Local and systemic effects of repeated intraperitoneal epirubicin treatment

The local toxicity, general morbidity and mortality of repeated intraperitoneal administration of epirubicin (0.5 mg/kg in 100 ml isotonic saline) was investigated using a rat model. This dose is equivalent to that which would be used in the human. After six perfusions, the incidence of peritoneal inflammation was similar in the epirubicin group and saline controls. The vesicant properties of the drug were reflected in a significantly higher incidence of peritoneal fibrosis (P = 0.0015) but adhesions were more common in the controls (29%) than in the epirubicin perfused animals (4%). Animals from both groups showed inflammatory collections within the liver. There were no chronic hepatic lesions such as fibrosis/cirrhosis. This may be owing to portal bacteraemia caused by repeated cannulation of the peritoneal cavity. Evidence of microabscess formation in the hepatic parenchyma was observed in both animals. No histologically demonstrable toxicity was observed in the heart or gastrointestinal tract of the animals included in this study. The mortality of the epirubicin treated rats (2/146 perfusions) was similar to that of the saline controls (2/84 perfusions). These findings indicate that repeated intraperitoneal perfusion with epirubicin is not associated with significant toxicity. This anthracycline is therefore suitable for prolonged cyclical intraperitoneal chemotherapy.     

Inhibitory effect of bile salts on the enterohepatic circulation of methotrexate in the unanesthetized rat: Inhibition of methotrexate intestinal absorption

Summary The effect of conjugated and unconjugated bile salts on the intestinal absorption of methotrexate (MTX) in the unanesthetized rat was investigated using a recycling perfusion technique. We initially determined the general characteristics of MTX absorption in vivo. Absorption of low (0.5 M) and high (6 M) concentrations of MTX was linear with time for 60 min perfusion and occurred at rates of 0.2 and 1.65 nmol/100 cm dry length/min, respectively. Absorption of 0.5 M MTX was pH-dependent and increased with decreasing perfusate pH. Absorption of MTX involves two processes: (1) a saturable process with a K_t of 0.98 M, and (2) a nonsaturable diffusion process. The unconjugated deoxycholate and the conjugated taurocholate inhibited the intestinal absorption of 1 M MTX in a concentration-dependent manner. The inhibitory effect of bile salts was reversible, and was not due to damage to the intestinal mucosa. The structural analogues folic acid and 5-methyltetrahydrofolate and the organic anions rose bengal and sulfobormophthalein were also inhibitory to MTX absorption. This study demonstrates that a variety of organic anions inhibit MTX intestinal absorption. The possible therapeutic importance of this observation is discussed.An abstract of this work was presented at the American Gastroenterology Annual Meeting, New Orleans, LA, May, 1984 and appeared in Gastroenterology 86: 1228, 1984Supported by the U.S. Public Health Service Grant AG 2767     

Effects of repeated intraperitoneal CDDP chemotherapy for the prevention of T3 and T4 gastric cancer

We studied the significance of repeated intraperitoneal CDDP administration, as adjuvant chemotherapy, for the prevention of T3 and T4 gastric cancer. Fifty-two patients who had been operated as Curability B were divided into the following two groups, and the data on survival rate, median survival time and interval of "free of recurrence" were accumulated and analyzed. Group A consisted of nineteen patients treated with intraperitoneal CDDP administration and oral anticancer drugs. Group B were treated with systemic chemotherapy. Group A was superior to Group B in comparing the analyzed data. These results suggested that repeated intraperitoneal CDDP chemotherapy for the prevention of T3 and T4 advanced gastric cancer would improve survival rate.     

Studies of the effectiveness and optimal administration of repeated intraperitoneal chemotherapy for peritoneal dissemination from gastric cancer

The optimal interval for drug administration was examined for repeated intraperitoneal chemotherapy (IPC). The subjects were 31 patients who underwent curative surgical resection excluding P1 or CY1 factor, followed by IPC. IPC was carried out 180 times in total, and the intervals were divided into three groups: 2-week interval 45 times, 3-week interval 10 times and 4-week or greater interval 94 times. The optimal method of drug administration was evaluated from the therapeutic outcome and the development of adverse effects with each interval time. The cytology of ascites obtained via an i.p. port was examined before each drug administration, and those with a negative change (CY0) were judged as responders. The adverse effects in the patients receiving drugs at 2-week intervals were grade 1 or 2, although the incidence was high compared with other patients. All responders obtained a negative change in CY within six courses. At present, we conclude that it is reasonable for IPC to be carried out six times at 2-week intervals.     

