title: Immunomodulatory therapy in refractory/recurrent ovarian cancer.
abstract: OBJECTIVE
  To investigate the efficacy and toxicity of immunomodulatory therapy (IMT) alone or as an add-on to palliative/salvage chemotherapy in patients with refractory/recurrent epithelial ovarian cancer (EOC).
  
  
  METHODS
  We retrospectively analyzed the efficacy and toxicity of IMT in 15 patients with refractory/recurrent EOC who had previously received multiple chemotherapy regimens.
  
  
  RESULTS
  The median age of the patients was 56 years (range, 41-75 years). Three patients were platinum-sensitive, two were platinum-resistant, and the remaining 10 patients were refractory to platinum-based front-line chemotherapy. IMT consisted of picibanil (OK-432) on Day 1, interleukin-2 and/or interferon-α on Day 2 administered by subcutaneous injection (every week or 2-weekly). Five patients never received metronomic oral cyclophosphamide. After IMT, three patients achieved partial remission (PR, lasting for 11 months, ≥ 12 months, and 16 months), and six patients had stable disease (SD). The disease stabilizing rate (PR+SD) was 60% (3/3 in platinum-sensitive and 6/12 in platinum-resistant/refractory patients). The absolute lymphocyte count (ALC) at 1 month after IMT was significantly higher in the PR+SD group (median 1242.0/μL) than in the progression group (median 325.0/μL) (p = 0.012). No ≥ Grade 3 toxicities were observed. The median post-IMT survival time was 12 months (range, 2-39 months).
  
  
  CONCLUSIONS
  IMT alone or add-on to palliative/salvage chemotherapy for refractory/recurrent EOC achieves a substantial disease stabilizing rate without severe toxicity, which might be a potential option in selected patients. The ALC 1 month after IMT could be an early indicator to disease stabilization.
authors.affiliation: Division of Gynecologic Oncology, Department of Obstetrics and Gynecology, Chang Gung Memorial Hospital and Chang Gung University, Taoyuan, Taiwan.
authors.forename: Chao-Yu
authors.initials: CY
authors.lastname: Chen
authors.affiliation: Division of Gynecologic Oncology, Department of Obstetrics and Gynecology, Chang Gung Memorial Hospital and Chang Gung University, Taoyuan, Taiwan.
authors.forename: Chyong-Huey
authors.initials: CH
authors.lastname: Lai
authors.affiliation: Gynecologic Cancer Research Center and Biostatistics and Informatics Unit, Clinical Trial Center, Chang Gung Memorial Hospital, Taoyuan, Taiwan.
authors.forename: Lan-Yan
authors.initials: LY
authors.lastname: Yang
authors.affiliation: Division of Gynecologic Oncology, Department of Obstetrics and Gynecology, Chang Gung Memorial Hospital and Chang Gung University, Taoyuan, Taiwan.
authors.forename: Yun-Hsin
authors.initials: YH
authors.lastname: Tang
authors.affiliation: Division of Gynecologic Oncology, Department of Obstetrics and Gynecology, Chang Gung Memorial Hospital and Chang Gung University, Taoyuan, Taiwan.
authors.forename: Hung-Hsueh
authors.initials: HH
authors.lastname: Chou
authors.affiliation: Research Center of Clinical Informatics and Medical Statistics, Chang Gung University, Taoyuan, Taiwan.
authors.forename: Chee-Jen
authors.initials: CJ
authors.lastname: Chang
authors.affiliation: Division of Gynecologic Oncology, Department of Obstetrics and Gynecology, Chang Gung Memorial Hospital and Chang Gung University, Taoyuan, Taiwan. Electronic address: 51424@cgmh.org.tw.
authors.forename: Cheng-Tao
authors.initials: CT
authors.lastname: Lin
mesh_terms: D000328:Adult; D000368:Aged; D000970:Antineoplastic Agents / Q000008:administration & dosage; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000627:therapeutic use*; D000077216:Carcinoma, Ovarian Epithelial; D004334:Drug Administration Schedule; D005260:Female; D006801:Humans; D056747:Immunomodulation; D007279:Injections, Subcutaneous; D016898:Interferon-alpha / Q000008:administration & dosage; D007376:Interleukin-2 / Q000008:administration & dosage; D008875:Middle Aged; D009364:Neoplasm Recurrence, Local / Q000188:drug therapy* / Q000401:mortality; D009375:Neoplasms, Glandular and Epithelial / Q000188:drug therapy* / Q000401:mortality; D010051:Ovarian Neoplasms / Q000188:drug therapy* / Q000401:mortality; D010166:Palliative Care / Q000379:methods; D010844:Picibanil / Q000008:administration & dosage; D012189:Retrospective Studies; D016879:Salvage Therapy / Q000379:methods; D015996:Survival Rate; D016896:Treatment Outcome
chemical_list: D000970:Antineoplastic Agents; D016898:Interferon-alpha; D007376:Interleukin-2; D010844:Picibanil
keywords: epithelial ovarian cancer; immunomodulatory therapy; recurrence