Long-term survival in metastatic melanoma patients treated with sequential biochemotherapy: report of a Phase II study

The overall survival for patients with metastatic melanoma is very poor, with a median survival of 8.5 months. In this Phase II trial, we assessed the efficacy, safety, and tolerability of a sequential biochemotherapy schedule, using dacarbazine as antiblastic agent and immunomodulant doses of interleukin-2 and interferon-alfa. Thirty-one eligible patients with metastatic melanoma received dacarbazine IV as antiblastic therapy and interluekin-2, plus interferon-alfa SC as sequential immunotherapy, for 6 months. Responding and nonprogressing patients were subsequently maintained on immunotherapy treatment for further 6 months. Twenty-nine patients had an adequate trial, and were assessable for both response and toxicities, with a median follow-up of 49 months. The overall response rate was 52 percent (3 CR and 12 PR), SD was 8 (27 percent) and PD were achieved in 6 patients (21 percent). The median survival duration of responders was 28 months, significantly longer (p < 0.001) than the 16 months of nonresponders. Therapy was well tolerated and produced a significant improvement in progressive-free survival. Further studies, thus, are recommended for larger groups of patients not only to confirm these results, but also to apply this biochemotherapy regimen as adjuvant postsurgical treatment in early stages of malignant melanoma.     

肝动脉泵生物化疗治疗进展期黑色素瘤肝转移Ⅱ期临床研究

背景与目的：黑色素瘤肝转移全身治疗效果不佳,国外研究发现肝动脉灌注化疗可显著改善疗效,本研究进一步探讨肝动脉泵为基础的生物化疗治疗肝转移的疗效及对生存期的影响。方法：选择进展期黑色素瘤肝转移患者21例,予肝动脉泵置入,行淋巴细胞删除性化疗（福莫司汀＋达卡巴嗪）,化疗后立刻进行自体细胞因子诱导的杀伤细胞回输．并同时应用白介素-2、粒细胞巨噬细胞集落刺激因子治疗,28d为一周期。疗效评定采用实体瘤疗效评价标准。对21例患者的疾病控制率、不良反应发生率、无进展生存期、总生存期进行分析。结果：可评价疗效患者共17例,完全缓解1例,部分缓解1例,稳定6例．进展9例。疾病控制率47．06％（8／17）。中位无进展生存期3个月。中位生存期6个月。Ⅲ～Ⅳ级的不良反应占38．1％（8／21）。结论：对于进展期黑色素瘤肝转移患者。以肝动脉泵为基础的生物化疗可明显改善患者的疾病控制率。无进展生存期、总生存期有延长趋势,毒副作用可耐受,是一种有良好前景的治疗模式。     

A Phase Ⅱ Trial of Gefitinib as Maintenance Therapy after First-Line Chemotherapy for Advanced Non-Small Cell Lung Cancer in China

Objective:To investigate the efficacy and safety of gefitinib as maintenance therapy for advanced non-small cell lung cancer (NSCLC) patients who obtained disease control (DC) after first-line chemotherapy in Chinese population. Methods:Chinese patients with advanced NSCLC treated with standard chemotherapy and obtained DC were assigned to receive gefitinib as maintenance treatment. The primary end point was overall survival time (OS), the second end point was disease control rate (DCR) and progression-free survival time (PFS). DCR included complete response (CR) plus partial response (PR) and plus stable disease (SD). The impact of epidermal growth factor receptor (EGFR) mutation status on the treatment as exploratory point was also evaluated by denaturing high-performance liquid chromatography (DHPLC). Results:Among 75 enrolled patients, the overall response rate was 37% and the DCR (CR + PR +SD) was 66%. The median PFS and OS were 17.13 months and 26.13 months respectively, with 1- and 2-year survival rates 89.3% and 34.7%. Patients harboring somatic EGFR mutations obtained a prolonged median PFS and OS compared with EGFR wide type (25.1 vs. 13.0 months, P=0.019 and 33.37 vs. 25.57 months, P=0.014, respectively). In COX regression model, only EGFR mutation status was the independently factor influencing both PFS and OS (P=0.029 and 0.017, respectively), however, rash status was the predictor in terms of PFS (P=0.027).Conclusion:Gefitinib produced encouraging survival when delivered as maintenance therapy in Chinese patients obtaining DC after first-line chemotherapy, especially for patients carrying somatic EGFR mutations. EGFR mutation is an independently predictive factor of survival.     

