Combination of consecutive low-dose cisplatin with ifosfamide and epirubicin (CLD-IEP) in sarcoma uteri.

9066 Purpose: To evaluate the efficacy and toxicity of CLD-IEP for patients (pts) with sarcoma uteri.,Eligible criteria were: a histologic proof of advanced or recurrent sarcoma uteri; measurable lesions; age between 18 and 80 yrs; WHO PS 0-3; WBC >= 3,000/μL; platelet count >= 100,000/μL; hemoglobin level >= 9 g/dL; adequate liver function; C-Cr >= 40 mL/min; no lung, heart, or brain disease; no previous neoplastic disease; no prior chemotherapy; and informed consent. The CLD-IEP regimen was ifosfamide 700 mg/m2 infused over 2 hrs days 1 through 4; epirubicin 50 mg/m2 bolus day 7; and cisplatin 15 mg/m2 infused over 4 hrs days 1 through 5. The treatment was repeated at 4-week intervals.,To date, thirty-seven eligible pts (16 leiomyosarcoma [LMS], 4 endometrial stromal sarcoma, and 17 carcinosarcoma) were enrolled in this study and all pts were assessable for response, toxicity, and survival. The median age was 53 yrs (range, 37-77). Twelve pts received CLD-IEP in the neoadjuvant setting. Nine pts had prior radiotherapy. After a median of 4 cycles (range, 2-13), we observed objective responses in 22 pts (59%), with 5 (14%) CRs and 17 (46%) PRs (95% CI, 41% to 77%, 5% to 23%, 28% to 64%, respectively). Of 16 pts with LMS, 1 CR and 7 PRs (1 pt with good PR surviving more than 48 months after the start of CLD-IEP) were observed. Median overall survival time (MOS) after the start of CLD-IEP for all 37 pts was 17.5 months (range, 2.7 to 61.5). MOS was 20.8 months in the responders versus 9.9 months in the non-responders (Log-rank, p=0.023). The median progression-free survival time of the responders was 10.5 months. NCI-CTC grade 3 or 4 leucopoenia, neutropenia, thrombocytopenia, and anemia occurred in 63%, 75%, 12%, and 18%, respectively. There was no significant nausea/vomiting, nephrotoxicity, or CNS toxicity.,CLD-IEP regimen has significant to moderate anti-tumor activity with acceptable toxicity in pts with sarcoma uteri including LMS. No significant financial relationships to disclose.