Updated analysis of SWOG-directed intergroup study 0116: a phase III trial of adjuvant radiochemotherapy versus observation after curative gastric cancer resection.

Purpose: Surgical resection of gastric cancer has produced suboptimal survival despite multiple randomized trials that used postoperative chemotherapy or more aggressive surgical procedures. We performed a randomized phase III trial of postoperative radiochemotherapy in those at moderate risk of locoregional failure (LRF) following surgery. We originally reported results with 4-year median follow-up.

Surgery for gastric cancer: what the trials indicate.

To optimize the therapeutic value of an operation for cancer, surgeons must weigh survival value against mortality/morbidity risk. As a result of several prospective, randomized trials, many surgeons feel that international opinion has reached a consensus. Reflexively radical surgical hubris has certainly given way to a more nuanced, customized approach to this disease.

Improved regional control and survival with "low Maruyama Index" surgery in gastric cancer: autopsy findings from the Dutch D1-D2 Trial.

Based on more than 11 years of follow-up, autopsy-based analysis of recurrence in the Dutch D1-D2 Trial permits meaningful assessment of patterns of failure with respect to the Maruyama Index (MI). We previously reported that a low Maruyama Index was an independent predictor of both overall and disease-specific survival. Autopsy results are available for 441 deaths on study.

Impact of hospital volume on recurrence and survival after surgery for gastric cancer.

Background: Some, but not all, studies using registry data have suggested a small but significant long-term survival advantage following a curative surgical resection of gastric cancer at hospitals where the volume of such surgeries is high. However, because such data may be significantly influenced by the impact of postoperative mortality, and may be imbalanced for factors important to survival, the true nature of this relationship remains uncertain.

Methods: We conducted a nested volume-outcome study in a sample of 448 surgical survivors with stage IB through IV (M0) gastric and gastroesophageal junction adenocarcinoma, previously randomized to adjuvant chemoradiation after surgery or surgery alone, to measure the effect of hospital surgical volume, as assessed by Medicare claims data, on overall survival and gastric cancer recurrence.

Gastric cancer: D2 dissection or low Maruyama Index-based surgery--a debate.

This article provides perspectives on the surgical approaches required optimally to manage patients with respectable gastric adenocarcinoma. The status of techniques of surgical resection in the management of gastric cancer is reviewed. The premise of this approach is that extended gastrectomy with D2 lymph node dissection is good.

Low maruyama index surgery for gastric cancer.

Background: Japanese definitions and treatment guidelines have dominated extent-of-surgery concepts in gastric cancer for over 4 decades, despite the fact that such definitions/guidelines have changed considerably over time, and the fact they have largely failed to improve survival in prospective, randomized clinical trials.

Aim: To briefly review lessons from previous surgical trials in gastric cancer, and, more specifically, to review data validating the concept of "low Maruyama Index surgery" as a data-driven guide to surgical treatment.

Methods: Review of results from blinded multivariate analyses of two separate, prospective, randomized clinical trials: (a) the Macdonald Trial of adjuvant postoperative chemo-radiation, Intergroup 0116, conducted in North America; and (b) the Dutch D1-D2 Trial.

Low Maruyama index surgery for gastric cancer: blinded reanalysis of the Dutch D1-D2 trial.

A quantitative estimate of residual nodal disease after gastric cancer surgery, the Maruyama index of unresected disease (MI), proved to be a strong independent predictor of survival in a large U.S. adjuvant chemoradiation study in which surgical undertreatment was frequent.

Changing gastric cancer treatment in the United States and the pursuit of quality.

The low incidence of gastric cancer in the US presents various quality challenges. For most US practitioners, individual experience is inadequate. Accrual to clinical trials testing new treatments can be daunting.

Determinants for urinary and plasma isoflavones in humans after soy intake.

