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ARTICLE |

Intensive Diagnostic Follow-up After Treatment of Primary Breast Cancer: Title and subTitle BreakA Randomized Trial FREE

Marco Rosselli Del Turco, MD; Domenico Palli, MD; Angelo Cariddi, MD; Stefano Ciatto, MD; Paolo Pacini, MD; Vito Distante, MD
[+] Author Affiliations

A complete list of collaborators appears at the end of the article.

Reprint requests to Breast Unit, Centro per lo Studio e la Prevenzione Oncologica, Viale Alessandro Volta 171, 50131, Florence, Italy (Dr Rosselli Del Turco).


JAMA. 1994;271(20):1593-1597. doi:10.1001/jama.1994.03510440053032
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Objective.  —To evaluate the effectiveness of early detection of intrathoracic and bone metastases in reducing mortality in breast cancer patients.

Design.  —Randomized clinical trial allocating breast cancer patients to two alternative follow-up protocols (intensive vs clinical) for at least 5 years.

Setting.  —Twelve breast clinics (referral centers) in different areas in Italy.

Patients.  —A total of 1243 consecutive patients (either premenopausal or postmenopausal) surgically treated for unilateral invasive breast carcinoma with no evidence of metastases. The two study groups were well balanced in terms of clinical and prognostic characteristics.

Intervention.  —Patients in both treatment groups had physical examination and mammography, while patients of the intensive follow-up group had, in addition, chest roentgenography and bone scan every 6 months.

Main Outcome Measures.  —Vital status at 5 years was the main outcome; information was available for all except five patients (0.4%). Relapse-free survival was also analyzed.

Results.  —Overall, 393 recurrences (104 local and 289 distant) were observed during the study. Increased detection of isolated intrathoracic and bone metastases was evident in the intensive follow-up group compared with the clinical follow-up group (112 vs 71 cases), while no difference was observed for other sites and for local and/or regional recurrences. The 5-year relapse-free survival rate was significantly higher for the clinical follow-up group, with patients in the intensive follow-up group showing earlier detection of recurrences. No difference in 5-year overall mortality (18.6% vs 19.5%) was observed between the two follow-up groups.

Conclusions.  —Periodic chest roentgenography and bone scan allow earlier detection of distant metastases, but anticipated diagnosis appears to be the only effect of intensive follow-up, and no impact on prognosis is evident after 5 years. Periodic intensive follow-up with chest roentgenography and bone scan should not be recommended as a routine policy.(JAMA. 1994;271:1593-1597)

REFERENCES

Schapira DV, Urban N.  A minimalist policy for breast cancer surveillance. JAMA . 1991;;265:380-382.
Wertheimer MD.  Against minimalism in breast cancer follow-up. JAMA . 1991;;265:396-397.
Hietanen P.  Chest radiography in the follow-up of breast cancer. Acta Radiol . 1986;;25:15-18.
Logager VB, Vestergaard A, Herrstedt J, Thomsen HS, Zedeler K, Dombernowsky P.  The limited value of routine chest x-ray in the follow-up of stage II breast cancer. Eur J Cancer . 1990;;26: 553-555.
Zwaveling A, Albers GHR, Felthuis W, Hermans J.  An evaluation of routine follow-up for detection of breast cancer recurrences. J Surg Oncol . 1987;;34:194-197.
Andreoli C, Buranelli F, Campa T, et al.  Chest x-ray survey in breast cancer follow-up: a contrary view. Tumori . 1987;;73:463-465.
Ciatto S, Pacini P, Andreoli C, et al.  Chest x-ray survey in the follow-up of breast cancer patients. Br J Cancer . 1989;;60:102-103.
Tomin R, Donegan WL.  Screening for recurrent breast cancer: its effectiveness and prognostic value. J Clin Oncol . 1987;;5:62-67.
Horton J.  Follow-up of breast cancer patients. Cancer . 1984;;53:790-797.
Rutgers EJTH, van Slooten EA, Kluck HM.  Follow-up after treatment of primary breast cancer. Br J Surg . 1989;;76:187-190.
Ciatto S, Rosselli Del Turco M, Pacini P, De Luca Cardillo C, Bastiani P, Bravetti P.  Early detection of local recurrences in the follow-up of primary breast cancer. Tumori . 1984;;70:179-183.
Scanlon EF, Oviedo MA, Cunningham MP, et al.  Preoperative and follow-up procedures on patients with breast cancer. Cancer . 1980;;46:977-979.
Winchester DP, Sener SF, Khandekar JD, et al.  Symptomatology as an indicator of recurrent or metastatic breast cancer. Cancer . 1979;;43:956-960.
Ciatto S, Herd-Smith A.  The role of chest x-ray in the follow-up of primary breast cancer. Tumori . 1983;;69:151-154.
Chaudary MA, Maisey MN, Shaw PJ, Rubens RD, Hayward JL.  Sequential bone scans and chest radiographs in the postoperative management of early breast cancer. Br J Surg . 1983;;70:517-518.
Perez DJ, Milan J, Ford HT, et al.  Detection of breast carcinoma metastases in bone: relative merits of x-rays and skeletal scintigraphy. Lancet . 1983;; 2:613-616.
Thomsen HS, Rasmussen D, Munck O, et al.  Bone metastases in primary operable breast cancer: the role of a yearly scintigraphy. Eur J Cancer Clin Oncol . 1987;;23:779-781.
Coleman RE, Fogelman I, Habibollahi F, North WRS, Rubens RD.  Selection of patients with breast cancer for routine follow-up bone scans. Clin Oncol (R Coll Radiol) . 1990;;2:328-332.
Forza Operativa Nazionale sul Carcinoma Mammario (F.O.N.Ca.M.). I Tumori Della Mammella: Protocollo di Trattamento e Anatomia Patologica . Milan, Italy: Consiglio Nazionale delle Ricerche; 1985;.
Kaplan EL, Meier P.  Nonparametric estimation from incomplete observations. J Am Stat Assoc . 1958;;53:457-481.
Capocaccia R, Verdecchia A, Micheli A, et al.  Breast cancer incidence and prevalence estimated from survival and mortality. Cancer Causes Control . 1990;;1:23-29.
Zelen M.  A hypothesis for the natural time history of breast cancer. Cancer Res . 1968;;28:207-216.

