Randomized multicenter trial of sentinel node biopsy versus standard axillary treatment in operable breast cancer: The ALMANAC trial

Journal of the National Cancer Institute

Volumn 98, Issue 9, 2006, Pages 599-609

  Mansel, Robert E ^a   Fallowfield, Lesley ^b   Kissin, Mark ^c   Goyal, Amit ^a   Newcombe, Robert G ^a   Dixon, J Michael ^d   Yiangou, Constantinos ^e   Horgan, Kieran ^f   Bundred, Nigel ^g   Monypenny, Ian ^a   England, David ^h   Sibbering, Mark ⁱ   Abdullah, Tholkifl I ^j   Barr, Lester ^g   Chetty, Utheshtra ^d   Sinnett, Dudley H ^k   Fleissig, Anne ^b   Clarke, Dayalan ^a   Ell, Peter J ^l  

^a CARDIFF UNIVERSITY   (United Kingdom)

^b BRIGHTON AND SUSSEX MEDICAL SCHOOL   (United Kingdom)

^c ROYAL SURREY COUNTY HOSPITAL   (United Kingdom)

^d WESTERN GENERAL HOSPITAL   (United Kingdom)

^e QUEEN ALEXANDRA HOSPITAL   (United Kingdom)

^f LEEDS GENERAL INFIRMARY   (United Kingdom)

^g MANCHESTER UNIVERSITY NHS FOUNDATION TRUST   (United Kingdom)

^h QUEEN ELIZABETH HOSPITAL   (United Kingdom)

ⁱ DERBY CITY GENERAL HOSPITAL   (United Kingdom)

^j EDITH CAVELL HOSPITAL   (United Kingdom)

^k CHARING CROSS HOSPITAL   (United Kingdom)

^l MIDDLESEX HOSPITAL   (United Kingdom)

more..

Author keywords

[No Author keywords available]

Indexed keywords

ADULT; ANXIETY; ARM MOVEMENT; ARTICLE; AXILLARY LYMPH NODE; BREAST CANCER; CANCER MORTALITY; CANCER RADIOTHERAPY; CANCER RECURRENCE; CANCER STAGING; CLINICAL PROTOCOL; CLINICAL TRIAL; CONFIDENCE INTERVAL; CONTROLLED CLINICAL TRIAL; CONTROLLED STUDY; CONVALESCENCE; DAILY LIFE ACTIVITY; FEMALE; HUMAN; INTERMETHOD COMPARISON; LENGTH OF STAY; LYMPH NODE DISSECTION; LYMPH NODE METASTASIS; LYMPHATIC DRAINAGE; LYMPHEDEMA; MAJOR CLINICAL STUDY; MALE; MASTECTOMY; MEDICAL DECISION MAKING; MEDICAL RECORD; MORBIDITY; MULTICENTER STUDY; OPERATION DURATION; OUTCOME ASSESSMENT; POSTOPERATIVE PERIOD; PRIORITY JOURNAL; QUALITY OF LIFE; RANDOMIZED CONTROLLED TRIAL; RISK ASSESSMENT; SCORING SYSTEM; SENSORY DYSFUNCTION; SENTINEL LYMPH NODE BIOPSY; STATISTICAL ANALYSIS; ADJUVANT THERAPY; ARM; AXILLA; BREAST TUMOR; INCIDENCE; LUNG CARCINOMA; LYMPHADENECTOMY; METHODOLOGY; MIDDLE AGED; MOVEMENT (PHYSIOLOGY); PAGET NIPPLE DISEASE; PATHOLOGY; PATHOPHYSIOLOGY; SHOULDER; SURGICAL INFECTION; TREATMENT OUTCOME; WOUND DRAINAGE;

ARM; AXILLA; BREAST NEOPLASMS; BREAST NEOPLASMS, MALE; CARCINOMA, DUCTAL, BREAST; CARCINOMA, LOBULAR; DRAINAGE; FEMALE; HUMANS; INCIDENCE; LENGTH OF STAY; LYMPH NODE EXCISION; LYMPHATIC METASTASIS; LYMPHEDEMA; MALE; MASTECTOMY; MIDDLE AGED; MOVEMENT; QUALITY OF LIFE; RADIOTHERAPY, ADJUVANT; RISK ASSESSMENT; SENTINEL LYMPH NODE BIOPSY; SHOULDER; SURGICAL WOUND INFECTION; TREATMENT OUTCOME;

