Understanding the adverse event experience in the S-TRAC adjuvant trial of sunitinib for high-risk renal cell carcinoma
Abstract
Until recently, the sole treatment for patients with nonmetastatic renal cell carcinoma (RCC) was nephrectomy followed by observation. As metastatic RCC (mRCC) remains largely incurable (5-year survival rate ∼12%), adjuvant treatment, with potential to prevent/delay disease recurrence, is needed. In November 2017, sunitinib was approved in the USA as the first adjuvant therapy for patients at high risk for recurrent RCC postnephrectomy based on results from the S-TRAC trial. Patients eligible for adjuvant treatment have no evidence of disease and may be less willing to tolerate side effects. Therefore, proactive adverse event management is critical for keeping patients on adjuvant treatment and requires understanding the subtle differences in the adverse event profile of sunitinib in the adjuvant versus metastatic RCC setting.
Papers of special note have been highlighted as: • of interest
References
- 1. SEER cancer statistics review. 1975–2015 (2018). https://seer.cancer.gov/csr/1975_2015/
- 2. . Epidemiologic and socioeconomic burden of metastatic renal cell carcinoma (mRCC): a literature review. Cancer Treat. Rev. 34(3), 193–205 (2008).
- 3. . Renal cell cancer stage migration: analysis of the National Cancer Data Base. Cancer 113(1), 78–83 (2008).
- 4. American Cancer Society. Survival rates for kidney cancer, by stage (2018). www.cancer.org/cancer/kidney-cancer/detection-diagnosis-staging/survival-rates.html
- 5. . Surveillance strategies for renal cell carcinoma patients following nephrectomy. Rev. Urol. 8(1), 1–7 (2006).
- 6. Adjuvant sunitinib in high-risk renal-cell carcinoma after nephrectomy. N. Engl. J. Med. 375(23), 2246–2254 (2016).
- 7. . Postoperative surveillance protocol for patients with localized and locally advanced renal cell carcinoma based on a validated prognostic nomogram and risk group stratification system. J. Urol. 74(2), 466–472; discussion 472; quiz 801 (2005).
- 8. National Cancer Institute. SEER cancer statistics factsheets: kidney and renal pelvis cancer (2016). http://seer.cancer.gov/statfacts/html/kidrp.html
- 9. Comparative clinical benefits of systemic adjuvant therapy for paradigm solid tumors. Cancer Treat. Rev. 39(1), 27–43 (2013). • This is a review of adjuvant therapy in current use for five types of solid tumors. Presents rationale for adjuvant therapy.
- 10. Pfizer. Sutent (sunitinib) prescribing information. NY, USA (2017).
- 11. Adjuvant sunitinib or sorafenib for high-risk, non-metastatic renal-cell carcinoma (ECOG-ACRIN E2805): a double-blind, placebo-controlled, randomised, Phase III trial. Lancet 387(10032), 2008–2016 (2016).
- 12. Randomized Phase III trial of adjuvant pazopanib versus placebo after nephrectomy in patients with localized or locally advanced renal cell carcinoma. J. Clin. Oncol. 35(35), 3916–3923 (2017).
- 13. GlaxoSmithKline. Votrient (pazopanib) prescribing information. Research Triangle Park, Durham, NC, USA (2009).
- 14. Pazopanib versus sunitinib in metastatic renal-cell carcinoma. N. Engl. J. Med. 369(8), 722–731 (2013).
- 15. . Adjuvant therapy in renal cell carcinoma-past, present, and future. Semin. Oncol. 40(4), 482–491 (2013).
- 16. Sunitinib versus interferon alfa in metastatic renal-cell carcinoma. N. Engl. J. Med. 356(2), 115–124 (2007).
- 17. Overall survival and updated results for sunitinib compared with interferon alfa in patients with metastatic renal cell carcinoma. J. Clin. Oncol. 27(22), 3584–3590 (2009).
- 18. Adjuvant sunitinib in patients with high-risk renal cell carcinoma: safety, therapy management, and patient-reported outcomes in the S-TRAC trial. Ann. Oncol. 29(10) 2098–2104 (2018).
- 19. . Management of side effects associated with sunitinib therapy for patients with renal cell carcinoma. Onco. Targets Ther. 2, 51–61 (2009).
- 20. . Sunitinib toxicity management – a practical approach. Can. Urol. Assoc. J. 10(Suppl. 7), S248–S251 (2016).
