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Tables and Studies - Traditional Chinese Medicine in the Treatment of Breast Cancer
Isaac Cohen, LAc, OMD, Mary Tagliaferri, MD, LAc & Debu Tripathy, MD

Table 1: Commonly Prescribed Herbs for Prevention of Breast Cancer
Table 2: Formulas Commonly Used in the Trials

Table 3: Formulas Used in Sixth Breast Cancer Prevention Trial
Table 4: Herbs Commonly Prescribed with Chemotherapy, and Chinese Anticancer Agents

Table 5: Histology and Chinese Medical Syndrome Classification

Table 6: Five Year Survival Rates for 216 Cases of Breast Cancer
Table 7: Relationship Between Five Year Survival Rates and Age

Table 8: Relationship Between Five Year Survival Rates and Pattern Differentiation in Chinese Medicine for 216 Cases of Breast Cancer
Table 9: Fact Protocol Kang Lai Te Comparative Ratios of Treatment Effectiveness for Breast Cancer
Study 1
Study 2

Study 3
Study 4

Study 5
Other Studies

Table1: Commonly Prescribed Herbs for Prevention of Breast Cancer
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Pinyin name Botanical name and family Traditional indications Modern research Chemical constituents
Chai Hu Radix Bupleurum chinensis DC. (Umbelliferae) Reducing fever, soothing the liver and upper GI, cures organ ptosis. CNS effects (antipyretic effect, sedative effect, analgesic and antitussive effect.) Anti-inflammatory effect. GI effect (hepato-protective and choleretic effect, prevents gastric ulcer. Hypolipemic effect. Antimicrobial effect, protects from renal damage. Triterpene saponins: saikosaponins a, b1- b4, c, d, e and f. Essential oils: bupleurmol, spinasterol, stigmasterol
Dang Gui Radix Angelica sinensis (Oliv.) Diels (Umbelliferae) Enriching the blood and activating blood circulation. Regulating menstruation and relieving menstrual pain. Used for constipation. Different fractions can both inhibit and stimulate uterine contractions. Endometrial proliferation without direct oestrogenic effect was found. Decreases contraction magnitude and frequency of heart muscle. Significantly dilates and increases coronary flow. Decreases artery pressure while reducing arterial resistance and increasing arterial flow. Inhibits platelet aggregation and serotonin release. Decreases blood lipids and reduces arteriosclerosis. Analgesic effect. Antiasthmatic effect. Essential oils: ligustilide, ferulic acid, n-butyli-denephthalide, nvalero- phenone-O-carboxylic acid. Novolatile: brefeldin A, sitosterol, stigmasterol, sitosterol-D-glucoside, vitamin A, B12 and E.
Bai Shao Radix Paeonia lactiflora Pall. (Ranunculaceae) Supplements blood, controls pain, alleviates sudden onset of disease, subdues hyperactive liver, controls excessive sweating. Antispasmodic and analgesic effect by lowering muscle tonicity. Sedative effect, inhibits gastric secretions and inhibits gastric ulceration. Antibacterial effect. Protects from myocardial ischemia and from platelet aggregation. Causes coronary and peripheral vasodialation. Paeoniflorin, paeonol, paeonin, albiflorin, oxypaeoniflorin, benzoylpaeoniflorin and paeoniflorigenone. Benzoic acid, sitosterol, gallotannin, pedunculagin. Polysaccharide: peonan SA. Acidic polysaccharide: peonan SB, peonan PA and Triterpenoids.
Chen Pi Pericarpium Citrus reticulata blanco (Rutaceae) Regulating the flow of qi and invigorating digestive function. Eliminating damp and resolving phlegm. Inhibits GI smooth muscle movement. Inhibits gastric ulceration without inhibition of gastric secretions. Expectorant and antitussive effect. Anti-inflammatory and antiallergic effect. Relaxes uterine muscle contraction. Essential oil: d-limonene, citrol. Monoterpenes: pinene, pinene, camphene, myrcene, 3-carene, phellandrene, phellandrene, terpinene. Flavones, alkaloids, synephrine and N-methyltyramine.
Wang Bu Liu Xing Semen Vaccariae pyramidata Medic. (Caryophyllacea) Moves blood, regulates menses, increases lactation, disperses swelling carbuncles, promotes healing of incised wounds. Stimulates uterine contraction. Saponins: vacasegoside, isosaponarin. Starch, fat, alkaloids, cyclic peptides.

