|
Advertisement |
|
|
||
 |
|
|||||
|
|||||
|
 |
||||||
|
||||||
|
||||||
|
© 2000 American Society for Clinical Oncology
Correspondence Re: "Doc, Shouldn’t We Be Getting Some Tests?"Sound Shore Medical Center New Rochelle, NY To the Editor:The article "Doc, Shouldn’t We Be Getting Some Tests?"1 was read with great interest. I have generally been using these guidelines in my practice for many years, but recently have been reconsidering. Although technically correct, the article leaves out certain issues that are worthy of discussion. The first issue is the value of the office visit. Although follow-up mammograms may find an occasional curable breast cancer, the patient need not see the oncologist to get a follow-up mammogram. The primary care physician can do the routine care for other health concerns. Data of which I am aware show that routine oncology office visits prolong survival. Therefore, if we are to be consistent, we should not have patients come back for routine office visits, and we should revert to the type of episodic emergency oncology care that we have been decrying for years. The second issue is the value of these tests for some of the patients, even if the median survival does not improve. There are data showing that patients with isolated hepatic recurrences can have their survival improved by timely surgery.2 Let us further take the case of a woman with an estrogen receptor–positive tumor treated previously only with lumpectomy and radiation therapy who develops a significant rise in the CA 27.29 marker. It makes sense to consider hormonal therapy for her now rather than to wait until she has significant symptoms or perhaps a hip fracture. I am afraid that there may be many cases where we may lose the trees for the forest. If the patients are coming to us to monitor their condition, we should either refuse and say that monitoring is not helpful for the majority of patients, or we should monitor the patients with all the weapons we have in a judicious manner. REFERENCES
1.
Loprinzi CL, Hayes D, Smith T: Doc, shouldn’t we be getting some tests? J Clin Oncol 18: 2345-2348, 2000 2. Fong Y, Fortner J, Sun RL, et al: Clinical score for predicting recurrence after hepatic resection for metastatic colorectal cancer: Analysis of 1001 consecutive cases. Ann Surg 230: 309-321, 1999[Medline]
Response
Georgetown University Medical Center Washington, DC In Reply:Dr Bernhardt raises frequently voiced concerns. (1) Are the American Society of Clinical Oncology (ASCO) guidelines regarding monitoring of circulating tumor markers in asymptomatic breast cancer patients who are free of detectable disease incorrect or inconsistent?1-3 (2) Are practice guidelines, in general, too constrictive to be of practical use for individual patients? All three of us are both practicing oncologists and members of one or more guidelines expert panels. Therefore, we share his concerns but believe that both the specific guidelines and the process are valid. First, Bernhardt questions the validity and utility of the specific guidelines for monitoring breast cancer patients after primary and adjuvant therapy. He should be assured that the recommendations of the ASCO expert panels were very thoughtfully (and, on occasion, contentiously) crafted, given the available evidence at the time. In regard to his concern about consistency, improvement in overall survival was not the only criterion for a recommendation. Indeed, the four end points considered were prolongation of overall survival, disease-free survival, quality of life, and/or cost reduction if the first three were equal.4 There is no evidence that initiation of a new systemic therapy in an asymptomatic patient in response to a rising marker (or an asymptomatic, radiographically detected metastasis) results in longer overall survival when compared with initiating the same therapy when symptoms occur.5 Clearly, early treatment is the fundamental tenant of screening for early detection and surgical treatment of new breast cancer and, of course, of application of adjuvant systemic therapy. However, these therapies are administered years before a micrometastasis is destined to appear as a nearly universally incurable recurrence. One could argue that in the classic metastatic setting, the modest survival benefits of recently introduced therapies, such as aromatase inhibitors and trastuzumab, might be enhanced by earlier application. Indeed, both of these therapies are now in or entering prospective randomized clinical trials in the adjuvant setting. However, the average lead time between a rising, circulating tumor marker and detection of a symptomatic metastasis is 3 to 6 months.6 It is difficult to assume that earlier application of treatment because of this short lead time would be likely to result in substantially increased overall survival. Bernhardt should distinguish the potential survival benefits of resection of