顺铂或多西紫杉醇同期放化疗治疗局部晚期宫颈癌疗效分析

目的：比较顺铂或多西紫杉醇同期放化疗治疗局部晚期宫颈癌疗效。方法：38例IIb到IVa期患者随机分为每周顺铂同期放化疗组（22例）或多西紫杉醇同期放化疗组（16例）。顺铂30mg/m2或多西紫杉醇25mg/m2抗过敏预处理,每周放疗的第一天同步静脉滴注,连续6周;放疗方法：两组患者外照射放疗采用直线加速器盆腔大野DT 30Gy后中央挡铅改为盆腔四野加量照射至DT 50Gy,常规分割,180-200cGy/F,盆腔四野照射期间每周局部后装铱192照射一次,每次剂量6Gy,共6次,A点剂量达3600cGy。观察两组治疗效果和不良反应并进行比较。结果：两组患者总有效率82%vs 87%,临床获益率91%vs 94%,差异无统计学意义（P〉0.05）;两组随访1年无进展生存率（PFS）比较77%vs 81%,总生存率（OS）95%vs 100%,差异无统计学意义（P〉0.05）;但多西紫杉醇同期放化组较顺铂同期放化组治疗无论在血液系统不良反应和非血液系统不良反应方面都明显降低,统计学比较差异有显著性P〈0.05。结论：多西紫杉醇同期放化疗可取得不亚于顺铂同期放化治疗的疗效,且多西紫杉醇不良反应明显降低。     

紫杉醇联合顺铂、5-氟尿嘧啶(TPF方案)新辅助化疗治疗晚期鼻咽癌的临床分析

目的:评价紫杉醇联合顺铂(DDP)、5-氟尿嘧啶(5-FU)(TPF方案)治疗晚期鼻咽癌的疗效和不良反应.方法:Ⅲ-Ⅳa 期鼻咽癌患者98例随机分为紫杉醇+顺铂+5-氟尿嘧啶新辅助化疗联合同期放化疗(治疗组)及以5-氟尿嘧啶+顺铂组成的同期放化疗组(对照组).新辅助化疗药用量:紫杉醇 135mg/m2,d1,顺铂20mg/m2,d1-5,5-氟尿嘧啶750mg/ m2,d1-5,每21天重复,治疗组所有病人均接受两个疗程TPF方案新辅助化疗.第2程新辅助化疗后14天即开始放疗.两组同期放疗相同.放疗采取 6MV X线常规照射,鼻咽部总剂量约 DT 70Gy/49天,颈部预防剂量约 DT 50-55Gy/35-42天,治疗剂量约 60-70 Gy/42-49天.比较两组疗效及不良反应.结果:治疗组鼻咽及颈部肿瘤消失的平均剂量小于对照组(P＜0.05) ;两组肿瘤临床全消率分别为87.8%与77.6%(P＜0.01).不良反应主要为粒细胞下降、脱发、口腔黏膜反应及胃肠道反应,均能耐受.结论:紫杉醇联合顺铂、5-氟尿嘧啶新辅助化疗治疗晚期鼻咽癌可提高肿瘤消失率,是治疗晚期鼻咽癌有效安全的方案.     

顺铂与多西紫杉醇同步放化疗治疗中陵期富颈癌64例疗效观察

目的探讨治疗中晚期宫颈癌同步放化疗的化疗药物选择。方法64例中晚期宫颈癌患者同步放化疗随机分成顺铂组（30例）及多西紫杉醇组（34例），两组在同样放疗的基础上，顺铂组同步给予顺铂40mg／m^2，每周1次，化疗6周；多西紫杉醇组同步给予多西紫杉醇25mg／m^2，每周1次，化疗6周。放疗方法：两组患者均采用^60Co全盆对穿两头照射野DT30Gr后，改为^60Co盆腔四野照射并后装治疗。观察两组的治疗效果和不良反应，并进行比较。结果外照射结束时两组的有效率分别为96．67％及100％，差异无显著性（P〉0．05），两组4年生存率分别为56．67％及73．52％，差异有显著性（P〈0．05），局部复发率分别为10．00％及5．88％，差异有显著性（P〈0．05），远处转移率分别为8．82％及5．88％，差异有显著性（P〈0．05）。顺铂组有较明显的骨髓抑制和消化道反应，而且肾功损害明显，差异有显著性（P〈0．05）。结论多西紫杉醇同步放化疗能明显提高患者的生存率，降低局部复发率及远处转移率，副作用相对较轻。     