Table2: Formulas Commonly Used in the Trials
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Formula Name TCM Differentiation
Dan Zhi Xiao Yao San (Moutan and Gardenia Rambling Powder) plus Yi Huang Tang (Change Yellow Discharge Decoction) plus San Miao San (Three Wonders Powder ) with Xiang Fu (Rhizoma Cypery rotundi) Liver qi depression with damp heat pattern
Dan Zhi Xiao Yao San (Moutan and Gardenia Rambling Powder) plus Tao Hong Si Wu Tang (Persica and Carthamus Four Materials Decoction) plus Qing Pi (Pericarpium Citri reticulatae viridis), Yan Hu Suo (Rhizoma Corydalis) and Yu Jin (Rhizoma Curcuma) Liver qi depression with blood stasis pattern
Dan Shen Gui Pi Tang (Salvia Restore the Spleen Decoction) plus Xiang Fu (Rhizoma Cyperi rotundi) and Yu Jin (Rhizoma Curcuma) Liver qi depression with heart/ spleen vacuity pattern

Table 3: Formulas Used in Sixth Breast Cancer Prevention Trial
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1. For Liver QI Depression and Binding Pattern

2. For Irregularity of the Chong and Ren Pattern

Chai Hu (Radix Bupleuri) Shu Di Huang (Radix Rehmanniae Glutinosae Conquitae)
Dang Gui (Radix Angelica Sinensis) Shan Yao (Radix Dioscoreae Oppositae)
Chi Shao (Radix Paeoniae Rubrae) Gou Qi Zi (Fructus Lycii Chinensis)
Bai Shao (Radix Paeoniae Lactiflorae) Shan Zhu Yu (Fructus Corni Officinalis)
Tao Ren (Semen Persicae) Lu Jiao Jiao (Colla Cornu Cervi)
Hong Hua (Flos Carthami Tinctorii) Tu Si Zi (Semen Cuscutae)
Dan Shen (Radix Salviae Miltiorrhizae) Xia Ku Cao (Spica Prunellae Vulgaris)
Xiang Fu (Rhizoma Cyperi Rotundi) Hai Zao (Herba Sargassii)
Xia Ku Cao (Spica Prunellae Vulgaris) Kun Bu (Thallus Algae)
Lian Qiao (Fructus Forsythiae Suspensae) Hong Hua (Flos Carthami Tinctorii)
Chuan Lian Zi (Fructus Meliae Toosendan) Bai Shao (Radix Paeoniae Lactiflorae)
Gua Lou Ren (Semen Trichosanthis)  
Chen Pi (Pericarpium Citri Reticulatae)  
Yan Hu Suo (Rhizoma Corydalis Yanhusuo)  
Chuan Sha Jia (Squama Manitis Pentadactylae)  
Ban Xia (Rhizoma Pinelliae Ternatae)  
Hai Zao (Herba Sargassii)  
Kun Bu (Thallus Algae)  
The herbs were made into capsules and given 6 capsules 3 times a day for formula 1, and 4 capsules 3 times a day for formula 2.

