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Showing posts with the label Cancer Surgery

Juniper Publishers - FDA 510 (k) Process- How To Get It Right The First Time?

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  Cancer Therapy & Oncology International Journal Abstract The medical devices that are designated to be marketed need to go through a clearance process set forth by FDA. The Premarket notification (PMN) or 510(k) is the most common regulatory pathway in US but poses many challenges to medical device manufacturers. FDA has cleared more than 1, 40,000 medical devices since 1976. This is a clearance process, and not an approval, for medical devices. 510(K) submission has a purpose, a process and should be well understood in order to avoid unnecessary delays and failures. Keywords: Medical device; Regulation; FDA; 510(K); Substantially Equivalent Abbreviations: FDA: Food and Drug Administration, PMA: Premarket Approval; SE: Substantially Equivalent; Introduction Getting a clearance letter from FDA on 510(K) for a medical device is a milestone and the ultimate goal for any medical device manufacturer, be it a small ...

Juniper Publishers - A Rare Case of Imatinib-Induced Pneumonitis

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  Cancer Therapy & Oncology International Journal Abstract Gastrointestinal stromal tumors (GISTs) are rare mesenchymal neoplasms that may affect any portion of the gastrointestinal tract. Surgical resection was previously considered the only treatment modality available, thus prognosis in patients with advanced disease was poor. The emergence of novel therapeutic agents such as imatinib mesylate has altered how physicians now approach and manage these unique malignancies. The addition of these targeted agents has resulted in a significant benefit in median overall survival. Imatinib treatment is generally well tolerated. Side effects such as oedema, rash and gastrointestinal upset may be observed. However respiratory complaints are exceedingly rare. We report a case of imatinib-induced interstitial pneumonitis after five months of treatment in a patient with intermediate risk gastrointestinal stromal tumor of the stomach. Keywords: Imatinib Mesylate; Glivec; Inter...

Juniper Publishers - Cancer Therapy & Oncology International Journal

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  Chimeric Antigen Receptor Engineered T (CAR-T) Cells and Cancer Therapy Editorial Gene therapy has demonstrated significant potential as a cancer therapy in the last few years. The greatest successes have been reached by genetic modification of autologous patient T cells with chimeric antigen receptors (CARs), which are novel and synthetic receptors composed of the antigen-binding domain from a B cell receptor fused to the signaling elements associated with a T cell receptor [1]. CAR-T cells are targeted towards malignant cells expressed defined associated antigens. CAR-T cells can overcome the major challenges of immunotherapy such as tolerance to self-antigens and cancer immune system evasion mechanism [2]. Structure of CAR CAR is composed of an extracellular antigen-bindingdomain derived from an antibody (mostly a single-chain fragment of vari...

Juniper Publishers - Role of Distal loopogram Before Defunctioning Stoma Reversal- Results From An Indian Tertiary-Care Center

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  Cancer Therapy & Oncology International Journal Abstract Aim: To determine the utility of routine distal loopogram before stoma reversal and its impact on the management of patients with a low rectal anastomosis. Methods: This is a retrospective review of a prospectively maintained database of the patients underwent stoma reversal between June 1, 2011, and July 31, 2015. Primary variable assessed was accuracy of findings on preoperative distal loopogram in predicting postoperative complications after stoma reversal. Secondary variable was accuracy of findings on colonoscopy in predicting postoperative complications after stoma reversal. Results: One hundred fifty-seven patients who underwent stoma reversal were included in the study. Distal loopogram was found to be abnormal in 23 patients (15%). Overall, 17 patients developed postoperative complication in the form of anastomotic leakage or subacute intestinal obstruction. Colo...

Basics of Surgical Oncology - Juniper Publishers

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Cancer Therapy & Oncology - Juniper Publishers Abstract This article aims to standardize terms used in Surgical Oncology that are the basis for the treatment of cancer patients. Terms like: Patient out of cancer treatment, Patient in stage IV, In block tumor resection, Ganglionic relay, Local and regional control, Systemic Control, Unknown Primary Origin, Unresectability, Inoperability, Multiple Organ Resection, Preoperative Nutritional Status, Minimum Oncologic Procedure, Resection margins, Prognostic Factors, Peritoneal Washing Cytology, Adjuvant, Neoadjuvant and Peri-adjuvant Therapy. Keywords: Basic terms in Surgical Oncology; Cancer Surgery Abbreviations: OCT: Patient Out of Cancer Treatment; UPO: Unknown Primary Origin; BMI: Body Mass Index. Introduction There are basic oncological principles universally accepted and those principles were born from the experience accumulated in Cancer Treatment Centers after years of observing the results ...