PurposeThe efficacy of neoadjuvant chemoradiotherapy (NCRT) plus surgery for locally advanced esophageal squamous cell carcinoma (ESCC) remains controversial. In this trial, we compared the survival and safety of NCRT plus surgery with surgery alone in patients with locally advanced ESCC.Patients and MethodsFrom June 2007 to December 2014, 451 patients with potentially resectable thoracic ESCC, clinically staged as T1-4N1M0/T4N0M0, were randomly allocated to NCRT plus surgery (group CRT; n = 224) and surgery alone (group S; n = 227). In group CRT, patients received vinorelbine 25 mg/m2 intravenously (IV) on days 1 and 8 and cisplatin 75 mg/m2 IV day 1, or 25 mg/m2 IV on days 1 to 4 every 3 weeks for two cycles, with a total concurrent radiation dose of 40.0 Gy administered in 20 fractions of 2.0 Gy on 5 days per week. In both groups, patients underwent McKeown or Ivor Lewis esophagectomy. The primary end point was overall survival.ResultsThe pathologic complete response rate was 43.2% in group CRT. Compared with group S, group CRT had a higher R0 resection rate (98.4% v 91.2%; P = .002), a better median overall survival (100.1 months v 66.5 months; hazard ratio, 0.71; 95% CI, 0.53 to 0.96; P = .025), and a prolonged disease-free survival (100.1 months v 41.7 months; hazard ratio, 0.58; 95% CI, 0.43 to 0.78; P < .001). Leukopenia (48.9%) and neutropenia (45.7%) were the most common grade 3 or 4 adverse events during chemoradiotherapy. Incidences of postoperative complications were similar between groups, with the exception of arrhythmia (group CRT: 13% v group S: 4.0%; P = .001). Peritreatment mortality was 2.2% in group CRT versus 0.4% in group S (P = .212).ConclusionThis trial shows that NCRT plus surgery improves survival over surgery alone among patients with locally advanced ESCC, with acceptable and manageable adverse events.

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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.

IMPORTANCEThe prognosis of patients with locally advanced esophageal squamous cell carcinoma (ESCC) remains poor after surgery. Neoadjuvant chemoradiotherapy (NCRT) has been shown to potentially improve survival.OBJECTIVE To compare the treatment efficacy of NCRT plus surgery with surgery alone for long-term survival among patients with locally advanced ESCC. DESIGN, SETTING, AND PARTICIPANTSThe Neoadjuvant Chemoradiotherapy for Esophageal Cancer 5010 study was a multicenter open-label randomized phase 3 clinical trial that enrolled patients between June 1, 2007, and December 31, 2014. Follow-up ended on December 31, 2019. The study was conducted at 8 centers in China. A total of 451 patients aged 18 to 70 years with thoracic ESCC stage T1-4N1M0/T4N0M0 were enrolled and randomized. Data were analyzed from December 1, 2019, to June 30, 2020.INTERVENTIONS Patients randomized to receive NCRT plus surgery (NCRT group) received preoperative chemotherapy (25 mg/m 2 of vinorelbine on days 1 and 8 and 75 mg/m 2 of cisplatin on day 1 or 25 mg/m 2 of cisplatin on days 1 to 4) every 3 weeks for 2 cycles and concurrent radiotherapy (40.0 Gy, administered in 20 fractions of 2.0 Gy for 5 days per week) followed by surgery. Patients randomized to receive surgery alone (surgery group) underwent surgery after randomization. MAIN OUTCOMES AND MEASURESThe primary end point was overall survival in the intention-to-treat population. The secondary end point was disease-free survival.RESULTS A total of 451 patients (mean [SD] age, 56.5 [7.0] years; 367 men [81.4%]) were randomized to the NCRT (n = 224) and surgery (n = 227) groups and were eligible for the intention-to-treat analysis. By December 31, 2019, 224 deaths had occurred. The median follow-up was 53.5 months (interquartile range, 18.2-87.4 months). Patients receiving NCRT plus surgery had prolonged overall survival compared with those receiving surgery alone (hazard ratio, 0.74; 95% CI, 0.57-0.97; P = .03), with a 5-year survival rate of 59.9% (95% CI, 52.9%-66.1%) vs 49.1% (95% CI, 42.3%-55.6%), respectively. Patients in the NCRT group compared with the surgery group also had prolonged disease-free survival (hazard ratio, 0.60; 95% CI, 0.45-0.80; P < .001), with a 5-year survival rate of 63.6% (95% CI, 56.0%-70.2%) vs 43.0% (95% CI, 36.0%-49.7%), respectively. CONCLUSIONS AND RELEVANCEIn this randomized clinical trial, treatment with NCRT plus surgery significantly improved long-term overall survival and disease-free survival and therefore may be considered a standard of care for patients with locally advanced ESCC.

BACKGROUND. Retropharyngeal lymph node (RLN) metastasis was not included in the current American Joint Committee on Cancer (AJCC) staging system (6th edition) for nasopharyngeal carcinoma (NPC).The object of the current study was to investigate the prognostic value and staging categories of RLN metastasis in NPC detected by magnetic resonance imaging (MRI). METHODS. All 924 consecutive patients with newly diagnosed NPC were examined with MRI before treatment with definitive intent radiotherapy. RESULTS. The incidence of RLN metastasis was 73.5%. On multivariate analysis, RLN metastasis was found to be an independent prognostic factor for distant metastasis‐free survival (DMFS) in all patients (P = .040). In patients with N0 disease, significant differences were observed between patients with and those without RLN metastasis after adjusting for T classification (P = .046). With regard to laterality, no significant differences were observed in DMFS between patients with unilateral and bilateral RLN metastasis in N0 disease (P = .734). No significant difference in the hazards ratios for either DMFS or disease‐free survival (DFS) was found between patients with N0 disease with RLN metastasis and patients with N1 disease (P = .092 and P = .149, respectively). When RLN was classified as N1 disease, there was a better segregation of different N classifications in terms of DFS and DMFS curves, whereas the difference in hazards ratios for N0 and N1 disease was more obvious in DMFS (from 0.461 vs 0.785 to 0.317 vs 0.690). CONCLUSIONS. The results of the current MRI‐based study demonstrate that RLN metastasis affects the DMFS rates of NPC. The authors propose that RLN metastasis be classified as N1 disease, regardless of its laterality. Cancer 2008. ©2008 American Cancer Society.