Consumption of soy foods leads to a biphasic appearance pattern of isoflavones (IFLs) in blood and urine, with peaks appearing at 1-2 h and 4-8 h after intake, but its causes are not understood. IFLs were measured repeatedly from plasma and/or urine after intake of soy foods, IFL glucosides, or aglycons without or with a mildly or radically reduced gut flora as a result of oral antibiotic (AB) treatment, or this combined with mechanical bowel preparation (AB+MBP). The typical biphasic IFL pattern in blood and/or urine was observed when a soy protein drink without (control) or with AB treatment or when IFL glucosides or aglycons were consumed.

Time dependent ethnic convergence in colorectal cancer survival in Hawaii.

Background: Although colorectal cancer death rates have been declining, this trend is not consistent across all ethnic groups. Biological, environmental, behavioral and socioeconomic explanations exist, but the reason for this discrepancy remains inconclusive. We examined the hypothesis that improved cancer screening across all ethnic groups will reduce ethnic differences in colorectal cancer survival.

Surgical quality control in gastric cancer trials.

Quality control in prospective randomized surgical trials of gastric cancer treatment is reviewed. Progress and innovations in this area are described. Methodologic suggestions for future trials are made.

Ultrasound-guided radiofrequency thermal ablation of liver tumors: percutaneous, laparoscopic, and open surgical approaches.

Only 10% to 20% of patients with primary and colorectal metastatic liver tumors are candidates for curative surgical resection. Even after curative treatment, tumors recur commonly in the liver. As a less invasive therapy, radiofrequency thermal ablation (RFA) of primary, metastatic, and recurrent liver tumors was performed under percutaneous, laparoscopic, or open intraoperative ultrasound guidance.

Staging, stage migration, and patterns of spread in gastric cancer.

Background concerning tumor node metastasis (TNM) staging of gastric cancer is presented, with special attention to the issue of stage migration. Patterns of spread are also reviewed and current problems in local-regional control are emphasized.

Surgical treatment variation in a prospective, randomized trial of chemoradiotherapy in gastric cancer: the effect of undertreatment.

Background: Intergroup 0116 (Southwest Oncology Group 9008), a national, multicenter, two-armed, prospective, randomized trial of adjuvant postoperative chemoradiotherapy, has demonstrated significant benefit.

Methods: We prospectively captured complete surgical information, including the treatment of various lymph node stations, for 553 of the 556 eligible participants in this trial. Before any survival analysis, we coded D level by using the Japanese general rules and used the Maruyama program to estimate the likelihood of disease in undissected regional node stations, defining the sum of these estimates as the Maruyama Index of Unresected Disease (MI).

Chemoradiotherapy after surgery compared with surgery alone for adenocarcinoma of the stomach or gastroesophageal junction.

Background: Surgical resection of adenocarcinoma of the stomach is curative in less than 40 percent of cases. We investigated the effect of surgery plus postoperative (adjuvant) chemoradiotherapy on the survival of patients with resectable adenocarcinoma of the stomach or gastroesophageal junction.

Methods: A total of 556 patients with resected adenocarcinoma of the stomach or gastroesophageal junction were randomly assigned to surgery plus postoperative chemoradiotherapy or surgery alone.

Current practice of radioiodine treatment in the management of differentiated thyroid cancer in Germany.

This prospective, observational study of a cohort of thyroid cancer patients in Germany focusses on the "real-world" practice in the management of thyroid cancer patients. This report includes data from 2376 patients with primary differentiated thyroid carcinoma first diagnosed in the year 1996. The study reveals considerable differences in actual practice concerning surgery and radioiodine treatment.

Analysis of medical-decision making and the use of standards of care in oncology.

Guidelines in medicine have been proposed as a way to assist physicians in the clinical decision-making process. Increasingly, they form the basis for assessing accountability in the delivery of healthcare services. However, experiences with their evaluation, as the most important step in the continuous guidelines process, are rare.

Confronting actual practice with practice guidelines in oncology.

Improving health care quality requires the availability of data to identify and eliminate unnecessary variations in the care process. Variations can be caused by an ineffective implementation of research findings or by obstacles to the translation of research into clinical practice. The analysis of current patterns of care by the use of routine data from electronic patient records or clinical registries may help highlight these deficiencies in actual care.