A phase III study of adjuvant chemotherapy in advanced nasopharyngeal carcinoma patients.
OBJECTIVE
To evaluate the role of adjuvant chemotherapy in locally advanced nasopharyngeal carcinoma (NPC) patients, we conducted a randomized Phase III trial comparing radiotherapy (RT) followed by adjuvant chemotherapy to RT alone in patients with advanced NPC.


METHODS
Between November 1994 and March 1999, 157 patients with Stage IV, M(0) (UICC/AJCC, 1992) advanced NPC disease were randomized to receive standard radiotherapy, as follows: 35-40 fractions, 1.8-2.0 Gy/fraction/day, 5 days/week, to a total dose 70-72 Gy with or without 9 weekly cycles of 24-h infusional chemotherapy (20 mg/m(2) cisplatin, 2,200 mg/m(2) 5-fluorouracil, and 120 mg/m(2) leucovorin) after RT. Of 157 patients enrolled, 154 (77 radiotherapy, 77 combined therapy) were evaluable for survival and toxicity analysis.


RESULTS
With a median follow-up of 49.5 months, the 5-year overall survival and relapse-free survival rates were 60.5% vs. 54.5% (p = 0.5) and 49.5% vs. 54.4% (p = 0.38) for the radiotherapy-alone group and the combined radiotherapy and adjuvant chemotherapy group, respectively. The Cox regression showed that the hazard rates ratio of combined treatment to RT alone was 0.673 (p value = 0.232); the 95% confidence interval was 0.352 and 1.288, respectively. Patients who received combined treatment had a lower systemic relapse rate than radiotherapy-alone patients, according to relapse pattern analysis. The incidence of leukopenia (>or= Grade 3) occurred in 17 out of 819 (2.1%) cycles of weekly chemotherapy. No patient developed moderate to severe mucositis (>or= Grade 3).


CONCLUSIONS
We conclude that adjuvant chemotherapy after RT for patients with advanced NPC has no benefit for overall survival or relapse-free survival.
Chi
Kwan-Hwa
KH
Cancer Center, Veterans General Hospital-Taipei, National Yang-Ming University, Taipei, Taiwan, Republic of China. khchi@vghtpe.gov.tw
Chang
Yue-Cune
YC
Guo
Wan-Yao
WY
Leung
Mein-Jung
MJ
Shiau
Cheng-Yin
CY
Chen
Sheng-Yu
SY
Wang
Ling-Wei
LW
Lai
Yuen-Liang
YL
Hsu
Mau-Min
MM
Lian
Shi-Long
SL
Chang
Ching-Hsiung
CH
Liu
Tsang-Wu
TW
Chin
Yung-Hsin
YH
Yen
Sang-Hue
SH
Perng
Cheng-Hwang
CH
Chen
Kuang Y
KY
D000328:Adult; D000368:Aged; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000008:administration & dosage / Q000627:therapeutic use*; D002423:Cause of Death; D017024:Chemotherapy, Adjuvant; D002945:Cisplatin / Q000008:administration & dosage; D016001:Confidence Intervals; D018572:Disease-Free Survival; D005260:Female; D005472:Fluorouracil / Q000008:administration & dosage; D005500:Follow-Up Studies; D006801:Humans; D002955:Leucovorin / Q000008:administration & dosage; D008297:Male; D008875:Middle Aged; D009303:Nasopharyngeal Neoplasms / Q000188:drug therapy* / Q000401:mortality / Q000532:radiotherapy*; D009367:Neoplasm Staging; D016016:Proportional Hazards Models; D011879:Radiotherapy Dosage; D016019:Survival Analysis
D002945:Cisplatin; D002955:Leucovorin; D005472:Fluorouracil