Sequential therapies with sorafenib and sunitinib in advanced or metastatic renal cell carcinoma.

PURPOSE: To investigate whether patients with metastatic renal cell carcinoma benefit from sequential therapies with the tyrosine kinase inhibitors (TKIs) sorafenib and sunitinib. PATIENTS AND METHODS: A total of 89 patients were treated in nine German centres between 2002 and 2009. The TKI sequence started as first-, second- or third-line therapy after prior chemo- or immunotherapy. When progression was diagnosed, treatment was switched to the second TKI until further progression. RESULTS: Overall progression-free survival (PFS) of patients receiving sunitinib followed by sorafenib shows no statistically significant difference to patients receiving sorafenib followed by sunitinib (15.4 months vs. 12.1 months). The secondary use of sorafenib resulted in a median PFS of 3.8 months if the TKI sequence had been started as a first-line treatment and of 3.5 months if the TKI sequence had been started second-line treatment. The secondary use of sunitinib resulted in a median PFS of 3.4 and 4.0 months, respectively. OS was 28.8 months for all patients, without a statistically significant difference between the two groups. CONCLUSIONS: This study endorses the notion of a clinical benefit of the sequential use of sorafenib and sunitinib and supports observations from previous studies. In terms of the optimal succession of the two TKIs, the study does not allow a definite answer.

A prospective observational study of anaemia management in cancer patients - results from the German Cancer Anaemia Registry.

The use of erythropoiesis-stimulating agents (ESA) in cancer patients is still under debate. However, little is known about rationales, strategies, objectives, and effectiveness of anaemia treatments in common practice. The Cancer Anaemia Registry prospectively surveyed about 2000 cancer patients with anaemia throughout Germany. The main objectives of anaemia treatment regardless of modality were to improve quality of life (QOL) and to correct haemoglobin (Hb) levels. The Hb threshold for any anaemia treatment (means ± SD: 9.4 ± 1.2 g/dL) but not for blood transfusions (8.7 ± 1.0 g/dL) depended on cancer type and treatment strategy. Physicians preferred ESA as first-line treatment to prevent transfusions in patients with solid tumours, if they thought that chemotherapy caused the anaemia. If they suspected other causes or patients had lymphoproliferative malignancies, physicians preferred transfusions or attempted to correct underlying disorders; both mainly to improve QOL or prognosis. Effectiveness of all strategies was comparable. However, ESA most effectively prevented transfusions; primary transfusions appeared less suitable for correcting Hb or improving QOL. Using supportive treatments for QOL improvement was common whereas diagnostic measures and intravenous iron therapy were underused. Prospective clinical trials using QOL as end point and evaluating diagnostics in cancer-associated anaemia are warranted.

Hemoglobin levels that trigger erythropoiesis-stimulating agent treatment decisions for cancer-associated anemia--examination of practice in Germany.

OBJECTIVE: Given the safety concerns regarding off-label use of erythropoiesis-stimulating agents (ESAs) in the treatment of cancer-associated anemia, data from the German Cancer Anemia Registry (CAR) were analyzed to examine whether current practice in Germany adheres to treatment guidelines. RESEARCH DESIGN AND METHODS: CAR was a web-based registry gathering patient data for 12 weeks following anemia diagnosis or until the primary treatment objective was achieved. RESULTS: Of over 2000 patients surveyed, 783 were treated with ESAs. Treatment was primarily aimed at improvement of quality of life (37.3%), hemoglobin correction (32.7%), and prevention of transfusions (24.4%). The average hemoglobin level triggering ESA treatment was 9.7 g/dL (6.0 mmol/L), however, starting levels varied with cancer type. For 67.8% of patients, transfusions could be avoided. ESA treatment was stopped at 11.2 g/dL (7.0 mmol/L) and maximum hemoglobin levels during the study averaged 11.8 g/dL (7.3 mmol/L). In 4.8% of the women and 6.0% of the men, maximum hemoglobin levels were >14 g/dL (8.7 mmol/L); in 15.6% and 9.1%, respectively, levels were between 13 and 14 g/dL. The median hemoglobin level triggering transfusion was 8.3 g/dL (5.2 mmol/L), irrespective of the malignant disease. CONCLUSION: Current use of ESAs for the treatment of cancer-associated anemia in Germany appears to be in good compliance with treatment guidelines. Similar results obtained from other studies in Europe and the US indicate this to be true beyond Germany.