A phase III randomised trial on the addition of a contact X-ray brachytherapy boost to standard neoadjuvant chemo-radiotherapy for organ preservation in early rectal adenocarcinoma: 5 year results of the OPERA trial

被引：6

作者：

Baron, D. ^{[1
]}

Loscos, T. Pace ^{[1
]}

Schiappa, R. ^{[1
]}

Barbet, N. ^{[2
]}

Dost, E. ^{[1
]}

Ben Dhia, S. ^{[1
]}

Soltani, S. ^{[3
]}

Mineur, L. ^{[4
]}

Martel, I. ^{[5
]}

Horn, S. ^{[6
]}

Picardi, C. ^{[7
,8
]}

Stewart, A. ^{[9
]}

Cotte, E. ^{[6
]}

Coquard, R. ^{[2
]}

Baudin, G. ^{[1
]}

Evesque, L. ^{[1
]}

Dhadda, A. ^{[1
,10
]}

Myint, A. Sun ^{[11
]}

Gerard, J. P. ^{[1
]}

Doyen, J. ^{[1
]}

机构：

[1] Univ Cote Azur, Ctr Antoine Lacassagne, Nice, France

[2] Ctr Oncol Radiotherapie Bayard, Villeurbanne, France

[3] CHU St Etienne, St Etienne, France

[4] Inst Sainte Catherine, Avignon, France

[5] Ctr Reg Lutte Canc Leon Berard, Lyon, France

[6] CHU Lyon, Lyon, France

[7] Klin Bethanien, Swiss Med Network, Zurich, Switzerland

[8] Hirslanden Klin, Zurich, Switzerland

[9] St Lukes Canc Ctr, Guildford, England

[10] Castle Hill Hosp, Queens Ctr Oncol & Haematol, Kingston Upon Hull, England

[11] Clatterbridge Canc Ctr, Clatterbridge, England

来源：

ANNALS OF ONCOLOGY | 2025年 / 36卷 / 02期

关键词：

organ preservation; rectal cancer; neoadjuvant treatment; contact X-ray brachytherapy; TME surgery; randomised trial; CANCER; RADIOTHERAPY; SPHINCTER; OUTCOMES;

D O I：

10.1016/j.annonc.2024.10.827

中图分类号：

R73 [肿瘤学];

学科分类号：

100214 ;

摘要：

Background: The OPERA trial has shown that a contact X-ray brachytherapy 50 kV (CXB) boost with neoadjuvant chemoradiotherapy (NCRT) can increase organ preservation (OP) rate for early rectal adenocarcinoma (ADK) of low- mid rectum. We report the results after 5 years of follow-up. Patients and methods: OPERA was a multicentre, phase III trial that included operable patients (pts), with cT2-cT3b low-mid rectal ADK, tumours <5 cm, cN0 or cN1 <8 mm. All pts received external beam radiotherapy (EBRT): 45 Gy in 25 fractions with concurrent capecitabine. Pts were randomly assigned (1:1) to receive a boost of EBRT in group A (9 Gy/5 fractions) or a boost with CXB (90 Gy/3 fractions) in group B. The primary end point was OP rate. Results: Out of 148 patients randomised, 141 were eligible. Between week 14-24, a clinical complete (or near) response was observed in 44 pts in group A (64%) versus 66 in group B (92%); P < 0.001. The 3-year OP rate was 59% in group A versus 81% in group B (P = 0.003). After update the median follow-up was 61.1 months [56.8-64.5]. The 5-year local regrowth was 39% in group A and 17% in group B (P = 0.1). The difference in OP was still highly significant between both groups: A 56% versus B 79% (P = 0.004). The difference was more significant if tumours <3 cm, with an OP rate of 93% in group B compared to 54% in group A. Of the 28 local regrowths, 3 occurred after 3 years of follow-up. Rectal bleeding (grade 1-2), which was the most prevalent toxicity during follow-up, disappeared most of the time after three years. Bowel function was not worsened by the CXB boost. Conclusion: The OPERA trial was the first trial to demonstrate that CXB dose escalation was increasing the OP rate with good bowel function at 3 years. At 5 years, these results are sustained, especially in small early-stage tumours. The occurrence of some local regrowth after 3 years necessitates close surveillance of these pts during the 5-year period.

引用

页码：208 / 215

页数：8

共 16 条

[1] Late toxicities and clinical outcome at 5 years of the ACCORD 12/0405-PRODIGE 02 trial comparing two neoadjuvant chemoradiotherapy regimens for intermediate-risk rectal cancer [J].

Azria, D. ;

Doyen, J. ;

Jarlier, M. ;

Martel-Lafay, I. ;

Hennequin, C. ;

Etienne, P. ;

Vendrely, V. ;

Francois, E. ;

de la Roche, G. ;

Bouche, O. ;

Mirabel, X. ;

Denis, B. ;

Mineur, L. ;

Berdah, J. ;

Mahe, M. ;

Becouran, Y. ;

Dupuis, O. ;

Lledo, G. ;

Seitz, J. ;

Bedenne, L. ;

Gourgou-Bourgade, S. ;

Juzyna, B. ;

Conroy, T. ;

Gerard, J. .

