含脂质体阿霉素方案在乳腺癌术后辅助化疗中的安全性评价

目的 评价含脂质体阿霉素方案在乳腺癌术后辅助化疗中的安全性。方法 收集2014年9月至2016年8月接受术后辅助化疗的乳腺癌患者29例。化疗方案分别为：3周FAC方案（5-FU 500 mg／m2,脂质体阿霉素30 mg／m2,环磷酰胺500 mg／m2,每21天重复,共3个周期）14例;2周AC方案（脂质体阿霉素30 mg／m2,环磷酰胺600 mg／m2;每14天重复,共4个周期）11例;3周AC方案（脂质体阿霉素30 mg／m2,环磷酰胺600 mg／m2;每21天重复,共4个周期）4例。毒副反应按照NCI CTCAE 4.0.3版本分为1～5级。心脏毒性的评估包括定期检查心电图、心脏超声等。结果 所有患者中最显著的毒副反应为中性粒细胞减少,发生率为79.3％（23／29）;其次为手足综合征和口腔炎,发生率分别为51.7％（15／29）、27.6％（8／29）。AC方案组患者3级手足综合征的发生率为26.7％（4／15）,高于FAC方案组的0（0／14）。本组中无1例左心室射血分数降低10％以上;无1例出现充血性心力衰竭。结论 含脂质体阿霉素方案在乳腺癌术后辅助化疗中是安全的。     

Adjuvant cytotoxic and endocrine therapy in pre- and postmenopausal patients with breast cancer and one to nine infiltrated nodes: five-year results of the Hellenic Cooperative Oncology Group randomized HE 10/92 study

SUMMARY: The present randomized phase III trial was designed to detect a 15% benefit in relapse-free survival (RFS) or overall survival (OS) from the incorporation of adjuvant tamoxifen to the combination of CNF [cyclophosphamide, 500 mg/m2; mitoxantrone (Novantrone), 10 mg/m2; fluorouracil, 500 mg/m2 chemotherapy and ovarian ablation in premenopausal patients with node-positive breast cancer and conversely from the incorporation of CNF chemotherapy to adjuvant tamoxifen in node-positive postmenopausal patients. From April 1992 until March 1998, 456 patients with operable breast cancer and one to nine infiltrated axillary nodes entered the study. Premenopausal patients were treated with six cycles of CNF chemotherapy followed by ovarian ablation with monthly injections of triptoreline 3.75 mg for 1 year (Group A, 84 patients) or the same treatment followed by 5 years of tamoxifen (Group B, 92 patients). Postmenopausal patients received 5 years of tamoxifen (Group C, 145 patients) or 6 cycles of CNF followed by 5 years of tamoxifen (Group D, 135 patients). Adjuvant radiation was administered to all patients with partial mastectomy. After a median follow-up period of 5 years, 125 patients (27%) relapsed and 79 (17%) died. The 5-year actuarial RFS for premenopausal patients was 65% in Group A and 68% in Group B (p = 0.86) and for postmenopausal patients 70% in Group C and 67% in Group D (p = 0.36). Also, the respective OS rates were 77% and 80% (p = 0.68) for premenopausal and 84% and 78% (p = 0.10) for postmenopausal patients. Severe toxicities were infrequently seen, with the exception of leukopenia (18%), among the 311 patients treated with CNF. In conclusion, the present study failed to demonstrate a 15% difference in RFS in favor of node-positive premenopausal patients treated with an additional 5 years of tamoxifen after CNF adjuvant chemotherapy and ovarian ablation. Similarly, six cycles of CNF preceding 5 years of tamoxifen did not translate to a 15% RFS benefit in node-positive postmenopausal patients.     

