| Autor: |
A. de Graeff, A.S.T. Planting, P.H.M. de Mulder, H.E.R. Verdonk, W. Oster, G. Catimel, J.B. Vermorken |
| Rok vydání: |
1995 |
| Předmět: |
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| Zdroj: |
European Journal of Cancer. 31:S85-S86 |
| ISSN: |
0959-8049 |
| DOI: |
10.1016/0959-8049(95)95645-m |
| Popis: |
High dose single agent cisplatin (C) regimens yield high response rates in advanced head and neck cancer (HNC) but nephro-, neuro- and ototoxicity preclude further dose escalation. In weekly C regimens bone marrow toxicity causes frequent treatment delays jeopardizing the dose intensity of C. In this study patients (pts) with HNC are randomized between C 70 mg/m 2 /wk for six weeks with or without amifostine (AMI) 740 mg/m 2 . AMI is administered as a 15 min infusion directly prior to C. C is administered in 250 cc 3% NaCl as a 1-hour infusion with standard preand posthydration. The antiemetic schedule consists of thietylperazine, ondansetron and dexamethasone. Up till 3/95 53 pts are randomized; 39 are fully evaluable for response and toxicity, one pt is not evaluable and 13 too early for evaluation. Characteristics of the 39 fully evaluable pts: male:female ratio is 29:10; median age 52 years (range 36−68), median WHO performance status I (0−2); locally advanced disease 30 pts, locally recurrent 7 pts metastatic disease in 2 pts. Eighteen pts were randomized to C + AMI and 21 to C. In total these 39 pts received 210 C administrations, median 6 per patient (range 3−6), equal in both treatment arms. In the C alone arm 5/21 pts had treatment delays because of bone marrow toxicity versus 0/18 in the C + AMI arm. Thrombocytopenia grade 3 + 4 wasalso more frequent in the C alone arm: 5/21 versus 1/18. Other differences observed in favour of the C + AMI arm are: hypomagnesaemia > CTC-grade 1 in 2/18 versus 8/21. Side effects of AMI were short lasting hypotension in 7 pts and occasional sneezing. Other toxicities are until now not different between both treatment arms. A CR was observed in 2 and a PR in 21 pts (RR%: 60%). The study will continue to 60 evaluable pts. In case of significant reduction of toxicity by the addition of AMI further dose escalation of C is planned. |
| Databáze: |
OpenAIRE |
| Externí odkaz: |
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Full Text from ScienceDirect