Clinical results using biochemotherapy as a standard of care in advanced melanoma

Phase II studies of biochemotherapy in metastatic melanoma patients have reported response rates of 47-63%. Even though these were highly selected patients, we were intrigued by these promising response rates and began using this regimen as standard care in advanced melanoma patients. We report the results of the first 65 patients with AJCC stage IV melanoma (n = 57) or unresectable stage III (n = 8) melanoma treated with concurrent biochemotherapy at Memorial Hospital. Treatment was repeated every 3 weeks and patients were assessed for antitumour effects after every other cycle. The overall response rate among the 63 patients evaluable for response was 29% (three complete responses, 15 partial responses). The median duration of responses was 3.7 months. The response rate among previously treated and previously untreated patients was 6% and 38%, respectively. The estimated median survival for all patients was 8.5 months; the median survival for previously untreated patients was 9.2 months. Tumour response did not correlate with survival. Our experience, which is a retrospective evaluation, does not provide support for the routine use of biochemotherapy as standard treatment. The low response rate among previously treated patients indicates that biochemotherapy is not useful as second-line therapy.     

贝伐珠单抗联合FOLFOX或FOLFIRI方案治疗转移性结直肠癌的临床研究

目的 观察贝伐珠单抗联合FOLFOX或FOLFIRI方案用于转移性结直肠癌一线及二线治疗的临床疗效和毒副反应。方法 回顾性分析2005年11月至2012年8月接受贝伐珠单抗联合FOLFOX或FOLFIRI方案作为一线及二线治疗的57例转移性结直肠癌患者的临床资料。采用RECIST 1.1版评价疗效,用NCI-CTC 3.0版评价不良反应,用Kaplan-Meier法进行生存分析。结果 57例结直肠癌患者中,19例（33.3％）获PR,28例（49.2％）获SD,有效率（RR）为33.3％,疾病控制率（DCR）为82.5％。贝伐珠单抗联合化疗用于一线与二线治疗患者的RR或DCR差异均无统计学意义（P＞0.05）;贝伐珠单抗联合FOLFOX方案与FOLFIRI方案的RR或DCR差异均无统计学意义（P＞0.05）。57例患者的无进展生存期（PFS）及总生存期（OS）分别为8.83个月及14.80个月。一线与二线治疗及贝伐珠单抗联合FOLFOX方案与FOLFIRI方案的中位PFS或OS差异均无统计学意义（P＞0.05）。主要不良反应包括白细胞减少、血小板减少及恶心呕吐。贝伐珠单抗相关的不良反应主要包括高血压3例,蛋白尿1例,鼻衄2例,均为1～2级,药物可以控制。结论 贝伐珠单抗联合化疗治疗转移性结直肠癌能够提高治疗疗效,不良反应可以耐受。     

30例自体外周造血干细胞移植治疗多发性骨髓瘤的疗效及预后因素评价

目的:对30例多发性骨髓瘤（multiple myeloma,MM）患者经自体外周造血干细胞移植（autologous hematopoietic stem cell transplantation ,APBSCT）治疗后的临床疗效进行评估,并分析可能影响预后的因素。方法:30例MM患者有2 例复发行2 次APBSCT,因此共计移植32例次。移植前予常规联合化疗（11例含万珂）,化疗联合G-CSF 动员APBSC ,选择以马法兰为基础的预处理方案,d0 天回输。结果:动员后患者采集的单个核细胞（MNC）中位数为6.41× 108/kg,CD34+细胞4.75× 106/kg。APBSCT后中位中性粒细胞和血小板重建时间分别为9.5 天和11天。APBSCT后CR和VGPR 率分别为37.5% 和34.4% ,中位生存期（overallsurvival ,OS）为67.27个月,中位无进展生存期（progression-freesurvival ,PFS）为29.77个月,其中CR组、PR组中位PFS 分别为29个月、20个月,VGPR 组中位PFS 未达到,CR+VGPR组与PR组PFS 比较P=0.025。万珂组和非万珂组CR率分别为63.6% 和23.8%（P=0.034）,万珂组中位OS及PFS 均未达到,非万珂组中位PFS 为22个月（P=0.045）。 结论:硼替佐米诱导序贯APBSCT可获得更长的无病生存。APBSCT作为MM诱导缓解后的强化治疗,缓解率高,且移植后获得VGPR 以上反应的患者PFS 获益。      

Advantages of concurrent biochemotherapy modified by decrescendo interleukin-2, granulocyte colony-stimulating factor, and tamoxifen for patients with metastatic melanoma.

