PMID- 32893992
OWN - NLM
STAT- MEDLINE
DCOM- 20210628
LR  - 20210703
IS  - 1743-7563 (Electronic)
IS  - 1743-7555 (Print)
IS  - 1743-7555 (Linking)
VI  - 17
IP  - 3
DP  - 2021 Jun
TI  - Bevacizumab plus cisplatin/pemetrexed then bevacizumab alone for unresectable 
      malignant pleural mesothelioma: A Japanese safety study.
PG  - 264-272
LID - 10.1111/ajco.13455 [doi]
AB  - AIMS: Malignant pleural mesothelioma (MPM) is an aggressive malignancy with poor 
      prognosis and limited treatment options. Cisplatin plus pemetrexed is the only 
      approved first-line treatment for patients with unresectable MPM. Recently, 
      promising outcomes were observed with first-line bevacizumab combined with 
      cisplatin/pemetrexed, leading to the recommendation of this regimen as a 
      first-line treatment option for patients with MPM. Bevacizumab plus 
      cisplatin/pemetrexed has been shown to be safe and effective in non-small cell 
      lung cancer, however, there are no efficacy or safety data in Japanese patients 
      with MPM treated with this regimen. We conducted a multicenter study to evaluate 
      tolerability and safety for Japanese patients with chemotherapy-naive, 
      unresectable MPM. METHODS: Eligible patients (n = 7) received bevacizumab plus 
      cisplatin/pemetrexed (up to six cycles), then single-agent bevacizumab until 
      disease progression or onset of unacceptable adverse events (AEs), according to 
      the 3+3 design analogy. RESULTS: One patient (14.3%) reported an AE (gastric 
      ulcer) meeting tolerability criteria. All patients experienced gastrointestinal 
      disorders, including nausea (grade 1/2 only, n = 6, 85.7%) and constipation 
      (grade 1/2 only, n = 5, 71.4%). Five patients (71.4%) had grade 3 hypertension. 
      Two patients discontinued treatment due to gastric ulcer (n = 1) and proteinuria 
      (n = 1). At data cut-off, four patients had stable disease, two had partial 
      response and one had non-complete response/non-progressive disease due to the 
      absence of target lesions. CONCLUSIONS: Bevacizumab plus cisplatin/pemetrexed 
      then bevacizumab was well tolerated in Japanese patients with MPM.
CI  - (c) 2020 The Authors. Asia-Pacific Journal of Clinical Oncology published by John 
      Wiley & Sons Australia, Ltd.
FAU - Nakano, Takashi
AU  - Nakano T
AUID- ORCID: 0000-0002-0135-1051
AD  - Center for Respiratory Medicine, Otemae Hospital, Osaka, Japan.
AD  - Division of Respiratory Medicine, Department of Internal Medicine, Hyogo College 
      of Medicine, Nishinomiya, Japan.
FAU - Kuribayashi, Kozo
AU  - Kuribayashi K
AD  - Division of Respiratory Medicine, Department of Internal Medicine, Hyogo College 
      of Medicine, Nishinomiya, Japan.
FAU - Kondo, Masashi
AU  - Kondo M
AD  - Department of Respiratory Medicine, Nagoya University Graduate School of 
      Medicine, Nagoya, Japan.
FAU - Morise, Masahiro
AU  - Morise M
AD  - Department of Respiratory Medicine, Nagoya University Graduate School of 
      Medicine, Nagoya, Japan.
FAU - Tada, Yuji
AU  - Tada Y
AD  - Department of Respirology, Chiba University, Chiba, Japan.
FAU - Hirano, Katsuya
AU  - Hirano K
AD  - Department of Respiratory Medicine, Hyogo Prefectural Amagasaki General Medical 
      Center, Amagasaki, Japan.
FAU - Hayashi, Morihiko
AU  - Hayashi M
AD  - Chugai Pharmaceutical Co., Ltd., Tokyo, Japan.
FAU - Tanaka, Misa
AU  - Tanaka M
AD  - Chugai Pharmaceutical Co., Ltd., Tokyo, Japan.
FAU - Hirabayashi, Masataka
AU  - Hirabayashi M
AD  - Department of Respiratory Medicine, Hyogo Prefectural Amagasaki General Medical 
      Center, Amagasaki, Japan.
