BACKGROUND: The aim of this study was to compare the efficacy and safety of nivolumab as second-line and later-line (third-line or thereafter) therapy in metastatic renal cell carcinoma (mRCC). METHODS: Sixty-seven patients who received nivolumab after the failure of at least one molecular-targeted therapy were evaluated. The patients were divided into two groups based on the line of nivolumab: second-line and later-line groups. Efficacy was assessed using progression-free survival and overall survival (OS) after nivolumab initiation, and objective response rate. Safety was assessed using the incidence of immune-related adverse events. These outcomes were compared between the second-line and later-line groups. RESULTS: Forty-two patients (62.7%) received nivolumab as second-line therapy. There was no significant difference in the progression-free survival (median: 5.06 vs. 6.28 months, p = 0.691) or objective response rate (35.7% vs. 32.0%, p = 0.757) between the second-line and later-line groups. The OS tended to be longer in the second-line group (not reached vs. 26.0 months, p = 0.118), and the rate of patients who received subsequent therapy after nivolumab failure was significantly higher in the second-line group (90.9% vs. 55.0%, p = 0.0025). There was no difference in the incidences of immune-related adverse events between the second-line and later-line groups (any grade: 54.8% vs. 48.0%, p = 0.592; grade ≥ 3: 19.1% vs. 20.0%, p = 0.924). CONCLUSIONS: The efficacy of nivolumab did not deteriorate and the tolerability was also maintained even in later-line therapy. However, a tendency of longer OS and a higher chance of subsequent therapy after nivolumab failure were observed with nivolumab as second-line therapy.
BACKGROUND: The aim of this study was to compare the efficacy and safety of nivolumab as second-line and later-line (third-line or thereafter) therapy in metastatic renal cell carcinoma (mRCC). METHODS: Sixty-seven patients who received nivolumab after the failure of at least one molecular-targeted therapy were evaluated. The patients were divided into two groups based on the line of nivolumab: second-line and later-line groups. Efficacy was assessed using progression-free survival and overall survival (OS) after nivolumab initiation, and objective response rate. Safety was assessed using the incidence of immune-related adverse events. These outcomes were compared between the second-line and later-line groups. RESULTS: Forty-two patients (62.7%) received nivolumab as second-line therapy. There was no significant difference in the progression-free survival (median: 5.06 vs. 6.28 months, p = 0.691) or objective response rate (35.7% vs. 32.0%, p = 0.757) between the second-line and later-line groups. The OS tended to be longer in the second-line group (not reached vs. 26.0 months, p = 0.118), and the rate of patients who received subsequent therapy after nivolumab failure was significantly higher in the second-line group (90.9% vs. 55.0%, p = 0.0025). There was no difference in the incidences of immune-related adverse events between the second-line and later-line groups (any grade: 54.8% vs. 48.0%, p = 0.592; grade ≥ 3: 19.1% vs. 20.0%, p = 0.924). CONCLUSIONS: The efficacy of nivolumab did not deteriorate and the tolerability was also maintained even in later-line therapy. However, a tendency of longer OS and a higher chance of subsequent therapy after nivolumab failure were observed with nivolumab as second-line therapy.
