Temsirolimus in Asian Metastatic/Recurrent Non-clear Cell Renal Carcinoma
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Purpose Temsirolimus is effective in the treatment for metastatic non-clear cell renal cell carcinoma (nccRCC) with poor prognosis. We aim to investigate the efficacy and tolerability of temsirolimus in treatment of naïve Asian patients with metastatic/recurrent nccRCC. Materials and Methods From January 2008 to July 2017, data of treatment-naïve, metastatic/recurrent nccRCC patients, who were treated with temsirolimus according to the standard protocol, were collected. The primary end-point was progression-free survival (PFS). Secondary end points were overall survival (OS), objective response rate (ORR), and tolerability of temsirolimus. Results Forty-four metastatic/recurrent nccRCC patients, 10 from prospective and 34 from retrospective groups, were enrolled; 24 patients (54%) were papillary type, and other histology subtypes included 11 chromophobes (25%), two collecting ducts (5%), one Xp11.2 translocation (2%), and six others (14%). The median PFS and OS were 7.6 months and 17.6 months, respectively. ORR was 11% and disease control rate was 83%. Patients with prior nephrectomy had longer PFS (hazard ratio [HR], 0.16; 95% confidence interval [CI], 0.06 to 0.42; p < 0.001) and OS (HR, 0.15; 95% CI, 0.05 to 0.45; p < 0.001). Compared to favorable/ intermediate prognosis group, poor prognosis group had shorter median PFS (4.7 months vs. 7.6 months [HR, 2.91; 95% CI, 1.39 to 6.12; p=0.005]) and median OS (9.2 months vs. 17.6 months [HR, 2.84; 95% CI, 1.23 to 6.56; p=0.015]). Conclusion Temsirolimus not only benefits poor-risk nccRCC patients, but it is also effective in favorable or intermediate-risk group in Asians. Temsirolimus was well-tolerated with manageable adverse events.
Abstract
Purpose Temsirolimus is effective in the treatment for metastatic non-clear cell renal cell carcinoma (nccRCC) with poor prognosis. We aim to investigate the efficacy and tolerability of temsirolimus in treatment of naïve Asian patients with metastatic/recurrent nccRCC. Materials and Methods From January 2008 to July 2017, data of treatment-naïve, metastatic/recurrent nccRCC patients, who were treated with temsirolimus according to the standard protocol, were collected. The primary end-point was progression-free survival (PFS). Secondary end points were overall survival (OS), objective response rate (ORR), and tolerability of temsirolimus. Results Forty-four metastatic/recurrent nccRCC patients, 10 from prospective and 34 from retrospective groups, were enrolled; 24 patients (54%) were papillary type, and other histology subtypes included 11 chromophobes (25%), two collecting ducts (5%), one Xp11.2 translocation (2%), and six others (14%). The median PFS and OS were 7.6 months and 17.6 months, respectively. ORR was 11% and disease control rate was 83%. Patients with prior nephrectomy had longer PFS (hazard ratio [HR], 0.16; 95% confidence interval [CI], 0.06 to 0.42; p < 0.001) and OS (HR, 0.15; 95% CI, 0.05 to 0.45; p < 0.001). Compared to favorable/ intermediate prognosis group, poor prognosis group had shorter median PFS (4.7 months vs. 7.6 months [HR, 2.91; 95% CI, 1.39 to 6.12; p=0.005]) and median OS (9.2 months vs. 17.6 months [HR, 2.84; 95% CI, 1.23 to 6.56; p=0.015]). Conclusion Temsirolimus not only benefits poor-risk nccRCC patients, but it is also effective in favorable or intermediate-risk group in Asians. Temsirolimus was well-tolerated with manageable adverse events.
참고문헌 (18)
- Lopez-Beltran A, "Unclassified renal cell carcinoma : a report of 56 cases", BJU Int, 110, pp.786~793 (2012)
- Moch H, "The 2016 WHO classification of tumours of the urinary system and male genital organs-part a : renal, penile, and testicular tumours", Eur Urol, 70, pp.93~105 (2016)
- Tsimafeyeu I, "Management of non-clear cell renal cell carcinoma : current approaches", Urol Oncol, 35, pp.5~13 (2017)
- Zibelman M, "A review of interventional clinical trials in renal cell carcinoma: a status report from the ClinicalTrials.gov WebSite", Clin Genitourin Cancer, 13, pp.142~149 (2015)
- Gore ME, "Final results from the large sunitinib global expanded-access trial in metastatic renal cell carcinoma", Br J Cancer, 113, pp.12~19 (2015)
- 홍민희, "Treatment Outcomes of Sunitinib Treatment in Advanced Renal Cell Carcinoma Patients: A Single Cancer Center Experience in Korea", Cancer Research and Treatment, 41(2), pp.67~72 (2009), 대한암학회
- Stadler WM, "Safety and efficacy results of the advanced renal cell carcinoma sorafenib expanded access program in North America", Cancer, 116, pp.1272~1280 (2010)
- Stadler WM, "The Advanced Renal Cell Carcinoma Sorafenib (ARCCS) expanded access trial: safety and efficacy in patients (pts) with non-clear cell (NCC) renal cell carcinoma (RCC)", J Clin Oncol, 25(18 Suppl), pp.5036~ (2007)
- Hudes G, "Temsirolimus, interferon alfa, or both for advanced renal-cell carcinoma", N Engl J Med, 356, pp.2271~2281 (2007)
- Dutcher JP, "Effect of temsirolimus versus interferonalpha on outcome of patients with advanced renal cell carcinoma of different tumor histologies", Med Oncol, 26, pp.202~209 (2009)
- Tannir NM, "Everolimus versus sunitinib prospective evaluation in metastatic non-clear cell renal cell carcinoma(ESPN) : a randomized multicenter phase 2 trial", Eur Urol, 69, pp.866~874 (2016)
- Armstrong AJ, "Final clinical results of a randomized phase II international trial of everolimus vs. sunitinib in patients with metastatic non-clear cell renal cell carcinoma (ASPEN)", J Clin Oncol, 33(15 Suppl), pp.4507~ (2015)
- Hay N, "Upstream and downstream of mTOR", Genes Dev, 18, pp.1926~1945 (2004)
- Del Bufalo D, "Antiangiogenic potential of the Mammalian target of rapamycin inhibitor temsirolimus", Cancer Res, 66, pp.5549~5554 (2006)
- Pantuck AJ, "Pathobiology, prognosis, and targeted therapy for renal cell carcinoma : exploiting the hypoxia-induced pathway", Clin Cancer Res, 9, pp.4641~4652 (2003)
- Buti S, "First-Line Pazopanib in NOn-clear-cell Renal cArcinoMA: The Italian Retrospective Multicenter PANORAMA Study", Clin Genitourin Cancer, 15, pp.e609~e614 (2017)
- 정기선, "Pazopanib for the Treatment of Non-clear Cell Renal Cell Carcinoma: A Single-Arm, Open-Label, Multicenter, Phase II Study", Cancer Research and Treatment, 50(2), pp.488~494 (2018), 대한암학회
- Choueiri TK, "Cabozantinib versus sunitinib as initial therapy for metastatic renal cell carcinoma of intermediate or poor risk(Alliance A031203 CABOSUN randomised trial) : progressionfree survival by independent review and overall survival update", Eur J Cancer, 94, pp.115~125 (2018)