Neoadjuvant Chemotherapy without Radiation in Colorectal Cancer

Bhudia, Jyotsna; Glynne‐Jones, Rob; Smith, Thomas P.; Hall, Marcia

doi:10.1055/s-0040-1713746

Cited by 12 publications

(5 citation statements)

References 92 publications

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“…Third, we evaluated the effect of preoperative CRT with S-1. Tumor shrinkage due to preoperative treatment may allow improved curative surgery [ 33 , 34 ], and this could also be expected to be associated with improved anal function preservation [ 35 , 36 ]. Among patients with Rb and Rb-P lesions, 56% were able to achieve anal preservation.…”

Section: Discussionmentioning

confidence: 99%

Efficacy and safety of preoperative chemoradiotherapy with S-1 for advanced rectal cancer: a phase II study

Ushigome

Funahashi

Kaneko

et al. 2023

Rep Pract Oncol Radiother.

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Background Preoperative chemoradiotherapy (CRT) for patients with rectal cancer is not yet established in Japan. We aimed to evaluate the efficacy and safety of preoperative CRT with S-1, a fixed-dose combination of tegafur, gimeracil, and oteracil potassium. Materials and methods We conducted a prospective, interventional, non-randomized single-center study. Radiotherapy was administered at a total dose of 45 Gy (1.8 Gy in 25 fractions) for five weeks. S-1 was administered orally for nine weeks (five weeks during and four weeks after radiotherapy) at a dose of 80 mg/m 2 /day. The endpoint was the pathological complete response (pCR) rate. Results Twenty-eight patients were finally enrolled. The following patient characteristics were recorded: clinical Stage (II: n = 12, III: n = 16), median age (66 years, range 40–77 years), male/female ratio (20/8), and lesion site (Ra-Rb:3/Rb:23/Rb-P:2). Preoperative treatment was completed in 27 patients (96%). Treatment abandonment occurred because of diarrhea. Grade 3 or higher adverse events were observed in one (4%) patient with two events. No serious adverse events occurred in the ≥ 70 years group. The response rate was 68% in all patients and 68% among elderly patients. Radical resection was achieved in all patients, including 19 (68%) who underwent sphincter-preserving surgery. The pCR rate was 11% (three patients). The five-year disease-free survival rate was 68%, and the overall survival rate was 82%. Local recurrence occurred in only one patient five years after surgery. Conclusion Preoperative CRT with S-1 alone may be a safe and acceptable regimen from the perspective of adverse events and oncological outcomes. Trial registration UMIN Clinical Trial Registry: UMIN000013598. Registered 1 April 2014, https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recpt-no=R000015887

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Section: Discussionmentioning

confidence: 99%

Efficacy and safety of preoperative chemoradiotherapy with S-1 for advanced rectal cancer: a phase II study

Ushigome

Funahashi

Kaneko

et al. 2023

Rep Pract Oncol Radiother.

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“…Chemotherapy itself can produce significant local responses at sites of bulky primary disease, including achieving complete pathologic regression in rectal cancer without radiation. 38 These local effects of full-dose Copyright © 2022 Wolters Kluwer Health, Inc. All rights reserved.…”

Section: Discussionmentioning

confidence: 99%

“…Another important finding from PRODIGE 23 and RAPIDO was the impressive pathologic CR rates in the TNT groups—28% in both studies. Chemotherapy itself can produce significant local responses at sites of bulky primary disease, including achieving complete pathologic regression in rectal cancer without radiation 38. These local effects of full-dose chemotherapy are well established in a variety of tumors and can influence local tumor outcomes, beyond their role in treating micrometastatic disease 39,40.…”

Section: Discussionmentioning

confidence: 99%

Nonoperative Management Following Complete Response in Rectal Cancer After Short-course Radiation Therapy and Consolidation Chemotherapy

