Randomized phase 3 study of the anti-disialoganglioside antibody dinutuximab and irinotecan vs irinotecan or topotecan for second-line treatment of small cell lung cancer
M. J. Edelman
1
,
Mikhail Dvorkin
2
,
Konstatin Laktionov
3
,
Alejandro Navarro
4
,
Oscar Juan
5
,
Vadim Kozlov
6
,
Gil Golden
7
,
Odette Jordan
7
,
Cq Deng
7
,
Dmitriy Bentsion
8
,
Christos Chouaïd
9
,
Hristo Dechev
10
,
Afshin Dowlati
11
,
Natalia Fernández Núñez
12
,
Olexandr Ivashchuk
13
,
Ivane Kiladze
14
,
Tsira Kortua
15
,
J. S. Hoch
16
,
Aleksandr Luft
17
,
Tamta Makharadze
18
,
YoungJoo Min
19
,
Xavier Quantin
20
2
State Budgetary Healthcare Institution of Omsk Region, Omsk, Russia
|
5
Hospital Universitari I Politécnic La Fe, València, Spain
|
6
State Budgetary Healthcare Institution of Novosibirsk Region, Novosibirsk, Russia
|
7
United Therapeutics Corporation, Durham, NC, USA
|
8
State Budgetary Healthcare Institution, Sverdlovsk Regional Oncology Dispensary, Ekaterinburg, Russia
|
9
Centre Hospitalier Intercommunal Créteil, Créteil, France
|
10
Complex Oncology Center – Burgas EOOD, Burgas, Bulgaria
|
11
University Hospitals Cleveland Medical Center, Cleveland, OH, USA
|
13
Municipal Institution, Chernivtsi Regional Clinical Oncology Dispensary, State Higher Educational Establishment of Ukraine, Bukovinian State Medical University, Chernivtsi, Ukraine
|
14
LTD Accad. F. Todua Medical Center, Research Institute of Clinical Medicine, Tbilisi, Georgia
|
15
Multiprofile Clinic Consilium Medulla, Tbilisi, Georgia
|
16
Princess Margaret Hospital, Toronto, Ontario, Canada
|
17
State Budgetary Healthcare Institution, Leningrad Regional Clinical Hospital, Saint-Petersburg, Russia
|
18
Cancer Center of Adjara Autonomous Republic, Batumi, Georgia
|
20
Institut du Cancer de Montpellier, Montpellier, France
|
Publication type: Journal Article
Publication date: 2022-04-01
scimago Q1
wos Q1
SJR: 1.752
CiteScore: 8.6
Impact factor: 4.4
ISSN: 01695002, 18728332
PubMed ID:
35278766
Cancer Research
Oncology
Pulmonary and Respiratory Medicine
Abstract
Topotecan is approved as second-line treatment for small cell lung cancer (SCLC). Irinotecan is also frequently used given its more convenient schedule and superior tolerability. Preclinical studies support disialoganglioside (GD2) as an SCLC target and the combination of dinutuximab, an anti-GD2 antibody, plus irinotecan in this setting. We tested dinutuximab/irinotecan versus irinotecan or topotecan as second-line therapy in relapsed/refractory (RR) SCLC.Patients with RR SCLC and Eastern Cooperative Oncology Group performance status 0-1 were randomized 2:2:1 to receive dinutuximab 16-17.5 mg/m2 intravenous (IV)/irinotecan 350 mg/m2 IV (day 1), irinotecan 350 mg/m2 IV (day 1), or topotecan 1.5 mg/m2 IV (days 1-5) in 21-day cycles. The primary endpoint was overall survival (OS); secondary endpoints were progression-free survival (PFS), objective response rate (ORR; complete response [CR] + partial response [PR]), and clinical benefit rate (CBR; CR + PR + stable disease). Safety/tolerability were also assessed.A total of 471 patients were randomized to dinutuximab/irinotecan (n = 187), irinotecan (n = 190), or topotecan (n = 94). Age, sex, performance status, prior therapies, and metastatic disease sites were similar between groups. Survival and response rates were not improved for patients receiving dinutuximab/irinotecan versus those receiving irinotecan or topotecan (median OS 6.9 vs 7.0 vs 7.4 months [p = 0.3132]; median PFS 3.5 vs 3.0 vs 3.4 months [p = 0.3482]; ORR confirmed 17.1% vs 18.9% vs 20.2% [p = 0.8043]; and CBR 67.4% vs 58.9% vs 68.1% [p = 0.0989]), respectively. Grade 3/4 adverse events (≥5% receiving dinutuximab/irinotecan) included neutropenia, anemia, diarrhea, and asthenia.Dinutuximab/irinotecan treatment did not result in improved OS in RR SCLC versus irinotecan alone. Irinotecan administered every 21 days demonstrated comparable activity to topotecan administered daily × 5 every 21 days.gov Identifier. NCT03098030.
