顺铂和5-氟尿嘧啶/醛氢叶酸双周疗法治疗晚期乳腺癌临床研究

 目的 观察顺铂（Cisplatin，DDP），5|氟尿嘧啶（5|Fluorouracil，5|Fu）/醛氢叶酸（Leucovorin，LV）双周疗法治疗晚期乳腺癌的疗效及其毒性。方法 病理明确的36例晚期乳腺癌病人进入研究组，全组病人既往均行CMF/CAF方案化疗及常规放疗。治疗方法：LV200mg/m2，静脉输注2h，后接5-Fu 375mg/m2静推10min，再接5|Fu 3.0g/m2，用输液泵连续静脉输注48h，顺铂25mg/m2，d1|2，静脉滴注，以上治疗每两周一次，28天重复，所有病人至少接受2疗程的治疗。结果 经过两周期的化疗，完全缓解（Complete remission，CR）2例（5.6%），部分缓解（prtial remission PR）18例（50%），10例病人稳定（27.7%），恶心、呕吐和骨髓抑制为主要不良反应，毒性相对较弱。结论 顺铂和5-氟尿嘧啶/醛氢叶酸双周疗法治疗晚期乳腺癌缓解率高，毒性相对低。     

TPLF方案治疗晚期胃癌的临床观察

目的:评价紫杉醇(TAX)联合顺铂(DDP)、醛氢叶酸(LV)和氟尿嘧啶(5-FU)组成的TPLF方案治疗晚期胃癌的疗效及安全性。方法:44例晚期胃癌患者采用TPLF化疗方案:TAX175mg/m2,静脉滴注,第1天;DDP75mg/m2 生理盐水1500~2000ml腹腔内灌注,第2天;LV200mg/m2,静脉滴注,第2~4天;5-FU250mg/m2,静脉推注,第2天,后1500mg/m2,72h持续静脉滴注。21天为1周期,2个周期后评定疗效。结果:44例均可评价疗效,获得完全缓解(CR)3例,部分缓解(PR)23例,总有效率(CR PR)为59·1%,进展(PD)6例;中位肿瘤进展时间7·2个月,中位生存期9·8个月。不良反应主要表现为白细胞减少和恶心、呕吐等胃肠道反应及脱发。结论:TPLF方案是治疗晚期胃癌患者较好的化疗方案,缓解率较高,提高生活质量,毒副反应可耐受,可以作为初治或复发的晚期胃癌二线治疗方案。     

草酸铂或顺铂联合氟脲嘧啶及醛氢叶酸治疗晚期胃癌的对比研究

目的：比较L-OHP＋CF＋5-FU方案与DDP＋CF＋5-FU方案对初次化疗的Ⅲ期胃癌患者的疗效、不良反应及生活质量的改善情况。方法：A组（34例）接受L-OHP＋CF＋5-FU方案治疗；B组（36例）接受DDP＋CF＋5-FU方案治疗。两组均以3周为1周期．重复3个周期。客观疗效与不良反应按WHO标准进行评价，生活质量根据临床受益疗效评价。结果：A、B两组客观疗效（CR＋PR）分别为52．9％及50．0％，P〉0．05；白细胞减少及恶心呕吐反应B组均较A组明显（P〈0．01）；外周神经炎A组比B组明显（P〈0．05），但较轻微，均在Ⅰ～Ⅱ度范围内。两组均未发现其他严重的不良反应。临床受益疗效A组高于B组（P〈0．05）。结论：L-OHP＋CF＋5-FU方案与DDP＋CF＋5-FU方案治疗晚期胃癌的客观疗效无明显差异性．但前者耐受性好，患者生活质量改善明显。     

EPLF方案治疗胃癌远处转移临床疗效评价

目的评价EPLF方案治疗胃癌远处转移的疗效和毒副反应.方法表阿霉素(EPI)60mg/m2,静脉推注,第1天;顺铂(DDP)30 mg/m2,静脉滴入2 h,第1～5天;甲酰四氢叶酸钙(LV)150 mg/m2,静脉推注,第1～5天;氟尿嘧啶(5-Fu)500 mg/m2,静脉点滴,持续16 h,第1～5天.28 d为一周期.结果CR 3例(9.4%),PR 12例(37.5%),总有效率(CR PR)46.9%(15/32).主要毒副反应为剂量限制性骨髓抑制,75.0%的患者出现白细胞下降,其中Ⅲ～Ⅳ度占15.6%(5/32),需要配合G-CSF的应用.心电图改变为2例.中位生存期为7.8个月.结论EPLP方案治疗胃癌远处转移疗效较好,毒副反应可耐受,可作为一线用药.     