A randomized multicenter trial comparing mitoxantrone, cyclophosphamide, and fluorouracil with doxorubicin, cyclophosphamide, and fluorouracil in the therapy of metastatic breast carcinoma

Three hundred thirty-one women with metastatic breast cancer were randomized to receive combination chemotherapy with either cyclophosphamide, Novantrone (mitoxantrone; Lederle Laboratories, Wayne, NJ), and fluorouracil (CNF) or cyclophosphamide, Adriamycin (doxorubicin; Adria Laboratories, Columbus, OH), and fluorouracil (CAF). Patients could not have had prior chemotherapy, although adjuvant chemotherapy was acceptable. Initial doses were 500 mg/m2 of cyclophosphamide and 500 mg/m2 of fluorouracil with either 10 mg/m2 of mitoxantrone or 50 mg/m2 of doxorubicin, administered intravenously (IV) on day 1 and repeated every 3 weeks. There were no statistically significant differences in pretreatment or prior therapy characteristics between the groups. For patients assigned to the CNF and CAF groups, respectively, 25 (18%) were premenopausal, 39 (40%) were estrogen receptor (ER) negative, 39 (38%) had a disease-free interval less than 1 year, and 24 (26%) had received prior adjuvant chemotherapy. All patients were compared for response rate, duration of response, time to progression or death, time to treatment failure (TTF), and survival. None of these parameters were statistically significant favoring one regimen over the other. The response rate (complete [CR] and partial response [PR]) was 29% for the CNF group (95% confidence interval of 22% to 37%) and 37% for the CAF group (95% confidence interval of 29% to 45%). The median response duration and TTF were 171 days and 125 days for the CNF group and 254 days and 147 days for the CAF group, respectively. The median survival times for the CNF group and the CAF group were 377 and 385 days, respectively. The major dose-limiting toxicity for both regimens was leukopenia, manifested as granulocytopenia. The incidence of stomatitis/mucositis was 10% in the CNF group and 19% in the CAF group. Alopecia occurred in 49% of CNF patients (severely for 4%) and in 86% of CAF patients (severely for 39%). Nausea/vomiting occurred in 80% of CNF patients and in 81% of CAF patients; the degree of severity was also comparable. There was significantly less cardiotoxicity observed in the CNF group compared with the CAF group. Although CNF is somewhat less effective in overall response rate, survival curves are identical. CNF can be offered to patients who reject anthracycline-containing regimens because of fear of alopecia.     

Secondary leukemia after epirubicin-based adjuvant chemotherapy in operable breast cancer patients: 16 years experience of the French Adjuvant Study Group.

BACKGROUND: The purpose of this study was to evaluate incidence and risk factors of secondary leukemia after adjuvant epirubicin-based chemotherapy in breast cancer patients. PATIENTS AND METHODS: Among eight French Adjuvant Study Group trials, 3653 patients were assessable: 2603 received epirubicin; 682 received hormonotherapy; and 368 had no systemic treatment. Chemotherapy was FEC regimen in 85% of cases (fluorouracil 500 mg/m2, epirubicin 50, 75 or 100 mg/m2, cyclophosphamide 500 mg/m2, three or six cycles). Epirubicin cumulative dose was <300 mg/m2 in 1045 patients; 300-600 mg/m2 in 1187; and > or =600 mg/m2 in 286, followed by radiotherapy in 96% of cases. The median follow-up was 104 months. RESULTS: Eight cases of leukemia occurred in epirubicin-exposed patients and one in non-exposed patients. After 9 years, the risk of developing a leukemia was 0.34% (95% confidence interval 0.11-0.57) in epirubicin-exposed patients. In patients receiving chemotherapy, leukemia subtypes were: AML2 (two), AML3 (one), AML4 (three) and ALL (two). None of the classically recognized risk factors was significantly correlated with the occurrence of a leukemia. CONCLUSION: Irrespective of the dose, the incidence of secondary leukemia after adjuvant epirubicin-based chemotherapy was low. After a long follow-up, the benefit/risk ratio for early breast cancer patients remained in favor of epirubicin-based adjuvant chemotherapy: eight cases (0.31%) occurred, and in some of them, treatment causality could be debatable.     

