PMID- 33026712
OWN - NLM
STAT- MEDLINE
DCOM- 20211119
LR  - 20240330
IS  - 1759-7714 (Electronic)
IS  - 1759-7706 (Print)
IS  - 1759-7706 (Linking)
VI  - 11
IP  - 12
DP  - 2020 Dec
TI  - Phase II study of durvalumab and tremelimumab in pulmonary sarcomatoid carcinoma: 
      KCSG-LU16-07.
PG  - 3482-3489
LID - 10.1111/1759-7714.13684 [doi]
AB  - BACKGROUND: Pulmonary sarcomatoid carcinoma (PSC) is rare with a poor outcome and 
      is resistant to conventional cytotoxic chemotherapy. The efficacy and safety of 
      durvalumab and tremelimumab for treating recurrent or metastatic PSCs were 
      assessed by a nonrandomized, open-label, phase II study. METHODS: A total of 18 
      patients with recurrent or metastatic PSC received 1500 mg of durvalumab and 75 
      mg of tremelimumab every four weeks, followed by 750 mg of durvalumab every 
      two weeks until the disease progressed, or an unacceptable toxicity level was 
      reached. The primary endpoint was the objective response rate (ORR). The 
      secondary endpoints were progression-free survival (PFS), overall survival (OS), 
      and toxicity. Genomic profiling of PSC by next-generation sequencing (NGS) and 
      determination of peripheral blood lymphocyte subsets using flow cytometry were 
      performed for exploratory analysis. RESULTS: A total of 15 out of 18 patients 
      were evaluated for the analysis of the primary endpoint. At the data cutoff 
      point, the ORR of 26.7% (95% confidence interval [CI]: 7.8-55.1) was achieved 
      with the median follow-up duration of 12.0 months (range, 8.4-16.1). Median PFS 
      and OS were 5.9 months (95% CI: 1.1-11.9) and 15.4 months (95% CI: 11.1-not 
      reached), respectively. Treatment-related adverse events (AEs) of any grade were 
      reported in 16 patients; the most common AEs were pruritus (n = 5), pneumonitis 
      (n = 4), and rash (n = 4). Treatment was discontinued in two patients due to AEs 
      of grade >/= 3. CONCLUSIONS: Durvalumab and tremelimumab demonstrated clinical 
      benefit with a prolonged survival and manageable toxicity profile in patients 
      with recurrent or metastatic PSC.
CI  - (c) 2020 The Authors. Thoracic Cancer published by China Lung Oncology Group and 
      John Wiley & Sons Australia, Ltd.
FAU - Kim, Miso
AU  - Kim M
AD  - Department of Internal Medicine, Seoul National University Hospital, Seoul 
      National University College of Medicine, Seoul, Republic of Korea.
AD  - Cancer Research Institute, Seoul National University College of Medicine, Seoul, 
      Republic of Korea.
FAU - Keam, Bhumsuk
AU  - Keam B
AUID- ORCID: 0000-0001-8196-4247
AD  - Department of Internal Medicine, Seoul National University Hospital, Seoul 
      National University College of Medicine, Seoul, Republic of Korea.
AD  - Cancer Research Institute, Seoul National University College of Medicine, Seoul, 
      Republic of Korea.
FAU - Ock, Chan-Young
AU  - Ock CY
AD  - Department of Internal Medicine, Seoul National University Hospital, Seoul 
      National University College of Medicine, Seoul, Republic of Korea.
AD  - Cancer Research Institute, Seoul National University College of Medicine, Seoul, 
      Republic of Korea.
FAU - Kim, Se Hyun
AU  - Kim SH
AUID- ORCID: 0000-0002-2292-906X
AD  - Department of Internal Medicine, Seoul National University Bundang Hospital, 
      Seoul National University College of Medicine, Seongnam, Republic of Korea.
FAU - Kim, Yu Jung
AU  - Kim YJ
AD  - Department of Internal Medicine, Seoul National University Bundang Hospital, 
      Seoul National University College of Medicine, Seongnam, Republic of Korea.
FAU - Lim, Sun Min
AU  - Lim SM
AD  - Department of Internal Medicine, CHA Bundang Medical Center, Seongnam, Republic 
      of Korea.
FAU - Kim, Jin-Soo
AU  - Kim JS
AD  - Department of Internal Medicine, Seoul National University Boramae Medical 
      Center, Seoul, Republic of Korea.
FAU - Kim, Tae Min
AU  - Kim TM
AD  - Department of Internal Medicine, Seoul National University Hospital, Seoul 
      National University College of Medicine, Seoul, Republic of Korea.
