A retrospective study of second-line chemotherapy for unresectable or recurrent squamous cell carcinoma of the esophagus refractory to chemotherapy with 5-fluorouracil plus platinum

Background In Japan, chemotherapeutic agents that have been approved for the treatment of esophageal cancer include cisplatin, nedaplatin, 5-fluorouracil, vindesine, and docetaxel. We retrospectively investigated the efficacy and toxicity of a combination of nedaplatin plus vindesine, or docetaxel alone, for patients with unresectable or recurrent squamous cell carcinoma of the esophagus refractory to prior chemotherapy with 5-fluorouracil plus platinum. Methods Nedaplatin was administered at 90 mg/m² intravenously on day 1, and vindesine was administered at 3 mg/m² intravenously on days 1 and 8 every 28 days. Docetaxel 60 mg/m² or 70 mg/m² was administered intravenously every 21 days. We analyzed the response rate, overall survival time, progression-free survival time, and toxicity in 24 patients treated with nedaplatin plus vindesine and 28 patients treated with docetaxel. Results In patients treated with nedaplatin plus vindesine, the response rate of the 13 patients with measurable lesions was 8% (1/13), the median progression-free survival time was 1.8 months, and the median survival time was 5.5 months. In patients treated with docetaxel, the response rate of the 17 patients with measurable lesions was 18% (3/17), the median progression-free survival time was 2.1 months, and the median survival time was 5.1 months. The most frequent toxicity was neutropenia (grade 4; 13% in the group with nedaplatin plus vindesine and 50% in the docetaxel group), and febrile neutropenia (grade 3; 4% and 18%, respectively). Conclusion The efficacy of the two regimens for unresectable or recurrent squamous cell carcinoma of the esophagus refractory to chemotherapy with 5-fluorouracil plus platinum was unsatisfactory. New, more effective therapies are needed.     

Dose escalation study of docetaxel and nedaplatin in patients with relapsed or refractory squamous cell carcinoma of the esophagus pretreated using cisplatin, 5-fluorouracil, and radiation

Background Definitive chemoradiation with cisplatin (CDDP) and 5-fluorouracil (5FU) has been playing an important role in the treatment of esophageal cancer, but some patients are not curable or have recurrent lesions. However, few chemotherapeutic regimens are available for such patients. Docetaxel and nedaplatin are active for esophageal cancer. We conducted a dose-escalation study of docetaxel and nedaplatin as second line-chemotherapy after definitive chemoradiation in patients with relapsed or refractory squamous cell carcinoma of the esophagus after chemoradiation. Methods Nedaplatin was administered on day 1 and docetaxel was administered on days 1 and 15, every 4 weeks. Dose escalation was based on the dose-limiting toxicity (DLT) observed during the first cycle. Results Twelve patients were enrolled. At a docetaxel dose of 30 mg/m² and a nedaplatin dose of 80 mg/m², one grade 4 neutropenia occurred and caused one treatment break longer than 2 weeks, but there were few DLTs. At doses of 35 and 80 mg/m², respectively, two grade 4 neutropenias and one grade 2 thrombopenia occurred and caused three treatment breaks longer than 2 weeks. Therefore, the maximum tolerated dose was established at this dose level. Two grade 3 anorexias and one grade 3 nausea occurred, but other non-hematological toxicities were generally mild. Responses were seen in one-fourth of the 12 patients, including one complete remission. Conclusion The recommended doses of docetaxel and nedaplatin were 30 and 80 mg/m², respectively. This combination could be a potential second-line treatment for this target population.     

多西他赛联合奈达铂、氟尿嘧啶治疗晚期食管癌的临床观察

背景与目的:文献研究表明,多西他赛联合顺铂、氟尿嘧啶对晚期胃癌及胃食管贲门癌有效。本研究旨在评价多西他赛联合奈达铂、氟尿嘧啶(DNF方案)治疗晚期食管癌的临床疗效和毒副反应。方法:DNF方案治疗43例食管癌患者。具体用法:多西他赛75mg/m2第1天静脉滴注60min;奈达铂100mg/m2第1天静脉滴注3h;醛氢叶酸钙200mg/m2,第1天静脉滴注2h,随后氟尿嘧啶375mg/m2静脉推注10min,再以氟尿嘧啶2.6g/m2持续泵入46h。21d为一周期,每2周期按WHO疗效评价标准评价疗效,所有患者至少接受2周期化疗。结果:43例患者共接受144个周期的化疗,所有患者均可评价疗效。完全缓解2例(4.65%),部分缓解25例(58.14%),稳定9例(20.93%),进展7例(16.28%),总有效率为62.79%,中位疾病进展时间201d,中位生存时间310d。3~4度不良反应主要包括9例(20.93%)粒细胞减少(其中2例伴发热),3例(6.98%)血小板减少,4例(9.30%)恶心呕吐。化疗相关性死亡1例。结论:多西他赛联合奈达铂、氟尿嘧啶方案治疗晚期食管癌疗效较好,毒性可以接受,值得临床应用及进...     

