Abstract
Background
The efficacy of weekly paclitaxel has not been well characterized in either cervical or endometrial cancer.
Methods
Eligible women had disseminated endometrial or squamous cell cancer of the cervix, one prior chemotherapy regimen, measurable disease, and a Gynecologic Oncology Group (GOG) performance status of 0–2. At entry, all laboratory results were within normal limits. Paclitaxel 80 mg/m2 was administered by intravenous infusion over 1 h every 7 days. Response served as the endpoint of the trial.
Results
Forty-four patients were registered, and 15 of 16 patients with endometrial cancer and 20 of 28 patients with cervical cancer were evaluable for response. Four of the 15 (26.7%) endometrial cancer patients responded to treatment, with one complete response of 22 weeks and three partial responses. Stable disease was present in 26.7%. Two of the 20 (10%) cervical cancer patients responded to treatment, with one complete response of 25 weeks and one partial response of 14 weeks. Stable disease was present in 35%. Adverse effects were minimal and easily managed with dose adjustments as needed.
Conclusion
Although confirmatory larger trials are needed, weekly paclitaxel appears promising for advanced endometrial carcinoma, and possibly for squamous cell carcinoma of the cervix.
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References
Homesley HD, Blessing JA, Sorosky J, et al. (2005) Phase II trial of liposomal doxorubicin at 40 mg/m2 every 4 weeks in endometrial carcinoma: a Gynecologic Oncology Group Study. Gynecol Oncol 98:294–298
Bonomi P, Blessing JA, Stehman FB, et al. (1985) Randomized trial of three cisplatin dose schedules in squamous-cell carcinoma of the cervix: a Gynecologic Oncology Group study. J Clin Oncol 3:1079–1085
Lhomme C, Vermorken JB, Mickiewicz E, et al. (2000) Phase II trial of vinorelbine in patients with advanced and/or recurrent cervical carcinoma: an EORTC Gynaecological Cancer Cooperative Group Study. Eur J Cancer 36:194–199
Schilder RJ, Blessing JA, Morgan M, et al. (2000) Evaluation of gemcitabine in patients with squamous cell carcinoma of the cervix: a phase II study of the Gynecologic Oncology Group. Gynecol Oncol 76:204–207
Ota S, Sugiyama T, Ushijima K, et al. (2001) Remission of metastatic cervical adenocarcinoma with weekly paclitaxel. Int J Gynecol Cancer 11:167–168
Moore DH, Blessing JA, McQuellon RP, et al. (2004) 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 22:3113–3119
Terauchi F, Nagashima T, Kobayashi Y, et al. (2005) A pilot study of weekly paclitaxel administration for patients with relapsed cervical cancer after heavy medication. Gan to Kagaku Ryoho (Japanese Journal of Cancer & Chemotherapy) 32:641–644
Eisenhauer EA, ten Bokkel Huinink WW, Swenerton KD, et al. (1994) European-Canadian randomized trial of paclitaxel in relapsed ovarian cancer: high dose versus low dose and long versus short infusion. J Clin Oncol 12:2654–2666
Greco FA, Hainsworth JD (1994) Paclitaxel (Taxol): phase I/II trial comparing 1 hour infusion schedules. Semin Oncol 21:3–8
Schiller JH, Storer B, Tutsch K, et al. (1994) Phase I trial of 3-hour infusion of paclitaxel with or without granulocyte colony-stimulating factor in patients with advanced cancer. J Clin Oncol 12:241–248
Balat O, Kudelka AP, Tunca JC, et al. (1996) Prolonged stabilization of progressive platinum-refractory ovarian cancer with paclitaxel: brief report. Eur J Gynecol Oncol 17:264–266
Tsavaris N, Polyzos A, Kosmas C, et al. (1997) A feasibility study of 1 h paclitaxel infusion in patients with solid tumors. Cancer Chemo Pharm Cancer Chemotherapy & Pharmacology 40: 353–357
Seidman AD, Hudis CA, Albanel J, et al. (1998) Dose-dense therapy with weekly 1-h paclitaxel infusion in the treatment of metastatic breast cancer. J Clin Oncol 16:3353–3361
Klaassen U, Wilke H, Strumberg D, et al. (1996) Phase I study with a weekly 1 h infusion of paclitaxel in heavily pretreated patients with metastatic breast and ovarian cancer. Eur J Cancer 32A:547–549
Loffler TM, Freund W, Lipke J, et al. (1996) Schedule-and dose-intensified paclitaxel as weekly 1-hour infusion in pretreated solid tumors: results of a phase I/II trial. Semin Oncol 23:32–34
Abu-Rustum N, Aghajanian C, Barakat RR, et al. (1997) Salvage weekly paclitaxel in recurrent ovarian cancer. Semin Oncol 24:62–67
Fennelly D, Aghajanian C, Shapiro F, et al. (1997) Phase I and pharmacologic study of paclitaxel administered weekly in patients with relapsed ovarian cancer. J Clin Oncol 15:187–192
Perez EA, Vogel CL, Irwin DH, et al. (2001) Multicenter phase II trial of weekly paclitaxel in women with metastatic breast cancer. J Clin Oncol 19:4216–4223
Markman M, Hall J, Spitz D, et al. (2002) Phase II trial of weekly single-agent paclitaxel in platinum/paclitaxel-refractory ovarian cancer. J Clin Oncol 20:2365–2369
Rosenberg P, Andersson H, Boman K, et al. (2002) Randomized trial of single agent paclitaxel given weekly versus every 3 weeks and with per oral versus intravenous steroid premedication to patients with ovarian cancer previously treated with platinum. Acta Oncol 41:418–424
Vaughn DJ, Broome CM, Hussain M, et al. (2002) Phase II trial of weekly paclitaxel in patients with previously treated advanced urothelial cancer. J Clin Oncol 20:937–940
Boruta DM 2nd, Fowler WC Jr, Gehrig PA, et al. (2003) Weekly paclitaxel infusion as salvage therapy in ovarian cancer. Cancer Invest 21:675–681
Markman M, Fowler J (2004) Activity of weekly paclitaxel in patients with advanced endometrial cancer previously treated with both a platinum agent and paclitaxel. Gynecol Oncol 92:180–182
Akizuki S, Katsumata N, Yamanaka Y, et al. (2005) Weekly paclitaxel in patients with CAP-resistant advanced or recurrent endometrial carcinoma: a series of four patients. Int J Clin Oncol 10:272–275
Ball HG, Blessing JA, Lentz SS, et al. (1996) A phase II trial of paclitaxel in patients with advanced or recurrent adenocarcinoma of the endometrium: a Gynecologic Oncology Group study. Gynecol Oncol 62:278–281
Woo HL, Swenerton KD, Hoskins PH (1996) Taxol is active in platinum-resistant endometrial adenocarcinoma. Am J Clin Oncol 19:290–291
Lissoni A, Zanetta G, Losa G, et al. (1996) Phase II study of paclitaxel as salvage treatment in advanced endometrial cancer. Ann Oncol 7:861–863
Nishio S, Ota S, Sugiyama T, et al. (2003) Weekly 1-h paclitaxel infusion in patients with recurrent endometrial cancer: a preliminary study. In J Clinical Oncol 8:45–48
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Homesley, H.D., Meltzer, N.P., Nieves, L. et al. A phase II trial of weekly 1-hour paclitaxel as second-line therapy for endometrial and cervical cancer. Int J Clin Oncol 13, 62–65 (2008). https://doi.org/10.1007/s10147-007-0731-5
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DOI: https://doi.org/10.1007/s10147-007-0731-5