Table 4: Herbs Commonly Prescribed with Chemotherapy, and Chinese Anticancer Agents
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Pinyin name Botanical name and family Traditional indications Modern research Chemical Constituents
Huang Qi Radix Astragalus membranaceus (Fisch.) Bge. (Leguminosae) Supplements qi, increases yang, consolidates the surface, increases resistance to disease, controls sweating, delivers fluids, disperses swelling, discharges pus. Increased CD4/CD8 ratio and phagocytic activity in patients with gastric cancer undergoing chemotherapy. Stimulation of lymphocyte IL-2, IL-3, IL-6, TNFa and IFN-g. Diuretic effect and antinephrotoxic effect. Antiinflammatory effect. Hepatoprotective effect. Saponins: astragalosides I-VIII, acetylastragaloside I. Flavones: kaempferol, quercitin, isorhamnetin, rhamnocitin, formononetin, calycosin. Polysaccharides: astragalans I,II,III. Glucans: AG-1 and AG- 2.
Bai Zhu Rhizoma Atractylodis macrocephalae Koidz. (Compositae) Replenishes qi and reinforces the spleen. Harmonises the spleen and stomach, relieves fatigue. Induces diuresis and eliminates damp. Arrests excessive perspiration and spontaneous sweating. Increased phagocytosis, lymphocyte transformation, rosette formation, and serum IgG post chemotherapy. Increases body weight and endurance. Potentiates reticuloendothelial system. Diuretic effect, antiulcerative effect, hypoglycaemic effect. Anticoagulant effect. Hepatoprotective effect. Lowers blood pressure and dialates blood vessels. Essential oil:s atractylon. Lactones: atractylenolides II,III. Vitamin A. Sesquiterpene and furfural.
Ling Zhi Ganoderma lucidum (Leyss. Ex Fr.) Karst. (Basidiomycetes) Nourishes, tonifies, supplements qi and blood. Removes toxins, astringes essence and disperses accumulation. Relieves fatigue and subdues deficiency insomnia. Antitussive effect. Expectorant effect. Hypotensive effect. Hepatoprotective effect. Antibacterial effect. Sensitises radiation effect. Protects from radiation damage. Immune stimulating effect. Ergosterol, coumarin, mannitol, polysaccharides, organic acids, resins.
Dang Shen Radix Codonopsis pilosula (Franch.) Nannf. (Campanulaceae) Tonifies qi, increases body resistance, promotes digestion & absorption of nutrients. Increases secretion of body fluids. Promotes digestion and metabolism. Stimulates the CNS: decreases monoxidase-B (MAO-B) activity in the brain. Hematopeiteic. Hypotensive effect. Significantly decreases erythrocyte electrophoretic time and fibrinogen. Enhances cardiac function and increases tolerance to cold without increasing body weight and it elevates activity of superoxide dismutase (SOD). Increases phagocytosis. Promotes leukocyte production. Increases haemoglobin levels, antagonises insulin induced hypoglycaemia, but was ineffective with phagocytosis and the transformation of lymphocytes. It also inhibited type II allergic reactions and stimulated the adrenal cortex Inhibits transplanted sarcoma 180 in mice. Phytosterols and triterpenes: spinasterol and Dglucopyranoside, 7-stigmasterol, 5,22-stigmasterol, taraxerol, taraxeryl acetate and friedelin. Phenols: syringaldehyde, vanillic acid, syringin, tangshenoside I. Essential oils: methyl palmitate, octadecane, nonadecane, heptadecane, carboxylic acid.
Fu Ling Sclerotium Poria cocos (Schw.) Wolf (Polyporaceae) Induces diuresis and excretes dampness. Invigorates the spleen function. Tranquillises the mind. Increased monocyte GM-CSF production Enhanced recovery of myelosuppression in mice after radiation. Increased spontaneous rosette formation, lymphocyte transformation, and serum IgG. Diuretic effect. Sedative effect. Antitumour promotion effect. Increases cardiac contractility. Polysaccharide: -pachyman. Triterpene: pachymic acid, tumulosic acid, eburicoic acid, pinicolic acid.
Antineoplastic agents        
Pu Gong Ying Herba Taraxacum mongolicum Hand.- Mazz. (Compositae) Removes toxic heat. Removes swelling and nodulation. Relieves dysuria. Antimicrobial effect. Immune stimulating effect: increases peripheral lymphoblast transformation rate. Choloretic effect and hepatoprotective effect. Taraxasterol, taraxacerin, taraxicin, choline, inulin and pectins.
Jin Yin Hua Flos Lonicera japonica Thunb. (Caprifoliaceae) Removes toxic heat. Dispels wind heat. Antimicrobial effect. Anti-inflammatory effect, antilipaemic effect. Decreases pregnancy rate after mating. Antispasmodic effect. Diuretic effect. Chlorogenic acid. Inositol and flavonone. Essential oils: 2,6,6- trimethyl-2-vinyl-5-hydroxytetrahydropyran and linalool.
Shan Ci Gu Bulbus Cremastra variabilis (Blume) Nakai (Orichidaceae) Reduces heat. Removes toxins, disperses accumulation, dissipates swelling. Antineoplastic effect. Cardiotonic effect. Antiviral effect. Tulipine, colchicines.
Huang Yao Zi Rhizoma Dioscorea bulbifera L. (Dioscoreaceae) Resolves phlegm. Controls cough. Disperses goitre and controls bleeding. Antibacterial effect. Antifungal effect. Increases uterine contraction. Terpenoids: diosbulbin A,B,C,D. 2,4,6,7-tetrahydroxy-9,10-dihydrophenanthrene, 2,4,5,6- tetrahydroxy-phenanthrene. Tannin.
Bai Hua She She Cao Herba Oldenladia diffusa (Willd.) Roxb. (Rubiaceae) Removes toxic damp heat, clears abscesses, infections with fever. Increases phagocytosis, lowers fever, arrests growth of spermatogonia and empties convoluted seminiferoous tubules. Iridoid glycosides: oldenlandosides Aand B. hentriacontane, stigmasterol, ursolic acid, oleanolic acid, b sitosterol, sitosterol-Dglucoside, p-coumaric acid and flavonoid glycosides.

