Whole-breast irradiation with or without a boost for patients treated with breast-conserving surgery for early breast cancer: 20-year follow-up of a randomised phase 3 trial
Summary Background Since the introduction of breast-conserving treatment, various radiation doses after lumpectomy have been used. In a phase 3 randomised controlled trial, we investigated the effect of a radiation boost of 16 Gy on overall survival, local control, and fibrosis for patients with sta...
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| Veröffentlicht in: | The lancet oncology 2015, Vol.16 (1), p.47-56 |
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| creator | Bartelink, Harry, Dr Maingon, Philippe, MD Poortmans, Philip, MD Weltens, Caroline, MD Fourquet, Alain, MD Jager, Jos, MD Schinagl, Dominic, MD Oei, Bing, MD Rodenhuis, Carla, MD Horiot, Jean-Claude, MD Struikmans, Henk, MD Van Limbergen, Erik, MD Kirova, Youlia, MD Elkhuizen, Paula, MD Bongartz, Rudolf, MD Miralbell, Raymond, MD Morgan, David, MD Dubois, Jean-Bernard, MD Remouchamps, Vincent, MD Mirimanoff, René-Olivier, MD Collette, Sandra, MSc Collette, Laurence, PhD |
| description | Summary Background Since the introduction of breast-conserving treatment, various radiation doses after lumpectomy have been used. In a phase 3 randomised controlled trial, we investigated the effect of a radiation boost of 16 Gy on overall survival, local control, and fibrosis for patients with stage I and II breast cancer who underwent breast-conserving treatment compared with patients who received no boost. Here, we present the 20-year follow-up results. Methods Patients with microscopically complete excision for invasive disease followed by whole-breast irradiation of 50 Gy in 5 weeks were centrally randomised (1:1) with a minimisation algorithm to receive 16 Gy boost or no boost, with minimisation for age, menopausal status, presence of extensive ductal carcinoma in situ, clinical tumour size, nodal status, and institution. Neither patients nor investigators were masked to treatment allocation. The primary endpoint was overall survival in the intention-to-treat population. The trial is registered with ClinicalTrials.gov , number NCT02295033. Findings Between May 24, 1989, and June 25, 1996, 2657 patients were randomly assigned to receive no radiation boost and 2661 patients randomly assigned to receive a radiation boost. Median follow-up was 17·2 years (IQR 13·0–19·0). 20-year overall survival was 59·7% (99% CI 56·3–63·0) in the boost group versus 61·1% (57·6–64·3) in the no boost group, hazard ratio (HR) 1·05 (99% CI 0·92–1·19, p=0·323). Ipsilateral breast tumour recurrence was the first treatment failure for 354 patients (13%) in the no boost group versus 237 patients (9%) in the boost group, HR 0·65 (99% CI 0·52–0·81, p |
| doi_str_mv | 10.1016/S1470-2045(14)71156-8 |
| format | Article |
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In a phase 3 randomised controlled trial, we investigated the effect of a radiation boost of 16 Gy on overall survival, local control, and fibrosis for patients with stage I and II breast cancer who underwent breast-conserving treatment compared with patients who received no boost. Here, we present the 20-year follow-up results. Methods Patients with microscopically complete excision for invasive disease followed by whole-breast irradiation of 50 Gy in 5 weeks were centrally randomised (1:1) with a minimisation algorithm to receive 16 Gy boost or no boost, with minimisation for age, menopausal status, presence of extensive ductal carcinoma in situ, clinical tumour size, nodal status, and institution. Neither patients nor investigators were masked to treatment allocation. The primary endpoint was overall survival in the intention-to-treat population. The trial is registered with ClinicalTrials.gov , number NCT02295033. Findings Between May 24, 1989, and June 25, 1996, 2657 patients were randomly assigned to receive no radiation boost and 2661 patients randomly assigned to receive a radiation boost. Median follow-up was 17·2 years (IQR 13·0–19·0). 