Association of clinical parameters and overall survival (OS) in patients (pts) with metastatic renal cell carcinoma (mRCC) treated with high-dose interleukin-2 (HD IL-2).

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476 Background: HD IL-2 immunotherapy can provide durable responses in mRCC, but has a high incidence of severe adverse events (AEs). Therefore, determining pts most likely to achieve response before and during HD-IL2 treatment will help clinicians and pts best utilize HD IL-2 for the treatment of mRCC. Methods: Sequential clear cell mRCC pts treated with HD IL-2 at the University of Utah Huntsman Cancer Institute from 2000 to 2012 were included. The following clinical parameters were assessed: AE incidence, type and severity; total dose of IL-2 received and use of a 40 MIU dose cap; baseline weight, age, gender and MSKCC prognostic risk; and systemic therapy pre- or post-HD IL-2. Univariate and multivariate analyses were constructed using COX Proportional Hazard model. Results: 85 pts with clear cell mRCC treated with HD IL-2 were included with a median age of 56 years (range 32-76). Pts belonged to the following MSKCC categories: 11 (13%) good, 70 (82%) intermediate, and 4 (5%) poor risk. The median OS was 817 days. Multivariate analysis identified 6 factors associated with OS including: MSKCC prognostic group (intermediate vs good HR = 4.31, CI 1.41-16.04), grade 3 rigors (no vs yes HR = 3.07, CI 1.49-6.47), baseline weight (<80 vs >80 kg HR = 2.18, CI 1.08-4.39), total dose of IL-2 administered (quartile 1 vs 2 HR 2.90, CI 1.06-8.57; quartile 1 vs 3 HR 7.37, CI 2.63-21.54; quartile 1 vs 4 HR 25.17, CI 7.34-102.01), composite of the number and severity of AEs (continuous, HR 5.11, CI 1.01-27.56), and gender (female vs male HR 2.84, CI 1.06-7.20). Factors not associated with an OS benefit in this model include age at metastatic disease, use of a 40 MIU IL-2 dose cap and systemic therapy pre- or post-HD IL2. Conclusions: The following parameters predicted an OS benefit with HD IL-2 when controlled for MSKCC prognostic risk and systemic therapy pre or post HD IL-2: fewer and less severe AEs; higher baseline weight; male gender; and the ability to tolerate a higher cumulative dose of IL-2. Notably increased age did not portend poor outcome, and should not be considered a contraindication to treatment with HD IL-2 in otherwise eligible patients.

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