三维适形放疗联合多西紫杉醇化疗治疗食管癌的临床观察

目的:评价三维适形放疗联合多西紫杉醇化疗治疗食管癌的临床疗效和安全性。方法:32例不能手术或拒绝手术的中晚期食管癌患者根据入选标准随机分成同期放化疗(治疗组)和单纯三维适形放疗(对照组),每组16例,治疗组在放疗的同时给予多西紫杉醇20-30mg/m2静脉滴注,每周1次,连续6周,在放疗第一天同时进行。两组放疗方法相同,均采用直线加速器6MVX线,2Gy/次,5次/每周。照射总剂量54-64Gy,采用X线和CT检查比较两组近期疗效,并且比较两组间不良反应的差别。结果:同期放化疗组与单纯放疗组完全缓解率(CR)分别为56.3%和37.5%,有效率(CR+PR)分别为87.5%和56.3%。同期放化疗组不良反应尤其是放射性食管炎,及Ⅰ、Ⅱ度骨髓抑制较对照组大,但经处理后均能顺利完成治疗。结论:三维适形放疗联合多西紫杉醇化疗较单纯放疗组疗效好,可提高中晚期食管癌的近期有效率,不良反应患者能耐受。     

三维适形放疗联合多西紫杉醇化疗治疗食管癌的临床观察

目的：评价三维适形放疗联合多西紫杉醇化疗治疗食管癌的临床疗效和安全性。方法：32例不能手术或拒绝手术的中晚期食管癌患者根据入选标准随机分成同期放化疗（治疗组）和单纯三维适形放疗（对照组）,每组16例,治疗组在放疗的同时给予多西紫杉醇20-30mg/m2静脉滴注,每周1次,连续6周,在放疗第一天同时进行。两组放疗方法相同,均采用直线加速器6MVX线,2Gy/次,5次/每周。照射总剂量54-64Gy,采用X线和CT检查比较两组近期疗效,并且比较两组间不良反应的差别。结果：同期放化疗组与单纯放疗组完全缓解率（CR）分别为56.3%和37.5%,有效率（CR＋PR）分别为87.5%和56.3%。同期放化疗组不良反应尤其是放射性食管炎,及Ⅰ、Ⅱ度骨髓抑制较对照组大,但经处理后均能顺利完成治疗。结论：三维适形放疗联合多西紫杉醇化疗较单纯放疗组疗效好,可提高中晚期食管癌的近期有效率,不良反应患者能耐受。     