Combination chemotherapy with cmf (cyclophosphamide, methotrexate, 5-Fluorouracil) versus cnf (mitoxantrone, 5-Fluorouracil, cyclophosphamide) in advanced breast-cancer - a multicenter randomized study

A multicentric randomized study was conducted to compare the CNF regimen (cyclophosphamide at 600 mg/m2/iv, mitoxantrone at 10 mg/m2/iv, 5-fluorouracil at 600 mg/m2/iv) with the CMF regimen (methotrexate at 40 mg/m2/iv instead of mitoxantrone) administered every 3 weeks to previously untreated locally advanced or metastatic breast cancer patients. In 119 patients evaluable for therapeutic response, complete plus partial response rate was 44% for CNF and 29% for CMF (p>0.05; 95% C.I.: CNF=32%-56%, CMF=18%-40%). No statistically significant difference regarding time to progression, over survival or response to second-line chemotherapy with Epidoxorubicin was observed between the two regimens. Both regimens were well tolerated, but the percent of alopecia and leucopenia was significantly higher in the CNF patient group (31% versus 5% and 18% versus 0%, respectively; p<0.01). In conclusion, CNF was demonstrated to be slightly more toxic but more effective as compared to CMF (global response: 44% versus 29%, respectively). These findings should be taken into consideration when planning future studies of adjuvant chemotherapy.     

Long-term cardiac follow-up in relapse-free patients after six courses of fluorouracil, epirubicin, and cyclophosphamide, with either 50 or 100 mg of epirubicin, as adjuvant therapy for node-positive breast cancer: French adjuvant study group.

PURPOSE To evaluate long-term cardiac function in patients without disease who had received six cycles of fluorouracil 500 mg/m(2), epirubicin 50 mg/m(2), and cyclophosphamide 500 mg/m(2) (FEC 50) or the same regimen with epirubicin 100 mg/m(2) (FEC 100) as adjuvant chemotherapy for node-positive breast cancer in the French Adjuvant Study Group-05 trial. PATIENTS AND METHODS One hundred fifty patients (FEC 50, n = 65; FEC 100, n = 85) who were without disease and who gave their informed consent were enrolled for long-term cardiac assessment. The assessment included cardiac events occurring after the end of chemotherapy, vital signs, concomitant disease, ECG, isotopic left ventricular ejection fraction (LVEF), and echographic parameters. Abnormal files were blindly reviewed by cardiologists and oncologists. Results The median follow-up time was 102 months. After FEC 100, LVEF was less than 50% in five patients (radioisotopic method), and two patients experienced congestive heart failure (CHF) that was possibly related to treatment. Asymptomatic left ventricular dysfunction (LVD) was experienced in 18 patients after FEC 100 and in one patient after FEC 50. In these patients, treatment causality was probable in eight patients. Two additional years after this assessment, all 18 patients were still asymptomatic. CONCLUSION After more than 8 years of follow-up, the cardiac toxicity observed after adjuvant treatment with FEC 100 comprised two cases of well-controlled CHF and 18 cases of asymptomatic LVD. In the majority of women with primary breast cancer, the benefits of treatment with FEC 100 in terms of disease-free and overall survival outweigh the risks, and cardiac risk factors should be carefully evaluated in patient selection.     

High dose chemotherapy as adjuvant treatment in operable Breast Cancer with 10 or more involved axillary lymph nodes

