TY - JOUR
T1 - Lurbinectedin in patients with pretreated neuroendocrine tumours
T2 - Results from a phase II basket study
AU - Longo-Muñoz, Federico
AU - Castellano, Daniel
AU - Alexandre, Jerome
AU - Chawla, Sant P.
AU - Fernández, Cristian
AU - Kahatt, Carmen
AU - Alfaro, Vicente
AU - Siguero, Mariano
AU - Zeaiter, Ali
AU - Moreno, Victor
AU - Sanz-García, Enrique
AU - Awada, Ahmad
AU - Santaballa, Ana
AU - Subbiah, Vivek
N1 - Publisher Copyright:
© 2022 The Author(s)
PY - 2022/9
Y1 - 2022/9
N2 - Background: Patients with neuroendocrine tumours (NETs) need alternative therapies after failure of first-line therapy. Patients and methods: This phase II trial evaluated lurbinectedin, a selective inhibitor of oncogenic transcription, at 3.2 mg/m2 as a 1-h intravenous infusion every 3 weeks in 32 NETs patients treated in the second- or third-line setting. The primary efficacy endpoint was overall response rate (ORR) according to RECIST v1.1 assessed by the investigators. Secondary endpoints included duration of response (DoR), progression-free survival (PFS), overall survival (OS) and safety. Results: Two of 31 evaluable patients had confirmed partial responses (ORR = 6.5%; 95%CI, 0.8–21.4%). Median DoR was 4.7 months (95% CI, 4.0–5.4 months), median PFS was 1.4 months (95% CI, 1.2–3.0 months) and median OS was 7.4 months (95% CI, 3.4–16.2 months). Lurbinectedin showed an acceptable, predictable and manageable safety profile. The most common grade 3/4 toxicity was neutropenia (40.6%; grade 4, 12.4%; febrile neutropenia, 3.1%). Conclusions: Considering the exploratory aim of this trial that evaluated a heterogeneous population of NETs patients, and the signs of antitumour activity observed (two confirmed partial responses and seven long disease stabilisations), further development of lurbinectedin is warranted in a more selected NETs population. Trial registration number: Sponsor Study Code: PM1183-B-005-14. EudraCT number: 2014-003773-42. ClinicalTrials.gov reference: NCT02454972.
AB - Background: Patients with neuroendocrine tumours (NETs) need alternative therapies after failure of first-line therapy. Patients and methods: This phase II trial evaluated lurbinectedin, a selective inhibitor of oncogenic transcription, at 3.2 mg/m2 as a 1-h intravenous infusion every 3 weeks in 32 NETs patients treated in the second- or third-line setting. The primary efficacy endpoint was overall response rate (ORR) according to RECIST v1.1 assessed by the investigators. Secondary endpoints included duration of response (DoR), progression-free survival (PFS), overall survival (OS) and safety. Results: Two of 31 evaluable patients had confirmed partial responses (ORR = 6.5%; 95%CI, 0.8–21.4%). Median DoR was 4.7 months (95% CI, 4.0–5.4 months), median PFS was 1.4 months (95% CI, 1.2–3.0 months) and median OS was 7.4 months (95% CI, 3.4–16.2 months). Lurbinectedin showed an acceptable, predictable and manageable safety profile. The most common grade 3/4 toxicity was neutropenia (40.6%; grade 4, 12.4%; febrile neutropenia, 3.1%). Conclusions: Considering the exploratory aim of this trial that evaluated a heterogeneous population of NETs patients, and the signs of antitumour activity observed (two confirmed partial responses and seven long disease stabilisations), further development of lurbinectedin is warranted in a more selected NETs population. Trial registration number: Sponsor Study Code: PM1183-B-005-14. EudraCT number: 2014-003773-42. ClinicalTrials.gov reference: NCT02454972.
KW - Lurbinectedin
KW - Neuroendocrine tumours
KW - Phase II trial
KW - Small cell
UR - http://www.scopus.com/inward/record.url?scp=85133799048&partnerID=8YFLogxK
UR - http://www.scopus.com/inward/citedby.url?scp=85133799048&partnerID=8YFLogxK
U2 - 10.1016/j.ejca.2022.06.024
DO - 10.1016/j.ejca.2022.06.024
M3 - Article
C2 - 35830841
AN - SCOPUS:85133799048
SN - 0959-8049
VL - 172
SP - 340
EP - 348
JO - European Journal of Cancer
JF - European Journal of Cancer
ER -