Gynecologic
Oncology
Group
Gynecologic Oncology Group
Uterine Corpus Trials: GCIG
David Scott Miller, M.D., F.A.C.O.G., F....
Gynecologic
Oncology
Group
PHASE III TRIAL OF PELVIC RADIATION THERAPY
VERSUS VAGINAL CUFF BRACHYTHERAPY
FOLLOWED BY PACLI...
Gynecologic
Oncology
Group
GOG0249
• Objectives
– Recurrence free survival
– Survival
– Patterns of failure
– QOL
• Stats
...
Gynecologic
Oncology
Group
Uterine Corpus Committee
0184R
• GOG0258 (UC0704): A Randomized
Phase III Trial of Cisplatin an...
Gynecologic
Oncology
Group
GOG258
XRT 45Gy
Cisplatin 50mg/m2 D1 and D28
Vaginal brachytherapy
Carboplatin AUC 6
Paclitaxel...
Gynecologic
Oncology
Group
GOG0258
• Objectives
– Recurrence free survival
– Survival
– Adverse effects
• Stats
– 28% decr...
Gynecologic
Oncology
Group
Uterine Corpus Committee
Pelvic Recurrence
• 33 + 99 has resulted in:
– TAH-BSO lymphadenectomy...
Gynecologic
Oncology
Group
GOG
0238
Gynecologic
Oncology
Group
GOG0238
• Objectives
– PFS
– Sites of recurrence
– OS
• Stats
– Phase II-III
– Interim analysis...
Gynecologic
Oncology
Group
Uterine Corpus Committee
150R & 161R
• GOG0261 (UC0701): Randomized Phase
III Trial of Carbopla...
Gynecologic
Oncology
Group
GOG0261
Gynecologic
Oncology
Group
GOG261
• Objectives
– OS
– PFS
– Toxicity
– QOL
• Stats
– Noninferiority
– Death rate < 11%
– N...
Gynecologic
Oncology
Group
Concept
Biweekly dactinomycin now needs to be
tested against 8-day MTX/FAR, arguably
the most c...
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GOG update - David Miller

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GOG update - David Miller

  1. 1. Gynecologic Oncology Group Gynecologic Oncology Group Uterine Corpus Trials: GCIG 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.
  2. 2. Gynecologic Oncology Group 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
  3. 3. Gynecologic Oncology Group GOG0249 • Objectives – Recurrence free survival – Survival – Patterns of failure – QOL • Stats – 49% decrease in recurrence/death – 85% > 92% 3 yr RFS – N = 562 • Activated 23 Mar 2009
  4. 4. Gynecologic Oncology Group Uterine Corpus Committee 0184R • GOG0258 (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 Carcinoma
  5. 5. Gynecologic Oncology Group GOG258 XRT 45Gy Cisplatin 50mg/m2 D1 and D28 Vaginal brachytherapy Carboplatin AUC 6 Paclitaxel 175mg/m2 q3weeks X4 Surgical debulking; optimal Stage III and IVA Register and randomize ARM 1 ARM 2 Carboplatin AUC 6 Paclitaxel 175mg/m2 q3weeks X6 XRT 45Gy Cisplatin 50mg/m2 D1 and D28 Vaginal brachytherapy Carboplatin AUC 6 Paclitaxel 175mg/m2 q3weeks X4 Surgical debulking; optimal Stage III and IVA Register and randomize ARM 1 ARM 2 Carboplatin AUC 6 Paclitaxel 175mg/m2 q3weeks X6
  6. 6. Gynecologic Oncology Group GOG0258 • Objectives – Recurrence free survival – Survival – Adverse effects • Stats – 28% decrease recurrence/death – 61% > 70% 3 yr RFS – N = 804
  7. 7. Gynecologic Oncology Group Uterine Corpus Committee Pelvic Recurrence • 33 + 99 has resulted in: – TAH-BSO lymphadenectomy alone – fewer using adjuvant WPRT • 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
  8. 8. Gynecologic Oncology Group GOG 0238
  9. 9. Gynecologic Oncology Group GOG0238 • Objectives – PFS – Sites of recurrence – OS • Stats – Phase II-III – Interim analysis > 60 failures – Opened Feb ‘08 – N = 164
  10. 10. Gynecologic Oncology Group Uterine Corpus Committee 150R & 161R • GOG0261 (UC0701): Randomized Phase III Trial of Carboplatin plus Paclitaxel versus Ifosfamide plus Taxol in Patients with Advanced, Persistent or Recurrent Carcinosarcoma
  11. 11. Gynecologic Oncology Group GOG0261
  12. 12. Gynecologic Oncology Group GOG261 • Objectives – OS – PFS – Toxicity – QOL • Stats – Noninferiority – Death rate < 11% – N = 415, (264 deaths)
  13. 13. Gynecologic Oncology Group Concept Biweekly dactinomycin now needs to be tested against 8-day MTX/FAR, arguably the most commonly used regimen worldwide. The 8-day regimen has a similar primary response but a vastly different cost, resource and utility profile, and it has never been subjected to the scrutiny of a multi-centred RCT.

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