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Article: Quality of life after total laparoscopic hysterectomy versus total abdominal hysterectomy for stage I endometrial cancer (LACE): A randomised trial

TitleQuality of life after total laparoscopic hysterectomy versus total abdominal hysterectomy for stage I endometrial cancer (LACE): A randomised trial
Authors
Issue Date2010
PublisherThe Lancet Publishing Group. The Journal's web site is located at http://www.elsevier.com/locate/j.lancetoncol
Citation
The Lancet Oncology, 2010, v. 11 n. 8, p. 772-780 How to Cite?
AbstractBackground: This two-stage randomised controlled trial, comparing total laparoscopic hysterectomy (TLH) with total abdominal hysterectomy (TAH) for stage I endometrial cancer (LACE), began in 2005. The primary objective of stage 1 was to assess whether TLH results in equivalent or improved quality of life (QoL) up to 6 months after surgery compared with TAH. The primary objective of stage 2 was to test the hypothesis that disease-free survival at 4·5 years is equivalent for TLH and TAH. Here, we present the results of stage 1. Methods: Between Oct 7, 2005, and April 16, 2008, 361 participants were enrolled in the QoL substudy at 19 centres across Australia, New Zealand, and Hong Kong; 332 completed the QoL analysis. Randomisation was done centrally and independently from other study procedures via a computer-generated, web-based system (providing concealment of the next assigned treatment), using stratified permuted blocks of three and six patients. Patients with histologically confirmed stage I endometrioid adenocarcinoma and Eastern Cooperative Oncology Group performance status less than 2 were randomly assigned to TLH (n=190) or TAH (n=142), stratified by histological grade and study centre. Patients and study personnel were not masked to treatment assignment. QoL was measured at baseline, 1 and 4 weeks (early), and 3 and 6 months (late) after surgery, using the Functional Assessment of Cancer Therapy-General (FACT-G) questionnaire. The primary endpoint was the difference between groups in QoL change from baseline at early and late timepoints (a 5% difference was considered clinically significant). Analysis was done according to the intention-to-treat principle. Patients for both stages of the trial have now been recruited and are being followed up for disease-specific outcomes. The LACE trial is registered with ClinicalTrials.gov, number NCT00096408. Findings: Eight of 332 patients (2·4%) had treatment conversion-seven from TLH to TAH and one from TAH to TLH (patient preference). In the early phase of recovery, patients who had TLH reported significantly greater improvement in QoL from baseline compared with those who had TAH, in all subscales apart from emotional and social wellbeing. Improvements in QoL up to 6 months after surgery continued to favour TLH, except in the emotional and social wellbeing measures of FACT and the visual analogue scale of the EuroQoL five dimensions (EuroQoL-VAS). Operating time was significantly longer in the TLH group (138 min [SD 43]) than in the TAH group (109 min [34]; p=0·001). Although the proportion of intraoperative adverse events was similar between groups (TAH eight of 142 [5·6%] vs TLH 14 of 190 [7·4%]; p=0·53); postoperatively, twice as many patients in the TAH group experienced adverse events of grade 3 or higher (33 of 142 [23·2%] vs 22 of 190 [11·6%] in the TLH group; p=0·004). Postoperative serious adverse events occurred more in the TAH group (27 of 142 [19·0%]) than in the TLH group (16 of 190 [7·9%]; p=0·002). Interpretation: QoL improvements from baseline during early and later phases of recovery, and the adverse event profile, favour TLH compared with TAH for treatment of stage I endometrial cancer. Funding: Cancer Council Queensland, Cancer Council New South Wales, Cancer Council Victoria, Cancer Council Western Australia; NHMRC project grant 456110; Cancer Australia project grant 631523; The Women and Infants Research Foundation, Western Australia; Royal Brisbane and Women's Hospital Foundation; Wesley Research Institute; Gallipoli Research Foundation; Gynetech; TYCO Healthcare, Australia; Johnson and Johnson Medical, Australia; Hunter New England Centre for Gynaecological Cancer; Genesis Oncology Trust; and Smart Health Research Grant QLD Health. © 2010 Elsevier Ltd.
Persistent Identifierhttp://hdl.handle.net/10722/125629
ISSN
2015 Impact Factor: 26.509
2015 SCImago Journal Rankings: 13.940
ISI Accession Number ID
Funding AgencyGrant Number
Cancer Council Queensland
Cancer Council New South Wales
Cancer Council Victoria
Cancer Council Western Australia
NHMRC456110
Cancer Australia631523
Women and Infants Research Foundation, Western Australia
Royal Brisbane and Women's Hospital Foundation
Wesley Research Institute
Gallipoli Research Foundation
Gynetech
TYCO Healthcare, Australia
Johnson and Johnson Medical, Australia
Hunter New England Centre for Gynaecological Cancer
Genesis Oncology Trust
QLD Health
Bristol-Myers Squibb
Funding Information:

Cancer Council Queensland, Cancer Council New South Wales, Cancer Council Victoria, Cancer Council Western Australia; NHMRC project grant 456110; Cancer Australia project grant 631523; The Women and Infants Research Foundation, Western Australia; Royal Brisbane and Women's Hospital Foundation; Wesley Research Institute; Gallipoli Research Foundation; Gynetech; TYCO Healthcare, Australia; Johnson and Johnson Medical, Australia; Hunter New England Centre for Gynaecological Cancer; Genesis Oncology Trust; and Smart Health Research Grant QLD Health.