isolated colon cancer metastases from those of resection of breast cancer metastases. The biology and metastatic patterns of the two seem to differ. In fact, on the basis of a considerable body of evidence, the ASCO tumor marker guidelines panel recommended routine monitoring of circulating carcinoembryonic antigen levels after complete resection in selected colon cancer patients.1,3 Similar data supporting such an approach in breast cancer are lacking.5 Does routine tumor marker screening improve quality of life? It is difficult to palliate an asymptomatic patient. However, one could argue that delaying onset of symptoms might result in overall improved global quality of life. Such an approach requires relatively nontoxic therapy to replace whatever therapy (if any) the patient is currently receiving. Perhaps, in postmenopausal patients with estrogen receptor–positive tumors, substitution of aromatase inhibitors for tamoxifen might be successful, but this issue is unstudied. In the absence of a survival benefit, the emotional consequences of identifying impending recurrence might outweigh the benefits of delaying onset of symptoms. One could also argue that a negative test is reassuring to both patient and doctor. However, nearly 50% of all recurrences fail to have a preceding elevation in any circulating tumor marker.6 Furthermore, at any single clinic visit of an asymptomatic patient, the negative predictive value of a nonelevated marker is high, but mostly because it is very unlikely she will have a recurrence in the next 6 months anyway. For example, even for node-positive patients in year 2 or 3, the risk of recurrence is only 6% to 8%.7 In addition, those patients who are reassured by negative test results need to be counterbalanced by the relatively frequent false-positive tests that clearly cause angst.5,6 In the only study that formally examined the issue, quality of life was not better (actually worse, but not statistically significant) in the group who had more intensive monitoring.8 Bernhardt questions the consistency between the guidelines regarding tumor markers and those regarding routine office visits. Again, the goals and end points of the recommendation must be considered. We agree that subspecialty office visits are unlikely to improve survival. However, several investigators have addressed the importance of such visits, and at least two prospective randomized trials have been conducted that failed to demonstrate any differences in time to detection of recurrence, medical outcomes, or survival in the group who was observed by subspecialists.9-16 However, in general, results from these and other studies do suggest that patients prefer at least some follow-up with an oncologist. Given the relatively frequent moderate and long-term toxicities of antineoplastic chemo- and endocrine therapies, it seems reasonable to continue some oncologic follow-up. Moreover, it seems likely that oncologists will be better prepared to discuss issues regarding chemo- and surgical prevention, genetic testing, and other concerns. Indeed, it is possible that specialty care might actually decrease costs of follow-up because trained oncologists may be more likely to follow data-driven, evidence-based guidelines than to order a battery of nonindicated tests! Finally, we share Bernhardt’s concerns over whether guidelines should be reconsidered. Do we "lose the trees for the forest?" Are guidelines merely cost savings for the population but not good care for individual patients? The use of evidence-based practice guidelines is a relatively new phenomenon in medicine, and thorough evaluations of their validity and efficacy in improving clinical outcomes are just beginning to appear in the literature. The most comprehensive review of the evidence showed that guidelines improved both process and outcome of medical care in most cases,17 and there is substantial evidence that these improvements extend to oncology.18 Regardless, most oncologists recognize the importance of following strict "protocols," whether on clinical trials or off. Importantly, the results of a recently reported study suggested that overall survival was longer for Austrian women with newly diagnosed breast cancer who participated in prospective randomized clinical trials compared with those who were treated off-study.19 We recognize that "doctors need to be doctors" and that occasional deviation from clinical guidelines is not only acceptable, it is indicated in some cases. Clearly, the human body and mind are biologic systems, not engineered machines, and 100% adherence to guidelines may well reflect poor consideration for the individual.20 Nonetheless, we are committed to the concept of guideline development and implementation, with the goal of improved patient care but also with the understanding that they are dynamic and require frequent re-evaluation, validation, and modification. REFERENCES
1.
