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Purpose: To compare the diagnostic characteristics of two geriatric screening tools (G8 and Flemish version of the Triage Risk Screening Tool [fTRST]) to identify patients with a geriatric risk profile and to evaluate their prognostic value for functional decline and overall survival (OS)., Patients and Methods: Patients ≥ 70 years old with a malignant tumor were included if a new cancer event occurred requiring treatment decision. Geriatric screening with G8 and fTRST (cutoff ≥ 1 [fTRST (1)] and ≥ 2 [fTRST (2)] evaluated) was performed in all patients, as well as a geriatric assessment (GA) evaluating social situation, functionality (activities of daily living [ADL] + instrumental activities of daily living [IADL]), cognition, depression, and nutrition. Functionality was re-evaluated 2 to 3 months after cancer treatment decision, and death rate was followed. Functional decline and OS were evaluated in relation to normal versus abnormal score on both screening tools., Results: Nine hundred thirty-seven patients were included (October 2009 to July 2011). G8 and fTRST (1) showed high sensitivity (86.5% to 91.3%) and moderate negative predictive value (61.3% to 63.4%) to detect patients with a geriatric risk profile. G8 and fTRST (1) were strongly prognostic for functional decline on ADL and IADL, and G8, fTRST (1), and fTRST (2) were prognostic for OS (all P < .001). G8 had the strongest prognostic value for OS (hazard ratio for G8 normal v abnormal, 0.38; 95% CI, 0.27 to 0.52)., Conclusion: Both geriatric screening tools, G8 and fTRST, are simple and useful instruments in older patients with cancer for identifying patients with a geriatric risk profile and have a strong prognostic value for functional decline and OS.

Purpose: To compare a full-dose epirubicin-cyclophosphamide (HEC) regimen with classical cyclophosphamide, methotrexate, and fluorouracil (CMF) therapy and with a moderate-dose epirubicin-cyclophosphamide regimen (EC) in the adjuvant therapy of node-positive breast cancer., Patients and Methods: Node-positive breast cancer patients who were aged 70 years or younger were randomly allocated to one of the following treatments: CMF for six cycles (oral cyclophosphamide); EC for eight cycles (epirubicin 60 mg/m(2), cyclophosphamide 500 mg/m(2); day 1 every 3 weeks); and HEC for eight cycles (epirubicin 100 mg/m(2), cyclophosphamide 830 mg/m(2); day 1 every 3 weeks)., Results: Two hundred fifty-five, 267, and 255 eligible patients were treated with CMF, EC, and HEC, respectively. Patient characteristics were well balanced among the three arms. One and three cases of congestive heart failure were reported in the EC and HEC arms, respectively. Three cases of acute myeloid leukemia were reported in the HEC arm. After 4 years of median follow-up, no statistically significant differences were observed between HEC and CMF (event-free survival [EFS]: hazards ratio [HR] = 0.96, 95% confidence interval [CI], 0.70 to 1.31, P =.80; distant-EFS: HR = 0.97, 95% CI, 0.70 to 1.34, P =.87; overall survival [OS]: HR = 0.97, 95% CI, 0.65 to 1.44, P =.87). HEC is more effective than EC (EFS: HR = 0.73, 95% CI, 0.54 to 0.99, P =.04; distant-EFS: HR = 0.75, 95% CI, 0.55 to 1.02, P =.06; OS HR = 0.69, 95% CI, 0.47 to 1.00, P =.05)., Conclusion: This three-arm study does not show an advantage in favor of an adequately dosed epirubicin-based regimen over classical CMF in the adjuvant therapy of node-positive pre- and postmenopausal women with breast cancer. Moreover, this study confirms that there is a dose-response curve for epirubicin in breast cancer adjuvant therapy.

Purpose: We compared prospectively the antitumor efficacy of two combination chemotherapy regimens with two different dose levels of epirubicin as first-line treatment for advanced breast cancer., Patients and Methods: One hundred forty-one fully assessable patients were randomized to receive either our intensified schedule (group A, n = 71) of epirubicin 50 mg/m2 on days 1 and 8 (every 3 weeks), or a non-intensified program (group B, n = 70) in which epirubicin was only administered on day 1. Both groups also received fluorouracil (5 FU) and cyclophosphamide 500 mg/m2 on day 1 of each course., Results: A statistically significant difference in response rate was observed (69% in group A v 41% in group B, P < .001) for both locally advanced (LA) and recurrent metastatic (RM) disease. Response duration (22 v 14 months, P < .01) and time to progression (TTP; 19 v 8 months, P < .02) were also significantly improved. Overall survival was similar in both groups. However, univariate and/or multivariate analyses showed a meaningful relationship between type of treatment allocated, dose-intensity (DI) of epirubicin, and response rate, as well as between TTP and survival. Ultimately, TTP and survival were also influenced by further treatment modalities, namely, hormonotherapy and chemotherapy., Conclusion: This study validates prospectively the concept of a dose-response relationship for an anthracycline-based chemotherapy in previously untreated advanced breast cancer.