Application of quality-of-life measurements in clinical trials and in clinical practice for gynecologic cancer patients

References

• Schlaerth JB, Spirtos NM, Schlaerth AC. Radical trachelectomy and pelvic lymphadenectomy with uterine preservation in the treatment of cervical cancer. Am. J. Obstet. Gynecol.188(1), 29–34 (2003).
   PubMed Web of Science ®Google Scholar
• Ditto A, Martinelli F, Borreani C et al. Quality of life and sexual, bladder, and intestinal dysfunctions after class III nerve-sparing and class II radical hysterectomies: a questionnaire-based study. Int. J. Gynecol. Cancer19(5), 953–957 (2009).
   PubMed Web of Science ®Google Scholar
• Van Eijkeren MA, Van Der Wijk I, El Sharouni SY, Heintz AP. Benefits and side effects of lateral ovarian transposition (LOT) performed during radical hysterectomy and pelvic lymphadenectomy for early stage cervical cancer. Int. J. Gynecol. Cancer9(5), 396–400 (1999).
   PubMed Web of Science ®Google Scholar
• Buist MR, Pijpers RJ, van Lingen A et al. Laparoscopic detection of sentinel lymph nodes followed by lymph node dissection in patients with early stage cervical cancer. Gynecol. Oncol.90(2), 290–296 (2003).
   PubMed Web of Science ®Google Scholar
• Marnitz S, Köhler C, Roth C et al. Is there a benefit of pretreatment laparoscopic transperitoneal surgical staging in patients with advanced cervical cancer? Gynecol. Oncol.99(3), 536–544 (2005).
   PubMed Web of Science ®Google Scholar
• Spensley S, Hunter RD, Livsey J et al. Clinical outcome for chemoradiotherapy in carcinoma of the cervix. Clin. Oncol. (R. Coll. Radiol.)21(1), 49–55 (2009).
   PubMed Web of Science ®Google Scholar
• Barker CL, Routledge JA, Farnell DJ et al. The impact of radiotherapy late effects on quality of life in gynaecological cancer patients. Br. J. Cancer100(10), 1558–1565 (2009).
   PubMed Web of Science ®Google Scholar
• Macdonald DM, Lin LL, Biehl K et al. Combined intensity-modulated radiation therapy and brachytherapy in the treatment of cervical cancer. Int. J. Radiat. Oncol. Biol. Phys.71(2), 618–624 (2008).
   PubMed Web of Science ®Google Scholar
• Vergote I, de Wever I, Tjalma W et al. Interval debulking surgery: an alternative for primary surgical debulking? Semin. Surg. Oncol.19(1), 49–53 (2000).
   PubMedGoogle Scholar
• Rustin GJ, van der Burg ME; MRC and EORTC Collaborators. A randomized trial in ovarian cancer (OC) of early treatment of relapse based on CA125 level alone versus delayed treatment based on conventional clinical indicators (MRC OV05/EORTC 55955 trials). Presented at: ASCO Meeting, FL, USA, 29 May–2 June 2009.
   Google Scholar
• Bookman MA; Gynecologic Cancer InterGroup (GCIG). GOG0182-ICON5: 5-arm Phase III randomized trial of paclitaxel (P) and carboplatin (C) vs combinations with gemcitabine (G), PEG-liposomal doxorubicin (D), or topotecan (T) in patients (pts) with advanced-stage epithelial ovarian (EOC) or primary peritoneal (PPC) carcinoma. J. Clin. Oncol. ASCO Annual Meeting Proceedings Part I.24(18S), (2006).
   Google Scholar
• Kaye SB. Bevacizumab for the treatment of epithelial ovarian cancer: will this be its finest hour? J. Clin. Oncol.25(33), 5150–5152 (2007).
   PubMed Web of Science ®Google Scholar
• Creutzberg CL, Nout RA, van de Poll-Franse LV et al. Long term outcome of the randomised PORTEC-1 trial and quality of life of the endometrial cancer survivors. Int. J. Gynecol. Cancer19(Suppl. 2), 235 (2009).
   Google Scholar
• The writing committee on behalf of the ASTEC study group. Efficacy of systematic pelvic lymphadenectomy in endometrial cancer (MRC ASTEC trial): a randomised study. Lancet373, 125–136 (2009).
   PubMed Web of Science ®Google Scholar
• The ASTEC/EN.5 writing committee on behalf of the ASTEC/EN.5 Study Group. Adjuvant external beam radiotherapy in the treatment of endometrial cancer (MRC ASTEC and NCIC CTG EN.5 randomised trials): pooled trial results, systematic review, and meta-analysis. Lancet373, 137–146 (2009).
   PubMed Web of Science ®Google Scholar
• Nout RA, Putter H, Jürgenliemk-Schulz IM et al. Vaginal brachytherapy versus external beam pelvic radiotherapy for high-intermediate risk endometrial cancer: results of the randomized PORTEC-2 trial. J. Clin. Oncol.26(Suppl.) (2008) (Abstract LBA5503).
