title: The impact of docetaxel-related toxicities on health-related quality of life in patients with metastatic cancer (QoliTax).
abstract: BACKGROUND
  Docetaxel is a widely used cytotoxic agent. This study evaluates the impact of docetaxel toxicities on patient's health-related quality of life (QoL).
  
  
  METHODS
  We conducted a multicenter, prospective, non-interventional trial, in which the QoL was assessed using the EORTC QLQ-C30 questionnaires at baseline and every 4 weeks up to 40 weeks in patients receiving a docetaxel-based chemotherapy for metastatic disease. Treatment-related adverse events were correlated with the corresponding QoL scores. Uni- and multivariate analyses were applied.
  
  
  RESULTS
  From January 2008 to June 2011, a total of 2659 patients were included. The majority of patients (48.1%) had prostate cancer, followed by breast (17.1%) and non-small-cell-lung cancer (15.8%). Patients received a median of 5 docetaxel cycles with the median dose of 75 mg/m(2). The presence of grade 3/4 diarrhea showed the strongest effect on global health status/QoL average scores (50.91 versus 33.06), followed by vomiting (50.91 versus 35.17), dyspnea (50.94 versus 35.81), mucositis/stomatitis (50.88 versus 36.41), nausea (50.91 versus 36.68), infection (50.90 versus 37.14), fatigue (50.90 versus 43.82) and anemia (50.91 versus 41.03), P < 0.05 for all comparisons. Grade 3/4 leukopenia/neutropenia, alopecia, constipation, neurotoxicity and nail disorders had no significant impact on the global health status/QoL or other items.
  
  
  CONCLUSIONS
  In this large non-interventional trial, docetaxel-associated grade 3 or 4 toxicities were shown to have a strong detrimental effect on patient's QoL. Notably, diarrhea and vomiting had the strongest negative impact on QoL measures. This has to be kept in mind while making therapeutic decisions and providing optimized supportive treatment measures.
  
  
  BACKGROUND
  This study was registered at Deutsches Krebsstudienregister (DKSR, primary registry in the WHO Registry Network) with the ID 527.
authors.affiliation: Institute of Clinical Cancer Research, Krankenhaus Nordwest, University Cancer Center, Frankfurt. Electronic address: albatran@aol.com.
authors.forename: S-E
authors.initials: SE
authors.lastname: Al-Batran
authors.affiliation: Institute of Clinical Cancer Research, Krankenhaus Nordwest, University Cancer Center, Frankfurt.
authors.forename: W
authors.initials: W
authors.lastname: Hozaeel
authors.affiliation: Clinic for Oncology and Hematology, Krankenhaus Nordwest, Frankfurt.
authors.forename: F K
authors.initials: FK
authors.lastname: Tauchert
authors.affiliation: Interdisciplinary Tumour Centre, University Hospital Mannheim, Mannheim.
authors.forename: R-D
authors.initials: RD
authors.lastname: Hofheinz
authors.affiliation: WiSP Research Institute, Langenfeld.
authors.forename: A
authors.initials: A
authors.lastname: Hinke
authors.affiliation: Alcedis GmbH, Gießen.
authors.forename: C
authors.initials: C
authors.lastname: Windemuth-Kieselbach
authors.affiliation: Oncology and Urology, Wissenschaftskontor Nord GmbH & Co KG, Rostock.
authors.forename: A
authors.initials: A
authors.lastname: Hübner
authors.affiliation: Clinic for Urology, Vinzenzkrankenhaus Hannover, Hannover.
authors.forename: M
authors.initials: M
authors.lastname: Burmester
authors.affiliation: Oncology and Hematology, Onkologisches Ambulanzzentrum, Hannover.
authors.forename: M
authors.initials: M
authors.lastname: Koenigsmann
authors.affiliation: Oncology and Hematology, Onkologische Praxis, Moers.
authors.forename: J
authors.initials: J
authors.lastname: Wiegand
authors.affiliation: Institute of Clinical Cancer Research, Krankenhaus Nordwest, University Cancer Center, Frankfurt.
authors.forename: G
authors.initials: G
authors.lastname: Zur Hausen
authors.affiliation: Clinical Study Unit.
authors.forename: B
authors.initials: B
authors.lastname: Linsse
authors.affiliation: Medical Oncology, Sanofi-Aventis Deutschland GmbH, Berlin, Germany.
authors.forename: R
authors.initials: R
authors.lastname: Kuhl
authors.affiliation: Institute of Clinical Cancer Research, Krankenhaus Nordwest, University Cancer Center, Frankfurt.
authors.forename: C
authors.initials: C
authors.lastname: Pauligk
mesh_terms: D000368:Aged; D000970:Antineoplastic Agents / Q000009:adverse effects*; D003967:Diarrhea / Q000139:chemically induced / Q000523:psychology; D000077143:Docetaxel; D064420:Drug-Related Side Effects and Adverse Reactions / Q000175:diagnosis / Q000523:psychology*; D005260:Female; D005858:Germany; D006801:Humans; D016015:Logistic Models; D008297:Male; D008875:Middle Aged; D015999:Multivariate Analysis; D009362:Neoplasm Metastasis; D009369:Neoplasms / Q000188:drug therapy* / Q000473:pathology / Q000523:psychology; D018579:Patient Selection; D011446:Prospective Studies; D011788:Quality of Life; D012307:Risk Factors; D012720:Severity of Illness Index; D011795:Surveys and Questionnaires; D043823:Taxoids / Q000009:adverse effects*; D013997:Time Factors; D016896:Treatment Outcome; D014839:Vomiting / Q000139:chemically induced / Q000523:psychology
chemical_list: D000970:Antineoplastic Agents; D043823:Taxoids; D000077143:Docetaxel
keywords: HRQoL; QoL; cancer; docetaxel; quality of life