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Journal of Chinese Integrative Medicine ›› 2010, Vol. 8 ›› Issue (12): 1159-1164.doi: 10.3736/jcim20101208

• Original Clinical Research • Previous Articles     Next Articles

Clinical study on survival benefit for elderly patients with resected stage I or E colorectal cancer based on traditional Chinese medicine syndrome differentiation and treatment

 Li Taoa,Ying-jie Zhua, Xian-mei Lua,Ying Gua,Ai-guang Zhaoa,Jian Zhenga,Chuan-gang Fub,Jin-kun Yanga   

  1. a First Department of Oncology, Longhua Hospital, Shanghai University of Traditional Chinese Medicine, Shanghai 200032, China
    b Department of Anorectal Surgery, Changhai Hospital, Second Military Medical University, Shanghai 200433, China
  • Received:2010-07-15 Accepted:2010-08-15 Online:2010-12-20 Published:2010-12-15
  • Contact: Jian Zheng E-mail:zzf725@sina.com

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Background

The incidence of colorectal cancer is high among the elderly. Traditional Chinese medicine (TCM) has been widely used in the treatment for colorectal cancer of old people. However, controlled trials with large sample size evaluating the effect of TCM are rare.

Objective

This research aimed to evaluate the survival benefit of using TCM syndrome differentiation treatment for elderly patients with stage Ⅱ or Ⅲ colorectal cancer. Design, setting, participants and interventions: A total of 78 patients over 70 with resected stage Ⅱ or Ⅲ colorectal cancer were selected from the First Department of Oncology, Longhua Hospital of Shanghai University of Traditional Chinese Medicine, and Department of Anorectal Surgery, Changhai Hospital of Second Military Medical University. Patients were assigned to either integrated treatment group or Western medicine group by their own wills.Main outcome measures: Cox regression analysis was performed to determine all the potential factors which may affect prognosis such as gender, primary site, pathological type, TNM stage, chemotherapy period, radiotherapy and TCM therapy.

Results

A total of 78 cases were included in this study with 37 cases in integrated treatment group and 41 cases in Western medicine group. Cox regression analysis suggested that the TNM stage (P=0.001) and TCM therapy (P=0.021) were independent prognostic factors. The hazard ratio [Exp(β)] of TCM therapy was 0.393, and 95% confidence interval (CI) was 0.178-0.870. Median disease-free survival (DFS) of Western medicine group was 41.293 months. DFS of integrated treatment group did not reach the median at the time of analysis. There was significant difference between the two groups (P=0.012). The 1-, 2-, 3-, 4-, and 5-year DFS rates of Western medicine group were 87.7%, 69.6%, 63.4%, 46.5%, and 29.6%, respectively. The 1-, 2-, 3-, 4-, and 5-year DFS rates of integrated therapy group were 100%, 86.3%, 74.6%, 74.6%, and 74.6%, respectively.

Conclusion

TCM syndrome differentiation and treatment is important for improving the prognosis of stage Ⅱ or Ⅲ colorectal cancer in elderly patients. Integrated treatment shows benefit for reducing relapse and metastasis rates, and prolonging survival for elderly patients. The influence of integrated treatment needs to be further evaluated.

Key words: Colorectal neoplasms, Aged, Syndrome differentiation treatment, Disease-free survival, Disease-free survival, Clinical trial

Table 1

Assignment table"

Factor Assignment
Gender Male: 1; Female: 2.
Primary site Colon: 1; Rectum: 2.
TNM stage Stage II : 1 ? Stage IE : 2.
Pathological type Adenocarcinoma/ Moderately differentiated adenocarcinoma : 1 ; Poorly differentiated adenocarcinoma/ Mucinous adenocarcinoma/ Signet-ring cell carcinoma: 2.
Chemotherapy times 3 — 5 times: 1; ^6 times: 2.
Radiotherapy Non-radiotherapy: 0; Radiotherapy: 1.
TCM therapy No: 0; Yes: 1.
Relapse or metastasis No: 0; Yes: 1.

