Long-term results of a randomized phase III trial of TPF induction chemotherapy followed by surgery and radiation in locally advanced oral squamous cell carcinoma.

Previously, we conducted a randomized phase III trial of TPF (docetaxel, cisplatin, and 5-fluorouracil) induction chemotherapy in surgically managed locally advanced oral squamous cell carcinoma (OSCC) and found no improvement in overall survival. This study reports long-term follow-up results from our initial trial. All patients had clinical stage III or IVA locally advanced OSCC. In the experimental group, patients received two cycles of TPF induction chemotherapy (75mg/m2 docetaxel d1, 75mg/m2 cisplatin d1, and 750mg/m2/day 5-fluorouracil d1-5) followed by radical surgery and post-operative radiotherapy; in the control group, patients received upfront radical surgery and post-operative radiotherapy. The primary endpoint was overall survival. Among 256 enrolled patients with a median follow-up of 70 months, estimated 5-year overall survival, disease-free survival, locoregional recurrence-free survival, and distant metastasis-free survival rates were 61.1%, 52.7%, 55.2%, and 60.4%, respectively. There were no significant differences in survival rates between experimental and control groups. However, patients with favorable pathologic responses had improved outcomes compared to those with unfavorable pathologic responses and to those in the control group. Although TPF induction chemotherapy did not improve long-term survival compared to surgery upfront in patients with stage III and IVA OSCC, a favorable pathologic response after induction chemotherapy may be used as a major endpoint and prognosticator in future studies. Furthermore, the negative results observed in this trial may be represent type II error from an underpowered study. Future larger scale phase III trials are warranted to investigate whether a significant benefit exists for TPF induction chemotherapy in surgically managed OSCC.

[Nutritional risk screening and enteral nutrition in patients with oral and maxillofacial cancers].

PURPOSE: To screen the nutritional risk of patients with oral and maxillofacial cancers using NRS2002 and evaluate the clinical usefulness of NRS2002. Meanwhile, nutritional support was given after screening and the effect was evaluated. METHODS: Fifty-nine patients with oral and maxillofacial cancers were enrolled in this study. The medical history and the intake condition of all patients were recorded, body weight and height were measured.The serum hemoglobin (Hb), lymphocyte count (LC), albumin (Alb), pre-albumin (PA) of the patients were detected. According to the requirements of NRS2002, the patients were screened before and after surgery. The patients with nutritional risks were divided into experimental group and control group randomly. The blood biochemical parameters in the two groups were compared after nutritional intervention. The data was analyzed by student's t test and Chi-square test with SPSS11.5 software package. RESULTS: Nutritional risk pre-operatively was 27.1% while the figure increased to 71.2% after operation (P < 0.05). Compared to pre-operation, nutritional risk increased significantly. Hb, LC, Alb and PA decreased significantly (P < 0.01). Before nutritional intervention,there was no difference of the biochemical stats between the patients in the experimental group and the control group (P > 0.05). After 7 days' treatment, the biochemical parameters except Hb and PA increased significantly in the control group. In the experimental group, LC, Alb and PA increased significantly (P < 0.05), especially Alb (P < 0.01), but Hb decreased. Compared with the control group, the NRS 2002 score decreased significantly in the experimental group after nutritional intervention. CONCLUSIONS: NRS2002 can reflect the nutritional risk of the patients with oral and maxillofacial cancers conveniently and swiftly. Nutritional support after operation can significantly increase the nutritional status of the patients, reduce the infectious complications and improve the prognosis.