吉西他滨联合顺铂二线治疗晚期乳腺癌

目的观察国产吉西他滨(泽菲)联合顺铂组成的GP方案二线治疗蒽环类或紫杉类耐药性晚期乳腺癌的疗效与安全性。方法2003~2005年以GP方案治疗蒽环类或紫杉类耐药性晚期乳腺癌29例,泽菲1250mg/m2静滴,第1、8天,顺铂80mg/m2静滴,第1天,每21天为1周期。以WHO标准评价疗效和毒性。结果29例患者,中位化疗周期数为3周期(2~4周期),其中CR1例(3·4%),PR14例(48·3%),SD8例(27·6%),PD6例(20·7%),有效率为51·7%。随访2年,中位TTP35周(12~44周),中位生存期为62周(45~81周)。主要毒性反应为恶心、呕吐与骨髓抑制。结论国产吉西他滨和顺铂联合方案治疗蒽环类或紫杉类耐药性晚期乳腺癌疗效较好,使用方便,毒性反应较轻,是二线治疗蒽环类或紫杉类耐药性晚期乳腺癌的有效解救方案。     

Cisplatin, epirubicin, and lonidamine combination regimen as first-line chemotherapy for metastatic breast cancer: a pilot study

 We assessed the activity and tolerability of a cisplatin, epirubicin, and lonidamine combination regimen as first-line chemotherapy in 28 advanced breast cancer patients. The schedule of treatment was as follows: 60 mg/m² epirubicin followed by 40 mg/m² cisplatin given on days 1 and 2 every 21 days, with 450 mg lonidamine being given per os (three tablets) on days of chemotherapy administration and in the period intervening between one cycle and the next. Patients received a median of 5 (range 1 – 6) cycles. Overall, 22 patients were evaluable for response and 28, for toxicity. Four patients refused to continue the treatment after the first course, one was lost to follow-up, and one died due to toxicity (septic shock). The incidence of grade 3/4 nausea and vomiting was found to be greater than that expected with epirubicin and lonidamine alone. The addition of cisplatin resulted in an increase in platelet and hemoglobin toxicities, whereas the WBC toxicity did not differ from that expected with epirubicin and lonidamine. The hematological toxicity was found to be cumulative, leading to treatment delay in about 50% of patients at the fifth and sixth courses. The activity of this cytotoxic regimen was noteworthy, with the overall response rate being 81.8% (31.8% complete responses and 50.0% partial responses) in evaluable patients. This response rate decreased to 64.2% when all registered patients were included according to an intent-to-treat analysis. In conclusion, the association of cisplatin, epirubicin, and lonidamine given on the schedule described herein, appears to be very active but substantially toxic. We are now testing this combination in a randomized comparison, with the cisplatin dose being reduced to 30 mg/m² given on days 1 and 2. Received: 1 January 1997 / Accepted: 22 July 1997     

