BACKGROUND: It remains unclear how early treatment interruption of nivolumab plus ipilimumab due to immune-related adverse events affects the outcome of previously untreated metastatic renal cell carcinoma (mRCC). OBJECTIVE: To investigate the prognostic impact of the early interruption of nivolumab plus ipilimumab, used as first-line therapy for mRCC. PATIENTS AND METHODS: We retrospectively evaluated 59 intermediate- or poor-risk mRCC patients who received nivolumab plus ipilimumab as first-line therapy. Based on whether early treatment interruption was implemented within the initial four treatment cycles (i.e., 3 months) or not, progression-free survival (PFS), overall survival (OS), and objective response rate (ORR) were compared. The prognostic association was further compared with that of 186 patients treated with tyrosine kinase inhibitors (TKIs) as first-line therapy. RESULTS: Twenty-three of the 59 patients (39%) experienced interruption of nivolumab plus ipilimumab therapy. The patients with interruption had longer PFS (p = 0.0055), similar OS (p = 0.366), and likely higher ORR (p = 0.0660) than those without interruption. Of the patients treated with TKIs, 60 of 186 (32%) experienced interruption, with shorter PFS (p = 0.0121), similar OS (p = 0.378), and similar ORR (p = 0.738) than those without interruption. In the 23 patients with nivolumab plus ipilimumab interruption, high-dose corticosteroids were administered in seven patients (30%). PFS (p = 0.638), OS (p = 0.968), or ORR (p = 0.760) did not differ based on corticosteroid administration. CONCLUSIONS: Early treatment interruption, which exerted a negative effect for TKIs, was a preferable event for nivolumab plus ipilimumab when considering PFS. Furthermore, early administration of high-dose corticosteroids did not diminish the anti-tumor effect of nivolumab plus ipilimumab.
BACKGROUND: It remains unclear how early treatment interruption of nivolumab plus ipilimumab due to immune-related adverse events affects the outcome of previously untreated metastatic renal cell carcinoma (mRCC). OBJECTIVE: To investigate the prognostic impact of the early interruption of nivolumab plus ipilimumab, used as first-line therapy for mRCC. PATIENTS AND METHODS: We retrospectively evaluated 59 intermediate- or poor-risk mRCC patients who received nivolumab plus ipilimumab as first-line therapy. Based on whether early treatment interruption was implemented within the initial four treatment cycles (i.e., 3 months) or not, progression-free survival (PFS), overall survival (OS), and objective response rate (ORR) were compared. The prognostic association was further compared with that of 186 patients treated with tyrosine kinase inhibitors (TKIs) as first-line therapy. RESULTS: Twenty-three of the 59 patients (39%) experienced interruption of nivolumab plus ipilimumab therapy. The patients with interruption had longer PFS (p = 0.0055), similar OS (p = 0.366), and likely higher ORR (p = 0.0660) than those without interruption. Of the patients treated with TKIs, 60 of 186 (32%) experienced interruption, with shorter PFS (p = 0.0121), similar OS (p = 0.378), and similar ORR (p = 0.738) than those without interruption. In the 23 patients with nivolumab plus ipilimumab interruption, high-dose corticosteroids were administered in seven patients (30%). PFS (p = 0.638), OS (p = 0.968), or ORR (p = 0.760) did not differ based on corticosteroid administration. CONCLUSIONS: Early treatment interruption, which exerted a negative effect for TKIs, was a preferable event for nivolumab plus ipilimumab when considering PFS. Furthermore, early administration of high-dose corticosteroids did not diminish the anti-tumor effect of nivolumab plus ipilimumab.
Authors: Camillo Porta; Antonin Levy; Robert Hawkins; Daniel Castellano; Joaquim Bellmunt; Paul Nathan; Ray McDermott; John Wagstaff; Paul Donnellan; John McCaffrey; Francis Vekeman; Maureen P Neary; Jose Diaz; Faisal Mehmud; Mei Sheng Duh Journal: Cancer Med Date: 2014-07-18 Impact factor: 4.452
Authors: Robert J Motzer; Bernard Escudier; David F McDermott; Osvaldo Arén Frontera; Bohuslav Melichar; Thomas Powles; Frede Donskov; Elizabeth R Plimack; Philippe Barthélémy; Hans J Hammers; Saby George; Viktor Grünwald; Camillo Porta; Victoria Neiman; Alain Ravaud; Toni K Choueiri; Brian I Rini; Pamela Salman; Christian K Kollmannsberger; Scott S Tykodi; Marc-Oliver Grimm; Howard Gurney; Raya Leibowitz-Amit; Poul F Geertsen; Asim Amin; Yoshihiko Tomita; M Brent McHenry; Shruti Shally Saggi; Nizar M Tannir Journal: J Immunother Cancer Date: 2020-07 Impact factor: 13.751
Authors: S Aeppli; M Schmaus; T Eisen; B Escudier; V Grünwald; J Larkin; D McDermott; J Oldenburg; C Porta; B I Rini; M Schmidinger; C N Sternberg; C Rothermundt; P M Putora Journal: ESMO Open Date: 2021-01-15
Authors: Laurence Albiges; Nizar M Tannir; Mauricio Burotto; David McDermott; Elizabeth R Plimack; Philippe Barthélémy; Camillo Porta; Thomas Powles; Frede Donskov; Saby George; Christian K Kollmannsberger; Howard Gurney; Marc-Oliver Grimm; Yoshihiko Tomita; Daniel Castellano; Brian I Rini; Toni K Choueiri; Shruti Shally Saggi; M Brent McHenry; Robert J Motzer Journal: ESMO Open Date: 2020-11