Abstract
High-dose interleukin-2 (HD IL-2) was approved for treatment of metastatic renal cell carcinoma (mRCC) in 1992 and for metastatic melanoma (mM) in 1998, in an era predating targeted therapies and immune checkpoint inhibitors. The PROCLAIMSM registry was established to collect and analyze data for patients treated with HD IL-2 in the current era. This analysis includes 170 patients with mM and 192 patients with mRCC treated between 2005 and 2012 with survival data current as of July 27, 2015. For patients with mM, complete response (CR) was observed in 5 %, partial response (PR) in 10 %, stable disease (SD) in 22 %, and 63 % had progressive disease (PD). The median overall survival (mOS) for these patients was 19.6 months, with a median follow-up of 43.1 months. The mOS was not reached for patients achieving CR or PR, and was 33.4 months for patients with SD. For patients with mRCC, 6 % achieved CR, 9 % had PR, 22 % had SD, and 62 % had PD. The mOS was 41 months, with a median follow-up of 46.6 months. The mOS for patients who had CR and PR was not reached and was 49.6 months for patients with SD. There were no treatment-related deaths among 362 patients. The duration of mOS for patients with mM and mRCC is longer than historically reported. These data support a continued role for IL-2 in the treatment of eligible patients with mM or mRCC and warrant further evaluation of HD IL-2 in combination or sequence with other therapeutic agents.Electronic supplementary materialThe online version of this article (doi:10.1007/s00262-016-1910-x) contains supplementary material, which is available to authorized users.
Highlights
Treatment options for patients with metastatic melanoma and metastatic renal cell carcinomawere limited and the prognosis was poor with 5-year overall survival (OS) of 5–10 %, respectively [1]
Patients received a second cycle of highdose interleukin-2 (HD IL-2) after approximately a 9-day rest period, per the Demographic and disease characteristics for both mM
The PROCLAIM observational database informs upon the real-world use and outcome of HD IL-2 for mM and metastatic renal cell carcinoma (mRCC)
Summary
Treatment options for patients with metastatic melanoma (mM) and metastatic renal cell carcinoma (mRCC)were limited and the prognosis was poor with 5-year overall survival (OS) of 5–10 %, respectively [1]. Treatment options for patients with metastatic melanoma (mM) and metastatic renal cell carcinoma (mRCC). The finding that some patients with these malignancies responded to highdose interleukin-2 (HD IL-2) led to Food and Drug. Administration (FDA) approval of HD IL-2 for mRCC in and for mM in 1998. The historical response rates and overall survival reported at the time of approval were. The trials that led to FDA approval were single arm, uncontrolled studies and early on were associated with significant therapy-related deaths, 2 and. %, respectively, in melanoma and renal cell carcinoma. They were not analyzed for the survival impact of stable disease. Recent studies have reported improved survival for patients with both malignancies treated with HD IL-2, with
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