Annals of Coloproctology

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How to Achieve a Higher Pathologic Complete Response in Patients With Locally Advanced Rectal Cancer Who Receive Preoperative Chemoradiation Therapy: Suk-Hwan Lee; Ann Coloproctol. 2019;35(1):3-8. Published online February 28, 2019; DOI: https://doi.org/10.3393/ac.2019.02.17

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The current standard of care for treating patients with locally advanced rectal cancer includes preoperative chemoradiation therapy (PCRT) followed by a total mesorectal excision and postoperative adjuvant chemotherapy. A subset of these patients has achieved a pathologic complete response (pCR) and they have shown improved disease-free and overall survival compared to non-pCR patients. Thus, many efforts have been made to achieve a higher pCR through PCRT. In this review, results from various ongoing and recently completed clinical trials that are being or have been conducted with an aim to improve tumor response by modifying therapy will be discussed.

Citations

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Predictors of Pathologic Response After Total Neoadjuvant Therapy in Patients With Rectal Adenocarcinoma: A National Cancer Database Analysis
David M McDermott, Sarah A Singh, Paul B Renz, Shaakir Hasan, Josh Weir
Cureus.2021;[Epub] CrossRef
Can Pretreatment Blood Biomarkers Predict Pathological Response to Neoadjuvant Chemoradiotherapy in Patients with Locally Advanced Rectal Cancer?
Marina Morais, Telma Fonseca, Raquel Machado-Neves, Mrinalini Honavar, Ana Rita Coelho, Joanne Lopes, Elisabete Barbosa, Emanuel Guerreiro, Silvestre Carneiro
Future Oncology.2021; 17(35): 4947. CrossRef
Pretreatment Blood Biomarkers Predict Pathologic Responses to Neo-Crt in Patients with Locally Advanced Rectal Cancer
Aijie Li, Kewen He, Dong Guo, Chao Liu, Duoying Wang, Xiangkui Mu, Jinming Yu
Future Oncology.2019; 15(28): 3233. CrossRef

Original Articles

Prognostic Impact of Immunonutritional Status Changes During Preoperative Chemoradiation in Patients With Rectal Cancer: Yong Joon Lee, Woo Ram Kim, Jeonghee Han, Yoon Dae Han, Min Soo Cho, Hyuk Hur, Kang Young Lee, Nam Kyu Kim, Byung Soh Min; Ann Coloproctol. 2016;32(6):208-214. Published online December 31, 2016; DOI: https://doi.org/10.3393/ac.2016.32.6.208

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Abstract PDF

Purpose

Previous studies have demonstrated the prognostic impact of the prognostic nutritional index (PNI), a proposed indicator of immunonutritional statuses of surgical patients, on patients with various gastrointestinal cancers. Although the prognostic impact of the PNI on patients with colorectal cancer has been well established, its value has not been studied in patients treated with preoperative chemoradiation (pCRT). This study aimed to evaluate the prognostic impact of PNI on patients receiving pCRT for locally advanced rectal cancer (LARC).

Methods

Patients with LARC who underwent curative pCRT followed by surgical resection were enrolled. The PNI was measured in all patients before and after pCRT, and the difference in values was calculated as the PNI difference (dPNI). Patients were classified according to dPNI (<5, 5–10, and >10). Clinicopathologic parameters and long-term oncologic outcomes were assessed according to dPNI classification.

Results

No significant intergroup differences were observed in clinicopathologic parameters such as age, histologic grade, tumor location, tumor-node-metastasis stage, and postoperative complications. Approximately 53% of the patients had a mild dPNI (<5); only 15% had a high dPNI (>10). Univariate and multivariate analyses identified the dPNI as an independent prognostic factor for disease-free status (P < 0.01; hazard ratio [HR], 2.792; 95% confidence interval [CI], 1.577–4.942) and for cancer-specific survival (P = 0.012; HR, 2.469; 95%CI, 1.225–4.978).

Conclusion

The dPNI is predictive of long-term outcomes in pCRT-treated patients with LARC. Further prospective studies should investigate whether immune-nutritional status correction during pCRT would improve oncologic outcomes.