Table 5: Histology and Chinese Medical Syndrome Classification
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Chinese Medical Differentiation Type
  Invasive Non-Invasive  
Stage Sim; Ad Sc Med Ecz DCIS LCIS Liver Spleen Stasis Def
1 16 19 2 2 1 37 7 40 22 4  
II 21 22 3 2 6     37 33 1 1
III 15 21 2         17 15 2 19
IV 22 18           8 11 2 19
Total 74 80 7 4 7 37 7 102 81 9 24
% 34.3 37.0 3.2 1.9 3.2 47.3 37.5 4.2 11.1    

Sim= Carcinoma; Ad=Adenocarcinoma; Sc= Scirrhous; Med= Medullary carcinoma; Ecz= Eczematoid cancer; DCIS= Presence of Ductal Carcinoma In-situ; LCIS= Lobular Carcinoma In-situ; Liver= Liver Stagnation (Depression) Qi Stagnation Type; Spleen= Spleen Deficiency with Phlegm and Damp Type; Stasis= Stasis and Toxin Type; Def= Blood and Qi Deficiency Type

Table 6: Five Year Survival Rates for 216 Cases of Breast Cancer
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Stage Total N of survivors % of survivors N of Deaths % of Deaths
I+ DCIS, LCIS 66 65 98.5 1/td> 1.5
II 72 71 98.6 1 1.4
III 38 30 78.9 8 21.1
IV 40 4 10.0 36 90.0
Total 216 170 78.7 46 21.3

Table 7: Relationship Between Five Year Survival Rates and Age
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    Under 30 31-40 41-50 51-60 Over 60
Survivors 170 2 13 95 47 13
Deaths 46 0 6 16 17 7
Total 216 2 19 111 64 20

Of the 216 patients, 8 received Chinese herbal medicine as sole therapy; the remaining patients received a combination of TCM and WM treatment. The herbs were administered daily from between 5 years and 3 months to 17 years. Between 1970-1980 CMF (Cyclophosphamide, Methotraxate and 5-Fluorouracil) chemotherapy was used and since 1980 adriamycin or mitoxanthrone replaced cyclophosphomide. The dose and schedule of chemotherapy were similar to common oncological practice.

The overall 5 year survival rate was 78.7% (170/216) for all stages. The 5-year survival rate was related to age and histological classification as follows. The highest percentage of 5-year survivors (86%) was in the 41-50 year old population (see tables 6 & 7). In terms of histological classification, highest survival rates were observed in patients with adenocarcinoma (91.3%).

