Annals of Coloproctology

Original Article

Colorectal cancer

Is clinical complete response as accurate as pathological complete response in patients with mid-low locally advanced rectal cancer?: Niyaz Shadmanov, Vusal Aliyev, Guglielmo Niccolò Piozzi, Barıs Bakır, Suha Goksel, Oktar Asoglu; Ann Coloproctol. 2025;41(1):57-67. Published online February 28, 2025; DOI: https://doi.org/10.3393/ac.2024.00339.0048

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Graphical Abstract Abstract PDF: Purpose
The standard treatment for locally advanced rectal cancer involves neoadjuvant chemoradiation followed by total mesorectal excision surgery. A subset of patients achieves pathologic complete response (pCR), representing the optimal treatment outcome. This study compares the long-term oncological outcomes of patients who achieved pCR with those who attained clinical complete response (cCR) after total neoadjuvant therapy, managed using a watch-and-wait approach.
Methods
This study retrospectively evaluated patients with mid-low locally advanced rectal cancer who underwent neoadjuvant treatment from January 1, 2005, to May 1, 2023. The pCR and cCR groups were compared based on demographic, clinical, histopathological, and long-term survival outcomes.
Results
The median follow-up times were 54 months (range, 7–83 months) for the cCR group (n=73), 96 months (range, 7–215 months) for the pCR group (n=63), and 72 months (range, 4–212 months) for the pathological incomplete clinical response (pICR) group (n=627). In the cCR group, 15 patients (20.5%) experienced local regrowth, and 5 (6.8%) developed distant metastasis (DM). The pCR group had no cases of local recurrence, but 3 patients (4.8%) developed DM. Among the pICR patients, 58 (9.2%) experienced local recurrence, and 92 (14.6%) had DM. Five-year disease-free survival rates were 90.0% for cCR, 92.0% for pCR, and 69.5% for pICR (P=0.022). Five-year overall survival rates were 93.1% for cCR, 92.0% for pCR, and 78.1% for pICR. There were no significant differences in outcomes between the cCR and pCR groups (P=0.810); however, the pICR group exhibited poorer outcomes (P=0.002).
Conclusion
This study shows no significant long-term oncological differences between patients who exhibited cCR and those who experienced pCR.

Reviews

Colorectal cancer

Survival outcomes of salvage surgery in the watch-and-wait approach for rectal cancer with clinical complete response after neoadjuvant chemoradiotherapy: a systematic review and meta-analysis: Wenjie Lin, Ian Jun Yan Wee, Isaac Seow-En, Aik Yong Chok, Emile Kwong-Wei Tan; Ann Coloproctol. 2023;39(6):447-456. Published online December 28, 2023; DOI: https://doi.org/10.3393/ac.2022.01221.0174

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8 Citations

Abstract PDF Supplementary Material

Purpose
This systematic review and meta-analysis compared the outcomes of the watch-and-wait (WW) approach versus radical surgery (RS) in rectal cancers with clinical complete response (cCR) after neoadjuvant chemoradiotherapy.
Methods
This study followed the PRISMA guidelines. Major databases were searched to identify relevant articles. WW and RS were compared through meta-analyses of pooled proportions. Primary outcomes included overall survival (OS), disease-free survival (DFS), local recurrence, and distant metastasis rates. Pooled salvage surgery rates and outcomes were also collected. The Newcastle-Ottawa scale was employed to assess the risk of bias.
Results
Eleven studies including 1,112 rectal cancer patients showing cCR after neoadjuvant chemoradiation were included. Of these patients, 378 were treated nonoperatively with WW, 663 underwent RS, and 71 underwent local excision. The 2-year OS (risk ratio [RR], 0.95; P = 0.94), 5-year OS (RR, 2.59; P = 0.25), and distant metastasis rates (RR, 1.05; P = 0.80) showed no significant differences between WW and RS. Local recurrence was more frequent in the WW group (RR, 6.93; P < 0.001), and 78.4% of patients later underwent salvage surgery (R0 resection rate, 97.5%). The 2-year DFS (RR, 1.58; P = 0.05) and 5-year DFS (RR, 2.07; P = 0.02) were higher among RS cases. However, after adjustment for R0 salvage surgery, DFS showed no significant between-group difference (RR, 0.82; P = 0.41).
Conclusion
Local recurrence rates are higher for WW than RS, but complete salvage surgery is often possible with similar long-term outcomes. WW is a viable strategy for rectal cancer with cCR after neoadjuvant chemoradiation, but further research is required to improve patient selection.

