In a phase II study, 77 patients with metastatic breast cancer were treated with pirarubicin, 70 mg/m2 iv every 3 weeks. Most of them had received prior hormonal (n = 39) and/or chemotherapeutic drug treatment for advanced disease, including anthracycline-containing regimens in 17. After a median of 5.5 treatment cycles (range 1-14), objective tumor response was seen in 22/71 (31%) evaluable patients (4CR, 18 PR). Stable disease occurred in 34 (48%) patients, whereas the tumor progressed in 15 (21%). Significant hematologic toxicity (WHO grade III-IV) requiring interval and/or dose adjustments was observed in 41 (58%) patients. Other treatment-related side effects were generally mild, and included alopecia in 52 (73%), nausea and/or emesis in 50 (70%), and stomatitis and diarrhea in 3 patients each. There was no treatment-related death, nor was there any evidence of cardiac toxicity thus far. In summary, the early results of this trial suggest that pirarubicin is an active and rather well tolerated drug in pretreated patients with advanced breast cancer.
Background: Recently, we have demonstrated that BMI significantly impacts on the efficacy of anastrozole but not tamoxifen (TAM) in premenopausal breast cancer patients. As aromatase inhibitors (AIs) are a mainstay in the treatment of endocrine responsive postmenopausal breast cancer patients, it is of certain interest, if this influence of BMI on endocrine therapy is also true for the postmenopausal situation. Methods: For analysis of the ABCSG 6 and 6a trial, patients were classified as normal weight (BMI 18.5-24.9 kg/m2) or as overweight (BMI ≥25kg/m) according to WHO criteria. The underweight population was excluded from the analyses.
We retrospectively analysed the ABCSG 6 trial, which examined the efficacy of TAM versus TAM + aminoglutethimide (first generation AI) in endocrine responsive postmenopausal breast cancer patients. All patients have been censored after 60 months since the majority of patients without events have been re-randomized into trial ABCSG 6a after 5 years. Further, we retrospectively analysed the ABCSG 6a trial, which examined 3 additional years of anastrozole versus no further treatment after 5 years of endocrine treatment.
Results: 1,566 patients (311 events/214 deaths) and 477 patients (108 events/64 deaths) were included in the analyses of the ABCSG-6 trial and the ABCSG-6a trial, respectively. About two thirds of all patients in both trials were overweight and one third was normal weight. Analysing the ABCSG 6 trial, no difference in disease free survival (DFS) and overall survival (OS) between normal weight and overweight patients treated with TAM versus TAM + aminoglutethimide could be observed. Analysing the ABCSG-6a trial, normal weight patients treated with anastrozole showed a remarkable and significant reduced risk in DFS and OS compared to control (HR 0.464, 95%CI 0.242 0.842 p=0.02 and HR 0.372, 95%CI 0.16 0.863, p=0.02). In contrast, in overweight patients anastrozole compared to control did not improve DFS and OS (HR 0.991, 95%CI 0.611 1.608, p=0.97 and HR 0.871, 95%CI 0.456 1.662, p=0.67). Conclusion: BMI impacts on the efficacy of anastrozole but not tamoxifen in postmenopausal breast cancer patients. It seems that overweight patients in contrast to normal weight patients do not benefit from additional 3 years of anastrozole after 5 years of endocrine therapy.
Citation Information: Cancer Res 2010;70(24 Suppl):Abstract nr PD09-05.
A 29-year-old man was admitted to hospital, unconscious and with extensive bleedings in skin and muscles. For many weeks he had been practically starving himself with suicidal intent. Physical examination revealed signs of anaemia and gingivitis with hypertrophy of the tooth borders and bleeding gums, as well as bright blood on rectal examination. There were extensive ecchymoses and petechiae, especially in the legs. Some of the body hair was corkscrew-curly. Haemoglobin level was 7.2 g/dl, mean corpuscular volume 93 fl, reticulocyte count 29/1000. The Rumpel-Leede test was abnormal (60 petechiae/4 cm2), as were the vitamin C level (0.026 mg/dl whole blood) and the ascorbic acid tolerance test. As these findings indicated scurvy, vitamin C was administered, 1 g daily intravenously for 5 days, followed by 500 mg daily by mouth. Remarkable improvement was apparent as early as 72 hours after onset of treatment. The endogenous depression, the underlying cause of the suicide attempt, was treated with clomipramine. When the patient was discharged after 13 days his physical and mental state was much improved.
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