培美曲塞二线治疗晚期子宫内膜癌近期疗效观察

目的评价培美曲塞联合奈达铂应用于一线化疗失败的晚期子宫内膜癌患者的疗效与安全性。方法 12例既往紫杉醇+卡铂一线化疗失败的晚期子宫内膜癌患者,接受培美曲塞二钠500 mg/m2+奈达铂80 mg/m2治疗。入选患者至少接受2个周期以上化疗,最多接受6个周期化疗。结果共12例患者接受培美曲塞联合奈达铂治疗,部分缓解3例(25.0%),肿瘤稳定5例(41.7%)。不良反应主要为骨髓抑制(Ⅲ/Ⅳ度),贫血占25.0%,中性粒细胞下降占41.7%,血小板减少占25.0%,无治疗相关死亡。结论对于既往一线化疗失败晚期子宫内膜癌,国产培美曲塞值得临床试用。     

盐酸吉西他滨治疗避部晚期和复发性妇科癌症的初步观察

[目的]初探盐酸吉西他滨(健择)治疗晚期和复发性妇癌的效果和毒性.[方法]2000年12月～2001年8月7例局部晚期和复发性妇癌接受健择治疗,其中2例卵巢癌采用GT方案健择800mg/m2静注30分钟,d1,8,泰素帝40mg/m2静点,d1,8,28天重复;3例宫颈癌,1例阴道癌及1例子宫内膜癌均予以GP方案健择800mg/m2静注30分钟,d1,8,顺铂20mg/m2静注,d2～4,28天重复.7例患者共接受13个疗程.[结果]7例均可评价疗效和毒性.1例宫颈癌ⅠB2期新辅助化疗获得部分缓解,6例病情进展(PD),其中肺转移4例中2例肿瘤缩小或肺包裹性积液减少(不及50%),但伴有其他病灶增大或出现新转移灶.主要不良反应是血液学毒性,白细胞下降Ⅱ度占46.2%疗程,贫血Ⅲ度占15.4%疗程,血小板减少Ⅲ～Ⅳ度占38.4%疗程.[结论]健择与顺铂或泰素帝联合在宫颈癌新辅助化疗中提高放疗增敏性,在多脏器、多部位转移的复发妇癌患者的拯救性治疗中疗效差,毒性较大但能耐受.     

紫杉醇每周疗法联合LFP方案治疗34例晚期食管癌

[目的]评价周剂量紫杉醇(PTX)每周疗法联合氟尿嘧啶(5-Fu)、顺铂(DDP)、醛氢叶酸(CF)治疗食管癌的疗效和毒性.[方法] 34例Ⅲ、Ⅳ期食管癌患者给予6周实验方案化疗,国产PTX 80mg/m2静脉滴注,每周1次,连续6周;DDP 50mg/m2静脉滴注,第8、29天;5-Fu 500mg/m2静脉滴注,每周1次,连续6周,每次6～8h;醛氢叶酸100mg/次,静脉滴注,每周1次,在5-Fu前2h内给药,6周为1个疗程,1个疗程后评价疗效.[结果]32例可评价疗效,完全缓解3例,部分缓解18例,总有效率为65.6%.毒副作用主要为剂量限制性毒性,表现为骨髓抑制.[结论]紫杉醇每周疗法联合氟尿嘧啶、顺铂、醛氢叶酸是治疗晚期食管癌较好的化疗方案.     

紫杉醇联合奥沙利铂治疗30例晚期胃癌临床观察

[目的]观察紫杉醇(PTX)联合奥沙利铂(L-OHP)治疗晚期胃癌的疗效和毒性.[方法] 30例晚期胃癌患者采用紫杉醇联合奥沙利铂方案化疗:PTX 130mg/m2,静脉滴注,第1天;L-OHP 130mg/m2,静脉滴注,第1天.28天为1周期,至少2周期后评定疗效.[结果]26例可评价疗效,其中完全缓解4例,部分缓解14例,总有效率为69.2%;中位无进展期7.2个月;中位生存期12.5个月.毒副作用主要为骨髓抑制、周围神经炎和脱发.[结论]紫杉醇联合奥沙利铂方案治疗晚期胃癌患者,缓解率高,耐受性良好.     