Reddy

Safar²,

Jia

et al. 2022

American Journal of Clinical Oncology

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Purpose: The purpose of his study was to report on a cohort of patients managed with nonoperative management (NOM) with a watch-and-wait strategy after achieving complete response (CR) to sequential short-course radiation therapy (SCRT) and consolidation chemotherapy.Methods: This was a retrospective study of patients treated SCRT and chemotherapy who achieved a CR and were managed with NOM. Bowel function was assessed with European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire Core 30, EORTC Quality of Life Questionnaire-Colorectal Cancer 29, and the low anterior resection syndrome (LARS) questionnaires. Endpoints included overall survival (OS), freedom from local failure (FFLF), freedom from distant metastasis, and disease-free survival (DFS).Results: Twenty-six patients met inclusion criteria. Seven (26.9%) patients developed local failure at a median of 6.8 months following CR, of which 5 were successfully salvaged. Median FFLF was not reached, with 6-month, 1-, and 2-year FFLF rates of 100.0%, 82.3%, and 71.3%. Median OS was not reached, with 6-month, 1-, and 2-year OS rates of 100%. Median DFS was not reached, with 6-month, 1-, and 2-year DFS rates of 100%, 95.0%, and 89.4%. Questionnaire response rate was 83.3%. Median LARS score was 27. Major, minor, and no LARS occurred in 3 (20%), 6 (40%), and 6 (40%) patients, respectively. There were no differences in questionnaire scores between patients who had the majority of their anal sphincter complex irradiated and those who did not. Conclusion:NOM with a watch-and-wait strategy is safe and feasible in patients with locally advanced rectal cancer who achieve CR after sequential SCRT and chemotherapy, with evidence for good anorectal function.

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“…Next, we evaluated the effect of preoperative CRT with S-1. Tumor shrinkage due to preoperative treatment may contribute to improved curative surgery [28,29], and it can also be expected to be associated with improved anal function preservation [30,31]. Similar studies using S-1 have reported pCR rates of 22.2% [27] and 10.8% [21], although there were slight differences in the regimen.…”

Section: Discussionmentioning

confidence: 99%

Efficacy and Safety of Preoperative Chemoradiotherapy With S-1 for Advanced Rectal Cancer: A Phase II Study

Ushigome

Funahashi

Kaneko

et al. 2021

Preprint

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Background: Preoperative chemoradiotherapy (CRT) for patients with rectal cancer has not yet been established in Japan. We conducted a non-randomized phase II study to evaluate the efficacy and safety of preoperative CRT with S-1, a fixed-dose combination of tegafur, gimeracil, and oteracil potassium. Methods: We conducted a prospective, interventional, single-center study. Radiotherapy was administered at a total dose of 45 Gy (1.8 Gy in 25 fractions) for five weeks. S-1 was administered orally for a total of nine weeks (five weeks during and four weeks after radiotherapy) at a dose of 80 mg/m2/day. The endpoint was the pathological complete response (pCR) rate. The required sample size was calculated to be 30 individuals. The characteristics of the 28 patients included were as follows: cStage (II:12/ III:16), median age of 66 years (range 40–77 years), male/female (20/8), and lesion site (Ra-Rb:3/Rb:23/Rb-P:2). Results: Preoperative treatment was completed in 27 patients (96%). Treatment abandon was because of diarrhea. Grade 3 or higher adverse events were observed in only two patients (7%). Clinical downstaging was performed in eight patients (29%). Radical resection was achieved in 27 patients (96%), including 19 (68%) who underwent sphincter-preserving surgery. The pCR rate was 11% (three patients). The three-year disease-free survival rate was 79%, and the overall survival was 89%. No local recurrence occurred three years after surgery. Conclusions: Preoperative CRT with S-1 has an acceptable safety profile, and can potentially contribute to preserving anal function in patients with rectal cancer.Trial registration: UMIN Clinical Trial Registry: UMIN000013598. Registered 1 April 2014, https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000015887

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Neoadjuvant Chemotherapy without Radiation in Colorectal Cancer

Cited by 12 publications

References 92 publications

Efficacy and safety of preoperative chemoradiotherapy with S-1 for advanced rectal cancer: a phase II study

Efficacy and safety of preoperative chemoradiotherapy with S-1 for advanced rectal cancer: a phase II study

Nonoperative Management Following Complete Response in Rectal Cancer After Short-course Radiation Therapy and Consolidation Chemotherapy

Efficacy and Safety of Preoperative Chemoradiotherapy With S-1 for Advanced Rectal Cancer: A Phase II Study

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