Citations

Citations to this article as recorded by

Phase 2, Multicenter, Open-label, Nonrandomized Study of Neoadjuvant Chemotherapy Liposomal Irinotecan With 5-Fluorouracil, Leucovorin, and Oxaliplatin, Followed by Chemoradiotherapy in Patients With Rectal Cancer in a Watch-and-Wait Program
César Muñoz, María-C. Riesco Martinez, Lisardo Ugidos, Pilar García-Alfonso, Rafael Alvarez-Gallego, Paloma Peinado, Carmen Toledano, Luka Mihic-Góngora, Justo Gabriel Ortega Anselmi, Enrique Sanz Garcia, Emilio Vicente, Yolanda Quijano, Hipólito J. Durán
American Journal of Clinical Oncology.2025; 48(3): 142. CrossRef
Therapeutic Management of Locally Advanced Rectal Cancer: Existing and Prospective Approaches
Horia-Dan Lișcu, Nicolae Verga, Dimitrie-Ionuț Atasiei, Andreea-Teodora Ilie, Maria Vrabie, Laura Roșu, Alexandra Poștaru, Stefania Glăvan, Adriana Lucaș, Maria Dinulescu, Andreea Delea, Andreea-Iuliana Ionescu
Journal of Clinical Medicine.2025; 14(3): 912. CrossRef
A management of patients achieving clinical complete response after neoadjuvant therapy and perspectives: on locally advanced rectal cancer
Yu-Xin Liu, Xin-Rong Yang, Lan-Qing Peng, Zhuo-Hong Li
Frontiers in Oncology.2025;[Epub] CrossRef
ACCORD study: a national multi‐centre study of the watch and wait approach in patients with rectal cancer in Aotearoa New Zealand

ANZ Journal of Surgery.2025; 95(3): 440. CrossRef
Advancing Personalized Medicine in the Treatment of Locally Advanced Rectal Cancer
Francesco Giulio Sullo, Alessandro Passardi, Chiara Gallio, Chiara Molinari, Giorgia Marisi, Eleonora Pozzi, Leonardo Solaini, Alessandro Bittoni
Journal of Clinical Medicine.2024; 13(9): 2562. CrossRef
Tailoring rectal cancer surgery: Surgical approaches and anatomical insights during deep pelvic dissection for optimal outcomes in low‐lying rectal cancer
Youn Young Park, Nam Kyu Kim
Annals of Gastroenterological Surgery.2024; 8(5): 761. CrossRef
Combined Transanal and Laparoscopic Approach for Full-Thickness Local Excision of Locally Advanced Rectal Cancer Following Near-Complete Response after Chemotherapy
Joshua S. H. Lim, Si-Lin Koo, Iain Beehuat Tan, Isaac Seow-En
World Journal of Colorectal Surgery.2024; 13(3): 95. CrossRef
Watch‐and‐Wait Approach Following Neoadjuvant Chemo‐Radiotherapy for Locally Advanced Rectal Cancer: A Retrospective Single‐Center Cohort Study
Georgi Kalev, Sylvia Buettner, Tianzuo Zhan, Ralf‐Dieter Hofheinz, Judit Boda‐Heggemann, Christoph Reissfelder, Steffen Seyfried, Georgi Vassilev, Julia Hardt
Journal of Surgical Oncology.2024;[Epub] CrossRef

Update and Debate Issues in Surgical Treatment of Middle and Low Rectal Cancer: Nam Kyu Kim, Min Sung Kim, Sami F. AL-Asari; J Korean Soc Coloproctol. 2012;28(5):230-240. Published online October 31, 2012; DOI: https://doi.org/10.3393/jksc.2012.28.5.230

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11 Citations

Abstract PDF

Based on a review of the literature, this paper provides an update on surgical treatment of middle and low rectal cancer and discusses issues of debate surrounding that treatment. The main goal of the surgical treatment of rectal cancer is radical resection of the tumor and surrounding lymphatic tissue. Local excision of early rectal cancer can be another treatment option, in which the patient can avoid possible complications related to radical surgery. Neoadjuvant chemoradiation therapy (CRT) has been recommended for patients with cT3-4N0 or any T N+ rectal cancer because CRT shows better local control and less toxicity than adjuvant CRT. However, recent clinical trials showed promising results for local excision after neoadjuvant CRT in selected patients with low rectal cancer. In addition, the "wait and see" concept is another modality that has been reported for the management of tumors that show complete clinical remission after neoadjuvant CRT. Although radical surgery for middle and low rectal cancer is the cornerstone therapy, an ultralow anterior resection with or without intersphincteric resection (ISR) has become an alternative standard surgical method for selected patients. Many studies have reported on the oncological safety of the ISR, but few of them have addressed the issue the functional outcome. Furthermore, an abdominoperineal resection (APR) has problems with high rates of tumor perforations and positive circumferential resection margins, and those factors have contributed to its having a high rate of local recurrence and a poor survival rate for rectal cancer compared with sphincter-saving procedures. Recently, great efforts have been made to reduce these problems, and the total levator excision or the extended APR concept has emerged. Surgical management for low rectal cancer should aim to radically excise the tumor and to preserve as much of the sphincter function as possible by using multidisciplinary approaches. However, further prospective clinical trials are needed for tailored treatment of rectal cancer patients.

