A feasible study of docetaxel/nedaplatin combined chemotherapy for relapsed or refractory esophageal cancer patients as a 2nd-line chemotherapy

As a 2nd-line treatment for relapsed or refractory esophageal cancer patients after chemoradiotherapy, we performed a combination chemotherapy of DOC/CDGP for 11 patients.Intravenous drip infusion of DOC 30 mg/m(2)and CDGP 30 mg/m(2)on days 1, 8 and 15, and 4 weeks treatment was assumed as 1 cycle.We treated 8 of 11 patients with more than 2 cycles, and 4 of 8 patients were treated with radiation therapy (RT). The effects by RECIST revealed partial response (PR) in 2 patients (50%), stable disease (SD) in 1 patient and progress disease (PD) in 1 patient without RT, and PR in 3 patients and not effective in 1 patient with RT, respectively. There was no treatment-related death nor adverse event of grade 4. The Hematological toxicities of leukopenia of grade 3 were observed in 3 patients. Non-hematological toxicites more than grade 3 were not observed. The combination chemotherapy of DOC/CDGP was concluded to be safe and effective for relapsed or refractory esophageal cancer patients as a 2nd line treatment.     

长春瑞滨联合顺铂治疗放疗后复发食管癌32例疗效观察

[目的]观察长春瑞滨(NVB)联合顺铂(DDP，NP方案)治疗放疗后复发食管癌的临床疗效及毒副反应。[方法]32例放疗后复发食管癌患者采用NP方案化疗，NVB 30mg／m^2．快速静脉滴入d1.8，DDP 80mg／m^2，静脉滴入d1.2，28天为1个周期，共83个周期，平均每例2．6个周期。[结果]总有效率为40．5％，完全缓解(CR)6．2％、部分缓解(PR)34．3％、稳定(SD)37．5％、进展(PD)22％．中位缓解期(TTP)4．8个月。毒副反应主要表现为骨髓抑制，白细胞减少发生率84．3％。[结论]NP方案治疗放疗后复发食管癌疗效肯定，毒副反应能够耐受。     

盖诺联合顺铂治疗中、晚期食管癌的临床疗效观察

目的观察盖诺(NVB)联合顺铂(CDDP)的NP方案治疗食管癌的疗效和毒副反应。方法对46例食管癌患者应用NP方案进行治疗,其中NVB25~30mg/m2,静脉滴入,d1、d8给药;DDP30mg/m2,静脉冲入,d1~3给药,21~28天为1周期,每例至少治疗2个周期。结果46例患者中总有效率(RR)为45.7%(21/46),其中CR2.2%(1/46),PR43.5%(20/46),SD34.8%(16/46),PD19.6%(9/46),中位生存期9.6个月(2~24个月),主要毒副反应为骨髓抑制及消化道反应。结论盖诺联合顺铂治疗食管癌疗效确切,毒副反应可以耐受。     

Phase I trial of topotecan in combination with gemcitabine in refractory solid tumor patients

PURPOSE: To determine maximum tolerated dose (MTD) and evidence of antitumor activity of topotecan in combination with gemcitabine in refractory cancer patients. METHODS: This was a Phase I, prospective, dose-escalation trial that employed a novel-dosing schema to investigate clinical safety. Patients were treated in six cohorts with topotecan (T)+gemcitabine (G). The doses of T and G were administered by 30-minute IV infusion, T on days one through five (0.3 mg/m2 to 1 mg/m2) and G on days one and 15 of a 28-day cycle (1000 mg/m2 to 1500 mg/m2). Toxicity was monitored. RESULTS: Twenty-three cancer patients were enrolled (colorectal, n=5; lung, n=4; gastric, n=4; esophageal, n=2; other, n=8). Two of three patients developed grade 3 nonhematologic toxicity attributed to study regimen, thereby fulfilling dose limiting toxicity requirements at cohort 6 (T, 1 mg/m2, G, 1500 mg/m2). Maximum tolerated dose (MTD) was established at cohort 5 (T, 1 mg/m2, G, 1250 mg/m2). Ten patients were treated at cohort 5. Nonhematologic adverse effects (AEs) >grade 3 attributed to the study regimen were not observed. Hematologic toxicity was frequent. Twenty-five percent of patients in cohort 2 and 50% of patients in cohorts 4, 5, and 6 had a reduction of ANC to <500 mm3. All neutropenic episodes were less than one week in duration. Five of the patients in the last three cohorts required delay and/or dose-reduction of G. Nineteen of 23 enrolled patients were evaluable for response. Two patients achieved a minimal response. CONCLUSIONS: The MTD was observed at a T dose of 1 mg/m2 administered on days 1 through 15, and a G dose of 1250 mg/m2 administered on days 1 and 15 via 30 minute intravenous (IV) infusion.     

