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Pegylated liposomal doxorubicin for first-line treatment of epithelial ovarian cancer

  1. Theresa A Lawrie1,*,
  2. Roy Rabbie2,
  3. Clemens Thoma3,
  4. Jo Morrison4

Editorial Group: Cochrane Gynaecological Cancer Group

Published Online: 21 OCT 2013

Assessed as up-to-date: 14 AUG 2013

DOI: 10.1002/14651858.CD010482.pub2


How to Cite

Lawrie TA, Rabbie R, Thoma C, Morrison J. Pegylated liposomal doxorubicin for first-line treatment of epithelial ovarian cancer. Cochrane Database of Systematic Reviews 2013, Issue 10. Art. No.: CD010482. DOI: 10.1002/14651858.CD010482.pub2.

Author Information

  1. 1

    Royal United Hospital, Cochrane Gynaecological Cancer Group, Bath, UK

  2. 2

    Epsom and St Helier University Hospitals NHS Trust, Department of Respiratory Medicine, London, UK

  3. 3

    University of Oxford, Nuffield Department of Obstetrics & Gynaecology, Oxford, UK

  4. 4

    Musgrove Park Hospital, Department of Obstetrics and Gynaecology, Taunton, Somerset, UK

*Theresa A Lawrie, Cochrane Gynaecological Cancer Group, Royal United Hospital, Education Centre, Bath, BA13NG, UK. tess@lawrie.com.