80例Ⅲ、Ⅳ期鼻咽癌采用DFP与PFB方案同期化放疗的疗效比较

目的:应用DFP方案(多西紫杉醇,5-氟脲嘧啶和顺铂)及PFB方案(5-氟脲嘧啶,顺铂和平阳霉素)与放疗同步治疗Ⅲ,Ⅳ期鼻咽癌,观察比较两组的局控率,生存率及不良反应.方法:对80例经过病理学证实且无远处转移的Ⅲ,Ⅳ期初治鼻咽癌患者给予同期化放疗,随机分为DFP组和PFB组,两组各40例.DFP组多西紫杉醇60mg·m2·d,静脉滴注,d1(或d1,d8),顺铂25mg·m2·d,静脉滴注,d2～5,5-氟脲嘧啶500mg·m2·d,静脉滴注,d2～5.PFB组顺铂25mg·m2·d,静脉滴注,d1～5,5-氟脲嘧啶500mg·m2·d,静脉滴注,d1～5,平阳霉素16mg,深部肌注,d1,3,5.两组均为21天一个周期,共2个周期.放疗采用60COγ线照射,常规分割,与化疗同期进行.肿瘤原发灶DT 65～70Gy/6.5～7.5周,颈部转移淋巴结区DT 55～66Gy/6～7周.颈部,锁骨上窝预防照射区DT 50Gy/5周.结果:DFP组总有效率(CR PR)为95.0%,1年无复发生存率为85.0%,1年无转移生存率为90.0%;PFB组总有效率(CR PR)为85.0%,1年无复发生存率为80.0%,1年无转移生存率为70.0%.两组间有效率、1年无复发生存率比较差异无显著性,1年无转移生存率比较差异有统计学意义(P＜0.05).最常见的不良反应为恶心,呕吐,DFP组主要不良反应是急性口腔粘膜炎和白细胞下降(Ⅲ Ⅳ度分别为50.0%和40.0%),但在G-CSF的支持下均可耐受.结论:DFP组和PFB组相比,近期疗效和1年无复发生存率相似,1年无转移生存率DFP组优于PFB组,但Ⅲ～Ⅳ度不良反应较PFB组为重,应有切实的措施减轻不良反应.     

不同化疗方案与调强放疗同期治疗局部晚期鼻咽癌的临床研究

目的:观察顺铂与多西紫杉醇每周方案联合调强放疗同期治疗局部晚期鼻咽癌的临床疗效、不良反应.方法:2003年1月至2008年10月初治的局部晚期鼻咽癌患者63例,年龄13-72岁(中位年龄53岁),男39例,女24例,其中Ⅲ期42例、Ⅳa期21例.随机分为两组,顺铂加调强放疗组(DDP组)32例,多西紫杉醇加调强放疗组(DTX组)31例,DDP组为放疗期间每周用顺铂25mg/m2;DTX组为每周用多西紫杉醇25mg/m2.共用5-6次.调强放疗给鼻咽部肿瘤(PGTVnx)70.6-76.6Gy/(31-33)次、颈部肿大淋巴结(PGTVnd)61.6-70.6Gy/(28-33)次.治疗相关不良反应按国际常见不良反应标准第3版(CTCAE V3.0)分级.结果:DDP组中位随访时间46个月,DTX组44个月;DDP组出现III级血液不良反应为2例,无IV级血液毒性,DTX组出现III级血液不良反应3例,IV级1例,两组均未见粒细胞减少引起的发热及败血症,两组比较无显著性差异(P=0.511).DDP组III度急性口腔粘膜反应为18例,无IV度反应;DTX组III度急性口腔粘膜反应为19例,IV度1例,两组比较无显著性差异(P=0.504).两组3年的局部区域控制率、无远处转移率和总生存率分别为92.6%、81.3%、90.5%;93.1%、85.3%、91.8%;两组5年的局部区域控制率、无远处转移率和总生存率分别为85.7%、72.6%、86.6%;93.1%、80.7%、91.8%.两组3年、5年总生存率比较无显著性差异(P＞0.05).结论:顺铂与多西紫杉醇每周方案联合调强放疗同期治疗局部晚期鼻咽癌的临床疗效基本相似,不良反应多西紫杉醇组稍重,但无统计学意义.     

