2 research outputs found
ΠΡΡΠΈΠ»Π΅ΡΠ½ΡΡ ΠΎΠ±ΡΠ°Ρ Π²ΡΠΆΠΈΠ²Π°Π΅ΠΌΠΎΡΡΡ Π±ΠΎΠ»ΡΠ½ΡΡ ΠΌΠ΅ΡΠ°ΡΡΠ°ΡΠΈΡΠ΅ΡΠΊΠΈΠΌ ΡΠ°ΠΊΠΎΠΌ ΠΏΠΎΡΠΊΠΈ, ΠΏΠΎΠ»ΡΡΠ°Π²ΡΠΈΡ ΡΠ²Π΅ΡΠΎΠ»ΠΈΠΌΡΡ ΠΏΡΠΈ ΠΏΡΠΎΠ³ΡΠ΅ΡΡΠΈΡΠΎΠ²Π°Π½ΠΈΠΈ Π½Π° ΡΠΎΠ½Π΅ Π»Π΅ΡΠ΅Π½ΠΈΡ Π±Π΅Π²Π°ΡΠΈΠ·ΡΠΌΠ°Π±ΠΎΠΌ: ΠΏΡΠΎΡΠΏΠ΅ΠΊΡΠΈΠ²Π½ΠΎΠ΅ ΠΌΠ½ΠΎΠ³ΠΎΡΠ΅Π½ΡΡΠΎΠ²ΠΎΠ΅ ΠΈΡΡΠ»Π΅Π΄ΠΎΠ²Π°Π½ΠΈΠ΅ CRAD001LRU02T
Background. In a CRAD001LRU02T study of everolimus for metastatic renal cell carcinoma patients previously treated with bevacizumab Β±Β interferon, median overall survival (OS) was 17.4 months (95 % confidence interval 13.5β21.3 month).Objective of final analysis was to evaluate 5-year OS and long-term toxicity in this study.Materials and methods. Survival data were collected from 37 patients with bevacizumab-refractory metastatic renal cell carcinoma who received everolimus in a completed prospective multicenter study. Patients were predominantly male, 89 % had ECOG performance status of 0/1, 51 % received previous bevacizumab in combination with interferon, and 38/62% had MSKCC favorable/intermediate risk disease.Results. The 5-year survival rate was 16.2% (95 % confidence interval 14.1β18.3 %), with a median follow-up of 5 years. The 1-, and 3-year OS rates were 81.0 and 43.0 %, respectively. The median duration of second-line of everolimus was 315 (range 61β569) days. 11 (29.7 %) patients received third-line therapy with a median duration of 3.6 months. Confirmed objective tumor responses were seen in 5 (14.0 %) patients. 70.0 % (n = 26) patients had a stable disease. 