RESUMO
BACKGROUND: Although many cancers have seen a significant improvement in survival and reduction in morbidity in the past few decades, the same cannot be said about adenocarcinoma stomach. Upfront surgery in non metastatic stomach cancers definitely improves survival. It is well established that any form of adjuvant therapy adds to the improvement in survival, controversy remains if adjuvant chemoradiotherapy is the standard or not. METHODOLOGY: This study is a single arm bidirectional observational study of the stomach cancer patients undergoing adjuvant concurrent chemoradiotherapy with 5 FU (5 Fluorouracil) with an aim to estimate the disease free survival (DFS) and to analyze toxicity patterns. A total of 73 patients with stomach cancer undergoing gastric resection with a curative intent were evaluated. RESULTS: With a median follow up of 16 months, the estimated disease free survival is 31.6 months. Of the 73 patients, recurrences were observed in 33 patients and the most common site was liver metastasis. Except for 2 patients, out of which one expired because of 5 FU induced myocardial infarction and another expired because of neutropenic sepsis during the first cycle of chemotherapy, most of the patients tolerated the regimen well. CONCLUSION: 5 FU based adjuvant CT-RT can be safely given in the Indian population with acceptable survival rates.
RESUMO
AIM: To evaluate the efficacy and safety of nimesulide 1% w/w spray in minor soft-tissue injuries in adult Indians through a multicentric, open-labeled, phase III trial. MATERIALS AND METHODS: 125 eligible patients, who met the selection criteria and gave written informed consent, were screened, enrolled, and treated with nimesulide 1% spray for seven days. Patients were assessed at baseline, day 1, day 4, and day 8 for efficacy and safety. Primary efficacy variable pain intensity, was measured using a NRS 1-100 mm (numerical rating scale). Secondary efficacy variables were degree of inflammation and edema and degree of functional impairment; overall assessment of efficacy was done by patient (patient global assessment - PGA) and by investigator (investigator global assessment - IGA) on days 4 and 8. RESULT: There was a statistically significant reduction in the NRS score, degree of pain, edema (inflammation), and improvement in functional impairment on days 4 and 8 and in serum creatine kinase levels on day 8 in comparison with baseline. Global assessment of efficacy on day 8 was rated as "very good (21%)," "good (67.70%)," and "fair (11.30%)" by investigators and "very good (25%)," "good (58.90%)," and "fair (16.1%)" by patients. Two mild adverse events were reported in two patients, which resolved without any intervention. One (local irritation) was reported as not related, while the other (itching sensation) was probably related to the study drug. CONCLUSION: Nimesulide 1% spray was effective with a good safety profile and can be considered is a good alternative to oral analgesic therapy in minor soft-tissue injuries.
