848P - Overall survival (OS) in metastatic renal cell carcinoma (mRCC): a comparison between sorafenib (SO) and best supportive care (BSC) after first line...

Date 29 September 2012
Event ESMO Congress 2012
Session Poster presentation I
Topics Anticancer agents
Renal Cell Cancer
Therapy
Biological Therapy
Presenter Per Sandström
Authors P. Sandström1, R. Sandin2, J. Kowalski3, T. Wahlgren4, M. Jakobsson4, S. Lundstam5, B. Ljungberg6, U. Harmenberg1
  • 1Department Of Oncology-pathology, Karolinska University Hospital and Karolinska Institutet, 17170 - Stockholm/SE
  • 2Global Clinical Developlement And Medical Affairs, Pfizer AB, 19190 - Sollentuna/SE
  • 3Department Of Clinical Science, Intervention And Technology, Karolinska University Hospital Huddinge and Karolinska Institutet, 14186 - Stockholm/SE
  • 4Oncology, Pfizer AB, 19190 - Sollentuna/SE
  • 5Department Of Urology, University Hospital, and the Sahlgrenska Academy, 41345 - Gothenburg/SE
  • 6Department Of Surgical And Perioperative Sciences, Urology And Andrology, Umeå University, Umeå/SE

Abstract

Background

There is a paucity of efficacy data after first line treatment with SU in mRCC. This retrospective register study compared OS in patients treated with SO and BSC after first line treatment with SU in Sweden.

Methods

Three Swedish national health registers were used: the Swedish Cancer register (diagnosis and death), the National Patient Register (in-/out-patient data), and the Swedish Prescribed Drug Register. 135 patients identified with mRCC, diagnosed no later than 2009, were recorded as having received 1st-line treatment with SU; 59 patients received SO and 76 patients received BSC. Multivariate analysis was performed using the Cox proportional hazards model including estimation of adjusted OS. The regression model included the covariates: age, gender, nephrectomy, time since diagnosis and metastatic disease, time since mRCC diagnoses and start of systemic therapy, geographical region, institutional size, and duration of first line SU treatment. Sensitivity analysis with combinations of explanatory variables, was performed to test the robustness of the results.

Results

Patients characteristics differed between the SO and BSC patients, but available information did not indicate a clear advantage in favor of any treatment arm. OS for patients prescribed with SO was improved compared with OS for BSC patients. Including all covariates, median adjusted OS was 9,9 vs. 6,6 months, respectively for patients treated with SO and BSC (HR = 0.652, 95% CI: 0.412, 1.030; P < 0.067). Sensitivity analysis showed a robust and significant reduction in risk of death for patients treated with SO; range of 29-42% (HR: 0,58-0,71). In all models, nephrectomy was independently associated with significantly improved OS. Other individual covariates were generally not statistically significant, likely due to a low number of observations.

Conclusion

An improved OS for mRCC patients was seen in patients receiving SO compared to BSC after first line treatment with SU. Some caution should be taken with interpreting the results as confounding due to unmeasured covariates may exist.

Disclosure

P. Sandström: Has had an advisory role for Pfizer, Roche, GSK, Novartis, and Bayer, has received honoraria from Pfizer, Roche, bayer, GSK and Novartis and has received research funding from Pfizer and Bayer.

R. Sandin: Rickard Sandin is an employee of Pfizer AB and owns Pfizer stock.

J. Kowalski: Jan Kowalski is concultant and received compensation from Pfizer for the statistical work for the abstract.

T. Wahlgren: Thomas Wahlgren is an employee of Pfizer AB and owns Pfizer stock.

M. Jakobsson: Maria Jakobsson is an employee of Pfizer AB and owns Pfizer stock.

S. Lundstam: Has had an advisory board role for GSK and Bayer, has received honoraria from Pfizerand GSK, and has received research funding from Pfizer.

B. Ljungberg: Has had an advisory role for Pfizer, GSK, Novartis, Astellas and Bayer, and has received honoraria from Pfizer, Novartis, GSK and Bayer.

U. Harmenberg: Has had an advisory role for Pfizer, Roche, GSK, Novartis, and Bayer, has received honoraria from Pfizer, Roche, and Novartis and has received research funding from Pfizer, GSK and Novartis.