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Summary: A prospective, randomized trial comparing cisplatin/5-fluorouracil with cisplatin/paclitaxel in metastatic or recurrent head and neck cancer demonstrated that there was no significant difference in efficacy between the two treatments. However, cisplatin/ paclitaxel produced substantially less toxicity. Such reductions in toxicity, said Dr. Murphy, were likely to lead more patients to complete the regimen.
This trial followed a previous trial that compared the efficacy of high-dose (200 mg/m2) versus low-dose (135 mg/m2 CIVI) paclitaxel in combination with cisplatin (75 mg/m2). That study showed no difference in survival between the high- and low-dose regimens, and both combinations produced toxicity levels sufficient to lead to a high withdrawal rate. We hypothesized that reducing the toxicity associated with cisplatin/paclitaxel might be important in maintaining patients on this combination regimen. The current trial recruited patients with untreated, advanced squamous cell head or neck cancers, measurable or evaluable disease, and adequate organ system function. On average, patients were male and aged 60 years. They were randomized to one of two arms: either cisplatin (100 mg/m2)/5-fluorouracil (1 gm/m2) or cisplatin (75 mg/m2)/paclitaxel (175 mg/m2). In cases of hematologic or gastrointestinal toxicity, Dr. Murphy and colleagues allowed a 20% reduction in dosage or permitted substitution of carboplatin for cisplatin. Twenty-three patients on the cisplatin/5-fluorouracil arm and 7 on the cisplatin/paclitaxel arm switched to carboplatin, and 12 patients on the cisplatin/5-fluorouracil arm and 8 patients on the cisplatin/paclitaxel arm were removed from the trial because of toxicity. Researchers did not report the relationship between hematologic toxicity and the use of either cisplatin or carboplatin. The primary endpoint of the study was one-year survival.
Results:
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These results gave substantially higher one-year survival and median survival rates than reported in previous trials. Although survival did not differ significantly between arms, there was substantially more hematologic toxicity and more vomiting, diarrhea, and mucositis with the cisplatin/5-fluorouracil regimen. Quality of life and pain control results also favored the cisplatin/paclitaxel arm. Dr. Murphy added that some improvement in results may also be due to better patient selection for these therapies and more experience in patient care on the part of physicians.
"This regimen now represents a new benchmark for further studies," said Dr. Murphy. Reducing toxicity with use of cisplatin/paclitaxel may improve compliance and therefore outcome, she said. Whether it would become a new standard of care was not definite yet, but she suggested that the Eastern Cooperative Oncology Group, which sponsored the trial, will look favorably on the results.
| Reporter: Aaron Levin |
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2001 by DOL Inc. All rights reserved. |