顺铂每周方案同步放化疗治疗局部晚期鼻咽癌

[目的]评价顺铂每周方案同步放化疗治疗局部晚期鼻咽癌的有效率、生存率和毒副反应。[方法]67例局部晚期鼻咽癌患者随机分为同步放化疗组32例和单纯放疗组35例。同步放化疗组每周同步应用顺铂（DDP）40mg。两组病人放疗方法一致,均常规放疗,鼻咽部剂量为70Gy/7周,颈淋巴结剂量为56～70Gy/5.5～7周。[结果]同步放化组CR率为84.4%,而单放组为57.1%（P〈0.05）。同步放化组恶心呕吐发生率高于单放组,但对症处理后患者均可耐受。同步放化组和单放组1、3年生存率分别为91.4%、77.1%和87.1%、60.4%,两组比较差异具有统计学意义（P〈0.05）。[结论]顺铂每周方案同步放化疗能提高局部晚期鼻咽癌患者的有效率和生存率,毒副作用可以耐受。     

多西他赛联合顺铂同步放化疗治疗局部晚期鼻咽癌的临床观察

目的:观察多西他赛联合顺铂同步放化疗治疗局部晚期鼻咽癌的近期疗效及不良反应。方法:回顾性分析42例同步放化疗的初治局部晚期鼻咽癌患者,放疗期间全身静脉化疗2周期,于放疗第1周、第5周进行。多西他赛联合顺铂(TP)化疗组17例,采用多西他赛75mg/m2,d1,顺铂30mg/(m2.d),d1-3,顺铂联合氟尿嘧啶(PF)化疗组25例,采用顺铂30mg/(m2.d),d1-3,氟尿嘧啶750mg/(m2.d),d1-5。全组给予同步常规分割放疗,鼻咽病灶DT 66-78Gy/33-39次,颈部转移淋巴结DT 62-70Gy/31-35次。结果:多西他赛联合顺铂(TP)同步放化疗组,鼻咽部病灶完全缓解率82.35%(14/17),颈部转移淋巴结完全缓解率88.24%(15/17),1年、2年生存率分别为94.12%、82.35%。顺铂联合氟尿嘧啶(PF)同步放化疗组,鼻咽部病灶完全缓解率76.0%(19/25),颈部转移淋巴结完全缓解率84.0%(21/25),1年、2年生存率分别为88.0%、76.0%。两组间均无显著性差异(P>0.05),两组间急性口腔黏膜反应、胃肠道反应差异有统计学意义(P<0.05)。结论:多西他赛和顺铂(TP)同步放化疗治疗局部晚期鼻咽癌近期疗效较好,不良反应可以耐受。     

同步放化疗治疗中晚期食管癌60例

目的 观察对中晚期食管癌患者同步放化疗,疗效及毒副作用.方法 中晚期食管癌120例,随机分放化疗组60例(简称放化组)和单纯放疗组60例(简称单放组).放疗采用常规分割,DT40 Gy后缩小照射野,避开脊髓斜野照射,加量DT20～30 Gy,6～7周完成.放化组放疗1、4周后应用顺铂(DDP)20 mg/d、亚叶酸钙(CF)0.1 g/d,CF静脉滴注1/2量时5-氟尿嘧啶(5-Fu)500 mg/d静脉滴注,连续5 d为1个周期,化疗当天进行放疗.结果 放化组与单放组1、2、3年生存率分别为67%、46%、34%和52%、38%、24%;放射性肺炎分别为14例和12例;外周血细胞下降分别为26例和17例;胃肠道反应分别为25例和9例;死亡分别为38例和48例.两组治疗效果比较差异有统计学意义(P＜0.05).结论 放疗同步PLF方案化疗治疗中晚期食管癌生存率高,毒副作用及不良反应低.     

A Randomized Controlled Trial Comparing Clinical Outcomes and Toxicity of Lobaplatin- Versus Cisplatin-Based Concurrent Chemotherapy Plus Radiotherapy and High-Dose-Rate Brachytherapy for FIGO Stage II and III Cervical Cancer