Publication History

  1. Publication Status: Edited (no change to conclusions)
  2. Published Online: 21 OCT 2013

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References

References to studies included in this review

  1. References to studies included in this review
  2. References to studies excluded from this review
  3. Additional references
GOG0182/ICON 5 2009 {published data only}
  • Bookman MA. Erratum. Journal of Clinical Oncology 2009;27(13):2305.
  • Bookman MA and the Gynecologic Cancer InterGroup (GCIG). GOG0182-ICON5: 5-arm phase III randomized trial of paclitaxel (P) and carboplatin (C) vs combinations with gemcitabine (G), PEG-lipososomal doxorubicin (D), or topotecan (T) in patients (pts) with advanced-stage epithelial ovarian (EOC) or primary peritoneal (PPC) carcinoma. Journal of Clinical Oncology, 2006 ASCO Annual Meeting Proceedings Part I. 2006; Vol. 24, 18S (June 20 Suppl):5002.
  • Bookman MA and the Gynecologic Cancer InterGroup (GCIG). GOG0182-ICON5: 5-arm phase III randomized trial of paclitaxel (P) and carboplatin (C) vs combinations with gemcitabine (G), PEG-lipososomal doxorubicin (D), or topotecan (T) in patients (pts) with advanced-stage epithelial ovarian (EOC) or primary peritoneal (PPC) carcinoma [abstract]. Journal of Clinical Oncology 2006;24(Suppl 18):A-5002:256s.
  • Bookman MA, Brady MF, McGuire WP, Harper PG, Alberts DS, Friedlander M, et al. Evaluation of new platinum-based treatment regimens in advanced-stage ovarian cancer: a Phase III Trial of the Gynecologic Cancer Intergroup. Journal of Clinical Oncology 2009;27(9):1419-25.
  • Bookman MA, Greer BE, Ozols RF. Optimal therapy of advanced ovarian cancer: carboplatin and paclitaxel vs. cisplatin and paclitaxel (GOG 158) and an update on GOG0 182-ICON5. International Journal of Gynecological Cancer 2003;13(6):735-40.
  • Copeland LJB and the Gynecologic Cancer Intergroup (GCIG). Clinical trials of newer regimens for treating ovarian cancer: the rationale for Gynecologic Oncology Group Protocol GOG 182-ICON5. Gynecologic Oncology 2003;90:(2 Part 2):S1-7.
MITO-2 2011 {published data only}
  • Pignata S, Scambia G, Ferrandina G, Savarese A, Sorio R, Breda E, et al. Carboplatin plus paclitaxel versus carboplatin plus pegylated liposomal doxorubicin as first-line treatment for patients with ovarian cancer: the MITO-2 randomized phase III trial. Journal of Clinical Oncology 2011;29(27):3628-35.
  • Pignata S, Scambia G, Savarese A, Breda E, Scollo P, De Vivo R, et al. Safety of a 3-weekly schedule of carboplatin plus pegylated liposomal doxorubicin as first line chemotherapy in patients with ovarian cancer: preliminary results of the MITO-2 randomized trial. BioMedCentral (BMC) Cancer 2006;6:202. http://www.biomedcentral.com/1471-2407/6/202..
  • Pignata S, Scambia G, Savarese A, Breda E, Sorio R, Pisano C, et al. Carboplatin and pegylated liposomal doxorubicin for advanced ovarian cancer: preliminary activity results of the MITO-2 phase III trial. Oncology 2009;76(1):49-54.
  • Pignata S, Scambia G, Savarese A, Breda E, Sorio R, Vernaglia Lombardi A, et al. Carboplatin plus paclitaxel versus carboplatin plus Stealth liposomal doxorubicin in patients with advanced ovarian cancer: preliminary activity results of the MITO-2 randomized multicenter trial [Abstract]. Journal of Clinical Oncology; 2007 ASCO Annual Meeting. 2007; Vol. 25:18S(abstract 5532).
  • Pignata S, Scambia G, Savarese A, Sorio R, Breda E, Ferrandina G, et al. Carboplatin plus paclitaxel (CP) versus carboplatin plus stealth liposomal doxorubicin (CLD) in patients with advanced ovarian cancer (AOC): activity and safety results of the MITO-2 randomized multicenter trial [abstract]. Journal of Clinical Oncology; 2009 ASCO Annual Meeting. 2009; Vol. 27:15S(Suppl; abstract LBA5508).
  • Pignata S, Scambia G, Savarese A, Sorio R, Breda E, Legge F, et al. Carboplatin (C) plus paclitaxel (P) versus carboplatin plus pegylated liposomal doxorubicin (PLD) in patients with advanced ovarian cancer (AOC): final analysis of the MITO-2 randomized multicenter trial. Journal of Clinical Oncology; 2010 ASCO Annual Meeting. 2010; Vol. 28:18s, 2010 (Suppl; abstract LBA5033).
  • Pignata S, Scambia G, Savarese A, Sorio R, Breda E, Legge F, et al. Carboplatin plus paclitaxel versus carboplatin plus pegylated liposomal doxorubicin as firstline treatment for patients with ovarian cancer: the MITO-2 (multicentre Italian trials in ovarian cancer) randomized phase III trial. Annals of Oncology; 35th ESMO Congress, Milan, Italy. 2010.
  • Pignata S, Scambia G, Savarese A, Zagonel V, Gebbia V, Scollo P, et al. Carboplatin plus paclitaxel (CP) versus carboplatin plus Stealth liposomal doxorubicin (CLD) in patients with advanced ovarian cancer (AOC): preliminary safety results of the MITO-2 randomized multicenter trial. Journal of Clinical Oncology; 2005 ASCO Annual Meeting. 2005; Vol. 23:16S (Suppl, abstract 5014).

References to studies excluded from this review

  1. References to studies included in this review
  2. References to studies excluded from this review
  3. Additional references
Pontamianou 2005 {published data only}
  • Potamianou A, Androulakis N, Papakotoulas P, Toufexi H, Latoufis C, Kouroussis C, et al. Sequential combination of paclitaxel-carboplatin and paclitaxel-liposomal doxorubicin as a first-line treatment in patients with ovarian cancer. A multicenter phase II trial. Oncology 2005;69(4):348-53.
SWOG S9912 2009 {published data only}
  • Smith HO, Moon J, Wilczynski SP, Tiersten AD, Hannigan EV, Robinson WR, et al. Southwest Oncology Group Trial S9912: intraperitoneal cisplatin and paclitaxel plus intravenous paclitaxel and pegylated liposomal doxorubicin as primary chemotherapy of small-volume residual stage III ovarian cancer. Gynecologic Oncology 2009;114(2):206-9.

