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Slide 1 - Uterine Leiomyosarcoma: Discussion Martee L. Hensley, M.D. Attending Physician, Gynecologic Medical Oncology Memorial Sloan-Kettering Cancer Center Professor of Medicine Weill Cornell Medical College
Slide 2 - Abstracts 010 and 011: Does morcellation surgery for uterine LMS affect outcome? THE IMPACT OF OPERATIVE TECHNIQUES TO THE ONSET OF PERITONEAL TUMOR DISSEMINATION IN PATIENTS WITH UTERINE LEIOMYOSARCOMAS F Menge; E Hartmann; M Mathew; B Kasper; P Hohenberger IMPACT OF TUMOR MORCELLATION ON THE NATURAL HISTORY OF UTERINE LEIOMYOSARCOMA (ULMS) C Serrano; T Oduyebo; J Manola; YFeng; M Muto; S George
Slide 3 - Menge abstract summary Detailed attention to the surgical techniques—included the “myoma drill” cases with morcellation cases Total of 23 uLMS cases in 10 years 6 morcellation cases compared with 15 non-morcellation (4 metastatic cases excluded) p = 0.08 --3 cases with “peritoneal only” recurrence
Slide 4 - Serrano abstract summary only intra-abdominal morcellation included Reasonable case match for post-op management 16 morcellation cases Imbalance for BSO RESULTS: RFS is significantly poorer after morcellation Recurrences are peritoneal Significant prognostic factor in small multivariate analysis that included tumor size and mitotic rate
Slide 5 - Tumor morcellation led to a decrease in Recurrence Free Survival (RFS) Median RFS Morcellation = 10.8 months Median RFS TAH = 25.7 months p-value = 0.034
Slide 6 - In perspective: MSKCC retrospective of re-operation after SCH (n=12) or morcellation (n=5) procedures in pts found to have uterine malignancies (EmCa =8; LMS=5; ESS=3; CS=1) 5 morcellation procedures; 4/5 underwent re-operation 2/4 were upstaged due to finding of residual peritoneal disease at time of re-operation. Both of the patients had uterine LMS There were a total of 13 re-staging procedures; 2/13 patients (15%) were upstaged—both had uLMS Einstein, Int J Gynecol Cancer, 2007
Slide 7 - In perspective: Retrospective comparison of pelvic recurrence at 3 months among morcellation (n=34) and no-morcellation hysterectomy (n=89) in patients with uterine malignancies Morcellation pts: pelvic recurrence 8.82% Hysterectomy pts: pelvic recurrence 3.66% P=0.25 Morice P, Gynaecol Oncol 2003
Slide 8 - Uterine LMSNomogram to predict 5 year OS C-index = 0.683 Zivanovic, Hensley. Cancer 2012
Slide 9 - Discussion : Easy for us to say, post-hoc, that morcellation is BAD But can we conclude that morcellation SHOULD NOT BE DONE? Takamizawa, Gynecol Obstet Invest 1999
Slide 10 - Research agenda? Identify a reliable tool for discerning pre-operatively which leiomyomas have high likelihood of being uLMS (or other malignancy). Imaging characteristics? Imaging modality? Presentation? (bleeding v. not?) Post-menopausal growing fibroid? Nomogram of multiple pre-op features? The challenge is the database—need all that information on thousands of patients when the incidence of malignancy is 0.4%
Slide 11 - Abstracts 012 and 013: What are the systemic treatment options for uLMS LMS-02: A PHASE II SINGLE-ARM MULTICENTER STUDY OF TRABECTEDIN IN COMBINATION WITH DOXORUBICIN AS FIRST LINE TREATMENT OF METASTATIC AND/OR LOCALLY ADVANCED LEIOMYOSARCOMA OF UTERINE (U-LMS) OR SOFT-TISSUE (ST-LMS) ORIGIN: RESULTS FROM BOTH COHORTS, FOR THE FRENCH SARCOMA GROUP (FSG) F Duffaud; C Chevreau; N Penel,; ALe Cesne; CGuillemet; C Delcambre; AFloquet; D Cupissol; ARey; P Pautier IMPACT OF CHEMOTHERAPY IN UTERINE SARCOMA (UTS): REVIEW OF 12 CLINICAL TRIALS FROM EORTC INVOLVING ADVANCED UTS COMPARED TO OTHER SOFT TISSUE SARCOMA (STS) I Ray-Coquard,; A Natukunda; J-Y Blay; P Casali; I Judson; A Krarup Hansen; L Lindner; AP Dei Tos; H Gelderblom; S Marreaud; S Litiere; P Rutkowski; P Hohenberger; A Gronchi; Wvan der Graaf
Slide 12 - Ray-Coquard EORTC retrospective study: outcomes in ut sarcomas 225 pt with uterine sarcoma, 71% ut LMS (160 LMS pts) Response to chemo higher (30%) among pts with high grade cancers v. low grade (13.5%) Histologic grade and performance status were prognostic for OS among all the ut sarcoma pts Responses higher with dox-based chemo compared with ifos alone LMS responses were 20% v. 33% for other histologies
Slide 13 - Median OS 10.9 months among the 225 ut sarcoma pts v. 11.7 for other STS types Median PFS 4.1 months ut sarcoma v. 3.71 other STS Response to chemotherapy 23% among uterine sarcoma patients
