Abstract
Objective
To evaluate the efficacy and toxicity of combined paclitaxel and carboplatin treatment for persistent or recurrent uterine sarcoma.
Methods
Paclitaxel was administrated at 175 mg/m2 intravenously over 3 h plus carboplatin at AUC 5 intravenously over 30 min every 3-week cycle in patients with recurrent or progressive uterine sarcoma, who were unsuitable candidates for curative treatment with either surgery or radiotherapy. The Simon’s two-stage optimal design was chosen for defining the total number of patients required for the phase II study. A total of 13 patients were entered in the study at the first stage of trial. A median of four cycles were administrated per patient, with a range of one to nine cycles. Prior to the study, 4 (30.8 %) of the 13 patients had received radiotherapy or chemotherapy. The response was measured by evaluation of the size of the mass by CT scan.
Results
The overall response rate was 15.4 % (2/13), with two patients exhibiting partial responses. There was 1 (7.7 %) case of stable disease and 9 (69.2 %) cases of progression disease. The median progression free survival was 2.23 months (95 % confidence interval 1.94–3.67). Peripheral neuropathy and hematologic toxicity, including anemia and neutropenia, were the most frequent adverse events. One patient died from treatment-related toxicities.
Conclusions
Paclitaxel in combination with carboplatin demonstrated acceptable levels of toxicity, but it was not active in the treatment of recurrent or progressive uterine sarcoma. This regimen might have limited role for advanced uterine sarcomas.
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References
Chauveinc L, Deniaud E, Plancher C, Sastre X, Amsani F, de la Rochefordiere A et al (1999) Uterine sarcomas: the Curie Institut experience. Prognosis factors and adjuvant treatments. Gynecol Oncol 72:232–237
Shumsky AG, Stuart GC, Brasher PM, Nation JG, Robertson DI, Sangkarat S (1994) An evaluation of routine follow-up of patients treated for endometrial carcinoma. Gynecol Oncol 55:229–233
Brooks SE, Zhan M, Cote T, Baquet CR (2004) Surveillance, epidemiology, and end results analysis of 2677 cases of uterine sarcoma 1989–1999. Gynecol Oncol 93:204–208
Jeong NH, Lee JM, Lee SK (2010) Current status in the management of uterine corpus cancer in Korea. J Gynecol Oncol 21:151–162
Omura GA, Major FJ, Blessing JA, Sedlacek TV, Thigpen JT, Creasman WT et al (1983) A randomized study of adriamycin with and without dimethyl triazenoimidazole carboxamide in advanced uterine sarcomas. Cancer 52:626–632
Muss HB, Bundy B, DiSaia PJ, Homesley HD, Fowler WC Jr, Creasman W et al (1985) Treatment of recurrent or advanced uterine sarcoma. A randomized trial of doxorubicin versus doxorubicin and cyclophosphamide (a phase III trial of the Gynecologic Oncology Group). Cancer 55:1648–1653
Sutton GP, Blessing JA, Rosenshein N, Photopulos G, DiSaia PJ (1989) Phase II trial of ifosfamide and mesna in mixed mesodermal tumors of the uterus (a Gynecologic Oncology Group study). Am J Obstet Gynecol 161:309–312
Thigpen JT, Blessing JA, Beecham J, Homesley H, Yordan E (1991) Phase II trial of cisplatin as first-line chemotherapy in patients with advanced or recurrent uterine sarcomas: a Gynecologic Oncology Group study. J Clin Oncol 9:1962–1966
Curtin JP, Blessing JA, Soper JT, DeGeest K (2001) Paclitaxel in the treatment of carcinosarcoma of the uterus: a Gynecologic Oncology Group study. Gynecol Oncol 83:268–270
Powell MA, Filiaci VL, Rose PG, Mannel RS, Hanjani P, Degeest K et al (2010) Phase II evaluation of paclitaxel and carboplatin in the treatment of carcinosarcoma of the uterus: a Gynecologic Oncology Group study. J Clin Oncol 28:2727–2731
Toyoshima M, Akahira J, Matsunaga G, Niikura H, Ito K, Yaegashi N et al (2004) Clinical experience with combination paclitaxel and carboplatin therapy for advanced or recurrent carcinosarcoma of the uterus. Gynecol Oncol 94:774–778
