Originally published as JCO Early Release 10.1200/JCO.2008.16.2891 on August 18 2008

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

Marko Kornmann, Doris Henne-Bruns, Franz Porzsolt

Clinic for General, Visceral, and Transplantation Surgery, and Clinical Economics, University of Ulm, Ulm, Germany

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.^1,2 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.³

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.^4-8 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.²

The summarized data of the five studies^4-8 and the side effects reported for each study (summarized in Kornmann and Henne-Bruns²) 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 long-term morbidity, generally reported as separate publications (summarized in Kornmann and Henne-Bruns²). Each of the end points was displayed in a different color.

View larger version (40K): [in this window] [in a new window] [PowerPoint Slide for Teaching]   Fig 1. Comparative graphic illustrations of health care services based on the example of neoadjuvant radiotherapy for rectal cancer. The illustrations are based on four quadrants showing 100 squares representing % or events. The results of radiation (A) are shown on the two left quadrants and the results without radiation (B) on the right. The relative incidence of postoperative mortality, local recurrence, and distant metastasis is displayed in the two upper quadrants; important long-term undesired events (eg, fecal incontinence, circulatory diseases, and second cancers) are displayed in the two lower quadrants. The upper quadrants show the results of all patients, and the lower quadrants show the undesirable events among long-term survivors. To better differentiate the criteria, each is represented in a different color. Calculation of relative incidences is described in Kornmann et al.3

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,⁶ 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).

Although available studies on rectal cancer unanimously show that neoadjuvant therapy can reduce the rate of local recurrence by one half,¹ the majority of lay persons (86%) voted against neoadjuvant therapy. Guidelines of many countries do not reflect this preference of lay persons; rather, they recommend the treatment that is focused on local control. Therefore, we investigated several guidelines or contacted their authors to find out whether patients or their representatives were involved. We found that in six of 13 guidelines, patient representatives were involved.³ As 86% of the test persons in our study voted against the neoadjuvant therapy, it is unclear to us whether the patient representatives in the guideline groups who recommended neoadjuvant therapy in 11 (85%) of 13 guidelines had the possibility to discuss the recommendations in detail. Analysis of the decisions showed that the physicians were more concerned about recurrence, whereas lay persons were more concerned about quality-of-life criteria.

Our data substantiate findings from numerous publications describing that patients often decide differently than experts.^9-11 The main limitation of this study is the fact that lay persons and not patients, directly affected by this disease, were asked to decide. Patients may still want more than lay persons.¹² They may be more afraid of local recurrence than lay persons or physicians and therefore may decide differently. As a future project, it is important to determine treatment preferences according to our tables directly among patients with rectal cancer. It was also reported more than a decade ago that patients misinterpret the seriousness of their illness.¹² Patients with little secondary education were significantly more likely to underestimate the seriousness of their condition.¹² In our analysis, lay persons decided similarly to highly educated groups. Another possible limitation of this study may be the insufficiently provided information of patients and relatives. However, the informal discussion after our presentation clearly indicated that the participants were satisfied: some lay persons who participated as test persons in our study had previously made decisions on neoadjuvant therapy to advise one of their relatives. These people confirmed that this detailed information would have been very helpful if it was available at the time they had to discuss the treatment options with their relatives. Such comments raise the question of whether we should invest more resources for the preparation of high-quality patient information. In the future, such information should be presented to each patient before treatment. This may give patients the chance to choose an intervention guided on individual preferences. Additionally, we may learn more about possible differences in the preferences of physicians, lay persons, and patients.

The following conclusions can be drawn from the results of our study: (1) Providing adequate information for lay persons requires careful preparation of data. Otherwise, complex medical data and the derived conclusions cannot be understood by patients and lay persons. (2) It may be reasonable from an ethical and economic point to spend more resources in the future for the preparation of scientific information material for patients and lay persons.

AUTHORS’ DISCLOSURES OF POTENTIAL CONFLICTS OF INTEREST

The author(s) indicated no potential conflicts of interest.

AUTHOR CONTRIBUTIONS

Conception and design: Marko Kornmann

Provision of study materials or patients: Marko Kornmann, Doris Henne-Bruns, Franz Porzsolt

Collection and assembly of data: Marko Kornmann, Franz Porzsolt

Data analysis and interpretation: Marko Kornmann, Franz Porzsolt

Manuscript writing: Marko Kornmann, Doris Henne-Bruns, Franz Porzsolt

Final approval of manuscript: Marko Kornmann, Doris Henne-Bruns, Franz Porzsolt

ACKNOWLEDGMENTS

This article is based on a study reported in detail in the journal Zentralblatt für Chirurgie by Kornmann et al.³

NOTES

published online ahead of print at www.jco.org August 18, 2008

REFERENCES

1. Junginger T, Hermanek P, Oberholzer K, et al: Rectal carcinoma: Is too much neoadjuvant therapy performed? Proposals for a more selective MRI based indication. Zentralbl Chir 131:275-284, 2006[Medline]

2. Kornmann M, Henne-Bruns D: Quality of data for evidence based medicine: Rectal cancer and preoperative 5x5 radiation. Zentralbl Chir 133:20-24, 2008[CrossRef][Medline]

3. Kornmann M, Porzsolt F, Henne-Bruns D: Lay assessment of health care services using rectal cancer as example. Zentralbl Chir 133:148-155, 2008[CrossRef][Medline]

4. Cedermark B, Johansson H, Rutqvist LE, et al: The Stockholm I trial of preoperative short term radiotherapy in operable rectal carcinoma: A prospective randomized trial—Stockholm Colorectal Cancer Study Group. Cancer 75:2269-2275, 1995[CrossRef][Medline]

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6. Swedish Rectal Cancer Trial: Improved survival with preoperative radiotherapy in resectable rectal cancer. N Engl J Med 336:980-987, 1997[Abstract/Free Full Text]

7. Kapiteijn E, Marijnen CA, Nagtegaal ID, et al: Preoperative radiotherapy combined with total mesorectal excision for resectable rectal cancer. N Engl J Med 345:638-646, 2001[Abstract/Free Full Text]

8. Sauer R, Sauer R, Becker H, et al: Preoperative versus postoperative chemoradiotherapy for rectal cancer. N Engl J Med 351:1731-1740, 2004[Abstract/Free Full Text]

9. Davis A: Patient's right to decide is new value in health care. ANA Publ 14-17, 1985

10. Heisler M, Vijan S, Anderson RM, et al: When do patients and their physicians agree on diabetes treatment goals and strategies, and what difference does it make? J Gen Intern Med 18:893-902, 2003[CrossRef][Medline]

11. Rothenbacher D, Ruter G, Brenner H: Prognostic value of physicians’ assessment of compliance regarding all-cause mortality in patients with type 2 diabetes: Primary care follow-up study. BMC Fam Pract 7:42, 2006[CrossRef][Medline]

12. Mackillop WJ, Stewart WE, Ginsburg AD, et al: Cancer patients’ perceptions of their disease and its treatment. Br J Cancer 58:355-358, 1988[Medline]

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