紫杉醇治疗食管癌疗效分析

目的 观察国产紫杉醇（紫素,ＴＡＸ）单药,与顺铂和５－氟尿嘧啶联合治疗食管癌的疗效。方法：用从我国红豆杉吕提取的ＴＡＸ治疗Ⅲ,Ⅳ期食管癌,单药治疗食管癌：ＴＡＸ１５０～１７５ｍｇ／ｍ＾２静滴３小时,每３周一次,共２周期。ＴＡＸ／ＤＤＰ／５－ＦＵ联合化疗：ＴＡＸ１３５ｍｇ／ｍ＾２,ｉｖ;ＤＤＰ每天２５ｍｇ／ｍ＾２第１～３天静滴,５－ＦＵ每天５００～７５０ｍｇ／ｍ＾２第１～５天静滴,联合化疗每２８天重     

异长春花碱加异环磷酰胺加顺铂联合化疗治疗晚期非小细胞肺癌

目的 评价异长春花碱加异环磷酰胺加顺铂（NIP）联合方案作为第一线化疗对晚期非小细胞肺癌病人的疗效及毒副作用。方法 化疗方案包括异长春花碱25mg/m^2 20min静脉输注第1d和第8d,异环磷酰胺1．2g/m^2 3h静脉输注第1－3d,美司纳400mg-800mg于0、4、8h静脉推注第2－3d,顺铂25mg/m^2 2h静脉输注第1－3d。每3周重复疗程。结果 共54例病人进行本项研究。51例可评价疗效,54例可评价毒性反应。总缓解率为53％,3例（6％）完全缓解,24例（47％）部分缓解。16例（31％）肿瘤稳定,8例（16％）肿瘤发展。中位缓解期7个月,全组中位生存期10个月。本化疗方案的剂量限制毒性为骨髓抑制,其中72％的病人发生3－4度中性粒细胞下降。结论 NIP是治疗晚期非小细胞肺癌有效的联合化疗方案,毒性反应能够耐受,值得进一步研究。     

Docetaxel and cisplatin as first-line treatment for patients with metastatic esophageal cancer: a pilot study

BACKGROUND: We investigated the combination of docetaxel and cisplatin as first-line chemotherapy in patients with metastatic esophageal cancer. PATIENTS AND METHODS: 16 chemotherapy-na?ve patients with distant metastases were included in the study (15 male, 1 female; median age: 58.5 years (range 37-69); median ECOG performance status: 1). 11 patients (69%) had esophageal cancer, and 5 patients (31%) had cancer of the gastroesophageal junction. Patients received docetaxel 75 mg/m2 and cisplatin 80 mg/m2 on day 1 every 3 weeks. A total of 55 chemotherapy cycles was administered. The median number of cycles was 3 (range 1-6). RESULTS: The overall response rate was 31.3%. 4 out of 10 patients (40%) with squamous cell carcinoma and 1 out of 5 patients (20%) with adenocarcinoma responded to chemotherapy. The median overall survival was 29.6 weeks, and the median progression-free survival was 18.6 weeks. Hematological and non-hematological toxicities were moderate (neutropenia WHO grade III/IV: 42.9%, alopecia grade II/III: 64.3%, nausea/vomiting grade II/III: 57.2%, neurotoxicity grade II: 14.3%). CONCLUSION: The combination of docetaxel and cisplatin is an active regimen with moderate toxicity in the treatment of patients with metastatic esophageal cancer. This pilot study demonstrates the feasibility of a combination treatment containing a taxane and cisplatin in metastatic esophageal cancer.     