PURPOSE: Concurrent biochemotherapy results in high response rates but also significant toxicity in patients with metastatic melanoma. We attempted to improve its efficacy and decrease its toxicity by using decrescendo dosing of interleukin-2 (IL-2), posttreatment granulocyte colony-stimulating factor (G-CSF), and low-dose tamoxifen. PATIENTS AND METHODS: Forty-five patients with poor prognosis metastatic melanoma were treated at a community hospital inpatient oncology unit affiliated with the John Wayne Cancer Institute (Santa Monica, CA) between July 1995 and September 1997. A 5-day modified concurrent biochemotherapy regimen of dacarbazine, vinblastine, cisplatin, decrescendo IL-2, interferon alfa-2b, and tamoxifen was repeated at 21-day intervals. G-CSF was administered beginning on day 6 for 7 to 10 days. RESULTS: The overall response rate was 57% (95% confidence interval, 42% to 72%), the complete response rate was 23%, and the partial response rate was 34%. Complete remissions were achieved in an additional 11% of patients by surgical resection of residual disease after biochemotherapy. The median time to progression was 6.3 months and the median duration of survival was 11.4 months. At a maximum follow-up of 36 months (range, 10 to 36 months), 32% of patients are alive and 14% remain free of disease. Decrescendo IL-2 dosing and administration of G-CSF seemed to reduce toxicity, length of hospital stay, and readmission rates. No patient required intensive care unit monitoring, and there were no treatment-related deaths. CONCLUSION: The data from this study indicate that the modified concurrent biochemotherapy regimen reduces the toxicity of concurrent biochemotherapy with no apparent decrease in response rate in patients with poor prognosis metastatic melanoma.     

恶性黑色素瘤的生物治疗和生物化疗

OBJECTIVE: To evaluate the efficacy of postoperative biochemotherapy on survival of patients with malignant melanoma. METHODS: One hundred and five patients with malignant melanoma received postoperative biotherapy/biochemotherapy or radiotherapy/chemotherapy. The median time of follow-up was 3 years (from 1 to 5 years). RESULTS: The median survival time (MST) in the whole series of patients was 27 months (range: 2-72 months). The MST in patients received postoperative biotherapy/biochemotherapy (57 cases) was 32 months with a 3-year survival rate of 36.8%. That in patients received postoperative radiotherapy/chemotherapy (54 cases) was 20 months. CONCLUSION: Biotherapy/biochemotherapy following surgery may significantly improve survival in patients with malignant melanoma.     

GP和FP治疗转移性鼻咽癌的疗效观察

目的：观察吉西他滨＋顺铂（GP）方案和氟尿嘧啶＋顺铂（FP）方案治疗晚期复发转移性鼻咽癌的疗效及不良反应。方法：选择放疗后复发转移性鼻咽癌60例,分别采用GP方案或FP方案静脉化疗,21天为1周期。结果：GP组：CR5例、PR19例,有效率（CR＋PR）80％;FP组：CR2例、PR14例,有效率（CR＋PR）53．3％两组有效率有显著差异（P=0．0283）。中位PFS（无进展生存期）GP组8个月,FP组3个月（P=0．0001）。中位OS期（总生存期）GP组11个月,FP组7个月（P=0．0002）。两组毒性均能耐受。结论：GP方案较FP可以更好改善复发转移性鼻咽癌的RR、PFS和OS。     

First-line temozolomide combined with bevacizumab in metastatic melanoma: a multicentre phase II trial (SAKK 50/07)

