Phase II trial of simple oral therapy with capecitabine and cyclophosphamide in patients with metastatic breast cancer: SWOG S0430

Background.

Interest in oral agents for the treatment of metastatic breast cancer (MBC) has increased because many patients prefer oral to i.v. regimens. We evaluated a simple oral combination of capecitabine with cyclophosphamide (CPA) for MBC.

Methods.

The trial was designed to determine whether or not combination therapy would achieve a 42% response rate (RR) using the Response Evaluation Criteria in Solid Tumors (RECIST) in MBC. Patients with two or fewer prior chemotherapy regimens for MBC were eligible. Those with estrogen receptor–positive MBC had to have progressed on endocrine therapy. Patients had measurable disease or elevated mucin (MUC)-1 antigen and received CPA, 100 mg daily on days 1–14, and capecitabine, 1,500 mg twice daily on days 8–21, in 21-day cycles.

Results.

In 96 eligible patients, the median progression-free survival (PFS) interval was 5.9 months (95% confidence interval [CI], 3.7–8.0 months) and median overall survival (OS) time was 18.8 months (95% CI, 13.1–22.0 months). The RR was 36% (95% CI, 26%–48%) in 80 patients with measurable disease. The MUC-1 antigen RR was 33% (95% CI, 20%–48%), occurring in 15 of 46 patients with elevated MUC-1 antigen. Toxicity was mild, with no treatment-related deaths.

Conclusions.

PFS, OS, and RR outcomes with capecitabine plus CPA compare favorably with those of capecitabine monotherapy and combination therapy with bevacizumab, sorafenib, or ixabepilone. The addition of these other agents to capecitabine does not improve OS time in MBC patients, and this single-arm study does not suggest that the addition of CPA to capecitabine has this potential in an unselected MBC population. When OS prolongation is the goal, clinicians should choose single-agent capecitabine.     

Phase II study of an all-oral combination of vinorelbine with capecitabine in patients with metastatic breast cancer

Purpose  Combination of intravenous (i.v.) vinorelbine and capecitabine was shown to be feasible and effective in metastatic breast cancer (MBC). In an effort to improve patient convenience and to prolong infusion-free survival, we investigated in first-line treatment a regimen combining oral vinorelbine and capecitabine in a phase II study. Patients and methods  Fifty-two patients (median age, 60 years) with MBC received the combination consisting of oral vinorelbine 60 mg/m² on days 1, 8 and 15 plus capecitabine 1,000 mg/m² bid given from day 1 to day 14 in an open-label, multicentre phase II study [the recommended doses were established in a phase I study (Nolé et al. in Ann Oncol 17:332–339, 2006)]. Cycles were repeated every 3 weeks. Results  Seventy-nine percent of the patients had received prior adjuvant chemotherapy and 81% presented with visceral involvement. The median number of administered cycles per patient was 7 (range 1–18). Twenty-three responses were documented and validated by an independent panel review, yielding response rates of 44.2% (95% CI, 30.5–58.7) in the 52 enrolled patients and 54.8% (95% CI, 38.7–70.2) in the 42 evaluable patients. Median progression-free survival and median overall survival were 8.4 and 25.8 months, respectively. Neutropenia was the main dose-limiting toxicity but complications were uncommon, only one patient having experienced febrile neutropenia. Other frequently reported adverse events included, fatigue, nausea, vomiting, diarrhoea and constipation, stomatitis and hand-foot syndrome, which were rarely severe. Conclusions  This regimen combining oral vinorelbine with capecitabine is effective and manageable in the first-line treatment of MBC. Oral vinorelbine on days 1, 8 and 15 with capecitabine from days 1 to 14 every 3 weeks represents a convenient option which offers an all-oral treatment to the patients and prolongs their infusion-free survival.     

Capecitabine maintenance therapy after first-line chemotherapy in patients with metastatic colorectal cancer

Objective  

To evaluate the efficacy and toxicity of capecitabine maintenance therapy in metastatic colorectal cancer (mCRC) patients.     

