Five-day continuous infusion of 5-fluorouracil for advanced colorectal, gastric, and pancreatic adenocarcinoma.

In a retrospective study, 58 patients with advanced colorectal carcinoma received one or more 5-day infusions of 5-FU at 20 mg/kg per 24 hours followed by weekly IV 5-FU at 15 mg/kg. In 36 patients who received the infusion as first treatment (Group A), the response rate was 23% with a median duration of response of 8.0 months. No improvement in survival was noted. In 22 patients treated with the infusion after relapse on weekly 5-FU (Group B), the response rate was 10.5% with a median duration response of 4.5 months. Stable disease for 3-6 months was seen in 21%. Survival in Group B was improved when compared with a similar group of patients treated by weekly 5-FU without infusion (Group CB), but statistical significance was not obtained. Twenty percent of patients were alive two years after relapsing on weekly 5-FU when given the five-day infusion 5-FU and re-initiated on weekly 5-FU. Toxicity to the five-day infusion of 5-FU was minimal. Three of 69 (4.3%) infusions were not completed because of toxicity. A separate review of procarbazine indicated that it was minimally active in colorectal carcinoma. Other patients with gastric and pancreatic carcinoma were reviewed but no statistical significance for 5-FU infusion was seen for survival. A five day continuous infusion of 5-FU is recommended for colorectal cancer patients who relapse on weekly 5-FU therapy. Further study of the infusion in combination with other chemotherapy is warranted.     

Repetitive short-course hepatic arterial infusion chemotherapy with high-dose 5-fluorouracil and cisplatin in patients with advanced hepatocellular carcinoma

BACKGROUND: Hepatic arterial infusion chemotherapy (HAIC) has often been selected as a therapeutic option for patients with advanced hepatocellular carcinoma (HCC). The objective of the current study was to evaluate the efficacy and safety of repetitive HAIC with high-dose 5-fluorouracil (5-FU) and cisplatin given for 3 days in patients with advanced HCC. METHODS: Between January 2001 and December 2004, a total of 41 patients with unresectable advanced HCC were enrolled. The patients underwent HAIC via the implantable port system with 5-FU (at a dose of 500 mg/m(2) on Days 1-3) and cisplatin (at a dose of 60 mg/m(2) on Day 2) every 4 weeks. Tumor response was assessed at the end of every 3 cycles. RESULTS: The median age of the patients was 53 years and 34 patients (82.9%) had evidence of portal vein thrombosis. In total, 230 cycles of HAIC were administered to the 41 patients, with a median of 6 cycles given (range, 1-14 cycles). Nine patients (22.0%) achieved a partial response and 14 patients (34.1%) had stable disease. The median time to disease progression and overall survival were 7.0 months and 12.0 months, respectively. The overall survival was found to be significantly longer in the successful disease control group (patients with a complete response, partial response, and stable disease) than in the disease progression group (median of 14.0 months vs 6.0 months; P < .001). Adverse reactions were tolerable and successfully managed with conservative treatment. CONCLUSIONS: HAIC with high-dose 5-FU and cisplatin given for 3 days achieved effective and safe results in patients with advanced HCC. Therefore, repetitive short-course HAIC with high-dose 5-FU and cisplatin may be useful as an alternative therapeutic option for patients with advanced HCC.     

大剂量醛氢叶酸加5-FU持续滴注联合DDP治疗晚期食管癌及生存分析

目的:评价大剂量醛氢叶酸加5氟尿嘧啶(5-FU)持续48h滴注联合顺铂(DDP)方案治晚期食管癌的客观疗效、毒副反应并进行生存分析,探索晚期食管癌较合理治疗方案及相关预后因素。方法:对入选的晚期食管癌病人采用大剂量醛氢叶酸(200mg/m2) 5FU(3.0g/m2)持续48h滴注联合顺铂方案进行治疗。结果:共48例病人入选,中位年龄52.0岁,48例均可进行疗效及毒副作用评价。完全缓解(CR)9例,部份缓解(PR)20例,稳定(NC)17例,进展(PD)2例,总有效率为60.42%。主要的毒副反应为恶心呕吐、口腔粘膜炎、骨髓抑制及脱发等,大多数为Ⅰ~Ⅱ度反应,经常规对症治疗后见好转,未见治疗相关死亡。全组48例患者中位生存期为10.00个月,95%的可信区间为7.51~12.49。晚期食管癌治疗前如KPS评分<80或已出现内脏器官转移,提示预后较差,从治疗中获益将较少。治疗前功能状态及病变或转移部位是影响预后的相关因素,两者的P值分别为0和0.048。结论:大剂量醛氢叶酸 5FU持续48h滴注联合顺铂方案治疗晚期食管癌疗效好,且毒副反应轻,可作为晚期食管癌化疗的标准一线方案。     