   Google Scholar
• Fader AN, Michener CM, Frasure HE et al. Total laparoscopic hysterectomy versus laparoscopic-assisted vaginal hysterectomy in endometrial cancer: surgical and survival outcomes. Min. Invasive Gynecol.16(3), 333–339 (2009).
   PubMed Web of Science ®Google Scholar
• Nordin AJ; the National Group of Gynaecology NSSG Leads. Mode of detection of recurrent gynaecological malignancy: does routine follow-up delay diagnosis and treatment? Int. J. Gynecol. Cancer16, 1746–1748 (2006).
   PubMed Web of Science ®Google Scholar
• Oonk MH, van de Nieuwenhof HP, de Hullu JA, van der Zee AG. The role of sentinel node biopsy in gynecological cancer: a review. Curr. Opin. Oncol.21(5), 425–432 (2009).
   PubMed Web of Science ®Google Scholar
• van Doorn HC, Ansink A, Verhaar-Langereis M, Stalpers L. Neoadjuvant chemoradiation for advanced primary vulvar cancer. Cochrane Database Syst. Rev.19(3), CD003752 (2006).
   Google Scholar
• WHO. Constitution of the Word Health Organization. WHO Basic Documents, Geneva, Switzerland (1948).
   Google Scholar
• Schumacher M, Olschewski M, Schulgen G. Assessment of quality of life in clinical trials. Stat. Med.10(12), 1915–1930 (1991).
   PubMed Web of Science ®Google Scholar
• Leplege A, Hunt S. The problem of quality of life in medicine. JAMA278(1), 47–50 (1997).
   PubMed Web of Science ®Google Scholar
• Ware JE Jr, Sherbourne CD. The MOS 36-item Short Form Health Survey (SF-36). Conceptional framework and item selection. Med. Care30(6), 473–483 (1992).
   PubMed Web of Science ®Google Scholar
• The WHOQOL Group: The World Health Organization Quality of Life Assessment (WHOQOL). Position paper from the World Health Organization. Soc. Sci. Med.41, 1403–1409 (1995).
   PubMed Web of Science ®Google Scholar
• Aaronson N, Ahmedzai SM, Bergman B. for the European Organization for Research and Treatment of Cancer – Study Group on Quality of Life. The European Organization for Research and Treatment of Cancer QLQ-C30: a quality-of-life instrument for use in international clinical trials in oncology. J. Natl Cancer Inst.85, 365–376 (1993).
   PubMed Web of Science ®Google Scholar
• Cella DF, Bonomi AE. The functional assessment of cancer therapy (FACT) and functional assessment in HIV infection (FAHI) quality of life measurement system. In: Quality of Life and Pharmacoeconomics in Clinical Trials. Spilker B (Ed.). Lippincott-Raven Publishers, PA, USA (1996).
   Google Scholar
• Blazeby J, Sprangers M, Cull A, Groenvold M, Bottomley A. EORTC Quality of Life Group guidelines for developing questionnaire modules. EORTC Publications (3rd edition). Brussels, Belgium (2001).
   Google Scholar
• Greimel E, Bottomley A, Cull A; EORTC Quality of Life Group and the Quality of Life Unit. An international field study of the reliability and validity of a disease-specific questionnaire module (QLQ-OV28) in assessing the quality of life of patients with ovarian cancer. Eur. J. Cancer39(10), 1402–1408 (2003).
   PubMed Web of Science ®Google Scholar
• Greimel ER, Kuljanic Vlasic K, Waldenstrom AC; on behalf of the European Organization for Research and Treatment of Cancer Quality-of-Life Group. The European Organization for Research and Treatment of Cancer (EORTC) Quality-of-Life questionnaire cervical cancer module: EORTC QLQ-CX24. Cancer107(8), 1812–1822 (2006).
   PubMed Web of Science ®Google Scholar
• Fayers P, Machin D. Quality of Life: Assessment, Analysis and Interpretation. John Wiley & Sons, Chichester, UK (2000).
   Google Scholar
• Groenvold M, Morten AP, Aaronson NK et al; on behalf of the EORTC Quality of Life Group. The development of the EORTC QLQ-C15-PAL: a shortened questionnaire for cancer patients in palliative care. Eur. J. Cancer42(1), 55–64 (2006).
   PubMed Web of Science ®Google Scholar
• Kirkova J, Davis MP, Walsh D et al. Cancer symptom assessment instruments: a systematic review. J. Clin. Oncol.24(9), 1459–1473 (2006).
   PubMed Web of Science ®Google Scholar
• Cleeland CS, Mendoza TR, Wang XS et al. Assessing symptom distress in cancer patients. The MD Anderson Symptom Inventory. Cancer89(7), 1634–1646 (2000).
   PubMed Web of Science ®Google Scholar
• Mendoza TR, Wang XS, Cleeland CS et al. The rapid assessment of fatigue severity in cancer patients: use of the brief fatigue inventory. Cancer85(5), 1186–1196 (1999).
   PubMed Web of Science ®Google Scholar
• Donovan HS, Ward S, Serlin RC. Evaluation of the symptom representation questionnaire (SRQ) for assessing cancer related symptoms. J. Pain Symptom Manag.35(3), 242–257 (2008).
