Partial breast irradiation versus whole breast radiotherapy for early breast cancer.
Journal
The Cochrane database of systematic reviews
ISSN: 1469-493X
Titre abrégé: Cochrane Database Syst Rev
Pays: England
ID NLM: 100909747
Informations de publication
Date de publication:
30 08 2021
30 08 2021
Historique:
entrez:
30
8
2021
pubmed:
31
8
2021
medline:
25
11
2021
Statut:
epublish
Résumé
Breast-conserving therapy for women with breast cancer consists of local excision of the tumour (achieving clear margins) followed by radiotherapy (RT). Most true recurrences occur in the same quadrant as the original tumour. Whole breast radiotherapy (WBRT) may not protect against the development of a new primary cancer developing in other quadrants of the breast. In this Cochrane Review, we investigated the delivery of radiation to a limited volume of the breast around the tumour bed (partial breast irradiation (PBI)) sometimes with a shortened treatment duration (accelerated partial breast irradiation (APBI)). To determine whether PBI/APBI is equivalent to or better than conventional or hypofractionated WBRT after breast-conserving therapy for early-stage breast cancer. On 27 August 2020, we searched the Cochrane Breast Cancer Group Specialised Register, CENTRAL, MEDLINE, Embase, CINAHL and three trial databases. We searched for grey literature: OpenGrey (September 2020), reference lists of articles, conference proceedings and published abstracts, and applied no language restrictions. Randomised controlled trials (RCTs) without confounding, that evaluated conservative surgery plus PBI/APBI versus conservative surgery plus WBRT. Published and unpublished trials were eligible. Two review authors (BH and ML) performed data extraction, used Cochrane's risk of bias tool and resolved any disagreements through discussion, and assessed the certainty of the evidence for main outcomes using GRADE. Main outcomes were local recurrence-free survival, cosmesis, overall survival, toxicity (subcutaneous fibrosis), cause-specific survival, distant metastasis-free survival and subsequent mastectomy. We entered data into Review Manager 5 for analysis. We included nine RCTs that enrolled 15,187 women who had invasive breast cancer or ductal carcinoma in-situ (6.3%) with T1-2N0-1M0 Grade I or II unifocal tumours (less than 2 cm or 3 cm or less) treated with breast-conserving therapy with negative margins. This is the second update of the review and includes two new studies and 4432 more participants. Local recurrence-free survival is probably slightly reduced (by 3/1000, 95% CI 6 fewer to 0 fewer) with the use of PBI/APBI compared to WBRT (hazard ratio (HR) 1.21, 95% confidence interval (CI) 1.03 to 1.42; 8 studies, 13,168 participants; moderate-certainty evidence). Cosmesis (physician/nurse-reported) is probably worse (by 63/1000, 95% CI 35 more to 92 more) with the use of PBI/APBI (odds ratio (OR) 1.57, 95% CI 1.31 to 1.87; 6 studies, 3652 participants; moderate-certainty evidence). Overall survival is similar (0/1000 fewer, 95% CI 6 fewer to 6 more) with PBI/APBI and WBRT (HR 0.99, 95% CI 0.88 to 1.12; 8 studies, 13,175 participants; high-certainty evidence). Late radiation toxicity (subcutaneous fibrosis) is probably increased (by 14/1000 more, 95% CI 102 more to 188 more) with PBI/APBI (OR 5.07, 95% CI 3.81 to 6.74; 2 studies, 3011 participants; moderate-certainty evidence). The use of PBI/APBI probably makes little difference (1/1000 less, 95% CI 6 fewer to 3 more) to cause-specific survival (HR 1.06, 95% CI 0.83 to 1.36; 7 studies, 9865 participants; moderate-certainty evidence). We found the use of PBI/APBI compared with WBRT probably makes little or no difference (1/1000 fewer (95% CI 4 fewer to 6 more)) to distant metastasis-free survival (HR 0.95, 95% CI 0.80 to 1.13; 7 studies, 11,033 participants; moderate-certainty evidence). We found the use of PBI/APBI in comparison with WBRT makes little or no difference (2/1000 fewer, 95% CI 20 fewer to 20 more) to mastectomy rates (OR 0.98, 95% CI 0.78 to 1.23; 3 studies, 3740 participants, high-certainty evidence). It appeared that local recurrence-free survival is probably worse with PBI/APBI; however, the difference was small and nearly all women remain free of local recurrence. Overall survival is similar with PBI/APBI and WBRT, and we found little to no difference in other oncological outcomes. Some late effects (subcutaneous fibrosis) may be worse with PBI/APBI and its use is probably associated with worse cosmetic outcomes. The limitations of the data currently available mean that we cannot make definitive conclusions about the efficacy and safety or ways to deliver PBI/APBI. We await completion of ongoing trials.