EID: 33646465164     PISSN: 00278874     EISSN: 14602105     Source Type: Journal    
DOI: 10.1093/jnci/djj158     Document Type: Article

References (39)

1. Maunsell E, Brisson J, Deschenes L. Arm problems and psychological distress after surgery for breast cancer. Can J Surg 1993;36:315-20.
2. Hack TF, Cohen L, Katz J, Robson LS, Goss P. Physical and psychological morbidity after axillary lymph node dissection for breast cancer. J Clin Oncol 1999;17:143-9.
3. Roses DF, Brooks AD, Harris MN, Shapiro RL, Mitnick J. Complications of level I and II axillary dissection in the treatment of carcinoma of the breast. Ann Surg 1999;230:194-201.
4. Velanovich V, Szymanski W. Quality of life of breast cancer patients with lymphedema. Am J Surg 1999;177:184-7.
5. Warmuth MA, Bower G, Prosnitz LR, Chu L, Broadwater G, Peterson B, et al. Complications of axillary lymph node dissection for carcinoma of the breast: A report based on a patient survey. Cancer 1998;83:1362-8.
6. The UK NHS Breast Screening Programme 2001/2 statistics. http://www.cancerscreening.nhs.uk/breastscreen. [Last accessed: July 30, 2004.]
7. Clarke D, Newcombe RG, Mansel RE. The learning curve in sentinel node biopsy: The ALMANAC experience. Ann Surg Oncol 2004;11:211S-5S.
8. McMasters KM, Wong SL, Chao C, Woo C, Tuttle TM, Noyes RD, et al. Defining the optimal surgeon experience for breast cancer sentinel lymph node biopsy: A model for implementation of new surgical techniques. Ann Surg 2001;234:292-9.
9. Turner RR, Ollila DW, Krasne DL, Giuliano AE. Histopathologic validation of the sentinel lymph node hypothesis for breast carcinoma. Ann Surg 1997;226:271-6.
10. Temple LK, Baron R, Cody HS, III, Fey JV, Thaler HT, Borgen PI, et al. Sensory morbidity after sentinel lymph node biopsy and axillary dissection: A prospective study of 233 women. Ann Surg Oncol 2002;9: 654-62.
11. Giuliano AE, Haigh PI, Brennan MB, Hansen NM, Kelley MC, Ye W, et al. Prospective observational study of sentinel lymphadenectomy without further axillary dissection in patients with sentinel node-negative breast cancer. J Clin Oncol 2000;18:2553-9.
12. Schrenk P, Rieger R, Shamiyeh A, Wayand W. Morbidity following sentinel lymph node biopsy versus axillary lymph node dissection for patients with breast carcinoma. Cancer 2000;88:608-14.
13. Burak WE, Hollenbeck ST, Zervos EE, Hock KL, Kemp LC, Young DC. Sentinel lymph node biopsy results in less postoperative morbidity compared with axillary lymph node dissection for breast cancer. Am J Surg 2002;183:23-7.
14. Haid A, Koberle-Wuhrer R, Knauer M, Burtscher J, Fritzsche H, Peschina W, et al. Morbidity of breast cancer patients following complete axillary dissection or sentinel node biopsy only: A comparative evaluation. Breast Cancer Res Treat 2002;73:31-6.
15. Peintinger F, Reitsamer R, Stranzl H, Ralph G. Comparison of quality of life and arm complaints after axillary lymph node dissection vs sentinel lymph node biopsy in breast cancer patients. Br J Cancer 2003;89:648-52.
16. Swenson KK, Nissen MJ, Ceronsky C, Swenson L, Lee MW, Tuttle TM. Comparison of side effects between sentinel lymph node and axillary lymph node dissection for breast cancer. Ann Surg Oncol 2002;9:745-53.
17. Veronesi U, Paganelli G, Viale G, Luini A, Zurrida S, Galimberti V, et al. A randomized comparison of sentinel-node biopsy with routine axillary dissection in breast cancer. N Engl J Med 2003;349:546-53.
18. Fleissig A, Fallowfield LJ, Langridge CI, Johnson L, Newcombe RG, Dixon JM, et al. Post-operative arm morbidity and quality of life. Results of the ALMANAC randomised trial comparing sentinel node biopsy with standard axillary treatment in the management of patients with early breast cancer. Breast Cancer Res Treat 2006;95:279-93.
19. Mansel RE, Goyal A. European studies on breast lymphatic mapping. Semin Oncol 2004;31:304-10.
