Abstract
5001
Background: Besides initial surgery, there has been no established consensus regarding adjunctive therapy for optimally debulked patients with uterine CS. This study was designed to compare progression-free interval (PFI), overall survival (OS), toxicity, and failure patterns using WAI vs CIM chemotherapy for this uncommon group of female malignancies. Methods: Patients with stage I-IV disease, ≤ 1 cm residual tumor, and no extra-abdominal involvement were randomly assigned to either WAI (approximately 30 Gy followed by pelvic boost) or cisplatin 20 mg/m
2
/d × 4, ifosfamide 1.5 g/m
2
/d × 4 and mesna 120 mg/m
2
loading dose, then 1.5 g/m
2
/d × 24 h, repeated q 3 weeks × 3 cycles. Results: 224 patients were enrolled, of whom 207 (WAI = 105; CIM = 102) were eligible. Patient demographics and characteristics were similar between arms. FIGO stage (both arms) was: I = 64 (31%); II = 26 (12%); III = 93 (45%); IV = 24 (11%). GI toxicity ≥ grade 2 occurred frequently and similarly (31%, both arms). CIM was associated with more ≥ grade 3 anemia (11% vs 1%) and neurotoxicity (9% vs 0%) compared to WAI. Two deaths were attributed to RT-induced hepatitis. Sites of first recurrence in WAI vs CIM among the 97 (47%) patients who relapsed were: vagina, 4 vs 10; pelvis, 12 vs 12; abdomen, 23 vs 14; lung, 13 vs 13; other, 13 vs 9. The estimated probability of recurring within 5 years is 55% (WAI) and 49% (CIM). Adjusting for stage, the recurrence rate was 28.5% lower for CIM patients relative to WAI patients (hazard ratio [HR]: 0.715, 95% confidence interval [CI]: 0.474–1.077, p = 0.108, 2-tail test). The estimated death rate for CIM is 32.8% lower relative to WAI (HR: 0.672, 95% CI: 0.458–.986, p = 0.042). Conclusion: Compared to WAI, adjuvant CIM reduces the recurrence rate and significantly prolongs OS in optimally debulked uterine CS patients; however, due to a high relapse rate and poor OS, the imperative for new adjuvant therapies remains.
No significant financial relationships to disclose.