Planned organ preservation for selected T2-3 rectal cancer: French experience using chemoradiotherapy and contact xray boost.

751 Background: The Lyon R96-02 randomized trial has demonstrated in T2-3 rectal cancer that external beam radiotherapy (EBRT) with Contact X Ray brachytherapy (CXB) boost was increasing clinical complete response, sphincter preservation and in early cases organ preservation. We report French experience in 3 radiotherapy departments using CXB boost with chemoradiotherapy (CRT) in early T2T3N0. Methods: Selection based on digital rectal examination, colonoscopy, MRI (and/or Endorectal-ultrasound). Inclusion : adenocarcinoma (distal, middle rectum), T2 T3a-b, tumor diameter ≤ 4cm, N0, M0. Treatment : CXB (80-110 Gy/3-4 fr) followed by CRT (CAP 50). Tumor response assess on week 14 : DRE, rigid rectoscopy and MRI. Clinical complete response (cCR) defined as no visible tumor, supple rectal wall and TRG 1-2 on MRI. In case of cCR a close surveillance or local excision was proposed. Results: Between 2002 -2016, 84 patients treated. Median age: 75 years, Male: 59, Female: 25. Operable patients: 69 (83%). T2 : 52, T3 : 32 (Lyon Villeurbanne : 16, Macon : 11, Nice : 57). Median follow-up time : 53 months. cCR was achieved in 94% of cases. Local excision performed in 17 patients (ypT0 : 16). At 4 years, the cancer specific survival was 82% [CI:96-70] and the local relapse rate 12% [CI: 2-22]. No isolated perirectal lymph node relapse observed. After 4 years, 3 more local relapses observed (4, 6, 7 years). Main late toxicity ( > 6 months after treatment) was rectal bleeding (radiation telangiectasia) which required plasma argon coagulation in 5 patients. No TME surgery was performed and organ preservation was achieved in all cases. Bowel function was good in 85% of patients (LARS score < 20). Conclusions: When combining CXB with CRT, rectal cancer T2T3a-b N0 ≤4cm achieve a high rate of cCR (≥85%) with organ preservation, good bowel function, low rate of local relapse ( < 15%) and low toxicity. As rectal adenocarcinoma is radioresistant, the treatment must use a CXB boost. Like anal squamous cell cancer, planned organ preservation can be proposed to operable patients. The ongoing European OPERA trial aims at bringing evidence to this option.

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Contact x-ray brachytherapy 50 kV (CXB) for organ preservation in T2 T3a-b rectal cancer: Lyon-Nice experience in 120 patients.

Journal of Clinical Oncology ◽

10.1200/jco.2015.33.3_suppl.676 ◽

2015 ◽

Vol 33 (3_suppl) ◽

pp. 676-676

Author(s):

Jerome Doyen ◽

Eric Francois ◽

Anne-Claire Frin ◽

Karen Benezery ◽

Fuxiang Zhou ◽

...

Keyword(s):