References

 

DC FieldValueLanguage
dc.contributor.authorJanda, Men_HK
dc.contributor.authorGebski, Ven_HK
dc.contributor.authorBrand, Aen_HK
dc.contributor.authorHogg, Ren_HK
dc.contributor.authorJobling, TWen_HK
dc.contributor.authorLand, Ren_HK
dc.contributor.authorManolitsas, Ten_HK
dc.contributor.authorMcCartney, Aen_HK
dc.contributor.authorNascimento, Men_HK
dc.contributor.authorNeesham, Den_HK
dc.contributor.authorNicklin, JLen_HK
dc.contributor.authorOehler, MKen_HK
dc.contributor.authorOtton, Gen_HK
dc.contributor.authorPerrin, Len_HK
dc.contributor.authorSalfinger, Sen_HK
dc.contributor.authorHammond, Ien_HK
dc.contributor.authorLeung, Yen_HK
dc.contributor.authorWalsh, Ten_HK
dc.contributor.authorSykes, Pen_HK
dc.contributor.authorNgan, Hen_HK
dc.contributor.authorGarrett, Aen_HK
dc.contributor.authorLaney, Men_HK
dc.contributor.authorNg, TYen_HK
dc.contributor.authorTam, Ken_HK
dc.contributor.authorChan, Ken_HK
dc.contributor.authorWrede, CDHen_HK
dc.contributor.authorPather, Sen_HK
dc.contributor.authorSimcock, Ben_HK
dc.contributor.authorFarrell, Ren_HK
dc.contributor.authorObermair, Aen_HK
dc.date.accessioned2010-10-31T11:42:28Z-
dc.date.available2010-10-31T11:42:28Z-
dc.date.issued2010en_HK
dc.identifier.citationThe Lancet Oncology, 2010, v. 11 n. 8, p. 772-780en_HK
dc.identifier.issn1470-2045en_HK
dc.identifier.urihttp://hdl.handle.net/10722/125629-
dc.description.abstractBackground: This two-stage randomised controlled trial, comparing total laparoscopic hysterectomy (TLH) with total abdominal hysterectomy (TAH) for stage I endometrial cancer (LACE), began in 2005. The primary objective of stage 1 was to assess whether TLH results in equivalent or improved quality of life (QoL) up to 6 months after surgery compared with TAH. The primary objective of stage 2 was to test the hypothesis that disease-free survival at 4·5 years is equivalent for TLH and TAH. Here, we present the results of stage 1. Methods: Between Oct 7, 2005, and April 16, 2008, 361 participants were enrolled in the QoL substudy at 19 centres across Australia, New Zealand, and Hong Kong; 332 completed the QoL analysis. Randomisation was done centrally and independently from other study procedures via a computer-generated, web-based system (providing concealment of the next assigned treatment), using stratified permuted blocks of three and six patients. Patients with histologically confirmed stage I endometrioid adenocarcinoma and Eastern Cooperative Oncology Group performance status less than 2 were randomly assigned to TLH (n=190) or TAH (n=142), stratified by histological grade and study centre. Patients and study personnel were not masked to treatment assignment. QoL was measured at baseline, 1 and 4 weeks (early), and 3 and 6 months (late) after surgery, using the Functional Assessment of Cancer Therapy-General (FACT-G) questionnaire. The primary endpoint was the difference between groups in QoL change from baseline at early and late timepoints (a 5% difference was considered clinically significant). Analysis was done according to the intention-to-treat principle. Patients for both stages of the trial have now been recruited and are being followed up for disease-specific outcomes. The LACE trial is registered with ClinicalTrials.gov, number NCT00096408. Findings: Eight of 332 patients (2·4%) had treatment conversion-seven from TLH to TAH and one from TAH to TLH (patient preference). In the early phase of recovery, patients who had TLH reported significantly greater improvement in QoL from baseline compared with those who had TAH, in all subscales apart from emotional and social wellbeing. Improvements in QoL up to 6 months after surgery continued to favour TLH, except in the emotional and social wellbeing measures of FACT and the visual analogue scale of the EuroQoL five dimensions (EuroQoL-VAS). Operating time was significantly longer in the TLH group (138 min [SD 43]) than in the TAH group (109 min [34]; p=0·001). Although the proportion of intraoperative adverse events was similar between groups (TAH eight of 142 [5·6%] vs TLH 14 of 190 [7·4%]; p=0·53); postoperatively, twice as many patients in the TAH group experienced adverse events of grade 3 or higher (33 of 142 [23·2%] vs 