奥沙利铂联合5-氟尿嘧啶、亚叶酸钙治疗晚期胃癌的临床疗效观察

目的探讨奥沙利铂(OXA)联合氟尿嘧啶(5-Fu)和亚叶酸钙(CF)静脉滴注治疗晚期胃癌的临床疗效和不良反应。方法治疗组36例晚期胃癌患者,第1天奥沙利铂85mg/m2,静脉滴注2h静脉滴注,亚叶酸钙(CF)400mg/m2,静脉滴注2h后,氟尿嘧啶(5-Fu)400mg/m2,静脉推注15min;再用氟尿嘧啶(5-Fu)2400mg/m2,持续静脉滴注泵连续滴注46h。每2周重复1次,化疗3个周期后评价疗效;对照组32例晚期胃癌患者,亚叶酸钙(CF)100mg/m2,静脉滴注2h,d1-5,氟尿嘧啶(5-Fu)500mg/m2,静脉滴注6h,d1-5,顺铂(DDP)20mg/m2,静脉滴注2h,d1-5,每3周重复1次,化疗2个周期后评价疗效。结果治疗组完全缓解1例,部分缓解16例,有效率为47.2%,中位疾病进展时间为5.5个月,中位生存期为10.8个月,不良反应主要为感觉神经毒性。对照组部分缓解13例,有效率为40.6%,中位疾病进展时间为4.0个月,中位生存期为8.8个月,不良反应主要为恶心呕吐。结论奥沙利铂联合氟尿嘧啶和亚叶酸钙治疗晚期胃癌近期疗效较好,不良反应轻。     

氟尿嘧啶/亚叶酸钙+紫杉醇联合化疗双周方案治疗晚期胃癌

背景与目的：近来有临床研究显示紫杉醇(paclitaxel,PTX)可用于治疗胃癌,与5．氟尿嘧啶(5-fluorouracil,5-FU)联合治疗晚期胃癌疗效显著,不良反应轻。本研究观察5-Fu／亚叶酸钙(1eueovorin,CF) PTX联合化疗双周方案治疗晚期胃癌的临床疗效和不良反应。方法：采用高剂量5-FU／CF PTX深静脉输注方案(CF 200mg／m^2,静滴2小时,第1天;5-FU 500mg／m^2,静脉推注,第1天;5-FU 1500mg／m^2,静滴46小时;PTX90mg／m^2,静脉输注3小时,第1天),化疗方案以每两周为1周期,重复4周期后评定疗效。结果：全组20例均可评价疗效,总有效率为65．0％(13／20),其中完全缓解(CR)率为10.0％(2／20),部分缓解率为55．0％(11／20)。无治疗相关死亡,主要不良反应为口腔炎、手足综合征和脱发。结论：5-FU／CF PTX联合化疗双周方案治疗晚期胃癌缓解率较高、不良反应可耐受,是治疗晚期胃癌安全有效的化疗方案。     

奥沙利铂联合羟基喜树碱、亚叶酸钙/5-氟尿嘧啶治疗晚期胃癌

目的 :观察奥沙利铂 (L OHP)联合羟基喜树碱 (HCPT)、亚叶酸钙 (CF)和 5 氟尿嘧啶 (5 FU)组成的HLFO方案治疗晚期胃癌的临床疗效和毒副反应 ,并与后三种药物与顺铂 (PDD)组成的HLFP方案进行比较。方法 :采用随机分组的方法将 4 2例晚期胃癌患者分为L OHP +HCPT +CF +5 FU方案组 (治疗组 ) 2 2例与HCPT +CF +5 FU +DDP方案组 (对照组 ) 2 0例 ,观察两组的临床疗效和患者的耐受性。结果 :治疗组 2 2例有效率 5 9 1% (13 2 2 ) ,对照组 2 0例有效率 4 5 % (9 2 0 ) ,治疗组有效率高于对照组 ,但两组差异无统计学意义 (P >0 0 5 )。治疗组KPS评分的改善率为 72 7% ,对照组KPS评分的改善率为 4 0 % ,两组差异有统计学意义 (P <0 0 5 )。治疗组的中位生存期及 1年生存率均优于对照组 ,但生存期比较差异无统计学意义 (P >0 0 5 )。治疗组的周围神经毒性较对照组高 ,差异有统计学意义 (P <0 0 5 ) ;对照组的恶心呕吐反应较治疗组高 ,差异有统计学意义 ;其余不良反应均相似。结论 :与HLFP方案相比 ,HLFO方案能明显改善晚期胃癌患者的生活质量 ,消化道毒副反应较轻 ,值得进一步扩大样本量进行临床随机对照研究     

