HYCAMTIN (topotecan HCI) injection
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References

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  1. Hycamtin [package insert]. Research Triangle Park, NC: GlaxoSmithKline; 2006.

  2. Creemers GJ, Bolis G, Gore M, et al. Topotecan, an active drug in the second-line treatment of epithelial ovarian cancer: results of a large European phase II study. J Clin Oncol. 1996;14(12):3056-3061.

  3. ten Bokkel Huinink W, Gore M, Carmichael J, et al. Topotecan versus paclitaxel for the treatment of recurrent epithelial ovarian cancer. J Clin Oncol. 1997;15(6):2183-2193.

  4. Bookman MA, Malmström H, Bolis G, et al. Topotecan for the treatment of advanced epithelial ovarian cancer: an open-label phase II study in patients treated after prior chemotherapy that contained cisplatin or carboplatin and paclitaxel. J Clin Oncol. 1998;16(10):3345-3352.

  5. McGuire WP, Blessing JA, Bookman MA, Lentz SS, Dunton CJ. Topotecan has substantial antitumor activity as first-line salvage therapy in platinum-sensitive epithelial ovarian carcinoma: a Gynecologic Oncology Group study. J Clin Oncol. 2000;18(5):1062-1067.

  6. 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(14):3312-3322.

  7. Kudelka AP, Tresukosol D, Edwards CL, et al. Phase II study of intravenous topotecan as a 5-day infusion for refractory epithelial ovarian carcinoma. J Clin Oncol. 1996;14(5):1552-1557.

  8. Cesano A, Lane SR, Poulin R, Ross G, Fields SZ. Stabilization of disease as a useful predictor of survival following second-line chemotherapy in small cell lung cancer and ovarian cancer patients. Int J Oncol. 1999;15:1233-1238.

  9. Data on file, GlaxoSmithKline.

  10. von Pawel J, Gatzemeier U, Pujol J-L, et al. Phase II comparator study of oral versus intravenous topotecan in patients with chemosensitive small-cell lung cancer. J Clin Oncol. 2001;19:1743-1749.

  11. Ardizzoni A, Hansen H, Dombernowsky P, et al. Topotecan, a new active drug in the second-line treatment of small-cell lung cancer: a phase II study in patients with refractory and sensitive disease. J Clin Oncol. 1997;15:2090-2096.

  12. von Pawel J, Schiller JH, Shepherd FA, et al. Topotecan versus cyclophosphamide, doxorubicin, and vincristine for the treatment of recurrent small-cell lung cancer. J Clin Oncol. 1999;17:658-667.

  13. Eckardt J, Gralla R, Palmer MC, et al. Topotecan (T) as second-line therapy in patient (Pts) with small cell lung cancer (SCLC): a phase II study [abstract]. Ann Oncol. 1996;7(suppl 5):107. Abstract 513P.

  14. Depierre A, von Pawel J, Hans K, et al. Evaluation of topotecan (Hycamtin®) in relapsed small cell lung cancer (SCLC). A multicentre phase II study [abstract]. Lung Cancer. 1997;18(suppl 1). Abstract 126.

  15. Ogawara M, Negoro S, Nishiwaki Y, Fukuoka M, Watanabe K, Niitani H. Phase II study of topotecan (TOP) for relapsed small cell lung cancer (SCLC) [abstract]. Lung Cancer. 2000;29(suppl 1):40. Abstract 129.

  16. Treat J, Huang CH, Lane SR, Levin J. Topotecan in the treatment of relapsed small cell lung cancer patients with poor performance status. Oncologist. 2004;9:173-181.

  17. Gore M, ten Bokkel Huinink W, Carmichael J, et al. Clinical evidence for topotecan-paclitaxel non–cross-resistance in ovarian cancer. J Clin Oncol. 2001;19:1893-1900.

  18. The ICON and AGO Collaborators. Paclitaxel plus platinum-based chemotherapy versus conventional platinum-based chemotherapy in women with relapsed ovarian cancer: the ICON4/AGO-OVAR-2.2 trial. Lancet. 2003;361:2099-2106.

  19. Spiegelman D, Maurer LH, Ware JH, et al. Prognostic factors in small-cell carcinoma of the lung: an analysis of 1,521 patients. J Clin Oncol. 1989;7:344-354.

  20. Armstrong DK. Topotecan dosing guidelines in ovarian cancer: reduction and management of hematologic toxicity. Oncologist. 2004;9:33-42.