1 (2.7 %) patient achieved complete response after 4 years of therapy. One (2.7 %) patientΒ discontinued everolimus therapy on their own accord due to relapse of systemic lupus erythematosus and one (2.7 %)Β patient had 14-days interruption of an everolimus therapy due to grade 3 hyperglycemia. No grade 4 treatment-related toxicity was found.Conclusions. Everolimus provided an estimated 5-year survival rate of 16.2 % for bevacizumab-resistant metastatic renal cell carcinoma. Prolonged everolimus was not associated with new types or increased severity of adverse events.ΠΠ²Π΅Π΄Π΅Π½ΠΈΠ΅. Π ΠΈΡΡΠ»Π΅Π΄ΠΎΠ²Π°Π½ΠΈΠΈ CRAD001LRU02T ΡΡΡΠ΅ΠΊΡΠΈΠ²Π½ΠΎΡΡΠΈ ΡΠ²Π΅ΡΠΎΠ»ΠΈΠΌΡΡΠ° Ρ Π±ΠΎΠ»ΡΠ½ΡΡ
ΠΌΠ΅ΡΠ°ΡΡΠ°ΡΠΈΡΠ΅ΡΠΊΠΈΠΌ ΠΏΠΎΡΠ΅ΡΠ½ΠΎ-ΠΊΠ»Π΅ΡΠΎΡΠ½ΡΠΌ ΡΠ°ΠΊΠΎΠΌ, ΠΏΠΎΠ»ΡΡΠ°Π²ΡΠΈΡ
ΡΠ°Π½Π΅Π΅ ΡΠ΅ΡΠ°ΠΏΠΈΡ Π±Π΅Π²Π°ΡΠΈΠ·ΡΠΌΠ°Π±ΠΎΠΌ Π² ΠΊΠΎΠΌΠ±ΠΈΠ½Π°ΡΠΈΠΈ Ρ ΠΈΠ½ΡΠ΅ΡΡΠ΅ΡΠΎΠ½ΠΎΠΌ ΠΈΠ»ΠΈ Π±Π΅Π· Π½Π΅Π³ΠΎ, ΠΌΠ΅Π΄ΠΈΠ°Π½Π° ΠΎΠ±ΡΠ΅ΠΉ Π²ΡΠΆΠΈΠ²Π°Π΅ΠΌΠΎΡΡΠΈ (ΠΠ) ΡΠΎΡΡΠ°Π²ΠΈΠ»Π° 17,4 ΠΌΠ΅Ρ (95 % Π΄ΠΎΠ²Π΅ΡΠΈΡΠ΅Π»ΡΠ½ΡΠΉ ΠΈΠ½ΡΠ΅ΡΠ²Π°Π» 13,5β21,3 ΠΌΠ΅Ρ).Π¦Π΅Π»Ρ ΡΠ°Π±ΠΎΡΡ β ΠΎΡΠ΅Π½ΠΊΠ° 5-Π»Π΅ΡΠ½Π΅ΠΉ ΠΠ ΠΈ ΠΎΡΠ΄Π°Π»Π΅Π½Π½ΠΎΠΉ ΡΠΎΠΊΡΠΈΡΠ½ΠΎΡΡΠΈ Π² ΡΡΠΎΠΌ ΠΈΡΡΠ»Π΅Π΄ΠΎΠ²Π°Π½ΠΈΠΈ.ΠΠ°ΡΠ΅ΡΠΈΠ°Π»Ρ ΠΈ ΠΌΠ΅ΡΠΎΠ΄Ρ. ΠΠ°Π½Π½ΡΠ΅ ΠΏΠΎ ΠΠ Π±ΡΠ»ΠΈ ΠΏΠΎΠ»ΡΡΠ΅Π½Ρ Ρ 37 ΠΏΠ°ΡΠΈΠ΅Π½ΡΠΎΠ², ΡΠ΅ΡΡΠ°ΠΊΡΠ΅ΡΠ½ΡΡ
ΠΊ ΡΠ΅ΡΠ°ΠΏΠΈΠΈ Π±Π΅Π²Π°ΡΠΈΠ·ΡΠΌΠ°Π±ΠΎΠΌ ΠΈ ΠΏΠΎΠ»ΡΡΠΈΠ²ΡΠΈΡ
ΡΠ²Π΅ΡΠΎΠ»ΠΈΠΌΡΡ Π² ΡΠ°ΠΌΠΊΠ°Ρ
ΠΏΡΠΎΡΠΏΠ΅ΠΊΡΠΈΠ²Π½ΠΎΠ³ΠΎ ΠΌΠ½ΠΎΠ³ΠΎΡΠ΅Π½ΡΡΠΎΠ²ΠΎΠ³ΠΎ ΠΈΡΡΠ»Π΅Π΄ΠΎΠ²Π°Π½ΠΈΡ. ΠΠΎΠ»ΡΡΠΈΠ½ΡΡΠ²ΠΎ ΠΏΠ°ΡΠΈΠ΅Π½ΡΠΎΠ² β ΠΌΡΠΆΡΠΈΠ½Ρ, 89 % Π±ΠΎΠ»ΡΠ½ΡΡ
ΠΈΠΌΠ΅Π»ΠΈ ΡΡΠ°ΡΡΡ ΠΏΠΎ ΡΠΊΠ°Π»Π΅ ECOG 0 / 1, 51 % ΠΏΠ°ΡΠΈΠ΅Π½ΡΠΎΠ² ΠΏΠΎΠ»ΡΡΠΈΠ»ΠΈ ΠΏΡΠ΅Π΄ΡΠ΅ΡΡΠ²ΡΡΡΡΡ ΡΠ΅ΡΠ°ΠΏΠΈΡ Π±Π΅Π²Π°ΡΠΈΠ·ΡΠΌΠ°Π±ΠΎΠΌ Π² ΠΊΠΎΠΌΠ±ΠΈΠ½Π°ΡΠΈΠΈ Ρ ΠΈΠ½ΡΠ΅ΡΡΠ΅ΡΠΎΠ½ΠΎΠΌ. ΠΠ»Π°Π³ΠΎΠΏΡΠΈΡΡΠ½ΡΠΉ ΠΏΡΠΎΠ³Π½ΠΎΠ· ΠΈΠΌΠ΅Π»ΠΈ 38 % Π±ΠΎΠ»ΡΠ½ΡΡ