Effect of intraperitoneal chemotherapy on experimental peritoneal dissemination of gastric cancer

In vitro chemosensitivity test using a collagen-gel method was done on 165 primary gastric cancers. All of 5-FU, CBDCA, CDDP and docetaxel showed a high sensitivity. The effects of per oral (po) administration of TS-1, a combination of po TS-1 and intraperitoneal (ip) administration of CDDP, ip 5-FU and ip docetaxel, were evaluated in athymic mice bearing peritoneal dissemination of a gastric cancer cell line (MKN-45-P that shows a high rate of metastasis to the peritoneal cavity of nude mice). Nude mice were inoculated by ip with 10(7) MKN-45-P cells. No survival benefit was obtained after po administration of TS-1 (12 mg/kg) alone or ip CDDP alone. However, a combination of po TS-1 (8 mg/kg x 10 days, from day 3) and ip CDDP (3.5 mg/kg, day 6 and 13) showed a significant survival improvement than that of po TS-1 or ip CDDP treatment alone. ip administration of 30 mg/kg (3 times/week x 3 weeks) or 15 mg/kg (6 times/week x 3 weeks) of 5-FU significantly improved the survival of mice bearing MKN-45-P. 5-FU concentration of ascites after ip administration of 30 mg/kg of 5-FU was 600-fold higher than po administration of 12 mg/kg of TS-1 at peak level. ip injections of docetaxel of 8 mg/kg, and 2 mg/kg improved the survival of 4 and 1 mice, respectively, and they were tumor-free on day 90. Survival of mice treated with ip injection of CBDCA (100 mg/kg, on day 3, or 50 mg/ kg on day 3 and 10) was significantly better than the control group. These results suggest the potential of po TS-1 + ip CDDP, ip 5-FU, ip docetaxel and ip CBDCA administration for the treatment of peritoneal dissemination of gastric cancer.     

Effect of intraperitoneal chemotherapy and fibrinolytic therapy on tumor implantation in wound sites

Failure of surgical treatment for gastrointestinal cancers is often caused by recurrence of the tumor in traumatized peritoneal surfaces. This study examined the effect of intraperitoneal administration of doxorubicin and recombinant tissue plasminogen activator (rt-PA), a fibrinolytic agent, on incidence and volume of postoperative tumor implants in peritoneal wounds. Prior to randomization, a surgical wound was created on the right parietal peritoneum of 110 BDIX rats and 6 × 10⁵ DHD/K12 colon cancer cells were inoculated intraperitoneally (ip). The control group was given an intraperitoneal injection of saline. Five groups received 1 mg/kg of ip doxorubicin at different times postoperatively: at the end of surgery (DO), 3 hr after surgery (D + 3), postoperative day 1 (Dl), postoperative day 3 (D3), and postoperative day 7(D7). In a second set of experiments, five groups of rats received, in addition to postoperative doxorubicin, 5 mg/kg of intraoperative ip rt-PA. Incidence and volume of tumor implants in peritoneal wounds were assessed for each group 20 days after the tumor inoculation. All rats of the control group (incidence = 100%) developed tumor implants in peritoneal wounds. Mean (SD) volume was 16.2 (4.7) mm³. When administered at DO, D + 3, and Dl intraperitoneal doxorubicin reduced significantly the incidence and volume of tumor implants in wounds. Postoperative administration of doxorubicin at D3 and D7 did not affect significantly the incidence and the volume of tumor implants in peritoneal wounds. When rt-PA was administered intraoperatively, ip injection of doxorubicin at any postoperative timing decreased significantly the incidence and volume of tumor implants. In conclusion, ip doxorubicin administered before postoperative D3 may act on tumor cell implanted in peritoneal wounds. Delayed (D3, D7) ip administration of doxorubicin does not prevent the development of tumor implants in peritoneal wounds. Intraoperative administration of rt-PA may significantly increase the efficacy of delayed ip chemotherapy. © 1996 Wiley-Liss, Inc.     

