承前启后，精耕不辍——CBCSG006入选2015中国临床肿瘤学年度进展10大研究

　　中国临床肿瘤学会（CSCO）联合《中国医学论坛报》社（CMT）举办第4届“中国临床肿瘤学年度进展评选”活动，经过研究汇总、候选研究公示、网络及评委专家组投票等过程，最终确定票数位列前10位的研究，本期B2～B5版，将向全国读者介绍各项入选研究。2015年，中国临床肿瘤学家国际合作意识更强，在我国临床肿瘤学不断前进的道路上留下坚实的脚印。CSCO主任委员、广东省人民医院吴一龙教授和希思科临床肿瘤学研究基金会理事长、解放军南京八一医院全军肿瘤中心秦叔逵教授以此为契机，向全国肿瘤学家送上最真挚的祝贺。

　　广东省医学科学院、广东省肺癌研究所、广东省人民医院吴一龙教授：

　　中国临床肿瘤学会（CSCO）和《中国医学论坛报》社（CMT）再度联手，推出了2015年中国临床肿瘤学年度进展评选。细细浏览和品味这些临床研究和年度新闻事件，真有点“横看成岭侧成峰”的感觉，国际知名杂志包括《美国医学会杂志》（JAMA）、《柳叶刀·肿瘤学》（Lancet Oncol）和《临床肿瘤学杂志》（J Clin Oncol）中，都有中国人的名字领衔出现，印证了过去一年来中国临床肿瘤学的巨步向前！可喜可贺！

　　临床肿瘤学的进步，离不开设计良好、执行良好的临床试验，获评的项目，一半为可能改变中国甚至全球临床实践的临床试验，其中既有中国学者自己设计完成的多中心试验，更有中国学者领导全球研究的大型临床试验，这从不同的角度，诠释了新一代中国临床肿瘤学者的国际意识和现代医学的发展之路――只有随机对照临床试验才能形成强有力的临床证据，从而改变我们的临床实践。无疑，这些研究极具示范作用，未来的临床肿瘤学之路，就应该这样走！

　　感谢所有参与者，对中国临床肿瘤学会成立的年度事件给予关注。从1997年成立，到2015年成为国家一级学会，CSCO走过了一条团结、协作、务实之路，随着国际化进程，CSCO的影响力越来越大，相信CSCO将永远同全国的肿瘤专业工作者一起，共同推动中国临床肿瘤学发展。CSCO需要大家参与！

　　解放军南京八一医院、全军肿瘤中心秦叔逵教授：

　　新年伊始，万象更新，又到了盘点进步、展望未来的时候。中国临床肿瘤学会（CSCO）与《中国医学论坛报》社（CMT）继续精诚合作，第4次联合举办了2015年“中国临床肿瘤学年度进展评选”活动。从候选项目中可知，在过去一年里，全国临床肿瘤学领域的专家学者精耕不辍、成就显著，总结发表了许多具有中国特色的原创性研究和诊治经验，经过多轮投票，广泛评选，遴选出了十大研究进展，现应评委会之约，学习后点评如下。

　　乳腺癌

　　复旦大学附属肿瘤医院的胡夕春等在《柳叶刀·肿瘤学》（Lancet Oncol）发表了一项非盲、随机对照、混合设计的Ⅲ期临床研究（CBCSG006），结果证明了对于转移性三阴乳腺癌患者，以顺铂联合吉西他滨可以作为紫杉醇联合吉西他滨的替代治疗，作为一线化疗方案的首选，从而再次明确了顺铂在三阴乳腺癌治疗中的重要地位。

