Neoadjuvant Treatment of Rectal Carcinoma: Assessment of Health Care Services by Physicians and Lay Persons

Abstract

Because of demographic changes, an increase in malignant diseases can be expected in the coming decades. Colorectal cancer has become the second most common form of cancer in both sexes. Standards for the diagnosis and treatment of colorectal cancer have changed considerably during the last decade, for example, the number of examined lymph nodes and routine total mesorectal excision. Multimodal treatment strategies such as neoadjuvant radiotherapy or radio-chemotherapy should further improve prognosis. Preoperative therapy reduces the local recurrence rate by half but also causes considerable long-term morbidity without influencing the prognosis. There is a variety of data sets, some of which focus on recurrence rates and prognosis, and some of which focus on quality-of-life issues. This complex situation creates difficulties in making treatment decisions for both experts and, to a greater degree, patients and lay persons. Therefore, we completed a project to summarize and present the data from several clinical trials in a way that lay persons can also understand the most important aspects, thus enhancing patient involvement in the decision-making process. The final presentation for the patients was based on published data from five major prospective, randomized, double-arm, multicentric studies on neoadjuvant treatment of rectal cancer with long-term follow-up. The target population consisted of patients who were to undergo surgery for rectal cancer, either with or without additional neoadjuvant radiotherapy or radio-chemotherapy. End points were postoperative and total mortality, rates of local relapses, and distant metastases, as well as long-term morbidity, such as frequency of fecal incontinence, cardiovascular diseases, disturbance of sexual functions, and secondary cancers resulting from radiotherapy. A detailed summary of the long-term morbidity was published separately. The summarized data of the five studies and the side effects reported for each study (summarized in Kornmann and HenneBruns) were presented in a graphical form consisting of four squares (quadrants) as shown in Figure 1. The two quadrants on the left side showed the results of treatment with preoperative radiation and the two quadrants on the right side showed the results of treatment without preoperative radiation. The two upper quadrants displayed the results that were reported in the initial publication for mortality and recurrences. The two lower quadrants showed the results for longterm morbidity, generally reported as separate publications (summarized in Kornmann and Henne-Bruns). Each of the end points was displayed in a different color. The graphically displayed results of the five studies were presented as POWERPoint presentation or colored tables to different groups of test persons. An example of a colored table is shown in Figure 1. The first group of test persons consisted of German lay persons (n 59). The second group consisted of 20 Brazilian guests of the Brazil Center Baden-Wurttemberg. Eighteen physicians participating in a seminar during the 8th Annual Convention of the German Network of Evidence-Based Medicine in Berlin, Germany, in March 2007, constituted the third group. The fourth group consisted of participants at the Congress of Health Networkers—principally health insurance managers, employees in hospital administration, and employees of the pharmaceutical industry (n 34). The fifth group consisted of 21 persons affiliated with health care politics. In the first group, the participants were requested to vote on the treatment options in the five studies after a 20-minute introduction to the topic of rectal cancer. This introduction gave a brief overview about the anatomy, pathogenesis, treatment options, possible side effects, and life with cancer recurrence. After this introduction, the participants had the chance to discuss and ask questions before voting. Each study was then presented as an animated POWERPoint slide (Fig 1). The test persons had to vote for their preferred approach, surgery with (A) or without (B) neoadjuvant treatment, immediately after the presentation of the summarized data of each study. Only the five tables with the two different therapeutic concepts were shown to the second to fifth test groups. The 152 test persons made a total of 760 decisions, of which 86% (minimum, 73%; maximum, 93%) would choose not to receive neoadjuvant therapy. In only one of the five studies, a 10% survival benefit in favor of the radiotherapy group had been reported. Nevertheless, only 24% of all participants in this study preferred the treatment with preoperative radiation. When summarizing and presenting the data, we realized the difficulties in understanding the details and reported differences in the various studies. Preparing such a presentation involves considerable time and effort, because the necessary information had to be extracted and summarized from different publications with different subgroup analyses (eg, patients who underwent R0 resection or long-term survivors). JOURNAL OF CLINICAL ONCOLOGY COMMENTS AND CONTROVERSIES VOLUME 26 NUMBER 30 OCTOBER 2