吉西他滨联合顺铂方案二线治疗晚期卵巢癌的临床研究

目的 对紫杉类和卡铂药物一线化疗后复发的晚期卵巢癌患者进行吉西他滨联合顺铂方案化疗,评估其疗效及毒性.方法 紫杉类和卡铂一线化疗后复发的晚期卵巢癌患者接受吉西他滨1.0 g/m2,i.v.,dl,d8;顺铂25mg/m2,i.v.,d1～d3; 21天为1个疗程,至少应用2个疗程,然后评价临床疗效和毒性,并进行随访.结果 30例患者治疗总缓解率53.3％.其中完全缓解3例,部分缓解13例,无缓解14例;中位疾病进展时间6.8个月（3～18.7个月）,中位生存期11.8个月.毒性反应主要是骨髓抑制和胃肠道反应,Ⅲ～Ⅳ度毒性反应发生率为60％.结论 一线接受紫杉类和卡铂化疗后复发的晚期卵巢癌患者行吉西他滨联合顺铂化疗是有效方案,毒性可耐受.     

脂质体紫杉醇联合卡铂治疗老年晚期头颈部肿瘤的临床观察

目的探讨脂质体紫杉醇联合卡铂治疗老年晚期头颈部肿瘤的近期疗效及安全性。方法对22例老年晚期头颈部肿瘤进行化疗,方案为脂质体紫杉醇135 mg/m2,d1;卡铂300 mg/m2,d2,21~28天重复。2个周期后评价疗效及不良反应。结果 22例中21例可评价疗效,共完成周期数72个,完全缓解(CR)2例,部分缓解(PR)6例,稳定(SD)9例,进展(PD)4例,总有效率(CR+PR)38.1%,疾病控制率(CR+PR+SD)80.9%,主要不良反应为骨髓抑制、胃肠道反应、脱发、疲乏,其中Ⅲ~Ⅳ级不良反应为8例(38.1%),无化疗相关性死亡。结论脂质体紫杉醇联合卡铂治疗老年晚期头颈部肿瘤有较好的近期疗效,反应可耐受。     

白蛋白结合型紫杉醇联合铂类治疗晚期或复发性妇科肿瘤的临床分析

目的观察白蛋白结合型紫杉醇联合铂类治疗晚期或复发性妇科肿瘤的近期疗效和副反应。方法选取晚期或复发性妇科肿瘤患者38例（宫颈癌26例,卵巢癌11例,子宫内膜癌1例）,给予白蛋白结合型紫衫醇175 mg/m^2,d1,联合铂类（奈达铂80 mg/m^2,d1;卡铂曲线下面积（AUC）=4-5,d1;奥沙利铂130 mg/m^2,d1）静脉滴注,21天为一个疗程,直至疾病进展或出现不可耐受的不良反应,2个疗程后对治疗有效的患者进行评价。结果 38例患者中33例可评价疗效,完全缓解（CR）1例（3.0%）,部分缓解（PR）15例（45.5%）,疾病稳定（SD）9例（27.3%）,疾病进展（PD）8例（24.2%）,客观有效率（ORR）48.5%,中位无进展生存时间（PFS）为5.5个月;不良反应中骨髓抑制较常见,Ⅲ级中性粒细胞减少发生率为21.1%,无Ⅳ级骨髓抑制和过敏反应。结论白蛋白结合型紫杉醇联合铂类治疗晚期或复发性妇科肿瘤的近期疗效较好,毒副反应可以耐受。     

以多西紫杉醇为主联合化疗治疗晚期卵巢癌97例

目的 观察以多西紫杉醇(商品名:希存)为主联合化疗治疗晚期卵巢癌患者的疗效及不良反应.方法 对97例晚期卵巢癌患者施以1H多西紫杉醇75 mg/m2,第1天,静脉滴注(1 h),顺铂80mg/m2]或TC[多西紫杉醇75mg/m2,第1天,静脉滴注(1 h),卡铂300mg/m2第1天,静脉滴注并水化2 d]方案化疗,21 d为1个周期,化疗6～8个周期.以上两种方案在多西紫杉醇用药前12 h..给予地塞米松8mg口服,1次/12h,共3次.结果 CR9例,PR 74例,sD 6例,PD 8例,总有效率91.7%.最常见的不良反应为骨髓抑制,Ⅲ～Ⅳ度白细胞减少占15%,Ⅲ度血小板减少占6.5%,非血液学毒性轻微.结论 以多西紫杉醇为主联合化疗治疗晚期卵巢癌有较好的疗效,不良反应可以耐受.     