卡培他滨治疗蒽环类及紫杉类耐药的复发转移性乳腺癌的临床观察

目的:观察卡培他滨对蒽环类、紫杉类耐药的复发转移性乳腺癌的作用。方法:40例复发转移性乳腺癌患者,均经过蒽环类及紫杉类治疗后出现疾病进展。给予卡培他滨2510mg/(m2·d),分2次口服,连服2周,3周为1个周期。至少2个周期后评价疗效。结果:本组化疗均数为4个周期。CR1例,PR8例,SD23例,PD7例,有效率23.1%,疾病控制率(CR PR SD)为82.0%(32/39);TTP3.4个月;中位生存时间11.2个月。常见不良反应为手足综合征(70.0%)、皮肤色素沉着(60.0%)、恶心呕吐(52.5%)、腹泻(42.5%),2例出现3～4级严重腹泻而住院治疗。结论:卡培他滨对蒽环类、紫杉类耐药的复发转移性乳腺癌仍有一定的疗效,耐受性较好。     

Capecitabine monotherapy: review of studies in first-line HER-2-negative metastatic breast cancer

The goals of treatment for metastatic breast cancer (MBC) are to prolong overall survival (OS) while maximizing quality of life, palliating symptoms, and delaying tumor progression. For many years, anthracyclines and taxanes have been the mainstay of treatment for MBC, but these agents are now commonly administered earlier in the course of the disease. A recent meta-analysis revealed adverse effects on OS and overall response rates in patients with MBC receiving first-line anthracycline-based chemotherapy following relapse on adjuvant chemotherapy. Noncrossresistant cytotoxic agents and combinations that combine high clinical activity and acceptable tolerability while being convenient for patients are therefore needed for the first-line treatment of MBC patients. Capecitabine has substantial antitumor activity in the first-line treatment of patients with MBC in prospective, randomized, phase II/III clinical trials as monotherapy and in combination with biologic and novel agents. First-line capecitabine monotherapy has a favorable safety profile, lacking myelosuppression and alopecia, and does not compromise the administration of further lines of chemotherapy. Capecitabine is suitable for long-term administration without the cumulative toxicity that can limit the prolonged use of other chemotherapy agents. Here, we review the available data on capecitabine as a single agent for first-line treatment of patients with human epidermal growth factor receptor 2-negative MBC.     

Innovations in chemotherapy for metastatic colorectal cancer: an update of recent clinical trials

It has been estimated that cancer of the colon and rectum (CRC) would be diagnosed in 153,760 men and women in the U.S. alone in 2007. Approximately one in five patients has metastatic CRC (mCRC) at diagnosis, which, at best, is associated with a 5-year survival rate of just 10.3%. Oxaliplatin- and irinotecan-based combination regimens are standard first-line therapies for mCRC. Recent studies suggest that survival outcomes can possibly be further improved by adding biologic agents to chemotherapy. Novel treatment strategies are being investigated to optimize the opportunity for patients to receive and benefit from the increasing number of available active agents and to further improve the efficacy, safety, and tolerability of multiagent therapy. These include switching therapy before progression, maintenance therapy, and chemotherapy-free intervals. Recent innovations in chemotherapy for mCRC are reviewed, with a focus on emerging data that may significantly improve both survival and quality of life for patients with CRC in the future.     

A phase II study of trastuzumab and capecitabine for patients with HER2-overexpressing metastatic breast cancer: Japan Breast Cancer Research Network (JBCRN) 00 Trial

Purpose To determine the response rate and toxicity profile of trastuzumab and capecitabine in women with HER2-overexpressing advanced breast cancer. Patients and methods A total of 59 patients from 6 participating centers in Japan entered onto the study of trastuzumab and capecitabine. Eighty six percent of women had received prior chemotherapy as part of adjuvant (21.4%) or metastatic treatment (48.2%), or both (16.1%), including substantial portions of patients who had previously received either CMF (7.1%), anthracyclines (28.6%), taxanes (25.0%), or both types (25.0%) of chemotherapy. Results Responses were observed in 28 of 56 patients (overall response rate, 50%). The response rate was 65.0% in patients treated with trastuzumab and capecitabine as first-line therapy for metastatic disease, and 62.5% among HER2 +3 positive patients, while high response rates were also seen in women treated with second- or third-line therapy. Patients receiving trastuzumab and capecitabine as first-line therapy had a longer TTP than did patients receiving this treatment as second- or third-line therapy (median TTP, 280 vs. 130 days, P < 0.05). Further, patients receiving trastuzumab and capecitabine as first-line therapy had longer OS than did patients receiving this treatment as second- or third-line therapy (median OS, 780 days vs. 480 weeks, P < 0.05). The treatment-related adverse events were hand–foot syndrome (30.4%), nausea (25%), diarrhea (10.7%), stomatitis (10.7%), fatigue (7.1%), and vomiting (5.4%). However, the majority were Grade 1–2 adverse events and only six patients experienced Grade 3 adverse events. Further Grade 1 cardiac toxicity was observed in one patient, while there were no cases of alopecia and treatment-related death. Conclusion Trastuzumab in combination with capecitabine is highly active in women with HER2-overexpressing metastatic breast cancer and is well tolerated.     

