PMID- 37445743
OWN - NLM
STAT- MEDLINE
DCOM- 20230717
LR  - 20230718
IS  - 1422-0067 (Electronic)
IS  - 1422-0067 (Linking)
VI  - 24
IP  - 13
DP  - 2023 Jun 23
TI  - A Phase Ib Study of Durvalumab (MEDI4736) in Combination with Carbon-Ion 
      Radiotherapy and Weekly Cisplatin for Patients with Locally Advanced Cervical 
      Cancer (DECISION Study): The Early Safety and Efficacy Results.
LID - 10.3390/ijms241310565 [doi]
LID - 10565
AB  - We conducted a phase Ib study to examine the safety of a combination of 
      carbon-ion RT (CIRT) with durvalumab (MEDI4736; AstraZeneca) in patients with 
      locally advanced cervical cancer. This was an open-label, single-arm study with a 
      modified 3 + 3 design. Patients with newly diagnosed histologically proven 
      locally advanced cervical cancer were enrolled. All patients received 74.4 Gy of 
      CIRT in 20 fractions and concurrent weekly cisplatin (chemo-CIRT) at a dose of 40 
      mg/m(2). Durvalumab was administered (1500 mg/body) at weeks two and six. The 
      primary endpoint was the incidence of adverse events (AEs) and serious AEs 
      (SAEs), including dose-limiting toxicity (DLT). All three enrolled patients 
      completed the treatment without interruption. One patient developed 
      hypothyroidism after treatment and was determined to be an SAE. No other SAEs 
      were observed. The patient recovered after levothyroxine sodium hydrate 
      treatment. None of the AEs, including hypothyroidism, were associated with DLT in 
      the present study. All three patients achieved complete responses within the CIRT 
      region concerning treatment efficacy. This phase 1b trial demonstrates the safety 
      of combining chemo-CIRT and durvalumab for locally advanced cervical cancer in 
      the early phase. Further research is required as only three patients were 
      included in this study.
FAU - Okonogi, Noriyuki
AU  - Okonogi N
AUID- ORCID: 0000-0002-9486-1922
AD  - QST Hospital, National Institutes for Quantum Science and Technology, 4-9-1 
      Anagawa, Inage-ku, Chiba 263-8555, Japan.
FAU - Murata, Kazutoshi
AU  - Murata K
AUID- ORCID: 0000-0003-1836-6353
AD  - QST Hospital, National Institutes for Quantum Science and Technology, 4-9-1 
      Anagawa, Inage-ku, Chiba 263-8555, Japan.
FAU - Yamada, Shigeru
AU  - Yamada S
AUID- ORCID: 0000-0002-4271-0209
AD  - QST Hospital, National Institutes for Quantum Science and Technology, 4-9-1 
      Anagawa, Inage-ku, Chiba 263-8555, Japan.
FAU - Habu, Yuji
AU  - Habu Y
AUID- ORCID: 0000-0003-4987-8781
AD  - Department of Reproductive Medicine, Chiba University Graduate School of 
      Medicine, 1-8-1 Inohana, Chuo-ku, Chiba 260-8670, Japan.
FAU - Hori, Makoto
AU  - Hori M
AD  - Clinical Research Center, Chiba University Hospital, 1-8-1 Inohana, Chuo-ku, 
      Chiba 260-8677, Japan.
FAU - Kurokawa, Tomoya
AU  - Kurokawa T
AD  - Clinical Research Center, Chiba University Hospital, 1-8-1 Inohana, Chuo-ku, 
      Chiba 260-8677, Japan.
FAU - Inaba, Yosuke
AU  - Inaba Y
AUID- ORCID: 0000-0002-8659-2873
AD  - Clinical Research Center, Chiba University Hospital, 1-8-1 Inohana, Chuo-ku, 
      Chiba 260-8677, Japan.
FAU - Fujiwara, Tadami
AU  - Fujiwara T
AD  - Clinical Research Center, Chiba University Hospital, 1-8-1 Inohana, Chuo-ku, 
      Chiba 260-8677, Japan.
FAU - Fujii, Yasuhisa
AU  - Fujii Y
AD  - Clinical Research Center, Chiba University Hospital, 1-8-1 Inohana, Chuo-ku, 
      Chiba 260-8677, Japan.
FAU - Hanawa, Michiko
AU  - Hanawa M
AD  - Clinical Research Center, Chiba University Hospital, 1-8-1 Inohana, Chuo-ku, 
      Chiba 260-8677, Japan.
FAU - Kawasaki, Yohei
AU  - Kawasaki Y
AUID- ORCID: 0000-0002-7474-7647
AD  - Faculty of Nursing, Japanese Red Cross College of Nursing, 4-1-3 Hiroo, 
      Shibuya-Ku, Tokyo 150-0012, Japan.
