Nimotuzumab-cisplatin-radiation versus cisplatin-radiation in HPV negative oropharyngeal cancer.

BACKGROUND: Addition of nimotuzumab to weekly cisplatin and radiation improves outcomes in head and neck cancer. HPV negative oropharyngeal cancer has unsatisfactory treatment outcomes and is a candidate for escalation of treatment. We wanted to determine whether the addition of nimotuzumab to cisplatin-radiation could improve outcomes in these poor-risk tumors. METHODS: This was a subgroup analysis of a phase 3 randomized study. In this study, locally advanced head and neck cancer patients undergoing definitive chemoradiation were randomly allocated to weekly cisplatin (30 mg/m2 IV)- radiation (66-70 Gy) {CRT arm} or nimotuzumab (200 mg weekly) -weekly cisplatin (30 mg/m2)-radiation (66-70 Gy) {NCRT arm}. The data of HPV negative oropharyngeal cancer was extracted from the database of this study for the analysis. HPV testing was done with p16 immunohistochemistry (IHC) staining and reported according to the CAP criteria. The outcomes assessed were progression-free survival (PFS), disease-free survival (DFS), locoregional control, and overall survival (OS). Interaction test was performed between the study arms and HPV status prior to doing any HPV specific analysis for each of the studied outcomes. Kaplan Meier estimates for 2 year OS with 95%CI was calculated. The hazard ratio was obtained using COX regression analysis. RESULTS: We had 187 HPV negative oropharyngeal cancers, 91 in the CRT arm and 96 in NCRT arm. The interaction test was significant for PFS (p = 0.000), locoregional control (p = 0.007) and overall survival (p = 0.002) but not for DFS (p = 0.072). The 2- year PFS was 31.5% (95%CI 21.5-42) in CRT arm versus 57.2% (95%CI 45.8-67.1) in NCRT arm (HR -0.54; 95%CI 0.36-0.79, p = 0.002). The 2-year LRC was 41.4% (95%CI 29.8-52.6) in the CRT arm versus in 60.4% (95%CI 48.7-70.2) in the NCRT arm (HR -0.61; 95%CI 0.4-0.94, p = 0.024). The addition of nimotuzumab also lead to an improvement in 2-year OS from 39.0% (95%CI 28.4-49.6) to 57.6% (95%CI 46.3-67.4) (HR-0.63, 95%CI 0.43-0.92, p = 0.018). CONCLUSIONS: The addition of nimotuzumab to weekly cisplatin-radiation improves outcomes inclusive of OS in HPV negative oropharyngeal cancers.

A randomized phase 3 trial comparing nimotuzumab plus cisplatin chemoradiotherapy versus cisplatin chemoradiotherapy alone in locally advanced head and neck cancer.

BACKGROUND: Because the addition of nimotuzumab to chemoradiation in patients with locally advanced head and neck cancer improved outcomes in a phase 2 study, the authors conducted a phase 3 study to confirm these findings. METHODS: This open-label, investigator-initiated, phase 3, randomized trial was conducted from 2012 to 2018. Adult patients with locally advanced head and neck cancer who were fit for radical chemoradiation were randomized 1:1 to receive either radical radiotherapy (66-70 grays) with concurrent weekly cisplatin (30 mg/m2 ) (CRT) or the same schedule of CRT with weekly nimotuzumab (200 mg) (NCRT).The primary endpoint was progression-free survival (PFS); key secondary endpoints were disease-free survival (DFS), duration of locoregional control (LRC), and overall survival (OS). An intent-to-treat analysis also was performed. RESULTS: In total, 536 patients were allocated equally to both treatment arms. The median follow-up was 39.13 months. The addition of nimotuzumab improved PFS (hazard ratio [HR], 0.69; 95% CI, 0.53-0.89; P = .004), LRC (HR, 0.67; 95% CI, 0.50-0.89; P = .006), and DFS (HR, 0.71; 95% CI, 0.55-0.92; P = .008) and had a trend toward improved OS (HR, 0.84; 95% CI, 0.65-1.08; P = .163). Grade 3 through 5 adverse events were similar between the 2 arms, except for a higher incidence of mucositis in the NCRT arm (66.7% vs 55.8%; P = .01). CONCLUSIONS: The addition of nimotuzumab to concurrent weekly CRT improves PFS, LRC, and DFS. This combination provides a novel alternative therapeutic option to a 3-weekly schedule of 100 mg/m2 cisplatin in patients with locally advanced head and neck cancer who are treated with radical-intent CRT.

Giant Gastric Lipoma Presenting as Gastric Outlet Obstruction - A Case Report.

Gartric lipomas are rare. They are mostly small in size, and usually remain asymptomatic. We report a case of giant (14×11cm) gastric lipoma in a 46-year-old male who presented with features of gastric outlet obstruction clinically mimicking gastric malignancy. Upper endoscopy showed a large smooth polypoid mass with broad base arising from posterior wall of gastric antrum with areas of superficial ulcerations. Multiple endoscopic biopsy specimens were nondiagnostic. A computed tomography (CT) scan of the abdomen revealed a huge cauliflower- like intraluminal mass with lobulated surface projecting into gastric lumen and pyloric canal. The mass demonstrated uniform fat density consistent with lipoma. The case is presented to stress the diagnostic problems related to this condition, and emphasize the role of CT in arriving at a correct diagnosis of lipomatous gastrointestinal tract tumours.

Perigraft Seroma Presenting as Discharging Sinus and Spontaneous Exteriorization of Vascular Graft - A Rare Entity Following Vascular Repair with PTFE Graft.

Perigraft seroma presenting as discharging sinus and spontaneous exteriorization of vascular graft are rare complication of vascular injury repair with polytetrafluoroethylene (PTFE) grafts. We hereby report a case of young boy who presented with discharging sinuses and vascular graft coming out from one of the sinuses following vascular repair of femoral artery with PTFE graft after a follow-up of six months but the limb was salvaged. On evaluation PTFE graft was found to be thrombosed and collaterals were formed for distal perfusion. Because of persistent discharging sinuses, PTFE graft was removed and femoral artery was ligated proximal and distal to the graft. This case highlights an unusual complication of PTFE grafts that is commonly used in vascular surgery and also highlights the fact that these graft buy time for gradual collaterals formation for distal perfusion and hence when thrombosed and complicated can be safely removed.

Large Tubullo-villous Adenoma of Duodenum Presenting as Gastric Outlet Obstruction.

Tubullo-villous adenoma of duodenum is a rare entity. These are potentially malignant tumours and therefore, complete excision is the treatment of choice. However, at times preoperative diagnosis could not be always achieved posing difficulty in choosing the optimal surgical method of excision. We report a 40-year-old male patient presented with vague upper abdominal pain and vomiting for last 6 months. His computed tomography and endoscopy demonstrated intraluminal polypoidal mass. Endoscopic biopsies were negative for malignancy. Local surgical excision with tumour free margin was performed and histology revealed tubullo-villous adenoma.