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Second-line treatment after sunitinib therapy in patients with renal cell carcinoma: a comparison of axitinib and mammalian target of rapamycin inhibitors.

ABSTRACT: This retrospective study compared the outcomes of sequential therapy using sunitinib followed by axitinib or the mammalian target of rapamycin (mTOR) inhibitors (everolimus or temsirolimus). Among 234 patients treated with molecular-targeted drugs for metastatic renal cell carcinoma, we selected 137 patients treated with sunitinib as the first-line therapy. We then compared patients treated with axitinib (n = 52) or mTOR inhibitors (n = 31), as the second-line treatment, and investigated the progression-free survival (PFS) and overall survival (OS). The PFS of axitinib-treated patients (median 8.7 months) was superior to that of mTOR inhibitors-treated patients (median 3.4 months; P = 0.001). Additionally, the OS from baseline of axitinib-treated patients (median 69 months) was superior to that of mTOR inhibitors-treated patients (median 33.4 months; P = 0.034). A multivariate analysis was performed with the following factors: the drugs used for the second-line treatment, the Memorial Sloan Kettering Cancer Center risk classification during the initial treatment, whether the discontinuation of the first-line treatment was due to adverse events, and whether the duration of response of the first-line treatment was less than 6 or 12 months. Importantly, the drugs used for the second-line treatment and Memorial Sloan Kettering Cancer Center risk classification were independent factors. Our findings suggest that axitinib works better than mTOR inhibitors after the first-line treatment with sunitinib.

SUBMITTER: Tamada S

PROVIDER: S-EPMC6319347 | biostudies-literature | 2018 Dec

REPOSITORIES: biostudies-literature

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Second-line treatment after sunitinib therapy in patients with renal cell carcinoma: a comparison of axitinib and mammalian target of rapamycin inhibitors.

Tamada Satoshi S Iguchi Taro T Kato Minoru M Yasuda Sayaka S Yamasaki Takeshi T Nakatani Tatsuya T

Oncotarget 20181211 97

This retrospective study compared the outcomes of sequential therapy using sunitinib followed by axitinib or the mammalian target of rapamycin (mTOR) inhibitors (everolimus or temsirolimus). Among 234 patients treated with molecular-targeted drugs for metastatic renal cell carcinoma, we selected 137 patients treated with sunitinib as the first-line therapy. We then compared patients treated with axitinib (n = 52) or mTOR inhibitors (n = 31), as the second-line treatment, and investigated the pro ...[more]

PMID: 30651932

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Project description:BackgroundIn a single-group, phase 1b trial, avelumab plus axitinib resulted in objective responses in patients with advanced renal-cell carcinoma. This phase 3 trial involving previously untreated patients with advanced renal-cell carcinoma compared avelumab plus axitinib with the standard-of-care sunitinib.MethodsWe randomly assigned patients in a 1:1 ratio to receive avelumab (10 mg per kilogram of body weight) intravenously every 2 weeks plus axitinib (5 mg) orally twice daily or sunitinib (50 mg) orally once daily for 4 weeks (6-week cycle). The two independent primary end points were progression-free survival and overall survival among patients with programmed death ligand 1 (PD-L1)-positive tumors. A key secondary end point was progression-free survival in the overall population; other end points included objective response and safety.ResultsA total of 886 patients were assigned to receive avelumab plus axitinib (442 patients) or sunitinib (444 patients). Among the 560 patients with PD-L1-positive tumors (63.2%), the median progression-free survival was 13.8 months with avelumab plus axitinib, as compared with 7.2 months with sunitinib (hazard ratio for disease progression or death, 0.61; 95% confidence interval [CI], 0.47 to 0.79; P<0.001); in the overall population, the median progression-free survival was 13.8 months, as compared with 8.4 months (hazard ratio, 0.69; 95% CI, 0.56 to 0.84; P<0.001). Among the patients with PD-L1-positive tumors, the objective response rate was 55.2% with avelumab plus axitinib and 25.5% with sunitinib; at a median follow-up for overall survival of 11.6 months and 10.7 months in the two groups, 37 patients and 44 patients had died, respectively. Adverse events during treatment occurred in 99.5% of patients in the avelumab-plus-axitinib group and in 99.3% of patients in the sunitinib group; these events were grade 3 or higher in 71.2% and 71.5% of the patients in the respective groups.ConclusionsProgression-free survival was significantly longer with avelumab plus axitinib than with sunitinib among patients who received these agents as first-line treatment for advanced renal-cell carcinoma. (Funded by Pfizer and Merck [Darmstadt, Germany]; JAVELIN Renal 101 ClinicalTrials.gov number, NCT02684006.).

Project description:BackgroundThe data from the phase III clinical trial KEYNOTE-426 indicated that pembrolizumab plus axitinib compared with sunitinib could generate clinical benefits in patients with previously untreated advanced renal cell carcinoma (RCC). Given the incremental clinical benefits, we examined the potential cost-effectiveness of pembrolizumab plus axitinib versus sunitinib in the first-line setting for patients with advanced RCC from the U.S. payers' perspective.Materials and methodsCost and health outcomes were estimated at a willingness-to-pay (WTP) threshold of $100,000 to $150,000 per quality-adjusted life-year (QALY). One-way and probabilistic sensitivity analyses were performed by varying potentially modifiable parameters, and additional subgroup analyses were performed as well.ResultsUpon our analyses, the total treatment costs in the pembrolizumab plus axitinib and sunitinib groups were $522,796 and $348,424 and the QALYs gained 2.90 and 1.72, respectively. In the base-case analysis, compared with receiving sunitinib, patients with advanced RCC receiving pembrolizumab plus axitinib gained 1.18 more QALYs at an incremental cost-effectiveness ratio of $148,676/QALY. The results of subgroup analyses demonstrated that pembrolizumab plus axitinib was most cost-effective for patients who had one organ with metastasis.ConclusionFirst-line treatment with pembrolizumab plus axitinib, compared with sunitinib, is a cost-effective strategy when the value of WTP is from $100,000 to $150,000 per QALY in patients with advanced RCC. For patients with one-organ metastasis and those in International Metastatic Renal Cell Carcinoma Database Consortium poor risk group, first-line treatment with pembrolizumab plus axitinib is more cost-effective than others.Implications for practiceThis was the first study to examine the cost-effectiveness of pembrolizumab plus axitinib versus sunitinib in advanced renal cell carcinoma (RCC). This study found that first-line treatment with pembrolizumab plus axitinib is a cost-effective strategy when the value of willingness-to-pay is from $100,000 to $150,000 per quality-adjusted life-year in patients with advanced RCC from the U.S. payers' perspective.

Dataset Information

Second-line treatment after sunitinib therapy in patients with renal cell carcinoma: a comparison of axitinib and mammalian target of rapamycin inhibitors.

Publications

Second-line treatment after sunitinib therapy in patients with renal cell carcinoma: a comparison of axitinib and mammalian target of rapamycin inhibitors.

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