Uterine Sarcoma Treatment Regimens

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UTERINE SARCOMA TREATMENT REGIMENS

Clinical Trials: The National Comprehensive Cancer Network (NCCN) recommends cancer patient participation in clinical trials as the gold standard for treatment.

Cancer therapy selection, dosing, administration, and the management of related adverse events can be a complex process that should be handled by an experienced healthcare team. Clinicians must choose and verify treatment options based on the individual patient; drug dose modifications and supportive care interventions should be administered accordingly. The cancer treatment regimens below may include both U.S. Food and Drug Administration-approved and unapproved indications/regimens. These regimens are only provided to supplement the latest treatment strategies.

These Guidelines are a work in progress that may be refined as often as new significant data becomes available. The NCCN Guidelines® are a consensus statement of its authors regarding their views of currently accepted approaches to treatment. Any clinician seeking to apply or consult any NCCN Guidelines® is expected to use independent medical judgment in the context of individual clinical circumstances to determine any patient's care or treatment. The NCCN makes no warranties of any kind whatsoever regarding their content, use, or application and disclaims any responsibility for their application or use in any way.

Systemic Therapy for Uterine Sarcoma1

NOTE: All recommendations are category 2A unless otherwise indicated.

Combination Regimens

(Revised 6/2017)

© 2017 Haymarket Media, Inc.

REGIMEN

DOSING

Docetaxel + gemcitabine2ab (Preferred for leiomyosarcoma)

Days 1 and 8: Gemcitabine 900mg/m2 IV over 90 minutes followed by docetaxel 100mg/m2 IV over 60 minutes on day 8 followed by

Days 9–15: Granulocyte colony-stimulating factor (G-CSF) 150μ/m2 SQ Or Pegfilgrastim 6mg SQ on day 9 or 10.

Repeat cycle every 3 weeks until disease progression or toxicity occurs.

Doxorubicin + ifosfamide3

Day 1: Doxorubicin 50mg/m2 over 15 minutes followed by ifosfamide 5g/m2 via 24-hour continuous IV admixed with mesna 6g/m2 36-hour continuous IV.

Repeat cycle every 3 weeks if counts allow.

Doxorubicin + dacarbazine4

Day 1: Doxorubicin 60mg/m2 IV.

Days 1–4: Dacarbazine 750mg/m2 IV via continuous infusion for 96 hours.

Repeat cycle every 3 weeks.

Gemcitabine + dacarbazine5

Day 1: Gemcitabine 10mg/m2/min IV over 180 minutes followed by dacarbazine 500mg/m2 IV over 20 minutes.

Repeat every 2 weeks for a total of 12 cycles.

Gemcitabine + vinorelbine6

Days 1 and 8: Vinorelbine 25mg/m2 IV over 10 minutes followed by gemcitabine 800mg/m2 IV over 90 minutes.

Repeat cycle every 21 days.

Single-Agent Regimens

Dacarbazine5

Day 1: Dacarbazine 1200mg/m2 IV over 20 minutes.

Repeat cycle every 3 weeks for total of 8 cycles.

Doxorubicin7

Day 1: Doxorubicin 75mg/m2 IV bolus.

Repeat every 3 weeks.

Epirubicin8

Day 1: Epirubicin 75mg/m2 IV bolus.

Repeat every 3 weeks.

Eribulin9 (Category 2B)

Days 1 and 8: Eribulin 1.4mg/m2 IV.

Repeat every 21 days until disease progression or unacceptable toxicity.

Gemcitabine10

Days 1, 8, and 15: Gemcitabine 1,000mg/m2 IV over 30 minutes.

Repeat every 4 weeks.

Ifosfamide11

Days 1–5: Ifosfamide 1.5gm/m2 IV daily with mesna.

Liposomal doxorubicin12

Day 1: Liposomal doxorubicin 50mg/m2.

Repeat every 4 weeks.

Pazopanib13

Pazopanib 800mg orally once daily until disease progression or unacceptable toxicity.

Temozolomide12

Temozolomide 50–75mg/m2 daily for 6 of 8 weeks.

Trabectedin14-17c

Trabectedin 1.5mg/m2 via 24-hour continuous IV infusion.

Repeat once every 3 weeks.

Vinorelbine (Category 2B)18

Days 1 and 8: Vinorelbine 30mg/m2.

Repeat every 21 days.

Docetaxel (Category 3)19

Days 1, 8, and 15: Docetaxel 36mg/m2 IV over 1 hour.

Repeat every 28 days until disease progression or unacceptable toxicity.

Hormone Therapy1d

Medroxyprogesterone acetate (Category 2B for ER/PR-positive uLMS), megestrol acetate (Category 2B for ER/PR-positive uLMS), aromatase inhibitors, gonadotropin-releasing hormone analogs (Category 2B for low-grade ESS and ER/PR-positive uLMS)

Abbreviations: ER = estrogen receptor; ESS = endometrial stromal sarcoma; PR = progesterone receptor; SQ = subcutaneous; uLMS = uterine leiomyosarcoma; UUS = undifferentiated uterine sarcoma.

a Preferred for uLMS.

b Patients with prior pelvic irradiation received gemcitabine 675mg/m2 IV and docetaxel 75mg/m2 IV.

c For uLMS that has been treated with a prior anthracycline-containing regimen.

d For low-grade ESS or hormone-receptor positive (ER/PR) uLMS; preferably there is small tumor volume or an indolent growth pace.

References

1. Referenced with permission from the NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines®) for Uterine Neoplasms V.2.2017. Available at: http://www.nccn.org/ professionals/physician_gls/pdf/uterine.pdf. Accessed June 1, 2017.