Hoskins PJ, Le N, Ellard S, Lee U, Martin LA, Swenerton KD et al (2008) Carboplatin plus paclitaxel for advanced or recurrent uterine malignant mixed mullerian tumors. The British Columbia Cancer Agency experience. Gynecol Oncol 108:58–62
Oliva E, Clement PB, Young RH (2000) Endometrial stromal tumor: an update on a group of tumors with a protean phenotype. Adv Anat Pathol 7:257
Evans HL (1982) Endometrial stromal sarcoma and poorly differentiated endometrial sarcoma. Cancer 50:2172
Calvert AH, Newell DR, Gumbrell LA, O’Reilly S, Burnell M, Boxall FE et al (1989) Carboplatin dosage: prospective evaluation of a simple formula based on renal function. J Clin Oncol 7:1748–1756
Jelliffe RW (1973) Letter: creatinine clearance: bedside estimate. Ann Intern Med 79:604–605
Simon R (1989) Optimal two-stage designs for phase II clinical trials. Control Clin Trials 10:1–10
Edmonson JH, Ryan LM, Blum RH, Brooks JS, Shiraki M, Frytak S et al (1993) Randomized comparison of doxorubicin alone versus ifosfamide plus doxorubicin or mitomycin, doxorubicin, and cisplatin against advanced soft tissue sarcomas. J Clin Oncol 11:1269–1275
Le Cesne A, Judson I, Crowther D, Rodenhuis S, Keizer HJ, Van Hoesel Q et al (2000) Randomized phase III study comparing conventional-dose doxorubicin plus ifosfamide versus high-dose doxorubicin plus ifosfamide plus recombinant human granulocyte-macrophage colony-stimulating factor in advanced soft tissue sarcomas: a trial of the European Organization for Research and Treatment of Cancer/Soft Tissue and Bone Sarcoma Group. J Clin Oncol 18:2676–2684
Antman K, Crowley J, Balcerzak SP, Rivkin SE, Weiss GR, Elias A et al (1993) An intergroup phase III randomized study of doxorubicin and dacarbazine with or without ifosfamide and mesna in advanced soft tissue and bone sarcomas. J Clin Oncol 11:1276–1285
Gallup DG, Blessing JA, Andersen W, Morgan MA (2003) Evaluation of paclitaxel in previously treated leiomyosarcoma of the uterus: a Gynecologic Oncology Group study. Gynecol Oncol 89:48–51
Pectasides D, Pectasides E, Papaxoinis G, Koumarianou A, Psyrri A, Xiros N et al (2009) Combination chemotherapy with docetaxel, vinorelbine and estramustine phosphate in metastatic androgen-resistant prostate cancer: a single institution experience. Anticancer Res 29(2):769–775
Arend R, Doneza JA, Wright JD (2011) Uterine carcinosarcoma. Curr Opin Oncol 23:531–536
Amant F, Coosemans A, Debiec-Rychter M, Timmerman D, Vergote I (2009) Clinical management of uterine sarcomas. Lancet Oncol 10(12):1188–1198
Hensley ML, Blessing JA, Degeest K, Abulafia O, Rose PG, Homesley HD (2008) Fixed-dose rate gemcitabine plus docetaxel as second-line therapy for metastatic uterine leiomyosarcoma: a Gynecologic Oncology Group phase II study. Gynecol Oncol 109:323–328
Look KY, Sandler A, Blessing JA, Lucci JA 3rd, Rose PG, Gynecologic Oncology Group (GOG) Study (2004) Phase II trial of gemcitabine as second-line chemotherapy of uterine leiomyosarcoma: a Gynecologic Oncology Group (GOG) Study. Gynecol Oncol 92:644–647
Maki RG, Wathen JK, Patel SR et al (2007) Randomized phase II study of gemcitabine and docetaxel compared with gemcitabine alone in patients with metastatic soft tissue sarcomas: results of sarcoma alliance for research through collaboration study. J Clin Oncol 25:2755–2763
Sutton G, Blessing JA, Ball H (1999) Phase II trial of paclitaxel in leiomyosarcoma of the uterus: a gynecologic oncology group study. Gynecol Oncol 74:346–349
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Yoo, H.J., Lim, M.C., Lim, S. et al. Phase II study of paclitaxel in combination with carboplatin for patients with recurrent or persistent uterine sarcoma. Arch Gynecol Obstet 286, 1529–1535 (2012). https://doi.org/10.1007/s00404-012-2466-4
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DOI: https://doi.org/10.1007/s00404-012-2466-4