Oktar Asoglu1, Handan Tokmak2, Baris Bakir3, Gokhan Demir4, Enis Ozyar5, Banu Atalar6, Suha Goksel7, Burak Koza8, Aslihan Guven Mert9, Atakan Demir10, Koray Guven11. 1. Bogazici Academy for Clinical Sciences General Surgery, Istanbul, Turkey. Electronic address: oktarasoglu@yahoo.com. 2. Acibadem University Maslak Hospital, Nuclear Medicine, Istanbul, Turkey. Electronic address: handantokmak@gmail.com. 3. İstanbul University, Istanbul Faculty of Medicine, Radiology Istanbul, Turkey. Electronic address: drbarisbakir@yahoo.com. 4. Acibadem University Maslak Hospital, Medical Oncology, Istanbul, Turkey. Electronic address: ogdemir@gmail.com. 5. Acibadem University Maslak Hospital, Radiation Oncology, Istanbul, Turkey. Electronic address: enis.ozyar@acibadem.com. 6. Acibadem University Maslak Hospital, Radiation Oncology, Istanbul, Turkey. Electronic address: banu.atalar@gmail.com. 7. Acibadem University Maslak Hospital, Pathology, Istanbul, Turkey. Electronic address: sugoksel@gmail.com. 8. Bogazici Academy for Clinical Sciences General Surgery, Istanbul, Turkey. Electronic address: bghb3333@gmail.com. 9. Acibadem University Maslak Hospital, Radiology, Istanbul, Turkey. Electronic address: aslihanguven@yahoo.com. 10. Acibadem University Maslak Hospital, Medical Oncology, Istanbul, Turkey. Electronic address: atakandemir85@gmail.com. 11. Acibadem University Maslak Hospital, Radiology, Istanbul, Turkey. Electronic address: korayguven@yahoo.com.
Abstract
BACKGROUND: The study aimed to assess if adherence to a total-neoadjuvant-treatment (TNT) protocol followed by observation(watch-and-wait) led to the successful nonoperative-management of low-rectal-cancer. METHODS: In this study, patients with primary, resectable-T3-T4, N0-N1 distal-rectal-adenocarcinoma underwent-chemoradiotherapy + consolidation-chemotherapy (TNT). During the-TNT-period, endoscopy, MRI, and FDG-PET/CT were performed. We allocated patients with complete-clinical-tumor-regression, who underwent endoscopy every two months, MRI every-four-months, and PET/CT every-six-months-after-treatment, to the observation-group(OG). All other patients were referred for surgery. The OG was followed-up. The primary endpoint was local tumor-ecurrence after allocation to the OG. RESULTS: Between 2015 and 2018, we enrolled 66-patients. Of 60-patients who were eligible to participate, 39 had complete-clinical-response(cCR) and were allocated to the OG, six underwent local-excision (LE), and 15 underwent total-mesorectal-excision (TME). The median follow-up duration was 22 (9-42) months. The local-recurrence-rate in the OG was 15.3%, and the LE and TME rates were 16.6% and 0%, respectively. All recurrence cases were salvaged through either LE or TME. The-distant-metastasis rate was 5.1%, 16.6%, and 12.5% in the OG, LE, and TME groups, respectively. The endoscopic negative-predictive-value(NPV) was 50%, and the positive-predictive-value(PPV) was 76.9% in the surgery group (LE + TME). MRI; NPV-50%, PPV-76.9%. PET/CT; NPV-100%, PPV-93.3%. Six patients(28.57%) from surgery group achieved complete pathological response (cPR). CONCLUSION: Our results indicated a high proportion of selected-rectal-cancers with-cCR after neo-adjuvant-therapy could potentially be managed non-operatively, and major surgery may be avoided.
BACKGROUND: The study aimed to assess if adherence to a total-neoadjuvant-treatment (TNT) protocol followed by observation(watch-and-wait) led to the successful nonoperative-management of low-rectal-cancer. METHODS: In this study, patients with primary, resectable-T3-T4, N0-N1 distal-rectal-adenocarcinoma underwent-chemoradiotherapy + consolidation-chemotherapy (TNT). During the-TNT-period, endoscopy, MRI, and FDG-PET/CT were performed. We allocated patients with complete-clinical-tumor-regression, who underwent endoscopy every two months, MRI every-four-months, and PET/CT every-six-months-after-treatment, to the observation-group(OG). All other patients were referred for surgery. The OG was followed-up. The primary endpoint was local tumor-ecurrence after allocation to the OG. RESULTS: Between 2015 and 2018, we enrolled 66-patients. Of 60-patients who were eligible to participate, 39 had complete-clinical-response(cCR) and were allocated to the OG, six underwent local-excision (LE), and 15 underwent total-mesorectal-excision (TME). The median follow-up duration was 22 (9-42) months. The local-recurrence-rate in the OG was 15.3%, and the LE and TME rates were 16.6% and 0%, respectively. All recurrence cases were salvaged through either LE or TME. The-distant-metastasis rate was 5.1%, 16.6%, and 12.5% in the OG, LE, and TME groups, respectively. The endoscopic negative-predictive-value(NPV) was 50%, and the positive-predictive-value(PPV) was 76.9% in the surgery group (LE + TME). MRI; NPV-50%, PPV-76.9%. PET/CT; NPV-100%, PPV-93.3%. Six patients(28.57%) from surgery group achieved complete pathological response (cPR). CONCLUSION: Our results indicated a high proportion of selected-rectal-cancers with-cCR after neo-adjuvant-therapy could potentially be managed non-operatively, and major surgery may be avoided.