Background: We designed this randomized controlled trial (RCT) to assess whether lobaplatin-basedconcurrent chemotherapy might be superior to cisplatin-based concurrent chemotherapy for FIGO stage II andIII cervical cancer in terms of efficacy and safety. Materials and Methods: This prospective, open-label RCTaims to enroll 180 patients with FIGO stage II and III cervical cancer, randomly allocated to one of the threetreatment groups (cisplatin 15mg/m2, cisplatin 20mg/m2 and lobaplatin 35mg/m2), with 60 patients in each group.All patients will receive external beam irradiation (EBRT) and high-dose-rate intracavitary brachytherapy(HDR-ICBT). Patients in cisplatin 15mg/m2 and 20mg/m2 groups will be administered four cycles of 15mg/m2or 20mg/m2 cisplatin intravenously once weekly from the second week to the fifth week during EBRT, whilepatients inthe lobaplatin 35mg/m2 group will be administered two cycles of 35mg/m2 lobaplatin intravenouslyin the second and fifth week respectively during pelvic EBRT. All participants will be followed up for at least 12months. Complete remission rate and progression-free survival (PFS) will be the primary endpoints. Overallsurvival (OS), incidence of adverse events (AEs), and quality of life will be the secondary endpoints. Results:Between March 2013 and March 2014, a total of 61 patients with FIGO stage II and III cervical cancer wererandomly assigned to cisplatin 15mg/m2 group (n=21), cisplatin 20mg/m2 group (n=21) and lobaplatin 35mg/m2group (n=19). We conducted a preliminary analysis of the results. Similar rates of complete remission and grades3-4 gastrointestinal reactions were observed for the three treatment groups (P=0.801 and 0.793, respectively).Grade 3-4 hematologic toxicity was more frequent in the lobaplatin group than the cisplatin group. Conclusions:This proposed study will be the first RCT to evaluate whether lobaplatin-based chemoraiotherapy will havebeneficial effects, compared with cisplatin-based chemoradiotherapy, on complete remission rate, PFS, OS, AEsand quality of life for FIGO stage II and III cervical cancer.     

Induction Docetaxel and Cisplatin Followed by Weekly Docetaxel and Cisplatin with Concurrent Radiotherapy in Locally Advanced Stage III Non Small Cell Lung Cancer (LA-NSCLC)-A Phase II Study

Purpose: The objective of this phase II study was to document the activity and to evaluate the toxicity of docetaxel and cisplatin as induction chemotherapy followed by concurrent docetaxel and cisplatin with thoracic radiation in locally advanced stage III non small cell lung cancer. Patients and Methods: Twenty-seven patients with stage III locally advanced non-small cell lung cancer received induction chemotherapy with two cycles of docetaxel 75mg/m2 and cisplatin 75mg/m2 D1 every 3 weeks. Patients without disease progress after induction chemotherapy were assigned to concurrent chemoradiotherapy 20mg/m2 docetaxel&25mg/m2 cisplatin administrated on day 1 every week for 6 weeks along with concurrent radiotherapy at a dose of 60Gy in 30 fractions (2 Gy/fraction and 5 fractions per week). The primary endpoint was to determine the overall response rate (ORR), the secondary endpoint was to evaluate time to progression (TTP) and safety profile. Results: After induction chemotherapy, the overall response rate (ORR) was 44.4%, 23 patients without disease progress were assigned to concurrent treatment with an overall response rate of 65%. Median survival time was 17 months, time to progression was 11.5 months and the one-year survival was 58%. Neutropenia was the most common toxicity during induction therapy (26% expressed grade 3-4) whereas esophagitis was the most common toxicity during concurrent phase (17.3% expressed grade 3-4); toxicities were manageable. Conclusion: Induction chemotherapy by docetaxel and cisplatin followed by weekly docetaxel and cisplatin with concurrent thoracic radiation therapy is feasible and tolerable. These results warrant further large randomized studies to document and confirm the effectiveness of this regimen. Key Words: Lung cancer , Docetaxel , Cisplatin , Concurrent chemoradiotherapy.     

