Adding chemotherapy to radiotherapy resulted in statistically significantly higher 5‑year overall, progression-free, and distant metastasis-free survival among patients with stage II nasopharyngeal carcinoma in a phase III randomized trial. Adding cisplatin-based chemotherapy to radiotherapy resulted in 8.7%, 10.1%, and 10.9% increases in the 5-year overall, progression-free, and distant metastasis–free survival rates, respectively, in the concurrent chemoradiotherapy arm, researchers from southern China—where nasopharyngeal carcinoma is endemic—reported in the Journal of the National Cancer Institute. There was, however, no statistically significant difference in the 5-year locoregional relapse-free survival rate.
Several prospective randomized trials and meta-analyses have shown that concurrent chemoradiotherapy with or without adjuvant chemotherapy is superior to radiotherapy alone in the treatment of locoregionally advanced nasopharyngeal carcinoma, the researchers noted. However, patients with stage I–II nasopharyngeal carcinoma have generally favorable prognoses and have largely been excluded from clinical trials with concurrent chemoradiotherapy. “To the best of our knowledge, this study is the first randomized trial to compare concurrent chemoradiotherapy with radiotherapy alone in early-stage nasopharyngeal carcinoma,” the researchers stated.
Patients were evaluated using the Chinese 1992 staging system and were eligible for this study if they had biopsy-proven World Health Organization type II/III nasopharyngeal carcinoma, stage II disease (T1-2, N1, M0 or T2, N0, M0 with parapharyngeal space involvement). Patients were excluded if they had previously been treated for nasopharyngeal carcinoma.
A total of 230 patients were randomly assigned to receive radiotherapy alone or with 30 mg/m2 concurrent cisplatin on day 1 weekly during radiotherapy. Cisplatin-based chemotherapy has been shown to result in higher response rates in previously untreated, recurrent, or metastatic nasopharyngeal carcinoma compared with noncisplatin regimens, the authors noted, adding that the optimal combination of cisplatin with radiotherapy has not yet been established.
At a median of 60 months, 22.8% of patients in the radiotherapy group developed tumor progression vs 11.2% in the concurrent chemoradiotherapy group. Of the 25 reported deaths, 21 were disease-related, 16 in the radiotherapy group and 5 in the concurrent chemoradiotherapy group. Patients in the chemoradiotherapy group had statistically significant higher rates of overall survival (94.5% vs 85.8% in the radiotherapy group), progression-free survival (87.9% vs 77.8%), and distant metastasis–free survival (94.8% vs 83.9%).
“Although [concurrent chemoradiotherapy] patients experienced more severe hematologic, gastrointestinal, and mucositis acute toxic effects than the patients undergoing radiotherapy alone, they were all tolerant of this regimen,” the researchers wrote. “In summary, we think that the optimal choice for early-stage [nasopharyngeal carcinoma] is cisplatin, at a weekly dose of 30 mg/m2, for both an optimal chemotherapy effect to eradicate small distant tumors and to ensure [nasopharyngeal carcinoma] patient compliance.” ■
Chen QY, et al: J Natl Cancer Inst 103:1761-1770, 2011.