20-year overall survival was 59·7% (99% CI 56·3–63·0) in the boost group versus 61·1% (57·6–64·3) in the no boost group, hazard ratio (HR) 1·05 (99% CI 0·92–1·19, p=0·323). Ipsilateral breast tumour recurrence was the first treatment failure for 354 patients (13%) in the no boost group versus 237 patients (9%) in the boost group, HR 0·65 (99% CI 0·52–0·81, p<0·0001). The 20-year cumulative incidence of ipsilatelal breast tumour recurrence was 16·4% (99% CI 14·1–18·8) in the no boost group versus 12·0% (9·8–14·4) in the boost group. Mastectomies as first salvage treatment for ipsilateral breast tumour recurrence occurred in 279 (79%) of 354 patients in the no boost group versus 178 (75%) of 237 in the boost group. The cumulative incidence of severe fibrosis at 20 years was 1·8% (99% CI 1·1–2·5) in the no boost group versus 5·2% (99% CI 3·9–6·4) in the boost group (p<0·0001). Interpretation A radiation boost after whole-breast irradiation has no effect on long-term overall survival, but can improve local control, with the largest absolute benefit in young patients, although it increases the risk of moderate to severe fibrosis. The extra radiation dose can be avoided in most patients older than age 60 years. Funding Fonds Cancer, Belgium.</description><identifier>ISSN: 1470-2045</identifier><identifier>EISSN: 1474-5488</identifier><identifier>DOI: 10.1016/S1470-2045(14)71156-8</identifier><identifier>PMID: 25500422</identifier><identifier>CODEN: LANCAO</identifier><language>eng</language><publisher>England: Elsevier Ltd</publisher><subject>Adult ; Age Factors ; Australia ; Breast cancer ; Breast Neoplasms - mortality ; Breast Neoplasms - pathology ; Breast Neoplasms - radiotherapy ; Breast Neoplasms - surgery ; Cancer therapies ; Dissection ; Europe ; Female ; Fibrosis ; Hematology, Oncology and Palliative Medicine ; Humans ; Intention to Treat Analysis ; Israel ; Kaplan-Meier Estimate ; Mastectomy ; Mastectomy, Segmental - adverse effects ; Mastectomy, Segmental - mortality ; Middle Aged ; Mortality ; Neoplasm Recurrence, Local ; Neoplasm Staging ; Patient Selection ; Proportional Hazards Models ; Radiation therapy ; Radiotherapy Dosage ; Radiotherapy, Adjuvant ; Reoperation ; Salvage Therapy ; Studies ; Time Factors ; Treatment Outcome</subject><ispartof>The lancet oncology, 2015, Vol.16 (1), p.47-56</ispartof><rights>Elsevier Ltd</rights><rights>2015 Elsevier Ltd</rights><rights>Copyright © 2015 Elsevier Ltd. All rights reserved.</rights><rights>Copyright Elsevier Limited Jan 2015</rights><lds50>peer_reviewed</lds50><woscitedreferencessubscribed>false</woscitedreferencessubscribed><citedby>FETCH-LOGICAL-c533t-352e69df8f66e51cb0315967f8d0bc435c511d93c49fee5377edc74986c8a8703</citedby><cites>FETCH-LOGICAL-c533t-352e69df8f66e51cb0315967f8d0bc435c511d93c49fee5377edc74986c8a8703</cites></display><links><openurl>$$Topenurl_article</openurl><openurlfulltext>$$Topenurlfull_article</openurlfulltext><thumbnail>$$Tsyndetics_thumb_exl</thumbnail><linktohtml>$$Uhttps://www.sciencedirect.com/science/article/pii/S1470204514711568$$EHTML$$P50$$Gelsevier$$H</linktohtml><link.rule.ids>314,776,780,3537,4010,27900,27901,27902,65534</link.rule.ids><backlink>$$Uhttps://www.ncbi.nlm.nih.gov/pubmed/25500422$$D View this record in