Ⅲ期非小细胞肺癌多学科综合治疗的临床效果

目的：比较同时放化疗加巩固化疗（CCT）和同时放化疗（CRT）对Ⅲ期非小细胞肺癌的近远期疗效及不良反应.方法：57例Ⅲ期非小细胞肺癌分为2组,CRT组（28例）采用多西他赛和顺铂每周化疗同时放疗,放疗采用三维适形放疗,化疗采用多西他赛30mg/m2和顺铂20mg/m2,每周重复,共5周,CCT组（29例）先按CRT组方案治疗结束后再加用多西他赛75mg/m2和顺铂75mg/m2巩固化疗,每3周重复,共2周期.结果：CCT组和CRT组有效率分别为68.9%和53.6%,1、2、3年生存率及中位生存期CCT组分别为64.5%、36.2%、17.3%和18个月,CRT组为48.6%、21.2%、10.7%和13个月,有统计学差异.两组不良反应CCT组血液学毒性较CRT组明显.结论：Ⅲ期非小细胞肺癌患者同期放化疗后巩固性化疗可提高近期疗效、中位生存期,含紫杉类与顺铂的化疗方案可认为是最佳的选择,但其不良反应也明显增加,作为标准治疗仍需临床试验证实.     

宫颈癌根治性手术后辅助调强放疗(IMRT)的临床观察

目的 探讨早期宫颈癌术后具有不良预后因素的患者行盆腔调强放射治疗(IMRT/sIMRT)的近期不良反应和复发率.方法 回顾分析2007年1月～2008年6月期间78例早期宫颈癌术后具有不良预后因素行放射治疗的患者资料,其中IMRT组有30例;常规组48例.调强放射治疗方法(IMRT/或sIMRT):CTV上界从腹主动脉...     

Phase I and pharmacokinetic study of weekly docetaxel, cisplatin, and daily capecitabine in patients with advanced solid tumors.

PURPOSE: Docetaxel, cisplatin, and capecitabine are three active chemotherapeutic agents with different mechanisms of action. This phase I study investigated the feasibility and pharmacokinetics of this combination given on a weekly schedule. EXPERIMENTAL DESIGN: Docetaxel and cisplatin were given i.v. over 30 minutes on days 1 and 8 and capecitabine was given orally bid on days 1 to 14 (every 21 days). Escalation occurred in cohorts of three patients until the maximum tolerated dose was defined. Pharmacokinetics studies of docetaxel and total and ultrafiltrate platinum after cisplatin administration were done on cycle 1 (with capecitabine) and cycle 2 (without capecitabine). RESULTS: Twenty-five patients were enrolled. Two of six patients at dose level 5 had a dose-limiting infection and diarrhea. One of six evaluable patients at dose level 4 (27 mg/m2 docetaxel, 27 mg/m2 cisplatin, 825 mg/m2 capecitabine) had a dose-limiting hypomagnesemia. Pharmacokinetics of docetaxel were similar on cycles 1 and 2. Area under the plasma concentrations versus time curves of total platinum was significantly greater in cycle 2 compared with cycle 1 (P = 0.001). There was no difference in the disposition of docetaxel on cycles 1 and 2. CONCLUSIONS: The recommended docetaxel, cisplatin, and capecitabine dose for phase II studies is 27/27/825 mg/m2. The alteration in total and ultrafiltrate platinum disposition on cycle 2 compared with cycle 1 may be inherent to sequential cisplatin administration; however, prior treatment with capecitabine cannot be ruled out as a factor.     

Phase II study of docetaxel and cisplatin administered as three consecutive weekly infusions for advanced non-small cell lung cancer.