Citations

Citations to this article as recorded by

Novel Index Based on Inflammatory Markers Correlates with Treatment Efficacy of Nivolumab for Recurrent/Metastatic Head and Neck Cancer
Hiroe Tada, Reika Kawabata-Iwakawa, Hideyuki Takahashi, Kazuaki Chikamatsu
Oncology.2024; 103(8): 714. CrossRef
Preoperative albumin-to-globulin ratio and prognostic nutritional index predict the prognosis of colorectal cancer: a retrospective study
JunHu Li, Na Zhu, Cheng Wang, LiuPing You, WenLong Guo, ZhiHan Yuan, Shuai Qi, HanZheng Zhao, JiaYong Yu, YueNan Huang
Scientific Reports.2023;[Epub] CrossRef
The modified Glasgow prognostic score is a reliable predictor of oncological outcomes in patients with rectal cancer undergoing neoadjuvant chemoradiotherapy
Atsushi Shimada, Takeru Matsuda, Ryuichiro Sawada, Hiroshi Hasegawa, Kimihiro Yamashita, Hitoshi Harada, Naoki Urakawa, Hironobu Goto, Shingo Kanaji, Taro Oshikiri, Yoshihiro Kakeji
Scientific Reports.2023;[Epub] CrossRef
Prognostic Value of Postoperative Neutrophil and Albumin: Reassessment One Month After Gastric Cancer Surgery
Ali Guner, Minah Cho, Yoo-Min Kim, Jae-Ho Cheong, Woo Jin Hyung, Hyoung-Il Kim
Frontiers in Oncology.2021;[Epub] CrossRef
Pelvimetric and Nutritional Factors Predicting Surgical Difficulty in Laparoscopic Resection for Rectal Cancer Following Preoperative Chemoradiotherapy
Yanwu Sun, Jianhua Chen, Chengwei Ye, Huiming Lin, Xingrong Lu, Ying Huang, Pan Chi
World Journal of Surgery.2021; 45(7): 2261. CrossRef
Inflammation‐nutritional markers of peripheral blood could predict survival in advanced non‐small‐cell lung cancer patients treated with PD‐1 inhibitors
Dan Pu, Qian Xu, Lai‐Yan Zhou, Yu‐Wen Zhou, Ji‐Yan Liu, Xue‐Lei Ma
Thoracic Cancer.2021; 12(21): 2914. CrossRef
Preoperative change of modified Glasgow prognostic score after stenting predicts the long-term outcomes of obstructive colorectal cancer
Ryuichiro Sato, Masaya Oikawa, Tetsuya Kakita, Takaho Okada, Tomoya Abe, Takashi Yazawa, Haruyuki Tsuchiya, Naoya Akazawa, Masaki Sato, Tetsuya Ohira, Yoshihiro Harada, Haruka Okano, Kei Ito, Noriaki Ohuchi, Takashi Tsuchiya
Surgery Today.2020; 50(3): 232. CrossRef
Prognostic impact of preoperative immunonutritional status in rectal mucinous adenocarcinoma
Yanwu Sun, Zhekun Huang, Huiming Lin, Pan Chi
Future Oncology.2020; 16(8): 339. CrossRef
Low Prognostic Nutritional Index Predicts Poor Clinical Outcomes in Patients with Stage IIIB Non-small-cell Lung Carcinoma Undergoing Chemoradiotherapy

Yurday Ozdemir, Erkan Topkan, Huseyin Mertsoylu, Ugur Selek
Cancer Management and Research.2020; Volume 12: 1959. CrossRef
Peripheral blood markers predictive of outcome and immune-related adverse events in advanced non-small cell lung cancer treated with PD-1 inhibitors
Lihong Peng, Yong Wang, Fen Liu, Xiaotong Qiu, Xinwei Zhang, Chen Fang, Xiaoyin Qian, Yong Li
Cancer Immunology, Immunotherapy.2020; 69(9): 1813. CrossRef
The prognostic value of the prognostic nutritional index and inflammation-based markers in obstructive colorectal cancer
Ryuichiro Sato, Masaya Oikawa, Tetsuya Kakita, Takaho Okada, Tomoya Abe, Takashi Yazawa, Haruyuki Tsuchiya, Naoya Akazawa, Masaki Sato, Tetsuya Ohira, Yoshihiro Harada, Haruka Okano, Kei Ito, Takashi Tsuchiya
Surgery Today.2020; 50(10): 1272. CrossRef
Preoperative Fibrinogen-Albumin Ratio Index (FARI) is a Reliable Prognosis and Chemoradiotherapy Sensitivity Predictor in Locally Advanced Rectal Cancer Patients Undergoing Radical Surgery Following Neoadjuvant Chemoradiotherapy