Second line chemotherapy with 5 fluorouracil and vinorelbine in anthracycline and taxane pretreated patients with metastatic breast cancer

Purpose. 5-Fluorouracil (5-FU) and Vinorelbine (Vin) are active in the second line therapy of metastatic breast cancer (MBC). We conducted a multi-institutional phase II study to assess the activity of the combination of 5-FU and Vin in anthracycline and taxane pretreated patients with MBC. Patients and Methods. Patients with MBC previously treated with anthracyclines and taxanes, who had measurable or evaluable disease, were treated with folinic acid 200 mg/m² IV, 5-FU 400 mg/m² IV bolus, and 5-FU 600 mg/m² continuous infusion over 24 hours on days 1, 2, 15, and 16 and Vin 25 mg/m² on days 1 and 15 of a 28-day cycle, for six cycles. Response rate, time to disease progression, overall survival, and toxicity were evaluated. Results. Thirty-eight patients were enrolled and 35 were evaluable for response. Grade III and IV neutropenia was seen in four and three patients, respectively. At a median follow-up of 19.5 months, 33 patients have progressed, 14 during treatment and 19 during the follow-up period, and 23 have died for an overall survival of 12.3 months. The time to progression was six months. Eight patients had a partial response and 14 had stable disease for a clinical benefit rate of 63%. Conclusion. The combination of 5-FU and Vin is well tolerated and is a good option for the palliative care of patients with MBC.     

多西紫杉醇联合氟尿嘧啶及顺铂治疗晚期胃癌

 目的 观察国产多西紫杉醇（TAT）联合亚叶酸钙／5-氟尿嘧啶（CF／5Fu）及顺铂（DDP）治疗晚期胃癌的临床疗效与不良反应。方法 41例晚期胃癌患者接受TAT与CF／5-Fu及DDP联合化疗：TAT75mg／m2，静滴1h，d1；CF100mg，静滴2h，d1-5；5-Fu500mg／m2，22h微泵持续静滴，d1-5；DDP25mg／m2，静滴，d，1-3。28天为一个周期。治疗2个周期后评价疗效和不良反应。结果 41例患者均可评价疗效。完全缓解2例，部分缓解23例，有效率61．0％。中位疾病进展时间7．5个月，中位生存期10．6个月，1年生存率41．5％。主要不良反应为骨髓抑制，脱发和周围神经炎。结论 国产多西紫杉醇联合亚叶酸钙／5-氟尿嘧啶及顺铂治疗晚期胃癌缓解率高，毒副反应可以耐受。     

低剂量5-氟尿嘧啶持续静注联合顺铂治疗晚期胃癌的临床研究

目的 :评价低剂量 5 氟尿嘧啶 (5 FU)持续滴注联合顺铂 (DDP)治疗晚期胃癌的疗效及其毒副作用。方法 :4 3例晚期胃癌 ,应用 5 FU 2 5 0mg m2 ·d ,经静脉微量泵持续 2 4小时注射 (civ) ,DDP 6mg m2 ·d ,1小时 ,每周 5天 ,均连用 3周 ;间隔1周后重复。化疗 2周期为 1疗程 ,按WHO标准评价疗效和毒性。结果 :4 3例中有 32例可以进行评价 ,其中CR 2例 (6 3% ) ,PR 11例 (34 4 % ) ,NC 7例 (2 1 9% )和PD 12例 (37 5 % ) ,总有效率 4 0 7% ;毒副反应主要为消化道反应 ,骨髓抑制较轻。结论 :低剂量 5 FU持续静注加顺铂方案是一个有效而低毒的方案 ,适用于晚期胃癌患者     

Pilot study of continuous low-dose 5-fluorouracil and cisplatin (FP regimen) for the treatment of metastatic breast cancer

