PMID- 33065643
OWN - NLM
STAT- MEDLINE
DCOM- 20211210
LR  - 20211214
IS  - 1528-1140 (Electronic)
IS  - 0003-4932 (Linking)
VI  - 274
IP  - 6
DP  - 2021 Dec 1
TI  - Multicenter Randomized Phase 2 Trial Comparing Chemoradiotherapy and Docetaxel 
      Plus 5-Fluorouracil and Cisplatin Chemotherapy as Initial Induction Therapy for 
      Subsequent Conversion Surgery in Patients With Clinical T4b Esophageal Cancer: 
      Short-term Results.
PG  - e465-e472
LID - 10.1097/SLA.0000000000004564 [doi]
AB  - OBJECTIVE: We conducted a multicenter randomized prospective phase 2 trial of 
      chemoradiotherapy (CRT) versus chemotherapy (CT) as initial induction therapy for 
      conversion surgery (CS) in clinical T4b esophageal cancer. We compared treatment 
      effects and adverse events (AEs). SUMMARY BACKGROUND DATA: Although induction 
      followed by CS is potentially curative for T4b esophageal cancer, the optimal 
      initial induction treatment is unclear. METHODS: Ninety-nine patients with T4b 
      esophageal cancer were randomly allocated to chemoradiotherapy (Group A, n = 49) 
      or CT (Group B, n = 50) as initial induction treatment. CRT consisted of 
      radiation (50.4 Gy) with cisplatin and 5-fluorouracil. CT consisted of 2 cycles 
      of docetaxel plus cisplatin and 5-fluorouracil (DCF). CRT or CT was followed by 
      CS if resectable. If unresectable, the patient received the other treatment as 
      secondary treatment. CS was performed if resectable after secondary treatment. 
      The primary end point was 2-year overall survival. RESULTS: In Group A, CS was 
      performed in 34 (69%) and 7 patients (14%) after initial and secondary treatment. 
      In Group B, CS was performed in 25 (50%) and 17 patients (34%) after initial and 
      secondary treatment. The R0 resection rate after initial and secondary treatment 
      was similar (78% vs 76%, P = 1.000). AEs including leukopenia, neutropenia, 
      febrile neutropenia, and diarrhea were significantly more frequent in Group B. 
      Group A had better histological complete response of the primary tumor (40% vs 
      17%, P = 0.028) and histological nodal status (P = 0.038). CONCLUSION: Upfront 
      CRT was superior to upfront CT in terms of pathological effects and AEs. The 
      Japan Registry of Clinical Trials (s051180164).
CI  - Copyright (c) 2020 Wolters Kluwer Health, Inc. All rights reserved.
FAU - Sugimura, Keijiro
AU  - Sugimura K
AD  - Department of Surgery, Osaka International Cancer Institute, Osaka, Japan.
FAU - Miyata, Hiroshi
AU  - Miyata H
AD  - Department of Surgery, Osaka International Cancer Institute, Osaka, Japan.
FAU - Tanaka, Koji
AU  - Tanaka K
AD  - Departments of Gastroenterological Surgery, Graduate School of Medicine, Osaka 
      University, Suita, Osaka, Japan.
FAU - Makino, Tomoki
AU  - Makino T
AD  - Departments of Gastroenterological Surgery, Graduate School of Medicine, Osaka 
      University, Suita, Osaka, Japan.
FAU - Takeno, Atsushi
AU  - Takeno A
AD  - Department of Surgery, Kansai Rosai Hospital, Hyogo, Japan.
FAU - Shiraishi, Osamu
AU  - Shiraishi O
AD  - Department of Surgery, Kindai University Faculty of Medicine, Osaka Sayama, 
      Osaka, Japan.
FAU - Motoori, Masaaki
AU  - Motoori M
AD  - Department of Surgery, Osaka General Medical Center, Osaka, Japan.
FAU - Yamasaki, Makoto
AU  - Yamasaki M
AD  - Departments of Gastroenterological Surgery, Graduate School of Medicine, Osaka 
      University, Suita, Osaka, Japan.
FAU - Kimura, Yutaka
AU  - Kimura Y
AD  - Department of Surgery, Kindai University Faculty of Medicine, Osaka Sayama, 
      Osaka, Japan.
FAU - Hirao, Motohiro
AU  - Hirao M
AD  - Department of Surgery, National Hospital Organization, Osaka National Hospital, 
      Osaka, Japan.
FAU - Fujitani, Kazumasa
AU  - Fujitani K
AD  - Department of Surgery, Osaka General Medical Center, Osaka, Japan.
FAU - Yasuda, Takushi
AU  - Yasuda T
AD  - Department of Surgery, Kindai University Faculty of Medicine, Osaka Sayama, 
      Osaka, Japan.
FAU - Mori, Masaki
AU  - Mori M
AD  - Department of Surgery and Science, Graduate School of Medical Sciences, Kyusyu 
      University, Japan.
FAU - Eguchi, Hidetoshi
AU  - Eguchi H
AD  - Departments of Gastroenterological Surgery, Graduate School of Medicine, Osaka 
      University, Suita, Osaka, Japan.
FAU - Yano, Masahiko
AU  - Yano M
AD  - Department of Surgery, Osaka International Cancer Institute, Osaka, Japan.
FAU - Doki, Yuichiro
AU  - Doki Y
AD  - Departments of Gastroenterological Surgery, Graduate School of Medicine, Osaka 
      University, Suita, Osaka, Japan.
LA  - eng
PT  - Clinical Trial, Phase II
PT  - Journal Article
PT  - Multicenter Study
PT  - Randomized Controlled Trial
PT  - Research Support, Non-U.S. Gov't
PL  - United States
TA  - Ann Surg
JT  - Annals of surgery
JID - 0372354
RN  - 15H5577CQD (Docetaxel)
RN  - Q20Q21Q62J (Cisplatin)
RN  - U3P01618RT (Fluorouracil)
SB  - IM
MH  - Adult
MH  - Aged
MH  - Antineoplastic Combined Chemotherapy Protocols/adverse effects/*therapeutic use
MH  - *Chemoradiotherapy/adverse effects
MH  - Cisplatin/adverse effects/*therapeutic use
MH  - Docetaxel/adverse effects/*therapeutic use
MH  - Esophageal Squamous Cell Carcinoma/pathology/surgery/*therapy
MH  - Esophagectomy/adverse effects
MH  - Female
MH  - Fluorouracil/adverse effects/*therapeutic use
MH  - Humans
MH  - *Induction Chemotherapy/adverse effects
MH  - Lymph Node Excision/adverse effects
MH  - Male
MH  - Middle Aged
MH  - Neoplasm Staging
MH  - Postoperative Complications
MH  - Prospective Studies
COIS- The authors report no conflicts of interest.
EDAT- 2020/10/17 06:00
MHDA- 2021/12/15 06:00
CRDT- 2020/10/16 20:19
PHST- 2020/10/17 06:00 [pubmed]
PHST- 2021/12/15 06:00 [medline]
PHST- 2020/10/16 20:19 [entrez]
AID - 00000658-202112000-00034 [pii]
AID - 10.1097/SLA.0000000000004564 [doi]
PST - ppublish
SO  - Ann Surg. 2021 Dec 1;274(6):e465-e472. doi: 10.1097/SLA.0000000000004564.