FAU - Hattori, Yoko
AU  - Hattori Y
AD  - Clinical Research Center, Chiba University Hospital, 1-8-1 Inohana, Chuo-ku, 
      Chiba 260-8677, Japan.
FAU - Suzuki, Kazuko
AU  - Suzuki K
AD  - QST Hospital, National Institutes for Quantum Science and Technology, 4-9-1 
      Anagawa, Inage-ku, Chiba 263-8555, Japan.
FAU - Tsuyuki, Kyoko
AU  - Tsuyuki K
AD  - QST Hospital, National Institutes for Quantum Science and Technology, 4-9-1 
      Anagawa, Inage-ku, Chiba 263-8555, Japan.
FAU - Wakatsuki, Masaru
AU  - Wakatsuki M
AD  - QST Hospital, National Institutes for Quantum Science and Technology, 4-9-1 
      Anagawa, Inage-ku, Chiba 263-8555, Japan.
FAU - Koto, Masashi
AU  - Koto M
AD  - QST Hospital, National Institutes for Quantum Science and Technology, 4-9-1 
      Anagawa, Inage-ku, Chiba 263-8555, Japan.
FAU - Hasegawa, Sumitaka
AU  - Hasegawa S
AD  - Department of Charged Particle Therapy Research, National Institutes for Quantum 
      Science and Technology, 4-9-1 Anagawa, Inage-ku, Chiba 263-8555, Japan.
FAU - Ishikawa, Hitoshi
AU  - Ishikawa H
AUID- ORCID: 0000-0002-0046-9787
AD  - QST Hospital, National Institutes for Quantum Science and Technology, 4-9-1 
      Anagawa, Inage-ku, Chiba 263-8555, Japan.
FAU - Hanaoka, Hideki
AU  - Hanaoka H
AD  - Clinical Research Center, Chiba University Hospital, 1-8-1 Inohana, Chuo-ku, 
      Chiba 260-8677, Japan.
FAU - Shozu, Makio
AU  - Shozu M
AD  - Department of Reproductive Medicine, Chiba University Graduate School of 
      Medicine, 1-8-1 Inohana, Chuo-ku, Chiba 260-8670, Japan.
FAU - Tsuji, Hiroshi
AU  - Tsuji H
AD  - QST Hospital, National Institutes for Quantum Science and Technology, 4-9-1 
      Anagawa, Inage-ku, Chiba 263-8555, Japan.
FAU - Usui, Hirokazu
AU  - Usui H
AUID- ORCID: 0000-0002-4331-6043
AD  - Department of Reproductive Medicine, Chiba University Graduate School of 
      Medicine, 1-8-1 Inohana, Chuo-ku, Chiba 260-8670, Japan.
LA  - eng
GR  - ESR-19-20362/AstraZeneca (Japan)/
PT  - Clinical Trial, Phase I
PT  - Journal Article
DEP - 20230623
PL  - Switzerland
TA  - Int J Mol Sci
JT  - International journal of molecular sciences
JID - 101092791
RN  - Q20Q21Q62J (Cisplatin)
RN  - 28X28X9OKV (durvalumab)
RN  - 0 (Antibodies, Monoclonal)
SB  - IM
MH  - Female
MH  - Humans
MH  - *Cisplatin/adverse effects
MH  - *Uterine Cervical Neoplasms/drug therapy/pathology
MH  - Antibodies, Monoclonal/adverse effects
MH  - Treatment Outcome
MH  - Antineoplastic Combined Chemotherapy Protocols/adverse effects
MH  - Chemoradiotherapy/adverse effects/methods
PMC - PMC10342070
OTO - NOTNLM
OT  - anti-PD-L1 antibody
OT  - carbon-ion radiotherapy
OT  - cisplatin
OT  - clinical trial
OT  - concurrent chemoradiotherapy
OT  - durvalumab
OT  - heavy ion radiotherapy
OT  - radiotherapy
OT  - uterine cervical neoplasms
COIS- The authors declare they have no other competing interests.
EDAT- 2023/07/14 13:07
MHDA- 2023/07/17 06:42
PMCR- 2023/06/23
CRDT- 2023/07/14 01:13
PHST- 2023/05/28 00:00 [received]
PHST- 2023/06/14 00:00 [revised]
PHST- 2023/06/16 00:00 [accepted]
PHST- 2023/07/17 06:42 [medline]
PHST- 2023/07/14 13:07 [pubmed]
PHST- 2023/07/14 01:13 [entrez]
PHST- 2023/06/23 00:00 [pmc-release]
AID - ijms241310565 [pii]
AID - ijms-24-10565 [pii]
AID - 10.3390/ijms241310565 [doi]
PST - epublish
SO  - Int J Mol Sci. 2023 Jun 23;24(13):10565. doi: 10.3390/ijms241310565.