Prospective Phase II Open-Label Randomized Controlled Trial to Compare Mandibular Preservation in Upfront Surgery With Neoadjuvant Chemotherapy Followed by Surgery in Operable Oral Cavity Cancer.

PURPOSE: The objective of this study was to explore the potential role and safety of neoadjuvant chemotherapy (NACT) in tumor shrinkage and resultant mandibular preservation in oral cancers compared with conventional surgical treatment. METHODS: This study was a single-center, randomized, phase II trial of treatment-naive histologically confirmed squamous cell carcinoma of the oral cavity with cT2-T4 and N0/N+, M0 (American Joint Committee on Cancer, seventh edition) stage, necessitating resection of the mandible for paramandibular disease in the absence of clinicoradiologic evidence of bone erosion. The patients were randomly assigned (1:1) to either upfront surgery (segmental resection) followed by adjuvant treatment (standard arm [SA]) or two cycles of NACT (docetaxel, cisplatin, and fluorouracil) at 3-week intervals (intervention arm [IA]), followed by surgery dictated by postchemotherapy disease extent. All patients in the IA received adjuvant chemoradiotherapy, and patients in the SA were treated as per final histopathology report. The primary end point was mandible preservation rate. The secondary end points were disease-free survival and treatment-related toxicity. RESULTS: Sixty-eight patients were enrolled over 3 years and randomly assigned to either SA (34 patients) or IA (34 patients). The median follow-up was 3.6 years (interquartile range, 0.95-7.05 years). Mandibular preservation was achieved in 16 of 34 patients (47% [95% CI, 31.49 to 63.24]) in the IA. The disease-free survival (P = .715, hazard ratio 0.911 [95% CI, 0.516 to 1.607]) and overall survival (P = .747, hazard ratio 0.899 [95% CI, 0.510 to 1.587]) were similar in both the arms. Complications were similar in both arms, but chemotherapy-induced toxicity was observed in the majority of patients (grade III: 14, 41.2%; grade IV: 11, 32.4%) in the IA. CONCLUSION: NACT plays a potential role in mandibular preservation in oral cancers with acceptable toxicities and no compromise in survival. However, this needs to be validated in a larger phase III randomized trial.

Quality of life comparison in thyroxine hormone withdrawal versus triiodothyronine supplementation prior to radioiodine ablation in differentiated thyroid carcinoma: a prospective cohort study in the Indian population.

BACKGROUND: Thyroid withdrawal in preparation for radioiodine ablation (RIA) may have a profound impact on health-related quality of life (HRQL). Cost implications and scheduling limit the use of recombinant TSH and triiodothyronine (T3) with its shorter half-life is a conceptually attractive alternative. METHODS: Prospective cohort study design with patients having withdrawal of thyroxine (n = 37) or T3 supplementation (n = 33). HRQL was assessed using EORTC QLQ-C30, QLQ-H&N35 and modified Billewicz questionnaires. Time interval to achieve optimal TSH levels (at least 30 mIU/ml) prior to RIA was determined. RESULTS: With the exception of emotional domain (QLQ-C30 p = 0.045), LT3 supplementation did not confer significant benefit when compared to LT4 withdrawal. Target serum TSH levels was achieved in 95% of patients by week 4 post thyroidectomy. CONCLUSIONS: LT3 supplementation delivered equivocal benefit and therefore the alternate strategies to minimize the impact on HRQL of reduction in the duration of hypothyroidism in T4 withdrawal are suggested.

Poorly differentiated thyroid carcinoma (PDTC) characteristics and the efficacy of radioactive iodine (RAI) therapy as an adjuvant treatment in a tertiary cancer care center.

BACKGROUND: Poorly differentiated thyroid cancer (PDTC) is biologically more aggressive. Surgery remains the mainstay of treatment. The utility of radioactive iodine (RAI) after surgery is unclear. METHODS: In this retrospective study, patients treated between Jan 2012 and Dec 2017 were included. The demographic, clinical and treatment-related details, including RAI ablation, were recorded and their survival analyzed. RESULTS: Thirty-five patients fulfilled the eligibility criteria. Majority was treatment naïve at presentation. All patients underwent surgery followed by RAI ablation, with a cumulative median dose of 220 mCi (range 40-1140). Sixteen patients received more than one radioiodine treatment for distant metastases. Incomplete resection, age > 45 years and the presence of distant metastasis influenced survival the most. The 3-year PFS of patients with PDTC was 69%. CONCLUSION: All patients in our series showed uptake and responded to treatment. Further use of molecular markers and functional molecular imaging would better our understanding of this entity.

Surgical outcomes of thyroid cancer patients in a tertiary cancer center in India.

BACKGROUND: Surgery is the mainstay in the management of thyroid cancer. Surgical outcomes need to be tempered against the excellent prognosis of the disease. AIMS: This study aims to study the surgical outcomes including the 30-day morbidity and 5-year survival of thyroid cancer patients. SETTINGS AND DESIGN: Retrospective analysis of a prospectively maintained surgical database in a tertiary cancer center in India. MATERIALS AND METHODS: We analyzed 221 surgically treated patients in the year 2012. STATISTICAL ANALYSIS: Used IBM SPSS 24.0 (Armonk, NY) with p < 0.05. RESULTS: The median age was 40 years with predominantly papillary thyroid carcinoma (55%). Localized disease in 47% of cases, locoregional disease in 42.5% and distant metastasis in 10.2% of cases at presentation was noted. Treatment naïve patients were 71% and revision surgeries were done in 29% patients. Extended thyroidectomy constituted 11% of the surgeries. Temporary hypocalcemia was seen in 30.8% of patients, 5% requiring intravenous calcium supplementation. Vocal cord palsy as per nerve at risk and chyle leak were seen in 4.5% and 3.1%, respectively. Aggressive histology, extended thyroidectomy, and inadvertent parathyroidectomy were significant factors associated with complications. Five year estimated overall survival with median follow-up of 50 months was 98%, and event-free survival was 84.8%. Advanced age, distant metastasis at presentation and aggressive histology connoted poor outcomes. CONCLUSION: Thyroid cancer, irrespective of the extent of disease, has good prognosis. Aggressive histology, the extent of thyroid surgery, distant metastasis and age are important factors, which should be factored in the algorithm of thyroid cancer management.