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Purpose: The EORTC QLQ-C30 and the Brief Pain Inventory (BPI) are validated tools for measuring quality of life (QOL) and the impact of pain in patients with advanced cancer. Interpretation of these instrument scores can be challenging and it is difficult to know what numerical changes translate to clinically significant impact in patients' lives. To address this issue, our study sought to establish the minimal clinically important differences (MCID) for these two instruments in a prospective cohort of patients with advanced cancer and painful bone metastases.Methods: Both anchor-based and distribution-based methods were used to estimate the MCID scores from patients enrolled in a randomized phase III trial evaluating two different re-irradiation treatment schedules. For the anchor-based method, the global QOL item from the QLQ-C30 was chosen as the anchor. Spearman correlation coefficients were calculated for all items and only those items with moderate or better correlation (|r| ≥ 0.30) with the anchor were used for subsequent analysis. A 10-point difference in the global QOL score was used to classify improvement and deterioration, and the MCID scores were calculated for each of these categories. These results were compared with scores obtained by the distribution-method, which estimates the MCID purely from the statistical characteristics of the sample population.Results: A total of 375 patients were included in this study with documented pain responses and completed QOL questionnaires at 2 months. 9/14 items in the QLQ-C30 and 6/10 items in the BPI were found to have moderate or better correlation with the anchor. For deterioration, statistically significant MCID scores were found in all items of the QLQ-C30 and BPI. For improvement, statistically significant MCID scores were found in 7/9 items of the QLQ-C30 and 2/6 items of the BPI. The MCID scores for deterioration were uniformly higher than the MCIDs for improvement. Using the distribution-based method, there was good agreement between the 0.5 standard deviation (SD) values and anchor-based scores for deterioration. For improvement, there was less agreement and the anchor-based scores were lower than the 0.5 SD values obtained from the distribution-based method.Conclusion: We present MCID scores for the QLQ-C30 and BPI instruments obtained from a large cohort of patients with advanced cancer undergoing re-irradiation for painful bone metastases. The results from this study were compared to other similar studies which showed larger MCID scores for improvement compared to deterioration. We hypothesize that disease trajectory and patient expectations are important factors in understanding the contrasting results. The results of this study can guide clinicians and researchers in the interpretation of these instruments. [ABSTRACT FROM AUTHOR]

Purpose: To determine if physician prediction of survival duration (PSD) is accurate for patients with metastatic breast or prostate cancer. Methods: Radiation Therapy Oncology Group 9714 (RTOG 9714) was a randomized comparison of radiotherapy schedules for treatment of bone metastases. The treating physician assigned a baseline Karnofsky Performance Score (KPS) and predicted survival duration at study entry. Patients completed the Functional Assessment of Cancer Therapy (FACT). These three were compared to actual survival time. Results: Eight hundred ninety-eight patients were eligible and analyzable. Actual median survival was 9.3 months. The median PSD was 12 months. PSD, KPS, and FACT were all moderately correlated with actual survival. Patients with higher KPS had a longer survival time (882 patients, Spearman's ρ = 0.259, p < 0.0001). The median survival of the 618 expired patients is 6.5 months (PSD was 12 months). The PSD was within 1 month of actual survival in 61 (10%), with 177 (29%) patients surviving more than 1 month longer than predicted and 375 (61%) surviving more than 1 month less than predicted. A univariate analysis of actual overall survival was performed, dividing the PSD into 4 groups. For predicted survivals of 6 months or less, less than 6 to less than 12 months, 12 months, and more than 12 months, median actual survivals were 7.0, 7.2, 9.7. and 13.5 months ( p < 0.0001). Conclusions: KPS, FACT scores, and PSD all are correlated with actual survival. Physicians on this study were able to predict which patients would have longer survival times, although prediction of survival was optimistic compared to actual survival by an average of 3 months. [ABSTRACT FROM AUTHOR]

Background: Radiation therapy is effective in palliating pain from bone metastases. We investigated whether 8 Gy delivered in a single treatment fraction provides pain and narcotic relief that is equivalent to that ot the standard treatment course of 30 Gy delivered in 10 treatment fractions over 2 weeks. Methods: A prospective, phase III randomized study of palliative radiation therapy was conducted for patients with breast or prostate cancer who had one to three sites of painful bone metastases and mod!rate to severe pain. Patients were randomly assigned to 8 Gy in one treatment fraction (8-Gy arm) or to 30 Gy in 10 treatment fractions (30-Gy arm). Pain relief at 3 months after randomization was evaluated with the Brief Pain Inventory. The Wilcoxon-Mann-Whitney test was used to compare response to treatment in terms of pain and narcotic relief between the two arms and for each stratification variable. All statistical comparisons were two-sided. Results: There were 455 patients in the 8-Gy arm and 443 in the 30-Gy arm; pretreatment characteristics were equally balanced between arms. Grade 2-4 acute toxicity was more frequent in the 30-Gy arm (17%) than in the 8-Gy arm (10%) (difference = 7%! 95% CI = 3% to 12%; P .002). Late toxicity was rare (4%) in both arms. The over- all response rate was 66%. Complete and partial response rates were 15% and 50%, respectively, in the 8-Gy arm coma pared with 18% and 48% in the 40-Gy arm (P = .6). At 3 months, 33% of all patients no longer required narcotic medications. The incidence of subsequent pathologic fracture was 5% for the 8-Gy arm and 4% for the 30-Gy arm. The retreatment rate was statistically significantly higher in the 8-Gy arm (18%) than in the 30-Gy arm (9%)(P<.001). Conclusions: Both regimens were equivalent in forms of pain and narcotic relief at 3 months and were well tolerated with few adverse effects. The 8-Gy arm had a higher rate of re-treatment but had less acute toxicity than the 30-Gy arm. [ABSTRACT FROM AUTHOR]

Purpose To establish a survival prediction model in the setting of a randomized trial of re-irradiation for painful bone metastases. Methods Data were randomly divided into training and testing sets with an approximately 3:2 ratio. Baseline factors of gender, primary cancer site, KPS, worst-pain score and age were included with backward variable selection to derive a model using the training set. A partial score was assigned by dividing the value of each statistically significant regression coefficient by the smallest statistically significant regression coefficient. The survival prediction score (SPS) was obtained by adding together partial scores for the variables that were statistically significant. Three risk groups were modelled. Results The training set included 460 patients and the testing set 351 patients. Only KPS and primary cancer site reached the 5%-significance level. Summing up the partial scores assigned to KPS (90–100, 0; 70–80, 1; 50–60, 2) and primary cancer site (breast, 0; prostate, 1.3; other, 2.6; lung, 3) totalled the SPS. The 1/3 and 2/3 percentiles of the SPS were 2 and 3.6. For the testing set, the median survival of the 3 groups was not reached, 11.3 (95% C.I. 8.5 – not reached) and 5.2 months (95% C.I. 3.7–6.5). The 3, 6 and 12 month survival rates for the worst group were 64.4% (95% C.I. 55.3–72.1%), 43.0% (95% C.I. 34.0–51.8%) and 19.7% (95% C.I. 12.4–28.1%) respectively, similar to that in the training set. Conclusion This survival prediction model will assist in choosing dose fractionation. We recommend a single 8 Gy in the worst group identified. [ABSTRACT FROM AUTHOR]