Combination therapy with cisplatin, 5'-deoxy-5-fluorouridine (5'-DFUR) and mitomycin (MMC) in patients with inoperable, advanced gastric cancer

The optimal dose of cisplatin (CDDP) for combination chemotherapy for the treatment of inoperable, advanced gastric cancer has yet to be established. We therefore performed a randomized study to compare the therapeutic usefulness of two dose levels of cisplatin. 5'-deoxy-5-fluorouridine (5'-DFUR 1,400 mg/m(2)/d) was given orally on days 1 to 4 and 15 to 18. Mitomycin C (MMC, 5.75 mg/m(2)/d) was injected intravenously on day 5. In addition, 80 mg/m2/d of CDDP (regimen A) or 60 mg/m(2)/d of CDDP (regimen B) was given by 2-h intravenous drip infusion on day 5. This treatment cycle was repeated every four weeks. Fifty-six patients were enrolled. Clinical response was evaluated in 32 patients (regimen A, 16 patients; regimen B? 16 patients) with measurable lesions. The response rate was significantly higher with regimen A (9 PR/16, 56.3%) than with regimen B (3 PR/16, 18.9%) (p=0.028, chi(2) test). Median survival was slightly but not significantly longer with regimen A (7.4 months) than with regimen B (6.3 months). Drug toxicity included myelosuppression and gastrointestinal symptoms, but there were no serious adverse reactions or differences in safety between the treatment regimens. Regimen A was associated with a high response rate and low toxicity. The optimal dose of CDDP in combination with 5'-DFUR and MMC for the treatment of advanced gastric cancer is regarded to be 80 mg/m(2).     

Low-dose mitomycin and weekly low-dose doxorubicin combination chemotherapy for patients with metastatic breast carcinoma previously treated with cyclophosphamide, methotrexate, and 5-fluorouracil

Forty-four evaluable patients with breast carcinoma previously treated with combination chemotherapy consisting of cyclophosphamide, methotrexate, and 5-fluorouracil (CMF) were treated with a combination chemotherapy regimen consisting of doxorubicin (A) (20 mg/m2 on days 1, 8, 15, and 22, repeated every 28 days) and mitomycin (MIT) (10 mg/m2 on day 1, repeated every 28 days). Five patients (11%) achieved a complete remission (CR) and 14 patients (32%) had a partial response (PR). The median duration of survival was 11.5 months and the median duration of response was 8 months for responders (CR and PR). Toxicity was moderate and consisted of neutropenia (74%), thrombocytopenia (25%), pneumonitis (11%), and cardiomyopathy (2%). The combination chemotherapy regimen A and MIT is an effective regimen for treating previously treated with CMF.     

Efficacy and toxicity of vinorelbine with doxorubicin/cyclophosphamide combination chemotherapy in a phase I-II study for advanced or recurrent breast cancer patients

BACKGROUND: To evaluate the efficacy and toxicity of vinorelbine (VNB) with doxorubicin/cyclophosphamide (AC) combination chemotherapy, a phase I-II study was carried out in patients with advanced or recurrent breast cancer. METHODS: The phase I part of this study was carried out to determine the treatment schedule and acceptable dose of VNB for the phase II study. In phase I, VNB was initially given as a short infusion on days 1, 8 and 15, every 4 weeks. The initial dose of vinorelbine was 15 mg/m2. In the AC regimen, 20 mg/m2 of doxorubicin (ADM) was given intravenously (i.v.) on days 1 and 8, and 100 mg/body of cyclophosphamide (CPA) was administered orally from days 1 to 14. Subsequently, a phase II study was carried out at the maximum acceptable dose (MAD). RESULTS: Twenty-three patients were entered into this study. In patients receiving VNB at a dose of 15 mg/m2, neutropenia (> or = grade 3) frequently occurred on day 15. The treatment schedule of this study was therefore changed to VNB given i.v. on days 1 and 8 with AC combination chemotherapy. In this treatment schedule, grade 4 neutropenia lasting for more than 4 days occurred in patients given VNB at a dose of 20 mg/m2 with AC more frequently than in those given 15 mg/m2 of VNB. Therefore, the MAD of VNB was determined to be 20 mg/m2 in this regimen. At this recommended dose, there were 1 complete (CR) and 8 partial responses (PRs) in 15 patients, with an overall response rate of 60.0%. No treatment-related death occurred. CONCLUSIONS: These data indicate that VNB plus AC combination chemotherapy was effective and well tolerated for breast cancer patients. A randomized trial of VNB plus AC vs. AC combination chemotherapy may be required to ascertain the benefit of this regimen for advanced or recurrent breast cancer patients.