Extensive liver metastasis of gastric cancer effectively treated by hepatic arterial infusion of 5-fluorouracil/cisplatin

Most gastric cancer patients with jaundice caused by extensive liver metastasis show no tumor shrinkage response to systemic chemotherapy, while often showing severe adverse reactions. Their prognosis is very poor. We experienced two patients for whom hepatic arterial infusion (HAI) of 5-fluorouracil (5-FU) and cisplatin through an implantable port was effective for treating extensive liver metastasis. One patient had jaundice (serum bilirubin level before HAI therapy, 12.4 mg/dl) caused by metachronous liver metastasis, and prior systemic chemotherapy with 5-FU and irinotecan had not been effective. The other patient had gastric cancer with synchronous liver metastasis and also exhibited jaundice (serum bilirubin level before HAI therapy, 11.8 mg/dl). Both patients were treated with HAI of cisplatin, 20 mg/m ² for 30 min on day 1, and continuous intraarterial infusion of 5-FU, 300 mg/m ² , from day 1 to day 4 every week. Their metastatic liver tumors were significantly reduced in volume and the jaundice disappeared. They survived for 30 and 27 weeks, respectively. A pharmacokinetic study conducted during the period of partial remission revealed that the extraction ratios of 5-FU and cisplatin in the liver were 0.89 and 0.024, respectively, suggesting a favorable first-pass effect of 5-FU. Although our findings here suggest that the successful local control of liver metastasis could improve the deteriorated condition and prolong the survival in some patients with far advanced cancer, it is essential to pay much attention to possible adverse effects during the treatment. Received: April 17, 2000 / Accepted: July 12, 2000     

Combination chemotherapy with navelbine and continuous infusion of 5-fluorouracil in metastatic, chemotherapy refractory breast cancer

Background:The protracted continuous infusion (PCI) of5-fluorouracil (5-FU) has proven in several studies an active and welltolerated treatment for advanced, pretreated breast cancer. Navelbine has alsoactivity in this setting. Patients and methods:Heavily pretreated patients with metastaticbreast carcinoma were eligible for the study. Treatment consisted of 5-FU 250mg/m² given as a PCI by an elastomeric pump and navelbine 20mg/m² on days 1 and 8, every four weeks. Eighty-three patients(median age 54 years; range 32–82 years) entered the study. The mediannumber of metastatic tumour sites was 2, with visceral involvement in 56patients. Apart from five patients with contraindications, all patients hadbeen pretreated with anthracyclines. Thirty-one patients had received taxanesand seventy-four bolus 5-FU. Results:A median of 5 cycles (range 1–14) per patient wasadministered. The median duration of 5-FU infusion was 17 weeks (range, 4-90).In the 80 evaluable patients (3 not yet evaluable) 12 complete remissions and24 partial remissions occurred (response rate, 45%). Median durationof response was 9 months. Toxicity was mild. Median survival was 20 months. Conclusions:PCI–5-FU combined with navelbine offers areasonable chance of tumour regression with modest side effects in patientswith heavily pretreated breast cancer.     

电化学治疗联合肝动脉插管置泵化疗治疗中晚期肝癌75例疗效观察

目的探讨电化学治疗(electrochemicaltherapy,ECHT)联合肝动脉化疗治疗中晚期肝癌的疗效。方法经开腹在直视下将特制的正负电极插入瘤体,通过电化学治疗仪将直流电施加于肿瘤,利用其产生的电离、电渗析作用,改变肿瘤组织生存的内环境,使肿瘤细胞代谢紊乱,发生变性、坏死,而达到治疗目的。治疗中局部可注入带正电荷的平阳霉素与高渗氯化钠溶液,以加速电化学反应,提高治疗效果。结果全组75例均为Ⅲ期,术后恢复良好,随访6个月~5年,1,2,3年生存率分别为85%,76.6%,73.5%,4例生存期已超过5年。结论电化学治疗肝癌疗效确切;创伤小、方法简便、安全性高、痛苦小、出血少,可避免肝叶切除术后所致的切面渗血,瘤体破裂及胆瘘等问题;不需阻断肝血流,可减少术后肝功能不全的发生。采用多电极合理设置的电化学治疗,并辅以肝动脉插管留置药泵周期性化疗,可提高疗效。     