紫杉醇联合顺铂治疗46例晚期头颈部肿瘤的临床观察

目的 观察紫杉醇联合顺铂治疗晚期头颈部肿瘤的疗效及毒副反应.方法 对46例晚期头颈部肿瘤进行化疗,方案为紫杉醇135 mg/m2,d1;顺铂25～40 mg/m2,d2～4.21 d为1周期,治疗2周期后评价疗效及毒副反应.结果 46例均可评价疗效,共完成周期数为160个,完全缓解(CR)2例,部分缓解(PR)14例,稳定(SD)18例,进展(PD)12例,总有效率(CR+PR)34.8%,疾病控制率(CR+PR+SD)73.9%,中位疾病进展时间6.7个月,中位生存期为22.3个月(2.0～52.5个月).主要毒副反应为骨髓抑制、胃肠道反应.结论 紫杉醇联合顺铂治疗晚期头颈部肿瘤疗效较好,毒副反应可耐受.     

顺铂联合紫杉醇与顺铂联合5-Fu同步放化疗治疗局部晚期宫颈癌近期疗效比较

[目的]评价顺铂联合紫杉醇同步放化疗与顺铂联合5-Fu同步放化疗治疗局部晚期宫颈癌的近期疗效及不良反应。[方法]78例局部晚期宫颈癌患者（Ⅱb～Ⅲb期）随机分为顺铂＋紫杉醇组（TP组,38例）和顺铂＋5-Fu组（FP组,40例）,每例患者均行根治性放疗。TP组化疗方案：顺铂35mg/m2静滴d1,8＋紫杉醇75mg/m2静滴d1,8,28d重复,共2个周期。FP组化疗方案：顺铂60mg/m2静滴d1＋5-Fu 4g/m2静脉维持96h,28d重复,共2个周期。[结果]TP组总有效率92.1%（35/38）,FP组总有效率87.5%（35/40）,两组比较无显著性差异（P〉0.05）。与FP组相比,TP组3级及以上骨髓抑制发生率较高（68.4%vs 35.0%）,2级及以上胃肠道反应发生率较低（34.2%vs 60.0%）,肝毒性发生率较高（52.6%vs 20.0%）,均有显著性差异（P均〈0.05）。[结论]顺铂联合紫杉醇同步放化疗与顺铂联合5-Fu同步放化疗治疗局部晚期宫颈癌的近期疗效相似,但胃肠道反应较低,TP方案可以作为FP方案的替代方案治疗局部晚期宫颈癌。     

Dose-dense cisplatin/paclitaxel. a well-tolerated and highly effective chemotherapeutic regimen in patients with advanced ovarian cancer

A randomised phase I/II trial with weekly cisplatin 70 mg/m(2) (days 1, 8, 15, 29, 36, 43) in combination with escalating doses of paclitaxel either 4-weekly or weekly was conducted in 49 patients with ovarian cancer; patients were chemotherapy-nai;ve or had a first relapse after platinum-based chemotherapy. Paclitaxel could be safely escalated to 225 mg/m(2) 4-weekly or 100 mg/m(2) weekly, with fatigue as the major adverse event. Myelosuppression, renal toxicity and neurotoxicity were mild to moderate. Pharmacokinetic analysis showed an approximately 2-fold reduction of DNA-adduct formation in leucocytes compared with cisplatin without paclitaxel. No pharmacokinetic interaction was found between paclitaxel and cisplatin. After (re-)induction, additional chemotherapy consisted of conventional paclitaxel/cisplatin, paclitaxel/carboplatin, paclitaxel single agent or carboplatin/cyclophosphamide. The overall response rate was 94% in 17 evaluable chemotherapy-nai;ve patients and 84% in 25 patients with recurrent disease. Median progression-free survival (PFS) was 17 months (chemotherapy-nai;ve: 23 months, recurrent: 11 months) and median overall survival was 41 months (chemotherapy-nai;ve: 48 months, recurrent: 24 months). In conclusion, both cisplatin/paclitaxel regimens showed excellent activity with manageable toxicity in patients with advanced ovarian cancer.     

