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In Reply

Dana-Farber Cancer Institute, Boston, MA

Ronald M. Bukowski

Cleveland Clinic Taussig Cancer Center, Cleveland, OH

Bernard Escudier

Institut Gustave Roussy, Villejuif, France

We thank Dr Strumberg for his comments on our recent original report.¹ This is a retrospective multicenter review as noted in the introduction, and was undertaken to determine whether the tyrosine kinase inhibitors sunitinib and sorafenib may have activity in metastatic papillary and chromophobe renal cell carcinoma (RCC). Whereas classically, non–clear cell RCCs have been perceived as having an unfavorable prognosis, a recent large international study² challenged this view in reporting the outcome of 1,001 patients with metastatic RCC (82 of whom had papillary histology), finding the 5-year survival rates of papillary and clear cell subtypes to be similar, in the range of 10%.

Dr Strumberg nicely summarized the data from the sunitinib and sorafenib expanded-access studies (EASs), which show a Response Evaluation Criteria in Solid Tumors Group–defined response rate of less than 10% and significant stable disease rates, validating our own results. Progression-free survival (PFS), rather than overall survival, is the preferred comparative end point in these studies, given that both sunitinib and sorafenib were approved based on PFS as a primary end point.^3,4 These abstracts report preliminary assessments, lack pathology review, and data from EASs can be quite variable, especially with regard to the schedule of events and the assessment of response. Therefore, the PFS data reported in these studies are overall inconclusive due to mainly high censorship (62%).⁵

One of the values of our study is to gather patients from experimented sites with a large cohort of RCC patients, in comparison with the EASs. Recently, temsirolimus, a mammalian target of rapamycin inhibitor, was recommended based on a subset of patients from the phase III study with non–clear cell histology, in whom there is absolutely no quality control of the type of histology.⁶ In summary, our study clearly states that "additional prospective studies and clinical experience with non–clear-cell subtypes are needed." The oncologist may not have access to such trials in practice, and based on available information, the use of tyrosine kinase inhibitors such as sunitinib, sorafenib, or temsirolimus⁷ may be justified in metastatic papillary and chromophobe RCC.

AUTHORS' DISCLOSURES OF POTENTIAL CONFLICTS OF INTEREST

Although all authors completed the disclosure declaration, the following author(s) indicated a financial or other interest that is relevant to the subject matter under consideration in this article. Certain relationships marked with a "U" are those for which no compensation was received; those relationships marked with a "C" were compensated. For a detailed description of the disclosure categories, or for more information about ASCO's conflict of interest policy, please refer to the Author Disclosure Declaration and the Disclosures of Potential Conflicts of Interest section in Information for Contributors.

Employment or Leadership Position: None Consultant or Advisory Role: Ronald M. Bukowski, Bayer (C), Pfizer (C), Genentech (C), Wyeth (C) Stock Ownership: None Honoraria: Toni K. Choueiri, Pfizer; Ronald M. Bukowski, Bayer, Pfizer, Genentech Research Funding: Ronald M. Bukowski, Bayer, Pfizer, Genentech, Celgene, Wyeth Expert Testimony: None Other Remuneration: None

REFERENCES

1. Choueiri TK, Plantade A, Elson P, et al: Efficacy of sunitinib and sorafenib in metastatic papilarry and chromophobe renal cell carcinoma. J Clin Oncol 26:127-131, 2008[Abstract/Free Full Text]

2. Patard JJ, Leray E, Rioux-Leclercq N, et al: Prognostic value of histologic subtypes in renal cell carcinoma: A multicenter experience. J Clin Oncol 23:2763-2771, 2005[Abstract/Free Full Text]

3. Motzer RJ, Hutson TE, Tomczak P, et al: Sunitinib versus interferon alfa in metastatic renalcell carcinoma. N Engl J Med 356:115-124, 2007[Abstract/Free Full Text]

4. Escudier B, Eisen T, Stadler WM, et al: Sorafenib in advanced clear-cell renal-cell carcinoma. N Engl J Med 356:125-134, 2007[Abstract/Free Full Text]

5. Knox JJ, Figlin RA, Stadler WM, et al: The advanced renal cell carcinoma sorafenib (ARCCS) expanded access trial in North America: Safety and efficacy. J Clin Oncol 25:237s, 2007 (suppl; abstr 5011),

6. National Comprehensive Cancer Network Clinical Practice Guidelines on Oncology: Kidney Cancer. http://www.nccn.org/professionals/physician_gls/PDF/kidney.pdf

7. Dutcher JP, Szczylik C, Tannir N, et al: Correlation of survival with tumor histology, age, and prognostic risk group for previously untreated patients with advanced renal cell carcinoma (adv RCC) receiving temsirolimus (TEMSR) or interferon-alpha (IFN). J Clin Oncol 25:243s, 2007 (suppl; abstr 5033)

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Related Correspondence

• Efficacy of Sunitinib and Sorafenib in Non–Clear Cell Renal Cell Carcinoma: Results From Expanded Access Studies
  Dirk Strumberg
  JCO 2008 26: 3469-3471 [Full Text]

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