GOG 161

Phase III Trial of Ifosfamide With or Without Paclitaxel in Advanced Uterine Carcinosarcoma: A Gynecologic Oncology Group Study

Pubmed

Hypothesis:Addition of paclitaxel to ifosfamide improve OS/ PFS in carcinosarcoma (GOG 108 there was no advantage to the combination of ifosfamide and cisplatin vs. ifosfamide alone related to median survival. GOG 130-B revealed a substantial response rate of carcinosarcoma to single-agent paclitaxel.)

Site: Uterus

Experimental arm: Ifosfamide 1.6 g/m2 IV daily for 3 days (1.2 g/m2 for irradiated patients) plus Paclitaxel 135 mg/m2 by 3 hour infusion day 1

Standard Arm: Ifosfamide 2 g/m2 IV for 3 days

Mesna iv or oral 1

Primary Outcome: Overall survival (OS)

Results:

Outcome Ifos Ifos Taxol p-value
OS (months)2 8.4 13.5 SS
PFS (months) 3.6 5.8 SS
ORR3 29% 45% SS
Toxicity
G1-4 neuropathy 8% 30% SS
Alopecia 40% 58% SS
Thrombocytopenia 11% 46% SS
G3-G4 Neutropenia 53% 44% NS

CNS related toxicity was similar in two arms

Conclusions:

  • Combination chemotherapy with Ifosfamide Taxol improves OS.
  • Treatment effect not different based on prior radiation or previous site of disease
  • No Quality of life assessments in this study

  1. Read GOG 261 design and mesna dosing schedules ↩︎
  2. Hazard Ratio: 0.69 (95% CI, 0.49 to 0.97; P = .03) ↩︎
  3. Overall Response Rate ↩︎

Author: Shitanshu Uppal

Assistant Professor Gynecologic Oncology University of Michigan, Ann Arbor

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