Sections du résumé
BACKGROUND
Breast-conserving therapy for women with breast cancer consists of local excision of the tumour (achieving clear margins) followed by radiotherapy (RT). Most true recurrences occur in the same quadrant as the original tumour. Whole breast radiotherapy (WBRT) may not protect against the development of a new primary cancer developing in other quadrants of the breast. In this Cochrane Review, we investigated the delivery of radiation to a limited volume of the breast around the tumour bed (partial breast irradiation (PBI)) sometimes with a shortened treatment duration (accelerated partial breast irradiation (APBI)).
OBJECTIVES
To determine whether PBI/APBI is equivalent to or better than conventional or hypofractionated WBRT after breast-conserving therapy for early-stage breast cancer.
SEARCH METHODS
On 27 August 2020, we searched the Cochrane Breast Cancer Group Specialised Register, CENTRAL, MEDLINE, Embase, CINAHL and three trial databases. We searched for grey literature: OpenGrey (September 2020), reference lists of articles, conference proceedings and published abstracts, and applied no language restrictions.
SELECTION CRITERIA
Randomised controlled trials (RCTs) without confounding, that evaluated conservative surgery plus PBI/APBI versus conservative surgery plus WBRT. Published and unpublished trials were eligible.
DATA COLLECTION AND ANALYSIS
Two review authors (BH and ML) performed data extraction, used Cochrane's risk of bias tool and resolved any disagreements through discussion, and assessed the certainty of the evidence for main outcomes using GRADE. Main outcomes were local recurrence-free survival, cosmesis, overall survival, toxicity (subcutaneous fibrosis), cause-specific survival, distant metastasis-free survival and subsequent mastectomy. We entered data into Review Manager 5 for analysis.
MAIN RESULTS
We included nine RCTs that enrolled 15,187 women who had invasive breast cancer or ductal carcinoma in-situ (6.3%) with T1-2N0-1M0 Grade I or II unifocal tumours (less than 2 cm or 3 cm or less) treated with breast-conserving therapy with negative margins. This is the second update of the review and includes two new studies and 4432 more participants. Local recurrence-free survival is probably slightly reduced (by 3/1000, 95% CI 6 fewer to 0 fewer) with the use of PBI/APBI compared to WBRT (hazard ratio (HR) 1.21, 95% confidence interval (CI) 1.03 to 1.42; 8 studies, 13,168 participants; moderate-certainty evidence). Cosmesis (physician/nurse-reported) is probably worse (by 63/1000, 95% CI 35 more to 92 more) with the use of PBI/APBI (odds ratio (OR) 1.57, 95% CI 1.31 to 1.87; 6 studies, 3652 participants; moderate-certainty evidence). Overall survival is similar (0/1000 fewer, 95% CI 6 fewer to 6 more) with PBI/APBI and WBRT (HR 0.99, 95% CI 0.88 to 1.12; 8 studies, 13,175 participants; high-certainty evidence). Late radiation toxicity (subcutaneous fibrosis) is probably increased (by 14/1000 more, 95% CI 102 more to 188 more) with PBI/APBI (OR 5.07, 95% CI 3.81 to 6.74; 2 studies, 3011 participants; moderate-certainty evidence). The use of PBI/APBI probably makes little difference (1/1000 less, 95% CI 6 fewer to 3 more) to cause-specific survival (HR 1.06, 95% CI 0.83 to 1.36; 7 studies, 9865 participants; moderate-certainty evidence). We found the use of PBI/APBI compared with WBRT probably makes little or no difference (1/1000 fewer (95% CI 4 fewer to 6 more)) to distant metastasis-free survival (HR 0.95, 95% CI 0.80 to 1.13; 7 studies, 11,033 participants; moderate-certainty evidence). We found the use of PBI/APBI in comparison with WBRT makes little or no difference (2/1000 fewer, 95% CI 20 fewer to 20 more) to mastectomy rates (OR 0.98, 95% CI 0.78 to 1.23; 3 studies, 3740 participants, high-certainty evidence).