BACKGROUND: it is well known that breast cancer patients with more than 10 axillary lymph nodes involved have poor prognosis even with extensive adjuvant chemotherapy. To improve this poor outcome, high-dose adjuvant chemotherapy has been applied to the these patients. This study was intended to clarify the efficacy and usefulness of high dose adjuvant chemotherapy (HDC) for high-risk breast cancer patients and its efficacy was compared with conventional adjuvant chemotherapy (non-HDC group). PATIENTS AND METHODS: Twelve patients with breast cancer involving more than 10 axillary nodes received high-dose chemotherapy with peripheral progenitor-stem cell transplantation (PBSCT). This regimen consists of BCNU (carmustine) 130 mg/m(2) x 3, CBDCA (carboplantin) 500 mg/m(2) x 3 and CPA (chyclophosphamide) 50 mg/kgx 2 after induction chemotherapy with 3 cycles of CE (chyclophosphamide 600 mg/m(2), epirubicin 60 mg/m(2)). RESULTS: Twelve patients completed the high-dose chemotherapy regimen as planned, no patient died of chemotherapy related toxicity. After a median follow-up period of 44 months, disease-free and overall survival at 48 months after the operation for 12 patients determined by Kaplan-Meier methods was 63 % and 83 %, respectively. Disease-free survival was superior in the high-dose chemotherapy group compared with the control group but a statistical difference was not observed. CONCLUSION: High-dose chemotherapy seems to be an effective and feasible treatment for high-risk breast cancer patients. However, the usefulness of high-dose adjuvant chemotherapy for high-risk breast cancer patients should be confirmed by a large-scale randomized trial.     

Adjuvant chemotherapy of premenopausal breast cancer with LH-RH analogue for ovarian protection--a case report

We report a case in which the LH-RH analogue, goserelin acetate was administered to a 26-year-old female patient diagnosed with premenopausal breast cancer and concurrently receiving anthracycline-based adjuvant chemotherapy for ovarian protection. After radical operation, pathological diagnosis showed that adjuvant chemotherapy was indicated. As she hoped for childbirth, at first goserelin was injected twice and then adjuvant chemotherapy was undergone concurrently with goserelin acetate for ovarian protection. The adjuvant chemotherapy consisted of 4 cycles of every four week intravenous dripinjection of adriamycin 50 mg/m2 and cyclophosphamide 500 mg/m2. The chemotherapy and goserelin acetate were completed at the same time. Menstruation recovered about two months after the finish of adjuvant therapy and was well-regulated after recovery. It is suggested that goserelin combined adjuvant chemotherapy for premenopausal breast cancer may be useful for ovarian protection.     

A phase II feasibility trial of dose-dense docetaxel followed by doxorubicin/cyclophosphamide as adjuvant or neoadjuvant treatment for women with node-positive or high-risk node-negative breast cancer

PURPOSE: Dose-dense adjuvant chemotherapy with doxorubicin/cyclophosphamide (AC) followed by paclitaxel has improved results compared with standard dosing at 3-week intervals. Because docetaxel might be more active than paclitaxel in the treatment of metastatic breast cancer, we explored the feasibility of substituting docetaxel for paclitaxel in dose-dense adjuvant therapy. PATIENTS AND METHODS: Seventy-six patients with node-positive breast cancer received treatment with 4 cycles of docetaxel followed by 4 cycles of AC administered with pegfilgrastim at 2-week intervals. When treatment proved difficult for the first 33 patients, 2 additional cohorts were treated: first, with a reduction of pegfilgrastim and dexamethasone prophylaxis doses (cohort 2) and then with a reduction of docetaxel from 100 mg/m2 to 75 mg/m2 (cohort 3). RESULTS: Treatment with dose-dense docetaxel at 100 mg/m2 resulted in unacceptable toxicity (24% of patients required hospitalization) and compromised subsequent dosing of AC as a result of neutropenia on the day of scheduled treatment. Only 21 patients (40%) who received docetaxel 100 mg/m2 were able to receive all 8 doses at full dose and on schedule. Reduction of docetaxel to 75 mg/m2 allowed 74% of patients to receive all 8 doses as scheduled. Delivery of AC as scheduled occurred in 82% of patients who received docetaxel 75 mg/m2 versus 40% when docetaxel 100 mg/m2 was administered. CONCLUSION: Full-dose docetaxel is difficult to administer as part of this dose-dense treatment regimen. Docetaxel 75 mg/m2 can be administered with improved subsequent delivery of 4 courses of dose-dense AC. Until comparative clinical studies are available, docetaxel should not be substituted for paclitaxel in dose-dense adjuvant chemotherapy for patients with high-risk breast cancer.     