Background. The effect of low-dose 5-fluorouracil (FU) and cisplatin therapy (FP regimen) against metastatic breast cancer was investigated. Methods. A pilot study of the FP regimen was performed in 11 patients with metastatic breast carcinoma who had previously received chemotherapy, including adriamycin, and/or hormonal therapy. Their median age was 56 years (range, 48–72 years). Visceral metastases were present in all patients. FU, at a dose of 170 mg/m² per day, was administered for 28 days by continuous intravenous infusion. Cisplatin (7 mg/m² per day) was given intravenously on days 1–5, 8–12, 15–19, and 22–26. After a 2-week interval, this treatment was repeated. Results. Of the 11 patients assessable for tumor response to the FP regimen, 4 patients (36%; 95% confidence intervals [CI], 8%–64%) achieved an objective response, with 1 showing a complete response and 3 showing a partial response. Median time to progression was 6.5 months (range, 4–25 months). The median survival time from the initiation of the FP regimen was 11 months (range, 3–25 months). Gastrointestinal and hematologic toxicity was mild. Conclusion. The FP regimen is promising for and has acceptable tolerance in patients with metastatic breast carcinoma refractory to previous anthracycline-containing chemotherapy. Received: July 27, 1998 / Accepted: September 22, 1999     

Protracted continuous infusion of 5-fluorouracil and low-dose leucovorin in patients with metastatic colorectal cancer resistant to 5-fluorouracil bolus-based chemotherapy: a phase II study

Continuous-infusion (c.i.) 5-fluorouracil (5-FU) can overcome resistance to bolus 5-FU, and leucovorin (LV) enhances the cytotoxic effects of 5-FU, mainly when the duration of exposure to the latter is prolonged. The main objective of this study was therefore to determine the activity of a prolonged infusion schedule of 5-FU + LV in patients with metastatic colorectal cancer resistant to a 5-FU bolus-based chemotherapy. Only patients with metastatic measurable disease in progression during or within 2 months of the end of a 5-FU bolus ± LV-based chemotherapy were eligible for the study. 5-FU and l-LV were given as a 14-day c.i. every 28 days, the 5-FU dose being 200 mg/m² per day and the l-LV dose being 5 mg/m² per day. A total of 59 patients entered the study, of which 48 were resistant to 5-FU + LV and 11, to 5-FU + levamisole. Treatment was well tolerated, and WHO grade 3–4 toxicities were uncommon (11% of patients developed stomatitis and 7%, diarrhea). According to an intent-to-treat analysis, 10 of 59 patients obtained an objective response (1 complete response, 9 partial responses), for an objective response rate of 16% (95% confidence interval 8–25%). The median progression-free survival and overall survival were 4 and 9 months, respectively. The protracted 5-FU + LV c.i. schedule used in the present study is a well-tolerated and moderately active regimen in metastatic colorectal cancer patients resistant to 5-FU bolus ± LV. Only randomized studies can determine whether this palliative treatment has advantages in comparison with other second-line therapies such as 5-FU c.i. without LV, irinotecan, or oxaliplatin. Received: 22 September 1998 / Accepted: 5 January 1999     

A phase II study with CPT-11 plus leucovorin and bolus IV 5-fluorouracil in patients with advanced colorectal carcinoma

Standard chemotherapy in advanced colorectal carcinoma (CRC) has not yet been established. The present study was conducted to assess the efficacy and toxicity profile of CPT-11, leucovorin (LV), and bolus 5-fluorouracil (5-FU) in a weekly schedule. Fifty-five patients were entered with no prior chemotherapy for advanced disease or adjuvant treatment ended at least 6 months preceding study entry, and 45 were assessable for response. Patients were treated with CPT-11 80 mg/m² (7 patients) or 70 mg/m² (48 patients). After completion of CPT-11 infusion, LV 200 mg/m² was administered over 2 hr followed immediately by 5-FU 450 mg/m², IV bolus, weekly for 6 weeks followed by a 2-week rest period. Treatment was continued for four cycles. Because of grade 3 and 4 diarrhea in four of the first seven patients, the study was amended to reduce the starting dose of CPT-11 from 80 to 70 mg/m² weekly. Four complete and 10 partial responses were observed (response rate: 25.5%), the median time to progression (TTP) was 7.7 months, 1-year survival rate was 62.3%, and the median overall survival was 15.0 months. Grade 3 and 4 diarrhea occurred in seven patients (12.7%), four of them treated with CPT-11 80 mg/m². Grade 3 myelotoxicity occurred in five patients (9.0%). Toxic death because of diarrhea, neutropenia, bacteremia, and sepsis occurred in a patient treated with CPT-11 80 mg/m². Our results confirm the efficacy of CPT-11, LV, and 5-FU in a weekly schedule in patients with advanced CRC. Further studies are needed to compare the present regimen with higher doses of CPT-11 with LV plus different schedules of 5-FU administration in the treatment of metastatic CRC.     

