title: A Pilot Study of Preoperative Single-Dose Ipilimumab and/or Cryoablation in Women with Early-Stage Breast Cancer with Comprehensive Immune Profiling.
abstract: OBJECTIVE
  To assess the safety and tolerability of preoperative cryoablation-mediated tumor antigen presentation and/or ipilimumab-mediated immune modulation in women with operable breast cancer.
  
  
  METHODS
  In this pilot study, 19 women with breast cancer for whom mastectomy was planned were treated with preoperative tumor cryoablation (n = 7), single-dose ipilimumab at 10 mg/kg (n = 6), or both (n = 6). The primary outcome for this pilot study was safety/tolerability as defined as freedom from delays in pre-planned, curative-intent mastectomy. Exploratory studies of immune activation were performed on peripheral blood and tumor.
  
  
  RESULTS
  Preoperative cryoablation and/or ipilimumab were safe and tolerable, with no delays in pre-planned surgery. Grade III toxicity was seen in 1 of 19 (unrelated rash after ipilimumab). Combination therapy was associated with sustained peripheral elevations in: Th1-type cytokines, activated (ICOS+) and proliferating (Ki67+) CD4+and CD8+T cells, and posttreatment proliferative T-effector cells relative to T-regulatory cells within tumor.
  
  
  CONCLUSIONS
  Preoperative cryoablation and single-dose ipilimumab are safe alone or in combination with no surgical delays incurred. Potentially favorable intratumoral and systemic immunologic effects were observed with the combination, suggesting the possibility for induced and synergistic antitumor immunity with this strategy. Clin Cancer Res; 22(23); 5729-37. ©2016 AACR.
authors: Memorial Sloan Kettering Cancer Center (MSKCC), New York, New York.
authors: Heather L
authors: HL
authors: McArthur
authors: MD Anderson Cancer Center, Houston, Texas.
authors: Adi
authors: A
authors: Diab
authors: Memorial Sloan Kettering Cancer Center (MSKCC), New York, New York.
authors: David B
authors: DB
authors: Page
authors: Memorial Sloan Kettering Cancer Center (MSKCC), New York, New York.
authors: Jianda
authors: J
authors: Yuan
authors: Memorial Sloan Kettering Cancer Center (MSKCC), New York, New York.
authors: Stephen B
authors: SB
authors: Solomon
authors: Memorial Sloan Kettering Cancer Center (MSKCC), New York, New York.
authors: Virgilio
authors: V
authors: Sacchini
authors: Memorial Sloan Kettering Cancer Center (MSKCC), New York, New York.
authors: Christopher
authors: C
authors: Comstock
authors: Memorial Sloan Kettering Cancer Center (MSKCC), New York, New York.
authors: Jeremy C
authors: JC
authors: Durack
authors: Memorial Sloan Kettering Cancer Center (MSKCC), New York, New York.
authors: Majid
authors: M
authors: Maybody
authors: Memorial Sloan Kettering Cancer Center (MSKCC), New York, New York.
authors: Janice
authors: J
authors: Sung
authors: Memorial Sloan Kettering Cancer Center (MSKCC), New York, New York.
authors: Arielle
authors: A
authors: Ginsberg
authors: Memorial Sloan Kettering Cancer Center (MSKCC), New York, New York.
authors: Phillip
authors: P
authors: Wong
authors: Memorial Sloan Kettering Cancer Center (MSKCC), New York, New York.
authors: Afsar
authors: A
authors: Barlas
authors: Memorial Sloan Kettering Cancer Center (MSKCC), New York, New York.
authors: Zhiwan
authors: Z
authors: Dong
authors: Memorial Sloan Kettering Cancer Center (MSKCC), New York, New York.
authors: Chunjun
authors: C
authors: Zhao
authors: Memorial Sloan Kettering Cancer Center (MSKCC), New York, New York.
authors: Brian
authors: B
authors: Blum
authors: Memorial Sloan Kettering Cancer Center (MSKCC), New York, New York.
authors: Sujata
authors: S
authors: Patil
authors: Memorial Sloan Kettering Cancer Center (MSKCC), New York, New York.
authors: Deirdre
authors: D
authors: Neville
authors: Memorial Sloan Kettering Cancer Center (MSKCC), New York, New York.
authors: Elizabeth A
authors: EA
authors: Comen
authors: Memorial Sloan Kettering Cancer Center (MSKCC), New York, New York.
authors: Elizabeth A
authors: EA
authors: Morris
authors: Memorial Sloan Kettering Cancer Center (MSKCC), New York, New York.
authors: Alan
authors: A
authors: Kotin
authors: Memorial Sloan Kettering Cancer Center (MSKCC), New York, New York.
authors: Edi
authors: E
authors: Brogi
authors: Memorial Sloan Kettering Cancer Center (MSKCC), New York, New York.
authors: Y Hannah
authors: YH
authors: Wen
authors: Memorial Sloan Kettering Cancer Center (MSKCC), New York, New York.
authors: Monica
authors: M
authors: Morrow
authors: Memorial Sloan Kettering Cancer Center (MSKCC), New York, New York.
authors: Mario E
authors: ME
authors: Lacouture
authors: MD Anderson Cancer Center, Houston, Texas.
authors: Padmanee
authors: P
authors: Sharma
authors: MD Anderson Cancer Center, Houston, Texas.
authors: James P
authors: JP
authors: Allison
authors: Memorial Sloan Kettering Cancer Center (MSKCC), New York, New York.
authors: Clifford A
authors: CA
authors: Hudis
authors: Memorial Sloan Kettering Cancer Center (MSKCC), New York, New York.
authors: Jedd D
authors: JD
authors: Wolchok
authors: Memorial Sloan Kettering Cancer Center (MSKCC), New York, New York.
authors: Larry
authors: L
authors: Norton
mesh_terms: D000328:Adult; D000368:Aged; D000951:Antigens, Neoplasm / Q000378:metabolism; D000074322:Antineoplastic Agents, Immunological / Q000627:therapeutic use*; D001943:Breast Neoplasms / Q000188:drug therapy* / Q000378:metabolism / Q000601:surgery*; D003131:Combined Modality Therapy / Q000379:methods; D003452:Cryosurgery / Q000379:methods; D005260:Female; D006801:Humans; D000074324:Ipilimumab / Q000627:therapeutic use*; D008875:Middle Aged; D010865:Pilot Projects; D011300:Preoperative Care / Q000379:methods; D018719:Erb-b2 Receptor Tyrosine Kinases / Q000378:metabolism; D050378:T-Lymphocytes, Regulatory / Q000187:drug effects / Q000378:metabolism
chemical_list: D000951:Antigens, Neoplasm; D000074322:Antineoplastic Agents, Immunological; D000074324:Ipilimumab; D018719:Erb-b2 Receptor Tyrosine Kinases