中等剂量卡培他滨单药治疗转移性乳腺癌的疗效及安全性

目的 观察中等剂量［2 000 mg/(m²·d)］卡培他滨治疗转移性乳腺癌的疗效和不良反应。方法卡培他滨单药治疗43例转移性乳腺癌,2 000 mg/(m²·d),d1～14,每3周为1周期。结果43例患者平均行8周期卡培他滨治疗,客观缓解率（CR+PR）为18.6%,临床获益率（CR+PR+SD）为86.0%。整体的中位无进展生存期（PFS）为7.1月（95%CI：5.8～8.4）,在一线治疗、二线治疗和三线及以上治疗亚组中差异无统计学意义,分别为7.1月、6.1月和8.1月（P=0.390）。在蒽环类药物与紫杉类药物治疗均失败的患者中,PFS明显缩短（6.1月 vs.7.1月,P=0.038）。大于65岁的患者PFS显著延长（8.1月 vs.6.1月,P=0.045）。主要不良反应为手足综合征19例（44.2%）。结论中等剂量［2 000 mg/(m²·d)］卡培他滨单药治疗转移性乳腺癌安全、有效。     

中等剂量卡培他滨单药治疗转移性乳腺癌的疗效及安全性

目的观察中等剂量［2 000 mg/(m²·d)］卡培他滨治疗转移性乳腺癌的疗效和不良反应。方法卡培他滨单药治疗43例转移性乳腺癌,2000 mg/(m²·d),d1～14,每3周为1周期。结果43例患者平均行8周期卡培他滨治疗,客观缓解率（CR+PR）为18.6%,临床获益率（CR+PR+SD）为86.0%。整体的中位无进展生存期（PFS）为7.1月（95%CI：5.8～8.4）,在一线治疗、二线治疗和三线及以上治疗亚组中差异无统计学意义,分别为7.1月、6.1月和8.1月（P=0.390）。在蒽环类药物与紫杉类药物治疗均失败的患者中,PFS明显缩短（6.1月 vs.7.1月,P=0.038）。大于65岁的患者PFS显著延长（8.1月 vs.6.1月,P=0.045）。主要不良反应为手足综合征19例（44.2%）。结论中等剂量［2 000 mg/(m²·d)］卡培他滨单药治疗转移性乳腺癌安全、有效。     

Capecitabine plus oxaliplatin (xelox) in the treatment of chemotherapy-naive patients with metastatic colorectal cancer

Background Capecitabine and oxaliplatin are both synergistically active against metastatic colorectal cancer (MCRC). We evaluated our experience at two centers with capecitabine and oxaliplatin combination (XELOX) in previously untreated patients with MCRC. Patients and methods We reviewed medical records of 85 previously untreated patients with MCRC who received first-line XELOX regimen. Oxaliplatin was given at a dose of 130 mg/m² on day 1 in combination with capecitabine 1500 mg/m²/day on days 1–14 every 3 weeks. Results Seventy six of 85 patients were evaluated for response and toxicity. Patients with a follow up of less than 6 months were excluded from the study. Objective response rate was 46% including 8 complete responses (10.5%) and 27 partial responses (35.5%). Additionally, 20 patients (26.3%) had disease stabilization at least 3 months after the treatment. The patients were followed for a median 12.5 months (range 2–32). Median time to disease progression (TTP) was 11 months (range 2–27 months). Median overall survival (OS) time has not yet been reached. One-year survival rate was 66%. Toxicity was modest with infrequent grade 3–4 adverse effects. Conclusion XELOX is an active regimen against MCRC in the first-line setting with favorable toxicity profile. Our results appear to be comparable, if not superior, to the results of other reports of first-line XELOX therapy in respect to objective response rates, survival data, and safety profile. Convenience with oral administration of every 3-week schedule makes XELOX regimen a compelling therapeutic option in the treatment of first-line MCRC.     

Contemporary issues and the potential uses of capecitabine in metastatic breast cancer

Since its first regulatory approval more than 10 years ago, oncologists have gained wide experience in using the oral fluoropyrimidine, capecitabine, as monotherapy or in combination with other agents and the body of evidence supporting these approaches continues to grow. Alongside this increasing experience has been the appearance of new challenges in patient management. We now recognise several different biological subtypes of breast cancer, such as HER2-positive disease. The standard of care in these tumours comprises anti-HER2 therapy, and phase III data show that capecitabine can be effectively combined with such agents. Another increasingly prominent and currently unresolved issue resulting from more effective treatment of metastatic disease is the management of patients with brain metastases. The introduction of new, well-tolerated, oral chemotherapies also provides the opportunity for longer duration of therapy. These new clinical scenarios are discussed in the current review.     

