Induction chemotherapy with lobaplatin and fluorouracil versus cisplatin and fluorouracil followed by chemoradiotherapy in patients with stage III–IVB nasopharyngeal carcinoma: an open-label, non-inferiority, randomised, controlled, phase 3 trial

Lv, Xing; Cao, Xun; Xia, Wei‐Xiong; Liu, Kui‐Yuan; Qiang, Meng‐Yun; Guo, Ling; Qian, Chao‐Nan; Cao, Kejiang; Mo, Hao‐Yuan; Li, Xianming; Li, Zihuang; Han, Fei; He, Yuxiang; Liu, Yumeng; Wu, Shaoxiong; Bai, Yongrui; Ke, Liangru; Qiu, Wen‐Ze; Hu, Liang; Li, Guoying; Miao, Jingjing; Li, Wang‐Zhong; Lv, Shu‐Hui; Chen, