Salivary Gland Tumors: Randomized Study of Adjuvant Chemo-Radiotherapy versus Radiotherapy Alone

Objective: Concurrent chemoradiation value of the resected salivary tumor adjuvant context against regular radiation therapy alone. Design: Prospective randomized clinical trial. Patients: 48 patients were randomized to either adjuvant postoperative radiology alone versus concurrent chemoradiotherapy (weekly cisplatin 40 mg/m2 for 6 cycles) “with resected high-risk salivary tumors of the large and minor salivary gland”. Main Outcome Measures: Recurrent locoregional Free survival, distant free survival, and overall survival. Results: Out of the 48 participants in the study 31 patients had parotid gland tumors. 23 patients received solely adjuvant radiation while 25 patients received concurrent chemoradiotherapy. In the chemoradiation group, platinum-based regimens were employed in all. The mean age in both groups was 48 years. Adenoid cystic carcinoma was the primary pathogenic form of both arms 56% (28 cases). Stage II patients were 35% and 32%, stage III was 39% and 48% and stage VIa were 26% and 20% in the radiation arm and chemoradiotherapy arm respectively. 40 of 48 patients (83%) had close or positive surgical margins and 30 of 48 patients (62%) have a perineural invasion. Both risk variables are more or less well balanced in both arms with no statistical difference. The 2- and 4-year estimates of the locoregional recurrence-free survival rate in the chemoradiation group were 95% and 73%, compared to 77.4% and 43.6% in the radiation arm respectively (p = 007). In the two-and four-year-old chemoradiation arm distant free metastases were 100% and 59% compared to 68% and 39% respectively in the radiation arm (p = 0.08). The overall survival estimates for 2 and 4 years were 93% and 78% respectively in the Chemoradiation Group but in the radiation-alone group were 95% and 48% respectively. The statistically significant differences were p = 0.009 by log-rank testing. Treatment was generally tolerated, although, in the chemoradiation group adverse symptoms, mainly mucositis increased. Conclusions: Adding weekly cisplatin as a radiosensitizer for locally advanced stage or high-grade salivary gland cancer with adjuvant conventional radiation looks to be helpful and justifies further exploration in selected patients.