AUTHORS' CONCLUSIONS
It appeared that local recurrence-free survival is probably worse with PBI/APBI; however, the difference was small and nearly all women remain free of local recurrence. Overall survival is similar with PBI/APBI and WBRT, and we found little to no difference in other oncological outcomes. Some late effects (subcutaneous fibrosis) may be worse with PBI/APBI and its use is probably associated with worse cosmetic outcomes. The limitations of the data currently available mean that we cannot make definitive conclusions about the efficacy and safety or ways to deliver PBI/APBI. We await completion of ongoing trials.
Identifiants
pubmed: 34459500
doi: 10.1002/14651858.CD007077.pub4
pmc: PMC8406917
doi:
Banques de données
ClinicalTrials.gov
['NCT00556907']
Types de publication
Journal Article
Research Support, Non-U.S. Gov't
Review
Systematic Review
Langues
eng
Sous-ensembles de citation
IM
Pagination
CD007077Commentaires et corrections
Type : UpdateOf
Informations de copyright
Copyright © 2021 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd.
Références
Eur J Cancer. 2013 Jul;49(10):2294-302
pubmed: 23523089
Int J Radiat Oncol Biol Phys. 2009 Sep 1;75(1):82-8
pubmed: 19231103
Clin Breast Cancer. 2014 Apr;14(2):141-6
pubmed: 24291378
J Natl Cancer Inst. 1959 Apr;22(4):719-48
pubmed: 13655060
Control Clin Trials. 1986 Sep;7(3):177-88
pubmed: 3802833
Lancet Oncol. 2018 Jun;19(6):834-844
pubmed: 29695348
Transl Oncol. 2013 Dec 01;6(6):619-27
pubmed: 24466364
Stat Med. 2002 Jun 15;21(11):1539-58
pubmed: 12111919
Lancet. 2011 Nov 12;378(9804):1707-16
pubmed: 22019144
Radiother Oncol. 1986 Dec;7(4):323-6
pubmed: 3809591
J Natl Cancer Inst. 2000 Jul 19;92(14):1143-50
pubmed: 10904087
Health Technol Assess. 2007 Aug;11(31):1-149, iii-iv
pubmed: 17669280
Brachytherapy. 2020 Jul - Aug;19(4):491-498
pubmed: 32340902
Lancet. 2016 Jan 16;387(10015):229-38
pubmed: 26494415
Lancet Oncol. 2017 Feb;18(2):259-268
pubmed: 28094198
Radiother Oncol. 1983 Nov;1(2):187-91
pubmed: 6680223
Eur J Cancer. 2015 Mar;51(4):451-463
pubmed: 25605582
Int J Radiat Oncol Biol Phys. 2004 Nov 1;60(3):731-40
pubmed: 15465189
Radiother Oncol. 2013 Aug;108(2):197-202
pubmed: 23742961
Int J Radiat Oncol Biol Phys. 1995 Mar 30;31(5):1341-6
pubmed: 7713792
Cancer. 2003 Aug 15;98(4):697-702
pubmed: 12910512
Radiat Oncol. 2013 Jan 07;8:9
pubmed: 23294485
Breast J. 2011 Sep-Oct;17(5):448-55
pubmed: 21790842
Int J Radiat Oncol Biol Phys. 1992;24(2):335-48
pubmed: 1526873
Breast Cancer Res Treat. 2013 Aug;140(3):519-25
pubmed: 23877341
J R Soc Med. 1978 May;71(5):339-42
pubmed: 650646
Radiother Oncol. 2016 Jul;120(1):119-23
pubmed: 27422584
Int J Radiat Oncol Biol Phys. 2007 Nov 1;69(3):724-31
pubmed: 17524571
Ann Surg Oncol. 2013 Sep;20(9):2873-80
pubmed: 23812769
Lancet Oncol. 2015 Mar;16(3):266-73