BackgroundOral temozolomide has shown similar efficacy to dacarbazine in phase III trials with median progression-free survival (PFS) of 2.1 months. Bevacizumab has an inhibitory effect on the proliferation of melanoma and sprouting endothelial cells. We evaluated the addition of bevacizumab to temozolomide to improve efficacy in stage IV melanoma.Patients and methodsPreviously untreated metastatic melanoma patients with Eastern Cooperative Oncology Group performance status of two or more were treated with temozolomide 150 mg/m² days 1–7 orally and bevacizumab 10 mg/kg body weight i.v. day 1 every 2 weeks until disease progression or unacceptable toxicity. The primary end point was disease stabilisation rate [complete response (CR), partial response (PR) or stable disease (SD)] at week 12 (DSR12); secondary end points were best overall response, PFS, overall survival (OS) and adverse events.ResultsSixty-two patients (median age 59 years) enrolled at nine Swiss centres. DSR12 was 52% (PR: 10 patients and SD: 22 patients). Confirmed overall response rate was 16.1% (CR: 1 patient and PR: 9 patients). Median PFS and OS were 4.2 and 9.6 months. OS (12.0 versus 9.2 months; P = 0.014) was higher in BRAF V600E wild-type patients.ConclusionsThe primary end point was surpassed showing promising activity of this bevacizumab/temozolomide combination with a favourable toxicity profile. Response and OS were significantly higher in BRAF wild-type patients.     

Biochemotherapy of metastatic melanoma in patients with or without recently diagnosed brain metastases

BACKGROUND: Brain metastases are an alarming complication of advanced melanoma, frequently contributing to patient demise. The authors performed a retrospective analysis to determine whether the treatment of metastatic melanoma with biochemotherapy would result in similar outcomes if brain metastases were first controlled with aggressive, central nervous system (CNS)-directed treatment. METHODS: Seventy melanoma patients were treated with biochemotherapy for metastatic melanoma between 1999 and 2005. Of these, 20 patients had recently diagnosed brain metastases, whereas 50 did not. Brain metastases (if present) were treated with stereotactic radiosurgery >or=28 days prior to systemic therapy. All patients were treated with biochemotherapy consisting of either dacarbazine or temozolomide in combination with a 96-hour continuous intravenous infusion of interleukin-2 and subcutaneous interferon-alpha-2B. The primary endpoint was survival from the time of the initial diagnosis of metastatic disease. RESULTS: Median survival from the time of the diagnosis of metastatic melanoma was 15.8 months for patients with brain metastases and 11.1 months for those without CNS involvement (P = .26 by the log-rank test; P = .075 by the Gehan Wilcoxon test). Dacarbazine-based and temozolomide-based regimens appeared similar with regard to their effect on overall survival and CNS disease progression. A plateau in further brain recurrences was observed in patients who survived for > 20 months. CONCLUSIONS: Data from the current study suggest that the outcome of biochemotherapy is comparable in patients with and those without brain metastases, if brain metastases are controlled with multidisciplinary treatment. Prolonged survival can be achieved in approximately 15% of patients, regardless of whether or not brain metastases are present.     

GEMOX方案和FOLFOX方案一线治疗晚期十二指肠癌的疗效观察

目的 探讨GEMOX方案和FOLFOX方案一线治疗晚期十二指肠癌的疗效和安全性。方法 回顾分析本院2008年6月至2016年1月收治的30例晚期十二指肠癌患者的临床及随访资料,其中10例未接受化疗,20例接受化疗（GEMOX方案9例、FOLFOX方案11例）,分别采用RECIST 1.1版与NCI-CTC 4.0版标准评价疗效和不良反应,Kaplan-Meier法进行生存分析。结果 GEMOX方案和FOLFOX方案均无CR和PR病例,其中GEMOX方案获SD 6例、PD 3例,疾病控制率（DCR）为66.7％,FOLFOX方案获SD 4例、PD 7例,DCR为36.4％,两组DCR的差异无统计学意义（P＞0.05）。GEMOX方案和FOLFOX方案的中位总生存期（OS）分别为27.9个月和15.2个月（P=0.179）;GEMOX方案的中位无进展生存期（PFS）为8.0个月,优于FOLFOX方案的4.4个月,差异有统计学意义（P=0.038）。常见不良反应多为1～2级,主要为白细胞减少、中性粒细胞减少、乏力、恶心、皮疹等。20例接受化疗患者的中位OS为26.9个月,优于10例未接受化疗的4.4个月,差异有统计学意义（P＜0.001）。结论 化疗可延长晚期十二指肠癌患者的生存时间。GEMOX方案和FOLFOX方案均对晚期十二指肠癌一线治疗有效,且耐受性良好,其中GEMOX方案的中位PFS可能更长。     