Additional references

  1. References to studies included in this review
  2. References to studies excluded from this review
  3. Additional references
A'Hern 1995
Aaronson 1993
  • Aaronson NK, Ahmedzai S, Bergman B, Bullinger M, Cull A, Duez NJ, et al. The European Organization for Research and Treatment of Cancer QLQ-C30: a quality-of-life instrument for use in international clinical trials in oncology. Journal of the National Cancer Institute 1993;85(5):365-76.
Burger 2011
  • Burger RA, Brady MF, Bookman MA, Fleming GF, Monk BJ, et al. for the Gynecologic Oncology Group. Incorporation of bevacizumab in the primary treatment of ovarian cancer. The New England Journal of Medicine 2011;365:2473-83.
CALYPSO 2010
  • Pujade-Lauraine E, Wagner U, Aavall-Lundqvist E, Gebski V, Heywood M, Vasey PA, et al. Pegylated liposomal doxorubicin and carboplatin compared with paclitaxel and carboplatin for patients with platinum-sensitive ovarian cancer in late relapse. Journal of Clinical Oncology 2010;28(20):3323-9.
Campbell 1989
CTCAE 2006
  • CTCAE. Common Terminology Criteria for Adverse Events v3.0 (CTCAE), 2006. http://ctep.cancer.gov/protocolDevelopment/electronic_applications/docs/ctcaev3.pdf.
Deeks 2001
  • Deeks JJ, Altman DG, Bradburn MJ. Statistical methods for examining for heterogeneity and combining results from several studies in meta-analysis. In: Egger M, Davey Smith G, Altman DG editor(s). Systematic Reviews in Healthcare: Meta-Analysis in Context. 2nd Edition. London: BMJ Publication Group, 2001.
DerSimonian 1986
EMA 2010
  • European Medicines Agency. EPARs for authorised medicinal products for human use. http://www.emea.europa.eu/docs/en_GB/document_library/EPAR_-_Summary_for_the_public/human/000089/WC500020173.pdf 2010 (accessed 24 January 2013).
EMA 2011
  • European Medicines Agency. Avastin (bevacizumab) product page. http://www.ema.europa.eu/docs/en_GB/document_library/EPAR_-_Product_Information/human/000582/WC500029271.pdf.
EUROCARE-4 2009
  • Sant M, Allemani C, Santaquilani M, Knijn A, Marchesi F, Capocaccia R. EUROCARE-4. Survival of cancer patients diagnosed in 1995-1999. Results and commentary. European Journal of Cancer 2009;45(6):931-91.
FIGO 2009
  • FIGO CinGO. Current FIGO staging for cancer of the vagina, fallopian tube, ovary, and gestational trophoblastic neoplasia. International Journal of Gynecology and Obstetrics 2009;105(1):3-4.
Gabizon 1997
  • Gabizon A, Martin F. Polyethylene glycol-coated (pegylated) liposomal doxorubicin: rationale for use in solid tumours. Drugs 1997;54(Suppl 4):15-21.
Gabizon 2001
GLOBOCAN 2008
  • Ferlay J, Shin HR, Bray F, Forman D, Mathers C, Parkin DM. GLOBOCAN 2008, Cancer Incidence and Mortality Worldwide. IARC CancerBase No. 10 [Internet]. Lyon, France: International Agency for Research on Cancer; 2010. http://globocan.iarc.fr. Lyon, France.
HeCOG 2010
  • Bafaloukos D, Linardou H, Aravantinos G, Papadimitriou G, Bamias A, Fountzilas G, et al. A randomized phase II study of carboplatin plus pegylated liposomal doxorubicin versus carboplatin plus paclitaxel in platinum sensitive ovarian cancer patients: a Hellenic Cooperative Oncology Group study. BMC Medicine 2010;8:3.
Higgins 2003
Higgins 2011
  • Higgins JPT, Green S (editors). Cochrane Handbook for Systematic Reviews of Interventions Version 5.1.0 [updated March 2011]. The Cochrane Collaboration, 2011. www.cochrane-handbook.org.
Jacobs 1988
  • Jacobs I, Bridges J, Reynolds C, Stabile I, Kemsley P, Grudzinskas J, et al. Multimodal approach to screening for ovarian cancer. The Lancet 1988;331(8580):268-71.
Janssen-Cilag 2011
  • Janssen-Cilag P, Ltd. CAELYX Product Information. http://www.janssen.com.au/Products/Caelyx. Amended 4 January 2011 (accessed 24 January 2013).
Katsumata 2009