  21. O’Reilly S, Rowinsky EK, Slichenmyer W, et al. Phase I and pharmacologic study of topotecan in patients with impaired renal function. J Clin Oncol. 1996;14:3062-3073.

  22. American Cancer Society. Ovarian Cancer Detailed Guide. Available at:
    www.cancer.org/docroot/CRI/content/CRI_2_4_7x_CRC_Ovarian_
    Cancer_PDF.asp. Accessed August 3, 2006.

  23. National Cancer Institute. Ovarian Germ Cell Tumors (PDQ®): Treatment. Health Professional Version. Available at: www.cancer.gov/cancertopics/pdq/
    treatment/ovarian-germ-cell/healthprofessional/allpages. Accessed August 3, 2006.

  24. National Cancer Institute. Ovarian Epithelial Cancer (PDQ®): Treatment. Health Professional Version. Available at: www.cancer.gov/cancertopics/
    pdq/treatment/ovarianepithelial/healthprofessional/allpages. Accessed August 3, 2006.

  25. National Cancer Institute. Ovarian Cancer (PDQ®): Screening. Health Professional Version. Available at: www.cancer.gov/cancertopics/pdq/
    screening/ovarian/healthprofessional/allpages. Accessed August 3, 2006.

  26. Möbus V, Pfaff PN, Volm T, Kreienberg R, Kaubitzsch S. Long time therapy with topotecan in patients with recurrence of ovarian carcinoma. Anticancer Res. 2001;21:3551-3556.

  27. American Cancer Society. Small Cell Lung Cancer Detailed Guide. Available at: www.cancer.org/docroot/CRI/content/CRI_2_4_7x_
    Lung_Cancer_-_Small_Cell_Detailed_Guide.asp. Accessed August 3, 2006.

  28. National Cancer Institute. Small Cell Lung Cancer (PDQ®): Treatment. Health Professional Version. Available at: www.cancer.gov/cancertopics/
    pdq/treatment/small-cell-lung/healthprofessional/allpages. Accessed August 3, 2006.

  29. National Cancer Institute. Lung Cancer (PDQ®): Prevention. Health Professional Version. Available at: www.cancer.gov/cancertopics/pdq/
    prevention/lung/healthprofessional/allpages. Accessed August 3, 2006.

  30. National Cancer Institute. Lung Cancer (PDQ®): Screening. Health Professional Version. Available at: www.cancer.gov/cancertopics/pdq/
    screening/lung/healthprofessional/allpages. Accessed August 3, 2006.

  31. Long HJ III, Bundy BN, Grendys EC Jr, et al. Randomized phase III trial of cisplatin with or without topotecan in carcinoma of the uterine cervix: a Gynecologic Oncology Group study. J Clin Oncol. 2005;23:4626-4633.

  32. Moore DH, Blessing JA, McQuellon RP, et al. Phase III study of cisplatin with or without paclitaxel in stage IVB, recurrent, or persistent squamous cell carcinoma of the cervix: a Gynecologic Oncology Group study. J Clin Oncol. 2004;22:3113-3119.

  33. Monk BJ, Huang HQ, Cella D, Long HJ III. Quality of life outcomes from a randomized phase III trial of cisplatin with or without topotecan in advanced carcinoma of the cervix: a Gynecologic Oncology Group study. J Clin Oncol. 2005;23:4617-4625.

  34. National Cancer Institute. Cancer Therapy Evaluation Program.
    Common Terminology Criteria for Adverse Events v3.0 (CTCAE).
    Available at: http://ctep.cancer.gov/reporting/ctc_v30.html.
    Accessed August 3, 2006.

  35. American Cancer Society. Cervical Cancer Detailed Guide.
    Available at: http://www.cancer.org/docroot/CRI/content/CRI_2_4_7x_
    CRC_Cervical_Cancer_PDF.asp. Accessed June 1, 2006.

  36. Ahmedin J, Siegel R, Ward E, et al. Cancer Statistics, 2006. CA Cancer J Clin. 2006;56:106-130. Available at:
    http://caonline.amcancersoc.org/cgi/content/full/56/2/106.
    Accessed April 20, 2006.

  37. National Cancer Institute. Cervical Cancer (PDQ®): Treatment.
    Available at: http://www.cancer.gov/cancertopics/pdq/treatment/cervical/
    healthprofessional/allpages. Accessed June 1, 2006.

  38. National Cancer Institute. Cervical Cancer (PDQ®): Screening. Available at: http://www.cancer.gov/cancertopics/pdq/screening/cervical/
    healthprofessional/allpages. Accessed June 1, 2006.

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