Siyi Lu, Zhenzhen Liu, Xin Zhou, Bingyan Wang, Fei Li, Yanpeng Ma, Wendong Wang, Junren Ma, Yuxia Wang, Hao Wang, Wei Fu
Cancer Management and Research.2020; Volume 12: 8555. CrossRef
Immunonutritional status and pulmonary cavitation in patients with tuberculosis: A revisit with an assessment of neutrophil/lymphocyte ratio
Makoto Nakao, Hideki Muramatsu, Sosuke Arakawa, Yusuke Sakai, Yuto Suzuki, Kohei Fujita, Hidefumi Sato
Respiratory Investigation.2019; 57(1): 60. CrossRef
Temporal changes in immune cell composition and cytokines in response to chemoradiation in rectal cancer
Yong Joon Lee, Sat Byol Lee, Suk Kyung Beak, Yoon Dae Han, Min Soo Cho, Hyuk Hur, Kang Young Lee, Nam Kyu Kim, Byung Soh Min
Scientific Reports.2018;[Epub] CrossRef
Impairment of Immunonutritional Status During Treatment is a Factor Associated With Oncologic Outcomes in Patients With Rectal Cancer Treated With Preoperative Chemoradiotherapy
In Ja Park
Annals of Coloproctology.2016; 32(6): 201. CrossRef

Clinical Impact of Tumor Regression Grade after Preoperative Chemoradiation for Locally Advanced Rectal Cancer: Subset Analyses in Lymph Node Negative Patients: Byung Soh Min, Nam Kyu Kim, Ju Yeon Pyo, Hoguen Kim, Jinsil Seong, Ki Chang Keum, Seung Kook Sohn, Chang Hwan Cho; J Korean Soc Coloproctol. 2011;27(1):31-40. Published online February 28, 2011; DOI: https://doi.org/10.3393/jksc.2011.27.1.31

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Abstract PDF

Background

We investigated the prognostic significance of tumor regression grade (TRG) after preoperative chemoradiation therapy (preop-CRT) for locally advanced rectal cancer especially in the patients without lymph node metastasis.

Methods

One-hundred seventy-eight patients who had cT3/4 tumors were given 5,040 cGy preoperative radiation with 5-fluorouracil/leucovorin chemotherapy. A total mesorectal excision was performed 4-6 weeks after preop-CRT. TRG was defined as follows: grade 1 as no cancer cells remaining; grade 2 as cancer cells outgrown by fibrosis; grade 3 as a minimal presence or absence of regression. The prognostic significance of TRG in comparison with histopathologic staging was analyzed.

Results

Seventeen patients (9.6%) showed TRG1. TRG was found to be significantly associated with cancer-specific survival (CSS; P = 0.001) and local recurrence (P = 0.039) in the univariate study, but not in the multivariate analysis. The ypN stage was the strongest prognostic factor in the multivariate analysis. Subgroup analysis revealed TRG to be an independent prognostic factor for the CSS of ypN0 patients (P = 0.031). TRG had a stronger impact on the CSS of ypN (-) patients (P = 0.002) than on that of ypN (+) patients (P = 0.521). In ypT2N0 and ypT3N0, CSS was better for TRG2 than for TRG3 (P = 0.041, P = 0.048), and in ypN (-) and TRG2 tumors, CSS was better for ypT1-2 than for ypT3-4 (P = 0.034).

Conclusion

TRG was found to be the strongest prognostic factor in patients without lymph node metastasis (ypN0), and different survival was observed according to TRG among patients with a specific histopathologic stage. Thus, TRG may provide an accurate prediction of prognosis and may be used for f tailoring treatment for patients without lymph node metastasis.

