Advances in Clinical and Experimental Medicine

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Advances in Clinical and Experimental Medicine

2011, vol. 20, nr 3, May-June, p. 335–342

Publication type: original article

Language: English

Examining the Efficacy of Sorafenib – a Meta-Analysis

Ocena skuteczności sorafenibu – metaanaliza

Usman Z. Paracha1,, Rehan Z. Paracha2,, Waseem Hassan1,, Ghulam Murtaza3,

1 Department of Pharmacy, Hajvery University, Lahore, Pakistan

2 Department of Virology, National University of Sciences and Technology, Islamabad, Pakistan

3 Department of Pharmaceutical Science, COMSATS Institute of Information Technology, Abbottabad, Pakistan

Abstract

Objectives. The recently approved drug sorafenib has been found to be effective against renal cell carcinoma and hepatocellular carcinoma. A meta-analysis to examine the extent to which this drug is effective in comparison to a placebo-based therapy regimen was conducted.
Material and Methods. We performed a literature survey and recognized randomized controlled trials that had judged the efficacy of sorafenib in comparison to placebos in preventing renal cell carcinoma or hepatocellular carcinoma. The authors have evaluated the data separately.
Results. This analysis contains data from 3,659 patients. The percentage of patients who responded either completely or partially to a sorafenib-based therapy regimen was 6.5% as compared to 2.2% from a placebo-based therapy regimen (log odds ratio = 0.48, 95% CI = 2.893, –1.933). It has also been found that the mean time for progression free survival (PFS) is 5 months for the sorafenib-based therapy regimen as compared to 2.88 months, which is the mean time for progression free survival with a placebo-based therapy regimen.
Conclusion. It was concluded that a sorafenib-based therapy regimen yields a better response and more time for progression free survival in patients with renal cell carcinoma or hepatocellular carcinoma as compared to a placebo-based therapy regimen.

Streszczenie

Cel pracy. Niedawno zatwierdzony lek sorafenib okazał się skuteczny w leczeniu raka miąższu nerki i raka wątrobowokomórkowego. Przeprowadzono metaanalizę, aby ocenić zakres skuteczności leku w porównaniu ze schematem leczenia opartym na placebo.
Materiał i metody. Autorzy przeprowadzili przegląd literatury i uznanych randomizowanych badań klinicznych, które miały ocenić skuteczność sorafenibu w porównaniu z placebo w zapobieganiu rakowi nerki lub rakowi wątrobowokomórkowemu. Autorzy dokonali oceny danych oddzielnie.
Wyniki. Analiza zawiera dane 3659 pacjentów. Całkowita liczba pacjentów, u których stwierdzono odpowiedź całkowitą lub częściową na leczenie za pomocą sorafenibu to 6,5% w porównaniu z 2,2% pacjentów, którym podawano placebo (logarytm ilorazu szans = 0,48; 95% CI = 2,893; –1,933). Stwierdzono również, że średni czas przeżycia bez progresji choroby (PFS) wynosi 5 miesięcy w grupie leczonej sorafenibem w porównaniu z 2,88 miesiąca średniego czasu przeżycia wolnego od progresji choroby w grupie otrzymującej placebo.
Wnioski. Stwierdzono, że leczenie za pomocą sorafenibu daje lepsze odpowiedzi i dłuższy czas przeżycia bez progresji choroby u pacjentów z rakiem nerki lub rakiem wątroby w porównaniu z podawaniem placebo.

Key words

carcinoma management, placebo, randomized controlled trials, progression free survival

Słowa kluczowe

leczenie raka, placebo, randomizowane badania kliniczne, przeżycie bez progresji choroby

References (17)

  1. Kane RC, Farrell AT, Madabushi R, Booth B, Chattopadhyay S, Sridhara R: Sorafenib for the treatment of Unresectable Hepatocellular Carcinoma. Oncologist 2009, 14, 95–100.
  2. Wilhelm S, Carter C, Lynch M, Lowinger T, Dumas J, Smith RA: Discovery and development of sorafenib: A multikinase inhibitor for treating cancer. Nat Rev Drug Discov 2006, 5, 835–845.
  3. Bracarda S, Caserta C, Sordini L, Rossi M, Hamzay A, Crino L: Protein kinase inhibitors in the treatment of renal cell carcinoma: sorafenib. Ann Oncol 2007, vi22–vi25.
  4. Ma WW, Adjei AA: Novel agents on the Horizon for Cancer Therapy. CA Cancer J Clin 2009, 59, 111–137.
  5. Wilhelm S, Carter C, Tang LE: BAY43-9006 exhibits broad spectrum oral antitumor activity and targets the RAF/ MEK/ERK pathway and receptor tyrosine kinases involved in tumor pregression and angiogenesis. Cancer Res 2004, 64, 7099–7109.
  6. Strumberg D, Clark JW, Awada A, Moore MJ, Richly H, Hendlisz A: Safety, Pharmacokinetics, and Preliminary Antitumor Activity of sorafenib: A review of four phase I trials in patients with advanced refractory solid tumors. Oncologist 2007, 12, 426–437.
  7. Scelo G, Brennan P: The epidemiology of bladder and kidney cancer. Clin Pract Urol 2007, 4, 205–217.
  8. McLaughlin JK, Lipworth L, Tarone RE: Epidemiologic aspects of renal cell carcinoma. Semin Oncol 2006, 33, 527–533.
  9. Eisen T, Oudard S, Szczylik C, Gravis G, Heinzer H, Middleton R.: Sorafenib for older patients with renal cell carcinoma: Subset analysis from a randomized trial. J Natl Cancer Inst 2008, 100 (20), 1454–1463.
  10. Strumberg D, Richly H, Hilger RA: Phase I clinical and pharmacokinetic study of the Novel Raf kinase and vascular endothelial growth factor receptor inhibitor BAY 43-9006 in patients with advanced refractory solid tumors. J Clin Oncol 2005, 23, 965–972.
  11. Abou Alfa GK, Schwartz L, Ricci, SE: Phase II study of sorafenib in patients with advanced hepatocellular carcinoma. J Clin Oncol 2006, 24, 4293–4300.
  12. McDermott DF, Sosman JA, Gonzalez R, Hodi FS, Linette GP, Richards J: Double-Blind Randomized Phase II Study of the combination of sorafenib and dacarbazine in patients with advanced melanoma: A report from the 11715 study group. J Clin Oncol 2008, 26 (13), 2178–2185.
  13. Agarwala SS, Keil Holz U, Hogg D, Robert C, Hersey P, Eggermont A: Randomized phase III study of paclitaxel plus carboplatin with or without sorafenib as second-line treatment in patients with advanced melanoma. J Clin Oncol 2007, 25 8510.
  14. Cheng A, Kang Y, Chen Z, Tsao C, Qin S, Kim J: Effi cacy and safety of sorafenib in patients in the Asia-Pacific region with advanced hepatocellular carcinoma: a phase III randomised, double-blind,placebo-controlled trial. Lancet Oncol 2009, 10, 25–34.
  15. Escudier B, Eisen T, Stadler WM, Szczylik C, Oudard S, Siebels M: Sorafenib in advanced clear cell renal cell carcinoma. N Engl J Med 2007, 356 (2), 125–134.
  16. Llovet JM, Ricci S, Mazzaferro V, Hilgard P, Gane E, Blanc JF: Sorafenib in Advanced Hepatocellular Carcinoma. N Engl J Med 2008, 378–390.
  17. Kane RC, Farrell AT, Saber H, Tang S, Williams G, Jee JM: Sorafenib for the treatment of advanced renal cell carcinoma. Clin Cancer Res 2006, 12 (24), 7271–7278.