Abstract
Background Oral cavity cancer ranks sixth among all cancers worldwide. India has the most oral cancer cases and accounts for one-third of the global oral cancer burden. Oral cavity cancer is known to be associated with an elevated likelihood of locoregional recurrences, which account for the bulk of post-surgery and radiotherapy treatment failures. Mitomycin C (MMC) is an antineoplastic and antibiotic agent that is administered topically rather than intravenously to treat bladder and intraperitoneal tumors to avoid recurrences. This study aimed to investigate the use of injection MMC as a local application on surgical resection beds for patients undergoing surgery for oral cancer and to assess its efficacy in preventing regional recurrences. Methodology In this prospective, interventional, pilot study, patients were assigned randomly to two groups using simple randomization. Group A involved the application of two gauze pieces soaked with MMC injection. Group B involved the application of two gauze pieces soaked with a 10% betadine solution. During the pectoralis major myocutaneous flap harvest procedure for reconstruction, two gauze pieces soaked with either injection MMC solution (20 mg MMC in 20 mL of 0.9% normal saline) or 10% betadine solution were placed on the surgical resection bed for a 45-minute contact period. Patients were evaluated daily in the postoperative period for local complications. Regular follow-up visits were scheduled for 15 months of follow-up. Results After exclusions at various phases, the final analysis included 50 patients in Group A and 50 patients in Group B. Minor complications, specifically blackening of the skin flap in the neck resulting in surgical site infections, were observed in 16% (eight patients) of the MMC group and in 6% (three patients) of the betadine group (p = 0.1997) patients. In the MMC group, two (4%) patients experienced locoregional recurrences at three months, four (8%) patients at six months, six (12%) patients at nine months, eight (16%) patients at 12 months, and 10 (20%) patients at 15 months of follow-up. In contrast, locoregional recurrences occurred in two (4%) patients in the betadine group at three months, six (12%) patients at six months, nine (18%) patients at nine months, 12 (24%) patients at 12 months, and 15 (30%) patients at 15 months. Although the difference in locoregional recurrences between the two groups was not statistically significant, there was a trend of decreasing locoregional recurrences in the MMC group relative to the betadine group as the duration of follow-up increased. In the subgroup analysis of patients with pathological extranodal extension (ENE), only 10 of 18 patients with ENE in Group A (55.55%) experienced a recurrence, whereas all 12 patients with ENE in Group B (100%) experienced a recurrence within the same time frame. This difference in locoregional recurrence rates between the two groups was statistically significant, with a p-value of 0.0100. Conclusions Our study demonstrated that the local administration of MMC on surgical resection beds may lower the risk of locoregional recurrences in patients with oral cancer, especially those with ENE. These findings contribute to the ongoing efforts to enhance treatment strategies and patient outcomes for this challenging malignancy.