20. Goyal A, Newcombe RG, Chhabra A, Mansel RE. Factors affecting failed localisation and false-negative rates of sentinel node biopsy in breast cancer - results of the ALMANAC validation phase. Breast Cancer Res Treat. Epub March 2006; PMID 16541308.
21. Steele RJ, Forrest AP, Gibson T, Stewart HJ, Chetty U. The efficacy of lower axillary sampling in obtaining lymph node status in breast cancer: a controlled randomized trial. Br J Surg 1985;72:368-9.
22. Kuhnke E. Determination of volume by measuring the circumferences. Folia Angiol 1976;24:228-32.
23. Brady MJ, Cella DF, Mo F, Bonomi AE, Tulsky DS, Lloyd SR, et al. Reliability and validity of the Functional Assessment of Cancer Therapy-Breast quality-of-life instrument. J Clin Oncol 1997;15:974-86.
24. Coster S, Poole K, Fallowfield LJ. The validation of a quality of life scale to assess the impact of arm morbidity in breast cancer patients post-operatively. Breast Cancer Res Treat 2001;68:273-82.
25. Cella D, Eton DT, Fairclough DL, Bonomi P, Heyes AE, Silberman C, et al. What is a clinically meaningful change on the Functional Assessment of Cancer Therapy-Lung (FACT-L) Questionnaire? Results from Eastern Cooperative Oncology Group (ECOG) Study 5592. J Clin Epidemiol 2002;55:285-95.
26. Eton DT, Cella D, Yost KJ, Yount SE, Peterman AH, Neuberg DS, et al. A combination of distribution- and anchor-based approaches determined minimally important differences (MIDs) for four endpoints in a breast cancer scale. J Clin Epidemiol 2004;57:898-910.
27. Fallowfield L, Cella D, Cuzick J, Francis S, Locker G, Howell A. Quality of life of postmenopausal women in the Arimidex, Tamoxifen, Alone or in Combination (ATAC) adjuvant breast cancer trial. J Clin Oncol 2004;22:4261-71.
28. Spielberger C. The manual for the state-trait inventory. Palo Alto (CA): Consulting Psychologists Press; 1983.
29. Wilson EB. Probable inference, the law of succession, and statistical inference. J Am Stat Assoc 1927;22:209-12.
30. Newcombe RG. Interval estimation for the difference between independent proportions: Comparison of eleven methods. Stat Med 1998;17:873-90.
31. Miettinen O, Nurminen M. Comparative analysis of two rates. Stat Med 1985;4:213-26.
32. Goyal A, Newcombe RG, Mansel RE. Clinical relevance of internal mammary node drainage in sentinel node biopsy for breast cancer. J Clin Oncol 2005;23:8S.
33. Erickson VS, Pearson ML, Ganz PA, Adams J, Kahn KL. Arm edema in breast cancer patients. J Natl Cancer Inst 2001;93:96-111.
34. Purushotham AD, Upponi S, Klevesath MB, Bobrow L, Millar K, Myles JP, et al. Morbidity after sentinel lymph node biopsy in primary breast cancer: results from a randomized controlled trial. J Clin Oncol 2005;23:4312-21.
35. Gemignani ML, Cody HS, III, Fey JV, Tran KN, Venkatraman E, Borgen PI. Impact of sentinel lymph node mapping on relative charges in patients with early-stage breast cancer. Ann Surg Oncol 2000;7:575-80.
36. Veronesi U, Galimberti V, Mariani L, Gatti G, Paganelli G, Viale G, et al. Sentinel node biopsy in breast cancer: Early results in 953 patients with negative sentinel node biopsy and no axillary dissection. Eur J Cancer 2005;41:231-7.
37. Naik AM, Fey J, Gemignani M, Heerdt A, Montgomery L, Petrek J, et al. The risk of axillary relapse after sentinel lymph node biopsy for breast cancer is comparable with that of axillary lymph node dissection: A follow-up study of 4008 procedures. Ann Surg 2004;240:462-8.
38. Goyal A, Horgan K, Kissin M, Yiangou C, Sibbering M, Lansdown M, et al. Sentinel lymph node biopsy in male breast cancer patients. Eur J Surg Oncol 2004;30:480-3.
39. Lyman GH, Giuliano AE, Somerfield MR, Benson AB, III, Bodurka DC, Burstein HJ, et al. ASCO Guideline Recommendations for sentinel lymph node biopsy in early-stage breast cancer. J Clin Oncol 2005;23:7703-20.