title: Randomized study of sequential cisplatin-topotecan/carboplatin-paclitaxel versus carboplatin-paclitaxel: effects on quality of life.
abstract: BACKGROUND
  A recent phase III trial compared the efficacy of cisplatin-topotecan (a topoisomerase I inhibitor) followed by carboplatin-paclitaxel (Arm 1) versus paclitaxel-carboplatin (Arm 2) in women with newly diagnosed stage IIB or greater ovarian cancer. There was a significantly lower response rate in the experimental arm compared to standard treatment, and less likelihood of normalized CA125 within the first 3 months. At 43 months follow-up, there were no significant group differences in progression-free survival. There were also significantly more side effects in the experimental arm.
  
  
  METHODS
  The current study examined quality of life (QoL) endpoints using the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC QLQ-C30) and the ovarian cancer module, QLQ-OV28, administered prior to randomization, at day 1 of treatment cycles 3, 5, and 7, at completion of the last cycle, and at 3 and 6 months following completion of chemotherapy.
  
  
  RESULTS
  Global QoL, physical symptoms, fatigue, and role, emotional, cognitive and social function (all from the EORTC QLQ-C30) significantly improved in both treatment arms, with no significant between-arm differences. Between-group differences in pain, insomnia, and peripheral neuropathy reported while on treatment did not differ at follow-up. Nausea and vomiting improved more with standard treatment both during and after treatment. Body image significantly differed between the groups only at cycle 5 (more deterioration in Arm 2) but group differences disappeared at follow-up. A stratified analysis of global QoL by debulking surgery status found no greater effect indicating that overall improvements in QoL were unrelated to surgical recovery.
  
  
  CONCLUSIONS
  There was no significant QoL advantage of cisplatin-topotecan. This finding, combined with no progression-free survival conferred by this combination, reaffirms carboplatin-paclitaxel as the standard of care for women with newly diagnosed ovarian cancer.
authors: University of British Columbia, Vancouver, British Columbia, Canada. lori.brotto@vch.ca.
authors: Lori
authors: L
authors: Brotto
authors: University of British Columbia, Vancouver, British Columbia, Canada.
authors: Michael
authors: M
authors: Brundage
authors: University of British Columbia, Vancouver, British Columbia, Canada.
authors: Paul
authors: P
authors: Hoskins
authors: University of British Columbia, Vancouver, British Columbia, Canada.
authors: Ignace
authors: I
authors: Vergote
authors: University of British Columbia, Vancouver, British Columbia, Canada.
authors: Andres
authors: A
authors: Cervantes
authors: University of British Columbia, Vancouver, British Columbia, Canada.
authors: Herraez A
authors: HA
authors: Casado
authors: University of British Columbia, Vancouver, British Columbia, Canada.
authors: A
authors: A
authors: Poveda
authors: University of British Columbia, Vancouver, British Columbia, Canada.
authors: Elizabeth
authors: E
authors: Eisenhauer
authors: University of British Columbia, Vancouver, British Columbia, Canada.
authors: Dongsheng
authors: D
authors: Tu
mesh_terms: D000328:Adult; D000368:Aged; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000009:adverse effects / Q000627:therapeutic use*; D001828:Body Image / Q000523:psychology; D016190:Carboplatin / Q000009:adverse effects / Q000627:therapeutic use*; D002945:Cisplatin / Q000009:adverse effects / Q000627:therapeutic use*; D018572:Disease-Free Survival; D005260:Female; D006801:Humans; D008875:Middle Aged; D010051:Ovarian Neoplasms / Q000188:drug therapy* / Q000523:psychology*; D017239:Paclitaxel / Q000009:adverse effects / Q000627:therapeutic use*; D011788:Quality of Life / Q000523:psychology*; D011795:Surveys and Questionnaires; D019772:Topotecan / Q000009:adverse effects / Q000627:therapeutic use*
chemical_list: D019772:Topotecan; D016190:Carboplatin; D017239:Paclitaxel; D002945:Cisplatin
keywords: Carboplatin-paclitaxel; Cisplatin-topotecan; Ovarian cancer; Quality of life