An analysis of the TCM classifications reveals that prognosis varies according to traditional pattern differentiation with qi and blood deficiency type being the worst prognosis (see table 8).

Table 8: Relationship Between Five Year Survival Rates and Pattern Differentiation in Chinese Medicine for 216 Cases of Breast Cancer
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Results of Follow-up Survey Number Liver depression and Qi Stagnation Type Spleen Deficiency with Phlegm and Damp Type Stasis and Toxin Type Qi and Blood Deficiency Type
Surviving 170 87 (85.3%) 73 (90.1%) 5 (55.6% 5 (20.8%)
Deaths 46  15 (14.7%) 8 (9.9%) 4 (44.4%) 19 (79.2%)
Total 216 102 81 9 24

Table 9: Fact Protocol Kang Lai Te Comparative Ratios of Treatment Effectiveness for Breast Cancer
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  CR PR NR CR+PR (%) of CR+PR
Experimental Group 4 6 5 10 (66.7)
Control Group .2 6 9 8 (47.1)

CR- complete remission; PR- partial remission (>50% of tumor load reduction); NR- No response (<50% of tumor load reduction)

Based on the TNM (tumour-node-metastasis) classification, 16 cases were stage two, 48 cases were stage three, 12 cases were stage four, and one case was not classified due to incomplete records. The diagnoses were all confirmed by clinical histological and pathological tests.

All of the subjects chosen for Teng Huang (Resina Garciniae) met one of the following criteria: i. did not receive prior therapy, ii. the cancer progressed on prior therapy, or, iii. had metastatic recurrence after treatment.

Teng Huang (Resina Garciniae) preparations were provided by the Jiang Xi Medicinal Processing Plant. Intravenous preparations contained 100 mg. One dose equalled 100-200 mg of Teng Huang in a 5% glucose solution. A 500 ml intravenous drip was administered to the patient twice per week and 60-90 mg were administered orally (30mg pills) 2 to 3 times per day. A soft plaster containing 5% concentration of Teng Huang was applied topically to the breast tumours and changed 2-3 times per week.

In general, the subjects received the herbal preparations before surgery. One month constituted one treatment cycle. After one or two treatment cycles, surgery was performed. Those for whom surgery was contraindicated, and those who refused surgical treatment, could complete multiple treatment cycles. Based on standard evaluation of tumour response, the results were as follows: markedly effective (tumour shrinkage greater than50%):15 cases (19.4%); effective (tumour shrinkage less than 50%): 44 cases (57.1%); ineffective (no change or increase in tumour size): 18 cases (23.3%).

The overall effectiveness rate was 76.60%. The rate for marked effectiveness was 19.5%. For all groups the period of effective remission was between 3 to 18 months (no median is provided).

During the course of treatment no bone marrow suppression was observed, and no cardiac, hepatic or renal toxicities observed. However, leakage from the intravenous drip caused soft tissue oedema. This was avoided by ensuring that there was no leak.

Study 1
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76 women diagnosed with breast cancer were treated post surgically with herbal medicine in addition to chemotherapy and radiation. Herbal treatment was given once daily for two to eight years. The age range was 33-76 years, with 80% of the women aged 45-65. According to cancer staging, 22 were diagnosed stage I, 48 stage II, and 6 stage III. Of the 76 women who entered the trial, 8 dropped out and the remaining 68 were evaluated, providing an 89% follow-up. The duration of observation was 2-8 years. All patients were able to complete their therapy; 28 women resumed work and the rest were able to manage their daily life. Among the 68 cases, 3 women (4.4%) had recurrence of disease during the follow-up time period and two of these died during the study. Overall survival was 97.1% and overall disease free survival was 95.6%. Unfortunately, the researchers do not report tumour size, the nodal status, ER status, median follow-up, 5 year analysis, the stage of the women who recurred and description of the type and dose of chemotherapy and radiation used in the trial.55

Study 2
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A retrospective study evaluating the clinical outcome of 216 cases of breast cancer treated with integrated TCM and WM from 1970-1988 was conducted at Guang An Men Hospital in Beijing.56 211/216 (97.7%) patients were women and 5/ 216 (2.3%) were men. The subjects ranged in age from 28-73; 175 (81.0%) were 41-60 years of age. The stage distribution was DCIS + LCIS: 44 (20.3%), stage I: 22 (10.1%), stage II: 72 (33.3%), stage III: 38 (17.6%), stage IV: 40 (18.5%) (see table 5).