A single-institute phase I/II trial combining nedaplatin dose escalation with a fixed dose of docetaxel for induction chemotherapy of oral squamous cell carcinoma

The purpose of this clinical trial was to assess the toxicity and efficacy of docetaxel plus nedaplatin induction chemotherapy in patients with locally advanced oral squamous cell carcinoma (OSCC). Twenty-one patients were enrolled in this phase I/II clinical study. The toxicities, response rates, and the maximum tolerated dose of nedaplatin that could be safely given preoperatively were assessed. Patients received escalating doses of nedaplatin (60, 70, 80, 90 mg/m²) combined with a fixed dose of docetaxel (60 mg/m²) on day one. Dose-limiting toxicity (DLT), grade 4 leukopenia lasting for two days or more, was seen in one patient at dose level 3; no other DLT was observed at any dose level. The overall response rate was 66.7%. The response rate was 100% at nedaplatin dose level 4, while that at dose level 1 was low (33.3%). Given these results, the recommended dose of nedaplatin in this regimen combined with fixed dose docetaxel (60 mg/m²) was determined to be 90 mg/m². Docetaxel 60 mg/m² plus nedaplatin 90 mg/m² induction chemotherapy can be recommended for patients with locally advanced oral squamous cell carcinoma. Based on these results, an early phase II clinical study using this dose level was conducted; docetaxel plus nedaplatin induction chemotherapy appears to be a useful regimen for the treatment of OSCC. A late phase II clinical study is warranted.     

Chemotherapy for an esophageal cancer patient undergoing continuous ambulatory peritoneal dialysis for chronic renal failure and measurement of plasma concentration of the drug

We administered chemoradiotherapy consisting of 5-fluorouracil (5-FU) combined with cisplatin, radiation and sequential chemotherapy using nedaplatin for an esophageal cancer patient undergoing continuous ambulatory peritoneal dialysis (CAPD) for chronic renal failure. There are no reports in the literature of chemotherapy for a patient maintained on CAPD. The dosage of each drug was based on that for a patient undergoing hemodialysis, and the plasma concentration of each drug was examined. Chemotherapy consisted of 3-10 mg/body of cisplatin with 60-min infusion and 450 mg/body of 5-FU with continuous infusion over 5 days. There were no side effects and no increase in the concentration of either of the drugs. Subsequently, 50 mg/body of nedaplatin, which is half the dose for a patient with normal renal function, was administered. The area under the blood concentration time curve (AUC) of nedaplatin was 15.85 microg/ml, which was slightly low compared with that after infusion of 80 mg/m2 in patients with normal renal function. Grade 3 leukopenia and thrombocytopenia occurred. As a final result, a partial response was obtained, and the patient was able to eat solid food after treatment. Although chemotherapy consisting of low-doses of cisplatin and 5-FU and a half dose of nedaplatin was administered safely, further study is needed to determine the suitable regimens for a patient maintained on CAPD.     

A successful resected case of far-advanced cancer at the esophagogastric junction by chemoradiotherapy with docetaxel, nedaplatin and 5-fluorouracil

The patient, a 73-year-old male, was admitted to our hospital because of dysphagia. A far-advanced cancer was diagnosed at the esophagogastric junction by upper gastrointestinal endoscopic examination. Pathological biopsy examinations revealed poorly-differentiated adenocarcinoma. Computed tomography (CT) of the chest and abdomen showed invasion to the diaphragm. Clinical Stage was IV in an unresectable far-advanced tumor. He received radiation therapy (40 Gy/total, 2 Gy/day×20 times) in combination with chemotherapy using docetaxel (40 mg/m2, day 1), nedaplatin (10mg/body, days 1-5) and 5-fluorouracil (500 mg/body, days 1-5). After this combination chemoradiation therapy (CRT), macroscopic examinations showed significant reductions in the size of tumor, leading a partial response according to the RECIST guidelines. He underwent total gastrectomy, partial resection of the lower esophagus via left thoracotomy, and Roux-en Y reconstruction with jejunostomy. Pathological examination of the resected specimens revealed Stage IV (T3N2P1CY0). The postoperative course was uneventful. He was treated on an outpatient basis without adjuvant therapy, and died 6 months after the operation by liver, spleen and lymph node metastases.     

