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Journal of Chinese Integrative Medicine ›› 2010, Vol. 8 ›› Issue (3): 224-230.doi: 10.3736/jcim20100305

• Original Clinical Research • Previous Articles     Next Articles

Survival benefit of an herbal formula for invigorating spleen for elderly patients with gastric cancer

 Ai-guang Zhaoa, Wen Caoa,  Yan Xua, Gang Zhaoc, Bing-ya Liud, Yong Caie, Jin-zu Yanga, Ying Gua, Wei Yuana,Ying-jie Zhu a, Ying-ying Hana, Jin-kun Yanga   

  1. a Department of Oncology, Longhua Hospital, Shanghai University of Traditional Chinese Medicine, Shanghai 200032, China
    b Department of Gastroenterology, the Second Hospital of Fuzhou, Fuzhou 350007, Fujian Province, China
    c Department of General Surgery, Renji Hospital, Medical College, Shanghai Jiao Tong University, Shanghai 200127, China
    d Institute of Digestive Surgery, Ruijin Hospital, Medical College, Shanghai Jiao Tong University, Shanghai 200025, China
    e Department of Preventive Medicine, School of Public Health, Shanghai Jiao Tong University, Shanghai 200025, China
  • Received:2009-08-14 Accepted:2010-01-11 Online:2010-03-20 Published:2010-03-15

Background

Gastric cancer is one of the most common malignant tumors. Traditional Chinese medicine (TCM) has been widely used in treatment of gastric cancer, but still lacking large sample controlled trial to evaluate its efficacy.
Objective

To analyze the prognostic factors of 220 elderly patients with gastric cancer, and to further study the efficacy of an herbal formula for invigorating spleen and its modifications based on syndrome differentiation of TCM in treatment of gastric cancer in elderly patients and the influence on prognosis.
Design, setting, participants and interventions

A total of 220 elderly patients aged 65 years or over with gastric cancer from Longhua Hospital of Shanghai University of Traditional Chinese Medicine, and Renji Hospital and Ruijin Hospital of Shanghai Jiao Tong University Medical College were prospectively enrolled. All patients were assigned to either traditional Chinese herbal medicine (TCHM) group (89 cases) or non-TCHM group (131 cases). Patients in the TCHM group were treated with an herbal formula for invigorating spleen plus chemotherapy, while patients in the non-TCHM group were only treated with chemotherapy.
Main outcome measures

Univariate and Cox regression analyses were performed to determine all the potential prognostic factors. Kaplan-Meier curves were used to assess the differences in survival time between TCHM group and non-TCHM group after stratification for TNM stage, surgery or chemotherapy.
Results

The 220 eligible patients were histologically confirmed adenocarcinoma of the stomach from 2001 to 2007. Eighty-nine cases in the TCHM group received three or more months of TCHM treatment, and 131 cases in the non-TCHM group did not receive TCHM treatment. Cox regression analysis suggested that the TNM stage, radical resection, three or more treatment cycles of chemotherapy, and TCHM treatment were independent prognostic factors (P<0.01). The patients receiving TCHM treatment demonstrated better prognosis than the other prognostic factors in multivariate analysis; the odds ratio [Exp(β)] of overall group was 0.322, and 95% confidence interval (CI) was from 0.212 to 0.489. Median overall survival of TCHM group was 41.129 months, and one-, three-, and five-year survival rates were 85.2%, 55.6% and 45.7% respectively. Median overall survival of non-TCHM group was 17.195 months, and one-, three-, and five-year survival rates were 63.9%, 26.9% and 21.9% respectively. In stratification analysis of stage for 96 patients who did not accepted radical resection or suffered from recurrence and metastasis (36 cases in the TCHM group, and 60 cases in the non-TCHM group), Cox regression analysis suggested that three or more treatment cycles of chemotherapy and TCHM treatment were independent prognostic factors for improving survival respectively (P<0.01). The hazard ratio [Exp(β)] of TCHM in stratification for late stage was 0.421, and 95% confidence interval was from 0.255 to 0.693. Median overall survivals were 17.819 months for TCHM group and 8.548 months for non-TCHM group. In stratification analysis of surgery and chemotherapy for 102 patients with Ib-Ⅳ (M0) who accepted radical resection (R0 resection) and three or more treatment cycles of chemotherapy (33 cases in the TCHM group, and 69 cases in the non-TCHM group), the disease-free survival and overall survival did not reach the median at the time of analysis. In the TCHM group, one-, three-, and five-year disease-free survival rates were 97.0%, 59.9% and 50.4%, and one-, three-, and five-year survival rates were 100.0%, 74.1% and 61.4%, respectively. In the non-TCHM group, one-, three-, and five-year disease-free survival rates were 82.6%, 51.1% and 51.1%, and one-, three-, and five-year survival rates were 86.9%, 55.6% and 55.6%, respectively.
Conclusion

The herbal formula for invigorating spleen has an important value for improving the prognosis of elderly patients with gastric cancer. This herbal formula shows survival benefit for advanced gastric cancer in elderly patients. The influence of TCHM on disease-free survival and overall survival of postoperative gastric cancer in elderly patients need to be further evaluated.

