Abstract

Combination of paclitaxel with carboplatin and cisplatin with fluoropyrimidines are the standards of the 1st and 2nd lines of treatment in pts with metastatic anal cancer. Regimen mDCF (docetaxel 40 mg/m2 d1, cisplatin 40 mg/m2 d1, 5-FU 2400 mg/m2 46-h d1-3, two-weekly) showed promising activity in the 1st line in the nonrandomized study. We performed an analysis of a prospective multicentric database of metastatic anal cancer pts to evaluate the efficacy of different regimens as 1st line systemic treatment in a real-life clinical practice setting. We analyzed a database of pts with metastatic anal cancer in 3 cancer centers in Russia. The primary endpoints were progression free survival (PFS) and overall response rate (ORR). Analysis was performed with the SPSS v.20 software package. The study included 68 pts with metastatic anal cancer. Sixty three (93%) pts received systemic treatment; female – 87%, average age - 68 years (20-83), ECOG 0-1/2/3/NA – in 22%/33%/31%/13%; synchronous metastases - in 30%; local relapse or primary tumor – in 60%; radiotherapy or chemoradiotherapy of primary tumor were previously? administered in 70%; lung metastases in 18%, liver - 38%, retroperitoneal lymph nodes metastases – 27%; peritoneal metastases – in 3% pts; average number of metastatic zones – 2 (1-5); metastasectomy was performed in 32% pts. The first line was weekly paclitaxel and carboplatin (CP) in 29 (46%), mDCF - in 10 (16%), platinum compounds with fluoropyrimidines (CF) – in 18 (29%), others regimen – in 6 (9%). Median PFS was 6 months in CP group, 3 months – in CF group, 10 months - in mDCF group, and 3 months – in other regimens group (HR 1,02, 95% CI 0,76-1,37, p=0,8); ORR was 9%, 10%, 50%, 0%, respectively (p=0,01). In the 1st line mDCF regimen shows the best ORR and numerically the longest median PFS, which warranted conducting of prospective randomized study to compare mDCF and paclitaxel with carboplatin.

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