To provide an overview of noninferiority trials in oncology with a special emphasis on methodologic issues, we conducted a systematic review of randomized trials assessing noninferiority of antineoplastic treatments. We identified 72 articles, of which 65 were randomized phase III trials with a single control arm, 3 were factorial phase III trials, and 4 were randomized phase II trials. Forty-six were trials in lung, colorectal, or breast cancer. The quality of reporting was improved chronologically (P < 0.01); the major deficiencies were claims of noninferiority when the results did not meet statistical criteria for noninferiority (7 articles) or when the noninferiority margin was not prespecified (5 articles). Four trials (6%) presented plans for switching from superiority to noninferiority. The analysis populations were intent to treat (ITT) in 52, perprotocol set (PPS) in 6, and both ITT and PPS in 11 trials. Noninferiority margins were set in 68 trials (94%); 1 trial used both of the conventional and effect retention methods, 17 trials used the conventional method, 5 trials used the effect retention method, and in 45 trials, the method was not specified. Some trials used margins that possibly were larger than the assured effects of the active controls. No trials explicitly took into consideration uncertainty in historical data. Two trials (3%) specified 2 values of margins. Our findings highlight critical deficiencies in design and reporting of noninferiority trials. Seven practical recommendations are presented. Clin Cancer Res; 18(7); 1-11. Ó2012 AACR.

According to "General Rule for Clinical and Pathological Record of Colorectal Cancer", 33 poorly differentiated adenocarcinomas of the colon and rectum among 569 resected colorectal cancers were clinicopathologically studied, comparing to the most common 355 well differentiated adenocarcinoma. Poorly differentiated adenocarcinomas represented as low as 5.8% of all cancers. When compared to well differentiated adenocarcinomas, poorly differentiated ones were more frequently found in the colon, especially remarkable in the right side, and macroscopically those predominantly included infiltrating ulcer types. Hepatic metastasis was found in a rate of 21.2%; lymph node metastasis, 66.7%; and 27.2% of positive lymph nodes were of the 3rd group of lymph nodes. Invasion depth of s (a2) and si (a1) were found in 81.8%; lymph vessel invasion in 97%; and venous invasion was positive in 87.9%. Compared to well differentiated adenocarcinomas, poorly differentiated adenocarcinomas showed significantly high rates in all items, namely, poorly differentiated adenocarcinomas were in more advanced stages such as stage IV and V. Curative resection rate was as low as 54.5%. Five-year survival rate was also low (38.4%) in all 33 cases, but was 59.6% in curative resection cases, that did not significantly differ from 75.1% in well differentiated adenocarcinoma cases.

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Thirty-one operative cases of gastric cancer in aged patients over 80 years were subjected to a study of their features, therapeutic results, preoperative laboratory findings and postoperative complications. 1) Differentiated advanced cancers were predominant in region A, and the resection rate was 90.3%, and curative resection rate, 64.3%. 2) The 5-year survival rates were 59.3% in curative resection group and 0% in non-curative resection group. 3) In patient groups in which preoperative laboratory findings included many abnormal items and other organs were combinedly resected, postoperative complications developed in higher frequencies. Abnormal preoperative laboratory findings and postoperative complications were predominantly found in the lung. Moreover, postopera tive mental diseases peculiar to aged people also occurred. For better operative outcomes, the importance of prevention and countermeasures against pulmonary complications and postoperative mental diseases should be emphasized. 4) To prevent postoperative complications and deaths immediately after surgery in aged patients, regional lymph node dissection and appropriate decision of resection area are important.

Thirty operated cases of colorectal cancer in aged patients over 80 years old were studied with reference to their characteristics, surgical outcomes, postoperative laboratory findings, and postoperative complications. 1) Well-differentiated advanced colonic carcinomas were predominant; and emergency operation for ileus or perforation represented 33.3%. 2) Resection rate was 96.7%; curative resection rate, 79.3%; and 5-year survival rate in curative resections, 54.3%. 3) Postoperative complications occurred in a high rate of 51.7%. The complications were commonly found in a patient group having 4 to 5 abnormal laboratory findings among 8 items and perforation, too. 4) Preoperative abnormal laboratory findings were commonly seen in terms of the lung and nutrition, which well corresponded with frequent occurrence of pneumonia and anastomotic breakdown. Moreover, encephalopathy or phrenophathy characteristic of aged people was also frequently observed. 5) It is thought that safe operation and postoperative management in response to each patient, which are able to prevent these postoperative complications and operative death, are necessary.

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