Abstract
Appropriate protocol for the sequential treatment of metastatic renal cell carcinoma (mRCC) has not been established yet. Some mRCC cases with favorable risk were reported to achieve complete remission and durable response using interferon alfa (IFNα) + low dose interleukin-2 (IL-2). Cytokine therapies may be suitable for some patients with mRCC as first-line therapy. The present study is a phase III, investigator-initiated, multicenter, prospective randomized controlled trial investigating patients with low and intermediate risk mRCC classified by Memorial Sloan-Kettering Cancer Center risk criteria to evaluate the efficacy and safety of sequential treatment with cytokine (IFNα + IL-2) as first-line and axitinib as second-line therapy versus sequential treatment with sunitinib as first-line and axitinib as second-line therapy, which is the current standard treatment for patients with favorable risk. The target sample size was set at 72 patients per group (total 144 cases). The study duration is 7 years, and the duration for recruitment is 4 years. Our expectation of this trial is to clarify first- and second-line sequential treatment for mRCC better, especially in patients with favorable risk and some with intermediate risk. The results of this trial will certainly contribute to new information for the strategy of first- and second-line sequential treatment for mRCC. Trial registrationUniversity hospital Medical Information Network (UMIN) Center identifier UMIN 000012522.
Highlights
Developed molecular target drugs and immune checkpoint inhibitors have changed treatment strategies for metastatic renal cell carcinoma because of their efficacy; complete recovery from mRCC remains very rare [1,2,3]
The administration of axitinib is terminated when progressive disease (PD) is confirmed by comprehensive evaluation based on Response Evaluation Criteria in Solid Tumors (RECIST) v.1.1, the patient dies, or severe adverse events (AEs) corresponding to discontinuation criteria occur
According to recent guidelines for mRCC developed as a result of large randomized controlled trial (RCT), for favorable risk classified by Memorial Sloan-Kettering Cancer Center (MSKCC) criteria [5] or the International mRCC Database Consortium criteria [4], a sequential treatment of sunitinib as first-line therapy [1] and nivolumab as secondline therapy [6] is recommended
Summary
Developed molecular target drugs and immune checkpoint inhibitors have changed treatment strategies for metastatic renal cell carcinoma (mRCC) because of their efficacy; complete recovery from mRCC remains very rare [1,2,3]. Based on the guidelines for mRCC treatment and the current Japanese system of national insurance, the recommended drug selection for mRCC categorized as favorable risk. Some mRCC cases meeting favorable risk criteria were reported to have achieved complete remission (CR) and durable response using interferon alfa (IFNα) + low dose interleukin-2 (IL-2) [8,9]; molecular targeted treatments may not achieve CR for patients with mRCC. We planned a prospective randomized controlled trial (RCT) for patients with low and intermediate risk mRCC (classified by MSKCC risk criteria) to evaluate the efficacy and safety of sequential treatment of cytokine (IFNα + IL-2) as first-line and axitinib as second-line therapy versus sequential treatment of sunitinib as first-line and axitinib as second-line therapy, which is the current standard treatment for favorable risk mRCC (ESCAPE Study)
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