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DELAYED TOTAL MESORECTAL EXCISION FOR MAJOR OR COMPLETE CLINICAL RESPONSE FOLLOWING RECTAL SPARING APPROACHES: A PROPENSITY SCORE-MATCHED ANALYSIS OF SHORT- AND LONG-TERMS OUTCOMES.
Quoc Riccardo Bao
*2, Stefania Ferrari
2, Alessandra Pulvirenti
2, Francesco Celotto
2, Giulia Battisti
2, Marco Scarpa
2, Paolo Delrio
1, Daniela Rega
1, Angelo Restivo
3, Claudio Coco
4, Maria Antonietta Gambacorta
4, Salvatore Pucciarelli
2, Gaya Spolverato
21Istituto Nazionale Tumori IRCCS Fondazione Pascale, Naples, Campania, Italy; 2Universita degli Studi di Padova, Padua, Veneto, Italy; 3Universita degli Studi di Cagliari, Cagliari, Sardinia, Italy; 4Fondazione Policlinico Universitario Agostino Gemelli IRCCS, Rome, Lazio, Italy
Background. Rectal sparing approaches, such as local excision (LE) and watch-and-wait (WW), are proposed for selected patients with major (mCR) or complete clinical response (cCR) after neoadjuvant treatment (NAT). In case of high-risk histopathological features (completion TME), local recurrence, or tumor local regrowth (salvage TME) TME is recommended. Recent studies showed an increased risk of distant metastasis in case of local regrowth. The primary aim of this study is to assess whether delayed TME (dTME) after rectal sparing approaches affects oncological outcomes. The secondary outcome was to evaluate whether dTME increases postoperative complications.
Methods. Data were extracted from a prospective, observational, and multicentre study (ReSARCh trial, clinicaltrial.gov NCT02710812). Patients who underwent TME after LE or WW as completion or salvage surgery were included in the analysis (dTME group). Propensity-score matching was performed based on sex, age, ASA score, BMI, CEA levels, tumor distance from the anal verge, and cTNM stage. The dTME group was matched with a cohort of patients who underwent TME after nCRT (standard TME (sTME)group) at our instituiton between 2015 and 2020. Outcomes analyzed were 30-day postoperative complications, reinterventions, and mortality, overall survival (OS) and cumulative incidence of overall (OR), local (LR), and distant recurrence (DR).
Results. A total of 38 patients were included in the dTME group and 217 in the sTME group. Of 38 patients who underwent dTME, 25 (65.8%) and 13 (34.2%) initially underwent a LE and WW approach. TME was performed for completion surgery after LE (n=18, 47.3%), for salvage surgery for local regrowth (n=13, 34.2%) and for local recurrence (n=7, 18.4%). After propensity-score matching, 66 patients were included in the sTME group. The groups were comparable, except for ASA score (p=0.05) with a prevalence of ASA I in the dTME group. 30-day complications, reintervention, and mortality were similar between the groups, although a higher rate of anastomotic leak in the sTME group was reported (20.0% Vs 3.0%, p=0.03). At a median follow-up of 59 months, there were no difference in the 5-year OS. The 5-year cumulative incidence of OR were 33% Vs 28%(p=0.3) in the dTME and sTME, respectively. The cumulative 5-year DR were 15% Vs 26% (p=0.4) in the dTME and sTME, respectively.
Conclusion. dTME, performed as completion and salvage surgery after rectal sparing approaches, doesn’t seem to compromise survival or increase recurrence risk compared to standard TME after NAT. Additionally, postoperative complication rates are comparable to s TME after neoadjuvant treatment. However, indications for organ preservation should be more accurate, and still limited by a high number of dTME.
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