PURPOSE: Immune-related response criteria (irRC) was developed to adequately assess tumor response to immunotherapy. The irRC are based on bidimensional measurements, as opposed to unidimensional measurements defined by Response Evaluation Criteria in Solid Tumors, which has been widely used in solid tumors. We aimed to compare response assessment by bidimensional versus unidimensional irRC in patients with advanced melanoma treated with ipilimumab. EXPERIMENTAL DESIGN: Fifty-seven patients with advanced melanoma treated with ipilimumab in a phase II, expanded access trial were studied. Bidimensional tumor measurement records prospectively conducted during the trial were reviewed to generate a second set of measurements using unidimensional, longest diameter measurements. The percent changes of measurements at follow-up, best overall response, and time-to-progression (TTP) were compared between bidimensional and unidimensional irRC. Interobserver variability for bidimensional and unidimensional measurements was assessed in 25 randomly selected patients. RESULTS: The percent changes at follow-up scans were highly concordant between the 2 criteria (Spearman r: 0.953-0.965, first to fourth follow-up). The best immune-related response was highly concordant between the 2 criteria (κw = 0.881). TTP was similar between the bidimensional and unidimensional assessments (progression-free at 6 months: 70% vs. 81%, respectively). The unidimensional measurements were more reproducible than bidimensional measurements, with the 95% limits of agreement of (-16.1%, 5.8%) versus (-31.3%, 19.7%), respectively. CONCLUSION: irRC using the unidimensional measurements provided highly concordant response assessment compared with the bidimensional irRC, with less measurement variability. The use of unidimensional irRC is proposed to assess response to immunotherapy in solid tumors, given its simplicity, higher reproducibility, and high concordance with the bidimensional irRC.
PURPOSE: Immune-related response criteria (irRC) was developed to adequately assess tumor response to immunotherapy. The irRC are based on bidimensional measurements, as opposed to unidimensional measurements defined by Response Evaluation Criteria in Solid Tumors, which has been widely used in solid tumors. We aimed to compare response assessment by bidimensional versus unidimensional irRC in patients with advanced melanoma treated with ipilimumab. EXPERIMENTAL DESIGN: Fifty-seven patients with advanced melanoma treated with ipilimumab in a phase II, expanded access trial were studied. Bidimensional tumor measurement records prospectively conducted during the trial were reviewed to generate a second set of measurements using unidimensional, longest diameter measurements. The percent changes of measurements at follow-up, best overall response, and time-to-progression (TTP) were compared between bidimensional and unidimensional irRC. Interobserver variability for bidimensional and unidimensional measurements was assessed in 25 randomly selected patients. RESULTS: The percent changes at follow-up scans were highly concordant between the 2 criteria (Spearman r: 0.953-0.965, first to fourth follow-up). The best immune-related response was highly concordant between the 2 criteria (κw = 0.881). TTP was similar between the bidimensional and unidimensional assessments (progression-free at 6 months: 70% vs. 81%, respectively). The unidimensional measurements were more reproducible than bidimensional measurements, with the 95% limits of agreement of (-16.1%, 5.8%) versus (-31.3%, 19.7%), respectively. CONCLUSION: irRC using the unidimensional measurements provided highly concordant response assessment compared with the bidimensional irRC, with less measurement variability. The use of unidimensional irRC is proposed to assess response to immunotherapy in solid tumors, given its simplicity, higher reproducibility, and high concordance with the bidimensional irRC.