Rectal Cancer ◽

Organ Preservation ◽

External Beam Radiotherapy ◽

Rectal Adenocarcinoma ◽

Bowel Function ◽

Complete Response ◽

Local Relapse ◽

Concurrent Chemotherapy ◽

High Rate ◽

X Ray

676 Background: Organ preservation (avoiding TME surgery) for T2 T3 a-b rectal cancer is a field of active clinical research. Contact X Ray CXB combined with external beam radiotherapy (EBRT) ± concurrent chemotherapy (CRT) is an attractive method to achieve clinical complete response (cCR) and consequently rectal preservation. We report an overview of 120 patients treated with CXB+EBRT over a 25 year period in Lyon since 1986 and then in Nice until 2012. Methods: Between 1986 and 2012, 120 patients presenting rectal adenocarcinoma T2 T3a-b (distal rectum: 87; middle rectum: 33) were treated with CXB +EBRT with conservative intent. In Lyon (1986-2001), 80 patients median age: 73y; T2:52; T3:28) risk were treated using CXB (80-110 Gy/3-4 fr/4-6 weeks) followed by EBRT (39 Gy/13 fr/18 days) and 192 Iridium implant boost (20 Gy). When cCR was achieved, close surveillance was proposed. In Nice (2002-2012), 40 patients (median age 81y; T2:22; T3:18) received CXB same regimen as in Lyon (using new Papillon 50 machine since 2009) + EBRT (45-50 Gy/5weeks) with concurrent chemotherapy (5-FU or Capecitabine). When cCR was achieved close surveillance was proposed or local excision (13 pts). Results: Median follow-up time 58 months in both groups. Local relapse occurred mainly in the 2 first years. Isolated lymph node recurrence <5%. Bowel function good or excellent when rectum preserved. Main clinical outcomes in table (some improved results in Nice possibly due to better treatment approach and patient selection). Conclusions: CXB with EBRT and concurrent capecitabine achieve safely high rate of cCR with organ preservation. The OPERA randomized trial will reproduce Lyon R 96 trial (Gerard JP, JCO 2004;22:2404) and test the superiority of CXB boost for organ preservation. [Table: see text]

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Does non-TME surgery of rectal cancer compromise the chance of cure? Preliminary surgical salvage data from OPERA phase III randomized trial.

Journal of Clinical Oncology ◽

10.1200/jco.2021.39.3_suppl.12 ◽

2021 ◽

Vol 39 (3_suppl) ◽

pp. 12-12

Author(s):

Arthur Sun Myint ◽

Brice Thamphya ◽

Jean-Pierre Gerard

Keyword(s):

Rectal Cancer ◽

Local Excision ◽

Organ Preservation ◽

Residual Disease ◽

Salvage Surgery ◽

Randomised Trial ◽

Complete Response ◽

Phase Iii ◽

Residual Tumour ◽

Surgical Salvage

12 Background: Non-operative modality (NOM) treatment of rectal cancer is gaining popularity as it avoids extirpative TME surgery and a stoma. OPERA trial was set up to evaluate the role of dose escalation using Contact X-ray brachytherapy [CXB] in improving the chance of organ preservation compared to the standard of care (EBCRT and TME surgery). We report on the preliminary surgical salvage data for treatment failures in the OPERA trial (NCT02505750). Methods: OPERA is a European phase 3 randomised trial between (Arm A- standard arm) EBCRT 45Gy/25/5weeks with oral capecitabine 825mg/m2 and EBRT boost of 9Gy/5/5 days randomised against (Arm B- experimental arm) EBCRT followed by CXB boost (90 Gy/3/4 weeks). Patients were assessed at 14, 20 and 24 weeks. Watch & wait policy was adopted for patients with cCR at 24 weeks after randomisation and surgery (TME or local excision) was offered for residual disease and also for local regrowth (recurrence) at a later date. Results: From July 2015 –June 2020, 148 patients were randomised of which 144 were evaluable (table). There were 71 patients in Arm A (standard) and 73 patients in Arm B (experimental). Median follow-up was 19 months (range 2-36 m). Overall clinical complete response (cCR) was observed in 103 out of 127 evaluable patients (81%) at 24 week in both arms (blinded). Surgery was carried out in 36/ 127 (28%) patients with suspected residual tumour. Further 13 patients had salvage surgery at a later date for local regrowth. At 19 months, 49/144 (34%) patients in total cohort had surgery. Local excision was carried out in 24 /49(49%) of which 3 proceeded to TME surgery due to R (1) or ypT2 adverse histology. TME surgery was carried out in 28/49 of which 8/28 (28.6%) had APER and 20/28(71.4%) had AR. In total, organ preservation (blinded) was achieved in 116/144 (80.5%) for the whole cohort. Kaplan Meier estimate of TME free survival is 76% at 19 months. Conclusions: Non-TME surgical treatment for cT2-cT3a-b rectal cancer is feasible in those who are fit and wish to avoid surgery (Watch & Wait). Those who needed surgery can be offered salvage surgery immediately for local residual disease or for local regrowth at a later date. Organ preservation of 80.5% (blinded) can be achieved without compromising their chance of cure. Clinical trial information: NCT02505750. [Table: see text]

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