title: Feasibility and safety of sequential research-related tumor core biopsies in clinical trials.
abstract: BACKGROUND
  There has been increasing interest in serial research biopsies in studies of targeted therapies. Definition of patient characteristics and optimal target tissue for safe research tumor biopsy in the era of antiangiogenic and targeted agents is needed.
  
  
  METHODS
  This institutional review board-approved, retrospective study included chart and interventional radiology case review from 6 phase 1/2 studies at the National Cancer Institute.
  
  
  RESULTS
  One hundred forty-two of 150 protocol patients who were approached gave consent for research biopsies. Patients' median age was 56 years (range, 27-78 years), their median body mass index was 25.8 kg/m(2) (range, 14.4-46.2 kg/m(2) ), they had an Eastern Cooperative Oncology Group performance status of 0 or 1, and they had normal end-organ function. Baseline biopsies were collected from 138 of 142 patients (97%), and paired specimens were collected from 96 (70%). Most patients had metastatic gynecologic cancers (85%), and 78% had target disease below the diaphragm with a median size of 2.7 cm (range, 1-14.5 cm). Protocol therapies included kinase inhibitors (35%), angiogenesis inhibitors (54%), and olaparib/carboplatin (11%); therapy was not interrupted for biopsies. All adverse events were uncomplicated and were observed in 4 patients (liver subcapsular hematoma in 1 patient, vasovagal syncope in 2 patients, and pneumothorax in 1 patient). The complication rate in obese patients was similar to that in nonobese patients (3 of 108 patients vs 1 of 34 patients, respectively). Sixty-seven patients (48%) were receiving bevacizumab at the time of subsequent biopsies. The complication rate was not different between patients who were and were not receiving bevacizumab (3 of 67 patients vs 1 of 71 patients, respectively). Ninety-five percent of biopsies yielded useable material.
  
  
  CONCLUSIONS
  Serial percutaneous core-needle biopsies can be obtained safely and yield material applicable for multiple translational applications. Obesity and/or concomitant antiangiogenic therapy and depth of disease did not increase the risk or preclude the successful acquisition of useful tissue.
authors.affiliation: Medical Oncology Branch, Center for Cancer Research, National Cancer Institute, Bethesda, MD 20892, USA. leej6@mail.nih.gov
authors.forename: Jung-min
authors.initials: JM
authors.lastname: Lee
authors.forename: John L
authors.initials: JL
authors.lastname: Hays
authors.forename: Anne M
authors.initials: AM
authors.lastname: Noonan
authors.forename: Jennifer
authors.initials: J
authors.lastname: Squires
authors.forename: Lori
authors.initials: L
authors.lastname: Minasian
authors.forename: Christina
authors.initials: C
authors.lastname: Annunziata
authors.forename: Bradford J
authors.initials: BJ
authors.lastname: Wood
authors.forename: Minshu
authors.initials: M
authors.lastname: Yu
authors.forename: Katherine R
authors.initials: KR
authors.lastname: Calvo
authors.forename: Nicole
authors.initials: N
authors.lastname: Houston
authors.forename: Nilofer
authors.initials: N
authors.lastname: Azad
authors.forename: Elise C
authors.initials: EC
authors.lastname: Kohn
mesh_terms: D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D061067:Antibodies, Monoclonal, Humanized / Q000627:therapeutic use; D000970:Antineoplastic Agents / Q000627:therapeutic use; D000068258:Bevacizumab; D062005:Biopsy, Large-Core Needle / Q000009:adverse effects / Q000379:methods*; D015992:Body Mass Index; D002986:Clinical Trials as Topic; D005240:Feasibility Studies; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D009369:Neoplasms / Q000175:diagnosis* / Q000188:drug therapy / Q000473:pathology; D012189:Retrospective Studies; D015996:Survival Rate
chemical_list: D061067:Antibodies, Monoclonal, Humanized; D000970:Antineoplastic Agents; D000068258:Bevacizumab