Leiomyosarcoma - null regimens

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The purpose of this page is to provide references to "null therapy" such as placebo and observation. While not clinically relevant, these references provide further insight into the historical development of the treatment landscape. See the main LMS page for current regimens.


Adjuvant therapy

Observation

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Regimen

Study Years 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.

Preceding treatment

References

  1. 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
  2. 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 PubMed NCT01533207