Surgery plus chemotherapy compared with surgery alone for localized squamous cell carcinoma of the thoracic esophagus: a Japan Clinical Oncology Group Study--JCOG9204.

Abstract

PURPOSE:

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.

PATIENTS AND 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.

CONCLUSION:

Postoperative adjuvant chemotherapy with cisplatin and fluorouracil is better able to prevent relapse in patients with esophageal cancer than surgery alone.

• Authors: Nobutoshi Ando, Toshifumi Iizuka, Hiroko Ide, Kaoru Ishida, Masayuki Shinoda, Tadashi Nishimaki, Wataru Takiyama, Hiroshi Watanabe, Kaichi Isono, Norio Aoyama, Hiroyasu Makuuchi, Otsuo Tanaka, Hideaki Yamana, Shunji Ikeuchi, Toshiyuki Kabuto, Kagami Nagai, Yutaka Shimada, Yoshihide Kinjo, Haruhiko Fukuda, Japan Clinical Oncology Group
• Journal: Journal of clinical oncology : official journal of the American Society of Clinical Oncology (J Clin Oncol) Vol. 21 Issue 24 Pg. 4592-6 (Dec 15 2003) ISSN: 0732-183X [Print] United States
• PMID: 14673047 (Publication Type: Clinical Trial, Comparative Study, Journal Article, Multicenter Study, Randomized Controlled Trial, Research Support, Non-U.S. Gov't)

Chemical References

• Cisplatin
• Fluorouracil

Topics

• Adult
• Aged
• Antineoplastic Combined Chemotherapy Protocols (therapeutic use)
• Carcinoma, Squamous Cell (drug therapy, surgery)
• Chemotherapy, Adjuvant
• Cisplatin (administration & dosage)
• Combined Modality Therapy
• Disease-Free Survival
• Esophageal Neoplasms (drug therapy, surgery)
• Esophagectomy
• Female
• Fluorouracil (administration & dosage)
• Humans
• Lymph Node Excision
• Male
• Middle Aged
• Prospective Studies