   PubMed Web of Science ®Google Scholar
• Higginson IH, Carr AJ. Measuring the quality of life: using quality of life measures in clinical setting. BMJ322, 1297–1300 (2001).
   PubMed Web of Science ®Google Scholar
• Jones GL, Ledger W, Bonnett TJ, Radley S, Parkinson N, Kennedy H. The impact of treatment for gynecologcial cancer on health-related quality of life (HRQoL): a systematic review. Am. J. Obstet. Gynecol.194(1), 26–42 (2006).
   PubMed Web of Science ®Google Scholar
• Vistad I, Fossa SD, Dahl AA. A critical review of patient-rated quality of life studies of long-term survivors of cervical cancer. Gynecol. Oncol.102(3), 563–572 (2006).
   PubMed Web of Science ®Google Scholar
• Bottomley A, Efficace F, Fayers PM. Standards are needed for quality of life in clinical trials. BMJ324(7346), 1156 (2002).
   PubMed Web of Science ®Google Scholar
• Efficace F, Bottomley A, Osoba D et al. Beyond the development of health-related quality of life (HRQOL) measures: a checklist for evaluating HRQOL outcomes in cancer clinical trials – does HRQOL evaluation in prostate cancer research inform clinical decision making? J. Clin. Oncol.21(18), 3502–3511 (2003).
   PubMed Web of Science ®Google Scholar
• Nout RA, Putter H, Jürgenliemk-Schulz IM et al. Quality of life after pelvic radiotherapy or vaginal brachytherapy for endometrial cancer: first results of the randomized PORTEC-2 Trial. J. Clin. Oncol.27(21), 3547–3556 (2009).
   PubMed Web of Science ®Google Scholar
• Wenzel L, Huang HQ, Monk BJ, Rose PG, Cella D. Quality of life comparisons in a randomized trial of interval secondary cytoreduction in advanced ovarian carcinoma: a Gynecologic Oncology Group study. J. Clin. Oncol.23(24), 5605–5612 (2005).
   PubMed Web of Science ®Google Scholar
• Greimel E, Bjelic-Radisic V, Pfisterer J et al. Randomized study of the Arbeitsgemeinschaft Gynaekologische Onkologie Ovarian Cancer Study Group comparing quality of life in patients with ovarian cancer treated with cisplatin/paclitaxel versus carboplatin/paclitaxel. J. Clin. Oncol.24(4), 579–586 (2006).
   PubMed Web of Science ®Google Scholar
• Bezjak A, Tu D, Bacon M et al. Quality of life in ovarian cancer patients: comparison of paclitaxel plus cisplatin with cyclophosphamide plus cisplatin in randomized study. J. Clin. Oncol.22(22), 4595–4603 (2004).
   PubMed Web of Science ®Google Scholar
• Kirwan JM, Symonds P, Green JA, Tierney J, Collingwood M, Williams CJ. A systematic review of acute and late toxicity of concomitant chemoradiation for cervical cancer. Radiother. Oncol.68(3), 217–226 (2003).
   PubMed Web of Science ®Google Scholar
• Frumovitz M, Sun CC, Schover LR et al. Quality of life and sexual functioning in cervical cancer survivors. J. Clin. Oncol.23(30), 7428–7436 (2005).
   PubMed Web of Science ®Google Scholar
• Greimel E, Winter R, Kapp K, Haas J. Quality of life and sexual functioning after cervical cancer treatment: a long term follow-up study. Psychooncology18(5), 476–482 (2009).
   PubMed Web of Science ®Google Scholar
• Korfage IJ, Essink-Bot ML, Mols F et al. Health-related quality of life in cervical cancer survivors: a population-based survey. Int. J. Rad. Oncol. Biol. Phys.73(5), 1501–1509 (2009).
   PubMed Web of Science ®Google Scholar
• Jeffery DD, Tzeng JP, Keefe FJ et al. Initial repot of the Cancer Patient-Reported Outcomes Measurement Information System (PROMIS) Sexual Function Committee. Cancer DOI: 10.1002/cnnr.24132 (2009) (Epub ahead of print).
   PubMed Web of Science ®Google Scholar
• Van de Poll-Franse L, Mols F, Essink-Bot ML et al. Impact of external beam adjuvant radiotherapy on health-related quality of life for long-term survivors of endometrial adenocarcinoma: a population-based study. Int. J. Rad. Oncol. Biol. Phys.69(1), 125–132 (2007).
   PubMed Web of Science ®Google Scholar
• Bradley S, Rose S, Lutgendorf S, Costanzo E, Anderson B. Quality of life and mental health in cervical and endometrial cancer survivors. Gynecol. Oncol.100(3), 479–486 (2006).
   PubMed Web of Science ®Google Scholar
• Wenzel L, DeAlba I, Habbal R et al. Quality of life in long-term cervical cancer survivors. Gynecol. Oncol.97(2), 310–317 (2005).
   PubMed Web of Science ®Google Scholar