长春瑞滨联合铂类治疗中晚期子宫内膜癌

目的：比较长春瑞滨和紫杉醇分别与铂类联合治疗中晚期子宫内膜癌的近期疗效及毒副反应。方法：33例晚期子宫内膜癌，治疗组（NP方案组）21例，长春瑞滨＋顺铂或卡铂化疗，长春瑞滨25mg／m^2，静注d1、8；顺铂25mg／m^2，静注d1～3，或卡铂（300mg／m^2或者AUC4～5）静脉滴注d1。对照组（TP方案组）12例：紫杉醇135～150mg／m^2，静注d1；顺铂或卡铂用法同前。结果：全组均完成2周期以上化疗，其中CR4例．PR14例，NC10例，PD5例。有效率（CR＋PR）54．54％。NP方案组，CR2例，PR9例，有效率（CR＋PR）52．38％；TP方案组，CR2例，PR5例，有效率（CR＋PR）58．33％，两组间无统计学差异（P〉0．05）。副反应主要为骨髓抑制、白细胞、血小板减少，Ⅲ～Ⅳ度发生率，NP组为71．43％，TP组为75．0％（P〉0．05）。结论：长春瑞滨＋铂类联合与紫杉醇＋铂类联合化疗治疗中晚期子宫内膜癌有相同的疗效且毒副反应可以耐受。     

Dose intensification of platinum compounds with glutathione protection as induction chemotherapy for advanced ovarian carcinoma.

Based on previous clinical experience indicating the tolerability and efficacy of high-dose cisplatin with glutathione protection in the treatment of advanced ovarian cancer, this study was undertaken to explore the efficacy and feasibility of an alternative high-dose, platinum-based approach including a combination of high-dose cisplatin plus carboplatin as induction chemotherapy of advanced ovarian carcinoma and intervention surgery. Fifty consecutive eligible patients with untreated stage III or IV epithelial ovarian cancer received 40 mg/m(2) cisplatin daily on days 1-4 and 160 mg/m(2) carboplatin on day 5. The cycle was repeated after 28 days. Patients received glutathione (2,500 mg) before each cisplatin or carboplatin administration and standard intravenous hydration. After 2 courses of induction chemotherapy, the patients underwent surgical reevaluation with debulking, when possible, followed by a further 3 cycles of 120 mg/m(2) cisplatin (i.e. 40 mg/m(2) daily for 3 consecutive days plus 600 mg/m(2) cyclophosphamide on day 3) except in instances of lack of response. All eligible patients were assessed for response and toxicity. The toxicity was moderate with lack of significant nephrotoxicity. Neurotoxicity and ototoxicity were acceptable and in no patient was treatment discontinued for those toxic effects. Myelotoxicity was somewhat more severe than that observed with our previous study with high-dose cisplatin and probably related to the addition of carboplatin. Of the 40 responsive patients, 23 (46%) had a pathological complete response and 4 (8%) had a clinical complete response (without second-look laparotomy). The efficacy of the present protocol was also documented by overall survival (median survival >48 months), which appeared to be better than expected with the current therapy in this group with advanced/bulky disease. The impressive efficacy suggests a possible contribution of reduced glutathione itself in improving the outcome, as supported by preclinical studies. The results of this study should be placed in context with current platinum-based therapy including paclitaxel.     

Phase III trial of carboplatin and paclitaxel compared with cisplatin and paclitaxel in patients with optimally resected stage III ovarian cancer: a Gynecologic Oncology Group study.