Citations

Citations to this article as recorded by

Tumor Regression Grade as a Prognostic Factor in Metastatic Colon Cancer Following Preoperative Chemotherapy
Yufei Yang, Dakui Luo, Ruoxin Zhang, Sanjun Cai, Qingguo Li, Xinxiang Li
Clinical Colorectal Cancer.2022; 21(2): 96. CrossRef
Prediction of tumor response of rectal cancer cells via 3D cell culture and in�vitro cytotoxicity assay before initiating preoperative chemoradiotherapy
Jeonghyun Kang, Min Park, Jina Kim, Hyuk Hur, Byung Min, Seung Baik, Kang Lee, Nam Kim
Oncology Letters.2019;[Epub] CrossRef
Prognostic significance of tumour regression grade after neoadjuvant chemoradiotherapy for a cohort of patients with locally advanced rectal cancer: an 8‐year retrospective single‐institutional study
L. Xu, S. Cai, T. Xiao, Y. Chen, H. Qiu, B. Wu, G. Lin, X. Sun, J. Lu, W. Zhou, Y. Xiao
Colorectal Disease.2017;[Epub] CrossRef
Neoadjuvant chemoradiotherapy for rectal cancer: how important is tumour regression?
Melanie J. McCoy, Chris Hemmings, Simon Hillery, Cheryl Penter, Max K. Bulsara, Nik Zeps, Cameron F. Platell
ANZ Journal of Surgery.2017;[Epub] CrossRef
Defining response to radiotherapy in rectal cancer using magnetic resonance imaging and histopathological scales
Muhammed R S Siddiqui, Jemma Bhoday, Nicholas J Battersby, Manish Chand, Nicholas P West, Al-Mutaz Abulafi, Paris P Tekkis, Gina Brown
World Journal of Gastroenterology.2016; 22(37): 8414. CrossRef
Interobserver agreement of radiologists assessing the response of rectal cancers to preoperative chemoradiation using the MRI tumour regression grading (mrTRG)
M.R.S. Siddiqui, K.L. Gormly, J. Bhoday, S. Balyansikova, N.J. Battersby, M. Chand, S. Rao, P. Tekkis, A.M. Abulafi, G. Brown
Clinical Radiology.2016; 71(9): 854. CrossRef
Controversies in the pathological assessment of colorectal cancer
Aoife Maguire
World Journal of Gastroenterology.2014; 20(29): 9850. CrossRef
The prognostic value of tumour regression grade following neoadjuvant chemoradiation therapy for rectal cancer
K. I. Abdul‐Jalil, K. M. Sheehan, J. Kehoe, R. Cummins, A. O'Grady, D. A. McNamara, J. Deasy, O. Breathnach, L. Grogan, B. D. P. O'Neill, C. Faul, I. Parker, E. W. Kay, B. T. Hennessy, P. Gillen
Colorectal Disease.2014;[Epub] CrossRef
Pathological grading of regression: an International Study Group perspective
Runjan Chetty, P Gill, Adrian C Bateman, David K Driman, Dhirendra Govender, Andrew R Bateman, Y J Chua, Godman Greywoode, Christine Hemmings, I Imat, Eleanor Jaynes, Cheok Soon Lee, Michael Locketz, Corwyn Rowsell, Anne Rullier, Stefano Serra, Eva Szentg
Journal of Clinical Pathology.2012; 65(10): 865. CrossRef
Pathological grading of regression following neoadjuvant chemoradiation therapy: the clinical need is now: Table 1
Tom P MacGregor, Tim S Maughan, Ricky A Sharma
Journal of Clinical Pathology.2012; 65(10): 867. CrossRef

Abdominoperineal Resection in the Treatment of Locally-advanced Low Rectal Cancer: Is Preoperative Chemoradiation Advantageous?.: Kim, Jeong Yeon , Kim, Jin Soo , Kim, Young Wan , Hur, Hyuk , Min, Byung Soh , Kim, Nam Kyu; J Korean Soc Coloproctol. 2010;26(2):129-136.; DOI: https://doi.org/10.3393/jksc.2010.26.2.129

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Abstract PDF: PURPOSE
An abdominoperineal resection (APR) has a poor prognosis. However, limited studies about the prognostic factors in APR and the role of preoperative chemoradiotherapy (CRT) have been performed even though in rectal cancer, the application of preoperative CRT provides better local control compared to postoperative CRT. The aim of this study was to identify the prognostic factors and the impact of preoperative CRT in patients who undergo an APR.
METHODS
A retrospective analysis was conducted with a total of 133 patients who underwent an APR, cT3, cT4, or cN(+) patients, for rectal cancer between January 1995 and October 2004. Fifty-one patients treated with preoperative CRT (Group 1) were compared with 82 APR patients treated with postoperative CRT (Group 2). Oncologic outcomes were compared between the two groups, and the clinicopathologic factors affecting the treatment outcomes were evaluated.
RESULTS
The median follow-up period was 61.2 mo (range 6 to 194 mo). Circumferential margin (CRM) involvement was significantly associated with local recurrence (LR) and with disease-free survival in APR patients (P<0.001, P=0.011). The 5-yr LR rate was significantly lower in Group 1 than in Group 2 (P=0.013) in the univariate analysis, but no difference was noted in multivariate analysis (P=0.315). In Group 1, CRM involvement, tumor size, and lymph node metastasis were significantly lower than they were in Group 2 (P=0.043, P=0.003, P<0.001).
CONCLUSION
For achieving adequate oncologic outcomes in APR patients, an adequate CRM should be acquired with an optimal operation. In addition, preoperative CRT would be helpful for high-risk APR patients with a threatening CRM margin, providing the benefit of tumor downstaging.