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Edelman M. J. et al. Randomized phase 3 study of the anti-disialoganglioside antibody dinutuximab and irinotecan vs irinotecan or topotecan for second-line treatment of small cell lung cancer // Lung Cancer. 2022. Vol. 166. pp. 135-142.
GOST all authors (up to 50)
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Edelman M. J., Dvorkin M., Laktionov K., Navarro A., Juan O., Kozlov V., Golden G., Jordan O., Deng C., Bentsion D., Chouaïd C., Dechev H., Dowlati A., Fernández Núñez N., Ivashchuk O., Kiladze I., Kortua T., Hoch J. S., Luft A., Makharadze T., Min Y., Quantin X. Randomized phase 3 study of the anti-disialoganglioside antibody dinutuximab and irinotecan vs irinotecan or topotecan for second-line treatment of small cell lung cancer // Lung Cancer. 2022. Vol. 166. pp. 135-142.
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TY - JOUR
DO - 10.1016/j.lungcan.2022.03.003
UR - https://doi.org/10.1016/j.lungcan.2022.03.003
TI - Randomized phase 3 study of the anti-disialoganglioside antibody dinutuximab and irinotecan vs irinotecan or topotecan for second-line treatment of small cell lung cancer
T2 - Lung Cancer
AU - Edelman, M. J.
AU - Dvorkin, Mikhail
AU - Laktionov, Konstatin
AU - Navarro, Alejandro
AU - Juan, Oscar
AU - Kozlov, Vadim
AU - Golden, Gil
AU - Jordan, Odette
AU - Deng, Cq
AU - Bentsion, Dmitriy
AU - Chouaïd, Christos
AU - Dechev, Hristo
AU - Dowlati, Afshin
AU - Fernández Núñez, Natalia
AU - Ivashchuk, Olexandr
AU - Kiladze, Ivane
AU - Kortua, Tsira
AU - Hoch, J. S.
AU - Luft, Aleksandr
AU - Makharadze, Tamta
AU - Min, YoungJoo
AU - Quantin, Xavier
PY - 2022
DA - 2022/04/01
PB - Elsevier
SP - 135-142
VL - 166
PMID - 35278766
SN - 0169-5002
SN - 1872-8332
ER -
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@article{2022_Edelman,
author = {M. J. Edelman and Mikhail Dvorkin and Konstatin Laktionov and Alejandro Navarro and Oscar Juan and Vadim Kozlov and Gil Golden and Odette Jordan and Cq Deng and Dmitriy Bentsion and Christos Chouaïd and Hristo Dechev and Afshin Dowlati and Natalia Fernández Núñez and Olexandr Ivashchuk and Ivane Kiladze and Tsira Kortua and J. S. Hoch and Aleksandr Luft and Tamta Makharadze and YoungJoo Min and Xavier Quantin},
title = {Randomized phase 3 study of the anti-disialoganglioside antibody dinutuximab and irinotecan vs irinotecan or topotecan for second-line treatment of small cell lung cancer},
journal = {Lung Cancer},
year = {2022},
volume = {166},
publisher = {Elsevier},
month = {apr},
url = {https://doi.org/10.1016/j.lungcan.2022.03.003},
pages = {135--142},
doi = {10.1016/j.lungcan.2022.03.003}
}
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