Toxicity of doxorubicin and cyclophosphamide (60 mg/600 mg/m2) in adjuvant chemotherapy for breast cancer

We evaluated the toxicity of 4 cycles of doxorubicin (60 mg/m2) and cyclophosphamide (600 mg/m2) every 3 weeks (AC 60/600) in adjuvant chemotherapy for breast cancer. Between 1994 and 2003, 62 patients received 6 cycles of doxorubicin (40 mg/m2) and cyclophosphamide (500 mg/m2) every 3 weeks (AC 40/500), and 106 patients received AC 60/600 as adjuvant chemotherapy for breast cancer. The performance status of all patients was 0 or 1. Toxicity was determined using the National Cancer Institute Common Toxicity Criteria (NCI-CTC) ver. 2. Grade 3/4 neutropenia was frequent in AC 60/600 (6.5% vs 24.3%, p < 0.001). However, febrile neutropenia was not significant in either group (1.6% vs 3.8%, p = 0.39). There was also no statistical difference in the toxicity greater than grade 3 of anemia, nausea, vomiting, fatigue, diarrhea and cardiotoxicity. There was no treatment-related death in both groups. The number of patients who completed chemotherapy was higher in those receiving AC 60/600 than in those receiving AC 40/500 (91.9% vs 99.1%, p = 0.026). AC 60/600 is tolerated and feasible in adjuvant chemotherapy of breast cancer in Japanese patients from the viewpoint of toxicities.     

The feasibility of FEC (75) as adjuvant chemotherapy for Japanese breast cancer patients

Recently, high-dose FEC (fluorouracil, epirubicin, and cyclophosphamide) has been increasingly used in adjuvant chemotherapy for breast cancer in Japan. However, the safety and tolerability of high-dose FEC are not well evaluated in Japanese breast cancer patients. We studied the feasibility of FEC (75) (fluorouracil: 500 mg/m(2), epirubicin: 75 mg/m(2), and cyclophosphamide:500 mg/m(2), q 3 w, 6 cycles) as adjuvant chemotherapy for 59 primary breast cancer patients. Out of these patients, 56 (94.9%) finished 6 cycles-FEC. The mean epirubicin dose received was 431.7 mg/m(2) (95.9% of the intended dose of 450 mg/m(2)). Forty-five (76.2%) of 59 patients experienced neutropenia of grade 3 or 4, while the rates of febrile neutropenia (grade 3) and infection (grade 2) were 3.4% and 10.2%, respectively. Anemia (88.2%), fatigue (42.4%), nausea (40.6%), liver dysfunction (40.7%), and vomiting (18.7%) occurred, however most of them were mild and categorized into grade 1 or 2. No patients developed any cardiac failure symptoms. This study shows FEC (75) is well tolerable as adjuvant chemotherapy for Japanese breast cancer patients.     

A phase III randomized trial comparing adjuvant concomitant chemoradiotherapy versus standard adjuvant chemotherapy followed by radiotherapy in operable node-positive breast cancer: final results

