Phase II trial of sunitinib and gemcitabine in patients with sarcomatoid and/or poor-risk metastatic renal cell carcinoma.

Michaelson, D.; McDermott, David F.; Atkins, Michael B.; Cho, D. C.; Olivier, Kara; Schwarzberg, Abraham B.; Choueiri, Toni K.

doi:10.1200/jco.2010.28.15_suppl.e15076

Cited by 9 publications

(8 citation statements)

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“…This study has been followed by a larger phase II study specifically in patients with sarcomatoid and/or poor-risk metastatic renal cell cancer. In the preliminary report this year, 3 of the 9 patients with sarcomatoid renal cell cancer treated obtained partial responses [28]. Follow-up is ongoing.…”

Section: Discussionmentioning

confidence: 98%

Long-term survival of patients with sarcomatoid renal cell cancer treated with chemotherapy

Dutcher

Nanus

2010

Med Oncol

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Sarcomatoid renal cell cancer is associated with a very poor prognosis, characterized by rapid progression of advanced disease. We previously reported the outcome of 18 patients with advanced sarcomatoid renal cell cancer treated with a regimen consisting of doxorubicin, 50 mg/m2 and gemcitabine, 1,500-2,000 mg/m2, administered every two weeks with growth factor support (A/G). Among the 18 patients, there were two complete and 5 partial responses and two patients with stable disease of more than 6 months of duration. We now report long-term survival of 4 patients with stage IV sarcomatoid renal cell carcinoma treated with this regimen at the 1,500 mg/m2 dose of gemcitabine, and achieving complete response (2 patients), or rendered complete responders following surgery after maximum response (2 patients). The two complete responders are alive, disease free at 6+ and 8+ years after starting A/G, and the 2 patients rendered CR by surgery survived 3½ and 6 years, respectively. Both died of progressive disease, one with clear cell recurrence, one with sarcomatoid recurrence. In summary, this regimen is associated with a high response rate, overall improvement in progression free survival and occasional meaningful long-term survival in a disease expected to be fatal within one year.

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Section: Discussionmentioning

confidence: 98%

Long-term survival of patients with sarcomatoid renal cell cancer treated with chemotherapy

Dutcher

Nanus

2010

Med Oncol

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“…13 Finally, chemotherapy has been used in combination with anti-VEGF agents. An interim analysis of an ongoing trial of gemcitabine and sunitinib 19 showed a partial response rate of 33% in patients with sRCC (n ¼ 9), with a TTP of 4.6 months. Two additional ongoing trials are also exploring the combination of systemic chemotherapy with anti-VEGF agents, the first using a combination of gemcitabine and sunitinib (NCT01164228) and the second using a combination of gemcitabine and capecitabine with bevacizumab (NCT00496587).…”

Section: Discussionmentioning

confidence: 99%

Outcome of Patients With Metastatic Sarcomatoid Renal Cell Carcinoma: Results From the International Metastatic Renal Cell Carcinoma Database Consortium

Kyriakopoulos

Chittoria

Choueiri

et al. 2015

Clinical Genitourinary Cancer

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“…The combination of gemcitabine and doxorubicin has been shown to have clinical activity in some patients with advanced sRCC, with an objective response rate of 15.8% as reported in a phase II ECOG-8802 study in 2009 [10]. More recently, other groups have evaluated the benefit of combination therapy with tyrosine kinase inhibitors and other targeted agents [11, 12]. We recently completed a phase II clinical trial at our institution using the combination of bevacizumab, capecitabine and gemcitabine in patients with metastatic or unresectable sRCC.…”

Section: Discussionmentioning

confidence: 99%

Clinically nonmetastatic renal cell carcinoma with sarcomatoid dedifferentiation: Natural history and outcomes after surgical resection with curative intent

Merrill

Wood

Tannir

et al. 2015

Urologic Oncology: Seminars and Original Investigations

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Purpose Renal cell carcinoma with sarcomatoid dedifferentiation (sRCC) is an aggressive malignancy associated with a poor prognosis. While existing literature focuses on patients presenting with metastatic disease, characteristics and outcomes for patients with localized disease are not well described. We aimed to evaluate post-nephrectomy characteristics, outcomes, and predictors of survival in patients with sRCC who presented with clinically localized disease. Patients and Methods An IRB-approved review from 1986–2011 identified 77 patients who presented with clinically localized disease, underwent nephrectomy and had sRCC in their primary kidney tumor. Clinical and pathologic variables were captured for each patient. Overall survival (OS) and recurrence-free survival (RFS) were calculated for all patients and those who had no evidence of disease (NED) following nephrectomy, respectively. Comparisons were made with categorical groupings in proportional hazards regression models for univariable and multivariable analyses. Results OS for the entire cohort (N=77) at 2 years was 50%. A total of 56 (77%) patients of the 73 who were NED following nephrectomy experienced a recurrence, with a median time to recurrence of 26.2 months. On multivariable analysis, tumor stage, pathologically positive lymph nodes, and year of nephrectomy were significant predictors of both OS and RFS. Limitations include the retrospective nature of this study and relatively small sample size. Conclusions Long-term survival for patients with sRCC, even in clinically localized disease is poor. Aggressive surveillance of those who are NED following nephrectomy is essential and further prospective studies evaluating the benefit of adjuvant systemic therapies in this cohort are warranted.

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Phase II trial of sunitinib and gemcitabine in patients with sarcomatoid and/or poor-risk metastatic renal cell carcinoma.

Cited by 9 publications

References 0 publications

Long-term survival of patients with sarcomatoid renal cell cancer treated with chemotherapy

Long-term survival of patients with sarcomatoid renal cell cancer treated with chemotherapy

Outcome of Patients With Metastatic Sarcomatoid Renal Cell Carcinoma: Results From the International Metastatic Renal Cell Carcinoma Database Consortium

Clinically nonmetastatic renal cell carcinoma with sarcomatoid dedifferentiation: Natural history and outcomes after surgical resection with curative intent

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