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Schapira DV, Urban N.  A minimalist policy for breast cancer surveillance. JAMA . 1991;;265:380-382.
Wertheimer MD.  Against minimalism in breast cancer follow-up. JAMA . 1991;;265:396-397.
Hietanen P.  Chest radiography in the follow-up of breast cancer. Acta Radiol . 1986;;25:15-18.
Logager VB, Vestergaard A, Herrstedt J, Thomsen HS, Zedeler K, Dombernowsky P.  The limited value of routine chest x-ray in the follow-up of stage II breast cancer. Eur J Cancer . 1990;;26: 553-555.
Zwaveling A, Albers GHR, Felthuis W, Hermans J.  An evaluation of routine follow-up for detection of breast cancer recurrences. J Surg Oncol . 1987;;34:194-197.
Andreoli C, Buranelli F, Campa T, et al.  Chest x-ray survey in breast cancer follow-up: a contrary view. Tumori . 1987;;73:463-465.
Ciatto S, Pacini P, Andreoli C, et al.  Chest x-ray survey in the follow-up of breast cancer patients. Br J Cancer . 1989;;60:102-103.
Tomin R, Donegan WL.  Screening for recurrent breast cancer: its effectiveness and prognostic value. J Clin Oncol . 1987;;5:62-67.
Horton J.  Follow-up of breast cancer patients. Cancer . 1984;;53:790-797.
Rutgers EJTH, van Slooten EA, Kluck HM.  Follow-up after treatment of primary breast cancer. Br J Surg . 1989;;76:187-190.
Ciatto S, Rosselli Del Turco M, Pacini P, De Luca Cardillo C, Bastiani P, Bravetti P.  Early detection of local recurrences in the follow-up of primary breast cancer. Tumori . 1984;;70:179-183.
Scanlon EF, Oviedo MA, Cunningham MP, et al.  Preoperative and follow-up procedures on patients with breast cancer. Cancer . 1980;;46:977-979.
Winchester DP, Sener SF, Khandekar JD, et al.  Symptomatology as an indicator of recurrent or metastatic breast cancer. Cancer . 1979;;43:956-960.
Ciatto S, Herd-Smith A.  The role of chest x-ray in the follow-up of primary breast cancer. Tumori . 1983;;69:151-154.
Chaudary MA, Maisey MN, Shaw PJ, Rubens RD, Hayward JL.  Sequential bone scans and chest radiographs in the postoperative management of early breast cancer. Br J Surg . 1983;;70:517-518.
Perez DJ, Milan J, Ford HT, et al.  Detection of breast carcinoma metastases in bone: relative merits of x-rays and skeletal scintigraphy. Lancet . 1983;; 2:613-616.
Thomsen HS, Rasmussen D, Munck O, et al.  Bone metastases in primary operable breast cancer: the role of a yearly scintigraphy. Eur J Cancer Clin Oncol . 1987;;23:779-781.
Coleman RE, Fogelman I, Habibollahi F, North WRS, Rubens RD.  Selection of patients with breast cancer for routine follow-up bone scans. Clin Oncol (R Coll Radiol) . 1990;;2:328-332.
Forza Operativa Nazionale sul Carcinoma Mammario (F.O.N.Ca.M.). I Tumori Della Mammella: Protocollo di Trattamento e Anatomia Patologica . Milan, Italy: Consiglio Nazionale delle Ricerche; 1985;.
Kaplan EL, Meier P.  Nonparametric estimation from incomplete observations. J Am Stat Assoc . 1958;;53:457-481.
Capocaccia R, Verdecchia A, Micheli A, et al.  Breast cancer incidence and prevalence estimated from survival and mortality. Cancer Causes Control . 1990;;1:23-29.
Zelen M.  A hypothesis for the natural time history of breast cancer. Cancer Res . 1968;;28:207-216.
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