Disadvantages of Preoperative Chemoradiation in Rectal Cancer.: Lee, Seung Hyun , Ahn, Byung Kwon , Baek, Sung Uhn; J Korean Soc Coloproctol. 2007;23(4):250-256.; DOI: https://doi.org/10.3393/jksc.2007.23.4.250

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Abstract PDF: PURPOSE
Preoperative chemoradiation therapy for rectal cancer seems to improve local control, anal sphincter preservation, resectability, and possibly survival in patients. However, there are several adverse effects, too. The aim of this study is to analyze the disadvantages of preoperative chemoradiation for rectal cancer.
METHODS
We retrospectively reviewed 139 patients who were treated by using preoperative chemoradiation for an adenocarcinoma of the rectum between January 1995 and December 2004. All patients had fixed or locally advanced lesions, as determined by digital rectal examination. No distant metastasis was proven before preoperative chemoradiation. All of the patiedts received the full scheduled dose of radiation (range, 5,000~5,400 rad). Concurrent intravenous chemotherapy with 5-fluorouracil (425 mg/m2/day) and leucovorin (45 mg/day) was administered continuously on days 1~5 and 29~33. The mean interval between chemoradiation and surgery was 4~6 weeks. After preoperative chemoradiation, 117 patients underwent an operation. We reviewed the side effects of preoperative chemoradiation, postoperative complications, and distant metastases detected during the preoperative period after preoperative chemoradiation and during the operation.
RESULTS
The side effects of preoperative chemoradiation were diarrhea (23%), radiation dermatitis (2.2%), fistula (0.7%), sepsis (0.7%), and rectal bleeding (0.7%). Two patients died from sepsis and rectal bleeding. The postoperative complications were bowel obstruction in 9 cases (7.7%), wound seroma in 8 cases (6.8%), wound infection in 5 cases (4.3%), anastomotic leakage in 5 cases (7.1%), rectovaginal fistula in 2 cases (2.8%), an enterocutaneous fistula in 2 cases (1.7%), and a vesicocutaneous fistula in 1 case (0.8%). Distant metastases were detected in 14 patients (10.1%) after preoperative chemoradiation.
CONCLUSIONS
Although preoperative chemoradiation can be performed safely, careful management for the side effects of preoperative chemoradiation and for postoperative complications is necessary. We need a more sensitive study method for detecting distant metastasis of rectal cancer, especially during scheduled preoperative chemoradiation.

Analysis of Criteria for Tumor Response after Preoperative Chemoradiation Therapy for Locally Advanced Rectal Cancer: Correlation between Tumor Volume Reduction and Histopathologic Downstaging.: Kim, Nam Kyu , Pyo, Hong Ryull , Baik, Seung Hyuk , Lee, Kang Young , Sohn, Seung Kook , Cho, Chang Hwan , Rha, Sun Young , Chung, Hyun Chul; J Korean Soc Coloproctol. 2004;20(5):296-302.