A case of adenosquamous gastric carcinoma successfully treated with TS-1, low-dose CDDP and docetaxel as neoadjuvant chemotherapy

The patient was a 66-year-old male with extremely advanced gastric cancer type 3 and diagnosed with adenocarcinoma by endoscopic biopsies specimens. Combined chemotherapy of TS-1, CDDP and docetaxel was prescribed in order for tumor reduction and downstaging. TS-1 (80 mg/m(2)) was administered 28 days followed by 14 days rest as one course. CDDP (8 mg/m(2)) was administered on days 1, 2, 14 and 15 and docetaxel (40 mg/m(2)) was administered on day 1 and 14, followed by 4 weeks rest as one course. After 2 courses of treatment, a CT scan revealed a minor response of tumor reduction. Therefore, total gastrectomy, partial pancreas body and tail resection, and D 2 lymph node dissection were performed. The patient had undergone adjuvant chemotherapy of TS-1 and biweekly docetaxel after surgery with no recurrence for 13 months. Adverse reactions were grade 3 neutropenia and grade 2 diarrhea. Combined chemotherapy of TS-1, low-dose CDDP and docetaxel were intensive and required constant patient monitoring. However, it proved effective and feasible as a neoadjuvant chemotherapy regimen for advanced gastric cancer.     

食管癌同期放化疗中奈达铂剂量递增临床Ⅰ期试验

[目的]探讨在食管癌同期放化疗中多西紫杉醇固定周剂量时奈达铂（NDP）的周最大耐受剂量（MTD）,并观察其不良反应。[方法]共入选20例初治食管鳞癌患者,采用三维适形放疗方法,DT：60～64Gy/30～32f,42～44d,同步化疗方案固定多西紫杉醇剂量20mg/w,共6w,NDP采用周剂量递增方法,起始剂量12mg/m2,递增剂量为6 mg/m2。剂量限制性毒性（DLT）定义为≥3级不良反应,出现DLT的前一剂量即为MTD。[结果]NDP 24mg/m2剂量水平时共有2例患者发生3～4级的DLT;NDP 18mg/m2、多西紫杉醇20mg即为MTD。主要不良反应为放射性食管炎、放射性肺炎、乏力和骨髓抑制。[结论]食管癌同步放化疗中固定多西紫杉醇20mg每周剂量时奈达铂每周最大耐受剂量为 18mg/m2。     

奈达铂联合5-氟脲嘧啶治疗晚期食管癌24例

目的 :观察奈达铂联合5-氟脲嘧啶治疗晚期食管癌的疗效和不良反应。 方法 :晚期食管鳞癌患者24例,奈达铂80～100mg/m²,加入生理盐水500ml中静滴2h,5-氟脲嘧啶1.0g/天,静脉滴注4h以上,第1～5天。28天为1周期,连用2个周期后评价疗效。 结果 :全组24例均可评价疗效及不良反应,总有效率41.7%。其中初治者14例,完全缓解1例,部分缓解6例,有效率50.0%;复治者10例,部分缓解3例,有效率30.0%。中位生存时间9.4个月,1年生存率25.0%。主要不良反应为骨髓抑制,4例(16.7%)患者出现Ⅲ度血小板下降,3例(12.5%)患者出现Ⅲ～Ⅳ度白细胞降低。消化道反应轻,未发现肝肾功能损害。 结论 :奈达铂联合5-氟脲嘧啶治疗晚期食管癌疗效肯定,不良反应小,尤其对老年患者耐受性好,可代替顺铂作为治疗晚期食管癌的一线方案,对顺铂耐药的患者亦有一定的疗效。     

Combination chemotherapy of TS-1, docetaxel and CDDP produces a remarkable response in a patient with advanced esophageal cancer

We report a patient with advanced esophageal cancer who achieved a complete response to combination chemotherapy of TS-1, docetaxel and CDDP. A 74-year-old man was admitted to our hospital for advanced esophageal cancer with a complaint of dysphagia. He received chemotherapy, consisting of TS-1 100 mg/body, docetaxel 35 mg/m(2), and CDDP 10 mg/m(2), every 3 weeks. TS-1 was administered for 14 days followed by 7 days rest; docetaxel and CDDP were administered by intravenous infusion at day one and day 8 after beginning TS-1. After three cycles of chemotherapy, his dysphagia disappeared, and endoscopic examination of the primary esophageal tumor showed a complete response. Endoscopic examination with biopsy confirmed the disappearance of the esophageal cancer. No severe side effects were observed during this chemotherapy. Combination chemotherapy of TS-1, docetaxel, and CDDP can thus be effective for advanced esophageal cancer.     

