PMID- 36729915
OWN - NLM
STAT- MEDLINE
DCOM- 20230727
LR  - 20230807
IS  - 1473-5741 (Electronic)
IS  - 0959-4973 (Linking)
VI  - 34
IP  - 7
DP  - 2023 Aug 1
TI  - Phase II study of gemcitabine, cisplatin, and bevacizumab for first recurrent and 
      refractory ovarian clear cell carcinoma Kansai Clinical Oncology Group-G1601.
PG  - 857-865
LID - 10.1097/CAD.0000000000001472 [doi]
AB  - Patients with advanced ovarian clear cell carcinoma (CCC) have a poor prognosis 
      in the absence of an effective standard treatment. Combination therapy with 
      gemcitabine, cisplatin, and bevacizumab (GPBev) is promising for ovarian CCC. 
      Thus, we conducted a multi-institutional, phase II trial in Japan to examine the 
      efficacy and safety of GPBev for CCC. This is the first study on the use of GPBev 
      for CCC. Eighteen patients (median age, 56.5 years) with pathologically confirmed 
      first recurrent or refractory CCC and having evaluable regions, as assessed using 
      RECIST, were recruited between January 2017 and May 2019. Gemcitabine (1000 mg/m 
      2 ), cisplatin (40 mg/m 2 ), and bevacizumab (10 mg/kg) were administered 
      intravenously on days 1 and 15, every 28 days, for 6-10 cycles, until disease 
      progression or intolerable toxicity. The primary endpoint was overall response 
      rate (ORR). The secondary endpoints included disease control rate (DCR) and 
      adverse events (AEs). Fifteen patients (83.3%) completed 6-10 cycles of 
      treatment; three patients (two with AEs and one with progressive disease) did 
      not. The ORR was 61.1% [complete response (CR) 3 and partial response (PR) 8] and 
      DCR was 88.9% (CR 3, PR 8, and stable disease 5). Grade 3 and 4 hematological AEs 
      were observed in 16.7 and 5.6% of the patients, respectively. Nonhematological 
      AEs of grades 3 and 4 were observed in 27.8 and 5.6% of the patients, 
      respectively. GPBev is a promising therapy for CCC owing to the high ORR and 
      acceptable toxicity for the first recurrence and refractory CCC.
CI  - Copyright (c) 2022 Wolters Kluwer Health, Inc. All rights reserved.
FAU - Ito, Kimihiko
AU  - Ito K
AD  - Department of Obstetrics and Gynecology, Kansai Rosai Hospital, Amagasaki.
FAU - Nakagawa, Mio
AU  - Nakagawa M
AD  - Department of Obstetrics and Gynecology, Kansai Rosai Hospital, Amagasaki.
FAU - Shimokawa, Mototsugu
AU  - Shimokawa M
AD  - Department of Biostatistics, Yamaguchi University Graduate School of Medicine, 
      Yamaguchi.
FAU - Hori, Kensuke
AU  - Hori K
AD  - Department of Obstetrics and Gynecology, Kansai Rosai Hospital, Amagasaki.
FAU - Tashima, Lena
AU  - Tashima L
AD  - Department of Obstetrics and Gynecology, Kansai Rosai Hospital, Amagasaki.
FAU - Goto, Mayako
AU  - Goto M
AD  - Department of Obstetrics and Gynecology, Kansai Rosai Hospital, Amagasaki.
FAU - Yanagida, Satoshi
AU  - Yanagida S
AD  - Department of Obstetrics and Gynecology, The Jikei University School of Medicine, 
      Minato-ku.
FAU - Suzuki, Jiro
AU  - Suzuki J
AD  - Department of Obstetrics and Gynecology, The Jikei University School of Medicine, 
      Minato-ku.
FAU - Kaya, Ryusuke
AU  - Kaya R
AD  - Department of Obstetrics and Gynecology, The Jikei University School of Medicine, 
      Minato-ku.
FAU - Kawabata, Ayako
AU  - Kawabata A
AD  - Department of Obstetrics and Gynecology, The Jikei University School of Medicine, 
      Minato-ku.
FAU - Yamada, Kyosuke
AU  - Yamada K
AD  - Department of Obstetrics and Gynecology, The Jikei University School of Medicine, 
      Minato-ku.
FAU - Park, Jongmyung
AU  - Park J
AD  - Department of Obstetrics and Gynecology, Kurume University School of Medicine, 
      Fukuoka.
FAU - Nasu, Hiroki
AU  - Nasu H
AD  - Department of Obstetrics and Gynecology, Kurume University School of Medicine, 
      Fukuoka.
FAU - Nishio, Shin
AU  - Nishio S
AD  - Department of Obstetrics and Gynecology, Kurume University School of Medicine, 
      Fukuoka.
FAU - Kondo, Eiji
AU  - Kondo E
AD  - Department of Obstetrics and Gynecology, Mie University, Graduate School of 
      Medicine, Tsu.
FAU - Kaneda, Michiko
AU  - Kaneda M
AD  - Department of Obstetrics and Gynecology, Mie University, Graduate School of 
      Medicine, Tsu.
FAU - Tsubamoto, Hiroshi
AU  - Tsubamoto H
AD  - Department of Obstetrics and Gynecology, Hyogo College of Medicine, Nishinomiya.
FAU - Arakawa, Atsushi
AU  - Arakawa A
AD  - Department of Obstetrics and Gynecology, Nagoya City University West Medical 
      Center, Nagoya.
FAU - Nagasawa, Takayuki
AU  - Nagasawa T
AD  - Department of Obstetrics and Gynecology, Iwate Medical University, Shiwa-gun.
FAU - Motohashi, Takashi
AU  - Motohashi T
AD  - Department of Obstetrics and Gynecology, Tokyo Women's Medical University 
      Hospital, Shinjyuku-ku, Japan.
LA  - eng
PT  - Clinical Trial, Phase II
PT  - Journal Article
PT  - Multicenter Study
PT  - Research Support, Non-U.S. Gov't
DEP - 20221205
PL  - England
TA  - Anticancer Drugs
JT  - Anti-cancer drugs
JID - 9100823
RN  - 2S9ZZM9Q9V (Bevacizumab)
RN  - Q20Q21Q62J (Cisplatin)
RN  - 0W860991D6 (Deoxycytidine)
RN  - 0 (Gemcitabine)
SB  - IM
MH  - Female
MH  - Humans
MH  - Middle Aged
MH  - Antineoplastic Combined Chemotherapy Protocols/adverse effects
MH  - Bevacizumab
MH  - *Carcinoma
MH  - Carcinoma, Ovarian Epithelial/drug therapy
MH  - Cisplatin
MH  - Deoxycytidine
MH  - Gemcitabine
MH  - *Ovarian Neoplasms/drug therapy
EDAT- 2023/02/03 06:00
MHDA- 2023/07/27 06:43
CRDT- 2023/02/02 12:54
PHST- 2023/07/27 06:43 [medline]
PHST- 2023/02/03 06:00 [pubmed]
PHST- 2023/02/02 12:54 [entrez]
AID - 00001813-990000000-00138 [pii]
AID - 10.1097/CAD.0000000000001472 [doi]
PST - ppublish
SO  - Anticancer Drugs. 2023 Aug 1;34(7):857-865. doi: 10.1097/CAD.0000000000001472. 
      Epub 2022 Dec 5.