PMID- 34959168
OWN - NLM
STAT- MEDLINE
DCOM- 20220324
LR  - 20220531
IS  - 2059-7029 (Electronic)
IS  - 2059-7029 (Linking)
VI  - 7
IP  - 1
DP  - 2022 Feb
TI  - Safety and efficacy of dendritic cell-based immunotherapy (DCVAC/LuCa) combined 
      with carboplatin/pemetrexed for patients with advanced non-squamous 
      non-small-cell lung cancer without oncogenic drivers.
PG  - 100334
LID - S2059-7029(21)00296-9 [pii]
LID - 10.1016/j.esmoop.2021.100334 [doi]
LID - 100334
AB  - BACKGROUND: Our prospective, open-label, single-arm phase II study investigated 
      the safety and efficacy of DCVAC/LuCa (dendritic cell vaccines for lung cancer) 
      combined with standard carboplatin/pemetrexed in advanced non-squamous (nsq) 
      non-small-cell lung cancer (NSCLC). PATIENTS AND METHODS: Eligible patients had 
      stage IV nsq NSCLC without oncogenic drivers and had not received prior systemic 
      cancer therapy. Treatment consisted of carboplatin/pemetrexed for up to 6 cycles 
      followed by 21 cycles of pemetrexed maintenance or until progression or 
      intolerance. Non-progression patients after two cycles of chemotherapy started to 
      receive DCVAC/LuCa subcutaneously (s.c.) on day 15 of cycle 3, and thereafter q3w 
      (day 15 of chemotherapy cycles) for up to 15 doses. Dosing of DCVAC/LuCa s.c. 
      varied among patients depending on the baseline number of leucocytes but remained 
      constant for each single patient. Safety was assessed by adverse events (AEs), 
      treatment-related adverse events (TRAEs), serious adverse events (SAEs), and 
      adverse events of special interest (AESIs). Efficacy was measured by overall 
      survival (OS), progression-free survival (PFS), time to progression (TTP), and 
      objective response rate (ORR). RESULTS: Sixty-one patients were enrolled. In the 
      safety population (n = 60), eight patients (13.33%) had grade 3 or greater TRAEs, 
      and six patients (10.0%) showed SAEs which were not related to leukapheresis or 
      DC vaccination. Six grade 1 AEs were considered to be related to leukapheresis. 
      No AESIs or DCVAC/LuCa-induced AEs were observed. The 2-year survival rate in the 
      modified intention-to-treat population (n = 44) was 52.57%. Median OS was not 
      reached. Median PFS was 8.0 months, median TTP was 10.2 months, and the ORR was 
      31.82%. CONCLUSION: In treatment-naive stage IV nsq NSCLC patients without 
      oncogenic drivers, the combination of carboplatin/pemetrexed and DCVAC/LuCa was 
      well tolerated and showed promising efficacy. Therefore, a study to prove our 
      immunotherapeutic concept in a randomized phase III trial is planned.
CI  - Copyright (c) 2021. Published by Elsevier Ltd.
FAU - Zhong, R
AU  - Zhong R
AD  - Department of Pulmonary Medicine, Shanghai Chest Hospital, Shanghai Jiaotong 
      University, Shanghai, China.
FAU - Ling, X
AU  - Ling X
AD  - Department of Pulmonary Medicine, Shanghai Chest Hospital, Shanghai Jiaotong 
      University, Shanghai, China.
FAU - Cao, S
AU  - Cao S
AD  - Department of Pulmonary Medicine, Shanghai Chest Hospital, Shanghai Jiaotong 
      University, Shanghai, China.
FAU - Xu, J
AU  - Xu J
AD  - Department of Pulmonary Medicine, Shanghai Chest Hospital, Shanghai Jiaotong 
      University, Shanghai, China.
FAU - Zhang, B
AU  - Zhang B
AD  - Department of Pulmonary Medicine, Shanghai Chest Hospital, Shanghai Jiaotong 
      University, Shanghai, China.
FAU - Zhang, X
AU  - Zhang X
AD  - Department of Pulmonary Medicine, Shanghai Chest Hospital, Shanghai Jiaotong 
      University, Shanghai, China.
FAU - Wang, H
AU  - Wang H
AD  - Department of Pulmonary Medicine, Shanghai Chest Hospital, Shanghai Jiaotong 
      University, Shanghai, China.
FAU - Han, B
AU  - Han B
AD  - Department of Pulmonary Medicine, Shanghai Chest Hospital, Shanghai Jiaotong 
      University, Shanghai, China. Electronic address: 18930858216@163.com.
FAU - Zhong, H
AU  - Zhong H
AD  - Department of Pulmonary Medicine, Shanghai Chest Hospital, Shanghai Jiaotong 
      University, Shanghai, China. Electronic address: eddiedong8@hotmail.com.
LA  - eng
PT  - Clinical Trial, Phase II
PT  - Journal Article
PT  - Research Support, Non-U.S. Gov't
DEP - 20211224
PL  - England
TA  - ESMO Open
JT  - ESMO open
JID - 101690685
RN  - 04Q9AIZ7NO (Pemetrexed)
RN  - 104713-70-4 (S-1,2-dichlorovinyl-N-acetylcysteine)
RN  - BG3F62OND5 (Carboplatin)
RN  - WYQ7N0BPYC (Acetylcysteine)
SB  - IM
MH  - Acetylcysteine/analogs & derivatives
MH  - Antineoplastic Combined Chemotherapy Protocols/adverse effects
MH  - Carboplatin/pharmacology/therapeutic use
MH  - *Carcinoma, Non-Small-Cell Lung/drug therapy
MH  - Dendritic Cells
MH  - Humans
MH  - Immunotherapy/adverse effects
MH  - *Lung Neoplasms/drug therapy
MH  - Pemetrexed/pharmacology/therapeutic use
MH  - Prospective Studies
PMC - PMC8718955
OTO - NOTNLM
OT  - DCVAC/LuCa
OT  - dendritic cell vaccination
OT  - non-small-cell lung cancer
COIS- Disclosure The authors have declared no conflicts of interest.
EDAT- 2021/12/28 06:00
MHDA- 2022/03/25 06:00
PMCR- 2021/12/24
CRDT- 2021/12/27 20:25
PHST- 2021/07/30 00:00 [received]
PHST- 2021/09/28 00:00 [revised]
PHST- 2021/11/15 00:00 [accepted]
PHST- 2021/12/28 06:00 [pubmed]
PHST- 2022/03/25 06:00 [medline]
PHST- 2021/12/27 20:25 [entrez]
PHST- 2021/12/24 00:00 [pmc-release]
AID - S2059-7029(21)00296-9 [pii]
AID - 100334 [pii]
AID - 10.1016/j.esmoop.2021.100334 [doi]
PST - ppublish
SO  - ESMO Open. 2022 Feb;7(1):100334. doi: 10.1016/j.esmoop.2021.100334. Epub 2021 Dec 
      24.