; NIVOLUMAB; PROGRAMMED DEATH 1 LIGAND 1; PROGRAMMED DEATH 1 LIGAND 2; TRIACYLGLYCEROL LIPASE; MONOCLONAL ANTIBODY;

ABDOMINAL PAIN; ADULT; ADVANCED CANCER; AGED; AMYLASE BLOOD LEVEL; ARTICLE; CANCER GROWTH; CANCER IMMUNOTHERAPY; CLINICAL ARTICLE; COHORT ANALYSIS; CONTROLLED STUDY; DRUG EFFICACY; DRUG SAFETY; FATIGUE; FEMALE; HUMAN; MULTIPLE CYCLE TREATMENT; OVERALL SURVIVAL; PHASE 2 CLINICAL TRIAL; PHENOTYPE; PRIORITY JOURNAL; PROGRESSION FREE SURVIVAL; PROSPECTIVE STUDY; PROTEIN EXPRESSION; SIDE EFFECT; TREATMENT RESPONSE; TRIACYLGLYCEROL LIPASE BLOOD LEVEL; UTERUS SARCOMA; AGE; CANCER STAGING; CLINICAL TRIAL; DISEASE FREE SURVIVAL; DOSE RESPONSE; DRUG ADMINISTRATION; INTRAVENOUS DRUG ADMINISTRATION; KAPLAN MEIER METHOD; LEIOMYOSARCOMA; MIDDLE AGED; MORTALITY; PATHOLOGY; PROGNOSIS; RETROSPECTIVE STUDY; SURVIVAL ANALYSIS; TREATMENT OUTCOME; TUMOR INVASION; UTERINE NEOPLASMS;

ADULT; AGE FACTORS; AGED; ANTIBODIES, MONOCLONAL; ANTIBODIES, MONOCLONAL, HUMANIZED; COHORT STUDIES; DISEASE-FREE SURVIVAL; DOSE-RESPONSE RELATIONSHIP, DRUG; DRUG ADMINISTRATION SCHEDULE; FEMALE; HUMANS; INFUSIONS, INTRAVENOUS; KAPLAN-MEIER ESTIMATE; LEIOMYOSARCOMA; MIDDLE AGED; NEOPLASM INVASIVENESS; NEOPLASM STAGING; PROGNOSIS; RETROSPECTIVE STUDIES; SURVIVAL ANALYSIS; TREATMENT OUTCOME; UTERINE NEOPLASMS;

EID: 85018293668     PISSN: 0008543X     EISSN: 10970142     Source Type: Journal    
DOI: 10.1002/cncr.30738     Document Type: Article

References (36)