Phase II trial of neoadjuvant chemotherapy with docetaxel,nedaplatin, and S1 for advanced esophageal squamous cell carcinoma

Although standard chemotherapy for esophageal cancer patients is fluorouracil and cisplatin, the prognosis is still unsatisfactory. A new therapeutic regimen combining docetaxel, cisplatin, and 5‐fluorouracil was recently developed to improve both local and distant tumor control. We developed a new regimen of docetaxel, nedaplatin, and S1 (DGS) and previously reported the recommended dose in a phase I dose‐escalation study. We then undertook a phase II study of DGS for advanced esophageal squamous cell carcinoma. Patients with clinical stage IB/II/III disease were eligible. Patients received two courses of chemotherapy: docetaxel 35 mg/m² with nedaplatin 40 mg/m² on day 8, 80 mg/m² S1 on days 1–14, and 2 weeks off. After completion of chemotherapy, patients underwent esophagectomy. The primary endpoint was the completion rate of protocol treatment (completion of two courses of preoperative chemotherapy and R0 surgery [no residual tumor]). We enrolled 32 patients. The completion rate of protocol treatment was 96.9%. During chemotherapy, the most common grade 3 or 4 toxicity was neutropenia (25.0%). No treatment‐related deaths were observed, and the incidence of operative morbidity was tolerable. The overall response rate after chemotherapy was 83.3%. This DGS regimen was well tolerated and highly active. This trial is registered with the University Hospital Medical Information Network (UMIN ID: 000014626).     

多西他赛联合奈达铂治疗晚期食管癌的临床观察

目的 观察多西他赛联合奈达铂治疗中晚期食管癌的有效性及安全性。方法全组共45例,其中男性30例,女性15例;年龄37岁-72岁,中位年龄54岁;鳞癌37例,腺癌8例;初治10例,复治35例,人组后给予多西他赛37．5mg／m^2,d1、d8;奈达铂80mg／m^2,d2。每3周重复。2周期后按WHO标准评价近期疗效和毒性反应。结果全组共接受了177周期治疗,每例1—6周期,平均3．9周期,均可评价疗效及毒副作用。全组1例CR（2．2％）,16例PR（35．6％）。初治或复治、分期、病理类型对近期疗效均无影响。常见毒性反应为骨髓抑制。结论多它赛联合奈达铂治疗中晚期食道癌有较好的疗效,并且毒性反应可以控制,值得临床推广使用。     

紫杉醇脂质体联合奈达铂治疗晚期食管癌的临床观察

目的:评价紫杉醇脂质体联合奈达铂治疗晚期食管癌的临床疗效和不良反应。方法:42例晚期食管癌患者接受紫杉醇脂质体(每周135mg/m2)联合奈达铂(每周80mg/m2)治疗,21d为1个化疗周期。所有患者均至少接受2个周期的化疗,每2个周期评价近期疗效和不良反应。随访生存情况,采用意向性治疗分析。结果:42例患者中有41例可评价近期疗效,其中完全缓解1例(2.4%),部分缓解16例(38.1%),稳定14例(33.3%),疾病进展10例(23.8%),总有效率为40.5%(17/42)。18例初治患者的总有效率为55.6%,24例复治患者的总有效率为29.2%。1年总生存率为42.6%,中位无进展时间为6.3个月,中位总生存时间为11.3个月。常见的不良反应主要为血液学不良反应,7例患者发生3～4度中性粒细胞减少,4例患者发生3度血小板减少。3～4度呕吐发生率为7.3%(3/41),无化疗相关性死亡病例。结论:紫杉醇脂质体联合奈达铂治疗晚期食管癌疗效确切,不良反应较轻,值得在临床上对此开展进一步的研究。     

Concurrent chemoradiotherapy with new platinum compound nedaplatin in oral cancer