, ΠΏΡΠΎΠΌΠ΅ΠΆΡΡΠΎΡΠ½ΡΠΉ β 62 %.Π Π΅Π·ΡΠ»ΡΡΠ°ΡΡ. ΠΡΠΈ ΠΌΠ΅Π΄ΠΈΠ°Π½Π΅ Π½Π°Π±Π»ΡΠ΄Π΅Π½ΠΈΡ 5 Π»Π΅Ρ 5-Π»Π΅ΡΠ½ΡΡ ΠΠ ΡΠΎΡΡΠ°Π²ΠΈΠ»Π° 16,2 % (95 % Π΄ΠΎΠ²Π΅ΡΠΈΡΠ΅Π»ΡΠ½ΡΠΉ ΠΈΠ½ΡΠ΅ΡΠ²Π°Π» 14,1β18,3 %),Β 1- ΠΈ 3-Π»Π΅ΡΠ½ΡΡ ΠΠ β 81,0 ΠΈ 43,0 % ΡΠΎΠΎΡΠ²Π΅ΡΡΡΠ²Π΅Π½Π½ΠΎ. ΠΠ΅Π΄ΠΈΠ°Π½Π° ΠΏΡΠΎΠ΄ΠΎΠ»ΠΆΠΈΡΠ΅Π»ΡΠ½ΠΎΡΡΠΈ 2-ΠΉ Π»ΠΈΠ½ΠΈΠΈ ΡΠ΅ΡΠ°ΠΏΠΈΠΈ ΡΠ²Π΅ΡΠΎΠ»ΠΈΠΌΡΡΠΎΠΌ ΡΠΎΡΡΠ°Π²ΠΈΠ»Π° 315 (61β569) ΡΡΡ. Π‘ ΠΌΠ΅Π΄ΠΈΠ°Π½ΠΎΠΉ Π΄Π»ΠΈΡΠ΅Π»ΡΠ½ΠΎΡΡΠΈ 3,6 ΠΌΠ΅Ρ 3-Ρ Π»ΠΈΠ½ΠΈΡ ΡΠ΅ΡΠ°ΠΏΠΈΠΈ ΠΏΠΎΠ»ΡΡΠΈΠ»ΠΈ 11 (29,7 %) ΠΏΠ°ΡΠΈΠ΅Π½ΡΠΎΠ². ΠΠΎΠ΄ΡΠ²Π΅ΡΠΆΠ΄Π΅Π½Π½ΡΠ΅ ΠΎΠ±ΡΠ΅ΠΊΡΠΈΠ²Π½ΡΠ΅ ΠΎΡΠ²Π΅ΡΡ ΠΎΡΠΌΠ΅ΡΠ΅Π½Ρ Ρ 5 (14,0 %) Π±ΠΎΠ»ΡΠ½ΡΡ
. Π‘ΡΠ°Π±ΠΈΠ»ΠΈΠ·Π°ΡΠΈΡ Π±ΠΎΠ»Π΅Π·Π½ΠΈ Π½Π°Π±Π»ΡΠ΄Π°Π»Π°ΡΡ Ρ 70,0 % (n = 26) ΠΏΠ°ΡΠΈΠ΅Π½ΡΠΎΠ². ΠΠΎΠ»Π½ΠΎΠ³ΠΎ ΠΎΡΠ²Π΅ΡΠ° ΡΠΏΡΡΡΡ 4 Π³ΠΎΠ΄Π° ΡΠ΅ΡΠ°ΠΏΠΈΠΈ Π΄ΠΎΡΡΠΈΠ³ 1 (2,7 %) ΠΏΠ°ΡΠΈΠ΅Π½Ρ. ΠΠ·-Π·Π° ΠΎΠ±ΠΎΡΡΡΠ΅Π½ΠΈΡ ΡΠΈΡΡΠ΅ΠΌΠ½ΠΎΠΉ ΠΊΡΠ°ΡΠ½ΠΎΠΉ Π²ΠΎΠ»ΡΠ°Π½ΠΊΠΈ 1 (2,7 %) Π±ΠΎΠ»ΡΠ½ΠΎΠΉ ΠΏΠΎ ΡΠΎΠ±ΡΡΠ²Π΅Π½Π½ΠΎΠΌΡ ΠΆΠ΅Π»Π°Π½ΠΈΡ ΠΏΡΠ΅ΠΊΡΠ°ΡΠΈΠ» ΡΠ΅ΡΠ°ΠΏΠΈΡ ΡΠ²Π΅ΡΠΎΠ»ΠΈΠΌΡΡΠΎΠΌ ΠΈ 1 (2,7 %) ΠΏΠ°ΡΠΈΠ΅Π½Ρ ΠΈΠΌΠ΅Π» ΠΏΠ΅ΡΠ΅ΡΡΠ² Π² Π»Π΅ΡΠ΅Π½ΠΈΠΈ Π² ΡΠ΅ΡΠ΅Π½ΠΈΠ΅ 14 ΡΡΡ Π² ΡΠ²ΡΠ·ΠΈ Ρ ΡΠ°Π·Π²ΠΈΡΠΈΠ΅ΠΌ Π³ΠΈΠΏΠ΅ΡΠ³Π»ΠΈΠΊΠ΅ΠΌΠΈΠΈ III ΡΡΠ΅ΠΏΠ΅Π½ΠΈ ΡΠΎΠΊΡΠΈΡΠ½ΠΎΡΡΠΈ. ΠΠ΅ΠΆΠ΅Π»Π°ΡΠ΅Π»ΡΠ½ΡΡ
ΡΠ²Π»Π΅Π½ΠΈΠΉ IV ΡΡΠ΅ΠΏΠ΅Π½ΠΈ ΡΡΠΆΠ΅ΡΡΠΈ Π½Π΅ Π²ΡΡΠ²Π»Π΅Π½ΠΎ.ΠΠ°ΠΊΠ»ΡΡΠ΅Π½ΠΈΠ΅. Π’Π΅ΡΠ°ΠΏΠΈΡ ΡΠ²Π΅ΡΠΎΠ»ΠΈΠΌΡΡΠΎΠΌ ΠΏΡΠΈΠ²Π΅Π»Π° ΠΊ 5-Π»Π΅ΡΠ½Π΅ΠΉ ΠΠ 16,2 % Ρ Π±ΠΎΠ»ΡΠ½ΡΡ
ΠΌΠ΅ΡΠ°ΡΡΠ°ΡΠΈΡΠ΅ΡΠΊΠΈΠΌ ΠΏΠΎΡΠ΅ΡΠ½ΠΎ-ΠΊΠ»Π΅ΡΠΎΡΠ½ΡΠΌ ΡΠ°ΠΊΠΎΠΌ, ΡΠ°Π½Π΅Π΅ ΡΠ΅Π·ΠΈΡΡΠ΅Π½ΡΠ½ΡΡ
ΠΊ ΡΠ΅ΡΠ°ΠΏΠΈΠΈ Π±Π΅Π²Π°ΡΠΈΠ·ΡΠΌΠ°Π±ΠΎΠΌ. ΠΠ»ΠΈΡΠ΅Π»ΡΠ½Π°Ρ ΡΠ΅ΡΠ°ΠΏΠΈΡ ΡΠ²Π΅ΡΠΎΠ»ΠΈΠΌΡΡΠΎΠΌ Π½Π΅ Π±ΡΠ»Π° Π°ΡΡΠΎΡΠΈΠΈΡΠΎΠ²Π°Π½Π° Ρ Π½ΠΎΠ²ΡΠΌΠΈ Π²ΠΈΠ΄Π°ΠΌΠΈ Π²ΡΡΠ°ΠΆΠ΅Π½Π½ΠΎΠΉ ΡΠΎΠΊΡΠΈΡΠ½ΠΎΡΡΠΈ ΠΈΠ»ΠΈ ΠΏΠΎΠ²ΡΡΠ΅Π½ΠΈΠ΅ΠΌ ΡΠ°ΡΡΠΎΡΡ Π½Π΅ΠΆΠ΅Π»Π°ΡΠ΅Π»ΡΠ½ΡΡ
ΡΠ²Π»Π΅Π½ΠΈΠΉ
Five-year overall survival of metastatic renal cell carcinoma patients treated with everolimus after progression on bevacizumab: a prospective multicenter study CRAD001LRU02T