1. Jemal A, Siegel R, Ward E, et al. Cancer statistics, 2008. CA Cancer J Clin. 2008;58:71-96.
2. Zivanovic O, Leitao M, Lasonos A, Lindsay M, Jacks Q, Abu Rustum N. Stage-specific outcomes of patients with uterine leiomyosarcoma: a comparison of the International Federation of Gynecology and Obstetrics and American Joint Committee on Cancer Staging Systems. J Clin Oncol. 2009;27:2066-2072.
3. Echt G, Jepson J, Steel J, et al. Treatment of uterine sarcomas. Cancer. 1990;66:35-39.
4. Gadducci A, Landoni F, Sartori E, et al. Uterine leiomyosarcoma: analysis of treatment failures and survival. Gynecol Oncol. 1996;62:25-32.
5. Salazar OM, Bonfiglio TA, Patten SF, et al. Uterine sarcomas: natural history, treatment and prognosis. Cancer. 1978;42:1152-1160.
6. Dinh TA, Oliva EA, Fuller Jr AF, et al. The treatment of uterine leiomyosarcoma. Results from a 10-year experience (1990-1999) at the Massachusetts General Hospital. Gynecol Oncol. 2004;92:648-652.
7. Raut CP, Nucci MR, Wang Q, et al. Predictive value of FIGO and AJCC staging systems in patients with uterine leiomyosarcoma. Eur J Cancer. 2009;45:2818-2824.
8. Hensley ML, Blessing JA, Mannel R, et al. Fixed-dose rate gemcitabine plus docetaxel as first-line therapy for metastatic uterine leiomyosarcoma: a Gynecologic Oncology Group phase II trial. Gynecol Oncol. 2008;109:329-334.
9. Muss HB, Bundy B, DiSaia PJ, et al. Treatment of recurrent or advanced uterine sarcoma. A randomized trial of doxorubicin versus doxorubicin and cyclophosphamide (a phase III trial of the Gynecologic Oncology Group). Cancer. 1985;55:1648-1653.
10. van der Graaf WT, Blay JY, Chawla SP, et al. EORTC Soft Tissue and Bone Sarcoma Group. PALETTE study group Pazopanib for metastatic soft-tissue sarcoma (PALETTE): a randomized, double-blind, placebo-controlled phase 3 trial. Lancet. 2012;379:1879-1886.
11. Demetri GD, von Mehren M, Jones RL, et al. Efficacy and safety of trabectedin or dacarbazine for metastatic liposarcoma or leiomyosarcoma after failure of conventional chemotherapy: results of a phase III randomized multicenter clinical trial. J Clin Oncol. 2016;34:786-793.
12. Ganjoo KN, Witten D, Patel M, et al. The prognostic value of tumor-associated macrophages in leiomyosarcoma: a single institution study. Am J Clin Oncol. 2011;34:82-86.
13. Espinosa I, Beck AH, Lee CH, et al. Coordinate expression of colony-stimulating factor-1 and colony-stimulating factor-1-related proteins is associated with poor prognosis in gynecological leiomyosarcoma. Am J Pathol. 2009;174:2347-2356.
14. Robbins PF, Morgan RA, Feldman SA, et al. Tumor regression in patients with metastatic synovial cell sarcoma and melanoma using genetically engineered lymphocytes reactive with NY-ESO-1. J Clin Oncol. 2011;29:917-924.
15. Kim JR, Moon YJ, Kwon KS, et al. Tumor infiltrating PD1-positive lymphocytes and the expression of PD-L1 predict poor prognosis of soft tissue sarcomas. PLoS One. 2013;8:e82870.
16. Rodriguez PC, Quiceno DG, Ochoa AC. L-arginine availability regulates T-lymphocyte cell-cycle progression. Blood. 2007;109:1568-1573.
17. Nagaraj S, Gabrilovich DI. Myeloid-derived suppressor cells in human cancer. Cancer J. 2010;16:348-353.
18. Motzer RJ, Escudier B, McDermott DF, et al. Nivolumab versus everolimus in advanced renal-cell carcinoma. N Engl J Med. 2015;373:1803-1813.
19. Robert C, Long GV, Brady B, et al. Nivolumab in previously untreated melanoma without BRAF mutation. N Engl J Med. 2015;372:320-330.
20. Borghaei H, Paz-Ares L, Horn L, et al. Nivolumab versus docetaxel in advanced nonsquamous non-small-cell lung cancer. N Engl J Med. 2015;373:1627-1639.
21. Eisenhauera EA, Therasseb P, Bogaertsc J, et al. New response evaluation criteria in solid tumours: revised RECIST guideline (version 1.1). Eur J Cancer. 2009;45:228-247.
22. Reimann KA, Chernoff M, Wilkening CL, et al. Preservation of lymphocyte immunophenotype and proliferative responses in cryopreserved peripheral blood mononuclear cells from human immunodeficiency virus type 1-infected donors: implications for multicenter clinical trials. The ACTG Immunology Advanced Technology Laboratories. Clin Diagn Lab Immunol. 2000;7:352-359.
23. Powles T, Eder JP, Fine DG, et al. MPDL3280A (anti-PD-L1) treatment leads to clinical activity in metastatic bladder cancer. Nature. 2014;515:558-562.
24. Tawbi HA, Burgess MA, Crowley J, et al. Safety and efficacy of PD-1 blockade using pembrolizumab in patients with advanced soft tissue (STS) and bone sarcomas (BS): results of SARC028—a multicenter phase II study [abstract 11006]. J Clin Oncol. 2016;34(suppl):11006.
25. Cho YL, Bae S, Koo MS, et al. Array comparative genomic hybridization analysis of uterine leiomyosarcoma. Gynecol Oncol. 2005;99:545-551.
26. Anderson J, Gustafsson K, Himoudi N. Licensing of killer dendritic ceels in mouse and humans: functional similarities between IKDC and human blood γδ T-lymphocytes. J Immunotoxicol. 2012;9:259-266.
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:e65821.
28. Lastwika KJ, Wilson W 3rd, 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;76:227-238.
29. Garon EB, Rizvi NA, Hui R, et al. Pembrolizumab for the treatment of non-small-cell lung cancer. N Engl J Med. 2015;372:2018-2028.
30. Gandini S, Massi D, Mandala M. PD-L1 expression in cancer patients receiving anti PD-1/PD-L1 antibodies: a systematic review and meta-analysis. Crit Rev Oncol Hematol. 2016;100:88-98.
31. Taube JM, Klein A, Brahmer JR, et al. Association of PD-1, PD-1 ligands, and other features of the tumor immune microenvironment with response to anti-PD-1 therapy. Clin Cancer Res. 2014;20:5064-5074.
32. Santarpia M, Karachaliou N. Tumor immune microenvironment characterization and response to anti-PD-1 therapy. Cancer Biol Med. 2015;12:74-78.
33. Pardoll DM. The blockade of immune checkpoints in cancer immunotherapy. Nat Rev Cancer. 2012;12:252-64.
34. Postow MA, Chesney J, Pavlick AC, et al. Nivolumab and ipilimumab versus ipilimumab in untreated melanoma. N Engl J Med. 2015;372:2006-2017.
35. Larkin J, Chiarion-Sileni V, Gonzalez R, et al. Combined nivolumab and ipilimumab or monotherapy in untreated melanoma. N Engl J Med. 2015;373:23-43.
36. Miao D, Adeegbe D, Rodig SJ, et al. Response and oligoclonal resistance to pembrolizumab in uterine leiomyosarcoma: genomic, neoantigen, and immunohistochemical evaluation [abstract 11043]. J Clin Oncol. 2016;34(suppl):11043.