Analysis of efficacy and toxicity of chemotherapy with cisplatin, 5-fluorouracil, methotrexate and leucovorin (PFML) and radiotherapy in the treatment of locally advanced squamous cell carcinoma of the head and neck

Purpose The aim of this study was to evaluate the efficacy and toxicity of concurrent chemoradiotherapy using cisplatin (CDDP), 5-fluorouracil (5-FU), methotrexate (MTX) and leucovorin (LV) (PFML) in patients with locally advanced squamous cell carcinoma of the head and neck (SCCHN). Methods Seventy-seven patients with previously untreated stages III–IV SCCHN were included in this trial. Patients received two cycles of chemotherapy repeated every 4 weeks. The chemotherapy regimen consisted CDDP (60 mg/m², day 4), 5-FU (600 mg/m² given over 24 h for 5 days, days 1–5), MTX (30 mg/m², day 1) and LV (20 mg/m², days 1–5). Radiation was targeted to begin on the starting day of chemotherapy, day 1. The total radiation dose to the primary site and neck lymph nodes was 70.0 Gy. When grade ≥3 toxicities were observed frequently, radiotherapy and/or chemotherapy were delayed or reduced. Results The main toxicities were mucositis (grade ≥3, 39%), leukocytopenia (grade ≥3, 34%) and neutropenia (grade ≥3, 30%). The overall clinical response rate and the pathological complete response (CR) were 94% (72/77) and 71% (55/77). The primary site CR and neck lymph node CR were 79% (61/77) and 85% (44/52), and 3-year survival rate was 73%. Conclusions This concurrent chemoradiotherapy with PFML was safe and well tolerated. The high CR rate justifies further evaluation of this chemoradiotherapy modality in locally advanced SCCHN patients.     

Medium-term results of neoadjuvant systemic chemotherapy using irinotecan, 5-fluorouracil,and leucovorin in patients with locally advanced rectal cancer

Aims

The aim of this study was to evaluate the usefulness of neoadjuvant systemic chemotherapy using irinotecan, 5-FU, and leucovorin (LV) for the treatment of locally advanced rectal cancer, which was a powerful ploychemotherapy in those days in Japan.

Methods

Between 2001 and 2004, 26 patients with T3 or T4 and N0-2 non-metastatic resectable rectal cancer were selectively enrolled in this study. Neoadjuvant chemotherapy consisted of two cycles of irinotecan (80 mg/m²), 5-FU (500 mg/m²), and LV (250 mg/m²) on days 1, 8, and 15 for 4 weeks. Surgical resection was performed in all the patients 2–4 weeks after the completion of chemotherapy.

Results

Overall down-staging was observed in 15 patients. T level and N level down-staging were observed in 12 and 13 patients, respectively. A pathological complete response was observed in one patients. The median follow-up period was 75 months (range, 8–97 months). Recurrences occurred in 5 patients including pelvic relapses in 3 and distant metastases in 2. The 5-year relapse-free and overall survival rates were 74% and 84%, respectively.

Conclusions

Neoadjuvant systemic chemotherapy comprised of a combination of multi-drugs as irinotecan, 5-FU, and LV may be beneficial to the prognoses of patients with locally advanced rectal cancer.     