扬创新风帆，远航科研征途

2015年中国临床肿瘤学年度进展入选研究简介

顺铂联合吉西他滨方案适用于转移性三阴性乳腺癌

通讯作者：复旦大学附属肿瘤医院胡夕春

研究出处：Lancet Oncol. 2015;16(4):436

　　为明确铂类为主的化疗方案对于三阴性乳腺癌的治疗效果，研究者于2011年1月14日至2013年11月14日期间，在国内12所癌症中心和医院进行了一项非盲、随机对照、混合设计的临床Ⅲ期研究。研究共纳入240例转移性三阴性乳腺癌患者，随机给予顺铂联合吉西他滨或紫杉醇联合吉西他滨行一线化疗，以评估铂类化疗方案的疗效。研究中，顺铂联合吉西他滨组平均随访时间为16.3个月，紫杉醇联合吉西他滨组平均随访时间15.9个月。研究发现，两组无进展生存（PFS）的风险比为0.692；顺铂联合吉西他滨组和紫杉醇联合吉西他滨组的中位PFS期分别为7.73个月和6.47个月；两组的不良事件发生率类似，无治疗相关的死亡发生。研究显示，顺铂联合吉西他滨对比紫杉醇联合吉西他滨，疗效不仅是非劣效而且更优。因此，顺铂联合吉西他滨可作为转移性三阴性乳腺癌患者的替代治疗甚或首选一线化疗策略。

Lancet Oncol. 2015;16(4):436-46.

Cisplatin plus gemcitabine versus paclitaxel plus gemcitabine as first-line therapy for metastatic triple-negative breast cancer (CBCSG006): a randomised, open-label, multicentre, phase 3 trial.

Hu XC, Zhang J, Xu BH, Cai L, Ragaz J, Wang ZH, Wang BY, Teng YE, Tong ZS, Pan YY, Yin YM, Wu CP, Jiang ZF, Wang XJ, Lou GY, Liu DG, Feng JF, Luo JF, Sun K, Gu YJ, Wu J, Shao ZM.

Department of Medical Oncology, Fudan University Shanghai Cancer Centre, Collaborative Innovation Centre for Cancer Medicine, Shanghai, China.

Department of Oncology, Shanghai Medical College, Shanghai, China.

Cancer Institute and Hospital, Chinese Academy of Medical Sciences, Beijing, China.

Department of Medical Oncology, Harbin Medical University Cancer Hospital, Harbin, China.

Faculty of Medicine, School of Population and Public Health, University of British Columbia, Vancouver, BC, Canada.

Department of Medical Oncology, The First Hospital of China Medical University, Shenyang, China.

Tianjin Medical University Cancer Institute and Hospital, Tianjin, China.

Department of Medical Oncology, The First Hospital, Anhui Medical University, Hefei, China.

Department of Oncology, The First Affiliated Hospital of Nanjing Medical University, Nanjing, China.

Department of Oncology, The Third Affiliated Hospital of Soochow University, Changzhou, China.

Beijing 307 Hospital of PLA, Beijing, China.

Department of Medical Oncology, Zhejiang Cancer Hospital, Hangzhou, China.

Breast Cancer Centre, Ruijin Hospital, Shanghai Jiaotong University School of Medicine, Shanghai, China.

Cancer Centre, Sun Yat-sen University, Guangzhou, China.

Jiangsu Cancer Hospital, Nanjing, China.

Department of Biostatistics, School of Public Health, Fudan University, Shanghai, China.

Biostatistics, Incyte Corporation, Wilmington DE, USA.

Department of Radiology, Fudan University Shanghai Cancer Centre, Collaborative Innovation Centre for Cancer Medicine, Shanghai, China.

Department of Breast Surgery, Fudan University Shanghai Cancer Centre, Collaborative Innovation Centre for Cancer Medicine, Shanghai, China.

BACKGROUND: Platinum chemotherapy has a role in the treatment of metastatic triple-negative breast cancer but its full potential has probably not yet been reached. We assessed whether a cisplatin plus gemcitabine regimen was non-inferior to or superior to paclitaxel plus gemcitabine as first-line therapy for patients with metastatic triple-negative breast cancer.

