Endometrial Committee
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Endometrial Committee David Scott Miller, M.D., F.A.C.O.G., F.A.C.S. Director and Dallas Foundation Chair in Gynecologic Oncology Professor of Obstetrics & Gynecology University of Texas Southwestern Medical Center Dallas, Texas, U.S.A.
description
Endometrial Committee. David Scott Miller, M.D., F.A.C.O.G., F.A.C.S. Director and Dallas Foundation Chair in Gynecologic Oncology Professor of Obstetrics & Gynecology University of Texas Southwestern Medical Center Dallas, Texas, U.S.A. Resected Endometrial. - PowerPoint PPT Presentation
Transcript of Endometrial Committee
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.
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
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
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
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
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
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
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
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
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
GTN
• Charge from the Executive
• RFP
• ISSTD
GTD Concepts
• Hydatidiform Mole Registry (Quinn)
• Pulse Act-D vs. 8 day MTX for Low Risk GTN