PURPOSE: To compare concomitant and sequential adjuvant chemoradiotherapy regimens in node-positive, operable breast cancer patients. METHODS AND MATERIALS: This was a randomized, French, multicenter, phase III trial enrolling 638 eligible women with prior breast surgery and positive axillary dissection. Patients in Arm A received 500 mg/m2 5-fluorouracil, 12 mg/m2 mitoxantrone, and 500 mg/m2 cyclophosphamide, with concomitant radiotherapy (50 Gy +/- 10-20-Gy boost). Patients in Arm B received 500 mg/m2 5-fluorouracil, 60 mg/m2 epirubicin, and 500 mg/m2 cyclophosphamide, with subsequent radiotherapy. Chemotherapy was administered on Day 1 every 21 days for 4 cycles. RESULTS: Median treatment durations were 64 and 126 days (Arms A and B, respectively), with no significant difference in overall or disease-free survival. Five-year locoregional relapse-free survival favored patients with conservative surgery (two thirds of the population), with less local and/or regional recurrence in Arm A than in Arm B (3% vs. 9%; p = 0.01). Multivariate analysis in this subgroup showed a 2.8-fold increased risk of locoregional recurrence with sequential chemoradiotherapy, independent of other prognostic factors (p = 0.027). Febrile neutropenia and Grade 3-4 leukopenia were significantly more frequent in Arm A. Subclinical left ventricular ejection fraction events at 1 year were more frequent with concomitant radiotherapy (p = 0.02). CONCLUSIONS: Concomitant radiotherapy with adjuvant fluorouracil, mitoxantrone, and cyclophosphamide has significantly better locoregional control in node-positive breast cancer after conservative surgery and 50% shorter treatment, albeit with slightly more acute toxicity. With mitoxantrone no longer available for adjuvant breast cancer treatment, alternative concomitant chemoradiotherapy studies are needed.     

Cardiac function evaluation in AMSA-treated patients

Cardiac function was monitored by means of ECG and systolic time intervals in 13 patients submitted to treatment with 4'-(9-acridinylamino) methanesulfon-m-aniside (AMSA) without the classical reconstitution vehicle N1N-dimethylacetamide. ECG changes were represented by flattening of T waves (100%), sporadic atrial extrasystoles (23%), and sporadic or coupled ventricular premature beats (7.6%). These alterations were transient and not dose related. The systolic time interval ratio, recorded at the end of infusion and 2 h after drug administration, did not change significantly from pretreatment values. Systolic time intervals recorded in 6 patients after the mean cumulative dose of 550 mg/m2, and in 3 patients after the mean cumulative dose of 1000 mg/m2, did not change from mean basal values. Present data failed to confirm the occurrence of a significantly cardiotoxic activity of AMSA.     

Mitoxantrone as second-line single agent in metastatic breast cancer

Mitoxantrone (MIX), a member of the anthraquinone chemical class, was found to be a potential anticancer agent. It has a similar spectrum of activity as Adriamycin in experimental and human tumors. Thirty-five female patients with metastatic breast cancer, refractory to previous chemotherapy, were treated between 1986 and 1987 with MIX (14 mg/m2 i.v. every 3 weeks); patients with diffuse bone metastases or heavily pretreated patients received 10-12 mg/m2 MIX. All patients were evaluable for response and toxicity. Two patients achieved complete response and 4 partial response, giving an overall response rate of 17%. Median time of response was 5.5 months. The drug was well tolerated. Objective response was obtained mostly in patients with a performance status (Karnofsky scale) of more than 70%, and in those who received more than 12 mg/m2 MIX per course. One patient developed cardiomyopathy, another an acute myocardial infarction, and 3 patients had pathological changes on echocardiography or multigated nuclear angiography. Hematological and gastrointestinal toxicity was tolerable. We found MIX to be a potentially effective second-line treatment with mild toxicity in patients with metastatic breast cancer.     