METHODS: For this open-label, randomised, phase 3, hybrid-designed trial undertaken at 12 institutions or hospitals in China, we included Chinese patients aged 18-70 years with previously untreated, histologically confirmed metastatic triple-negative breast cancer, and an ECOG performance status of 0-1. These patients were randomly assigned (1:1) to receive either cisplatin plus gemcitabine (cisplatin 75 mg/m(2) on day 1 and gemcitabine 1250 mg/m(2) on days 1 and 8) or paclitaxel plus gemcitabine (paclitaxel 175 mg/m(2) on day 1 and gemcitabine 1250 mg/m(2) on days 1 and 8) given intravenously every 3 weeks for a maximum of eight cycles. Randomisation was done centrally via an interactive web response system using block randomisation with a size of eight, with no stratification factors. Patients and investigator were aware of group assignments. The primary endpoint was progression-free survival and analyses were based on all patients who received at least one dose of assigned treatment. The margin used to establish non-inferiority was 1.2. If non-inferiority of cisplatin plus gemcitabine compared with paclitaxel plus gemcitabine was achieved, we would then test for superiority. The trial is registered with ClinicalTrials.gov, number NCT01287624.

FINDINGS: From Jan 14, 2011, to Nov 14, 2013, 240 patients were assessed for eligibility and randomly assigned to treatment (120 in the cisplatin plus gemcitabine group and 120 in the paclitaxel plus gemcitabine group). 236 patients received at least one dose of assigned chemotherapy and were included in the modified intention-to-treat analysis (118 per group). After a median follow-up of 16.3 months (IQR 14.4-26.8) in the cisplatin plus gemcitabine group and 15.9 months (10.7-25.4) in the paclitaxel plus gemcitabine group, the hazard ratio for progression-free survival was 0.692 (95% CI 0.523-0.915; pnon-inferiority<0.0001, psuperiority=0.009, thus cisplatin plus gemcitabine was both non-inferior to and superior to paclitaxel plus gemcitabine. Median progression-free survival was 7.73 months (95% CI 6.16-9.30) in the cisplatin plus gemcitabine group and 6.47 months (5.76-7.18) in the paclitaxel plus gemcitabine group. Grade 3 or 4 adverse events that differed significantly between the two groups included nausea (eight [7%] vs one [<1%]), vomiting (13 [11%] vs one [<1%]), musculoskeletal pain (none vs ten [8%]), anaemia (39 [33%] vs six [5%]), and thrombocytopenia (38 [32%] vs three [3%]), for the cisplatin plus gemcitabine compared with the paclitaxel plus gemcitabine groups, respectively. In addition, patients in the cisplatin plus gemcitabine group had significantly fewer events of grade 1-4 alopecia (12 [10%] vs 42 [36%]) and peripheral neuropathy (27 [23%] vs 60 [51%]), but more grade 1-4 anorexia (33 [28%] vs 10 [8%]), constipation (29 [25%] vs 11 [9%]), hypomagnesaemia (27 [23%] vs five [4%]), and hypokalaemia (10 [8%] vs two [2%]). Serious drug-related adverse events were seen in three patients in the paclitaxel plus gemcitabine group (interstitial pneumonia, anaphylaxis, and severe neutropenia) and four in the cisplatin plus gemcitabine group (pathological bone fracture, thrombocytopenia with subcutaneous haemorrhage, severe anaemia, and cardiogenic syncope). There were no treatment-related deaths.

INTERPRETATION: Cisplatin plus gemcitabine could be an alternative or even the preferred first-line chemotherapy strategy for patients with metastatic triple-negative breast cancer.

FUNDING: Shanghai Natural Science Foundation.

PMID: 25795409

DOI: 10.1016/S1470-2045(15)70064-1

Comment in:

Lancet Oncol. 2015;16(4):357-9.

Old drugs, new tricks for triple-negative breast cancer.

Carey L.

Division of Hematology/Oncology, University of North Carolina, NC, CB7305, USA.

PMID: 25795403

DOI: 10.1016/S1470-2045(15)70108-7