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Craniofacial Resection for Sinonasal Malignant Tumors: Statistical Analysis of Surgical Outcome over 17 Years at a Single Institution.

ABSTRACT: We present a retrospective analysis of surgical outcome of sinonasal malignant tumors. Overall survival (OS), disease-specific survival (DSS), local control (LC), and disease-free survival (DFS) were calculated in 32 patients. Prognostic factors for survival and functional outcomes were investigated. The median follow-up period was 70 months. At 5 years, OS, DSS, LC, and DFS rates were 0.722, 0.745, 0.851, and 0.707, respectively. Prognostic factors for poor OS were involvement of the frontal sinus (p = 0.023), T classification (T4, p = 0.025), surgical complications (p = 0.029), chemotherapy (p = 0.035) postsurgical infection (p = 0.043), involvement of the orbit (p = 0.048), histology (squamous cell carcinoma, p = 0.049), and radiotherapy (p = 0.043). Prognostic factors for poor DSS were radiotherapy (p = 0.030), chemotherapy (p = 0.036), positive surgical margin (p = 0.034), and T classification (T4, p = 0.050). LC was adversely influenced by surgical procedure (combined frontotemporal resection, p = 0.035) and positive surgical margin (p = 0.049). DFS was adversely influenced by positive surgical margin (p = 0.001). Prognostic factors for poor functional outcome were postsurgical infection (p = 0.039), postsurgical complications (p = 0.040), tumor location (maxillary sinus, p = 0.042, orbit, p = 0.0002), number of sinuses involved (number of sinuses involved was inversely proportional to functional outcome, p = 0.027), T classification (T4 p = 0.007), pathology (squamous cell carcinoma, p = 0.023), and chemotherapy (p = 0.048). Craniofacial resection was an effective surgical option.

SUBMITTER: Mine S

PROVIDER: S-EPMC3312121 | biostudies-other | 2011 Jul

REPOSITORIES: biostudies-other

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Project description:The conduct of clinical trials should be an integral part of routine patient care. Treating patients in trials incurs additional costs over and above standard of care (SOC), but the extent of the cost burden is not known. We undertook a retrospective cost attribution analysis to quantitate the treatment costs associated with cancer clinical trial protocols conducted over a 2 year period.All patients entered into oncology (non-haematology) clinical trials involving investigational medicinal products in 2009 and 2010 in a single UK institution were identified. The trial protocols on which they were treated were analysed to identify the treatment costs for the experimental arm(s) of the trial and the equivalent SOC had the patient not been entered in the trial. The treatment cost difference was calculated by subtracting the experimental treatment cost from SOC cost. For randomised trials, an average treatment cost was estimated by taking into account the number of arms and randomisation ratio. An estimate of the annual treatment costs was calculated.A total of 357 adult oncology patients were treated on 53 different trial protocols: 40 phase III, 2 randomised II/III and 11 phase II design. A total of 27 trials were academic, non-commercial sponsored trials and 26 were commercial sponsored trials. When compared with SOC, the average treatment cost per patient was an excess of £431 for a non-commercial trial (range £6393 excess to £6005 saving) and a saving of £9294 for a commercial trial (range £0 to £71,480). There was an overall treatment cost saving of £388,719 in 2009 and £496,556 in 2010, largely attributable to pharmaceutical company provision of free drug supplies.On an average, non-commercial trial protocols were associated with a small per patient excess treatment cost, whereas commercial trials were associated with a substantially higher cost saving. Taking into account the total number of patients recruited annually, treatment of patients on clinical trial protocols was associated with considerable cost savings across both the non-commercial and commercial portfolio.

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Craniofacial Resection for Sinonasal Malignant Tumors: Statistical Analysis of Surgical Outcome over 17 Years at a Single Institution.

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