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- W2263462528 abstract "8035 Background: Patients (pts) with MM metastatic to regional lymph nodes (LNs) (stage 3) are at high-risk of developing systemic disease and subsequent death. High-dose adjuvant alpha interferon (IFN) has proven in randomized studies to result in significant improvement in relapse-free survival (RFS), but the benefit on overall survival (OS) is less clear. BCT (cytotoxic chemotherapy with interleukin-2 (IL-2) and IFN) has shown high response rates in pts with metastatic MM. It is, therefore, hypothesized that using BCT in earlier stage disease may result in an improvement in OS for this high-risk population. Methods: This was a pilot phase 2 study of neoadjuvant BCT in pts with stage 3 MM with a planned accrual of 50 pts. Earlier results have previously been reported (Cancer 2002;94:470–6). LTFU is now obtained and reported here. Eligibility required biopsy confirmed MM to regional LNs without previous therapeutic lymphadenectomy. Two cycles of BCT were administered prior to and after lymphadenectomy. BCT was: cisplatin 20 mg/m 2 days (D) 1–4, vinblastine 1.6 mg/m 2 D 1–4, dacarbazine 800 mg/m 2 D 1, IFN 5 MIU/m 2 D 1–5, IL-2 9 MIU/m 2 continuous infusion D 1–4. The primary endpoints were RFS and OS. Results: Fifty-one pts were enrolled from 4–96 to 5–99. Three pts had stage 4 MM and are not included in this analysis. Of the remainder, 87.5% (42/48) had clinically detectable disease, while 12.5% (6/48) were sentinel lymph node positive. Twenty-five percent (12/48) had received prior IFN therapy. At a median follow-up of 75 months (mo), 54% are disease-free (26/48) and 65% are alive (31/48). The 5-year OS and RFS are 66% [95% confidence interval (CI) 50 - 78) and 56% (95% CI 41 - 69), respectively. Median survival has yet to be reached. After the 24-month time point there have been 3 relapses and 4 deaths. Toxicity was manageable. Conclusions: Neoadjuvant BCT may be an effective regimen for stage 3 MM. The LTFU of the current study shows favorable results in terms of RFS and OS when compared to historical controls. A subsequent larger, multicenter phase 2 study of neoadjuvant BCT has been completed. In addition, a cooperative group phase 3 study comparing adjuvant BCT to IFN is currently enrolling pts. [Table: see text]" @default.
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- W2263462528 date "2006-06-20" @default.
- W2263462528 modified "2023-09-27" @default.
- W2263462528 title "Phase II study of neoadjuvant biochemotherapy (BCT) for stage III malignant melanoma (MM): Results of long-term follow-up (LTFU)" @default.
- W2263462528 doi "https://doi.org/10.1200/jco.2006.24.18_suppl.8035" @default.
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