Continuing a cancer treatment despite tumor growth may be valuable: Sunitinib in renal cell carcinoma as example

Mauricio Burotto, Julia Wilkerson, Wilfred Stein, Robert Motzer, Susan Bates, Tito Fojo

Research output: Contribution to journalArticlepeer-review

25 Scopus citations


Background: The US FDA and the EMA have approved seven agents for the treatment of renal cell carcinoma, primarily based on differences in progression-free survival (PFS). Because PFS is an arbitrary endpoint we hypothesized that an analysis would demonstrate the growth rate of tumors remained constant at the time of RECIST-defined disease progression. Methods: We previously estimated the growth (g) and regression (d) rates and the stability of g using data from the Phase III trial comparing sunitinib and interferon. Results: Sufficient data were available and rate constants statistically valid in 321 of 374 patients randomized to sunitinib. Median d was 0·0052 days -1 ; in 53 patients no tumor growth was recorded. Median g was 0·00082 days -1 and was stable for a median of 275 days on therapy, remaining stable beyond 300, 600 and 900 days in 122, 65 and 27 patients, respectively. A possible increase in g while receiving sunitinib could be discerned in only 18 of 321 patients. Given a median g of 0·00082 days -1 the estimated median time to a second progression were sunitinib continued past RECIST-defined progression was 7.3 months. At 100, 200, and 300 days after starting therapy, an estimated 47%, 27%, and 13% of tumor remains sunitinib sensitive and could explain a RECIST-defined response to a new TKI. Conclusion: Prolonged stability of g with sunitinib suggests continued sunitinib beyond RECIST-defined progression may provide a beneficial outcome. Randomized trials in patients whose disease has "progressed" on sunitinib are needed to test this hypothesis.

Original languageEnglish
Article numbere96316
JournalPLoS ONE
Issue number5
StatePublished - 5 May 2014
Externally publishedYes


  • Angiogenesis Inhibitors
  • Antineoplastic Agents
  • Carcinoma, Renal Cell
  • Cell Proliferation
  • Disease-Free Survival
  • Humans
  • Indoles
  • Kidney Neoplasms
  • Pyrroles
  • Treatment Outcome


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