title: A phase II study of paclitaxel for the treatment of ovarian stromal tumors: An NRG Oncology/ Gynecologic Oncology Group Study.
abstract: OBJECTIVE
  To estimate the probability of complete clinical response and toxicity of paclitaxel as second-line chemotherapy in measurable disease patients with malignant tumors of the ovarian stroma, and to evaluate the value of inhibin for predicting response.
  
  
  METHODS
  Thirty-one patients with histologically confirmed ovarian stromal tumor were enrolled from 2000 to 2013. Patients were required to have measurable recurrent disease, and to have received only one prior chemotherapy regimen. Paclitaxel 175 mg/m2 was administered over a 3 hour infusion, cycling every 21 days. Inhibin levels were drawn within two weeks of initiation of treatment.
  
  
  RESULTS
  Of 31 women enrolled, there was only one complete response (3.2%), and partial response in eight of 31 cases (25.8%). The pretreatment inhibin level for the single patient who had complete response was 88 pg/mL. Median progression-free survival was 10.0 months and overall survival was 73.6 months. Myelosuppression was common with 12 of 31 patients (38.7%) suffering grade 3 or 4 neutropenia, leukopenia, or anemia.
  
  
  CONCLUSIONS
  There were too few complete responses to warrant continued evaluation of paclitaxel as a single agent treatment for women with recurrent malignant ovarian stromal tumors with measurable disease according to the primary objective of the study. Toxicity of the regimen was acceptable. Pretreatment inhibin is not a reliable tumor marker as it was not elevated in the majority of patients.
authors.affiliation: Hanjani Institute for Gynecologic Oncology, Abington Memorial Hospital, 1200 Old York Road, Abington, PA 19001, United States. Electronic address: eburton@abingtonhealth.org.
authors.forename: Elizabeth R
authors.initials: ER
authors.lastname: Burton
authors.affiliation: NRG Oncology Statistical Office, Roswell Park Cancer Institute, Elm & Carlton Streets, Buffalo, NY 14263, United States. Electronic address: mbrady@gogstats.org.
authors.forename: Mark
authors.initials: M
authors.lastname: Brady
authors.affiliation: East Carolina University, Greensville, NC 27858, United States. Electronic address: homesleyh@ecu.edu.
authors.forename: Howard D
authors.initials: HD
authors.lastname: Homesley
authors.affiliation: Cleveland Clinic Foundation, Cleveland, OH 44195, United States. Electronic address: rosep@ccf.org.
authors.forename: Peter G
authors.initials: PG
authors.lastname: Rose
authors.affiliation: Kagoshima City Hospital, Department of OB/GYN, Kagoshima City 892 8580, Japan. Electronic address: nakamura@ml.kch.kagoshima.kagoshima.jp.
authors.forename: Toshiaki
authors.initials: T
authors.lastname: Nakamura
authors.affiliation: Hershey Medical Center, GYN/Oncology, Hershey, PA 17033, United States. Electronic address: jkesterson@hmc.psu.edu.
authors.forename: Joshua P
authors.initials: JP
authors.lastname: Kesterson
authors.affiliation: Rush-Presbyterian St. Lukes Medical Center, Chicago, IL 60612, United States. Electronic address: Jacob_rotmensch@rush.edu.
authors.forename: Jacob
authors.initials: J
authors.lastname: Rotmensch
authors.affiliation: University of Mississippi Medical Center, Jackson, MS 39216, United States. Electronic address: jthigpen@umc.edu.
authors.forename: J
authors.initials: J
authors.lastname: Tate Thigpen
authors.affiliation: University of North Carolina School of Medicine, 101 Manning Drive, Chapel Hill, NC 27514, United States. Electronic address: lvl@med.unc.edu.
authors.forename: Linda
authors.initials: L
authors.lastname: Van Le
mesh_terms: D000328:Adult; D000972:Antineoplastic Agents, Phytogenic / Q000009:adverse effects / Q000627:therapeutic use*; D018572:Disease-Free Survival; D005260:Female; D006801:Humans; D008875:Middle Aged; D010051:Ovarian Neoplasms / Q000188:drug therapy*; D017239:Paclitaxel / Q000009:adverse effects / Q000627:therapeutic use*; D018312:Sex Cord-Gonadal Stromal Tumors / Q000188:drug therapy*
chemical_list: D000972:Antineoplastic Agents, Phytogenic; D017239:Paclitaxel
keywords: Paclitaxel; Stromal tumor of ovary