卡培他滨节拍化疗在转移性结直肠癌维持治疗中的探索性Ⅱ期研究

背景与目的:转移性结直肠癌患者一线诱导化疗后的维持治疗方案如何选择,尚存在争议。本研究将卡培他滨节拍化疗应用于转移性结直肠癌维持治疗,评估其疗效与安全性。方法:本研究是单臂、单中心探索性研究。接受一线诱导化疗(XELOX、mFOLFOX6、FOLFIRI)18～24周的转移性结直肠癌患者,评估为临床获益后接受卡培他滨500 mg,每天2次口服维持治疗,直至疾病进展。研究首要终点是无进展生存期(progression-free survival,PFS),包括卡培他滨维持治疗的PFS和诱导化疗续贯维持治疗的PFS。次要终点为总生存期(overall survival,OS)和不良反应。结果:2014年10月16日—2017年12月31日于上海交通大学医学院附属瑞金医院接受治疗的转移性结直肠癌患者37例接受节拍化疗维持治疗。中位随访时间15.0个月(4.0～41.4个月)。节拍化疗维持治疗的中位PFS为5.6个月(1.7～38.5个月),诱导化疗续贯维持治疗的中位PFS为11.4个月(6.8～44.3个月)。主要的不良反应为白细胞减少(8/37,21.6%)、恶心呕吐(5/37,13.5%)和手足综合征(3/37,8.1%)。没有1例患者出现3～4级严重不良反应。结论:卡培他滨节拍化疗应用于转移性结直肠癌诱导化疗后维持治疗安全、有效。     

Oral single-agent chemotherapy in older patients with solid tumours: A position paper from the International Society of Geriatric Oncology (SIOG)

Compared with intravenous (i.v.) chemotherapy, oral administration is convenient, requires fewer healthcare resources, is generally preferred by patients, and may be appropriate in older people with breast, colorectal and lung cancers. The effects of organ dysfunction on drug metabolism and drug interactions in patients with multiple comorbidities must be considered but are not specific to oral chemotherapy. Single-agent oral chemotherapy with capecitabine or vinorelbine is active in older patients with advanced or metastatic breast cancer. Choice of treatment is based mainly on different safety profiles. In the adjuvant treatment of colorectal cancer (CRC), single-agent oral capecitabine is an effective alternative to i.v. fluorouracil (5-FU) regimens. In metastatic CRC, oral, single-agent capecitabine has recently shown encouraging median overall survival in combination with bevacizumab. In non-small cell lung cancer, fit older patients, like their younger counterparts, benefit from platinum-based doublets, with carboplatin preferred to cisplatin. Single agent vinorelbine is an option for those less suited to combination chemotherapy, and oral may be an alternative to i.v. administration. For elderly cancer patients in general, metronomic chemotherapy combines good tolerability with acceptable activity.     