MEDLINE/PubMed$$Hfree_for_read</backlink></links><search><creatorcontrib>Bartelink, Harry, Dr</creatorcontrib><creatorcontrib>Maingon, Philippe, MD</creatorcontrib><creatorcontrib>Poortmans, Philip, MD</creatorcontrib><creatorcontrib>Weltens, Caroline, MD</creatorcontrib><creatorcontrib>Fourquet, Alain, MD</creatorcontrib><creatorcontrib>Jager, Jos, MD</creatorcontrib><creatorcontrib>Schinagl, Dominic, MD</creatorcontrib><creatorcontrib>Oei, Bing, MD</creatorcontrib><creatorcontrib>Rodenhuis, Carla, MD</creatorcontrib><creatorcontrib>Horiot, Jean-Claude, MD</creatorcontrib><creatorcontrib>Struikmans, Henk, MD</creatorcontrib><creatorcontrib>Van Limbergen, Erik, MD</creatorcontrib><creatorcontrib>Kirova, Youlia, MD</creatorcontrib><creatorcontrib>Elkhuizen, Paula, MD</creatorcontrib><creatorcontrib>Bongartz, Rudolf, MD</creatorcontrib><creatorcontrib>Miralbell, Raymond, MD</creatorcontrib><creatorcontrib>Morgan, David, MD</creatorcontrib><creatorcontrib>Dubois, Jean-Bernard, MD</creatorcontrib><creatorcontrib>Remouchamps, Vincent, MD</creatorcontrib><creatorcontrib>Mirimanoff, René-Olivier, MD</creatorcontrib><creatorcontrib>Collette, Sandra, MSc</creatorcontrib><creatorcontrib>Collette, Laurence, PhD</creatorcontrib><creatorcontrib>on behalf of the European Organisation for Research and Treatment of Cancer Radiation Oncology and Breast Cancer Groups</creatorcontrib><creatorcontrib>European Organisation for Research and Treatment of Cancer Radiation Oncology and Breast Cancer Groups</creatorcontrib><title>Whole-breast irradiation with or without a boost for patients treated with breast-conserving surgery for early breast cancer: 20-year follow-up of a randomised phase 3 trial</title><title>The lancet oncology</title><addtitle>Lancet Oncol</addtitle><description>Summary Background Since the introduction of breast-conserving treatment, various radiation doses after lumpectomy have been used. In a phase 3 randomised controlled trial, we investigated the effect of a radiation boost of 16 Gy on overall survival, local control, and fibrosis for patients with stage I and II breast cancer who underwent breast-conserving treatment compared with patients who received no boost. Here, we present the 20-year follow-up results. Methods Patients with microscopically complete excision for invasive disease followed by whole-breast irradiation of 50 Gy in 5 weeks were centrally randomised (1:1) with a minimisation algorithm to receive 16 Gy boost or no boost, with minimisation for age, menopausal status, presence of extensive ductal carcinoma in situ, clinical tumour size, nodal status, and institution. Neither patients nor investigators were masked to treatment allocation. The primary endpoint was overall survival in the intention-to-treat population. The trial is registered with ClinicalTrials.gov , number NCT02295033. Findings Between May 24, 1989, and June 25, 1996, 2657 patients were randomly assigned to receive no radiation boost and 2661 patients randomly assigned to receive a radiation boost. Median follow-up was 17·2 years (IQR 13·0–19·0). 20-year overall survival was 59·7% (99% CI 56·3–63·0) in the boost group versus 61·1% (57·6–64·3) in the no boost group, hazard ratio (HR) 1·05 (99% CI 0·92–1·19, p=0·323). Ipsilateral breast tumour recurrence was the first treatment failure for 354 patients (13%) in the no boost group versus 237 patients (9%) in the boost group, HR 0·65 (99% CI 0·52–0·81, p<0·0001). The 20-year cumulative incidence of ipsilatelal breast tumour recurrence was 16·4% (99% CI 14·1–18·8) in the no boost group versus 12·0% (9·8–14·4) in the boost group. Mastectomies as first salvage treatment for ipsilateral breast