Discontinuation of anti-PD-1 antibody therapy in the absence of disease progression or treatment limiting toxicity: clinical outcomes in advanced melanoma
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Discontinuation of anti-PD-1 antibody therapy in the absence of disease progression or treatment limiting toxicity : clinical outcomes in advanced melanoma. / Jansen, Y.J.L.; Rozeman, E A; Mason, R; Goldinger, S M; Geukes Foppen, M H; Højberg, L.; Schmidt, H.; van Thienen, J V; Haanen, J B A G; Tiainen, L; Svane, I.M.; Mäkelä, S; Seremet, T; Arance, A; Dummer, R; Bastholt, L; Nyakas, M; Straume, O; Menzies, A M; Long, G V; Atkinson, V; Blank, C U; Neyns, B.
In: Annals of Oncology, Vol. 30, No. 7, 2019, p. 1154-1161.Research output: Contribution to journal › Journal article › Research › peer-review
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TY - JOUR
T1 - Discontinuation of anti-PD-1 antibody therapy in the absence of disease progression or treatment limiting toxicity
T2 - clinical outcomes in advanced melanoma
AU - Jansen, Y.J.L.
AU - Rozeman, E A
AU - Mason, R
AU - Goldinger, S M
AU - Geukes Foppen, M H
AU - Højberg, L.
AU - Schmidt, H.
AU - van Thienen, J V
AU - Haanen, J B A G
AU - Tiainen, L
AU - Svane, I.M.
AU - Mäkelä, S
AU - Seremet, T
AU - Arance, A
AU - Dummer, R
AU - Bastholt, L
AU - Nyakas, M
AU - Straume, O
AU - Menzies, A M
AU - Long, G V
AU - Atkinson, V
AU - Blank, C U
AU - Neyns, B
PY - 2019
Y1 - 2019
N2 - BACKGROUND: Programmed cell death protein 1 (PD-1) blocking monoclonal antibodies improve the overall survival of patients with advanced melanoma but the optimal duration of treatment has not been established.PATIENTS AND METHODS: This academic real-world cohort study investigated the outcome of 185 advanced melanoma patients who electively discontinued anti-PD-1 therapy with pembrolizumab (N = 167) or nivolumab (N = 18) in the absence of disease progression (PD) or treatment limiting toxicity (TLT) at 14 medical centres across Europe and Australia.RESULTS: Median time on treatment was 12 months (range 0.7-43). The best objective tumour response at the time of treatment discontinuation was complete response (CR) in 117 (63%) patients, partial response (PR) in 44 (24%) patients and stable disease (SD) in 16 (9%) patients; 8 (4%) patients had no evaluable disease (NE). After a median follow-up of 18 months (range 0.7-48) after treatment discontinuation, 78% of patients remained free of progression. Median time to progression was 12 months (range 2-23). PD was less frequent in patients with CR (14%) compared with patients with PR (32%) and SD (50%). Six out of 19 (32%) patients who were retreated with an anti-PD-1 at the time of PD obtained a new antitumour response.CONCLUSIONS: In this real-world cohort of advanced melanoma patients discontinuing anti-PD-1 therapy in the absence of TLT or PD, the duration of anti-PD-1 therapy was shorter when compared with clinical trials. In patients obtaining a CR, and being treated for >6 months, the risk of relapse after treatment discontinuation was low. Patients achieving a PR or SD as best tumour response were at higher risk for progression after discontinuing therapy, and defining optimal treatment duration in such patients deserves further study. Retreatment with an anti-PD-1 at the time of progression may lead to renewed antitumour activity in some patients.CLINICAL TRIAL REGISTRATION: NCT02673970 (https://clinicaltrials.gov/ct2/show/NCT02673970?cond=melanoma&cntry=BE&city=Jette&rank=3).
AB - BACKGROUND: Programmed cell death protein 1 (PD-1) blocking monoclonal antibodies improve the overall survival of patients with advanced melanoma but the optimal duration of treatment has not been established.PATIENTS AND METHODS: This academic real-world cohort study investigated the outcome of 185 advanced melanoma patients who electively discontinued anti-PD-1 therapy with pembrolizumab (N = 167) or nivolumab (N = 18) in the absence of disease progression (PD) or treatment limiting toxicity (TLT) at 14 medical centres across Europe and Australia.RESULTS: Median time on treatment was 12 months (range 0.7-43). The best objective tumour response at the time of treatment discontinuation was complete response (CR) in 117 (63%) patients, partial response (PR) in 44 (24%) patients and stable disease (SD) in 16 (9%) patients; 8 (4%) patients had no evaluable disease (NE). After a median follow-up of 18 months (range 0.7-48) after treatment discontinuation, 78% of patients remained free of progression. Median time to progression was 12 months (range 2-23). PD was less frequent in patients with CR (14%) compared with patients with PR (32%) and SD (50%). Six out of 19 (32%) patients who were retreated with an anti-PD-1 at the time of PD obtained a new antitumour response.CONCLUSIONS: In this real-world cohort of advanced melanoma patients discontinuing anti-PD-1 therapy in the absence of TLT or PD, the duration of anti-PD-1 therapy was shorter when compared with clinical trials. In patients obtaining a CR, and being treated for >6 months, the risk of relapse after treatment discontinuation was low. Patients achieving a PR or SD as best tumour response were at higher risk for progression after discontinuing therapy, and defining optimal treatment duration in such patients deserves further study. Retreatment with an anti-PD-1 at the time of progression may lead to renewed antitumour activity in some patients.CLINICAL TRIAL REGISTRATION: NCT02673970 (https://clinicaltrials.gov/ct2/show/NCT02673970?cond=melanoma&cntry=BE&city=Jette&rank=3).
U2 - 10.1093/annonc/mdz110
DO - 10.1093/annonc/mdz110
M3 - Journal article
C2 - 30923820
VL - 30
SP - 1154
EP - 1161
JO - Annals of Oncology
JF - Annals of Oncology
SN - 0923-7534
IS - 7
ER -
ID: 237193566