Table 2

Characteristics of baseline data of patients in two groups"

Item Integrated treatment group (n=37) Western medicine group (n = 41)
Gender Male 22 23
Female 15 18
Primary site Colon 29 25
Rectum 8 16
TNM stage Stage II 22 21
Stage IE 15 20
Pathological type Adenocarcinoma/Moderately differentiated adenocarcinoma 31 35
Poorly differentiated adenocarcinoma/Mucinous adenocarcinoma/ Signet-ring cell carcinoma 6 6
Chemotherapy times 3 — 5 times 4 9
^6 times 33 32
Radiotherapy Non-radiotherapy 35 34
Radiotherapy 2 7
Relapse or metastasis Yes 9 20
No 28 21

Table 3

Constituent ratio comparison of two groups"

Factor Integrated treatment group Western medicine group P value
n Constituent ratio (%) n Constituent ratio (%)
Gender Male 22 22/37 (59.5) 23 23/41 (56.1) 0. 764
Female 15 15/37 (40.5) 18 18/41 (43.9)
Primary site Colon 29 29/37 (78.4) 25 25/41 (61.0) 0. 096
Rectum 8 8/37 (21.6) 16 16/41 (39.0)
TNM stage Stage II 22 22/37 (60.8) 21 21/41 (46.9) 0.465
Stage IE 15 15/37 (39.2) 20 20/41 (53.1)
Pathological type Adenocarcinoma/Moderately differentiated adenocarcinoma 31 31/37 (83.8) 35 35/41 (85.4)
Poorly differentiated adenocarcinoma/ Mucinous adenocarcinoma/Signet-ring cell carcinoma 6 6/37 (16.2) 6 6/41 (14.6) 0.847
Chemotherapy times 3 — 5 times 4 4/37 (10.8) 9 9/41 (22.0) 0. 187
^6 times 33 33/37 (89.2) 32 32/41 (78.0)
Radiotherapy Yes 35 35/37 (94.6) 34 34/41 (82.9) 0. 209

Table 4

Multivariate analysis of factors influencing DFS of resected stage Ⅱ or Ⅲ colorectal cancer in elderly people by Cox proportional hazard model"

Factor Regression coefficient (6) Standard error Wald test (W) jP value Hflmrd ratio [Exp (^D] 95^ Cl for Exp(fl)
Lower Upper
TNM stage 1,347 0.414 10, 583 0,001 3. 845 1,708 8,660
Chemotherapy times -0. 937 0.483 3.763 0,052 0.392 0,152 1,010
TCM therapy -0, 933 0,405 5,307 0.021 0,393 0,178 0,870

Figure 1

Disease-free survival curve of two groups"

