Rationale for superseding
This protocol was reviewed at the Medical Oncology Reference Committee May 2013 meeting and the consensus was to supersede it as it is no longer considered best practice. Other treatment schedules are more convenient, less toxic and better tolerated.
Between September 1997 and May 2003, 221 patients were randomly assigned to receive radiation therapy (RT) alone (n=110) or chemoradiation therapy (CRT; n=111). Patients in both arms received 70 Gy in 7 weeks using standard RT portals and techniques. Patients on CRT received concurrent cisplatin (25 mg/m2 on days 1 to 4) on weeks 1, 4, and 7 of RT and adjuvant cisplatin (20 mg/m2 on days 1 to 4) and fluorouracil (1,000 mg/m2 on days 1 to 4) every 4 weeks (weeks 11, 15, and 19) for three cycles after completion of RT. All patients were analysed by intent-to-treat analysis. The median follow-up time was 3.2 years.r
This study confirmed the findings of the Intergroup 00-99 Trial and demonstrated its applicability to endemic nasopharyngeal carcinoma (NPC). This study also confirmed that chemotherapy improves the distant metastasis control rate in NPC and that fractionated cisplatin is equally efficacious.r
Efficacy
Distant metastasis occurred in 38 patients on RT alone and 18 patients on CRT. The difference in 2-year cumulative incidence was 17% (95% CI, 14% to 20%; p=0.0029). The hazard ratio (HR) for disease-free survival was 0.57 (95% CI, 0.38 to 0.87; p=0.0093). The 2- and 3-year overall survival (OS) rates were 78% and 85% and 65% and 80% for RT alone and CRT, respectively. The HR for OS was 0.51 (95% CI, 0.31 to 0.81; p=0.0061).r
Overall survival by treatmentr
© Journal of Clinical Oncology 2005
Toxicity
Toxicityr
(Grades 3 and 4)
|
Radiation therapy only
n=107
(%)
|
Chemoradiation therapy
n=106
(%)
|
Mucositis/pharyngitis |
32 |
48 |
Anorexia |
4 |
22 |
Emesis |
0 |
5 |
Skin |
5 |
5 |
Other* |
0 |
4 |
Neutrophils |
0 |
13 |
Platelets |
0 |
2 |
Other** |
0 |
0 |
*Initial phase: renal toxicity, infection and metabolic toxicity. Adjuvant phase: GI toxicity and infection
** Included 1 haemoglobin and 2 WBC toxicities