Authors: P Therasse; S G Arbuck; E A Eisenhauer; J Wanders; R S Kaplan; L Rubinstein; J Verweij; M Van Glabbeke; A T van Oosterom; M C Christian; S G Gwyther Journal: J Natl Cancer Inst Date: 2000-02-02 Impact factor: 13.506
Authors: Mizuki Nishino; Mengye Guo; David M Jackman; Pamela J DiPiro; Jeffrey T Yap; Tak K Ho; Hiroto Hatabu; Pasi A Jänne; Annick D Van den Abbeele; Bruce E Johnson Journal: Acad Radiol Date: 2010-10-30 Impact factor: 3.173
Authors: Binsheng Zhao; Leonard P James; Chaya S Moskowitz; Pingzhen Guo; Michelle S Ginsberg; Robert A Lefkowitz; Yilin Qin; Gregory J Riely; Mark G Kris; Lawrence H Schwartz Journal: Radiology Date: 2009-07 Impact factor: 11.105
Authors: Jedd D Wolchok; Bart Neyns; Gerald Linette; Sylvie Negrier; Jose Lutzky; Luc Thomas; William Waterfield; Dirk Schadendorf; Michael Smylie; Troy Guthrie; Jean-Jacques Grob; Jason Chesney; Kevin Chin; Kun Chen; Axel Hoos; Steven J O'Day; Celeste Lebbé Journal: Lancet Oncol Date: 2009-12-08 Impact factor: 41.316
Authors: F Stephen Hodi; Marcus Butler; Darryl A Oble; Michael V Seiden; Frank G Haluska; Andrea Kruse; Suzanne Macrae; Marybeth Nelson; Christine Canning; Israel Lowy; Alan Korman; David Lautz; Sara Russell; Michael T Jaklitsch; Nikhil Ramaiya; Teresa C Chen; Donna Neuberg; James P Allison; Martin C Mihm; Glenn Dranoff Journal: Proc Natl Acad Sci U S A Date: 2008-02-19 Impact factor: 11.205
Authors: Jedd D Wolchok; Axel Hoos; Steven O'Day; Jeffrey S Weber; Omid Hamid; Celeste Lebbé; Michele Maio; Michael Binder; Oliver Bohnsack; Geoffrey Nichol; Rachel Humphrey; F Stephen Hodi Journal: Clin Cancer Res Date: 2009-11-24 Impact factor: 12.531
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: Jeffrey Weber; John A Thompson; Omid Hamid; David Minor; Asim Amin; Ilan Ron; Ruggero Ridolfi; Hazem Assi; Anthony Maraveyas; David Berman; Jonathan Siegel; Steven J O'Day Journal: Clin Cancer Res Date: 2009-08-11 Impact factor: 12.531
Authors: Lillian L Siu; S Percy Ivy; Erica L Dixon; Amy E Gravell; Steven A Reeves; Gary L Rosner Journal: Clin Cancer Res Date: 2017-09-01 Impact factor: 12.531
Authors: Valsamo Anagnostou; Mark Yarchoan; Aaron R Hansen; Hao Wang; Franco Verde; Elad Sharon; Deborah Collyar; Laura Q M Chow; Patrick M Forde Journal: Clin Cancer Res Date: 2017-09-01 Impact factor: 12.531
Authors: Grit S Herter-Sprie; Shohei Koyama; Houari Korideck; Josephine Hai; Jiehui Deng; Yvonne Y Li; Kevin A Buczkowski; Aaron K Grant; Soumya Ullas; Kevin Rhee; Jillian D Cavanaugh; Neermala Poudel Neupane; Camilla L Christensen; Jan M Herter; G Mike Makrigiorgos; F Stephen Hodi; Gordon J Freeman; Glenn Dranoff; Peter S Hammerman; Alec C Kimmelman; Kwok-Kin Wong Journal: JCI Insight Date: 2016-06-16
Authors: F Stephen Hodi; Wen-Jen Hwu; Richard Kefford; Jeffrey S Weber; Adil Daud; Omid Hamid; Amita Patnaik; Antoni Ribas; Caroline Robert; Tara C Gangadhar; Anthony M Joshua; Peter Hersey; Roxana Dronca; Richard Joseph; Darcy Hille; Dahai Xue; Xiaoyun Nicole Li; S Peter Kang; Scot Ebbinghaus; Andrea Perrone; Jedd D Wolchok Journal: J Clin Oncol Date: 2016-03-07 Impact factor: 44.544