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Abstract PDF: PURPOSE
Preoperative chemoradiation treatment (CCRT) for locally advanced rectal cancer has been known to be safe and effective. The aim of study is to find any correlation between tumor volume reduction and histopathologic downstaging in locally advanced rectal cancer by preoperative CCRT.
METHODS
A total of 16 patients of rectal cancer were selected. They had been T3,4 N (+) preoperatively staged by using a transrectal ultrasonography and pelvic MRI. Radiation was given, a total of 5,040 cGy over 5 weeks, and systemic chemotherapy was also given 5 FU 450 mg/m2 and leucovorin 20 mg/m2 concurrently intravenously during the first and the fifth week of CCRT. Surgery was done 4~6 weeks after completion of CCRT. A 3D CT image was obtained with AcQsim PQ 5000 3D (Philips, USA). Tumor volume was measured before and after CCRT.
RESULTS
The type of operative procedures were abdominoperineal resection 7, low anterior resection 5, coloanal anastomosis 3 and Hartmann operation 1. Volume reduction was ranged from 14.6% to 84.4%. Over a 50% tumor volume reductions were in 9 patients (56.2%). Pathologic complete remission was observed in 2 patients (12.5%), who showed 72% and 58.5% tumor volume reductions. Patients showing pT and/or pN downstaging patients (N=9) had a 55.9% tumor reductions (14.6~84.4%), and patients showing no pT and/or pN downstaging (N=7) had 51.8% volume reduction (24.7~79%).
CONCLUSIONS
Preoeperative CCRT has been thought to be able to decrease tumor size and volume and to increase respectability. However, among our 9 patients who showed over 50% tumor volume reductions, 3 patients did not show any T and N downstaging, which is really important for long-term oncologic outcomes.

The Outcome of Preoperative Chemoradiation to Locally Advanced Rectal Cancer.: Park, Hyung Seok , Ahn, Byung Kwon , Lee, Seung Hyun , Baek, Sung Uhn; J Korean Soc Coloproctol. 2004;20(5):277-282.

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Abstract PDF: PURPOSE
Tumor downstaging after preoperative chemoradiation has been associated with an intent to improve anal sphincter preservation, resectability, local control, and possibly survival in locally advanced rectal cancer. We performed this study to evaluate the outcome of preoperative chemoradiation for locally advanced rectal cancer.
METHODS
We retrospectively reviewed the cases of 82 patients who had been treated by using preoperative chemoradiation combined with surgery for adenocarcinoma of the rectum between January, 1995, and December, 2002. All patients had fixed or locally advanced lesions, which had been detected by using digital rectal examination. No distant metastasis was proven before preoperative chemoradiation. All of the patients received the full scheduled dose of radiation (range, 3,000~5,400 cGy). Concurrent intravenous chemotherapy with 5-fluorouracil (450 mg/m2/day) and leucovorin (45 mg/day) was administered continuously on days 1~5 and 29~33. The mean interval between chemoradiation and surgery was 5.6 weeks (2.7~9.6 weeks). The survival rate was estimated by using the Kaplan-Meier method and the log-rank test. We compared the survival of locally advanced rectal cancers treated by using preoperative chemoradiation with surgery with that of 444 patients with resectable rectal cancers treated by using curative surgery alone during same period.
RESULTS
A curative resection could be performed on 64 of the 82 patients (78.2%). A sphincter-preserving surgery was performed on 42 patients (51.2%). A pathologic complete response (pCR) occurred in 6 patients (7.3%). The 5-year survival rates of patients with a pCR was 66.7%. In the comparison of the 5-year survival rates between patients with locally advanced rectal cancer treated by using preoperative chemoradiation with curative surgery and patients with rectal cancer treated by using curative surgery alone, those of stage I, stage II, and stage III cancers were 100% vs. 89.5%, 86.9% vs. 86.3%, and 52.9% vs. 63.3%, respectively (P>0.05).
CONCLUSIONS
The survival rates for patients with locally advanced rectal cancers, which are expected to be unresectable or non-curative, treated by using preoperative chemoradiation with surgery were similar to those for patients with resectable rectal cancers treated by using curative surgery alone. We think that preoperative chemoradiation with surgery improves the survival of patients with locally advanced rectal cancer. J Korean Soc Coloproctol 2004;20:277-282

Clinical Results of Postoperative Chemoradiation on Advanced Rectal Cancers: Tumor Response, Toxicities, and Morbidity.: Lee, Dong Ryul , Lee, Han Il , Kim, Ho Gak , Kim, Eun Young , Ryoo, Hyun Mo , Yun, Sang Mo , Kim, Jin Cheon; J Korean Soc Coloproctol. 2004;20(3):138-144.