含利妥昔单抗化疗方案治疗套细胞淋巴瘤效果分析

目的探讨含利妥昔单抗化疗方案治疗套细胞淋巴瘤(MCL)患者效果及预后影响因素。方法回顾性分析2007年6月至2018年11月苏州大学附属第一医院血液科收治的56例≤65岁MCL患者临床资料,化疗方案中均包括利妥昔单抗,观察临床特征、治疗方案及生物学指标对总生存(OS)和无进展生存(PFS)的影响。结果56例患者中位发病年龄57岁,男性43例,女性13例。24例接受R-CHOP方案化疗;29例接受含阿糖胞苷方案化疗,其中15例接受R-hyper CVAD/R-MA方案化疗,14例接受R-CHOP/R-DAHP交替治疗;3例接受其他方案化疗。19例接受自体造血干细胞移植(ASCT)巩固治疗。56例患者中位OS时间74个月,2年OS率83.8%,3年OS率70.9%,2年PFS率72.0%,3年PFS率49.7%。国际预后指数(IPI)评分和治疗中是否接受ASCT是MCL患者OS和PFS的独立影响因素。含阿糖胞苷治疗组总有效率(ORR)93.1%,优于R-CHOP方案组(83.3%),差异无统计学意义(χ²=0.465,P=0.495);两组间OS及PFS差异均无统计学意义(OS:χ²=0.291,P=0.590;PFS:χ²=0.912,P=0.339)。诱导化疗达缓解的MCL患者中,ASCT巩固治疗可延长中位OS时间(72个月比124个月,χ²=3.973,P=0.040)及中位PFS时间(34个月比90个月,χ²=3.984,P=0.046)。简化MCL国际预后指数(sMIPI)评分中高危组患者中接受ASCT巩固治疗患者OS和PFS优于未接受ASCT治疗者(OS:χ²=5.037,P=0.025;PFS:χ²=6.787,P=0.009),而sMIPI评分低危组患者中,是否接受ASCT组间OS、PFS差异均无统计学意义(均P>0.05)。结论含阿糖胞苷的化疗方案对改善MCL患者的预后和生存并不理想。对于诱导化疗达缓解及sMIPI评分中高危组的MCL患者,ASCT巩固治疗可改善其预后,可作为年轻患者的一线巩固治疗方案。     

Biochemotherapy for metastatic melanoma with limited central nervous system involvement

OBJECTIVES: Biochemotherapy outcomes were examined in stage IV melanoma patients with previously treated or active central nervous system (CNS) metastases prior to systemic therapy. PATIENTS AND METHODS: Patients who received biochemotherapy for metastatic melanoma with active or pretreated CNS metastases were compared to patients without evidence of CNS metastases in terms of response, time to progression (TTP), overall survival (OS), and treatment toxicity. RESULTS: Twenty-six (16%) of 159 total patients began biochemotherapy with previously treated or active CNS metastases (group I), compared to 133 (84%) who were radiographically free of CNS involvement (group II). A partial or complete response to biochemotherapy was seen in 13 (50%) group I patients, compared to 56 (42%) group II patients (p = 0.243). The median TTP and median survival were 5.5 and 7.0 months, respectively, for group I patients and 6.0 and 9.9 months, respectively, for group II patients (p = 0.222 and 0.434 for TTP and OS, respectively). Five (19%) group I patients survived longer than 24 months. Gamma Knife radiosurgery or surgical resection of CNS disease prior to biochemotherapy improved survival versus delayed treatment (p = 0.017 and 0.005, respectively). CONCLUSION: Patients with limited CNS metastases and widespread systemic disease can achieve prolonged survival with targeted treatment of CNS lesions and aggressive systemic therapy.     

137 例MAID方案一线化疗转移软组织肉瘤的回顾性临床分析

目的:评价MAID方案一线治疗转移性STS 的临床疗效、不良反应和对生存期的影响。方法:根治术后出现远处转移的晚期STS 患者137 例,阿霉素（ADM）60mg/m2第1 天静脉滴注,异环磷酰胺（IFO ）8～10g/m2分4～5 天静脉滴注,IFO 开始静脉滴注的0、4、8h 各予美司纳（Mesna）每天总量的20% 静脉推注,氮烯咪胺（DTIC）200mg/m2静脉滴注,连续4～5 天。21天为1 个周期,完成2～6 个周期,中位周期数为4 个。结果:全组患者CR4 例（2.9%）,PR13例（9.5%）,SD88例（64.2%）,PD32例（23.4%）,有效率12.4% ,临床获益率76.6% 。PFS 2～14个月,mPFS（5.00± 1.12）个月,OS3～19个月,mOS（8.00± 1.32）个月。3 个月PFS 生存率56.9% ,6 个月PFS 生存率27.2% ,1 年PFS 生存率7.8% 。3 个月OS生存率100.0% ,6 个月OS生存率41.5% ,1 年OS生存率10.7% 。主要不良反应为骨髓抑制、胃肠道反应和脱发,其他不良反应少见。结论:MAID方案一线治疗转移性STS 疗效确切,能够有效控制疾病进展,不良反应可以耐受,作为进展期STS 的一线化疗方案具有明显的临床应用价值。      

