Is age ¡Ý 70 years an important predictor of adverse events among patients enrolled in metastatic melanoma trials? Findings from pooled analyses of therapeutic trials

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• 作者：Aminah Jatoi ; Jacob B. Allred ; Vera J. Suman ; Edward T. Creagan ; Gary A. Croghan ; Thomas Amatruda ; Svetomir N. Markovic
• 关键词：Melanoma ; Adverse events ; Pooled analysis ; Toxicity ; Elderly
• 刊名：Journal of Geriatric Oncology
• 出版年：2012
• 出版时间：October, 2012
• 年：2012
• 卷：3
• 期：4
• 页码：307-311
• 全文大小：292 K

文摘

Background

The current study was undertaken to explore whether older age predicts adverse event rates in metastatic melanoma patients participating in cancer clinical trials.

Methods

Six phase II studies conducted at our institution for patients with metastatic disease were used in these pooled analyses: 1) ABT-510; 2) bortezomib, paclitaxel, and carboplatin; 3) everolimus; 4) bevacizumab, paclitaxel, carboplatin; 5) carboplatin and nab-paclitaxel; and 6) temozolomide and everolimus. In total, 233 patients, 64 elderly (¡Ý 70 years) and 169 younger, were analyzed for age-based differences in grade 2 or worse adverse events and other clinical outcomes.

Results

Despite the fact that older patients had slightly worse performance scores, no differences in rates of adverse events were observed based on age. Only worse baseline performance score predicted a higher rate of adverse events: patients with performance scores of one or worse were almost 4 times more likely to experience adverse events. Median cancer progression free survival and overall survival were comparable between older and younger patients.

Conclusion

These findings suggest that concern for adverse event rates should not preclude the enrollment of elderly melanoma patients to cancer clinical trials. Such patients should continue to be monitored carefully for tumor response and toxicity.