title: Quality of life of advanced ovarian cancer patients in the randomized phase III study comparing primary debulking surgery versus neo-adjuvant chemotherapy.
abstract: OBJECTIVE
  The EORTC 55971 trial compared primary debulking surgery (PDS) versus neo-adjuvant chemotherapy (NACT) followed by interval debulking surgery (IDS). The impact of both treatment arms on quality of life (QOL) is reported.
  
  
  METHODS
  Patients with stages IIIc or IV ovarian cancer completed the EORTC QLQ-C30 before treatment, at the third and sixth cycle of chemotherapy, and at 6- and 12-month follow-up.
  
  
  RESULTS
  Data of 404 patients (N=201 PDS arm; N=203 IDS arm) were included in the QOL analysis. Between treatment arms no statistically significant differences were found in any of the QOL functioning scales. Patients showed a clinically relevant improvement (>10 points) on the global health/QOL, role functioning, emotional functioning and social functioning scales during and after treatment independent of the type of treatment. Clinically relevant differences from baseline to the follow-up assessments were noted for fatigue, pain, insomnia, appetite loss, constipation, diarrhea indicating symptom control in both treatment arms. Institutions with good QOL compliance were associated with better outcomes. There was a statistical significant difference in the overall debulking status with 39.9% optimal debulking surgery in institutions with good QOL compliance compared to 19.9% in institutions with poor QOL compliance (p=0.0011). Overall survival (median 32.30 versus 23.29 months; p=0.0006) and progression free survival (median 12.35 versus 9.92 months; p=0.0002) were also significantly better.
  
  
  CONCLUSIONS
  Survival and QOL after NACT followed by surgery was similar to survival and QOL after PDS followed by chemotherapy. However, institutions with good QOL compliance had better survival outcomes.
authors.affiliation: Department of Obstetrics and Gynecology, Medical University Graz, Graz, Austria. Electronic address: elfriede.greimel@medunigraz.at.
authors.forename: Elfriede
authors.initials: E
authors.lastname: Greimel
authors.forename: Gunnar B
authors.initials: GB
authors.lastname: Kristensen
authors.forename: Maria E L
authors.initials: ME
authors.lastname: van der Burg
authors.forename: Pluvio
authors.initials: P
authors.lastname: Coronado
authors.forename: Gordon
authors.initials: G
authors.lastname: Rustin
authors.forename: Angel Sanchez
authors.initials: AS
authors.lastname: del Rio
authors.forename: Nicholas S
authors.initials: NS
authors.lastname: Reed
authors.forename: Randi R
authors.initials: RR
authors.lastname: Nordal
authors.forename: Corneel
authors.initials: C
authors.lastname: Coens
authors.forename: Ignace
authors.initials: I
authors.lastname: Vergote
mesh_terms: D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000627:therapeutic use*; D000077216:Carcinoma, Ovarian Epithelial; D017024:Chemotherapy, Adjuvant; D018572:Disease-Free Survival; D005260:Female; D006801:Humans; D008875:Middle Aged; D020360:Neoadjuvant Therapy; D009367:Neoplasm Staging; D009375:Neoplasms, Glandular and Epithelial / Q000188:drug therapy* / Q000473:pathology / Q000523:psychology / Q000601:surgery*; D009944:Organoplatinum Compounds / Q000008:administration & dosage; D010051:Ovarian Neoplasms / Q000188:drug therapy* / Q000473:pathology / Q000523:psychology / Q000601:surgery*; D011788:Quality of Life; D015996:Survival Rate
chemical_list: D009944:Organoplatinum Compounds
keywords: Gynecologic oncology; Ovarian cancer; Patient-reported outcomes; Phase III trial; Quality of life