含卡培他滨方案一线或后线治疗晚期乳腺癌的疗效比较

目的 转移性乳腺癌的化疗中,早用或晚用卡培他滨的疗效是否具有差别,目前尚不明确.本研究旨在比较早或晚使用含卡培他滨方案治疗转移性乳腺癌患者的近期疗效和生存预后,明确卡培他滨的最佳使用时机.方法 回顾性分析2004-01-03-2014-09-11中山大学孙逸仙纪念医院乳腺肿瘤医学部92例资料齐全的转移性乳腺癌患者,均采用含卡培他滨为基础的方案治疗,其中接受含卡培他滨方案一线、二线或三线及以上治疗的患者分别31、32及29例,分析其近期有效率、无进展生存期及总生存期.结果 3组患者包括转移部位在内的基线特征是均衡的,P＞0.05.卡培他滨一线、二线、三线及以上治疗组的客观缓解率分别为64.5％(20/31)、50.0％(16/32)和27.6％(8/29),3组比较差异有统计学意义,x2 =8.282,P=0.016;3组患者的疾病控制率分别为90.3％(28/31)、84.4％(27/32)和62.1％(18/29),差异有统计学意义,x2=8.056,P=0.018.一线、二线、三线及以上接受含卡培他滨治疗患者的中位无进展生存期分别为9.7(95％CI=6.65～12.75)、8.1(95％CI=6.86～9.35)和4.1(95％CI=3.31～4.89)个月,差异有统计学意义,x2=26.436,P=0.001;病死率分别为48.4％(15/31)、53.1％(17/32)和58.6％(17/29),P=0.730;中位总生存期分别为38.6(95％CI=17.73～59.47)、37.1(95％CI=28.90～45.30)、32.3(95％CI=18.94～45.66)个月,早用卡培他滨组的总生存期有升高趋势,但差异无统计学意义,x2 =0.410,P=0.815.多因素分析显示,卡培他滨的使用时机是无进展生存期的独立影响因素,越早使用卡培他滨患者无进展生存期越佳;二线治疗和一线比较,HR为2.129,P=0.007;三线及以上治疗和一线比较,HR为6.229,P＜0.001.最常见的不良反应为手足综合征、腹泻和骨髓抑制,经对症支持治疗后患者均可耐受,3组的不良反应发生率差异无统计学意义.无患者因不良反应停止治疗或死亡.结论 转移性乳腺癌患者尽早使用含卡培他滨方案较延迟使用的近期疗效和中位无进展生存期均明显提高,总生存期也有升高的趋势,不良反应可耐受.     

Oral vinorelbine in metastatic breast cancer: a review of current clinical trial results

Background

Oral chemotherapy is one of the options for the treatment of endocrine non-responsive metastatic breast cancer.

Patients and methods

A search of the online PubMed database was undertaken to identify clinical trials evaluating oral vinorelbine in metastatic breast cancer. All the clinically relevant data have been analysed in this article.

Results

A total of 31 studies including more than 1000 patients have been included into this analysis. Oral vinorelbine either as a single-agent or in combination has shown consistent efficacy results (response rates between 27% and 85% in first-line). The all-oral combination of oral vinorelbine and capecitabine has shown comparable efficacy to a taxane-based combination in a randomised phase II study. Importantly, activity has also been observed in the subset of patients previously treated with anthracyclines and taxanes. For HER2-positive patients, oral vinorelbine in combination with trastuzumab is among the most active options. Oral vinorelbine presents a manageable tolerance profile. Neutropenia is the most common adverse event and alopecia is not frequently observed. Anti-emetic prophylaxis is recommended.

Conclusion

Taken together, these data indicate that oral vinorelbine is a highly effective and well tolerated agent which can be used in first-line and subsequent metastatic breast cancer settings. Moreover, this compound may offer the specific advantages of oral chemotherapy, as fewer and shorter hospital visits, delayed use of central venous access devices and maintained social activities.     

The combination of capecitabine and irinotecan in treating 5-Fluorouracil- and Oxaliplatin-pretreated metastatic colorectal cancer

Purpose Since the combination of capecitabine and irinotecan has successfully been used as a first-line treatment in metastatic colorectal cancer (MCRC), we expected promising results when given as a second-line treatment to metastatic colorectal patients who had been pretreated with 5-Fluorouracil and Oxaliplatin. Methods Thirty-three MCRC patients participated in this study and received an oral dose of 1,000 mg/m² capecitabine twice daily on days 1–14 and a dose of 100 mg/m² irinotecan infused over 90 min on days 1 and 8, every 3 weeks. Results The overall response rate in intent-to-treat was 33.3% (95% CI, 21.5–58.3%), including one complete response (3.0%) and ten partial responses (30.3%); 12 patients (36.4%) had disease stabilization and only 9 (27.3%) progressed. The median time to progression was 6.7 months (95% CI, 4.8–8.6 months). After a median follow-up time of 12 months, nine patients (27.3%) were still alive with metastatic disease. The median response duration for all patients was 6.7 months (95% CI, 3.9–9.5 months) and the median overall survival was 13.4 months (95% CI, 11.0–15.8 months) with a 1-year survival rate of 55.4%. Myelosuppression was commonly observed; NCI-CTC (v 2.0) grade 3/4 neutropenia, however, occurred in eight (24%) patients and grade 3 anemia was seen in one patient (3%). The most common (grade 3/4) non-hematological toxicity was diarrhea (15%) and the other severe grade 3/4 toxicities included nausea/vomiting in one patient (3%), stomatitis in one patient (3%), hand-foot syndrome in one patient (3%). Conclusions The combination of capecitabine and irinotecan is an effective and well-tolerated regimen for second-line treatment of metastatic colorectal cancer. However, further phase III trials are required to clarify its use in the treatment of metastastic colorectal cancer patients who have been pretreated with 5-fluorouracil and oxaliplatin.     