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Abstract PDF: PURPOSE
Adjuvant chemotherapy and radiotherapy have been considered effective treatments in advanced rectal cancers. Recently, several studies have reported that preoperative chemoradiation (CRT) may have advantages over postoperative CRT, particularly in reducing local recurrence and preserving the anal sphincter. We studied the short-term efficacy of preoperative CRT for locally advanced rectal cancers.
METHODS
Between Jun. 2000 and Aug. 2003, 23 patients were treated with preoperative CRT, followed by surgery (pre-CRT) and 31 patients were treated with chemoradiation postoperatively (post-CRT). We compared these two groups for the incidence and degree of side effects from CRT, postoperative complications, type of surgery, including anal sphincter preservation, and short-term recurrence.
RESULTS
The average age and male-to-female ratio of the pre- and the post-CRT groups were 58+/-11, years and 13:10, and 61+/-14 and 14:17, respectively. T downstagings were observed in 17 of 23 (74%) pre-CRT patients. On the RTOG-EORTC scale, the patients who showed hematological, intestinal and dermal side effects in the pre-CRT group and in the post-CRT group were 5, 5, 2 and 5, 2, 4, respectively and the difference was not statistically significant (P=0.41). Anal sphincter preserving surgical procedures were performed 91.3% (21/23) and 83.9% (26/31) of the patients in the pre- and the post-CRT groups, respectively. But this difference was not statistically significant (P=0.4). Postoperative complications in the pre-CRT group were anastomosis site leakages (n=3) and rectovaginal fistula (n=1). In the post-CRT group, complications were two anastomosis site leakages. Four of the 31 post-CRT group patients had recurrences such as locoregional area (n=2), liver (n=1), and lung (n=1) while no patient was observed in pre- CRT group.
CONCLUSIONS
Although pre-CRT group showed higher incidence of complications than post-CRT group, these were managed easily and safely. Pre-CRT seems to be an effective modality for treating advanced rectal cancers particularly for preserving anal sphincter. Long-term follow- up data are needed to clarify the effect of pre-CRT.

Randomized Controlled Trial

Prospective Randomized Trial Comparing Intravenous 5 Fluorouracil and Oral Doxifluridine as Preoperative Concurrent Chemoradiation for Locally Advanced Rectal Cancer.: Kim, Nam Kyu , Park, Jae Kun , Yun, Seong Hyeun , Roh, Jae Kyung , Sung, Jin Sil , Min, Jin Sik; J Korean Soc Coloproctol. 2000;16(6):469-473.

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Abstract PDF: PURPOSE
Preoperative radiation treatment with concomittant intravenous infusion of 5-fluorouracil has been known to be effective in shrinking and downstaging the tumor. Treatment with Doxifluridine (synthetic 5-deoxynucleoside derivative) medication prolongs drug exposure to tumor tissue, so it can be considered synergistic to concurrent radiotherapy. Intravenous 5-FU and oral Doxifluridine were compared with respect to tumor response, toxicity, and quality of life of patients.
METHODS
Twenty eight patients with rectal cancer, staged as over T3N1 or T4 by transrectal ultrasonography between July 1997 and December 1998 were included. Intravenous 5-FU (450 mg/m2/day) and leucovorin (20 mg/m2) was given for five consecutive days during first and fifth weeks of irradiation therapy (50.4 Gy) (N=14). Oral Doxifluridine (700 mg/m2/day) and leucovorin (20 mg/m2) was given daily during radiation treatment (N=14). Quality of life was scored according to twenty two activity items (good: >77, fair: >58, poor: <57). Surgical resection was performed four weeks after completion of concurrent chemoradiation treatment. Tumor response was classified as CR (Complete Response), PR (Partial Response: 50% diminution of tumor volume or downstaging), or NR (No Response).
RESULTS
Tumor response was CR: 3/14 (21.4%), PR: 7/14 (50%) and NR: 4/14 (28.6%) in IV arm versus CR: 2/14 (14.2%), PR: 6/14 (42.9%) and NR: 6/14 (42.9%) in oral arm (p=0.16, 0.23, 0.24, respectively). Quality of life was poor (36.4% vs 33.3%), fair and good (63.6% vs 66.7%, respectively) between IV arm and oral arm. Systemic recurrence during follow up periods was 1/14 (7.1%) in IV arm and 2/14 (14.3%) in oral arm, respectively (p=0.307). One local recurrence was observed in oral arm. Hematologic toxicity was 3/14 (21.4%) in IV arm versus 4/14 (28.5%) in oral arm, respectively. Gastrointestinal toxicity was 2/14 (14.3%) versus 5/14 (35.7%) and stomatitis was observed in IV arm (1/14, 7.1%) CONCLUSION: Oral doxifluridine based chemotherapy shows a comparable tumor response and oncologic results, but there was no benefits as far as quality of life and toxicity were concerned.