Citations

Citations to this article as recorded by

Neoadjuvant chemoradiotherapy up-regulates PD-L1 in radioresistant colorectal cancer
Sung Uk Bae, Hye Won Lee, Jee Young Park, Incheol Seo, Jae-Min Cho, Jin Young Kim, Ju Yup Lee, Yoo Jin Lee, Seong Kyu Baek, Nam Kyu Kim, Sang Jun Byun, Shin Kim
Clinical and Translational Radiation Oncology.2025; 51: 100906. CrossRef
Neoadjuvant chemoradiation alters biomarkers of anticancer immunotherapy responses in locally advanced rectal cancer
Incheol Seo, Hye Won Lee, Sang Jun Byun, Jee Young Park, Hyeonji Min, Sung Hwan Lee, Ju-Seog Lee, Shin Kim, Sung Uk Bae
Journal for ImmunoTherapy of Cancer.2021; 9(3): e001610. CrossRef
Anus-Preserving Surgery in Advanced Low-Lying Rectal Cancer: A Perspective on Oncological Safety of Intersphincteric Resection
Guglielmo Niccolò Piozzi, Se-Jin Baek, Jung-Myun Kwak, Jin Kim, Seon Hahn Kim
Cancers.2021; 13(19): 4793. CrossRef
Surgical Treatment of Low-Lying Rectal Cancer: Updates
Cristopher Varela, Nam Kyu Kim
Annals of Coloproctology.2021; 37(6): 395. CrossRef
Factors influencing changing bowel habits in patients undergoing sphincter‐saving surgery for rectal cancer
Hyeonju Jeong, JeongYun Park
International Wound Journal.2019; 16(S1): 71. CrossRef
Critical and Challenging Issues in the Surgical Management of Low-Lying Rectal Cancer
Aeris Jane D. Nacion, Youn Young Park, Seung Yoon Yang, Nam Kyu Kim
Yonsei Medical Journal.2018; 59(6): 703. CrossRef
Prognostic significance of tumor regression in locally advanced rectal cancer after preoperative radiochemotherapy
Mirko Omejc, Maja Potisek
Radiology and Oncology.2017; 52(1): 30. CrossRef
The influence of the distal resection margin length on local recurrence and long- term survival in patients with rectal cancer after chemoradiotherapy and sphincter- preserving rectal resection
Jan Grosek, Vaneja Velenik, Ibrahim Edhemovic, Mirko Omejc
Radiology and Oncology.2017; 51(2): 169. CrossRef
Robotic Total Mesorectal Excision using a Wristed Suction-irrigation Device for Efficient Traction and Visualization
Sung Uk Bae, Woon Kyung Jeong, Seong Kyu Baek
The Journal of Minimally Invasive Surgery.2017; 20(3): 120. CrossRef
The Role of Robotic Surgery for Rectal Cancer: Overcoming Technical Challenges in Laparoscopic Surgery by Advanced Techniques
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Oncological superiority of extralevator abdominoperineal resection over conventional abdominoperineal resection: a meta-analysis
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Original Articles

Capecitabine-based Neoadjuvant Chemoradiation Therapy in Locally-advanced Rectal Cancer.: Choi, Hong Jo , Park, Ki Jae , Lee, Tae Moo , Ha, Sang Sik , Lee, Ho Young , Lee, Hyung Sik; J Korean Soc Coloproctol. 2010;26(2):137-144.; DOI: https://doi.org/10.3393/jksc.2010.26.2.137