AD  - Cancer Research Institute, Seoul National University College of Medicine, Seoul, 
      Republic of Korea.
FAU - Hong, Sook-Hee
AU  - Hong SH
AD  - Department of Internal Medicine, Seoul St. Mary's Hospital, College of Medicine, 
      The Catholic University of Korea, Seoul, Republic of Korea.
FAU - Ahn, Mi Sun
AU  - Ahn MS
AD  - Department of Hematology-Oncology, Ajou University School of Medicine, Suwon, 
      Republic of Korea.
FAU - Shin, Seong Hoon
AU  - Shin SH
AD  - Department of Internal Medicine, Kosin University Gospel Hospital, Busan, 
      Republic of Korea.
FAU - Kang, Eun Joo
AU  - Kang EJ
AD  - Department of Internal Medicine, Korea University Medical Center, Korea 
      University College of Medicine, Seoul, Republic of Korea.
FAU - Kim, Dong-Wan
AU  - Kim DW
AUID- ORCID: 0000-0001-5124-7132
AD  - Department of Internal Medicine, Seoul National University Hospital, Seoul 
      National University College of Medicine, Seoul, Republic of Korea.
AD  - Cancer Research Institute, Seoul National University College of Medicine, Seoul, 
      Republic of Korea.
FAU - Im, Sun-Wha
AU  - Im SW
AD  - Genomic Medicine Institute, Medical Research Center, Seoul National University, 
      Seoul, Republic of Korea.
FAU - Kim, Jong-Il
AU  - Kim JI
AD  - Cancer Research Institute, Seoul National University College of Medicine, Seoul, 
      Republic of Korea.
AD  - Genomic Medicine Institute, Medical Research Center, Seoul National University, 
      Seoul, Republic of Korea.
AD  - Department of Biomedical Science, Seoul National University Graduate School, 
      Seoul, Republic of Korea.
FAU - Lee, Jong Seok
AU  - Lee JS
AD  - Department of Internal Medicine, Seoul National University Bundang Hospital, 
      Seoul National University College of Medicine, Seongnam, Republic of Korea.
FAU - Kim, Joo-Hang
AU  - Kim JH
AD  - Department of Internal Medicine, CHA Bundang Medical Center, Seongnam, Republic 
      of Korea.
FAU - Heo, Dae Seog
AU  - Heo DS
AD  - Department of Internal Medicine, Seoul National University Hospital, Seoul 
      National University College of Medicine, Seoul, Republic of Korea.
AD  - Cancer Research Institute, Seoul National University College of Medicine, Seoul, 
      Republic of Korea.
LA  - eng
PT  - Clinical Trial, Phase II
PT  - Journal Article
PT  - Research Support, Non-U.S. Gov't
DEP - 20201007
PL  - Singapore
TA  - Thorac Cancer
JT  - Thoracic cancer
JID - 101531441
RN  - 0 (Antibodies, Monoclonal)
RN  - 0 (Antibodies, Monoclonal, Humanized)
RN  - 28X28X9OKV (durvalumab)
RN  - QEN1X95CIX (tremelimumab)
SB  - IM
MH  - Adult
MH  - Aged
MH  - Antibodies, Monoclonal/pharmacology/*therapeutic use
MH  - Antibodies, Monoclonal, Humanized/pharmacology/*therapeutic use
MH  - Antineoplastic Combined Chemotherapy Protocols/pharmacology/*therapeutic use
MH  - Female
MH  - Humans
MH  - Immunotherapy/*methods
MH  - Lung Neoplasms/*drug therapy/pathology
MH  - Male
MH  - Middle Aged
PMC - PMC7705626
OTO - NOTNLM
OT  - Durvalumab
OT  - immunotherapy
OT  - non-small cell lung cancer
OT  - pulmonary sarcomatoid carcinoma
OT  - tremelimumab
EDAT- 2020/10/08 06:00
MHDA- 2021/11/20 06:00
PMCR- 2020/12/01
CRDT- 2020/10/07 12:12
PHST- 2020/08/06 00:00 [received]
PHST- 2020/09/16 00:00 [revised]
PHST- 2020/09/16 00:00 [accepted]
PHST- 2020/10/08 06:00 [pubmed]
PHST- 2021/11/20 06:00 [medline]
PHST- 2020/10/07 12:12 [entrez]
PHST- 2020/12/01 00:00 [pmc-release]
AID - TCA13684 [pii]
AID - 10.1111/1759-7714.13684 [doi]
PST - ppublish
SO  - Thorac Cancer. 2020 Dec;11(12):3482-3489. doi: 10.1111/1759-7714.13684. Epub 2020 
      Oct 7.