pubmed: 25637340
Cancer. 2000 May 15;88(10):2260-6
pubmed: 10820347
Clin Adv Hematol Oncol. 2006 Oct;4(10):719-21
pubmed: 17111558
Lancet Oncol. 2006 Jun;7(6):467-71
pubmed: 16750496
Eur J Cancer. 2010 Jan;46(1):95-101
pubmed: 19879131
Clin Oncol (R Coll Radiol). 2006 Oct;18(8):587-90
pubmed: 17051947
Trials. 2007 Jun 07;8:16
pubmed: 17555582
J Natl Compr Canc Netw. 2005 May;3(3):301-7
pubmed: 16002002
Int J Radiat Oncol Biol Phys. 2007 Jun 1;68(2):334-40
pubmed: 17363187
Lancet. 2019 Dec 14;394(10215):2155-2164
pubmed: 31813636
N Engl J Med. 2004 Sep 2;351(10):963-70
pubmed: 15342804
Int J Radiat Oncol Biol Phys. 2016 Sep 1;96(1):55-64
pubmed: 27511847
Breast Cancer Res Treat. 2019 Jun;175(3):531-545
pubmed: 30929116
Lancet. 2019 Dec 14;394(10215):2165-2172
pubmed: 31813635
J Natl Cancer Inst. 2004 Feb 4;96(3):175-84
pubmed: 14759984
Clin Adv Hematol Oncol. 2013 Feb;11(2):76-83
pubmed: 23598908
Radiother Oncol. 2007 Mar;82(3):254-64
pubmed: 17224195
Strahlenther Onkol. 2014 Apr;190(4):422-4
pubmed: 24638243
Ann Oncol. 2019 Oct 1;30(10):1541-1557
pubmed: 31373601
Clin Oncol (R Coll Radiol). 2008 Sep;20(7):497-501
pubmed: 18502105
Lancet. 2014 May 17;383(9930):1716
pubmed: 24835608
Clin Oncol (R Coll Radiol). 2005 Dec;17(8):618-22
pubmed: 16372487
J Clin Oncol. 2019 Feb 1;37(4):305-317
pubmed: 30532984
N Engl J Med. 2002 Oct 17;347(16):1233-41
pubmed: 12393820
Int J Radiat Oncol Biol Phys. 2015 Apr 1;91(5):968-76
pubmed: 25832689
J Clin Oncol. 2013 Nov 10;31(32):4038-45
pubmed: 23835717
Int J Radiat Oncol Biol Phys. 2009 Jul 15;74(4):987-1001
pubmed: 19545784
Lancet. 2008 Mar 29;371(9618):1098-107
pubmed: 18355913
Am J Surg. 2007 Oct;194(4):507-10
pubmed: 17826067
Radiother Oncol. 2010 Mar;94(3):264-73
pubmed: 20181402
Eur J Cancer. 2017 May;76:17-26
pubmed: 28262584
Cochrane Database Syst Rev. 2016 Jul 18;7:CD007077
pubmed: 27425375
Lancet Oncol. 2008 Apr;9(4):331-41
pubmed: 18356109
Radiother Oncol. 1995 Apr;35(1):17-60
pubmed: 7569012
J Can Assoc Radiol. 1981 Jun;32(2):125-8
pubmed: 7251618
Breast. 2006 Oct;15(5):581-3
pubmed: 16919956
Cancer. 2001 Jun 15;91(12):2273-81
pubmed: 11413515
N Engl J Med. 1995 Apr 6;332(14):907-11
pubmed: 7877647
Int J Radiat Oncol Biol Phys. 2004 Nov 15;60(4):1173-81
pubmed: 15519789
Radiother Oncol. 1995 Apr;35(1):11-5
pubmed: 7569011
Biometrics. 1985 Mar;41(1):55-68
pubmed: 4005387
J Clin Oncol. 2020 Dec 10;38(35):4175-4183
pubmed: 32840419
J Surg Oncol. 2002 Jul;80(3):121-8; discussion 129
pubmed: 12115793
J Clin Oncol. 1996 Oct;14(10):2756-68
pubmed: 8874337
Technol Eval Cent Assess Program Exec Summ. 2007 Aug;22(4):1-4
pubmed: 17849618
Eur J Cancer. 2015 Jul;51(11):1476-7
pubmed: 25963020
Cancer. 1985 Sep 1;56(5):979-90
pubmed: 2990668
Radiol Med. 2015 Nov;120(11):1078-82
pubmed: 25907992
Radiother Oncol. 2019 May;134:220-230