小剂量FP方案治疗晚期消化道肿瘤的临床观察

目的　观察低剂量氟脲嘧啶 (5 -FU)持续输注联合低剂量顺铂 (DDP)方案治疗晚期消化道恶性肿瘤的疗效。方法　 5 -FU2 0 0mg/m2 /d ,持续静脉输注 3～ 4周。DDP6mg/m2 /d ,静脉输注 1小时 ,每周用 5d ,连用 3～ 4周。以上方案连用二周期为一疗程 ,化疗后休息 1个月评定疗效。结果　全组 34例 ,总有效率为6 4 71% ,其中PR2 2例。胃癌、食管癌、结肠癌、胰腺癌的有效率分别为 :6 2 5 0 %、10 0 0 0 %、33 33%、5 0 0 0 % ;中位缓解期 4 8个月 (2～ 9个月 )。没有Ⅲ°～Ⅳ°毒副反应。结论　低剂量 5 -FU持续输注联合低剂量DDP方案治疗晚期消化道恶性肿瘤是一个有效低毒的化疗方案     

低剂量5-氟尿嘧啶持续静注联合顺铂,周剂量紫杉醇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)持续静注联合顺铂(DDP)，周剂量紫杉醇(TPF方案)治疗晚期胃癌的疗效及其毒性反应。方法28例晚期胃癌，应用5-Fu250mg／m^2．d，经静脉微量泵持续24小时注射，DDP6mg／m^2．d，1小时，每周5天，紫杉醇90mg／次／周，均连用3周：间隔一周重复。治疗2周期后，按WHO标准评价疗效和毒性。结果全组可评价病例28例，其中CR2例，PRD例，NC9例，PD7例，总有效率42．9％。毒副反应主要为骨髓抑制，消化道反应和脱发，大多数病人能耐受。结论PTF方案是治疗晚期胃癌较为理想的方案。     

Intermittent low-dose cisplatin infusion as a possible modulator of 5-fluorouracil

Background This study was designed to determine whether 5-fluorouracil combined with intermittent low-dose cisplatin (cis-diaminedichloroplatinum, CDDP), a 5-fluorouracil modulator, would be an effective antitumor regimen. Methods Sarcoma 180 tumor (mouse sarcoma) was implanted in mice, and intravenous CDDP injections (0.5 mg/kg) were given at intervals of 12 hours. Tumors were removed on days 1, 3, and 5 of treatment for quantification of the tumor tetrahydrofolate and blood platinum levels. One group of mice was treated with a combination of CDDP and 5-fluorouracil (10 mg/kg), and another group was treated with 5-fluorouracil alone. Tumor thymidylate synthetase levels and tumor weights were compared between these 2 groups. Results Blood total platinum levels rose as the number of doses increased, while the tumor tetrahydrofolate levels did not change. Neither the levels of thymidylate synthetase, nor tumor reduction, differed between the CDDP/5-fluorouracil and the 5-fluorouracil treatment groups. Conclusion No significant effect of intermittent low-dose CDDP therapy was seen on folic acid or thymidylate synthetase levels, or on tumor growth. The results of this study do not endorse the efficacy of intermittent low-dose CDDP as a modulator of 5-fluorouracil.     

Feasibility of chemoradiation therapy with protracted infusion of5-fluorouracil for esophageal cancer patients not suitable for cisplatin

Background Chemoradiation therapy is the standard treatment for esophageal cancer in patients not fit for surgery. The regimen most commonly used includes cisplatin and 5-fluorouracil. Little data exists regarding alternative chemotherapy regimens in patients not suitable for cisplatin. We report on a regimen using protracted infusion 5-fluorouracil alone for both curative and palliative indications.Methods Twenty-two patients with localized esophageal cancer suitable for curative chemoradiation therapy and24 patients suitable for palliative therapy were enrolled. Chemotherapy consisted of 5-fluorouracil 225 mg/m² daily throughout the radiation therapy. The radiation dose was 56 to 60 Gy in 28 to 30 fractions (curative patients) and 30 to 35 Gy in 15 fractions (palliative patients).Results The median age of the patients was 75 years. The regimen was tolerable. Significant grade 3 toxicities experienced were esophagitis (11%) and venous catheter toxicity (9%). The median survival was 17 months for curative patients and 9 months for palliative patients. The complete response rate was 86% endoscopically and 45% radiologically for curative patients. Relief of dysphagia was experienced in 67% of palliative patients. Quality of life was satisfactory in both groups.Conclusions This study showed that continuous-infusion5-fluorouracil given concurrently with radiation therapy isa useful alternative to platinum-based chemoradiation therapy in patients with esophageal carcinoma.     