tumour recurrence occurred in 279 (79%) of 354 patients in the no boost group versus 178 (75%) of 237 in the boost group. The cumulative incidence of severe fibrosis at 20 years was 1·8% (99% CI 1·1–2·5) in the no boost group versus 5·2% (99% CI 3·9–6·4) in the boost group (p<0·0001). Interpretation A radiation boost after whole-breast irradiation has no effect on long-term overall survival, but can improve local control, with the largest absolute benefit in young patients, although it increases the risk of moderate to severe fibrosis. The extra radiation dose can be avoided in most patients older than age 60 years. Funding Fonds Cancer, Belgium.</description><subject>Adult</subject><subject>Age Factors</subject><subject>Australia</subject><subject>Breast cancer</subject><subject>Breast Neoplasms - mortality</subject><subject>Breast Neoplasms - pathology</subject><subject>Breast Neoplasms - radiotherapy</subject><subject>Breast Neoplasms - surgery</subject><subject>Cancer therapies</subject><subject>Dissection</subject><subject>Europe</subject><subject>Female</subject><subject>Fibrosis</subject><subject>Hematology, Oncology and Palliative Medicine</subject><subject>Humans</subject><subject>Intention to Treat Analysis</subject><subject>Israel</subject><subject>Kaplan-Meier Estimate</subject><subject>Mastectomy</subject><subject>Mastectomy, Segmental - adverse effects</subject><subject>Mastectomy, Segmental - mortality</subject><subject>Middle Aged</subject><subject>Mortality</subject><subject>Neoplasm Recurrence, Local</subject><subject>Neoplasm Staging</subject><subject>Patient Selection</subject><subject>Proportional Hazards Models</subject><subject>Radiation therapy</subject><subject>Radiotherapy Dosage</subject><subject>Radiotherapy, Adjuvant</subject><subject>Reoperation</subject><subject>Salvage Therapy</subject><subject>Studies</subject><subject>Time Factors</subject><subject>Treatment 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Resource</delcategory><fulltext>fulltext</fulltext></delivery><addata><au>Bartelink, Harry, Dr</au><au>Maingon, Philippe, MD</au><au>Poortmans, Philip, MD</au><au>Weltens, Caroline, MD</au><au>Fourquet, Alain, MD</au><au>Jager, Jos, MD</au><au>Schinagl, Dominic, MD</au><au>Oei, Bing, MD</au><au>Rodenhuis, Carla, MD</au><au>Horiot, Jean-Claude, MD</au><au>Struikmans, Henk, MD</au><au>Van Limbergen, Erik, MD</au><au>Kirova, Youlia, MD</au><au>Elkhuizen, Paula, MD</au><au>Bongartz, Rudolf, MD</au><au>Miralbell, Raymond, MD</au><au>Morgan, David, MD</au><au>Dubois, Jean-Bernard, MD</au><au>Remouchamps, Vincent, MD</au><au>Mirimanoff, René-Olivier, MD</au><au>Collette, Sandra, MSc</au><au>Collette, Laurence, PhD</au><aucorp>on behalf of the European Organisation for Research and Treatment of Cancer Radiation Oncology and Breast Cancer Groups</aucorp><aucorp>European Organisation for Research and Treatment of Cancer Radiation Oncology and Breast Cancer Groups</aucorp><format>journal</format><genre>article</genre><ristype>JOUR</ristype><atitle>Whole-breast irradiation with or without a boost for patients treated with breast-conserving surgery for early breast cancer: 20-year follow-up of a randomised phase 3 trial</atitle><jtitle>The lancet oncology</jtitle><addtitle>Lancet Oncol</addtitle><date>2015</date><risdate>2015</risdate><volume>16</volume><issue>1</issue><spage>47</spage><epage>56</epage><pages>47-56</pages><issn>1470-2045</issn><eissn>1474-5488</eissn><coden>LANCAO</coden><abstract>Summary Background Since the introduction of breast-conserving treatment, various radiation doses after lumpectomy have been used. In a phase 3 randomised controlled trial, we investigated the effect