pubmed: 31005219
Breast Cancer Res Treat. 2015 Oct;153(3):539-47
pubmed: 26350524
Int J Radiat Oncol Biol Phys. 2010 Jun 1;77(2):509-15
pubmed: 19700248
Cancer. 1983 Dec 1;52(11):2173-9
pubmed: 6627221
Int J Radiat Oncol Biol Phys. 1979 Feb;5(2):257-61
pubmed: 110740
Lancet Oncol. 2013 Dec;14(13):1269-77
pubmed: 24225155
Int J Radiat Oncol Biol Phys. 2015 Jul 1;92(3):491-7
pubmed: 26068479
N Engl J Med. 1995 Nov 30;333(22):1456-61
pubmed: 7477145
Breast J. 2014 Mar-Apr;20(2):116-24
pubmed: 24372818
Breast. 2012 Feb;21(1):46-9
pubmed: 21865044
Lancet. 2010 Jul 10;376(9735):91-102
pubmed: 20570343
Strahlenther Onkol. 2020 Jun;196(6):579-582
pubmed: 32342118
J Clin Oncol. 2005 Oct 1;23(28):7074-80
pubmed: 16192590
Lancet Oncol. 2013 Oct;14(11):1086-1094
pubmed: 24055415
Radiother Oncol. 1995 Apr;35(1):5-7
pubmed: 7569013
Int J Radiat Oncol Biol Phys. 2000 Dec 1;48(5):1281-9
pubmed: 11121624
Lancet. 2014 Feb 15;383(9917):603-13
pubmed: 24224997
Eur J Cancer. 1995 Sep;31A(10):1574-9
pubmed: 7488404
J Clin Oncol. 1992 Mar;10(3):356-63
pubmed: 1445509
Radiother Oncol. 1996 Jun;39(3):223-7
pubmed: 8783398
Breast J. 2010 May-Jun;16(3):245-51
pubmed: 20210799
Int J Radiat Oncol Biol Phys. 2007 Nov 1;69(3):694-702
pubmed: 17531400
N Engl J Med. 1995 Nov 30;333(22):1444-55
pubmed: 7477144
J Clin Oncol. 2010 Jun 20;28(18):2996-3001
pubmed: 20479390
J Natl Cancer Inst. 2002 Aug 7;94(15):1143-50
pubmed: 12165639
Eur J Surg Oncol. 1988 Apr;14(2):133-40
pubmed: 3360154
Med Phys. 2007 Dec;34(12):4640-8
pubmed: 18196791
Nat Clin Pract Oncol. 2007 Jul;4(7):384-5
pubmed: 17549089
Eur J Surg Oncol. 2009 Jun;35(6):578-82
pubmed: 18938055
Adv Radiat Oncol. 2019 Sep 27;5(2):171-179
pubmed: 32280816
Semin Radiat Oncol. 2003 Jul;13(3):176-81
pubmed: 12903007
Semin Radiat Oncol. 2005 Apr;15(2):84-91
pubmed: 15809933
Am J Public Health. 1988 Aug;78(8):961-6
pubmed: 3260455
Clin Oncol (R Coll Radiol). 1993;5(5):278-83
pubmed: 8305334
N Engl J Med. 2004 Sep 2;351(10):971-7
pubmed: 15342805
Lancet. 2017 Sep 9;390(10099):1048-1060
pubmed: 28779963
Int J Radiat Oncol Biol Phys. 2016 Oct 1;96(2):259-265
pubmed: 27478165
Clin Oncol (R Coll Radiol). 1990 Jan;2(1):27-34
pubmed: 2261385
BMJ Open. 2017 Aug 17;7(8):e014944
pubmed: 28819067
Radiother Oncol. 2015 Jan;114(1):42-9
pubmed: 25480094
Int J Radiat Oncol Biol Phys. 2013 Dec 1;87(5):1051-7
pubmed: 24161420
Health Technol Assess. 2016 Sep;20(73):1-188
pubmed: 27689969
Cancer. 2009 Apr 15;115(8):1621-30
pubmed: 19224552
N Engl J Med. 2002 Oct 17;347(16):1227-32
pubmed: 12393819
Radiat Oncol. 2018 Apr 13;13(1):68
pubmed: 29653541
J Clin Oncol. 2008 May 1;26(13):2085-92
pubmed: 18285602
BMJ. 2003 Sep 6;327(7414):557-60
pubmed: 12958120
BMJ. 2020 Aug 19;370:m2836
pubmed: 32816842
J Clin Oncol. 1988 Dec;6(12):1798-810
pubmed: 3058874