title: Is Age ≥ 70 Years an Important Predictor of Adverse Events Among Patients Enrolled in Metastatic Melanoma Trials? Findings from Pooled Analyses of Therapeutic Trials.
abstract: 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 abraxane; and 6) temozolomide and everolimus. In total, 233 patients, 64 elderly (≥ 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, based on age, no differences in rates of adverse events were observed. 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.
authors.affiliation: Department of Oncology, Mayo Clinic, Rochester, Minnesota.
authors.forename: Aminah
authors.initials: A
authors.lastname: Jatoi
authors.forename: Jacob B
authors.initials: JB
authors.lastname: Allred
authors.forename: Vera J
authors.initials: VJ
authors.lastname: Suman
authors.forename: Edward T
authors.initials: ET
authors.lastname: Creagan
authors.forename: Gary A
authors.initials: GA
authors.lastname: Croghan
authors.forename: Thomas
authors.initials: T
authors.lastname: Amatruda
authors.forename: Svetomir N
authors.initials: SN
authors.lastname: Markovic