  • Katsumata N, Yasuda M, Takahashi F, Isonishi S, Jobo T, Aoki D, et al. Dose-dense paclitaxel once a week in combination with carboplatin every 3 weeks for advanced ovarian cancer: a phase 3, open-label, randomised controlled trial. The Lancet 2009;374(9698):1331-8.
Lawrie 2013
  • Lawrie TA, Bryant A, Cameron A, Gray E, Morrison J. Pegylated liposomal doxorubicin for relapsed epithelial ovarian cancer. Cochrane Database of Systematic Reviews 2013, Issue 7. [DOI: 10.1002/14651858.CD006910.pub2]
Markman 2010
  • Markman M, Moon J, Wilczynski S, Lopez AM, Rowland KM, Michelin DP, et al. Single agent carboplatin versus carboplatin plus pegylated liposomal doxorubicin in recurrent ovarian cancer: final survival results of a SWOG (S0200) phase 3 randomized trial. Gynecologic Oncology 2010;116(3):323-5.
Menon 2009
  • Menon U, Gentry-Maharaj A, Hallett R, Ryan A, Burnell M, Sharma A, et al. Sensitivity and specificity of multimodal and ultrasound screening for ovarian cancer, and stage distribution of detected cancers: results of the prevalence screen of the UK Collaborative Trial of Ovarian Cancer Screening (UKCTOCS). The Lancet Oncology 2009;10(4):327-40.
NICE 2003
  • National Institute for Health and Clinical Excellence. Guidance on the use of paclitaxel in the treatment of ovarian cancer (TA55). London: National Institute for Health and Clinical Excellence, 2003.
NICE 2011
  • National Institute for Health and Clinical Excellence. Ovarian cancer: the recognition and initial management of ovarian cancer (CG122). London: National Institute for Health and Clinical Excellence 2011.
OCMP 1991
  • Ovarian Cancer Meta-analysis Project. Cyclophosphamide plus cisplatin versus cyclophosphamide, doxorubicin and cisplatin chemotherapy of ovarian carcinoma. Journal of Clinical Oncology 1991;9:1668-74.
Ozols 1980
  • Ozols RF, Wilson JK, Weltz MD, Grotzinger KR, Myers CE, Young RC. Inhibition of human ovarian cancer colony formation by adriamycin and its major metabolites. Cancer Research 1980;40:4109-12.
Perren 2011
  • Perren TJ, Swart AM, Pfisterer J, Ledemann JA, Pujade-Lauraine E, Kristensen G, and the ICON7 Investigators. A phase 3 trial of bevacizumab in ovarian cancer. New England Journal of Medicine 2011;365:2484-96.
RevMan 2012
  • The Nordic Cochrane Centre, The Cochrane Collaboration. Review Manager (RevMan). 5.2. Copenhagen: The Nordic Cochrane Centre, The Cochrane Collaboration, 2012.
SEER 2007
  • Kosary CL. Chapter 16: Cancer of the ovary. In: Ries LAG, Young JL, Keel GE, Eisner MP, Lin YD, Horner M-J editor(s). Cancer Survival Among Adults: US SEER Program, 1988-2001. Bethesda: US Department of Health and Human Services; National Cancer Institute, 2007:133-44.
Stark 2013
  • Stark D, Nankivell M, Pujade-Lauraine E, Kristensen G, Elit L, Stockler M, et al. Standard chemotherapy with or without bevacizumab in advanced ovarian cancer: quality-of-life outcomes from the International Collaboration on Ovarian Neoplasms (ICON7) phase 3 randomised trial. The Lancet Oncology 2013;14(3):236-43.
Therasse 2000
  • Therasse P, Arbuck SG, Eisenhauer EA, Wanders J, Kaplan RS, Rubinstein L, et al. New guidelines to evaluate the response to treatment in solid tumors. European Organization for Research and Treatment of Cancer, National Cancer Institute of the United States, National Cancer Institute of Canada. Journal of the National Cancer Institute 2000;92(3):205-16.
Waterhouse 2001
  • Waterhouse DN, Tardi PG, Mayer LD, Bally MB. A comparison of liposomal formulations of doxorubicin with drug administered in free form: changing toxicity profiles. Drug Safety 2001;24:903-20.
Zunino 2002
  • Zunino F, Pratesi G. Antitumour antibodies. Oxford Textbook of Oncology. 2nd Edition. Oxford, UK: Oxford University Press, 2002:715-27.