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目的 观察甲酰四氢叶酸钙(CF)联合5-氟尿嘧啶(5-Fu)治疗晚期乳腺癌的疗效和安全性.方法 选择既往经过蒽环类、紫杉类等药物治疗无效的晚期乳腺癌31例,中位年龄48.0岁(27～66岁).采用CF联合5-Fu化疗方案治疗.CF[150 mg/(m2·d)]+ 5-Fu[600 mg/(m2·d)],连用5天,每天静脉滴注不少于12h,每4周为一周期.观察有效率及不良反应.结果 完全缓解2例(6.5％),部分缓解7例(22.6％),病情稳定6例(19.4％),进展16例(51.6％).总有效率为29.0％,临床获益率为48.4％,其中激素受体阴性患者更能获益(P＜0.05).中位有效期为2.3月(95％CI:1.1～4.1),中位生存期为9.5月(95％CI:4.7～14.8).15例(48.4％)生活质量改善,6例(19.4％)稳定,10例(32.3％)下降.不良反应主要是胃肠道反应(11例)、骨髓抑制(4例)和口腔炎(9例).结论 CF+ 5-Fu联合静脉滴注二线治疗晚期乳腺癌疗效确切,不良反应可控,患者易于耐受,可以作为复发转移的晚期难治性乳腺癌的解救治疗.     

弹性输液泵持续输注5-Fu联合DDP腹腔温热灌注治疗胃肠癌68例疗效观察

目的探讨弹性输液泵持续输注5-Fu联合DDP腹腔温热灌注对胃肠癌根治术后患者复发、转移、生存率的影响及毒副反应。方法将68例胃肠癌根治术后患者随机分为弹性输液泵持续输注5-Fu联合DDP腹腔温热灌注治疗组及普通静脉化疗对照组,每组34例,随访3年,比较2组1、2、3年复发、转移、生存率情况及毒副反应。结果治疗组1、2、3年肿瘤复发与转移率分别为8.8%、26.5%、41.2%;对照组分别为17.1%、41.2%、67.7%。2组比较,治疗组1、2年肿瘤复发转移率低于对照组,但差异无显著性,3年肿瘤复发与转移率比较差异有显著性(χ2=4.8,P<0.05)。治疗组1、2、3年生存率为91.2%、88.2%、76.5%,对照组分别为73.5%、61.8%、50.0%,治疗组高于对照组,2、3年差异有显著性(χ2=6.35、χ2=5.12,P<0.05)。结论弹性输液泵持续输注5-Fu联合DDP腹腔温热灌注治疗胃肠癌可减少术后肿瘤复发与转移,提高远期生存率,且毒副反应轻。     

Second-line chemotherapy with a hybrid-alternating regimen of bolus 5FU modulated by methotrexate and infusional 5FU modulated by folinic acid in patients with metastatic colorectal cancer pretreated with 5FU. A phase 2 study

BACKGROUND AND AIM: In vitro, methotrexate (MTX) is the best modulator for bolus 5-fluorouracil (5FU), whereas folinic acid (FA) is the best for continuous infusion. We evaluated the effect of 5FU modulated by both MTX (bolus administration) and FA (continuous infusion) as second-line treatment of patients with metastatic colorectal cancer. PATIENTS AND METHODS: Entry criteria were: at least one 5FU-based chemotherapy regimen as first-line treatment for metastatic disease, or progression within twelve months after 5FU-containing adjuvant therapy. Treatment schedule: MTX 200 mg/m2 i.v. days 1 and 15; 5FU 600 mg/m2 i.v. bolus, days 2 and 16; 5FU 200 mg/m2 i.v. continuous infusion for 21 days, starting on day 29; FA 20 mg/m2 i.v. bolus weekly during the three weeks of 5FU infusion. Cycles were repeated every 56 days. The primary end-point was tumour control rate, including partial responses and stabilizations. RESULTS: 34/35 patients enrolled were evaluable for response. Five (14.7%) had a partial response, 13 (38.2%) disease stabilization, and 16 (47.1%) progressed; tumour control rate was 52.9%. Median TTP was 5.8 months (95% CI 4.03-7.83); 29 patients had died. Median OAS was 15.9 months (95% CI 8.8-21.9). Toxicity was mild. CONCLUSIONS: The regimen constituted by 5FU modulated by MTX (bolus administration) and FA (continuous infusion) is active as second-line treatment of metastatic colorectal cancer.