Originally published by 2 Minute Medicine^® (view original article). Reused on AccessMedicine with permission.

1. Patients with low-risk nasopharyngeal carcinoma did not have significantly different disease-free survival rates whether they received radiotherapy alone or with concurrent chemoradiotherapy.

2. Patients in the radiotherapy alone group experienced significantly fewer serious adverse events compared to patients receiving concurrent chemoradiotherapy

Level of Evidence Rating: 1 (Excellent)

Study Rundown:

The current standard of care for management of stage II nasopharyngeal carcinoma is radiotherapy with concurrent chemotherapy, typically using a cisplatin-based agent. However, this treatment is fraught with a high risk of adverse events, weight loss and poor oncologic outcomes. Observational studies in recent years have determined that patients treated with radiotherapy alone have good survival outcomes, but this has never been compared head-to-head with concurrent chemotherapy. The present study by Tang et al randomized patients with stage II nasopharyngeal carcinoma to receiving radiation alone or chemoradiation to assess for differences in survival outcomes.

A total of 341 individuals participated in this trial, including 172 in the radiation group and 169 in the chemoradiation group. Baseline characteristics were well-balanced between the two groups. 95.9% of the radiation participants completed their complete treatment as defined by the protocol while only 60.4% of the chemoradiation group received all three rounds of chemotherapy and radiation. With a median follow-up time of 46 months, the locoregional failure rate was not different in the radiation (7.6%) versus chemoradiation (6.5%) groups, nor was the 3-year disease-free survival rate (90.5% vs. 91.9%). There were significantly fewer grade 3 or 4 adverse events reported amongst patients receiving radiation only in comparison to those who received chemotherapy.

This randomized controlled trial published by Tang et al demonstrated noninferior disease-free survival outcomes amongst patients with stage II nasopharyngeal carcinoma receiving radiation only compared to those receiving radiation with concurrent chemotherapy. These findings may influence practice and reduce the rate of serious adverse events experienced by patients with nasopharyngeal cancer in future. The conclusions reported here are strengthened by the randomized nature of this work which did well to control for confounding. However, these findings may be specific to the healthcare system and patient population in China, and therefore should be interpreted with clinical context in mind.

Click here to read this study in JAMA

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In Depth [randomized controlled trial]:

A multi-center, parallel group randomized controlled trial was conducted in China. Patients with stage II and T3N0M0 nasopharyngeal cancer who were between 18 and 65 years, had a Karnofsky performance status greater than 70 and met specific hematological parameters were included. Randomization was performed by a computer program using blocks of 4. Patients receiving chemotherapy were administered cisplatin at 100mg/m² for 3 cycles of 3 weeks each, concurrent to radiotherapy. The radiation protocol consisted of 68-70 Gy administered using guideline-specified practices.

The locoregional failure rate was 7.6% in the radiation group and 6.5% in the chemoradiation group (p =0.71), which was not significantly different. The 3-year disease-free survival was 90.5% in the radiation group and 91.9% in the chemoradiation group (p < 0.001). The absolute rate difference was 1.4% with a one-sided 95% confidence interval -7.4% to infinity. The hazard ratio for this outcome was 1.36 (0.70-2.66). The rate of serious adverse events reported in the radiotherapy group was 17% versus 46% in the chemoradiotherapy group (p<0.001). There was a significantly lower rate of the following adverse events in the radiation-only group specifically: leukopenia (1% vs 10%), neutropenia (2% vs 7%), nausea (1% vs 13%), vomiting (1% vs 15%), anorexia (5% vs 29%), weight loss (1%) vs 5%), and mucositis (10% vs 19%).

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