PURPOSE: In randomized trials the combination of cisplatin and paclitaxel was superior to cisplatin and cyclophosphamide in advanced-stage epithelial ovarian cancer. Although in nonrandomized trials, carboplatin and paclitaxel was a less toxic and highly active combination regimen, there remained concern regarding its efficacy in patients with small-volume, resected, stage III disease. Thus, we conducted a noninferiority trial of cisplatin and paclitaxel versus carboplatin and paclitaxel in this population. PATIENTS AND METHODS: Patients with advanced ovarian cancer and no residual mass greater than 1.0 cm after surgery were randomly assigned to receive cisplatin 75 mg/m2 plus a 24-hour infusion of paclitaxel 135 mg/m2 (arm I), or carboplatin area under the curve 7.5 intravenously plus paclitaxel 175 mg/m2 over 3 hours (arm II). RESULTS: Seven hundred ninety-two eligible patients were enrolled onto the study. Prognostic factors were similar in the two treatment groups. Gastrointestinal, renal, and metabolic toxicity, as well as grade 4 leukopenia, were significantly more frequent in arm I. Grade 2 or greater thrombocytopenia was more common in arm II. Neurologic toxicity was similar in both regimens. Median progression-free survival and overall survival were 19.4 and 48.7 months, respectively, for arm I compared with 20.7 and 57.4 months, respectively, for arm II. The relative risk (RR) of progression for the carboplatin plus paclitaxel group was 0.88 (95% confidence interval [CI], 0.75 to 1.03) and the RR of death was 0.84 (95% CI, 0.70 to 1.02). CONCLUSION: In patients with advanced ovarian cancer, a chemotherapy regimen consisting of carboplatin plus paclitaxel results in less toxicity, is easier to administer, and is not inferior, when compared with cisplatin plus paclitaxel.     

紫杉醇脂质体联合卡铂治疗培美曲塞联合顺铂化疗失败的晚期肺腺癌的临床观察

目的:探讨紫杉醇脂质体联合卡铂治疗培美曲塞联合顺铂化疗失败的晚期肺腺癌的临床疗效及安全性.方法:收集2012年1月至2015年4月22例对培美曲塞联合顺铂方案化疗失败的晚期肺腺癌患者,给予紫杉醇脂质体联合卡铂治疗,具体用药:紫杉醇脂质体175 mg/m2,静脉滴注,第1天;卡铂AUC 5,静脉滴注,第1天,21天为1个周期.至少化疗2个周期后评价疗效及不良反应.结果:全组22例患者均可评价疗效和不良反应.获完全缓解(complete response,CR)0例,部分缓解(partial response,PR)10例,稳定(stable disease,SD)8例,进展(progression disease,PD)4例,有效率(response rate,RR)为45.5%,疾病控制率(disease control rate,DCR)81.8%,中位无进展生存时间(progression free survival,PFS)5.6个月,中位总生存时间(overall survival,OS)9.5个月,1年生存率36.4%.主要不良反应为骨髓抑制,经对症处理后均缓解.结论:紫杉醇脂质体联合卡铂治疗培美曲塞和顺铂化疗失败的晚期肺腺癌疗效较好,不良反应可耐受.     

吉西他滨加卡铂与紫杉醇加顺铂治疗晚期鼻咽癌的疗效比较

目的:研究吉西他滨(GEM)加卡铂(CBP)与紫杉醇(DOC)加顺铂(DDP)治疗晚期鼻咽癌临床疗效及毒副反应。方法:GEM+CBP组(1组)用GEM1000mg/m2,静脉滴入,d1、d8;CBP400mg/m2,静脉滴入,d1,间隔21～28d为1个周期。DOC+DDP组(2组)用DOC135mg/m2,静脉滴入,d1;DDP30mg/m2,静脉滴入,d1～d3,间隔21～28d为1周期;完成2个周期后评价疗效。结果:1组化疗30例,完全缓解(CR)3例,部分缓解(PR)18例,总有效率(CR+PR)为70.0%(21/30);2组CR1例,PR12例,总有效率为43.3%(13/30),u=2.017,P=0.044。毒副反应主要表现为血液系统和消化系统,其中1组的骨髓抑制较重,而2组的消化系统反应较重,不良反应可耐受、可逆转。结论:对于在治疗后未控及复发的晚期鼻咽癌患者,两组均取得较好的疗效;GEM+CBP组较DOC+DDP组的缓解率高,患者耐受较好,较容易接受。     

Phase III randomised trial comparing paclitaxel/carboplatin with paclitaxel/cisplatin in patients with advanced non-small-cell lung cancer: a cooperative multinational trial.