Key words: Gastric cancer, The elderly, Invigorating spleen, Disease-free survival, Prospective study, Case-control study

Table 1

Patient characteristics and treatment regimens of overall group"

Characteristics Non-TCHM group TCHM group
Cases (Male/Female) 131 (100/31) 89 (66/23)
Age at diagnosis (Years) 65–89 65–88
Tumor location
Cardia/Fundus 18 15
Corpus/Antrum 110 73
Linitis plastica 3 1
Pathological characteristics
Adenocarcinoma/Moderately differentiated adenocarcinoma 43 37
Poorly differentiated adenocarcinoma 54 32
Mucinous adenocarcinoma/Signet-ring cell carcinoma 34 20
TNM stage
Stage Ⅰ 3 10
Stage Ⅱ 10 11
Stage Ⅲ 37 22
Stage Ⅳ 81 46
Surgery
Radical resection 71 53
Palliative resection 19 4
By-pass procedure/Non-surgery/Explorative laparotomy 41 32
Chemotherapy
Non-chemotherapy/Less than 3 treatment cycles 44 31
Three to five treatment cycles 31 15
Six treatment cycles and over 56 43
Failing in follow-up rate 4.58% (6/131) 7.87% (7/89)

Table 2

Multivariate analysis of factors influencing survival of overall group"

Factor Regression coefficient (β) Standard error Wald test P value Hazard ratio exp (β) 95% confidence interval for exp (β)
Stage Ⅳ 15.692 0.001
Stage Ⅱ –2.534 0.746 11.523 0.001 0.079 0.018, 0.343
Stage Ⅲ –0.876 0.314 7.783 0.005 0.416 0.225, 0.771
By-pass Procedure/Non-surgery/Explorative laparotomy 11.991 0.002
Radical resection –1.039 0.300 11.979 0.001 0.354 0.197, 0.637
Palliative resection –0.337 0.301 1.254 0.263 0.714 0.396, 1.288
Six treatment cycles and over 12.492 0.002
Non-chemotherapy/Less than three treatment cycles 0.824 0.246 11.199 0.001 2.280 1.407, 3.695
Three to five treatment cycles 0.129 0.255 0.256 0.613 1.138 0.690, 1.877
Jianpi herbal formula –1.134 0.214 28.224 0.000 0.322 0.212, 0.489

Table 3

Patient characteristics and treatment regimens of advanced disease subgroup"

Characteristics Non-TCHM group TCHM group
Cases (Male/Female) 60 (50/10) 36 (30/6)
Age at diagnosis (Years) 65–89 65–88
Tumor location
Cardia/Fundus 8 9
Corpus/Antrum 50 27
Linitis plastica 2 0
Pathological characteristics
Adenocarcinoma/Moderately differentiated adenocarcinoma 19 14
Poorly differentiated adenocarcinoma 24 14
Mucinous adenocarcinoma/Signet-ring cell carcinoma 17 8
Chemotherapy
Fluorouracil plus cisplatin/Oxaliplatin 9 9
Fluorouracil plus cisplatin/Oxaliplatin plus anthracycline 5 1
Fluorouracil plus cisplatin/Oxaliplatin plus paclitaxel/Docetaxel 1 1
Fluorouracil 0 5
Fluorouracil plus others 5 5
Non-chemotherapy 40 15
Failing in follow-up rate 1.7% (1/60) 13.9% (5/36)

Table 4

Multivariate analysis of factors influencing survival of advanced disease subgroup"

Factor Regression coefficient (β) Standard error Wald test P value Hazard ratio exp (β) 95% confidence interval for exp (β)
Chemotherapy –0.986 0.240 16.815 0.000 0.373 0.233, 0.598
Jianpi herbal formula –0.866 0.255 11.537 0.001 0.421 0.255, 0.693

Table 5

Patient characteristics and treatment regimens of postoperative subgroup"

Characteristics Non-TCHM group TCHM group
Cases (Male/Female) 69 (47/22) 33 (25/8)
Age at diagnosis (Years) 65– 83 65–76
Tumor location
Cardia/Fundus 5 2
Corpus/Antrum 64 30
Linitis plastica 0 1
Pathological characteristics
Adenocarcinoma/Moderately differentiated adenocarcinoma 18 10
Poorly differentiated adenocarcinoma 26 15
Mucinous adenocarcinoma/Signet-ring cell carcinoma 25 8
TNM stage
Stage Ⅰ 6 4
Stage Ⅱ 16 9
Stage Ⅲ 34 13
Stage Ⅳ 13 7
Chemotherapy
Fluorouracil plus cisplatin/Oxaliplatin 46 19
Fluorouracil plus cisplatin/Oxaliplatin plus anthracycline 3 3
Fluorouracil plus cisplatin/Oxaliplatin plus paclitaxel/Docetaxel 13 1
Fluorouracil 5 5
Fluorouracil plus others 2 5
Failing in follow-up rate 4.35% (3/69) 3.03% (1/33)
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