Research
Print page Print page
Switch language
The Capital Region of Denmark - a part of Copenhagen University Hospital
Published

Adjuvant Gemcitabine Plus Docetaxel Followed by Doxorubicin Versus Observation for High-Grade Uterine Leiomyosarcoma: A Phase III NRG Oncology/Gynecologic Oncology Group Study

Research output: Contribution to journalJournal articleResearchpeer-review

DOI

  1. Parenthood Rates and Use of Assisted Reproductive Techniques in Younger Hodgkin Lymphoma Survivors: A Danish Population-Based Study

    Research output: Contribution to journalJournal articleResearchpeer-review

  2. Adjuvant Pertuzumab and Trastuzumab in Early HER2-Positive Breast Cancer in the APHINITY Trial: 6 Years' Follow-Up

    Research output: Contribution to journalJournal articleResearchpeer-review

  1. In vitro 4-1BB stimulation promotes expansion of CD8+ tumor-infiltrating lymphocytes from various sarcoma subtypes

    Research output: Contribution to journalJournal articleResearchpeer-review

  2. Improved Survival of Children, Adolescents, and Young Adults With Head and Neck Soft Tissue Sarcomas in Denmark

    Research output: Contribution to journalJournal articleResearchpeer-review

  3. Eribulin versus dacarbazine in patients with leiomyosarcoma: subgroup analysis from a phase 3, open-label, randomised study

    Research output: Contribution to journalJournal articleResearchpeer-review

  • Martee L Hensley
  • Danielle Enserro
  • Helen Hatcher
  • Petronella B Ottevanger
  • Anders Krarup-Hansen
  • Jean-Yves Blay
  • Cyril Fisher
  • Katherine M Moxley
  • Shashikant B Lele
  • Jayanthi S Lea
  • Krishnansu S Tewari
  • Premal H Thaker
  • Oliver Zivanovic
  • David M O'Malley
  • Katina Robison
  • David S Miller
View graph of relations

PURPOSE: We conducted a randomized phase III trial to determine whether adjuvant chemotherapy improves survival in women with uterine leiomyosarcoma.

METHODS: Women with uterus-confined, high-grade leiomyosarcoma who were confirmed disease free by imaging were randomly assigned to four cycles of gemcitabine plus docetaxel, followed by four cycles of doxorubicin, or to observation. All were followed for evidence of recurrence. The primary end point was overall survival (OS).

RESULTS: With international collaboration, 38 of the targeted accrual of 216 patients were enrolled, after which the study was closed by the National Cancer Institute for accrual futility. Twenty patients were assigned to chemotherapy, 18 to observation. Among the 17 patients treated with at least one cycle of chemotherapy, grade 3 or 4 toxicities were observed in 47%; among the 18 patients assigned to observation, one had grade 3 hypertension. There were six deaths (chemotherapy, n = 5; observation, n = 1), all due to disease. The restricted mean survival time for OS was estimated as 34.3 months (95% CI, 25.3 to 43.3 months) in the chemotherapy arm and as 46.4 months (95% CI, 43.6 to 49.1 months) in the observation arm. There were eight recurrences in each arm. The restricted mean survival time for recurrence-free survival was estimated as 18.1 (95% CI, 14.2 to 22.0) months in the chemotherapy arm and as 14.6 months (95% CI, 10.3 to 19.0 months) in the observation arm. Neither survival outcome comparison was considered statistically robust, due to the small sample size.

CONCLUSION: Despite international collaboration to test the role of adjuvant chemotherapy in uterine-confined leiomyosarcoma, this study was closed for accrual futility. Although the sample size precludes robust statistical comparison, observed OS and recurrence-free survival data do not show superior outcomes with adjuvant chemotherapy.

Original languageEnglish
JournalJournal of clinical oncology : official journal of the American Society of Clinical Oncology
Pages (from-to)3324-3330
ISSN0732-183X
DOIs
Publication statusPublished - 20 Nov 2018

ID: 56573698