Progress report of a randomized trial comparing long‐term survival and late toxicity of concurrent chemoradiotherapy with adjuvant chemotherapy versus radiotherapy alone in patients with stage III to IVB nasopharyngeal carcinoma from endemic regions of China

Abstract

BACKGROUND:The objective of this study was to evaluate the long-term survival and late toxicities of concurrent-adjuvant chemotherapy in patients with stage III through IVB nasopharyngeal carcinoma (NPC) from endemic regions of China. METHODS: Patients with stage III to IVB NPC were assigned randomly to receive radiotherapy (RT) alone (the RT group) or RT plus concurrent adjuvant chemotherapy (the CRT group). CRT patients received concurrent cisplatin (40 mg/m 2 ) weekly during RT followed by cisplatin (80 mg/m 2 ) and fluorouracil (800 mg/m 2 daily for 5 days) every 4 weeks for 3 cycles. The primary endpoint was overall survival. RESULTS:In total, 316 patients underwent randomization, with 158 to each group. At a median follow-up of 70 months, the 5-year overall survival rate was 72% for the CRT group and 62% for the RT group (hazard ratio, 0.69; 95% confidence interval, 0.48-0.99; P 5.043). Failure-free survival was significantly higher in the CRT group (P 5.020). Most late toxicities were similar (33% vs 26%; P 5.089), except for cranial neuropathy (P 5.042), peripheral neuropathy (P 5.041), and ear damage (P 5.048), which were significantly increased in the CRT group. CONCLUSIONS: The addition of concurrent adjuvant chemotherapy to RT provides survival benefits to patients with stage III through IVB NPC in endemic regions of China, and it does not increase most late toxicities apart from cranial neuropathy, peripheral neuropathy, and ear damage. Cancer 2013;119:2230-8.

Chemotherapy for Nasopharyngeal Cancer: Neoadjuvant, Concomitant, and/or Adjuvant

“…Another randomized study by Chen et al that recruited 316 patients was able to demonstrate superior survival results favoring CRT + AC over RT alone, with 5-year OS 72 vs. 62 % (p=0.04). Fiveyear failure-free survival and PFS were also higher in the CRT + AC group (72 vs. 62 %, p=0.02; 68 vs. 57 %, p=0.02, respectively) [7].…”

The New T Staging System for Nasopharyngeal Carcinoma Based on Intensity Modulated Radiation Therapy: Results of a Prospective Multicentric Clinical Study

“…In the present study, the ratios of the replaced two-dimensional radiotherapy (2D-RT) as the mainstream therapy for NPC [22]. Combination therapy, with IMRT as the lead therapy, has dramatically improved the prognosis of NPC patients and the 5-year overall survival has reached 80% [6][7][8][9][10][11][12]. Zong et al [23] surveyed 1241 nasopharyngeal carcinoma (NPC) patients treated with IMRT, of whom 88.7% of patients received concurrent platinum-based chemotherapy.…”

“…Additionally, intensitymodulated radiotherapy (IMRT) has gradually replaced regular two-dimensional radiotherapy (2D-RT) as the mainstream therapy for NPC [3][4][5]. Combination therapy, with IMRT as the principle component, has dramatically improved the prognosis for NPC patients, with 5-year overall survival (OS) rates of over 80% [6][7][8][9][10][11][12].…”

Impact of intensity-modulated radiotherapy on nasopharyngeal carcinoma: Validation of the 7th edition AJCC staging system

“…Concurrent chemoradiotherapy has been repeatedly proven to improve survival [22,23]. However, only 39.7% (469/1181) of the stage II-IVB patients received concurrent chemotherapy in the study.…”