This protocol has been superseded due to the availability of superior alternatives.
The evidence supporting the use of this protocol comes from an open label, randomised non-inferiority trial comparing concurrent chemoradiation with carboplatin versus standard concurrent chemoradiation with cisplatin in patients with locally advanced nasopharyngeal cancer (NPC). Between August 1999 and December 2004, 206 patients were randomised to receive cisplatin, arm 1 (n=101) or carboplatin, arm 2 (n=105). Patients in arm 1 received cisplatin 100 mg/m2 d1, 22, 43 concurrently with radiation therapy followed by adjuvant chemotherapy consisting of cisplatin 80 mg/m2 and 5FU 1000 mg/m2/day d1 to 4 every 4 weeks for a total of 3 cycles. Patients in arm 2 received carboplatin 100 mg/m2 d1, 8, 15, 22, 29, 36 concurrently with radiation therapy followed by adjuvant chemotherapy consisting of carboplatin AUC 5 and 5FU 1000 mg/m2/day d1 to 4 every 4 weeks for a total of 3 cycles.r
The primary endpoint of this study was to compare the efficacy of carboplatin with that of cisplatin in locally advanced nasopharyngeal carcinoma in terms of DFS. The secondary end points included overall survival, toxicity and tolerability of the 2 regimens.r
Meta-analyses have confirmed an improvement in overall survival with the addition of concomitant chemotherapy to radiation therapy. The value of adjuvant chemotherapy following chemoradiation therapy is uncertain.rr
The meta-analyses conducted by Baujat et al. and Langendijk et al. suggested no significant benefit.rr More recently Ouyang et al. suggest a benefit of locoregional control but not in OS.r
Efficacy
After a median follow up of 26.3 months, 59% of patients in cisplatin arm completed the planned concurrent chemoradiation compared to 73% in the carboplatin arm. 42% cisplatin patients completed 3 cycles of adjuvant chemotherapy compared to 70% in the carboplatin group. The 3 year disease survival rates were 64.7% for the cisplatin group and 59.6% for the carboplatin group (p=0.522). The 3 year overall survival rates were 77% and 79% for cisplatin and carboplatin groups respectively (p=0.9884; HR 0.83, 95% CI 0.63-1.010).r
3 year Disease-free Survival and Overall Survival by intent-to-treat analysisr
© European Journal of Cancer 2007
Toxicity
There were more renal toxicity, leucopenia, and anaemia in the cisplatin group, and more thrombocytopenia in the carboplatin arm.r
© European Journal of Cancer 2007