of a radiation boost of 16 Gy on overall survival, local control, and fibrosis for patients with stage I and II breast cancer who underwent breast-conserving treatment compared with patients who received no boost. Here, we present the 20-year follow-up results. Methods Patients with microscopically complete excision for invasive disease followed by whole-breast irradiation of 50 Gy in 5 weeks were centrally randomised (1:1) with a minimisation algorithm to receive 16 Gy boost or no boost, with minimisation for age, menopausal status, presence of extensive ductal carcinoma in situ, clinical tumour size, nodal status, and institution. Neither patients nor investigators were masked to treatment allocation. The primary endpoint was overall survival in the intention-to-treat population. The trial is registered with ClinicalTrials.gov , number NCT02295033. Findings Between May 24, 1989, and June 25, 1996, 2657 patients were randomly assigned to receive no radiation boost and 2661 patients randomly assigned to receive a radiation boost. Median follow-up was 17·2 years (IQR 13·0–19·0). 20-year overall survival was 59·7% (99% CI 56·3–63·0) in the boost group versus 61·1% (57·6–64·3) in the no boost group, hazard ratio (HR) 1·05 (99% CI 0·92–1·19, p=0·323). Ipsilateral breast tumour recurrence was the first treatment failure for 354 patients (13%) in the no boost group versus 237 patients (9%) in the boost group, HR 0·65 (99% CI 0·52–0·81, p<0·0001). The 20-year cumulative incidence of ipsilatelal breast tumour recurrence was 16·4% (99% CI 14·1–18·8) in the no boost group versus 12·0% (9·8–14·4) in the boost group. Mastectomies as first salvage treatment for ipsilateral breast tumour recurrence occurred in 279 (79%) of 354 patients in the no boost group versus 178 (75%) of 237 in the boost group. The cumulative incidence of severe fibrosis at 20 years was 1·8% (99% CI 1·1–2·5) in the no boost group versus 5·2% (99% CI 3·9–6·4) in the boost group (p<0·0001). Interpretation A radiation boost after whole-breast irradiation has no effect on long-term overall survival, but can improve local control, with the largest absolute benefit in young patients, although it increases the risk of moderate to severe fibrosis. The extra radiation dose can be avoided in most patients older than age 60 years. Funding Fonds Cancer, Belgium.</abstract><cop>England</cop><pub>Elsevier Ltd</pub><pmid>25500422</pmid><doi>10.1016/S1470-2045(14)71156-8</doi><tpages>10</tpages></addata></record> |
| fulltext | fulltext |
| identifier | ISSN: 1470-2045 |
| ispartof | The lancet oncology, 2015, Vol.16 (1), p.47-56 |
| issn | 1470-2045 1474-5488 |
| language | eng |
| recordid | cdi_proquest_miscellaneous_1751215352 |
| source | MEDLINE; Elsevier ScienceDirect Journals Complete |
| subjects | Adult Age Factors Australia Breast cancer Breast Neoplasms - mortality Breast Neoplasms - pathology Breast Neoplasms - radiotherapy Breast Neoplasms - surgery Cancer therapies Dissection Europe Female Fibrosis Hematology, Oncology and Palliative Medicine Humans Intention to Treat Analysis Israel Kaplan-Meier Estimate Mastectomy Mastectomy, Segmental - adverse effects Mastectomy, Segmental - mortality Middle Aged Mortality Neoplasm Recurrence, Local Neoplasm Staging Patient Selection Proportional Hazards Models Radiation therapy Radiotherapy Dosage Radiotherapy, Adjuvant Reoperation Salvage Therapy Studies Time Factors Treatment Outcome |
| title | Whole-breast irradiation with or without a boost for patients treated with breast-conserving surgery for early breast cancer: 20-year follow-up of a randomised phase 3 trial |
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