自体造血干细胞移植可使中国高危多发性骨髓瘤患者获益更多

目的 评价自体造血干细胞移植（ASCT）对初治多发性骨髓瘤（MM）的疗效.方法 选取诱导治疗后获得部分缓解（PR）及以上疗效的42例初治MM患者进行ASCT,中位随访34.2个月后,观察患者的疗效、无进展生存（PFS）和总生存（OS）.选择同时期的49例诱导治疗后获得PR及以[上疗效的初治MM患者,进入非移植组（non-ASCT）,经巩固维持治疗后观察疗效、PFS和OS,比较两组的差异,分析ASCT在MM中的作用.结果 与non-ASCT组相比,ASCT可明显延长患者的OS（未达到/37.2个月,P=O.000）,而且对PFS也有延长趋势（33.9个月/39.8个月,P=0.133）.ASCT可明显改善DSⅢ期（P=0.009）和ISSⅢ期（P=0.049）患者PFS,但对DSⅠ /Ⅱ期和ISS Ⅰ/Ⅱ期患者的PFS改善不明显.ASCT可明显改善诱导治疗后获得CR患者的PFS（P=0.016）,对非常好的PR （VGPR） /PR患者的PFS改善不明显;不同年龄患者OS均明显改善（≤55岁,P=0.039;＞ 55岁,P=0.000）.ASCT可明显改善不同ISS分期患者的OS（Ⅰ/Ⅱ期,P=0.003;Ⅲ期,P=0.012）,对DSⅢ期患者的OS也有明显改善作用（P=0.000）,但对DSⅠ/Ⅱ期患者OS的作用不明显（P=0.446）.诱导治疗后获得CR和VGPR/PR的患者进行移植后,OS可进一步得到改善（CR,P=0.004; VGPR/PR,P=0.004）.结论 ASCT可明显改善初治MM患者的生存,使高龄和分期预后不良的MM患者获益更多.     

贝伐珠单抗联合化疗治疗4例晚期持续/复发性子宫肉瘤

目的：观察贝伐珠单抗（bevacizumab,BEV）联合化疗治疗晚期持续/复发性子宫肉瘤的临床疗效。方法回顾性分析中国医学科学院肿瘤医院院2006年5月至2014年5月接受贝伐珠单抗与化疗联合治疗的4例晚期持续/复发性子宫肉瘤患者的临床资料,评价治疗的总有效率、临床获益率、无进展生存时间（progres-sion free survival,PFS）和总生存时间（overall survival,OS）,并评价治疗的安全性和毒性反应。结果4例患者中,1例达完全缓解,无瘤生存时间为96个月;1例达部分缓解,PFS为13个月,OS为25个月;1例为疾病稳定,PFS为9个月,OS为24个月;1例为疾病进展,PFS为3个月,OS为9个月。治疗总有效率为50％（2/4）,临床获益率为75%（3/4）,平均PFS为30.25个月,平均OS为38.5个月。4例患者发生的与治疗相关的毒副反应主要是骨髓抑制和胃肠道反应,其中有1例患者为4度血液学毒性（血小板减少）,其余3例均为2度骨髓抑制（WBC减少）;非血液学毒性主要是胃肠道反应（恶心、呕吐）,其中2例患者为2度,2例患者为1度。结论BEV联合化疗可有效控制晚期持续/复发性子宫肉瘤,且耐受性良好,可作为治疗晚期持续/复发性子宫肉瘤安全、有效的候选方案。     

Efficacy and safety of bevacizumab plus capecitabine and irinotecan regimen for metastatic colorectal cancer