BACKGROUND: The combination of paclitaxel with cisplatin or carboplatin has significant activity in non-small-cell lung cancer (NSCLC). This phase III study of chemotherapy-na?ve advanced NSCLC patients was designed to assess whether response rate in patients receiving a paclitaxel/carboplatin combination was similar to that in patients receiving a paclitaxel/cisplatin combination. Paclitaxel was given at a dose of 200 mg/m(2) (3-h intravenous infusion) followed by either carboplatin at an AUC of 6 or cisplatin at a dose of 80 mg/m(2), all repeated every 3 weeks. Survival, toxicity and quality of life were also compared. PATIENTS AND METHODS: Patients were randomised to receive one of the two combinations, stratified according to centre, performance status, disease stage and histology. The primary analyses of response rate and survival were carried out on response-evaluable patients. Survival was also analysed for all randomised patients. Toxicity analyses were carried out on all treated patients. RESULTS: A total of 618 patients were randomised. The two treatment arms were well balanced with regard to gender (83% male), age (median 58 years), performance status (83% ECOG 0-1), stage (68% IV, 32% IIIB) and histology (38% squamous cell carcinoma). In the paclitaxel/carboplatin arm, 306 patients received a total of 1311 courses (median four courses, range 1-10 courses) while in the paclitaxel/cisplatin arm, 302 patients received a total of 1321 courses (median four courses, range 1-10 courses). In only 76% of courses, carboplatin was administered as planned at an AUC of 6, while in 96% of courses, cisplatin was given at the planned dose of 80 mg/m(2). The response rate was 25% (70 of 279) in the paclitaxel/carboplatin arm and 28% (80 of 284) in the paclitaxel/cisplatin arm (P = 0.45). Responses were reviewed by an independent radiological committee. For all randomised patients, median survival was 8.5 months in the paclitaxel/carboplatin arm and 9.8 months in the paclitaxel/cisplatin arm [hazard ratio 1.20, 90% confidence interval (CI) 1.03-1.40]; the 1-year survival rates were 33% and 38%, respectively. On the same dataset, a survival update after 22 months of additional follow-up yielded a median survival of 8.2 months in the paclitaxel/carboplatin arm and 9.8 months in the paclitaxel/cisplatin arm (hazard ratio 1.22, 90% CI 1.06-1.40; P = 0.019); the 2-year survival rates were 9% and 15%, respectively. Excluding neutropenia and thrombocytopenia, which were more frequent in the paclitaxel/carboplatin arm, and nausea/vomiting and nephrotoxicity, which were more frequent in the paclitaxel/cisplatin arm, the rate of severe toxicities was generally low and comparable between the two arms. Overall quality of life (EORTC QLQ-C30 and LC-13) was also similar between the two arms. CONCLUSIONS: This is the first trial comparing carboplatin and cisplatin in the treatment of advanced NSCLC. Although paclitaxel/carboplatin yielded a similar response rate, the significantly longer median survival obtained with paclitaxel/cisplatin indicates that cisplatin-based chemotherapy should be the first treatment option.     

Outcome of patients with a performance status of 2 in Eastern Cooperative Oncology Group Study E1594: a Phase II trial in patients with metastatic nonsmall cell lung carcinoma .