Phase II evaluation of sequential hepatic artery infusion of 5-fluorouracil and hepatic irradiation in metastatic colorectal carcinoma

Twenty-seven patients with measurable liver metastases from colorectal carcinoma were entered on a protocol of intermittent hepatic artery infusion (HAI) of 5-fluorouracil (5-FU) followed by consolidation with hepatic irradiation. Five partial responses were observed in 23 evaluable patients. Median duration of response was 3.5 months. A response was evident after chemotherapy alone in four of five responders. Hepatic irradiation converted one patient with stable disease after chemotherapy to a partial responder. Median survival for all patients was 9.0 months (range 1.5-34.0). Combined modality treatment with HAI of 5-FU followed hepatic irradiation was well tolerated but did not appear to be synergistic.     

紫杉醇联合小剂量顺铂和持续静滴低剂量氟尿嘧啶治疗晚期胃癌35例

目的观察紫杉醇(PTX)联合小剂量顺铂(PDD)和持续静滴低剂量氟尿嘧啶(5-FU)治疗晚期胃癌的疗效和毒副反应。方法全组35例患者中,贲门癌14例,胃体癌21例,应用PTX90mg/m2,第1、8天;5-FU250mg/m2持续24小时静滴,连用12天;PDD6mg/(m2.d)静滴,连用5天,间隔2天,再用5天,21天为1周期,平均用药3.06个周期。结果全组35例均可评价,获得CR3例,PR17例,SD10例,PD5例,有效率(CR PR)为57.1%,肿瘤控制率(CR PR SD)为85.7%,中位TTP为9个月(1~32个月),中位生存时间13个月(2~35个月)。主要不良反应为骨髓抑制、恶心呕吐和粘膜炎。结论紫杉醇联合小剂量顺铂和持续静滴低剂量氟尿嘧啶治疗晚期胃癌患者疗效较好,不良反应可以耐受,值得深入研究。     

An effective case of arterial infusion therapy of low-dose CDDP and continuous 5-FU for isolated hepatic recurrence of gastric carcinoma

We report an effective case of arterial infusion therapy of low-dose CDDP and continuous 5-FU for isolated hepatic recurrence of gastric carcinoma. An 83-year-old man was admitted for epigastric pain and vomiting due to a huge liver metastasis of gastric carcinoma in May, 1997. Nineteen months earlier, in October of 1995, he had undergone distal gastrectomy and D2 lymph node dissection with Billroth I reconstruction. His conclusive stage and pathological findings were as follows. The conclusive stage was stage II: t3, n0, P0, H0. Histological typing was tub 2. Lymph node involvement was not detected, but venous invasion was found in the surrounding regional lymph nodes. CEA had been getting elevated from November, 1996. But he had been well until March, 1997, when CT scans revealed huge hepatic recurrence. The artery-side port was placed for hepatic arterial infusion therapy for liver metastasis. Intra-arterial bolus injection of low-dose CDDP (5 mg) and continuous intra-arterial infusion of 5-FU (250 mg/day for 7 days) were started. Through 4 courses of this arterial infusion therapy, the patient improved. CT scans revealed shrinking of liver metastasis after 3 months of this therapy. The patient was followed in an outpatient clinic and continued to receive this arterial infusion therapy once every 4 weeks. New lung metastasis was detected 9 months after the start, but liver metastasis continued to be responded. The patient died from bleeding into the bile duct from the liver metastasis 16 months after the start of arterial infusion therapy, when metastatic lesions of liver continued to shrink. Arterial infusion therapy of low-dose CDDP and continuous 5-FU may be effective for isolated hepatic recurrence of gastric carcinoma.     