谷氨酰胺对术后早期腹腔化疗的结肠吻合口愈合的影响

目的研究应用谷氨酰胺(glutamine)对术后早期腹腔化疗条件下结肠吻合口愈合的影响。方法 Wistar大鼠60只, 随机分为3组:对照组, 单纯行肠切除吻合;术后早期腹腔化疗组(5-Fu组), 术后连续3天腹腔内注射氟尿嘧啶(5-Fu)(20mg/kg·d);glutamine组, 术后给予谷氨酰胺(1g/kg·d)7天及术后早期腹腔化疗。术后8天处死各组大鼠, 剖腹切取吻合口测量吻合口评分(评分越高提示吻合口与周围组织的黏连越重)和测量吻合口破裂压力及进行吻合口组织学评分。结果 谷氨酰胺组的吻合口评分2.00, 低于对照组(2.60), 显著低于5-Fu组的2.90, P＜0.05;差异有统计学意义。谷氨酰胺组的吻合口破裂压力229.95mmHg, 高于对照组(199.75mmHg), P＜0.05;显著高于5-Fu组(171.79mmHg), P＜0.01。谷氨酰胺组的吻合口组织学评分(2.9), 高于对照组(2.1)及5-Fu组(1.7), P＜0.05。结论 应用谷氨酰胺能提高吻合口愈合强度, 促进术后早期腹腔化疗条件下结肠吻合口愈合。     

腹腔热灌注化疗对胃癌术后患者免疫功能与生存的影响

目的探讨腹腔热灌注化疗对胃癌术后患者的免疫功能和疗效的影响。方法选择2008年3月至2010年6月住院治疗的64例胃癌术后患者,随机分成两组,每组各32例,对照组采用常规静脉化疗,治疗组在对照组治疗的基础上进行腹腔热灌注化疗,观察两组患者术后免疫功能与生存率。结果治疗组治疗后KPS评分为87.50%,对照组为65.62%,治疗组的生活质量改善高于对照组,P0.05;治疗组2、3年生存率(84%、62%)高于对照组(62%、53%),P0.05;对照组1、2、3年腹腔局部复发率(6.25%、9.38%和12.5%)低于对照组的3.15%、3.15%和6.25%,P0.05;治疗组CD3+、CD4+、CD4+/CD8+各值较治疗前增高,CD8+值减少,P0.01。结论腹腔循环热灌注化疗毒副反应小,无明显并发症;能显著提高胃癌患者术后的生存质量;降低胃癌患者术后的局部复发率。相比静脉化疗能明显提高胃癌患者的免疫功能。     

Outcomes associated with cytoreductive surgery and intraperitoneal hyperthermic chemotherapy in colorectal cancer patients with peritoneal surface disease and hepatic metastases

BACKGROUND:

Cytoreductive surgery (CS) and intraperitoneal hyperthermic chemotherapy (IPHC) can improve outcomes for selected patients with peritoneal carcinomatosis (PC) from colorectal cancer. The presence of parenchymal hepatic metastases (HM) is considered a relative contraindication for CS and IPHC. The purpose of the current study was to compare the overall survival of patients with HM to those without and to examine predictive factors.

METHODS:

This was a retrospective study of patients undergoing CS and IPHC between 1991 and 2007. Clinicopathologic information was obtained from a prospectively collected database and electronic medical records. Univariate and multivariate analyses were performed to evaluate variables predictive for overall survival.

RESULTS:

There were 142 patients who underwent CS and IPHC for PC from colorectal cancer, with 14 (9.9%) patients noted to have concurrent HM. The median number and size of the liver lesions was 1 (range, 1‐7 lesions) and 3.0 cm (range, 0.4 cm‐12 cm), respectively. The median overall survival for patients with HM was 23.0 months. Two‐year and 4‐year survival rates were 43.3% and 14.4%, respectively. Patients without HM had 2‐year and 4‐year survival rates of 36.8% and 17.4%, respectively. Overall survival was not significantly different for patients with and without HM (log‐rank P = .39).

CONCLUSIONS:

Patients with HM undergoing CS and IPHC for colorectal cancer were found to have no significant difference in overall survival compared with those without HM. Most patients had a single small lesion treated with a minor hepatic resection. Further study is indicated to define which patients with HM benefit most from this multimodality approach. Cancer 2009. © 2009 American Cancer Society.     