Study 3
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In a randomised controlled neoadjuvant trial, 32 patients with breast cancer were treated with a combination of FACT (5-FU, Adriamycin, Cyclophosphamide and tamoxifen) and Kang Lai Te Injection or FACT alone. 57 Kang Lai Te (KLT) is a lipid emulsion from the seed of wild barley (semen Coix lacryma-jobi L. var. ma-yuen (Roman.) Stapf (Gramineae). The ingredients in the seed that show anticancer activity are composed of four free fatty acids. 58 KLT has been shown to reverse adriamycin resistance in cell cultures.59 KLT is currently in clinical trials in the US in the treatment of Non Small Cell Lung Cancer (NSCLC).

The women in the trial were 27-66 years of age with an average age of 52. All patients had a Fine Needle Aspirate (FNA) to confirm diagnosis. All patients had Karnofsky scores above 80% (a performance scale for rating a persons usual activities; used to evaluate a patients progress after a therapeutic procedure). A total of 18 patients were ER positive and 14 were ER negative. 3 patients were diagnosed stage I + DCIS, 5 at stage Iia, 8 at stage Iib and 16 at stage IIIa.

The treatment protocols for the two groups were as follows. The experimental group received Cytoxan 800 mg and Adriamycin 50 mg IV on the first day. 5-Fu was administered as an intravenous drip (for a minimum of six hours) daily for 5 days. A 200 ml dose of Kang Lai Te injection was administered by intravenous drip, once per day, for 10 days. A total of 20 mg of tamoxifen was given twice a day for pre-menopausal women and 10 mg of tamoxifen twice a day was prescribed for post-menopausal women. In accordance with standard treatment protocol, Metoclopromide and Dexamethasone were prescribed prior to treatment to reduce nausea and vomiting. Due to the possible side effects of phlebitis from Kang Lai Te intravenous drip, the drip was inserted into the subclavicular vein. The control group did not receive Kang Lai Te, but all other medications were similar for both groups. The patients received two cycles of treatment. The tumour was measured using double diameter area measurement. Ultrasound measurements were recorded before treatment and one week after both cycles of treatment were completed.

The overall effective rate for all 32 cases was 56.2% (complete remission and partial remission (>50%) of the tumors). The experimental group had an effect rate of 66.7%, with complete remission (CR) of 26.7%. The control group had an effect rate of 47.1%, with a CR of 11.8% (see table 9). No tumour progression was observed in either group. Surgical excision was performed approximately two weeks after two cycles of chemotherapy were completed. All surgical margins were clear. Subjects in both groups experienced grade I and grade II bone marrow toxicity (primarily lowered WBC) and gastrointestinal toxicity. With supportive therapy, blood counts returned to normal and the GI distress was relieved. Toxicity experienced during the trial did not influence the administration of the second cycle of chemotherapy or the timely performance of surgery. In the experimental group, 86.7% of subjects had stable or improved Karnofsky scores. This was markedly better than the 52.9% in the control group.

Study 4
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Many herbs have been tested in China for their anticancer activity in the past decades, and several drugs currently in use or in clinical trials were developed from the herbs60. In-vitro antiproliferative assays on a panel of breast cancer cell lines treated with Chinese herbs traditionally used for breast cancer revealed that a high proportion of the herbs tested were highly active in vitro61. A clinical trial evaluating the anti-cancer effect of a single herb was conducted at Jiang Xi Province. The study included 77 women with breast cancer62. All 77 subjects were females between the ages of 20 and 86. The average age was 41.7.

