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Intensive vs Clinical Follow-up After Treatment of Primary Breast Cancer: 10-Year Update of a Randomized Trial
To the Editor: Two randomized trials performed in Italy1-2 failed to show any impact of intensive diagnostic follow-up on 5-year mortality for patients with primary breast cancer. We have now evaluated the mortality at 10 years in 1 of these large trials, designed to compare the effectiveness of 2 alternative follow-up protocols (intensive vs clinical) offered to study participants during the first 5 years after the treatment of primary breast cancer.
Methods.
A detailed description of the study protocol was published previously in THE JOURNAL.1 Briefly, 1243 consecutive patients surgically treated for unilateral invasive breast carcinoma with no evidence of metastases were included in the study and randomized in a 2-year period (1985-1986) by 12 participating centers in Italy. Overall, 622 patients were assigned to the intensive follow-up group and invited to have a periodic physical examination (every 3 months in the first 2 years and every 6 months thereafter) and annual mammography as well as biannual chest x-ray and bone scan; in contrast, 621 patients in the clinical follow-up group were offered physical examination and mammography with the same schedule but no other routine diagnostic test.1 The main prognostic characteristics of randomized patients were comparable in the 2 groups.
Results.
Tracking of patients was nearly complete and information on vital status at 10 years was available for 1233 patients (99.2%). Overall, 434 deaths were identified (222 in the intensive follow-up group and 212 in the clinical follow-up group). Estimated 10-year mortality cumulative rates were not different for the clinical (31.5%) and intensive (34.8%) follow-up groups (Figure 1). Survival analysis using the Cox proportional hazards method did not reveal any survival advantage for the intensive protocol (hazard ratio, 1.05; 95% confidence interval, 0.87-1.26).
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Figure. Overall 10-Year Kaplan-Meier Survival Curves by Group for 1243 Breast Cancer Patients Randomized to Intensive Diagnosis or Routine Clinical Follow-up
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Comment.
Medical efforts and financial expenditures devoted to follow-up programs for breast and other common solid tumors are increasing rapidly,3 particularly if multiple rigidly scheduled diagnostic tests are performed. Most breast cancer recurrences, however, are detected by the patient herself or by physical examination performed by a clinician.4 Except for mammographic examination, available evidence does not call for the routine use of any diagnostic or laboratory test, including tumor markers for which the effect on survival is still unclear.5-6 The cost-benefit aspects of periodic multitest examinations in cancer patients have been discussed in detail but no general consensus has been achieved on the definition of a specific protocol.6
Our updated results exclude any relevant long-term effect on mortality, even though cancer recurrences were detected earlier in the first 5 years of intensive follow-up, and confirm that such a protocol does not offer any survival advantage to breast cancer patients. These results provide additional evidence that to save resources, clinical follow-up could safely be recommended as a routine policy.
Before intensive monitoring programs are introduced, studies should evaluate whether newer diagnostic methods or the existence of better treatment modalities warrant intensive monitoring based on a survival advantage to patients.
AUTHOR INFORMATION
A complete list of the participants can be found in JAMA. 1994;271:1593-1597.
Dr Pacini is deceased.
Domenico Palli, MD;
Antonio Russo, MD;
Calogero Saieva, MD;
Stefano Ciatto, MD;
Marco Rosselli Del Turco, MD;
Vito Distante, MD;
Paolo Pacini, MD
Florence, Italy
for the National Research Council Project on Breast Cancer Follow-up
1. Rosselli Del Turco M, Palli D, Cariddi A, Ciatto S, Pacini P, Distante V. Intensive diagnostic follow-up after treatment of primary breast cancer: a randomized trial. JAMA. 1994;271:1593-1597.
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2. The GIVIO Investigators. Impact of follow-up testing on survival and health-related quality of life in breast cancer patients: a multicenter randomized controlled trial. JAMA. 1994;271:1587-1592.
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3. Mapelli V, Dirindin N, Grilli R. Economic evaluation of diagnostic follow-up after primary treatment for breast cancer. Ann Oncol. 1995;6(suppl 2):S61-S64.
4. Schapira DV, Urban N. A minimalist policy for breast surveillance. JAMA. 1991;265:380-382.
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5. Clinical practice guidelines for the use of tumor markers in breast and colorectal cancer: adopted on May 17, 1996 by the American Society of Clinical Oncology. J Clin Oncol. 1996;14:2843-2877.
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6. Follow-up after treatment for breast cancer: the Steering Committee on Clinical Practice Guidelines for the Care and Treatment of Breast Cancer. CMAJ. 1998;158(suppl 3):S65-S70.
Edited by Margaret A. Winker, MD, Deputy Editor, and Phil B. Fontanarosa, MD, Interim Coeditor.
JAMA. 1999;281:1586.
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