胃癌患者腹腔热灌注联合全身静脉化疗的临床效果及对免疫功能的影响

目的探讨胃癌患者采用腹腔热灌注联合全身静脉化疗的临床效果及对免疫功能、癌胚抗原(CEA)、糖链抗原19-9(CA19-9)水平的影响。方法选取2013年12月至2018年12月间陕西安康市中医医院收治的80例胃癌患者,按照术后化疗方法不同分为观察组和对照组,每组40例。观察组患者采用腹腔热灌注化疗+全身静脉化疗,对照组患者采用全身静脉化疗,比较两组患者化疗效果、治疗前后免疫功能(CD3+、CD4+和CD8+、CD4+/CD8+水平)、血清CEA、CA19-9水平和不良反应的发生情况。结果观察组患者总有效率为67. 5%,高于对照组的45. 0%,两组比较,差异有统计学意义(P <0. 05)。治疗后,两组患者CD3+、CD4+、CD4+/CD8+水平均较治疗前升高,CD8+水平降低,且观察组患者CD3+、CD4+和CD4+/CD8+水平高于对照组,CD8+水平低于对照组,差异均有统计学意义(均P <0. 05)。治疗后,两组患者CEA和CA19-9水平降低,且观察组均低于对照组,差异均有统计学意义(均P <0. 05)。两组患者均发生烫伤、骨髓抑制、恶心呕吐、肝肾功能损伤、脱水、皮疹和便秘等不良反应,但发生率比较,差异无统计学意义(P <0. 05)。结论腹腔热灌注联合全身静脉化疗对胃癌患者疗效较好,可改善患者免疫功能,降低血清CEA和CA19-9水平,安全性高,值得临床推广。     

经腹腔和静脉应用多西紫杉醇治疗胃癌恶性腹腔积液

目的 观察多西紫杉醇经腹腔和静脉双途径应用治疗胃癌恶性腹腔积液的疗效和安全性.方法 选取35例晚期胃癌伴恶性腹腔积液的患者随机分为两组,A组15例采用腹腔和静脉同时用药方法,用药方案为多西紫杉醇37.5mg/m2腹腔注入,同时多西紫杉醇37.5mg/m2静脉滴注,顺铂20mg/m2静脉滴注第1-5天,5-氟尿嘧啶每天750 mg/m2持续输注120小时,B组20例全部采用静脉用药方法,药物种类与剂量同A组,21天为1周期,每2个周期按WHO标准评价疗效及不良反应.结果 35例入组患者中完成2个周期者4例,3个周期者10例,4个周期者21例.35例患者均可评价疗效,A组CR 3例(20.0%),PR 7例(46.7%),SD3例(20.0%),PD2例(13.3%),总有效率(CR+PR)为66.7%;B组CR 1例(5.0%),PR 7例(35.0%),SD 8例(40．0%),PD 4例(20．0%),总有效率(CR+PR)为40.0%,两组比较无显著性差异（P>0.05).A组中位疾病进展时间(TTP)为6．8月,中位生存时间(MST)为15．2月;B组中位疾病进展时间(TTP)为5．9月,中位生存时间(MST)为14．6月,两组比较无显著性差异（P>0.05).主要不良反应有骨髓抑制、腹痛、腹泻、恶心呕吐、肌肉关节痛、口腔黏膜炎和脱发等,两组无显著性差异（P>0.05),均未见过敏反应及明显的肝肾功能受损,无治疗相关性死亡.〖HT5"H〗结论 多西紫杉醇腹腔应用对胃癌恶性腹腔积液的疗效和安全性较好,值得进一步探索和研究.     

经腹腔和静脉应用多西紫杉醇治疗胃癌恶性腹腔积液

目的：观察多西紫杉醇经腹腔和静脉双途径应用治疗胃癌恶性腹腔积液的疗效和安全性。方法：选取35例晚期胃癌伴恶性腹腔积液的患者随机分为两组,A组15例采用腹腔和静脉同时用药方法,用药方案为多西紫杉醇37.5mg/m2腹腔注入,同时多西紫杉醇37.5mg/m2静脉滴注,顺铂20mg/m2静脉滴注第1-5天,5-氟尿嘧啶每天750 mg/m2持续输注120小时,B组20例全部采用静脉用药方法,药物种类与剂量同A组,21天为1周期,每2个周期按WHO标准评价疗效及不良反应。结果：35例入组患者中完成2个周期者4例,3个周期者10例,4个周期者21例。35例患者均可评价疗效,A组CR 3例（20.0%）,PR 7例（46.7%）,SD 3例（20.0%）,PD 2例（13.3%）,总有效率（CR＋PR）为66.7%;B组CR 1例（5.0%）,PR 7例（35.0%）,SD 8例（40.0%）,PD 4例（20.0%）,总有效率（CR＋PR）为40.0%,两组比较无显著性差异（P〉0.05）。A组中位疾病进展时间（TTP）为6.8月,中位生存时间（MST）为15.2月;B组中位疾病进展时间（TTP）为5.9月,中位生存时间（MST）为14.6月,两组比较无显著性差异（P〉0.05）。主要不良反应有骨髓抑制、腹痛、腹泻、恶心呕吐、肌肉关节痛、口腔黏膜炎和脱发等,两组无显著性差异（P〉0.05）,均未见过敏反应及明显的肝肾功能受损,无治疗相关性死亡。结论：多西紫杉醇腹腔应用对胃癌恶性腹腔积液的疗效和安全性较好,值得进一步探索和研究。     