Background. In a CRAD001LRU02T study of everolimus for metastatic renal cell carcinoma patients previously treated with bevacizumab Β±Β interferon, median overall survival (OS) was 17.4 months (95 % confidence interval 13.5β21.3 month).Objective of final analysis was to evaluate 5-year OS and long-term toxicity in this study.Materials and methods. Survival data were collected from 37 patients with bevacizumab-refractory metastatic renal cell carcinoma who received everolimus in a completed prospective multicenter study. Patients were predominantly male, 89 % had ECOG performance status of 0/1, 51 % received previous bevacizumab in combination with interferon, and 38/62% had MSKCC favorable/intermediate risk disease.Results. The 5-year survival rate was 16.2% (95 % confidence interval 14.1β18.3 %), with a median follow-up of 5 years. The 1-, and 3-year OS rates were 81.0 and 43.0 %, respectively. The median duration of second-line of everolimus was 315 (range 61β569) days. 11 (29.7 %) patients received third-line therapy with a median duration of 3.6 months. Confirmed objective tumor responses were seen in 5 (14.0 %) patients. 70.0 % (n = 26) patients had a stable disease. 1 (2.7 %) patient achieved complete response after 4 years of therapy. One (2.7 %) patientΒ discontinued everolimus therapy on their own accord due to relapse of systemic lupus erythematosus and one (2.7 %)Β patient had 14-days interruption of an everolimus therapy due to grade 3 hyperglycemia. No grade 4 treatment-related toxicity was found.Conclusions. Everolimus provided an estimated 5-year survival rate of 16.2 % for bevacizumab-resistant metastatic renal cell carcinoma. Prolonged everolimus was not associated with new types or increased severity of adverse events