Recent phase III trials have proven the fact that adding bevacizumab to irinotecan plus infusional 5-fluorouracil (5-FU)/leucovorin (LV) should be preferred as a first-line treatment for metastatic colorectal cancer (mCRC). But, since the data regarding bevacizumab administered together with capecitabin, an oral fluoropyrimidine, and irinotecan in patients with mCRC is limited, we aimed to analyse the efficacy and safety of bevacizumab with capecitabine plus irinotecan (BEV-CAPIRI) regimen in mCRC patients. Records of patients treated with BEV-CAPIRI regimen between January 2005 and March 2008 were reviewed. Efficacy data regarding response rates (RR) as well as safety data were collected. Progression free survival (PFS) and overall survival (OS) analyses were done by using the Kaplan–Meier method. A total number of 53 metastatic colorectal cancer patients were treated with BEV-CAPIRI regimen. The median age of this population was 57.3 ± 11.5 (range 29–78). The treatment was well tolerated. The RR was 43.3%, while 30.1% of the patients achieved stable disease (SD). Median PFS and OS were 12.6 ± 1.4 and 20.6 ± 1.7 months, respectively. However, median OS was 21.3 months for male and 14.6 months for female patients. In addition, median OS and PFS was 25.3 months and 16.2 months for the patients who received BEV-CAPIRI as first-line treatment, respectively, and for the other patients it was 15.2 months and 10.2 months, respectively. In conclusion, BEV-CAPIRI is an effective and well-tolerated alternative regimen for mCRC, leading to disease control in a vast majority of patients with mCRC.     

含吉西他滨方案和CHOP样方案一线治疗结外NK/T细胞淋巴瘤效果观察

目的 比较含吉西他滨的联合方案和CHOP样联合方案一线治疗结外NK/T细胞淋巴瘤的效果及安全性.方法 回顾性分析河南省人民医院2012年3月至2017年3月39例初治结外NK/T细胞淋巴瘤患者,其中11例采用含吉西他滨联合方案,28例采用CHOP样联合方案.比较两组的完全缓解(CR)率、部分缓解(PR)率、总反应率(ORR)、总生存(OS)率、无进展生存(PFS)率及不良反应.结果吉西他滨组CR 5例,PR 3例;CHOP样组CR 8例,PR 5例;两组CR率和ORR比较,差异均无统计学意义(P=0.453,P=0.073);两组预计3年OS率(75%比33%)、3年PFS率(70%比29%)比较,差异均有统计学意义(χ2=5.606,P=0.018;χ2=3.924,P=0.048).单因素分析结果显示,治疗方案(P=0.018)、乳酸脱氢酶(LDH)升高(P=0.007)影响患者生存预后(均P<0.05).多因素分析结果显示,LDH升高增加患者的死亡风险(RR=6.331,95%CI2.339~17.136,P<0.001),采用含吉西他滨方案治疗降低患者的死亡风险(RR=0.101,95%CI0.023~0.452,P=0.003).不良反应多为1~2级,患者耐受性良好.结论 含吉西他滨联合方案较CHOP样联合方案可延长结外NK/T细胞淋巴瘤患者的生存时间,提高远期疗效.     

Complex combination biochemotherapy regimen in advanced metastatic melanoma in a non-intensive care unit: toxicity or benefit?

BACKGROUND: There is currently no chemotherapy or chemoimmunotherapy regimen that has shown impact on survival in patients with metastatic melanoma. Different biochemotherapy protocols showed promise with high response rates, but again without significant impact on survival. METHODS: We report the results of a retrospective analysis of a regimen consisting of dacarbazine, cisplatin, vindesine, interleukin-2 and interferon-alpha2b in 25 consecutively treated patients with regard to toxicity, efficacy and practicability. The treatment was performed on a regular dermatological ward. RESULTS: Grade III and IV toxicities were mainly haematological, with few cases of infection because of neutropenia seen. Best overall responses were CR 2/25, PR 2/25 and SD 9/25. The median progression free interval was 4 months (range 0-19) for all patients and the median survival time was 12 months (range 2-26). From a safety and practical point of view, there was no draw-back on treating patients in a non-intensive care unit. The median survival time is in the range of the one reported for monochemotherapy regimen. While there are some responding patients, the responses are short lived and go in parallel with high toxicity and impaired performance status. CONCLUSION: This complex and highly toxic chemoimmunotherapeutic regimen should not be considered as standard therapy in patients with metastatic malignant melanoma.