Leiomyosarcoma - null regimens
The purpose of this page is to provide references to "null therapy" such as placebo and observation. These references provide further insight into the historical development of the treatment landscape. See the main LMS page for regimens that include active anticancer treatment.
|Study||Dates of enrollment||Evidence||Comparator||Comparative Efficacy|
|Pautier et al. 2012 (SARCGYN)||2001-2009||Phase 3 (C)||API||Seems to have inferior DFS|
|Hensley et al. 2018 (GOG-0277)||2012-2016||Phase 3 (C)||GD, then Doxorubicin||Did not meet primary endpoint of OS|
No further treatment.
- GOG-0277: Hysterectomy
- SARCGYN: Pautier P, Floquet A, Gladieff L, Bompas E, Ray-Coquard I, Piperno-Neumann S, Selle F, Guillemet C, Weber B, Largillier R, Bertucci F, Opinel P, Duffaud F, Reynaud-Bougnoux A, Delcambre C, Isambert N, Kerbrat P, Netter-Pinon G, Pinto N, Duvillard P, Haie-Meder C, Lhommé C, Rey A; French Sarcoma Group. A randomized clinical trial of adjuvant chemotherapy with doxorubicin, ifosfamide, and cisplatin followed by radiotherapy versus radiotherapy alone in patients with localized uterine sarcomas (SARCGYN study). Ann Oncol. 2013 Apr;24(4):1099-104. Epub 2012 Nov 8. link to original article PubMed NCT00162721
- GOG-0277: Hensley ML, Enserro D, Hatcher H, Ottevanger PB, Krarup-Hansen A, Blay JY, Fisher C, Moxley KM, Lele SB, Lea JS, Tewari KS, Thaker PH, Zivanovic O, O'Malley DM, Robison K, Miller DS. Adjuvant gemcitabine plus docetaxel followed by doxorubicin versus observation for high-grade uterine leiomyosarcoma: a phase III NRG Oncology/Gynecologic Oncology Group study. J Clin Oncol. 2018 Nov 20;36(33):3324-30. Epub 2018 Oct 5. link to original article link to PMC article PubMed NCT01533207