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Abstract PDF: PURPOSE
The aim of the study was to evaluate the efficacy and the toxicity of preoperative treatment with capecitabine in combination with radiation therapy (RT) in patients with locally-advanced, resectable rectal cancer.
METHODS
Thirty-five patients with locally-advanced rectal cancer (cT3/4, N-/+) were treated with capecitabine (825 mg/m2, twice daily for 7 days/wk) and concomitant RT (50.4 Gy/28 fractions). Surgery was performed 6-8 wk after completion of the chemoradiation followed by 4-6 cycles of adjuvant capecitabine monotherapy (1,250 mg/m2, twice daily for 14 days every 3 wk).
RESULTS
The chemoradiation program was completed in all but 2 patients, for whom both capecitabine and RT were interrupted for 2 wk because of grade-3 diarrhea. A R0 resection under the principle of total mesorectal excision (low anterior resection, 26; intersphincteric resection, 6; abdominoperineal resection, 2) was performed in all but one patient with a low anterior resection with positive circumferential margin (R1). Primary tumor and node downstaging occurred in 57% and 60% of patients, respectively. The overall rate of downstaging, including both the primary tumor and node, was 77% (27 patients). A pathological complete response of the primary tumor was achieved in 4 patients (11%). No patient had grade-4 toxicity, and the only grade-3 toxicity developed was diarrhea in 2 patients (6%) during chemoradiation. During a median follow-up of 38 mo, distant metastases developed in 4 patients (multiple lung metastases, 2; aortocaval nodal metastases, 2), and another 2 patients showed local recurrence. The three-year disease-free survival was 83%.
CONCLUSION
This study suggests that preoperative capecitabine-based chemoradiation therapy is an effective and safe treatment modality for the tratment of locally-advanced, resectable rectal cancer.

Oncologic Result as According to Tumor Regression Grade after Neoadjuvant Chemoradiation Therapy in Locally Advanced Rectal Cancer.: Park, Jong Hyun , Song, Min Sang , Min, Hyo Suk , Kim, Ji Yeon; J Korean Soc Coloproctol. 2008;24(6):422-432.; DOI: https://doi.org/10.3393/jksc.2008.24.6.422

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Abstract PDF

PURPOSE
The effects of neoadjuvant chemoradiation therapy (NCRT) in cases of locally advanced rectal cancer include tumor downstaging with respect to a curative resection and a decreasing incidence of local recurrence. The aim of this study is to evaluate the oncologic results according to the tumor regression grade (TRG) after NCRT and radical surgical resection in cases of locally advanced rectal cancer.
METHODS
From 1999 to 2003, 140 consecutive patients, who suffered from locally advanced rectal cancer (T3 or T4, or lymph node positive) were enrolled in this study. They all received neoadjuvant chemoradiation therapy and a radical resection. Chemotherapy was based on 5-fluorouracil (5-FU), and the total radiation dose was 5,040 cGy over 6 weeks. A radical surgical resection, including a total mesorectal excision, was done 6 to 8 weeks after the completion of NCRT. We classified patients into subgroups by using the TRG; then, we investigated the overall and the disease-free survival rates and the local recurrence and the distant metastasis rates.
RESULTS
One hundred twenty-six (126, 90%) patients responded to radiation therapy. According to the TRG, the numbers of non- responders (Grade I, NR), partial responders (Grade II, PR), and patients who went into complete remission (Grade III, CR) were 14 (10%), 98 (70%), and 28 (20%), respectively. The overall survival (OS) and the disease-free survival (DFS) rates for 3 years (n=140) were 91.43% and 74.29%, and the rates for 5 years (n=117) were 81.20% and 67.52%, respectively. While there was no significant difference in the 3-year OS or DFS between the three groups stratified by TRG (P=0.1136, P=0.1215), the 5-year OS and DFS showed a statistical difference (P=0.0485, P=0.0458). Furthermore, the 3-year OS and DFS rates (P=0.0451, P=0.0458), as well as the 5-year OS and DFS rates (P=0.0139, P=0.0131) were significantly better for patients in the CR group than for the other patients. Still, no statistical significance differences existed between the CR group and the non-CR groups or between the TRG groups in terms of the local recurrence and the distant metastasis rates (P=0.447, P=0.271).
CONCLUSIONS
Any tumor response group that shows complete Rremission after NCRT and radical surgical resection has an oncologic benefit in overall survival and disease- free survival in our study.

Citations

Citations to this article as recorded by

A Phase II Study of Additional Four-Week Chemotherapy With Capecitabine During the Resting Periods After Six-Week Neoadjuvant Chemoradiotherapy in Patients With Locally Advanced Rectal Cancer
Kyung Ha Lee, Min Sang Song, Jun Boem Park, Jin Soo Kim, Dae Young Kang, Ji Yeon Kim
Annals of Coloproctology.2013; 29(5): 192. CrossRef

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