二维斑点追踪成像技术结合心肌做功评价蒽环类药物对乳腺癌患者左心室功能的影响#br#

背景与目的：应用二维斑点追踪成像（two-dimensional speckle tracking imaging,2D-STI）结合心肌做功评价蒽环类药物对乳腺癌患者左心室功能的影响。方法：前瞻性选择2019年9月—2020年3月在复旦大学附属肿瘤医院行蒽环类药物治疗的35例乳腺癌患者,分别于化疗前、化疗2个周期后、4个周期后行常规超声心动图检查并获取动态二维图像,同时使用肱动脉袖带血压计测量患者收缩期及舒张期血压值,测量左房内径（left atrial diameter,LAD）、左心室舒张末期内径（left ventricular end-diastolic diameter,LVEDD）、左心室收缩末期内径（left ventricular end-systolic diameter,LVESD）、舒张末期室间隔厚度（diastolic interventricular septal depth,IVSD）、左心室舒张末期容积（left ventricular end-diastolic volume,LVEDV）、左心室收缩末期容积（left ventricular end-systolic volume,LVESV）、左心室射血分数（left ventricular ejection fraction,LVEF）、二尖瓣口舒张早期峰值流速（early diastolic peak velocity,E峰）、舒张晚期峰值流速（late diastolic tissue velocity,A峰）、二尖瓣环间隔处舒张早期峰值速度（early diastolic tissue velocity,e’）,并计算E/A、E/e’;应用EchoPac软件脱机分析,获取左心室整体纵向应变（global longitudinal strain,GLS）、左心室分层纵向应变（GLSendo、GLSmid、GLSepi）,以及左心室心肌整体做功指数（global myocardial work index,GWI）、整体有用功（global constructive work,GCW）、整体无用功（global wasted work,GWW）、整体做功效率（global myocardial work efficiency,GWE）;并行统计学分析。结果：与化疗前比较,化疗2个周期乳腺癌患者GLSeondo、GLS有所减低,但差异无统计学意义（P＞0.05）;GWW增加,GWE降低（P＜0.05）;化疗4个周期后GLS、GLSendo、GWI、GCW、GWE均降低,GWW增加。与化疗2个周期后比较,化疗4个周期后乳腺癌患者GLS、GLSendo、GWI、GCW、GWE降低,GWW增加（P＜0.05）。与化疗前比较,化疗4个周期后乳腺癌患者E/e’升高（P＜0.05）。各周期结束后的其余各项超声心动图参数与化疗前比较差异均无统计学意义（P＞0.05）。结论：2D-STI能早期检测乳腺癌患者在蒽环类药物化疗中左心室功能的早期改变, GWW及GWE较其他参数更敏感。     

A retrospective clinical study of safety and efficacy of vinorelbine/epirubicin/fluorouracil （NEF） regimen as a postoperative chemotherapy for breast cancer

Objective： We aimed to investigate the safety and efficiency of vinorelbine/epirubidn/fluorouracil （NEF） regimen as adjuvant chemotherapy for breast cancer. Methods： From 2005 to 2008, 227 female breast cancer patients were treated with the NEF regimen： vinorelbine 25 mg/m^2 iv on days 1 and 8; epirubicin 60 mg/m2 iv gtt on day 1; 5-Fu 500 mg/m2 iv gtt on day 1. Chemotherapy was repeated every 21-28 days for a total of 6 cycles. Results： The major side effects were neutrope- nia and gastrointestinal syndrome, with a 5-year survival rate of 85.4%, Conclusion： NEF regimen is safe and guarantees a high survival rate which could be recommended as a adjuvant chemotherapy regimen for breast cancer,     

Radiochemotherapy in the Treatment of Breast Cancer

Radiotherapy and chemotherapy have established roles in the multidisciplinary management of early breast cancer. The optimal integration of these treatment modalities is controversial. The most common approach is to deliver each treatment modality sequentially. For patients with close surgical margins or with other risk factors for local recurrences, initiation of adjuvant treatment with radiotherapy is recommended. A sandwich regimen is not the preferred schedule because of a decreased dose density for anthracyline- and taxane-based regimens. However, it can be an option for patients receiving adjuvant cyclophosphamide, methotrexate and fluorouracil (CMF). Concomitant radio- and chemotherapy remain in principle an attractive treatment schedule to provide an additive interaction of tumour control and shortening the duration of the overall treatment of time. However, it should be avoided due to the potential risk of augmented cardiac and skin toxicity for anthracyclines. Recent studies revealed an increased locoregional control and a slight toxicity when radiotherapy was given concurrently with cyclophosphamide, mitoxantrone and fluorouracil (CNF). On the other hand, CNF is no longer considered as standard adjuvant chemotherapy in breast cancer because of reports of secondary acute myeloid leukaemias.     