[1] Lai YX , Jing DD . Current status in research of epidemic factors for colorectal cancer. Zhongguo Zhong Liu. 2007 ; 16(5):323-326. Chinese with abstract in English.
赖跃兴, 靖大道 . 大肠癌流行因素的研究现状.中国肿瘤. 2007; 16(5):323-326.
[2] Yu JP . Progress of diagnosis and treatment in colorectal cancer of old people. Liaoning Yi Xue Za Zhi. 1999; 13(5) : 227-229. Chinese.
于皆平 . 老年结直肠癌的诊治进展.辽宁医学杂志. 1999; 13(5) : 227-229.
[3] Chinese Anti-cancer Association . New criteria for diagnosis and treatment of common malignant tumors (fascicle of colorectal cancer). Beijing: Peking Union Medical College Press. 1999: 117-139. Chinese.
中国抗癌协会. 新编常见恶性肿瘤诊治规范(大肠癌分册).北京: 中国协和医科大学出版社. 1999: 117-139.
[4] State Bureau of Technical and Quality Supervision. Clinic terminology of traditional Chinese medical diagnosis and treatment — Syndromes. Beijing: Standards Press of China. 1997 : 1-3. Chinese.
国家技术监督局. 中华人民共和国国家标准: 中医临床诊疗术语证候部分.北京: 中国标准出版社. 1997: 1-3.
[5] Ministry of Health of the Peopled Republic of China. Guidelines for clinical research on Chinese new herbal medicines. Beijing: China Medical Science and Technology Press. 1997: 82. Chinese.
中华人民共和国卫生部. 中药新药临床研究指导原则. 北京: 中国医药科技出版社. 1997: 82.
[6] Liang Y, Liang YH, Li QF, Zhang L , Yuan X . Correlation analysis of colorectal cancer morbidity at different ages. Xinan Guo Fang Yi Yao. 2004; 14(5):574. Chinese.
梁酉, 梁艺华, 李清福, 张莉, 袁新 . 不同年龄人群大肠癌症患病率的相关性分析.西南国防医药. 2004; 14(5):574.
[7] O’ Connell MJ, Campbell ME, Goldberg RM, Grothey A, Seitz JF, Benedetti JK, Andre T, Haller DG, Sargent DJ . Survival following recurrence in stage II and IE colon cancer: findings from the ACCENT data set.[J] Clin Oncol. 2008; 26(14):2336-2341.
doi: 10.1200/JCO.2007.15.8261
[8] Goldberg RM, Tabah-Fisch I , Bleiberg H, de Gramont A, Tournigand C, Andre T, Rothenberg ML, Green E, Sargent DJ. Pooled analysis of safety and efficacy of oxaliplatin plus f luorouracil/leucovorin administered bimonthly in elderly patients with colorectal cancer.[J] Clin Oncol. 2006; 24(25):4085-4091.
doi: 10.1200/JCO.2006.06.9039
[9] Folprecht G, Cunningham D, Ross P, Glimelius B, Di Costanzo F , Wils J, Scheithauer W, Rougier P, Aranda Hecker H, Kohne CH. Efficacy of 5-fluorouracil- based chemotherapy in elderly patients with metastatic colorectal cancer: a pooled analysis of clinical trials. Ann Oncol. 2004; 15(9):1330-1338.
doi: 10.1093/annonc/mdh344
[10] Haller DG, Cassidy J, Tabernero J, Maroun JA, De Braud FG, Price TJ, Van Cutsem E, Hill M, Gilberg Schmoll H . Efficacy findings from a randomized phase IE trial of capecitabine plus oxaliplatin versus bolus 5-FU/LV for stage IE colon cancer (N016968): Impact of age on disease-free survival (DFS). J Clin Oncol. 2010; 28(15s) : 3521.
doi: 10.1200/jco.2010.28.15_suppl.3521
[11] O’Connell JB, Maggard MA, Ko CY . Colon cancer survival rates with the new American Joint Committee on Cancer sixth edition staging.[J] Natl Cancer Inst. 2004; 96(19) : 1420-1425.
doi: 10.1093/jnci/djh275
[12] Sargent DJ, Goldberg RM, Jacobson SD, Macdonald JS, Labianca R, Haller DG, Shepherd LE, Seitz JF, Francini G . A pooled analysis of adjuvant chemotherapy for resected colon cancer in elderly patients. N Engl[J] Med. 2001; 345(15):1091-1097.
[13] Ge JZ, Yang YF, Xu Y, Liang BY, Luo L, Wu Y, Wu XW, Liu DQ, Zhang X, Song FX , Geng ZY. Clinical research of relapse and metastasis of elderly patients with resected colorectal cancer using integrated traditional Chinese and Western medicine. Zhongguo Lao Nian Yi Xue Za Zhi. 2009; 29(1) : 73-76. Chinese.
葛建忠, 杨宇飞, 许云, 梁碧颜, 雒琳, 吴煜, 吴显文, 刘端祺, 张侠, 宋飞翔, 耿振英 . 中西医结合治疗老年结直肠癌根治术后复发转移的临床分析.中国老年医学杂志. 2009; 29(1) : 73-76.
[14] Qiu JX , Tang LD . Impact of Chinese herbs with effect of invigorating spleen and nourishing kidney on the multi-stage theory of cancer initiation and starting. Zhongguo Zhong Xi Yi Jie He Za Zhi. 1993; 8(5):16-19. Chinese.
邱佳信, 唐莱娣 . 健脾补肾中药对肿瘤成因多阶段学说中起始和启动的影响.中国中西医结合杂志. 1993; 8(5):16-19.
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