American Society of Clinical Oncology: Clinical practice guidelines for the use of tumor markers in breast and colorectal cancer. J Clin Oncol 14: 2843-2877, 1996
2.
American Society of Clinical Oncology: Recommended breast cancer surveillance guidelines. J Clin Oncol 15: 2149-2156, 1997 3. American Society of Clinical Oncology: 1997 update of recommendations for the use of tumor markers in breast and colorectal cancer. J Clin Oncol 16: 793-795, 1998[Abstract]
4.
Hayes DF, Bast R, Desch CE, et al: A tumor marker utility grading system (TMUGS): A framework to evaluate clinical utility of tumor markers. J Natl Cancer Inst 88: 1456-1466, 1996 5. Hayes DF: Evaluation of patients following primary therapy, in Harris J, Lippman M, Morrow M, et al (eds): Diseases of the Breast. Philadelphia, PA, Lippincott Williams & Wilkins, 2000, pp 709-730 6. Stearns V, Yamauchi H, Hayes DF: Circulating tumor markers in breast cancer: Accepted utilities and novel prospects. Breast Cancer Res Treat 52: 239-259, 1998[Medline]
7.
Saphner T, Tormey DC, Gray R: Annual hazard rates of recurrence for breast cancer after primary therapy. J Clin Oncol 14: 2738-2746, 1996
8.
Impact of follow-up testing on survival and health-related quality of life in breast cancer patients: A multicenter randomized controlled trial—The GIVIO Investigators. JAMA 271: 1587-1593, 1994 9. Dewar J. Follow up in breast cancer. BMJ 310:685-686, 1995 (editorial) 10. Adewuyi-Dalton R, Ziebland S, Grunfeld E, et al: Patients’ views of routine hospital follow-up: A qualitative study of women with breast cancer in remission. Psychooncology 7: 436-439, 1998[Medline]
11.
Rainsbury D: Routine follow up of breast cancer in primary care: Follow up by non-specialists should not be encouraged. BMJ 313: 1547, 1996 (letter)
12.
Grunfeld E, Mant D, Vessey MP, et al: Specialist and general practice views on routine follow-up of breast cancer patients in general practice. Fam Pract 12: 60-65, 1995
13.
Grunfeld E, Yudkin P, Adewuyl-Dalton R, et al: Follow up in breast cancer: Quality of life unaffected by general practice follow up. BMJ 311: 54, 1995 (letter) 14. Grunfeld E, Mant D, Vessey MP, et al: Evaluating primary care follow-up of breast cancer: Methods and preliminary results of three studies. Ann Oncol 6: 47-52, 1995
15.
Grunfeld E, Mant D, Yudkin P, et al: Routine follow up of breast cancer in primary care: Randomised trial. BMJ 313: 665-669, 1996
16.
Gulliford T, Opomu M, Wilson E, et al: Popularity of less frequent follow up for breast cancer in randomised study: Initial findings from the hotline study. BMJ 314: 174-177, 1997 17. Grimshaw JM, Russell IT: Effect of clinical guidelines on medical practice: A systematic review of rigorous evaluations. Lancet 342: 1317-1322, 1993[Medline] 18. Simone J, Hewitt M: Ensuring quality cancer care: A report of the Institute of Medicine/National Academy of Sciences. Washington, DC, National Academy Press, 1999 19. Gnant M: Impact of participation in randomized clinical trials on survival of women with early-stage breast cancer: An analysis of 7985 patients. Proc Am Soc Clin Oncol 19: 74a, 2000 (abstr 287) 20. James BC, Hammond ME: The challenge of variation in medical practice. Arch Pathol Lab Med 124: 1001-1003, 2000[Medline]
|
|||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|
|
|||||||||||
|
|||||||||||
|
|
Copyright © 2000 by the American Society of Clinical Oncology, Online ISSN: 1527-7755. Print ISSN: 0732-183X
|
