endometrial committee david scott miller, m.d., f.a.c.o.g., f.a.c.s. director and dallas foundation...
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Endometrial CommitteeDavid Scott Miller, M.D., F.A.C.O.G., F.A.C.S.
Director and Dallas Foundation Chair in Gynecologic OncologyProfessor of Obstetrics & Gynecology
University of Texas Southwestern Medical CenterDallas, Texas, U.S.A.
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Resected Endometrial
• GOG0249: A Phase III Trial of Pelvic Radiation Therapy versus Vaginal Cuff Brachytherapy Followed by Paclitaxel/Carboplatin Chemotherapy in Patients with High Risk, Early Stage Endometrial Cancer (23 Mar 2009)– RTOG
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Resected Endometrial
• PORTEC 3: Randomized Phase III Trial Comparing Concurrent Chemoradiation and Adjuvant Chemotherapy with Pelvic Radiation Alone in High Risk and Advanced Stage Endometrial Carcinoma– MaNGO, ANZGOG, NRCI, NCIC-CTG, NSGO
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Resected Endometrial
• GOG258 (UC0704): A Randomized Phase III Trial of Cisplatin and Tumor Volume Directed Irradiation Followed by Carboplatin and Paclitaxel vs. Carboplatin and Paclitaxel for Optimally Debulked, Advanced Endometrial Cancer (29 Jun 2009)– RTOG
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Study proposal
Proposed new study exploring if the combination of RT and CT is superior to CT:After 4 - A Phase III intergroup trial on adjuvant therapy in radically operated endometrial cancer patients (FIGO stage IC-IIIC) with high risk for micrometastatic disease
NSGOHR 0.51 (95 % CI 0.29-0.91) p=0.02
0.77
0.87
0.00
0.25
0.50
0.75
1.00
197 187 164 149 118 87random = 1187 175 153 130 106 75random = 0
Number at risk
0 1 2 3 4 5analysis time
random = 0 random = 1
CSS endometrioid carcinomas POOLED DATA
Pooled survival data
The combination of RT + CT is better than RT
Results of previous studies:
Thomas Hogberg, Lund Univ Hosp Oct 2009
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Radical surgeryTAH+BSO±LA
CTx4
Primary endpointOverall survival (OS)
CTx2
RTRandomization
Main inclusion criteriaa. Endometrioid carcinomab. Stage 1C grade 3 c. Stage IIA grade 3 and MI≥50%, IIB d. Stage IIIA-CRadical surgery, LA recommended but optionalMain exclusion criteriaSerous or clear cell carcinomaIIIA with only pos fluid cytology
CT : Paclitaxel 175 mg/m2, carboplatin AUC 5-6 (calculated) q 3 weeks
N=1000
Proposed study
Thomas Hogberg, Lund Univ Hosp Oct 2009
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Pelvic Recurrence
• GOG0238: A Randomized Trial of Pelvic Irradiation with or without Concurrent Weekly Cisplatin in Patients with Pelvic-only Recurrence of Carcinoma of the Uterine Corpus– RTOG, NCRI, SWOG
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EN.8 - A PHASE III STUDY OF STANDARD THERAPY VERSUS RIDAFOROLIMUS IN
WOMEN WITH RECURRENT OR METASTATIC ENDOMETRIAL CANCER WHO HAVE
PREVIOUS HAD CHEMOTHERAPY
Interested Groups: ACRIN, AGO-AUST, AGO-OVAR, Interested Groups: ACRIN, AGO-AUST, AGO-OVAR, ANZGOG?, DUTCH GOG, EORTC, GEICO, GINECO, ANZGOG?, DUTCH GOG, EORTC, GEICO, GINECO, JGOG, MANGO, MITO, NCRI, NSGO, SWOGJGOG, MANGO, MITO, NCRI, NSGO, SWOG
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Schema
Sample size: Approximately 460 patients
Arm 2:medroxy progesterone 200 mgor megestrol 160 mg (as per local practice) po dailyChemotherapy options
Survivalfollow-up
Diseaseprogression
Imagingq 8 weeks
Arm 1: ridaforolimus 40 mg po days 1-5 each week
RANDOMIZE
Women with recurrent or metastatic
endometrial cancer
1-2 Prior Chemotherapy
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Carcinosarcoma
GOG0261: Randomized Phase III Trial of Carboplatin plus Paclitaxel versus Ifosfamide plus Taxol in Patients with Advanced, Persistent or Recurrent Carcinosarcoma
NCRI, GINECO, JGOG, RTOG
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GTN
• Charge from the Executive
• RFP
• ISSTD
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GTD Concepts
• Hydatidiform Mole Registry (Quinn)
• Pulse Act-D vs. 8 day MTX for Low Risk GTN