Taiwanese Journal of Obstetrics and Gynecology
Volume 47, Issue 3 , Pages 322-326, September 2008

Salvage Chemotherapy in Recurrent Cervical Cancer With Biweekly Pegylated Liposomal Doxorubicin (Lipo-Dox)

  • Jen-Ruei Chen

      Affiliations

    • Department of Obstetrics and Gynecology, Mackay Memorial Hospital, Taipei, Taiwan
  • ,
  • Yuh-Cheng Yang

      Affiliations

    • Department of Obstetrics and Gynecology, Mackay Memorial Hospital, Taipei, Taiwan
    • Taipei Medical University, Taipei, Taiwan
    • Mackay Medicine, Nursing and Management College, Taipei, Taiwan
    • Department of Medical Research, Mackay Memorial Hospital, Taipei, Taiwan
  • ,
  • Tze-Chien Chen

      Affiliations

    • Department of Obstetrics and Gynecology, Mackay Memorial Hospital, Taipei, Taiwan
  • ,
  • Jerry Cheng-Yen Lai

      Affiliations

    • Department of Medical Research, Mackay Memorial Hospital, Taipei, Taiwan
  • ,
  • Shing-Jyh Chang

      Affiliations

    • Department of Obstetrics and Gynecology, Mackay Memorial Hospital, Taipei, Taiwan
    • National Tsing Hua University, Hsinchu, Taipei, Taiwan
  • ,
  • Chi-Long Chang

      Affiliations

    • Department of Obstetrics and Gynecology, Mackay Memorial Hospital, Taipei, Taiwan
  • ,
  • Kung-Liahng Wang

      Affiliations

    • Department of Obstetrics and Gynecology, Mackay Memorial Hospital, Taipei, Taiwan
    • Mackay Medicine, Nursing and Management College, Taipei, Taiwan
    • National Taipei College of Nursing, Taipei, Taiwan
    • Corresponding Author InformationCorrespondence to: Dr Kung-Liahng Wang, Division of Gynecologic Oncology, Department of Obstetrics and Gynecology, Mackay Memorial Hospital, 92, Section 2, Chung-Shan North Road, Taipei, Taiwan

Accepted 23 January 2008.

Article Outline

Summary 

Objective

To investigate the objective response rate to and tolerance of biweekly Lipo-Dox (TTY Biopharm Co. Ltd., Taipei, Taiwan) at a dosage of 20 mg/m2 in previously treated patients with recurrent cervical cancer.

Materials and Methods

This study was performed as a Simon's two-stage phase II clinical trial. Ten patients with recurrent cervical cancer were enrolled between April 2003 and December 2005 at the Mackay Memorial Hospital. Lipo-Dox (20 mg/m2 intravenous) diluted in 250 mL of 5% dextrose solution was administered at 2-weekly intervals.

Results

The mean age of the patients was 51 ± 11.1 years. The mean number of cycles of Lipo-Dox injection was 4.6 (range, 1—12 cycles). Nine patients (90%) had disease progression. Only one patient (10%) achieved a partial response, and this was also the only patient who experienced WHO grade 2 palmar-plantar erythrodysesthesia, which led to treatment delay for 2 months. The median survival time was 2 months (range, 2—6 months). The majority of patients experienced grade 1 or 2 anemia (30%), leukopenia (20%) or thrombocytopenia (20%), and others exhibited symptoms of nausea and vomiting (30%).

Conclusion

Salvage chemotherapy with Lipo-Dox at a dose of 20 mg/m2 administered at 2-weekly intervals produced limited responses in patients with recurrent cervical cancer. This trial will not proceed to the second stage. These results may discourage the management of recurrent cervical cancer with single-agent Lipo-Dox in future clinical trials.

Key Words:  cervical cancer , chemotherapy , Lipo-Dox , recurrent , liposomal doxorubicin

