Immunotherapy phase I trials in patients Older than 70 years with advanced solid tumours

H. Herin; S. Aspeslagh; E. Castanon; V. Dyevre; A. Marabelle; A. Varga; S. Postel Vinay; J. M. Michot; V. Ribrag; A. Gazzah; R. Bahleda; O. Mir; C. Massard; A. Hollebecque; J. C. Soria; C. Baldini

doi:10.1016/j.ejca.2018.03.002

Immunotherapy phase I trials in patients Older than 70 years with advanced solid tumours

H. Herin, S. Aspeslagh, E. Castanon, V. Dyevre, A. Marabelle, A. Varga, S. Postel Vinay, J. M. Michot, V. Ribrag, A. Gazzah, R. Bahleda, O. Mir, C. Massard, A. Hollebecque, J. C. Soria, C. Baldini

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Abstract

Background: The development of immune checkpoint blocker development brings new hope in older patients (OPs) because of clinical efficacy and low toxicity. Clinical indications are rising steadily, but very few data are available in the geriatric population where comorbidities, reduced functional reserve and immunosenescence may affect efficacy and tolerance. Methods: All cases of patients enrolled in immunotherapy phase I trials between January 2012 and December 2016 in the Drug Development Department (DITEP) at Gustave Roussy were retrospectively reviewed. Case–control analysis was performed in OPs (patients ≥ 70 years) matched to younger patients (YPs) (patients < 70 years) by trial and treatment dose. We compared cumulative incidence, grade and type of immune-related adverse events (IrAEs) and survival outcomes. Results: Among the 46 OPs and the 174 YPs enrolled in 14 phase I/II trials, 10 (22%) and 23 (13%) patients experienced grade III–IV IrAEs. Cumulative incidence of grade I–II IrAEs was significantly higher in OPs than YPs (p < 0.05). No significant difference was observed between the two groups for grade III–IV IrAEs (p = 0.50). Older age was not associated with lower dose intensity of treatment (p = 0.14). No significant difference was observed between OPs and YPs in median progression-free survival (hazards ratio 1.41, 95% confidence interval [CI] [0.94–2.11] p = 0.09) or median overall survival (HR 0.92, 95% CI [0.61–1.39] p = 0.77). Conclusion: Immune checkpoint blockade appears to be an acceptable treatment option for OPs in the setting of phase I trials.

Original language	English
Pages (from-to)	68-74
Number of pages	7
Journal	European Journal of Cancer
Volume	95
DOIs	https://doi.org/10.1016/j.ejca.2018.03.002
Publication status	Published - 1 May 2018

Keywords

Immunotherapy
Older patients
Phase I trials

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10.1016/j.ejca.2018.03.002

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Herin, H., Aspeslagh, S., Castanon, E., Dyevre, V., Marabelle, A., Varga, A., Postel Vinay, S., Michot, J. M., Ribrag, V., Gazzah, A., Bahleda, R., Mir, O., Massard, C., Hollebecque, A., Soria, J. C., & Baldini, C. (2018). Immunotherapy phase I trials in patients Older than 70 years with advanced solid tumours. European Journal of Cancer, 95, 68-74. https://doi.org/10.1016/j.ejca.2018.03.002

@article{d95968df4ee1447ba1b2e50d55c9e14c,

title = "Immunotherapy phase I trials in patients Older than 70 years with advanced solid tumours",

abstract = "Background: The development of immune checkpoint blocker development brings new hope in older patients (OPs) because of clinical efficacy and low toxicity. Clinical indications are rising steadily, but very few data are available in the geriatric population where comorbidities, reduced functional reserve and immunosenescence may affect efficacy and tolerance. Methods: All cases of patients enrolled in immunotherapy phase I trials between January 2012 and December 2016 in the Drug Development Department (DITEP) at Gustave Roussy were retrospectively reviewed. Case–control analysis was performed in OPs (patients ≥ 70 years) matched to younger patients (YPs) (patients < 70 years) by trial and treatment dose. We compared cumulative incidence, grade and type of immune-related adverse events (IrAEs) and survival outcomes. Results: Among the 46 OPs and the 174 YPs enrolled in 14 phase I/II trials, 10 (22%) and 23 (13%) patients experienced grade III–IV IrAEs. Cumulative incidence of grade I–II IrAEs was significantly higher in OPs than YPs (p < 0.05). No significant difference was observed between the two groups for grade III–IV IrAEs (p = 0.50). Older age was not associated with lower dose intensity of treatment (p = 0.14). No significant difference was observed between OPs and YPs in median progression-free survival (hazards ratio 1.41, 95% confidence interval [CI] [0.94–2.11] p = 0.09) or median overall survival (HR 0.92, 95% CI [0.61–1.39] p = 0.77). Conclusion: Immune checkpoint blockade appears to be an acceptable treatment option for OPs in the setting of phase I trials.",

keywords = "Immunotherapy, Older patients, Phase I trials",

author = "H. Herin and S. Aspeslagh and E. Castanon and V. Dyevre and A. Marabelle and A. Varga and {Postel Vinay}, S. and Michot, {J. M.} and V. Ribrag and A. Gazzah and R. Bahleda and O. Mir and C. Massard and A. Hollebecque and Soria, {J. C.} and C. Baldini",

note = "Publisher Copyright: {\textcopyright} 2018 Elsevier Ltd",

year = "2018",

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doi = "10.1016/j.ejca.2018.03.002",