Authors: Brian I Rini; Elizabeth R Plimack; Viktor Stus; Rustem Gafanov; Robert Hawkins; Dmitry Nosov; Frédéric Pouliot; Boris Alekseev; Denis Soulières; Bohuslav Melichar; Ihor Vynnychenko; Anna Kryzhanivska; Igor Bondarenko; Sergio J Azevedo; Delphine Borchiellini; Cezary Szczylik; Maurice Markus; Raymond S McDermott; Jens Bedke; Sophie Tartas; Yen-Hwa Chang; Satoshi Tamada; Qiong Shou; Rodolfo F Perini; Mei Chen; Michael B Atkins; Thomas Powles Journal: N Engl J Med Date: 2019-02-16 Impact factor: 91.245
Authors: I Stukalin; J C Wells; J Graham; T Yuasa; B Beuselinck; C Kollmansberger; D S Ernst; N Agarwal; T Le; F Donskov; A R Hansen; G A Bjarnason; S Srinivas; L A Wood; A S Alva; R Kanesvaran; S Y F Fu; I D Davis; T K Choueiri; D Y C Heng Journal: Curr Oncol Date: 2019-04-01 Impact factor: 3.677
Authors: Jonas Busch; Christoph Seidel; Barbara Erber; Ahi Sema Issever; Stefan Hinz; Carsten Kempkensteffen; Ahmed Magheli; Kurt Miller; Viktor Grünwald; Steffen Weikert Journal: Eur Urol Date: 2012-09-11 Impact factor: 20.096
Authors: A Y Shah; R R Kotecha; E A Lemke; A Chandramohan; J L Chaim; P Msaouel; L Xiao; J Gao; M T Campbell; A J Zurita; J Wang; P G Corn; E Jonasch; R J Motzer; P Sharma; M H Voss; N M Tannir Journal: Eur J Cancer Date: 2019-05-07 Impact factor: 9.162
Authors: Brian I Rini; Thomas Powles; Michael B Atkins; Bernard Escudier; David F McDermott; Cristina Suarez; Sergio Bracarda; Walter M Stadler; Frede Donskov; Jae Lyun Lee; Robert Hawkins; Alain Ravaud; Boris Alekseev; Michael Staehler; Motohide Uemura; Ugo De Giorgi; Begoña Mellado; Camillo Porta; Bohuslav Melichar; Howard Gurney; Jens Bedke; Toni K Choueiri; Francis Parnis; Tarik Khaznadar; Alpa Thobhani; Shi Li; Elisabeth Piault-Louis; Gretchen Frantz; Mahrukh Huseni; Christina Schiff; Marjorie C Green; Robert J Motzer Journal: Lancet Date: 2019-05-09 Impact factor: 79.321
Authors: Robert J Motzer; Nizar M Tannir; David F McDermott; Osvaldo Arén Frontera; Bohuslav Melichar; Toni K Choueiri; Elizabeth R Plimack; Philippe Barthélémy; Camillo Porta; Saby George; Thomas Powles; Frede Donskov; Victoria Neiman; Christian K Kollmannsberger; Pamela Salman; Howard Gurney; Robert Hawkins; Alain Ravaud; Marc-Oliver Grimm; Sergio Bracarda; Carlos H Barrios; Yoshihiko Tomita; Daniel Castellano; Brian I Rini; Allen C Chen; Sabeen Mekan; M Brent McHenry; Megan Wind-Rotolo; Justin Doan; Padmanee Sharma; Hans J Hammers; Bernard Escudier Journal: N Engl J Med Date: 2018-03-21 Impact factor: 91.245
Authors: E A Eisenhauer; P Therasse; J Bogaerts; L H Schwartz; D Sargent; R Ford; J Dancey; S Arbuck; S Gwyther; M Mooney; L Rubinstein; L Shankar; L Dodd; R Kaplan; D Lacombe; J Verweij Journal: Eur J Cancer Date: 2009-01 Impact factor: 9.162
Authors: Robert J Motzer; Bernard Escudier; David F McDermott; Saby George; Hans J Hammers; Sandhya Srinivas; Scott S Tykodi; Jeffrey A Sosman; Giuseppe Procopio; Elizabeth R Plimack; Daniel Castellano; Toni K Choueiri; Howard Gurney; Frede Donskov; Petri Bono; John Wagstaff; Thomas C Gauler; Takeshi Ueda; Yoshihiko Tomita; Fabio A Schutz; Christian Kollmannsberger; James Larkin; Alain Ravaud; Jason S Simon; Li-An Xu; Ian M Waxman; Padmanee Sharma Journal: N Engl J Med Date: 2015-09-25 Impact factor: 91.245