Weekly administration of low-dose taxane reduces myelosuppression and increases dose intensity as compared with an every third week schedule. We conducted a phase II trial of weekly docetaxel and cisplatin in patients with advanced non-small cell lung cancer (NSCLC) to evaluate safety and efficacy. Thirty-seven patients with chemona?ve stage IIIB (n=15), stage IV (n=16), or recurrence after operation (n=6) NSCLC received intravenous infusions of docetaxel at 35 mg/m(2) and cisplatin at 25 mg/m(2) for three consecutive weeks, followed by a week of rest. There were ten partial responses for an objective response rate of 30% (95% confidence interval (CI), 15-46%) in 33 evaluable patients and 27% (95% CI, 13-41%) in the intent-to-treatment population. The median survival was 12.8 months (range 2.5-17.1), and the 1-year survival was 54%. Hematologic toxicities, which were mild, included grade 4 neutropenia in 6%. There were none with febrile neutropenia or severe (grade 3-4) infections, and no septic deaths. The common nonhematologic toxicities included grade 2-3 nausea and vomiting (44%) and grade 2-3 diarrhea (14%). Consecutive weekly administrations of docetaxel and cisplatin for 3 weeks produces minimal myelosuppression and shows activity in the treatment of chemona?ve patients with advanced NSCLC. A randomized phase III trial is warranted to compare this 3 consecutive weeks protocol with administration of docetaxel and cisplatin every third week.     

多西紫杉醇不同给药方案治疗老年转移性乳腺癌临床观察

目的:比较多西紫杉醇每周方案及每3周方案治疗老年转移性乳腺癌的疗效与毒性.方法: 41例老年转移性乳腺癌患者,随机分组后,分别接受不同方案多西紫杉醇治疗.多西紫杉醇3周方案组22例,剂量为75mg/m2/3周;每周方案组19例,每次剂量为25mg/m2×3周,休息1周.评估多西紫杉醇不同用药方案疗效与毒性.结果: 单药多西紫杉醇治疗老年转移性乳腺癌的总有效率为34.1%.每周方案组与接受常规治疗方案组(多西紫杉醇每3周1次)的病人相比,有效率(RR)为36.8% vs 31.8%(P=0.504),两者比较差异无统计学意义;两组中Ⅲ-IV度骨髓抑制率为63.6%:31.6%(P<0.01).但每周方案中III- IV度神经病变高于每3周方案组,为26.3%:18.2%.结论: 单药多西紫杉醇治疗老年转移性乳腺癌有效.每周方案与每3周方案比较,有效率相近,但其血液学毒性低于每三周多西紫杉醇方案.每周方案对老年转移性乳腺癌患者是一较好的选择,可提高老年患者的生活质量.     

Phase I study of cisplatin and docetaxel plus mitomycin C in patients with metastatic non-small cell lung cancer

BACKGROUND: Docetaxel, cisplatin and mitomycin C are some of the active drugs used in the treatment of patients with metastatic non-small cell lung cancer (NSCLC). The purpose of this study was to determine the maximum tolerated dose (MTD) and recommended dose of the three drugs in combination for such patients. METHODS: Chemotherapy-native patients with metastatic NSCLC were enrolled in this study. The doses of docetaxel and cisplatin were fixed at 60 and 80 mg/m2, respectively. It was planned to increase the dose of mitomycin C from 4 to 6 and 8 mg/m2. All drugs were administered on day 1 and repeated every 3-4 weeks. RESULTS: All six patients received 60 mg/m2 of docetaxel and 80 mg/m2 of cisplatin, three of them with 4 mg/m2 of mitomycin C (level 1) and the other three with 6 mg/m2 of mitomycin C (level 2). Two of the three level 2 patients experienced dose-limiting toxicities (DLTs) in first cycle: febrile neutropenia and grade 3 hyponatremia. Based on these data, the MTD was concluded to be 60 mg/m2 for docetaxel, 80 mg/m2 for cisplatin and 6 mg/m2 for mitomycin C. Evaluation of the data from all of the cycles, however, showed that four of the six patients experienced DLTs. CONCLUSIONS: The addition of mitomycin C to docetaxel and cisplatin resulted in relatively high toxicities. It was impossible to use a high enough dose of mitomycin C to improve the survival of NSCLC patients. We therefore concluded that further evaluation of this combination is unwarranted.