Study 5
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Another study of locally advanced and metastatic breast cancer was conducted on 14 women63. All subjects were premenopausal women between 34-52 years of age (average 43 years). All subjects underwent pathological confirmation of diagnosis. Based on 1978 UICC staging: T2 N3 M0: 4 cases; T3 N3 M0: 3 cases; T 4 N3 M0: 3 cases; T3 N3 M1b: 2 cases; T4 N3 M1b: 2 cases. There was one case of bilateral breast cancer with bilateral axillary and subclavicular lymph nodes metastasis. There were also five cases of ulcerated tumours that were developing severe fungal infection. All of these patients were receiving treatment for the first time, as follows:

All 14 subjects first received 2 cycles of CMF chemotherapy. After the second cycle of chemotherapy was finished, Co staged fractional radiotherapy was administered. After conclusion of the first stage of radiotherapy, a cycle of CMF was administered. This was followed by radiation boost administered with direct fields to breast, subclavicular, and axillary nodes. In between radiotherapy and chemotherapy a Chinese herbal formula was administered daily. The formula above constituted one dose. One dose was administered daily five days per week, until the end of the final stage of radiotherapy.

After undergoing two cycles of chemotherapy, tumour size in the 14 subjects was reduced as follows: 50% reduction: 1 case (7.2%); 25% reduction: 6 cases (42.8%); No change: 7 cases (50%). After radiotherapy, tumours were completely eliminated in 13 subjects (92.8%). Only one subject (7.2%) had residual tumour mass who then underwent a radical mastectomy three weeks later. During the treatment period, four subjects (28.5%) had mild bone marrow suppression. For these four subjects, the dosage of the Chinese herbs was increased from five to seven doses per week and leucogen (CGSF) was also administered. After treatment, all four improved. One subject developed pneumonitis nine days after radiotherapy and was treated with steroids and antibiotics. She completely recovered after this treatment.

Survival Rates: One year, three year, and five year rates were as follows: 85.7% (12/14); 50% (7/14); 35.7% (5/14). One subject had a local recurrence six months after treatment and subsequently underwent radical mastectomy and two cycles of CAF chemotherapy. Today, seven years later, she is still alive. Clinical Staging and Survival Rates: For Stage 3 breast cancer (10 subjects) the five-year survival rate was 50%. For Stage 4 breast cancer (4 subjects), there was no fiveyear survival rate. All deaths were due to metastasis to the liver, lungs, brain, or bones. No deaths were due to local recurrence. This group of subjects did not develop any significant signs of toxicity as side effects of therapy.

Other studies
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Several other studies that looked at the combination of TCM and western therapies in early stage breast cancer show that the five-year survival is greater in the combined approach. One study64 showed that in 134 women with stage II-III breast cancer, receiving surgery, chemotherapy and herbs, the five-year survival was 88.8%. In another study 62 patients with stage II-III breast cancer were divided into equal groups receiving standard surgery, radiation and chemotherapy with or without herbs. The herbs were taken for the whole duration of the observation. The five year survival was 93.5% (29/31) in the herb group compared to 32% (10/31) in the control group65. In our prior review66 we reported the studies that detail the effect of Chinese herbal medicine and acupuncture for the amelioration of side effects encountered during breast cancer treatment, modulation of immune functions, augmentation of bone marrow suppression and the treatment of pain.

Fu Zheng Sheng Xue Tiao Yuan Tang (Boost the Upright, Raise Blood, and Regulate the Origin Decoction) Dang Shen (Radix Codonopsis Pilosulae) 15g, He Shou Wu (Radix Polygoni Multiflori) 10g, Nu Zhen Zi (Fructus Ligustri Lucidi) 20g, Gu Sui Bu (Rhizoma Gusuibu) 10g, Ji Xue Teng (Radix et Caulis Jixueteng) 15g, Mai Ya (Fructus Hordei Vulgaris Germinantus) 10g, Bai Zhu (Rhizoma Atractylodis Macrocephalae) 15g, Huang Jing (Rhizoma Polygonati) 15g.

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