Wu Jianqiu, Song Yongping, Su Liping, Xu Li, Chen Tingchao, Zhao Zhiyun, Zhang Mingzhi, Li Wei, Hu Yu, Zhang Xiaohong, Gao Yuhuan, Niu Zuoxing, Feng Ru, Wang Wei, Peng Jiewen, Li Xiaolin, Ouyang Xuenong, Wu Changping, Zhang Weijing, Zeng Yun, Xiao Zhen, Liang Yingmin, Zhuang Yongzhi, Wang Jishi, Sun Zimin, Bai Hai, Cui Tongjian, Feng Jifeng
Jiangsu Cancer Hospital, Nanjing, 210000, China.
Henan Cancer Hospital, Zhengzhou, China.
BMC Cancer. 2016 Jul 26;16:537. doi: 10.1186/s12885-016-2523-7.
The efficacy and safety of rituximab-based chemotherapy (R-chemo), the standard regimen for patients with diffuse large B-cell lymphoma (DLBCL), which is more common in Asia than in Western countries, are well confirmed in randomized controlled trials (RCTs). However, the safety and effectiveness of R-chemo in patients who are largely excluded from RCTs have not been well characterized. This real-world study investigated the safety and effectiveness of R-chemo as first-line treatment in Chinese patients with DLBCL.
Treatment-naive DLBCL patients who were CD20 positive and eligible to receive R-chemo were enrolled with no specific exclusion criteria. Data collected at baseline included age, gender, disease stage, international prognostic index (IPI), B symptoms, extranodal involvement, performance status, and medical history. In the present study, data on safety, treatment effectiveness, and HBV infection management were collected 120 days after the last R-chemo administration.
Overall, R-chemo was well tolerated. The safety profile of R-chemo in patients with a history of heart or liver disease was well described without any additional unexpected safety concerns. The overall response rate (ORR) in the Chinese patients from this study was 94.2 % (complete response [CR], 55.0 %; CR unconfirmed [CRu] 18.2 %; and partial response [PR], 20.9 %). Compared to patients with no history of disease, the CR and PR rates of patients with a history of heart or liver disease were lower and higher, respectively; this tendency could be in part explained by treatment interruptions in patients with heart or liver diseases. HBsAg positivity and a maximum tumor diameter of ≥7.5 cm negatively correlated with CR + CRu, whereas age and HBsAg positivity negatively correlated with CR.
This study further validated the safety and effectiveness of R-chemo in Chinese patients with DLBCL. Patients with a history of heart or liver disease may further benefit from R-chemo if preventive measures are taken to reduce hepatic and cardiovascular toxicity. In addition to IPI and tumor diameter, HBsAg positivity could also be a poor prognostic factor for CR in Chinese patients with DLBCL.
ClinicalTrials.gov # NCT01340443 , April 20, 2011.
利妥昔单抗联合化疗（R-化疗）是弥漫性大B细胞淋巴瘤（DLBCL）患者的标准治疗方案，在亚洲比西方国家更为常见，其疗效和安全性已在随机对照试验（RCT）中得到充分证实。然而，在很大程度上被排除在RCT之外的患者中，R-化疗的安全性和有效性尚未得到很好的描述。这项真实世界研究调查了R-化疗作为中国DLBCL患者一线治疗的安全性和有效性。
纳入未接受过治疗、CD20阳性且 eligible to receive R-chemo的DLBCL患者，无特定排除标准。基线时收集的数据包括年龄、性别、疾病分期、国际预后指数（IPI）、B症状、结外受累情况、体能状态和病史。在本研究中，在最后一次R-化疗给药120天后收集有关安全性、治疗有效性和HBV感染管理的数据。
总体而言，R-化疗耐受性良好。对有心脏或肝脏疾病史的患者，R-化疗的安全性特征得到了很好的描述，没有任何额外的意外安全问题。本研究中中国患者的总体缓解率（ORR）为94.2%（完全缓解[CR]，55.0%；未确认的CR[CRu]，18.2%；部分缓解[PR]，20.9%）。与无疾病史的患者相比，有心脏或肝脏疾病史的患者的CR和PR率分别较低和较高；这种趋势部分可以通过心脏或肝脏疾病患者的治疗中断来解释。HBsAg阳性和最大肿瘤直径≥7.5 cm与CR+CRu呈负相关，而年龄和HBsAg阳性与CR呈负相关。
本研究进一步验证了R-化疗在中国DLBCL患者中的安全性和有效性。有心脏或肝脏疾病史的患者如果采取预防措施以降低肝脏和心血管毒性，可能会从R-化疗中进一步获益。除了IPI和肿瘤直径外，HBsAg阳性也可能是中国DLBCL患者CR的不良预后因素。
ClinicalTrials.gov # NCT01340443，2011年4月20日。
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