Long-term complete response of multiple hepatic metastases from carcinoma of the papilla of Vater using intrahepatic infusion of 5-FU with low-dose cisplatin following pancreaticoduodenectomy

Of all distant metastases from carcinoma of the papilla of Vater (CPV), the liver is the most frequent site (more than 60%) and should be specifically targeted in the effort to improve the prognosis. However, the optimal chemotherapy regimen for nonresectable liver metastasis has not been clearly established. In this preliminary report, we note a patient with multiple hepatic metastases from CPV successfully treated using intrahepatic infusion of 5-fluorouracil (FU) with low-dose cisplatin. A 62-year-old woman underwent curative pylorus-preserving pancreaticoduodenectomy for CPV. Four months after surgery, followup computed tomography (CT) demonstrated multiple liver metastases. Weekly intrahepatic arterial infusion chemotherapy of 5-FU, 350 mg/m², with low-dose cisplatin (7 mg/m²) was started. Ten months after starting chemotherapy, a complete response was obtained. To date, the patient continues to receive this weekly hepatic arterial infusion chemotherapy without any side effects, and she has successfully maintained a long-term complete response for 20 months. The patient remains well and was able to proceed with daily activity at the last follow up 30 months after starting this chemotherapy regimen. This regimen is safe and effective and is recommended as one of the treatment choices for liver metastases from CPV.     

Oxaliplatin and protracted continuous 5-fluorouracil infusion in patients with pretreated advanced colorectal carcinoma

Background:Both OHP and 5-FU are clinically active as single agents in the treatment of metastatic colorectal cancer (MCRC). Clinical and laboratory studies suggest a synergistic interaction between these agents. This phase II study was performed to evaluate the activity of a schedule including OHP and protracted 5-FU infusion in 5-FU-resistant MCRC. Patients and methods:From October 1997 to January 2000, 50 patients with measurable progressive MCRC after one or more 5-FU-based regimens were treated. OHP (2–3-hour i.v. infusion) on day 1 and 5-FU (protracted i.v. infusion using elastomeric/electronic pump through a central venous catheter) on days 1–21 were administered every 3 weeks, at the following 4 dose levels: 1) OHP 100 mg/m² + 5-FU 200 mg/m² (21 patients); 2) OHP 100 mg/m² + 5-FU 250 mg/m² (3 patients); 3) OHP 130 mg/m² + 5-FU 200 mg/m² (10 patients); 4) OHP 130 mg/m² + 5-FU 250 mg/m² (16 patients). Results:Objective responses were 1 (2%) CR; 10 (20%) PR, for a median duration of 8 months; 23 (46%) stable diseases, for a median duration of 6 months; 16 (32%) progressions. CR + PR was higher in patients who had previously received no more than one line of chemotherapy for metastatic disease as compared with patients who had received two or more lines of therapy (33% vs. 5%, P < 0.01). The median time to progression was four months (one to nine). All dose levels (313 cycles) were well tolerated with mild toxicity. Major toxicity (grade 3 WHO) included: anaemia in 1 patient (2%), nausea and vomiting in 1 patient (2%), diarrhoea in 4 patients (8%) and stomatitis in 1 patient (2%); grade 1 and 2 peripheral neuropathy were encountered, respectively, in 30 (60%) and 8 (16%) patients. The median survival was 13 months (9–17), with 32 patients still alive after a median follow-up of 8 months. Conclusions:This study suggests that 1) OHP plus protracted 5-FU infusion is an active combination in MCRC patients resistant to pre-treatment bolus 5-FU; 2) it has a good tolerability profile and 3) the optimum dose level is OHP 130 mg/m² and 5-FU 250 mg/m².     

Determination of platinum in plasma of patients affected by inoperable lung carcinoma treated with radiotherapy and concurrent low-dose continuous infusion ofcis-dichlorodiammine platinum(II)

Platinum microquantities were determined in plasma of patients affected by lung carcinoma during treatment with radiotherapy (RT) and concurrent low-dose continuous infusion ofcis-dichlorodiammineplatinum(II) (CDDP). RT was given at 50 Gy in continuous course; CDDP was continuously infused at 4 mg/m² daily for 100h/week for 5 weeks, and the infusions were separated by 68h of rest. The percentage of free drug versus total drug in plasma was about 3%. It did not vary with therapy duration and was not significantly different from that found in 5-day continuous infusions at much higher daily doses. Never-theless, maximal values of free Pt in plasma were very low and agreed with the low level of CDDP toxicity encountered on the present administration schedule.     

