Sorafenib with interleukin-2 vs sorafenib alone in metastatic renal cell carcinoma: the ROSORC trial

Procopio, Giuseppe; Verzoni, Elena; Bracarda, Sergio; Ricci, Sergio; Sacco, Cosimo; Ridolfi, Laura; Porta, Camillo; Miceli, Rosalba; Zilembo, Nicoletta; Bajetta, Emilio

doi:10.1038/bjc.2011.103

Cited by 65 publications

(45 citation statements)

References 29 publications

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“…These median PFS and duration of therapy findings are within the 5.7-to 9.1-month median PFS range previously reported for first-line sorafenib. 4,19,[22][23][24] The median duration of therapy for patients receiving sorafenib after sunitinib was somewhat shorter than that for the entire population; however, the duration of previous therapy was not captured. This could reflect the emergence of cross resistance or it might be a consequence of diminishing efficacy with the line of treatment.…”

Section: Discussionmentioning

confidence: 96%

Sorafenib Treatment of Advanced Renal Cell Carcinoma Patients in Daily Practice: The Large International PREDICT Study

Jäger

Mardiak

et al. 2015

Clinical Genitourinary Cancer

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This large, prospective, noninterventional study assessed the efficacy and safety of sorafenib in patients with advanced renal cell carcinoma (RCC) in a clinical practice setting. Sorafenib was generally well tolerated, with no unexpected adverse events observed, and provided clinical benefit in this diverse patient population. Background: Patients with advanced renal cell carcinoma in routine clinical practice can differ considerably from those in phase III studies. Patients and Methods: PREDICT (Patient characteristics in REnal cell carcinoma and Daily practICe Treatment with sorafenib) was a prospective, noninterventional study of open-label sorafenib for the treatment of advanced RCC conducted in 18 countries. Patient characteristics, therapy duration, tumor status, and tolerability were assessed at baseline and during routine follow-up. Results: Overall, 2599 patients were evaluable for safety and 2311 for efficacy. The diverse population included patients with brain metastases (5%), non-clear-cell histologies (17%), high Memorial Sloan-Kettering Cancer Center risk score (11%), poor Eastern Cooperative Oncology Group performance status (PS ! 2, 29%), and patients with no previous nephrectomy (16%) or no previous systemic therapy (37%). The median duration of sorafenib therapy was 7.3 months and was similar in clinically relevant subgroups (eg, patients with PS 2, brain metastases, or concomitant hypertension or diabetes [range, 6.7-7.0 months]). The median duration of therapy was shorter for patients with PS 3 or non-clear-cell histologies (4.6 and 4.8 months, respectively). The most common drug-related adverse events were handefoot skin reaction (20%), diarrhea (17%), and rash (8%). Conclusion: Sorafenib was generally well tolerated and provided clinical benefit in a large, diverse population of patients with advanced RCC treated in routine clinical practice.

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Section: Discussionmentioning

confidence: 96%

Sorafenib Treatment of Advanced Renal Cell Carcinoma Patients in Daily Practice: The Large International PREDICT Study

Jäger

Mardiak

et al. 2015

Clinical Genitourinary Cancer

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“…The ROSORC phase II trial randomized patients with metastatic RCC to received sorafenib alone or sorafenib in combination with subcutaneous IL-2 4.5 MIU fi ve times per week for 6 in every 8 weeks [ 35 ] (Table 8.2 ). The dose of IL-2 was reduced after the fi rst 20 patients in the combination arm were treated, due to the onset of adverse events, mainly asthenia.…”

Section: Sorafenib and Cytokine Combinationmentioning

confidence: 99%

First-Generation Tyrosine Kinase Inhibitors: Clinical Results

Wong

Eisen

2014

Renal Cell Carcinoma

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“…The German workshop participants assessed pazopanib as a now equivalent alternative in this group. Since sorafenib is not generally approved in Europe for first-line therapy due to available data, no recommendation was given on this point [18,19,20,21]. …”

Section: Characterization Of Patient Populations In First-line Therapymentioning

confidence: 99%

Treatment Algorithm for Metastatic Renal Cell Carcinoma - Recommendations Based on Evidence and Clinical Practice

Bergmann¹,

Beck

Bothe

et al. 2014

Oncol Res Treat

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Until a few years ago, the treatment options for metastatic renal cell cancer (mRCC) were very limited. The growing understanding of the molecular pathomechanisms underlying RCC allowed the development of new treatment approaches. Meanwhile, several approved target-oriented substances from different drug classes are available for mRCC. The mechanism of action of vascular endothelial growth factor (VEGF) and VEGF receptor or mTOR inhibition is well documented by phase III trials and reflected in the current guidelines. However, no predictive biomarkers have been identified in mRCC so far to demonstrate a benefit by a specific compound in an individual patient. Meanwhile, the sequential use of ‘targeted therapies' in mRCC has been established as standard treatment. The optimal sequence of available agents is still unclear. A German RCC expert panel discussed and developed an algorithm for the choices of first- and second-line treatment in mRCC based on established clinical criteria.

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Sorafenib with interleukin-2 vs sorafenib alone in metastatic renal cell carcinoma: the ROSORC trial

Cited by 65 publications

References 29 publications

Sorafenib Treatment of Advanced Renal Cell Carcinoma Patients in Daily Practice: The Large International PREDICT Study

Sorafenib Treatment of Advanced Renal Cell Carcinoma Patients in Daily Practice: The Large International PREDICT Study

First-Generation Tyrosine Kinase Inhibitors: Clinical Results

Treatment Algorithm for Metastatic Renal Cell Carcinoma - Recommendations Based on Evidence and Clinical Practice

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