Eleven patients with oral cancer were treated with the new platinum agent, nedaplatin, and 5-fluorouracil and simultaneous radiation therapy. The regimen was of 5 days' duration: 5-fluorouracil 400-500 mg/m(2) (days 1-5), nedaplatin 80-90 mg/m(2) (day 4), and a total radiation dose of 8-10 Gy (days 1-5). Of the 11 patients, 4 (36.4%) showed complete response and 5 (45.4%) showed partial response; the total response rate was 81.8%. Major side effects were hypochromia (27%), leukopenia (64%), granulocytopenia (55%), thrombocytopenia (36%), nausea and vomiting (82%), and mucositis (45%). Toxicity was grade 2 or less in most of the 11 patients. The results indicate that the regimen composed of combination chemotherapy with nedaplatin and radiation therapy is effective in the treatment of patients with squamous cell carcinoma of the oral region.     

Retrospective analysis of 27 consecutive patients treated with docetaxel/nedaplatin combination therapy as a second-line regimen for advanced esophageal cancer

Background The aim of this study was to evaluate the efficacy and safety of combination therapy with docetaxel and nedaplatin in advanced esophageal cancer as a second-line regimen in an outpatient setting. Methods Twenty-seven consecutive patients with advanced esophageal cancer who received docetaxel/nedaplatin combination therapy as a second-line regimen were retrospectively evaluated. The combination therapy consisted of intravenous administration of docetaxel 30 mg/m² and nedaplatin 40 mg/m² every 2 weeks. Results The patients received a median of 7.4 cycles of treatment (range, 2–25 cycles ). No complete response was observed, and 3 of the 27 patients (11%) achieved partial responses. The disease control rate (partial response + stable disease) was 52%. The median survival time (MST) was 11.4 months. Severe hematological adverse events (grade 3–4) were: neutropenia (n = 10; 37%) and anemia (n = 5; 19%); there was neither febrile neutropenia nor grade 3-4 thrombocytopenia. Furthermore, no severe nonhematological adverse events or treatment-related deaths were observed. Conclusion Combination therapy of docetaxel with nedaplatin was safe and well tolerated; however, the development of more effective therapy is warranted to improve the prognosis of esophageal cancer.     

奈达铂联合诺维本治疗晚期食管癌的临床疗效观察

目的：观察奈达铂联合诺维本治疗晚期食管癌的疗效和不良反应。方法：晚期食管鳞癌34例,奈达铂80-100mg/m^2加入NS 500ml静脉滴注2h以上,第1天;诺维本25mg/m^2加入NS 40ml中静脉推注,第1、8天,21天为1周期,连用2个周期后评价疗效。结果：全组34例均可评价疗效及不良反应,总有效率58.8%。其中初治21例中,PR 14例,有效率66.7%;复治13例中,PR 6例,有效率46.2%。主要不良反应为骨髓抑制,7例（20.6%）患者出现Ⅲ-Ⅳ度白细胞下降,3例（8.8%）患者出现Ⅲ-Ⅳ度血小板下降。消化道反应轻,未发现肝肾功能损害。结论：奈达铂联合诺维本治疗晚期食管癌疗效肯定,不良反应小,值得临床推广使用。     

Docetaxel vs 5-fluorouracil plus vinorelbine in metastatic breast cancer after anthracycline therapy failure

This multicentre, randomised phase III study compared docetaxel with 5-fluorouracil+vinorelbine in patients with metastatic breast cancer after failure of neo/adjuvant or one line of palliative anthracycline-based chemotherapy. One hundred and seventy-six metastatic breast cancer patients were randomised to receive docetaxel (100 mg m(-2)) every 3 weeks or 5-fluorouracil+vinorelbine: 5-fluorouracil (750 mg m(-2) per day continuous infusion) D1-5 plus vinorelbine (25 mg m(-2)) D1 and D5 of each 3-week cycle. Eighty-six patients received 516 cycles of docetaxel; 90 patients received 476 cycles of 5-fluorouracil+vinorelbine. Median time to progression (6.5 vs 5.1 months) and overall survival (16.0 vs 15.0 months) did not differ significantly between the docetaxel and 5-fluorouracil+vinorelbine arms, respectively. Six (7%) complete responses and 31 (36%) partial responses occurred with docetaxel (overall response rate 43%, 95% confidence interval: 32-53%), while 4 (4.4%) complete responses and 31 (34.4%) partial responses occurred with 5-fluorouracil+vinorelbine (overall response rate 38.8%, 95% confidence interval: 29-49%). Main grade 3-4 toxicities were (docetaxel vs 5-fluorouracil+vinorelbine): neutropenia 82% vs 67%; stomatitis 5% vs 40%; febrile neutropenia 13% vs 22%; and infection 2% vs 7%. There was one possible treatment-related death in the docetaxel arm and five with 5-fluorouracil+vinorelbine. In anthracycline-pretreated metastatic breast cancer patients, docetaxel showed comparable efficacy to 5-fluorouracil+vinorelbine, but was less toxic.     