BACKGROUND: Eastern Cooperative Oncology Group (ECOG) Study E1594 compared paclitaxel and cisplatin with three newer chemotherapy doublets in the treatment of patients with advanced nonsmall cell lung carcinoma (NSCLC). The accrual of patients with an ECOG performance status (PS) of 2 was discontinued due to a perceived rate of unacceptable toxicity. METHODS: Patients were stratified by PS and randomized to one of the following treatments: 1) paclitaxel (135 mg/m2) over 24 hours with cisplatin (75 mg/m2) on a 21-day cycle; 2) cisplatin (100 mg/m2) with gemcitabine (1 g/m2) on Days 1, 8, and 15 on a 28-day cycle; 3) cisplatin (75 mg/m2) with docetaxel (75 mg/m2) on a 21-day cycle; and 4) paclitaxel (225 mg/m2) over 3 hours with carboplatin (area under the curve, 6). All tests of statistical significance were two-sided. RESULTS: Sixty-eight patients with an ECOG PS of 2 were enrolled, and 64 patients were evaluable for toxicity and response. Fifty-six percent of 64 evaluable patients were male, and 81% had Stage IV disease. Grade 3-4 hematologic toxicities occurred in > 50% of the patients in each treatment group. Nonhematologic Grade 3-4 toxicities occurred significantly less often in the paclitaxel and carboplatin arm (P = 0.0032). The overall rate of toxicity did not differ significantly from the rate of toxicity in the PS-0 or PS-1 cohorts. There were 5 deaths (7.35%) among 68 patients with a PS of 2 during therapy; however, only 2 of those deaths were attributed to therapy. The overall response rate for the 64 evaluable patients was 14%. The overall median survival of all 68 patients with a PS of 2, as determined by an intent-to-treat analysis, was 4.1 months. CONCLUSIONS: Patients with advanced NSCLC and a PS of 2 experienced a large number of adverse reactions and overall poor survival. A comparison with patients with a PS of 0-1 suggests that these events and the shorter survival were related to disease process rather than treatment. Alternative strategies need to be explored with therapy specifically tailored for this group of patients.     

Weekly paclitaxel and carboplatin combination chemotherapy in patients with advanced squamous cell carcinoma of the head and neck

BACKGROUND: The combination of paclitaxel and carboplatin is active in the treatment of squamous cell carcinoma of the head and neck (SCCHN). However, considerable toxicity develops with 3-weekly drug administration. Treatment on a weekly basis may allow for a higher dose intensity with less adverse effects. PATIENTS AND METHODS: Enrolled in this study were 31 patients with locally advanced, metastatic or relapsed SCCHN, most of them pretreated. They received weekly i.v. infusions of 80 mg/m(2) paclitaxel over 1 h combined with carboplatin at an area under the concentration time curve of 2 mg/ml/min over 30 min. RESULTS: The overall response rate was 52% with 1 complete response and 16 partial responses. Median progression-free survival was 5.4 months, median overall survival 12.8 months. Grade 3/4 hematologic adverse events occurred in 7 patients and grade 3 peripheral neuropathy in one. 10 patients required dose reduction or treatment delay due to neutropenia, thrombocytopenia or neuropathy. CONCLUSIONS: Weekly administration of paclitaxel and carboplatin appears to be safe and efficacious in patients with advanced, metastatic or recurrent SCCHN.     

Paclitaxel, cisplatin, and epirubicin first-line chemotherapy in stage III and IV ovarian carcinoma: long-term results of a phase II study

BACKGROUND: The combination of paclitaxel with cisplatin or carboplatin has become the preferred chemotherapy regimen in the treatment of epithelial ovarian carcinoma. Anthracyclines also have activity in this disease. We conducted a Phase II study by using the combination of paclitaxel, cisplatin, and epirubicin for the treatment of advanced ovarian carcinoma. METHODS: Forty consecutive patients with optimally (n = 7) or suboptimally (n = 33) debulked advanced ovarian carcinoma (International Federation of Gynecology and Obstetrics (FIGO) Stage III or IV) were treated with paclitaxel, 135 mg/m(2), as a 3-hour intravenous infusion, cisplatin 75 mg/m(2) intravenously (i.v.), and epirubicin 50 mg/m(2) i.v. every 3 weeks on an outpatient basis. Granulocyte-colony stimulating factor was administered at a dose of 5 microg/kg/day on Days 5-9. RESULTS: Among 28 patients with measurable disease, 24 (86%%) achieved an objective response including 19 complete and 5 partial responses. Among 18 patients who underwent reassessment laparotomy, pathologic complete response was confirmed in 9 patients. At a minimum follow-up of 40 months, the median overall survival had not been reached whereas the median time to progression for all patients was 18.7 months. The median remission duration for women with measurable disease who responded to treatment was 14 months. The treatment was well tolerated without toxic deaths; the most common toxicity was Grade 3/4 neutropenia that occurred in 30% of patients. Significant neuropathy (Grade 2 or higher) developed in only 8% of patients. CONCLUSIONS: The combination of paclitaxel, cisplatin, and epirubicin is a well tolerated outpatient regimen with significant activity in the treatment of advanced epithelial ovarian carcinoma.