Abstract
PURPOSE: To investigate the toxicity of nelfinavir, administered during preoperative chemoradiotherapy (CRT) in patients with locally advanced cancer. MATERIAL AND METHODS: Twelve patients were treated with to 50.4Gy combined with capecitabine 825mg/m2 BID. Three dose levels nelfinavir were tested: 750mg BID (DL1), 1250mg BID (DL2) and an level of 1000mg BID (DL3). Surgery was performed between 8 and 10weeks completion of CRT. Primary endpoint was dose-limiting toxicity (DLT), any grade 3 or higher non-hematological or grade 4 or higher toxicity. RESULTS: Eleven patients could be analyzed: 5 were treated in DL2 and 3 in DL3. The first 3 patients in DL1 did not develop a DLT. In patient developed gr 3 diarrhea, 1 patient had gr 3 transaminase patient had a gr 3 cholangitis with unknown cause. An intermediate dose tested in DL3. In this group 2 patients developed gr 3 diarrhea and 1 3 transaminase elevation and gr 4 post-operative wound complication. patients achieved a pathological complete response (pCR). CONCLUSIONS: 750mg BID was defined as the recommended phase II dose in combination capecitabine and 50.4Gy pre-operative radiotherapy in rectal cancer. response evaluations are promising, but a further phase II study is more information about efficacy of this treatment regimen.
Original language | English |
---|---|
Pages (from-to) | 184-188 |
Number of pages | 5 |
Journal | Radiotherapy and Oncology |
Volume | 107 |
Issue number | 2 |
DOIs | |
Publication status | Published - May 2013 |
Keywords
- Rectal cancer
- Chemoradiation
- Phase I
- Nelfinavir
- HIV PROTEASE INHIBITOR
- PREOPERATIVE RADIATION
- COLORECTAL-CANCER
- MANAGEMENT
- MUTATIONS
- PATHWAY
- CELLS
- VIVO
- CHEMORADIOTHERAPY
- INDINAVIR