Background: In clinical practice, discontinuation or dose reduction of everolimus may be induced not only by grade 3 or 4 toxicities but also by prolonged grade 2 toxicities, such as stomatitis and/or cutaneous toxicity, which share some pathogenetic mechanisms. We assessed the correlation between either everolimus discontinuation or dose reduction induced by stomatitis-cutaneous toxicity events (SCTE) and clinical outcome of patients with metastatic renal-cell cancer (mRCC). Patients and Methods: We retrospectively reviewed the clinical data of patients with mRCC treated with everolimus in 2 Italian centers. Clinical evidence of SCTE was evaluated, and corresponding clinical data were reviewed for response and clinical outcome. Results: Seventy-nine mRCC patients treated with everolimus (57 male, 22 female; median age 66 years; range, 44-88 years) were evaluated. SCTE were observed in 20 (25%) of 79 patients at a median of 30.5 days of everolimus treatment (range, 10-270 days). Partial response or stable disease was achieved in 15 (79%) of 19 evaluable patients with SCTE compared to 28 (48%) of 58 with no SCTE (P = .03). At a median follow-up of 19 months, a significant difference was found in the median PFS equal to 7.8 months (95% confidence interval [CI], 2.8-24.4) in SCTE patients versus 4.3 months (95% CI, 2.7-7.5) in non-SCTE patients (P = .029), and in the median OS equal to 30.6 months (95% CI, 19.6-not reached) in SCTE patients versus 13.5 months (95% CI, 9.9-17.7) in non-SCTE patients (P = .0007). Conclusion: These data suggest that SCTE may be a predictive marker of favorable outcome in mRCC patients treated with everolimus.
Correlation of Stomatitis and Cutaneous Toxicity With Clinical Outcome in Patients With Metastatic Renal-Cell Carcinoma Treated With Everolimus / Conteduca, Vincenza; Santoni, Matteo; Medri, Matelda; Scarpi, Emanuela; Burattini, Luciano; Lolli, Cristian; Rossi, Lorena; Savini, Agnese; Berardi, Rossana; Stanganelli, Ignazio; Cascinu, Stefano; De Giorgi, Ugo. - In: CLINICAL GENITOURINARY CANCER. - ISSN 1558-7673. - 14:5(2016), pp. 426-431. [10.1016/j.clgc.2016.02.012]
Correlation of Stomatitis and Cutaneous Toxicity With Clinical Outcome in Patients With Metastatic Renal-Cell Carcinoma Treated With Everolimus
STANGANELLI, Ignazio;
2016-01-01
Abstract
Background: In clinical practice, discontinuation or dose reduction of everolimus may be induced not only by grade 3 or 4 toxicities but also by prolonged grade 2 toxicities, such as stomatitis and/or cutaneous toxicity, which share some pathogenetic mechanisms. We assessed the correlation between either everolimus discontinuation or dose reduction induced by stomatitis-cutaneous toxicity events (SCTE) and clinical outcome of patients with metastatic renal-cell cancer (mRCC). Patients and Methods: We retrospectively reviewed the clinical data of patients with mRCC treated with everolimus in 2 Italian centers. Clinical evidence of SCTE was evaluated, and corresponding clinical data were reviewed for response and clinical outcome. Results: Seventy-nine mRCC patients treated with everolimus (57 male, 22 female; median age 66 years; range, 44-88 years) were evaluated. SCTE were observed in 20 (25%) of 79 patients at a median of 30.5 days of everolimus treatment (range, 10-270 days). Partial response or stable disease was achieved in 15 (79%) of 19 evaluable patients with SCTE compared to 28 (48%) of 58 with no SCTE (P = .03). At a median follow-up of 19 months, a significant difference was found in the median PFS equal to 7.8 months (95% confidence interval [CI], 2.8-24.4) in SCTE patients versus 4.3 months (95% CI, 2.7-7.5) in non-SCTE patients (P = .029), and in the median OS equal to 30.6 months (95% CI, 19.6-not reached) in SCTE patients versus 13.5 months (95% CI, 9.9-17.7) in non-SCTE patients (P = .0007). Conclusion: These data suggest that SCTE may be a predictive marker of favorable outcome in mRCC patients treated with everolimus.I documenti in IRIS sono protetti da copyright e tutti i diritti sono riservati, salvo diversa indicazione.