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Herin, H, Aspeslagh, S, Castanon, E, Dyevre, V, Marabelle, A, Varga, A, Postel Vinay, S, Michot, JM, Ribrag, V, Gazzah, A, Bahleda, R, Mir, O, Massard, C, Hollebecque, A, Soria, JC & Baldini, C 2018, 'Immunotherapy phase I trials in patients Older than 70 years with advanced solid tumours', European Journal of Cancer, vol. 95, pp. 68-74. https://doi.org/10.1016/j.ejca.2018.03.002

TY - JOUR

T1 - Immunotherapy phase I trials in patients Older than 70 years with advanced solid tumours

AU - Herin, H.

AU - Aspeslagh, S.

AU - Castanon, E.

AU - Dyevre, V.

AU - Marabelle, A.

AU - Varga, A.

AU - Postel Vinay, S.

AU - Michot, J. M.

AU - Ribrag, V.

AU - Gazzah, A.

AU - Bahleda, R.

AU - Mir, O.

AU - Massard, C.

AU - Hollebecque, A.

AU - Soria, J. C.

AU - Baldini, C.

PY - 2018/5/1

Y1 - 2018/5/1

N2 - Background: The development of immune checkpoint blocker development brings new hope in older patients (OPs) because of clinical efficacy and low toxicity. Clinical indications are rising steadily, but very few data are available in the geriatric population where comorbidities, reduced functional reserve and immunosenescence may affect efficacy and tolerance. Methods: All cases of patients enrolled in immunotherapy phase I trials between January 2012 and December 2016 in the Drug Development Department (DITEP) at Gustave Roussy were retrospectively reviewed. Case–control analysis was performed in OPs (patients ≥ 70 years) matched to younger patients (YPs) (patients < 70 years) by trial and treatment dose. We compared cumulative incidence, grade and type of immune-related adverse events (IrAEs) and survival outcomes. Results: Among the 46 OPs and the 174 YPs enrolled in 14 phase I/II trials, 10 (22%) and 23 (13%) patients experienced grade III–IV IrAEs. Cumulative incidence of grade I–II IrAEs was significantly higher in OPs than YPs (p < 0.05). No significant difference was observed between the two groups for grade III–IV IrAEs (p = 0.50). Older age was not associated with lower dose intensity of treatment (p = 0.14). No significant difference was observed between OPs and YPs in median progression-free survival (hazards ratio 1.41, 95% confidence interval [CI] [0.94–2.11] p = 0.09) or median overall survival (HR 0.92, 95% CI [0.61–1.39] p = 0.77). Conclusion: Immune checkpoint blockade appears to be an acceptable treatment option for OPs in the setting of phase I trials.

AB - Background: The development of immune checkpoint blocker development brings new hope in older patients (OPs) because of clinical efficacy and low toxicity. Clinical indications are rising steadily, but very few data are available in the geriatric population where comorbidities, reduced functional reserve and immunosenescence may affect efficacy and tolerance. Methods: All cases of patients enrolled in immunotherapy phase I trials between January 2012 and December 2016 in the Drug Development Department (DITEP) at Gustave Roussy were retrospectively reviewed. Case–control analysis was performed in OPs (patients ≥ 70 years) matched to younger patients (YPs) (patients < 70 years) by trial and treatment dose. We compared cumulative incidence, grade and type of immune-related adverse events (IrAEs) and survival outcomes. Results: Among the 46 OPs and the 174 YPs enrolled in 14 phase I/II trials, 10 (22%) and 23 (13%) patients experienced grade III–IV IrAEs. Cumulative incidence of grade I–II IrAEs was significantly higher in OPs than YPs (p < 0.05). No significant difference was observed between the two groups for grade III–IV IrAEs (p = 0.50). Older age was not associated with lower dose intensity of treatment (p = 0.14). No significant difference was observed between OPs and YPs in median progression-free survival (hazards ratio 1.41, 95% confidence interval [CI] [0.94–2.11] p = 0.09) or median overall survival (HR 0.92, 95% CI [0.61–1.39] p = 0.77). Conclusion: Immune checkpoint blockade appears to be an acceptable treatment option for OPs in the setting of phase I trials.

KW - Immunotherapy

KW - Older patients

KW - Phase I trials

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U2 - 10.1016/j.ejca.2018.03.002

DO - 10.1016/j.ejca.2018.03.002

M3 - Article

C2 - 29635146

AN - SCOPUS:85045009283

SN - 0959-8049

VL - 95

SP - 68

EP - 74

JO - European Journal of Cancer

JF - European Journal of Cancer

ER -

Immunotherapy phase I trials in patients Older than 70 years with advanced solid tumours

Abstract

Keywords

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