ANNALS OF ONCOLOGY, 2017, 28 (10) :2436-2442

[2] The Clavien-Dindo Classification of Surgical Complications Five-Year Experience [J].

Clavien, Pierre A. ;

Barkun, Jeffrey ;

de Oliveira, Michelle L. ;

Vauthey, Jean Nicolas ;

Dindo, Daniel ;

Schulick, Richard D. ;

de Santibanes, Eduardo ;

Pekolj, Juan ;

Slankamenac, Ksenija ;

Bassi, Claudio ;

Graf, Rolf ;

Vonlanthen, Rene ;

Padbury, Robert ;

Cameron, John L. ;

Makuuchi, Masatoshi .

ANNALS OF SURGERY, 2009, 250 (02) :187-196

[3] Organ Preservation Using Contact Radiotherapy for Early Rectal Cancer: Outcomes of Patients Treated at a Single Centre in the UK [J].

Dhadda, A. S. ;

Martin, A. ;

Killeen, S. ;

Hunter, I. A. .

CLINICAL ONCOLOGY, 2017, 29 (03) :198-204

[4] Low Anterior Resection Syndrome Score Development and Validation of a Symptom-Based Scoring System for Bowel Dysfunction After Low Anterior Resection for Rectal Cancer [J].

Emmertsen, Katrine J. ;

Laurberg, Soren .

ANNALS OF SURGERY, 2012, 255 (05) :922-928

[5] Neoadjuvant chemoradiotherapy with radiation dose escalation with contact x-ray brachytherapy boost or external beam radiotherapy boost for organ preservation in early cT2-cT3 rectal adenocarcinoma (OPERA): a phase 3 randomised controlled trial [J].

Gerard, Jean-Pierre ;

Barbet, Nicolas ;

Schiappa, Renaud ;

Magne, Nicolas ;

Martel, Isabelle ;

Mineur, Laurent ;

Deberne, Melanie ;

Zilli, Thomas ;

Dhadda, Amandeep ;

Myint, Arthur Sun .

LANCET GASTROENTEROLOGY & HEPATOLOGY, 2023, 8 (04) :356-367

[6] Propensity score analysis of radical proctectomy versus organ preservation using contact X-ray brachytherapy for rectal cancer [J].

Gerard, Jean-Pierre ;

Montagne, Lucile ;

Thamphya, Brice ;

Doyen, Jerome ;

Schiappa, Renaud ;

Benezery, Karene ;

Gourgou, Sophie ;

Dejean, Catherine ;

Hannoun-Levi, Jean-Michel .

CLINICAL AND TRANSLATIONAL RADIATION ONCOLOGY, 2022, 33 :70-76

[7] Planned organ preservation for early T2-3 rectal adenocarcinoma: A French, multicentre study [J].

Gerard, Jean-Pierre ;

Barbet, Nicolas ;

Gal, Jocelyn ;

Dejean, Catherine ;

Evesque, Ludovic ;

Doyen, Jerome ;

Coquard, Regis ;

Gugenheim, Jean ;

Benizri, Emmanuel ;

Schiappa, Renaud ;

Baudin, Guillaume ;

Benezery, Karene ;

Francois, Eric .

EUROPEAN JOURNAL OF CANCER, 2019, 108 :1-16

[8] Improved sphincter preservation in low rectal cancer with high-dose preoperative radiotherapy: The Lyon R96-02 randomized trial [J].

Gerard, JP ;

Chapet, O ;

Nemoz, C ;

Hartweig, J ;

Romestaing, P ;

Coquard, R ;

Barbet, N ;

Maingon, P ;

Mahe, M ;

Baulieux, J ;

Partensky, C ;

Papillon, M ;

Glehen, O ;

Crozet, B ;

Grandjean, JP ;

Adeleine, P .

JOURNAL OF CLINICAL ONCOLOGY, 2004, 22 (12) :2404-2409

[9] 'Folfirinox' chemotherapy combined with contact x-ray brachytherapy 50 kVp and 'CAP50' chemoradiotherapy aiming at organ preservation for selected intermediate distal-middle cT2-T3 rectal cancers: A feasibility study [J].

Mitrea, D. ;

Barbet, N. ;

Pace-Loscos, T. ;

Scouarnec, C. ;

Ben-Dhia, S. ;

Baron, D. ;

Mineur, L. ;

Evesque, L. ;

Durand-Labrunie, J. ;

Gerard, J-P ;

Baudin, G. ;

Doyen, J. .

CANCER RADIOTHERAPIE, 2024, 28 (04) :323-332

[10] Dose Escalation Using Contact X-ray Brachytherapy After External Beam Radiotherapy as Nonsurgical Treatment Option for Rectal Cancer: Outcomes From a Single-Center Experience [J].

Myint, Arthur Sun ;

Smith, Fraser McLean ;

Gollins, Simon ;

Wong, Helen ;

Rao, Christopher ;

Whitmarsh, Karen ;

Sripadam, Raj ;

Rooney, Paul ;

Hershman, Michael ;

Pritchard, D. Mark .

INTERNATIONAL JOURNAL OF RADIATION ONCOLOGY BIOLOGY PHYSICS, 2018, 100 (03) :565-573

← 1 2 →