Original Articles

p53, Bcl-2 and Ki-67 Expression according to Tumor Response after Concurrent Chemoradiation Treatment for Advanced Rectal Cancer.: Kim, Nam Kyu , Park, Jae Kyun , Yang, Woo Ik , Yun, Seong Hyeon , Sung, Jin Sil , Min, Jin Sik; J Korean Soc Coloproctol. 2000;16(6):436-443.

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Abstract PDF: PURPOSE
Concurrent chemoradiation treatment (CCRT) for locally advanced rectal cancer is an important modality for curative resection, but its tumor response shows wide spectrum. The aim of study is to investigate any correlation between a related genetic mutations, proliferative index and tumor response after CCRT.
METHODS
A twenty three patients with rectal cancer, which preoperatively staged as over T3N1 or T4 determined by transrectal ultrasonography and MRI. Enrolled patients were given 5 FU 450 mg/m2 and leucovorin 20 mg/m2 intravenously for 5 days during the first and fifth weeks of radiation therapy (45~54 Gy). 4 weeks after completion of scheduled treatment, surgical resection was performed. Tumor response was classified into CR (complete remission), PR (partial response: 50% of diminution of tumor volume and downstaging), NR (no response). Paraffin-embedded tissues obtained before chemoradiation treatment were studied with immunohistochemical staining of p53, Bcl-2 and Ki-67. The extent of tumor response was correlated with proliferative activity as measured by immunostaining of Ki-67 proliferative antigen and expression of p53 and bcl-2 oncoproteins (less than 10%: negative, 10~25%: , 25~50%: , more than 50%: , Ki-67: to count a labeled cells per 1,000 cells).
RESULTS
All patients were resectable. CR was obtained in 4 (17.4%), PR in 10 (43.3%) and NR in 9 (39.2%). p53 mutation was noted in 16 (70%). p53 mutation was found in NR: 5 (31.3%), PR: 9 (56.2%), CR: 2 (12.5%), respectively. Bcl-2 expression was noted in 11 (48%). NR as in 4 (36.3%), PR: 3 (28.4%) and CR: 4 (36.3%), respectively. Ki-67 labeling index was NR: 615.4 446.2, PR: 663.2 296.4, CR: 765.5 188.3, respectively (CR PR Vs NR, p=0.029).
CONCLUSIONS
Immunohistochemical Expression of p53 and bcl-2 does not correlate with tumor response after CCRT, but Ki-67 labeling may be useful parameters for good radiosensitive tumor selected for CCRT.

Selective Approach to Sphincter-Saving Procedure after Chemoradiation in Low Rectal Cancer.: Lim, Dae Jin , Ahn, Soo Min , Sohn, Seung Kook , Kim, Nam Kyu; J Korean Soc Coloproctol. 1998;14(3):341-348.

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Abstract PDF: PURPOSE
The conventional surgical treatment for patients with potentially curable low rectal cancer is abdominoperineal resection. Recently there has been increasing interest in the use of preoperative radiation therapy and sphincter-saving procedure as primary therapy for selected low rectal cancers. We report our institutional experience with this approach.
METHODS
From 1995 to 1997, Twelve patients with resectable distal rectal cancer were offered sphincter-saving procedure, excluding the patients whose pretreatment tumor presentation demonstrated fixation to anal sphincter or puborectalis muscle. The distance from the anal verge to the distal tumor margin at initial diagnosis ranged from 1 to 5 cm. Patients received a median 50.4 Gy and chemotherapy Surgery was carried out 4 to 8 weeks after radiation.
RESULTS
No patient had toxic reaction that required interruption of chemoradiation. Four patients (33%) had complete pathologic response, but one patient with complete clinical response had residual cancer. Seven patients underwent hand-sewn coloanal anastomosis and five patients transanal excision en bloc. All patients were able to successfully undergo a sphincter-saving procedure. With a mean follow-up of 23 months (range, 6~32), the authors noted no recurrence or complication. Sphincter function was good in 92%. Daily bowel movements was two (range, 1~10).
CONCLUSION
Preoperative chemoradiation appears promising in terms of better patient compliance, lesser toxicity, and downstaging tumor, making the sphincter-saving procedure feasible in carefully selected cases. Surgical resection remains essential to confirm and to achieve complete clinical remission. The results of preoperative chemoradiation and sphinctersaving procedure are encouraging, but more experience is needed to determine whether this approach ultimately has similar local control and survival rate compared to standard surgery.

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