Impact of celecoxib on capecitabine tolerability and activity in pretreated metastatic breast cancer: results of a phase II study with biomarker evaluation

BACKGROUND: Preclinical evidence suggests that the cyclo-oxygenase-2 (COX-2) enzyme plays an important role in breast cancer progression. The aim of the present phase II study was to determine the activity and safety of the combination of the COX-2 inhibitor celecoxib with capecitabine in metastatic breast cancer (MBC) patients pretreated with anthracyclines and/or taxanes. METHODS: Eligible patients received capecitabine 1,000 mg/m(2) twice daily on days 1-14 every 21 days and celecoxib 200 mg twice daily, continuously, until disease progression or unacceptable toxicity. RESULTS: About 42 pretreated MBC patients were enrolled into the study. Median number of previous chemotherapy lines for metastatic disease was 2 (0-3). Seven patients (19%) responded to treatment while disease stabilization occurred in 17 patients (40.5%). Overall, 20 patients (47.5%) achieved clinical benefit [objective responses (CR) plus stable disease (SD) >/=6 months]. Median time to progression (TTP) and median overall survival (OS) were 5.2 and 17.8 months, respectively. Treatment was very well tolerated: grade 3 toxicities were observed in only five patients, respectively, and no grade 4 adverse events were reported. Celecoxib was never discontinued for toxicity. Analysis of COX-2 expression in the 22 patients with available tissue revealed a significantly longer TTP and OS for patients whose tumors over-expressed COX-2. CONCLUSIONS: The combination of capecitabine and celecoxib is active and safe in far advanced MBC patients. Interestingly, this association resulted in a lower-than-expected toxicity, as compared to single-agent capecitabine. The clinical relevance of COX-2 as determinant of sensitivity to treatment with celecoxib should be further evaluated in larger series of patients.     

转移性结直肠癌维持治疗的研究现状与治疗策略

结直肠癌是常见的恶性肿瘤之一,其发病率和死亡率分别位于第三位和第四位。大约60%的患者确诊时已处于晚期,其5年生存率在13%左右。近20年来,由于转移性结直肠癌(mCRC)晚期一线化疗方案及靶向药物的规范化应用,mCRC的治疗获得了重大突破。奥沙利铂、卡培他滨、贝伐珠单抗、西妥昔单抗等药物的应用使患者的中位生存期提高了一倍,5年生存率提高了20%。mCRC晚期一线治疗的常规模式是持续用药,直至病情进展或出现不可耐受的毒性。但是由于化疗药物的毒性累积,只有三分之一的患者能够坚持接受治疗直至病情进展。而患者在完成既定的初始化疗周期数,达到CR/PR/SD后,继续采用低剂量、低毒性的药物进行维持治疗,既可以延缓肿瘤的进展和转移,又可以减轻药物的毒副作用。目前,维持治疗已经成为mCRC晚期一线化疗后的主要治疗模式。但是,mCRC的最佳维持治疗方案仍无定论,现有的维持治疗方案仍不能找到最佳疗效与最大生活质量之间的平衡点。本文将回顾mCRC现有的维持治疗方案的临床研究,总结mCRC维持治疗现状,并对个体化的治疗策略进行讨论。     

奥沙利铂联合替吉奥方案与 XELOX 方案在晚期结直肠癌治疗中的疗效及毒副作用对比

目的：探讨奥沙利铂联合替吉奥方案与XELOX方案（奥沙利铂联合卡培他滨）治疗晚期结直肠癌的疗效及毒副作用。方法将168例晚期结直肠癌患者随机分为2组,对照组患者采用XELOX方案治疗,观察组患者采用奥沙利铂联合替吉奥方案进行治疗。观察对比2组患者化疗后的疗效情况和毒副作用发生情况。结果观察组化疗总有效率（CR＋PR）为48．84％,与对照组的51．22％比较,差异无统计学意义（P＞0．05）。2组患者化疗后的疾病控制率（DCR）比较差异不明显（P＞0．05）。化疗后,2组患者骨髓抑制、胃肠道反应、口腔黏膜病变、神经毒性和肾损伤的发生率比较差异不明显（P＞0．05）。观察组患者化疗后手足综合征和肝损伤的发生率均明显高于对照组（P＜0．05）。结论奥沙利铂联合替吉奥方案与XELOX方案化疗均可有效治疗晚期结直肠癌,且XELOX方案的不良反应更小,安全性更高,有利于临床治疗。