胃癌术后全身化疗联合腹腔化疗对患者免疫功能及预后的影响

目的探讨胃癌根治术后腹腔灌注化疗联合全身静脉化疗对免疫功能和预后的影响。方法选取2008年2月至2012年2月间收治的胃癌患者120例,按照随机数字表法分为观察组和对照组,每组60例。观察组患者术后行全身静脉化疗联合腹腔化疗,对照组患者仅给予全身静脉化疗,比较两组患者T细胞亚群、卡氏体力状态(KPS)评分、肿瘤复发率及生存率情况。结果观察组患者治疗后CD4~+、CD4~+/CD8~+水平与对照组比较,差异无统计学意义(P>0.05);观察组患者2、3年生存率明显高于对照组(P<0.05),术后肿瘤复发率明显低于对照组(P<0.05);观察组患者KPS评分有效率高于对照组,差异有统计学意义(P<0.05)。结论胃癌根治术后辅助全身静脉化疗并联合腹腔区域性化疗,可降低胃癌复发率、提高患者生存率、改善患者的体力状况和生存质量,值得临床推广。     

Weekly first-line chemotherapy of metastatic breast cancer with cyclophosphamide and epirubicin.

Forty-six patients with metastatic breast cancer who had not received previous chemotherapy for advanced disease entered a phase II trial of weekly chemotherapy with cyclophosphamide (250 mg/m2) + epirubicin (25 mg/m2) for 16 weeks. The overall response rate was 61% (95% confidence limits, 47-75%), with 10 complete and 17 partial responses. Toxicity was mild and confined to nausea and vomiting and asymptomatic neutropenia (except in 2 cases). Sixty-three per cent of patients had no side effects. Weekly cyclophosphamide + epirubicin is an active and nontoxic regimen for patients with metastatic breast cancer who have had no prior anthracycline-containing adjuvant chemotherapy.     

5-Fu加HCPT腹腔化疗联合平消片治疗晚期肝癌

目的　探讨 5一Fu、HCPT腹腔化疗联合平消片口服对晚期肝癌的疗效。方法　 6 5例不适宜手术及介入栓塞化疗的晚期肝癌病人 ,随机分 2组。实验组 :平消片长期口服 ,5一氟尿嘧啶 (5 -Fu) 75 0mg/m2 、羟基喜树碱 (HCPT) 10mg/m2 腹腔化疗 ,每周 1次 ,连用 2次 ,每 3周重复 ;对照组 :单纯给予护肝、对症、支持治疗。结果　实验组 :客观肝肿瘤缩小 6例 ,达PR 4例 (12 5 % ) ,CR 0例 ,NCl2例 (37 5 % ) ,PDl6例(5 0 0 % )。对照组 :无肝肿瘤缩小。两组腹水减少 1周以上者分别为 34 4 %、9% ,P <0 0 5。甲胎蛋白下降率分别为 31 3%、3% ,P <0 0 5。KPS评分增高率分别为 31 3%、9% ,P <0 0 5。差异均有统计学意义。血浆白蛋白回升率分别为 2 5 0 %、12 1% ,P >0 0 5 ,无统计学意义。中位生存期分别为 15周、7周。结论　低剂量 5 -Fu、HCPT腹腔化疗联合平消片口服治疗晚期肝癌不良反应轻 ,部分患者肿瘤缩小 ,生存质量提高 ,中位生存期明显延长。     