A case of advanced gastric cancer successfully treated by combination therapy of S-1 and docetaxel

A 70-year-old man with gastric cancer of Borrmann type 3, liver metastases and peritoneal dissemination was treated by combination therapy of S-1 and docetaxel (DOC). He received DOC intravenously at 40 mg/m(2) on day 1 and S-1 orally at 100 mg/body on day 1 to 14, repeated every 28 days. After 2 courses of treatment, a CT scan revealed improvement of the gastric wall thickness, the eminent decrease of the peritoneal fluid and the reduction of the liver metastasis. After 3 courses of treatment, the primary lesion was remarkably improved on endoscopic examination, and the tumor marker normalized after 4 courses of treatment. Toxicities included leukocytopenia (WHO grade 3), neutropenia ( grade 3), anorexia (grade 2), and nausea (grade 2). Outpatient chemotherapy was possible by reduction of dose (S-1 100--> 80 mg/body, DOC 40--> 32 mg/m2). The response was maintained on CT and endoscopic examination after 21 courses of treatment. A case of an advanced gastric cancer patient successfully treated by combination therapy of S-1 and DOC was reported.     

奈达铂联合多西他赛治疗晚期非小细胞肺癌临床观察

目的:观察奈达铂联合多西他赛治疗晚期非小细胞肺癌(non-small cell lung cancer,NSCLC)的疗效和不良反应.方法:78例经病理和/或细胞学确诊的NSCLC患者,随机分成治疗组40例和对照组38例.治疗组采用奈达铂 80mg/m2,静滴,d1.对照组采用顺铂25mg/m2,静滴,连续3d.两组均联合国产多西他赛75mg/m2,静滴d1;两种治疗方案均28天为1个周期.结果:治疗组和对照组治疗有效率分别为37.5%及42.1%,无明显统计学差异(P＞0.05);治疗组胃肠道反应明显低于对照组 (P＜0.05);两组肝毒性无明显差异,但肾毒性治疗组较对照组低(P=0.05);两组白细胞下降发生率分别为37.5%及39.5%,无显著差异;血红蛋白下降率分别为47.5%及52.6%, 无统计学差异;治疗组与对照组血小板下降率分别为47.5%及23.7%,具有统计学差异(P＜0.05).结论:治疗组与对照组的疗效基本接近,但治疗组胃肠道反应及肾毒性较轻,血小板的抑制率治疗组高于对照组外,血红蛋白及白细胞下降发生率无差异,奈达铂更易为医生和患者所接受.     

多西他赛联合奈达铂治疗PF方案耐药复发转移鼻咽癌的临床观察

目的:评价多西他赛联合奈达铂治疗对PF方案耐药复发、转移晚期鼻咽癌的初步疗效及其毒副反应,探讨治疗鼻咽癌的二线化疗方案.方法:诊断明确的转移、放疗后复发且对PF方案耐药的晚期鼻咽癌患者45例,奈达铂80 mg/m2,静脉滴入,d1;多西他赛75 mg/m2,静脉滴入,d2,每3周重复.化疗2个周期后根据WHO制定的实体瘤客观疗效评价标准和抗癌药物毒性分级(0～Ⅳ)标准评价疗效和不良反应.结果:45例患者共完成142个周期化疗,每例患者化疗周期数2～6个,中位化疗周期数为3个.完全缓解(CR)2例,部分缓解(PR)24例,稳定(SD)13例,进展(PD)6例,总有效率为57.8％(26/45).1年生存率为66.7％(30/45).毒副反应主要表现为脱发,粒细胞和血小板、血色素中轻度减少,其余毒副反应较少.结论:多西他赛联合奈达铂治疗对PF方案耐药的晚期鼻咽癌有效率高,不良反应可以耐受,是治疗晚期鼻咽癌较好的二线化疗方案.