Slide 14 - In perspective: 1977-2001 data window allows for long follow-up but limits treatment regimens to dox, ifos, CYVADIC Possibility for changes over time in response definitions, histologic diagnoses, and grading changes Some similarities to findings of nomogram for OS in ut LMS Grade matters We can all agree that better treatments are needed We must recognize the challenges in agreeing on grade in LMS
Slide 15 - In perspective: Median OS 10.1 months (range 9 to 11.9) in this dox and ifos-treated group with 0 prior regimens SARC 001 (gem v. gem-doce, 0-3 prior) Median OS 17.9 months with gem-doc v. 11.5 months with gem Evolution of both the efficacy of agents and supportive care improvements over 3 decades influence interpretation of these data
Slide 16 - Gem v. Gem-Docetaxel in STS Odds that Gem-Doce is superior to Gem for PFS = 98% Odds that Gem-Doce is superior to Gem for OS=97% Maki, Hensley, J Clin Oncol 2007
Slide 17 - LMS-02A phase II single-arm multicenter study of Trabectedin in combination with Doxorubicin as first-line treatment of metastatic and/or locally advanced leiomyosarcoma of uterine (U-LMS) or Soft Tissue (ST-LMS) origin: Results from both cohorts F.Duffaud, C. Chevreau, N. Penel, A. Le Cesne, C. Guillemet, C. Delcambre, A. Floquet, D. Cupissol, B. Lacas, P. Pautier French Sarcoma Group
Slide 18 - LMS02 – uterine results Response (44 pts): 25 PR ORR : 56.8% 13 stable diseases Disease control rate : 86% Median duration of response : 5.5 months (3.8 – 6.6) PFS rate at 12 weeks: 84 % [95% CI : 73%-94%]
Slide 19 - LMS 02 – discussion Important objective RR per RECIST for 1rst line therapy in LMS Compare favorably with other combinations for U-LMS Doxo-Ifo1; U-LMS 1rst line ORR: 30%, DCR : 82% Gem-Tax2; U-LMS 1rst line ORR: 36%, m PFS = 4.4 mo Compare favorably with other combinations for ST-LMS Ifo- containing3; all-LMS 1rst line ORR: 17%, High rates of disease control and of PFS in both cohorts of LMS 86% and 92% of DCR, PFS rates at 3 mo of 84% and 92%, for Uterine and Soft Tissue cohorts respectively Supports the hypothesis that Doxo + Trab is an active regimen, in both cohorts of LMS Van Glabbecke 20025, active agents 1rst line for LMS : 3 mo PFR ≥58% and 6 mo PFR >40% → Efficacy results of Doxo →Trab combi are very encouraging in U- and ST-LMS 1Sutton G Gynecol Oncol 1996, 2 Hensley Gynecol Oncol 2008, 3 Sleijfer S, EJC 2010 46: 72-83, 5Van Glabbecke M, EJC 2002 38:543
Slide 20 - LMS 02 – discussion Though well tolerated, Doxo + Trab is toxic but manageable in 1st line Less toxic than Doxo (75 mg) + Ifo (10 g), EORTC 62012 studya 46% febrile neutropenia, 35% anemia gr3-4, 33% thombocytopenia gr3-4 Compare favorably with Gem (900 mg)+Tax (100 mg), Hensleyb et al. 2008 for anemia and thrombocytopenia (24% anemia gr3, 14.5% thombocytopenia gr3-4 ) but 6% febrile neutropenia with Doxo+Trab vs. 0% with Gem+Tax, but in 45pts LMS02 results different than GEIS-20 study results GEIS-20: Doxo vs. Trab → Doxo combi (Martin-Proto et al. ECCO meeting 2013) Combination not superior to Doxo alone (ORR : 13% and 20% , mPFS 5.7 and 5.6 mo, for Combi and Doxo respectively) Trab → Doxo, all sarcoma subtypes, too small population Define appropriate 1st line regimen in LMS only A randomized phase III study, in 1st line, in LMS only, comparing best combinations regimens, is urgently needed, with new active combination drugs a Judson I. Ann Oncol LBA7 ESMO 2012; b Hensley M. Gyn Oncol 2008
Slide 21 - So many choices: 1st line treatment, metastatic ut LMS, good PS, organ function, large volume lung and peritoneal mets Gemcitabine Gemcitabine-docetaxel Doxorubicin Doxorubicin-ifosfamide Ifosfamide Trabectedin Trabectedin-doxorubicin Liposomal doxorubicin Pazopanib Dacarbazine 3-drug combinations
Slide 22 - Where shall we focus our efforts? The n=1 approach The n=1001 approach Genomic profiling of the great responder Since there is not likely one driver for every uLMS, try to find the one driver for each one? If you find the driver, will you have a drug? And how soon until Target mutation Oncogene bypass Feedback upregulation Prospective randomized trials with overall survival or at least PFS endpoints Aim to define best first- and second-line therapies for uLMS Dox-Trab v. Gem-Doc Dox-Trab v. Dox Gem-doce-placebo v. Gem-doce-bev Ad infinitum for questions BUT not for patients!
Slide 23 - In the end-- The bad guy: The good guys: Photo, Smithsonian Marine Station
Slide 24 - Acknowledgments Dr. Maki and CTOS for this invitation Authors and presenters of Abstracts 010, 011, 012, 013 for providing abstracts and slides for review The women who face the challenges of this disease every day—