紫杉醇脂质体与紫杉醇联合表阿霉素在乳腺癌新辅助化疗中的对照研究

目的　比较紫杉醇脂质体与普通紫杉醇联合表阿霉素两种方案在乳腺癌新辅助化疗中的临床疗效和安全性。方法　本试验采用开放式、随机、对照的方法进行研究。５６例需新辅助化疗的女性乳腺癌患者随机分为紫杉醇脂质体联合表阿霉素组（Ａ组）和普通紫杉醇联合表阿霉素组（Ｂ组）。Ａ组每周期予以紫杉醇脂质体１７５ｍｇ／ｍ^２,Ｂ组每周期予以紫杉醇１７５ｍｇ／ｍ^２,每周期两组表阿霉素均为７５ｍｇ／ｍ２。２１天为１周期,每周期评价毒性反应,２周期化疗后评价疗效。结果　入组病例中Ａ组完成２８例,Ｂ组完成２７例。Ａ组和Ｂ组的总有效率（ＣＲ＋ＰＲ）分别为５３.６％和４８.１％（Ｐ＞０.０５）。两组毒副反应中皮疹、皮肤潮红发生率具有明显差异,以Ａ组较低（Ｐ＜０.０５）;其他如血液学毒性、呕吐、腹泻及发热等基本一致（Ｐ＞０.０５）。结论　紫杉醇脂质体与普通紫杉醇联合表阿霉素方案在乳腺癌新辅助化疗中的疗效相当,但紫杉醇脂质体过敏反应发生率明显低于紫杉醇。     

Effect of perfusion temperature on glucose and electrolyte transport during hyperthermic intraperitoneal chemoperfusion (HIPEC) with oxaliplatin

Introduction

Hyperthermic intraperitoneal chemoperfusion (HIPEC) with oxaliplatin is increasingly used in patients with carcinomatosis from colorectal cancer. For reasons of chemical stability, oxaliplatin can only be administered in a dextrose (D5%) solution, and this causes peroperative glucose and electrolyte shifts. Here, we examined the influence of perfusion temperature on glucose and electrolyte transport, metabolic shifts, and surgical morbidity.

Methods

Patients with carcinomatosis underwent cytoreduction and HIPEC using oxaliplatin (460 mg/m² in D5%, open abdomen) during 30 min at 39°–41 °C. Intraperitoneal (IP) temperature was measured at three locations using thermocouple probes. The area under the temperature versus time curve (AUCt) was calculated using the trapezoid rule. The influence of perfusion temperature on surgical outcome was assessed using linear regression models and the Mann Whitney U test where appropriate.

Results

From July 2005 until March 2011, 145 procedures were performed in 139 patients with a diagnosis of CRC (70%), pseudomyxoma peritonei (11%), ovarian cancer (10%), or miscellaneous peritoneal malignancies (9%). Postoperative mortality and major morbidity were 1.4% and 26%, respectively. Higher perfusion temperature was related to more pronounced changes in serum glucose (P = 0.058), sodium (P = 0.017), and lactate (P < 0.001). The median duration of nasogastric drainage was 5 days, and this was unrelated to perfusion temperature (P = 0.76). The GI fistula rate and reoperation rate were 12.4% and 16.5% respectively; neither was related to perfusion temperature.

Conclusions

In patients undergoing HIPEC with oxaliplatin, perfusion temperature exacerbates peroperative metabolic shifts but does not affect surgical outcome.     

紫杉醇联合表阿霉素剂量密集辅助化疗的安全性观察

目的 观察紫杉醇(PTX)联合表阿霉素(EPI)剂鼍密集化疗在高复发风险的乳腺癌辅助化疗中的安全性和耐受性.方法 2004年1月至2006年12月共收治101例乳腺癌术后患者,均具有高复发风险.采用FIX联合EPI的方案进行辅助化疗,随机分为密集组和常规组,计划每例患者接受6个周期的化疗.结果 全组有98例患者按计划完成化疗,中位随访24个月,中位无复发生存和总牛存时间均未达到.密集组和常规组的无复发率分别为89.8%和87.8%,2年生存率分别为100%和93.9%,其中高危患者的无复发率分别为86.8%和81.3%,2年生存率分别为100%和90.6%.全组101例患者均可评价不良反应,主要不良反应为粒细胞减少、恶心、呕吐和脱发.密集组和常规组的Ⅲ～Ⅳ度粒细胞减少发生率分别为16.0%和54.9%(P=0.000),凶不良反应而延迟化疗的发生率分别为2.4%和6.0%(P=0.027),两组间其他不良反应差异无统计学意义.结论 PTX联合EPI剂量密集方案用于高复发风险乳腺癌患者的辅助化疗,不良反应可以耐受,是一个安全的、有潜力的方案.