[Phase II clinical trial of concurrent chemoradiotherapy (cisplatin plus 5-fluorouracil) for esophageal cancer].
OBJECTIVE
Concurrent chemoradiotherapy is a standard treatment for local advanced esophageal cancer in overseas countries; however, the treatment outcomes are various in China. This study was to evaluate the efficacy of concurrent chemoradiotherapy with cisplatin plus 5-fluorouracil (PF) regimen on esophageal cancer, and observe the adverse events.


METHODS
Forty-four patients with esophageal squamous cell carcinoma (ESCC) were randomized into two groups. Twenty-two patients in concurrent chemoradiotherapy (CRT) group received conventional fractionated radiotherapy of 50 Gy during 5 weeks, with 5 daily fractions of 2.0 Gy per week. Chemotherapy was started on the first day of irradiation: cisplatin 52.5 mg/m2 at Day 1, 5-fluorouracil 700 mg/m2 at Days 1-5, repeated 4 times every 28 days. Twenty-two patients in late course accelerated hyperfractionated radiotherapy (LCAF) group received conventional fractionated radiotherapy of 30 Gy during 3 weeks (the same scheme as that of CRT group),followed by accelerated hyperfractionated radiotherapy of 30 Gy during 2 weeks: twice a day, 1.5 Gy per fraction, with a minimal interval of 6 h between fractions,10 fractions per week.


RESULTS
The response rate was 95.5% in CRT group and 86.4% in LCAF group (P = 0.607). The 2-year local control rate and 2-year survival rate were 72.2% and 56.7% in CRT group, and 39.0% and 31.6% in LCAF group. Compared with LCAF group, CRT group obtained higher local control rate and survival rate, but only the difference of local control rate was significant (P = 0.014). Major acute adverse events in the two groups were radiation-induced esophagitis and radiation-induced pneumonia, while late adverse events were late injury in the esophagus and lung. Both acute and late adverse events in the two groups were mild.


CONCLUSIONS
Compared with LACF,CRT can significantly improve local control rate of ESCC, and may enhance survival rate. The adverse events are tolerable.
Lin
Qiang
Q
Department of Radiation Oncology, The Fourth Affiliated Hospital, Hebei Medical University, Shijiazhuang, Hebei, 050011, P. R. China.
Gao
Xian-Shu
XS
Qiao
Xue-Ying
XY
Chen
Kun
K
Wang
Ya-Di
YD
Zhou
Zhi-Guo
ZG
D000328:Adult; D000368:Aged; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000627:therapeutic use; D002294:Carcinoma, Squamous Cell / Q000188:drug therapy* / Q000473:pathology / Q000532:radiotherapy*; D002945:Cisplatin / Q000008:administration & dosage; D003131:Combined Modality Therapy; D019583:Dose Fractionation, Radiation; D004938:Esophageal Neoplasms / Q000188:drug therapy* / Q000473:pathology / Q000532:radiotherapy*; D004941:Esophagitis / Q000209:etiology; D005260:Female; D005472:Fluorouracil / Q000008:administration & dosage; D005500:Follow-Up Studies; D006801:Humans; D008297:Male; D008875:Middle Aged; D009367:Neoplasm Staging; D017564:Radiation Pneumonitis / Q000209:etiology; D012074:Remission Induction; D015996:Survival Rate
D002945:Cisplatin; D005472:Fluorouracil