Mary Ann Muckaden

BACKGROUND: The Edmonton Symptom Assessment Scale (ESAS) is widely used for symptom assessment in clinical and research settings. A sensitivity-specificity approach was used to identify the minimal clinically important difference (MCID) for improvement and deterioration for each of the 10 ESAS symptoms. METHODS: This multicenter, prospective, longitudinal study enrolled patients with advanced cancer. ESAS was measured at the first clinic visit and at a second visit 3 weeks later. For each symptom, the Patient's Global Impression ("better," "about the same," or "worse") was assessed at the second visit as the external criterion, and the MCID was determined on the basis of the optimal cutoff in the receiver operating characteristic (ROC) curve. A sensitivity analysis was conducted through the estimation of MCIDs with other approaches. RESULTS: For the 796 participants, the median duration between the 2 study visits was 21 days (interquartile range, 18-28 days). The area under the ROC curve varied from 0.70 to 0.87, and this suggested good responsiveness. For all 10 symptoms, the optimal cutoff was ≥1 point for improvement and ≤-1 point for deterioration, with sensitivities of 59% to 85% and specificities of 69% to 85%. With other approaches, the MCIDs varied from 0.8 to 2.2 for improvement and from -0.8 to -2.3 for deterioration in the within-patient analysis, from 1.2 to 1.6 with the one-half standard deviation approach, and from 1.3 to 1.7 with the standard error of measurement approach. CONCLUSIONS: ESAS was responsive to change. The optimal cutoffs were ≥1 point for improvement and ≤-1 point for deterioration for each of the 10 symptoms. Our findings have implications for sample size calculations and response determination.

BACKGROUND: Osteosarcoma of the head and neck region is a rare tumor and is a therapeutic challenge because of its aggressive nature and complex anatomical location. Standard management guidelines are lacking due to paucity of published data. METHODS: Fifty patients with head and neck osteosarcoma treated at our institute from 1995 to 2004 were reviewed. RESULTS: There were 32 men and 18 women (median, 30 years). Mandible (56%) was the most common site. Chondroblastic (46%) was the most common histopathological variant. Treatment comprised multimodality approach using surgery (100%), radiotherapy (36%), and chemotherapy (58%). After a median follow-up of 16.6 months, 46% were alive and disease free. Median overall survival was 45.7 months, and progression-free survival was 13.7 months. Mandible and maxilla were favorable sites. Postoperative adjuvant radiotherapy improved local control in patients with adverse prognostic factors. CONCLUSIONS: Surgery remains the mainstay of the treatment of head and neck osteosarcoma. Adjuvant radiotherapy improves outcome in patients with adverse factors.