Everolimus treatment-associated interstitial lung disease (ILD) as a prognostic factor in Japanese patients with metastatic renal cell carcinoma.

Abstract

e15531 Background: Interstitial lung disease (ILD) is one of the adverse events during treatment with everolimus for metastatic renal cell carcinoma (mRCC). Japanese study of everolimus treatment-associated ILD as a prognostic factor is rare. Methods: We retrospectively assessed the incidence and outcome of ILD in mRCC patients treated with everolimus. Between April 2010 and August 2012, 25 cases were treated with everolimus after the failure of one or two TKIs in our institute. All adverse events were graded in accordance with NCI CTCAE, version 3.0. Results: A total of 25 patients received treatment with everolimus and included 18 male and 7 female patients ranging in age from 21 to 84 years (median 62). According to MSKCC risk criteria, 6 cases were at favorable risk, 16 cases were at intermediate risk, and 3 cases were at poor risk. The median treatment term was 4 months (range 2-17 months). SD was reported in 19 cases and PD in 6 cases. Progression free survival was 3.5 months and overall survival was 12 months. ILD was found in 7 cases (28%). One was G1, five were G2, and one was G3. Corticosteroid therapy was initiated in 3 cases. In 5 of 7 ILD cases, everolimus was re-challenged. In our series, patients with ILD showed significantly better progression free survival than those without ILD (PFS was 8 months vs 3 months. Log-rank, P<0.001). There were no significant differences between the two groups in overall survival (12 months in patients with ILD vs 10 months in patients without ILD. Log-rank, NS). Conclusions: Everolimus appears to have been effective and well-tolerated in our institute. Re-challenge with everolimus was feasible after improving everolimus-induced ILD in cases of grade 1-2. To confirm these findings, the efficacy and AE profile of everolimus in Japanese patients should be investigated.