22 of 190 [11·6%] in the TLH group; p=0·004). Postoperative serious adverse events occurred more in the TAH group (27 of 142 [19·0%]) than in the TLH group (16 of 190 [7·9%]; p=0·002). Interpretation: QoL improvements from baseline during early and later phases of recovery, and the adverse event profile, favour TLH compared with TAH for treatment of stage I endometrial cancer. Funding: Cancer Council Queensland, Cancer Council New South Wales, Cancer Council Victoria, Cancer Council Western Australia; NHMRC project grant 456110; Cancer Australia project grant 631523; The Women and Infants Research Foundation, Western Australia; Royal Brisbane and Women's Hospital Foundation; Wesley Research Institute; Gallipoli Research Foundation; Gynetech; TYCO Healthcare, Australia; Johnson and Johnson Medical, Australia; Hunter New England Centre for Gynaecological Cancer; Genesis Oncology Trust; and Smart Health Research Grant QLD Health. © 2010 Elsevier Ltd.en_HK
dc.languageengen_HK
dc.publisherThe Lancet Publishing Group. The Journal's web site is located at http://www.elsevier.com/locate/j.lancetoncolen_HK
dc.relation.ispartofThe Lancet Oncologyen_HK
dc.rightsCreative Commons: Attribution 3.0 Hong Kong License-
dc.rightsNOTICE: this is the author’s version of a work that was accepted for publication in [The Lancet Oncology]. Changes resulting from the publishing process, such as peer review, editing, corrections, structural formatting, and other quality control mechanisms may not be reflected in this document. Changes may have been made to this work since it was submitted for publication. A definitive version was subsequently published in PUBLICATION, [VOL 11, ISSUE 8, (AUG 2010)] DOI 10.1016/S1470-2045(10)70145-5-
dc.titleQuality of life after total laparoscopic hysterectomy versus total abdominal hysterectomy for stage I endometrial cancer (LACE): A randomised trialen_HK
dc.typeArticleen_HK
dc.identifier.emailNgan, H:hysngan@hkucc.hku.hken_HK
dc.identifier.authorityNgan, H=rp00346en_HK
dc.description.naturepostprint-
dc.identifier.doi10.1016/S1470-2045(10)70145-5en_HK
dc.identifier.pmid20638899-
dc.identifier.scopuseid_2-s2.0-77955278878en_HK
dc.identifier.hkuros175333en_HK
dc.relation.referenceshttp://www.scopus.com/mlt/select.url?eid=2-s2.0-77955278878&selection=ref&src=s&origin=recordpageen_HK
dc.identifier.volume11en_HK
dc.identifier.issue8en_HK
dc.identifier.spage772en_HK
dc.identifier.epage780en_HK
dc.identifier.isiWOS:000281009500023-
dc.publisher.placeUnited Kingdomen_HK
dc.identifier.scopusauthoridJanda, M=7005192283en_HK
dc.identifier.scopusauthoridGebski, V=16233175200en_HK
dc.identifier.scopusauthoridBrand, A=23027063200en_HK
dc.identifier.scopusauthoridHogg, R=7201804395en_HK
dc.identifier.scopusauthoridJobling, TW=26643402000en_HK
dc.identifier.scopusauthoridLand, R=7004935541en_HK
dc.identifier.scopusauthoridManolitsas, T=6603060633en_HK
dc.identifier.scopusauthoridMcCartney, A=7004310422en_HK
dc.identifier.scopusauthoridNascimento, M=8632338600en_HK
dc.identifier.scopusauthoridNeesham, D=6507268632en_HK
dc.identifier.scopusauthoridNicklin, JL=35240667700en_HK
dc.identifier.scopusauthoridOehler, MK=7004087012en_HK
dc.identifier.scopusauthoridOtton, G=25637701500en_HK
dc.identifier.scopusauthoridPerrin, L=35415718900en_HK
dc.identifier.scopusauthoridSalfinger, S=6504323465en_HK
dc.identifier.scopusauthoridHammond, I=7004849540en_HK
dc.identifier.scopusauthoridLeung, Y=7201463926en_HK
dc.identifier.scopusauthoridWalsh, T=14420337200en_HK
dc.identifier.scopusauthoridSykes, P=7101668541en_HK
dc.identifier.scopusauthoridNgan, H=34571944100en_HK
dc.identifier.scopusauthoridGarrett, A=7006787646en_HK
dc.identifier.scopusauthoridLaney, M=6603586390en_HK
dc.identifier.scopusauthoridNg, TY=7402229853en_HK
dc.identifier.scopusauthoridTam, K=7201692816en_HK
dc.identifier.scopusauthoridChan, K=25622512400en_HK
dc.identifier.scopusauthoridWrede, CDH=55167598400en_HK
dc.identifier.scopusauthoridPather, S=8862538000en_HK
dc.identifier.scopusauthoridSimcock, B=26538079400en_HK
dc.identifier.scopusauthoridFarrell, R=33067922800en_HK
dc.identifier.scopusauthoridObermair, A=7006307099en_HK
dc.identifier.citeulike7602211-

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