Comparison of outcome endpoints in intermediate- and high-risk prostate cancer after combined-modality radiotherapy.

PURPOSE: To compare a standard radio-oncological and a surgical biochemical failure definition after combined-modality radiation therapy (CRT) in men with intermediate- and high-risk prostate cancer. METHODS: 425 men were treated with external beam radiotherapy (59.4 Gy, 33 fractions) and 125J seed-brachytherapy (S-BT, 100 Gy). Biochemical recurrence (BR) was defined either as radio-oncologic (rBR), using a +2 ng/mL prostate-specific antigen (PSA) increase above a nadir value, or as surgical (sBR), using a 2-year posttreatment PSA of ≥0.2 ng/mL. Biochemical recurrence-free, metastasis-free, cancer-specific, and overall survival were calculated at 5 and 10 years using the Kaplan-Meier method. Standard validation tests were used to compare both thresholds. RESULTS: After a median of 7 years, overall recurrence rates were 10.4% and 31.5% for rBR and sBR definitions, respectively. Both failure definitions proved sensitive for the prediction of metastases and cancer-specific death, whereas the rBR definition was significantly more specific. The accuracies of a correct prediction of metastases and death of prostate cancer were 73.1% vs. 96.2% and 72.2% vs. 92.9% for sBR vs. rBR, respectively. The inferior validity results of the sBR definition were attributable to a PSA-bounce phenomenon occurring in 56% of patients with sBR. Still, using the less suitable sBR definition, the results of CRT compared favorably to BRFS rates of surgical interventions. CONCLUSION: After CRT, the radio-oncological (aka Phoenix) failure definition is more reliable than a fixed surgical endpoint. Exclusively in high-risk patients, sBR offers a direct comparison across surgical and nonsurgical treatment options at 5 and 10 years.

Prognostic factors affecting locally recurrent rectal cancer and clinical significance of hemoglobin.

PURPOSE: To investigate potential prognostic factors, including hemoglobin levels before and during radiotherapy, for associations with survival and local control in patients with unirradiated locally recurrent rectal cancer. PATIENTS AND METHODS: Ten potential prognostic factors were investigated in 94 patients receiving radiotherapy for recurrent rectal cancer: age (or=69 years), gender, Eastern Cooperative Oncology Group performance status (0-1 vs. 2-3), American Joint Committee on Cancer (AJCC) stage (50 Gy), and hemoglobin levels before (<12 vs. >or=12 g/dL) and during (majority of levels: <12 vs. >or=12 g/dL) radiotherapy. Multivariate analyses were performed, including hemoglobin levels, either before or during radiotherapy (not both) because these are confounding variables. RESULTS: Improved survival was associated with better performance status (p<0.001), lower AJCC stage (p=0.023), surgery (p=0.011), chemotherapy (p=0.003), and hemoglobin levels>or=12 g/dL both before (p=0.031) and during (p<0.001) radiotherapy. On multivariate analyses, performance status, AJCC stage, and hemoglobin levels during radiotherapy maintained significance. Improved local control was associated with better performance status (p=0.040), lower AJCC stage (p=0.010), lower grading (p=0.012), surgery (p<0.001), chemotherapy (p<0.001), and hemoglobin levels>or=12 g/dL before (p<0.001) and during (p<0.001) radiotherapy. On multivariate analyses, chemotherapy, grading, and hemoglobin levels before and during radiotherapy remained significant. Subgroup analyses of the patients having surgery demonstrated the extent of resection to be significantly associated with local control (p=0.011) but not with survival (p=0.45). CONCLUSION: Predictors for outcome in patients who received radiotherapy for locally recurrent rectal cancer were performance status, AJCC stage, chemotherapy, surgery, extent of resection, histologic grading, and hemoglobin levels both before and during radiotherapy.