吉西他滨加低剂量5-氟尿嘧啶持续静脉输注治疗晚期原发性肝癌

目的:评价吉西他滨加低剂量5-氟尿嘧啶(5-Fu)持续静脉输注治疗晚期原发性肝癌(PHC)患者的疗效、临床受益反应(clinicalbenefit response,CBR)以及不良反应。方法:l5例晚期PHC患者,采用吉西他滨800-1000mg/m2,静滴,d1,8,5-Fu250mg/(m2.day)经锁骨下静脉持续输注12天,21天为一周期。结果:15例患者中,13例可以评价疗效,其中2例PR,6例SD,5例PD。患者的肿瘤进展时间(TTP)为1-6.2个月,中位TTP3.2个月。CBR率为60%(9/15)。主要毒副反应为骨髓抑制,Ⅲ度-Ⅳ度贫血3例(20%),Ⅲ度粒细胞减少和血小板减少各2例(13.3%)和1例(6.7%)。消化道反应较轻,Ⅲ度腹泻和口腔粘膜炎各1例(6.7%)。结论:吉西他滨加低剂量5-Fu持续静脉输注治疗晚期原发性肝癌有一定的疗效,CBR率较高,毒副反应可以耐受,在晚期PHC尚无特别有效治疗措施的情况下,值得临床试用。     

大容积加温低渗5-FU腹腔化疗预防胃癌术后复发和肝转移的药代动力学研究

背景与目的:目前,有关腹腔化疗药代动力学研究仅见于个别动物实验报告;本研究是探讨胃癌根治术后即时大容积、加温、低渗5-氟尿嘧啶(5-FU)液腹腔化疗药代动力学变化。方法:选择行胃癌根治术病人50例,关腹后即时经腹腔引流管快速注入43℃-45℃蒸馏水5-FU(500mg/L)液1250ml/m2。将上述50例病人按样本收集时间不同随机分为10组(每组5例),分别于注药后即刻、注药后5min、15min、30min、45min和1、3、6、12、24h抽取股动脉、股静脉、门静脉血样和腹腔液。同时选择准备行胃癌根治术病人25例,随机分为5组(每组5例),分别于术前1、3、6、12、24h经右下腹穿刺快速注入同样药液,开腹后立即抽取门静脉血样。以高效液相色谱法测定上述样本中5-FU浓度。结果:腹腔液峰浓度在腹腔给药结束后0h,门静脉血峰浓度在腹腔给药结束后15min,股动、静脉血峰浓度均在腹腔给药结束后1h。腹腔液峰浓度和平均浓度分别是股静脉血的167.7倍和180.4倍,门静脉血峰浓度和平均浓度分别是股静脉血的5.4倍和6.7倍。5-FU在腹腔液、门静脉血、股动脉血和股静脉血中的浓度变化均符合二室开放模型,主要药代动力学参数分别为:AUC0→tn(mg·L-1·h-1)依次为3667.36,143.82,31.02,26.84;α(h-1)依次为1.1076,0.6269,7.7923,21.5643;β(h-1)依次为0.03     

Radical radiation therapy with 5-fluorouracil infusion and mitomycin C for oesophageal squamous carcinoma

Thirty-five patients with clinically staged non-metastatic squamous carcinoma of the oesophagus were treated with radiation combined with mitomycin C, and 5-fluorouracil (5-FUra) infusion. Twenty patients were planned for a split course regimen 2250-2500 cGy in 10 fractions and chemotherapy. This dose of radiation to be repeated with another course of chemotherapy after 4 weeks rest. Fifteen patients were planned for a single course 4500-5000 cGy in 20 fractions and a single course of chemotherapy. Thirty-one patients are available for a minimum follow-up of one year, 26 patients for a minimum follow-up of 2 years. All 35 patients are included in the survival and local relapse-free analysis. Survival at one year is 47% and at 2 years 28%. The local relapse-free rate at both one and 2 years is 48%. There was an improvement in survival and local relapse-free rate for the single course regimen compared to the split course; 2 years survival 48% versus 12% (p = 0.24) local relapse-free rate 79% versus 27% (p = 0.07). All patients receiving radiation and chemotherapy were compared with historical controls treated by radiation alone. This matching procedure was done independent of knowledge of outcome (two controls were matched/case). Patients were matched for age, sex. TNM stage, and total radiation dose. There was a significant difference in survival p = 0.004 and local relapse-free rate p = 0.05 for patients receiving radiation and chemotherapy.(ABSTRACT TRUNCATED AT 250 WORDS)