Long-term outcome of adjuvant chemotherapy cyclophosphamide, mitoxantrone, and fluorouracil in women with breast cancer

The aim of the study is to report the long-term outcome and secondary tumours of early breast cancer patients of adjuvant CNF (cyclophosphamide, mitoxantrone, and 5-fluorouracil) chemotherapy. One hundred and ninety four patients, 185 primary early breast cancer and nine locoregionally recurrent breast cancer patients, were entered onto the trial between May 1986 and November 1993. The therapies included surgery, radiation therapy, adjuvant CNF chemotherapy, and tamoxifen according to hormonal status. Some of patients were treated twice with CMF (methotrexate). The median follow-up time was 12.9 years. Eighty nine (48%) primary breast cancers relapsed, and six locoregional breast cancers relapsed. After 5-10 years the relapse incidence decreased notably. Eighty three patients died of breast cancer, and nine of other causes. Two cases of leukemia, six cases of skin cancer, two cases of Hodgkin's disease, two cases of meningioma, and two cases of endometrial cancer were observed. This article confirms the feasibility of adjuvant CNF for early breast cancer patients. Questions of possible causability of secondary cancer have yet to be explored.     

Salvage chemotherapy for breast cancer patients treated with adjuvant adriamycin-containing regimen

Purpose of this study was to evaluate the efficacy of salvage chemotherapy given to women with breast cancer in relapse who had in the past received adjuvant treatment including adriamycin. Fourty-nine evaluable patients had an adjuvant chemotherapy with CMFAV in 6 or 12 cycles. On relapse these patients received either adriamycin 40 mg/m2, mitomycin 8 mg/m2 and vinblastine 6 mg/m2 (group A) or dibromodulcitol 500 mg, mitomycin 8 mg/m2 and vinblastine 6 mg/m2 (group B). In Group A, 22 patients with a mean age of 49.2 years relapsed 14 months on average after the end of adjuvant treatment. In 11 of them the main site of relapse was visceral. In group B, 27 patients with a mean age 49.5 years relapsed 6.5 months on average after the end of adjuvant treatment. In 15 of them the main site of relapse was visceral. According to the disease-free interval (DFI), in group A with DFI less than 12 months 3 patients (23%) responded partially whereas in patients with DFI longer than 12 months 4 patients (44.4%) had a partial response. In group B with DFI less than 12 months 4 patients (21%) responded partially, whereas 2 (25%) responded with DFI longer than 12 months. We conclude that salvage chemotherapy in this group of patients with an adriamycin-containing regimen is superior to a non-adriamycin regimen only if the DFI is longer than 12 months.     

Clinical comparison on the safety and efficacy of fluorouracil/pirarubicin/cyclophosphamide (FPC) with fluorouracil/ epirubicin/cyclophosphamide (FEC) as postoperative adjuvant chemotherapy in breast cancer

Objective: To compare the safety and efficacy of a combination of 5-Fu, pirarubicin and CTX (FPC) withFEC as a postoperative adjuvant chemotherapy for breast cancer. Methods: A total of 655 breast cancer patientswere treated postoperatively in Jiangsu Cancer Hospital and Research Institute from 1995-2005, 292 were treatedwith FPC (5-Fu 500mg/m2 iv gtt on day 1, pirarubicin 40mg/m2 iv on day 1, CTX 500mg/m2 iv on day 1 and acycle repeated every 21-28 days for totally 4-6 cycles); 363 with FEC (5-Fu 500mg/m2 iv gtt on day 1, epirubicin50mg/m2 iv on day 1 and day 2, CTX 500mg/m2 iv on day 1 and a cycle repeated every 21-28 days for totally4-6 cycles). Toxicity was evaluated after each cycle of chemotherapy. Results: Main side effects in both FPC andFEC groups were leukopenia and gastrointestinal toxicity, with a 5 year survival rate 88.7% in FPC and 85.7%in FEC group. Conclusions: FPC regimen is safe with superior long-term survival rate when compared withFEC, thus could be recommended as a postoperative chemotherapy regimen for Chinese patients with breastcancer.