Surgery plus chemotherapy compared with surgery alone for localized squamous cell carcinoma of the thoracic esophagus: a Japan Clinical Oncology Group Study--JCOG9204.
OBJECTIVE
We performed a multicenter randomized controlled trial to determine whether postoperative adjuvant chemotherapy improves outcome in patients with esophageal squamous cell carcinoma undergoing radical surgery.


METHODS
Patients undergoing transthoracic esophagectomy with lymphadenectomy between July 1992 and January 1997 at 17 institutions were randomly assigned to receive surgery alone or surgery plus chemotherapy including two courses of cisplatin (80 mg/m2 of body-surface area x 1 day) and fluorouracil (800 mg/m2 x 5 days) within 2 months after surgery. Adaptive stratification factors were institution and lymph node status (pN0 versus pN1). The primary end point was disease-free survival.


RESULTS
Of the 242 patients, 122 were assigned to surgery alone, and 120 to surgery plus chemotherapy. In the surgery plus chemotherapy group, 91 patients (75%) received both full courses of chemotherapy; grade 3 or 4 hematologic or nonhematologic toxicities were limited. The 5-year disease-free survival rate was 45% with surgery alone, and 55% with surgery plus chemotherapy (one-sided log-rank, P =.037). The 5-year overall survival rate was 52% and 61%, respectively (P =.13). Risk reduction by postoperative chemotherapy was remarkable in the subgroup with lymph node metastasis.


CONCLUSIONS
Postoperative adjuvant chemotherapy with cisplatin and fluorouracil is better able to prevent relapse in patients with esophageal cancer than surgery alone.
Ando
Nobutoshi
N
Departmentof Surgery, Keio University School of Medicine, Japan. nando@tdc.ac.jp
Iizuka
Toshifumi
T
Ide
Hiroko
H
Ishida
Kaoru
K
Shinoda
Masayuki
M
Nishimaki
Tadashi
T
Takiyama
Wataru
W
Watanabe
Hiroshi
H
Isono
Kaichi
K
Aoyama
Norio
N
Makuuchi
Hiroyasu
H
Tanaka
Otsuo
O
Yamana
Hideaki
H
Ikeuchi
Shunji
S
Kabuto
Toshiyuki
T
Nagai
Kagami
K
Shimada
Yutaka
Y
Kinjo
Yoshihide
Y
Fukuda
Haruhiko
H
D000328:Adult; D000368:Aged; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000627:therapeutic use*; D002294:Carcinoma, Squamous Cell / Q000188:drug therapy* / Q000601:surgery*; D017024:Chemotherapy, Adjuvant; D002945:Cisplatin / Q000008:administration & dosage; D003131:Combined Modality Therapy; D018572:Disease-Free Survival; D004938:Esophageal Neoplasms / Q000188:drug therapy* / Q000601:surgery*; D016629:Esophagectomy; D005260:Female; D005472:Fluorouracil / Q000008:administration & dosage; D006801:Humans; D008197:Lymph Node Excision; D008297:Male; D008875:Middle Aged; D011446:Prospective Studies
D002945:Cisplatin; D005472:Fluorouracil