LA  - eng
GR  - Chugai Pharmaceutical Co., Ltd./
PT  - Clinical Trial, Phase II
PT  - Journal Article
PT  - Multicenter Study
DEP - 20200907
PL  - Australia
TA  - Asia Pac J Clin Oncol
JT  - Asia-Pacific journal of clinical oncology
JID - 101241430
RN  - 04Q9AIZ7NO (Pemetrexed)
RN  - 2S9ZZM9Q9V (Bevacizumab)
RN  - Q20Q21Q62J (Cisplatin)
SB  - IM
MH  - Aged
MH  - Antineoplastic Combined Chemotherapy Protocols/*therapeutic use
MH  - Bevacizumab/administration & dosage
MH  - Cisplatin/administration & dosage
MH  - Female
MH  - Humans
MH  - Japan
MH  - Male
MH  - Mesothelioma, Malignant/*drug therapy/pathology
MH  - Middle Aged
MH  - Pemetrexed/administration & dosage
MH  - Pleural Neoplasms/*drug therapy/pathology
MH  - Prognosis
PMC - PMC8246920
OTO - NOTNLM
OT  - bevacizumab
OT  - cisplatin
OT  - malignant pleural mesothelioma
OT  - pemetrexed
OT  - safety
COIS- Takashi Nakano has received honoraria from MSD, Olympus Corporation, ISHIHARA 
      Sangyo, KYORIN Pharmaceutical, Nippon Boehringer Ingelheim and ONO 
      Pharmaceutical; acted in a consulting or advisory role for Nippon Boehringer 
      Ingelheim; and reports personal fees from Cancer and Chemotherapy Publishers, 
      Ishiyaku Publishers, IGAKU-SHOIN, Elsevier Japan K.K., Asakura Publishing, 
      Ministry of the Environment Japan and Amagasaki City, outside the submitted work. 
      Kozo Kuribayashi has received honoraria from AstraZeneca, Astellas Pharma, 
      Boehringer Ingelheim, Chugai Pharmaceutical, Kyowa Hakko Kirin, KYORIN 
      Pharmaceutical, Meiji-Seika-Pharma, Novartis, Ono Pharmaceutical and Taiho 
      Pharmaceutical. Masashi Kondo has received honoraria from Eli Lilly, MSD, Chugai 
      Pharmaceutical, Pfizer, Novartis, AstraZeneca, Nippon Boehringer Ingelheim, Taiho 
      Pharmaceutical and Kyowa Hakko Kirin. Masahiro Morise has received honoraria from 
      Chugai Pharmaceutical, Eli Lilly Japan K.K., Ono Pharmaceutical, Bristol-Myers 
      Squibb, Pfizer, AstraZeneca, Boehringer Ingelheim, Merck Serono and Novartis. 
      Yuji Tada has received honoraria from Chugai Pharmaceutical. Katsuya Hirano 
      reports personal fees from AstraZeneca K.K., Chugai Pharmaceutical, Eli Lilly, 
      Nippon Boehringer Ingelheim, Ono Pharmaceutical, Pfizer, Taiho Pharmaceutical and 
      Novartis, outside the submitted work. Morihiko Hayashi and Misa Tanaka are 
      employees of Chugai Pharmaceutical, and Misa Tanaka owns stock in Chugai 
      Pharmaceutical. Masataka Hirabayashi has received honoraria from AstraZeneca 
      K.K., Ono Pharmaceutical, KYORIN Pharmaceutical, Taiho Pharmaceutical, MSD, 
      Chugai Pharmaceutical, Pfizer, Boehringer Ingelheim and Eli Lilly.
EDAT- 2020/09/08 06:00
MHDA- 2021/06/29 06:00
PMCR- 2021/07/01
CRDT- 2020/09/07 08:41
PHST- 2019/09/02 00:00 [received]
PHST- 2020/08/10 00:00 [accepted]
PHST- 2020/09/08 06:00 [pubmed]
PHST- 2021/06/29 06:00 [medline]
PHST- 2020/09/07 08:41 [entrez]
PHST- 2021/07/01 00:00 [pmc-release]
AID - AJCO13455 [pii]
AID - 10.1111/ajco.13455 [doi]
PST - ppublish
SO  - Asia Pac J Clin Oncol. 2021 Jun;17(3):264-272. doi: 10.1111/ajco.13455. Epub 2020 
      Sep 7.