Phase II trial of neoadjuvant cisplatin, 5-fluorouracil and interferon-alpha in operable squamous cell carcinoma of the esophagus.
BACKGROUND
The combination of 5-fluorouracil (5-FU), cisplatin and interferon (IFN)-alpha was found to result in a high response rate in advanced esophageal squamous cell carcinoma (SCC).


METHODS
Resectable cases of esophageal SCC were treated with 3 cycles of chemotherapy consisting of cisplatin 70 mg/m(2) i.v. on day 1, 5-FU 500 mg/m(2)/day i.v. as a continuous infusion on days 1-5 and IFN-alpha 4 million units/m(2)/day s.c. on days 1-5. Cycles were repeated every 21 days. Esophagectomy was performed 3-5 weeks after the 3rd cycle of chemotherapy.


RESULTS
Thirty patients were enrolled in the trial. Toxic death was observed in 1 patient because of esophageal perforation. Pathologically, complete response was observed in 4 of 23 patients who had esophagectomy. At a median follow-up period of 21.4 months, median progression-free survival was 11.5 months and median overall survival was 26.3 months.


CONCLUSIONS
This regimen has substantial activity in localized SCC of the esophagus with encouraging survival duration.
Bazarbashi
Shouki
S
King Faisal Cancer Center, Riyadh, Saudi Arabia.
Abdelsalam
Mahmoud
M
Amin
Tarek
T
El-Bassiouni
Mazen
M
Soudy
Hussein
H
Elweshi
Amr
A
Alhusseiny
Hamed
H
Rehman
Khaled
K
Memon
Muhammed
M
Ajarim
Dahish
D
D000328:Adult; D000368:Aged; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000009:adverse effects / Q000627:therapeutic use*; D002294:Carcinoma, Squamous Cell / Q000188:drug therapy* / Q000473:pathology / Q000601:surgery; D002945:Cisplatin / Q000009:adverse effects / Q000627:therapeutic use*; D004305:Dose-Response Relationship, Drug; D004938:Esophageal Neoplasms / Q000188:drug therapy* / Q000473:pathology / Q000601:surgery; D016629:Esophagectomy; D005260:Female; D005472:Fluorouracil / Q000009:adverse effects / Q000627:therapeutic use*; D006801:Humans; D016898:Interferon-alpha / Q000009:adverse effects / Q000627:therapeutic use*; D008297:Male; D008875:Middle Aged; D020360:Neoadjuvant Therapy / Q000009:adverse effects; D009362:Neoplasm Metastasis / Q000188:drug therapy / Q000473:pathology; D012008:Recurrence; D015996:Survival Rate
D016898:Interferon-alpha; D002945:Cisplatin; D005472:Fluorouracil