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References 

  1. Bosch FX , Manos MM , Munoz N , et al.   Prevalence of human papillomavirus in cervical cancer: a worldwide perspective. International Biological Study on Cervical Cancer (IBSCC) Study Group . J Natl Cancer Inst . 1995;87:796–802
  2. Chen HS , Yang YC , Su TH , Wang TY , Huang YW . Human papillomavirus testing (hybrid capture II) to detect highgrade cervical intraepithelial neoplasia in women with mildly abnormal papanicolaou results . Taiwan J Obstet Gynecol . 2005;44:252–257
  3. Cheng WF . Human papillomavirus vaccine for cervical cancer: where are we now? . Taiwan J Obstet Gynecol . 2005;44:232–241
  4. Wang PD , Lin RS . Epidemiology of cervical cancer in Taiwan . Gynecol Oncol . 1996;62:344–352
  5. Bureau of Health Promotion  . Department of Health, Taiwan. November 16, 2006 . Available at: http://www.bhp.doh.gov.tw/asp/themeParkId=510/960305/pdf/951116.pdf [Date accessed: March 22, 2007]
  6. Tseng CC , Tseng CJ , Chang CC , et al.   Human papillomavirus deoxyribonucleic acid sequences and clinical outcomes of cervical cancer patients following radiotherapy . Taiwan J Obstet Gynecol . 2004;43:20–24
  7. Tambaro R, Scambia G, Di Maio M, Pisano C, Barletta E, Iaffaioli VR, et al. The role of chemotherapy in locally advanced, metastatic and recurrent cervical cancer . Crit Rev Oncol Hematol . 2004;52:33–44
  8. Lasic DD . Doxorubicin in sterically stabilized liposomes . Nature . 1996;380:561–562
  9. Verschraegen CF , Kavanagh JJ , Loyer E , et al. , Community Clinical Oncology Program    Phase II study of carboplatin and liposomal doxorubicin in patients with recurrent squamous cell carcinoma of the cervix . Cancer . 2001;92:2327–2333
  10. O'Byrne KJ , Bliss P , Graham JD , et al.   A phase III study of Doxil/Caelyx versus paclitaxel in platinum-treated, taxanenaive relapsed ovarian cancer . Proc Am Soc Clin Oncol . 2002;21:203a; [Abstract 808]
  11. Gordon AN , Fleagle JT , Guthrie D , Parkin DE , Gore ME , Lacave AJ . Recurrent epithelial ovarian carcinoma: a randomized phase III study of pegylated liposomal doxorubicin versus topotecan . J Clin Oncol . 2001;19:3312–3322
  12. Gordon AN , Tonda M , Sun S , Rackoff W , Doxil Study 30–49 Investigators  . Long-term survival advantage for women treated with pegylated liposomal doxorubicin compared with topotecan in a phase 3 randomized study of recurrent and refractory epithelial ovarian cancer . Gynecol Oncol . 2004;95:1–8
  13. Woll PJ, Carmichael J, Chan S, Howell A, Ranson M, Miles D, et al. Phase II study results on safety and tolerability of Caelyx® (Doxil®) in combination with paclitaxel in the treatment of metastatic breast cancer . Proc Am Soc Clin Oncol . 1999;18:117a; [Abstract 442]
  14. Harrison M , Tomlinson D , Stewart S . Liposomal-entrapped doxorubicin: an active agent in AIDS-related Kaposi's sarcoma . J Clin Oncol . 1995;13:914–920
  15. Chou HH , Wang KL , Chen CA , et al. , Taiwanese Gynecologic Oncology Group    Pegylated liposomal doxorubicin (Lipo-Dox) for platinum-resistant or refractory epithelial ovarian carcinoma: a Taiwanese gynecologic oncology group study with long-term follow-up . Gynecol Oncol . 2006;101:423–428
  16. Lorusso D , Naldini A , Testa A , D'Agostino G , Scambia G , Ferrandina G . Phase II study of pegylated liposomal doxorubicin in heavily pretreated epithelial ovarian cancer patients . Oncology . 2004;67:243–249
  17. Martin FJ , Gabizon A , et al.   Human pharmacokinetics of stealth liposomes containing doxorubicin . J Cell Biochem . 1992;50(Suppl 16E):98
  18. Gabizon A . Liposomal anthracyclines . Hematol Oncol Clin North Am . 1994;8:431–450
  19. Ferrandina G , Lorusso D , Longo R , Testa AC , Scambia G . Pegylated liposomal doxorubicin in platinum-treated recurrent or metastatic cervical carcinoma . Gynecol Oncol . 2005;98:332–333
  20. Rose PG , Blessing JA , Lele S , Abulafia O . Evaluation of pegylated liposomal doxorubicin (Doxil) as second-line chemotherapy of squamous cell carcinoma of the cervix: a phase II study of the Gynecologic Oncology Group . Gynecol Oncol . 2006;102:210–213

PII: S1028-4559(08)60132-1

doi:10.1016/S1028-4559(08)60132-1

Taiwanese Journal of Obstetrics and Gynecology
Volume 47, Issue 3 , Pages 322-326, September 2008