2. Hensley ML, Blessing JA, Mannel R, Rose PG. Fixed-dose rate gemcitabine plus docetaxel as first-line therapy for metastatic uterine leiomyosarcoma: a Gynecologic Oncology Group phase II trial. Gynecol Oncol. 2008;109(3):329–334.

3. Sutton G, Blessing JA, Malfetano JH. Ifosfamide and doxorubicin in the treatment of advanced leiomyosarcomas of the uterus: a Gynecologic Oncology Group study. Gynecol Oncol. 1996;62(2): 226–229.

4. Zalupski M, Metch B, Balcerzak S, et al. Phase III comparison of doxorubicin and dacarbazine given by bolus versus infusion in patients with soft-tissue sarcomas: a Southwest Oncology Group study. J Natl Cancer Inst. 1991;83(13):926–932.

5. Garcia-Del-Muro X, Lopez-Pousa A, Maurel J, et al. Randomized phase II study comparing gemcitabine plus dacarbazine versus dacarbazine alone in patients with previously treated soft tissue sarcoma: a Spanish Group for Research on Sarcomas study. J Clin Oncol. 2011;29(18):2528–2533.

6. Dileo P, Morgan J, Zahrieh D, et al. Gemcitabine and vinorelbine combination chemotherapy for patients with advanced soft tissue sarcomas. Cancer. 2007;109(9):1863–1869.

7. Judson I, Radford JA, Harris M, et al. Randomized phase II trial of pegylated liposomal doxorubicin (DOXIL/CAELYX) versus doxorubicin in the treatment of advanced or metastatic soft tissue sarcoma: a study by the EORTC Soft Tissue and Bone Sarcoma Group. Eur J Cancer. 2001;37(7):870–877.

8. Mouridsen HT, Bastholt L, Somers R, et al. Adriamycin versus epirubicin in advanced soft tissue sarcomas. A randomized phase II/phase III study of the EORTC Soft Tissue and Bone Sarcoma Group. Eur J Cancer Clin Oncol. 1987;23(10):1477–1483.

9. Schöffski P, Maki RG, Italiano A, et al. Randomized, open-label, multicenter, phase III study of eribulin versus dacarbazine in patients (pts) with leiomyosarcoma (LMS) and adipocytic sarcoma (ADI). J Clin Oncol. 2015;33(18_suppl):L2BA10502.

10. Look KY, Sandler A, Blessing JA, et al. Phase II trial of gemcitabine as second-line chemotherapy of uterine leiomyosarcoma: a Gynecologic Oncology Group (GOG) Study. Gynecol Oncol. 2004;92(2):644–647.

11. Sutton GP, Blessing JA, Barrett RJ, et al. Phase II trial of ifosfamide and mesna in leiomyosarcoma of the uterus: a Gynecologic Oncology Group study. Am J Obstet Gynecol. 1992;166(2):556–559.

12. Amant F, Coosemans A, Debiec-Rychter M, et al. Clinical management of uterine sarcomas. Lancet Oncol. 2009;10(12):1188–1198.

13. van der Graaf WT, Blay JY, Chawla SP, et al. Pazopanib for metastatic soft-tissue sarcoma (PALETTE): a randomised, double-blind, placebo-controlled phase 3 trial. Lancet. 2012;379(9829):1879–1886.

14. Gajdos C, Elias A. Trabectedin: safety and efficacy in the treatment of advanced sarcoma. Clin Med Insights Oncol. 2011;5:35–43.

15. Demetri GD, Chawla SP, von Mehren M, et al. Efficacy and safety of trabectedin in patients with advanced or metastatic liposarcoma or leiomyosarcoma after failure of prior anthracyclines and ifosfamide: results of a randomized phase II study of two different schedules. J Clin Oncol. 2009;27(25): 4188–4196.

16. Fayette J, Boyle H, Chabaud S, et al. Efficacy of trabectedin for advanced sarcomas in clinical trials versus compassionate use programs: analysis of 92 patients treated in a single institution. Anticancer Drugs. 2010;21(1):113–119.

17. Pautier P, Floquet A, Chevreau C, et al; French Sarcoma Group. Trabectedin in combination with doxorubicin for first-line treatment of advanced uterine or soft-tissue leiomyosarcoma (LMS-02): a non-randomised, multicentre, phase 2 trial. Lancet Oncol. 2015;16(4):457–464.

18. Muggia F, Blessing JA, Method M. Evaluation of vinorelbine in persistent or recurrent squamous cell carcinoma of the cervix: a Gynecologic Oncology Group study. Gynecol Oncol. 2004;92(2):639–643.

19. Garcia AA, Blessing JA, Nolte S, Mannel RS. A phase II evaluation of weekly docetaxel in the treatment of recurrent or persistent endometrial carcinoma: a study by the Gynecologic Oncology Group. Gynecol Oncol. 2008;111(1):22–26.


Gynecological Cancer Drug Monographs

Gynecologic Cancers

ALKERAN AVASTIN Bleomycin
Carboplatin Cisplatin COSMEGEN
Cyclophosphamide CYTOXAN INJECTION DEPO-PROVERA
DOXIL Doxorubicin HCl Doxorubicin HCl Solution
GEMZAR HEXALEN HYCAMTIN
LYNPARZA Megestrol acetate Methotrexate for injection
Methotrexate injection RUBRACA TAXOL
Thiotepa TREXALL Vinblastine for injection
Vinblastine injection ZEJULA

Data provided by the Monthly Prescribing Reference (MPR) Hematology/Oncology Edition.

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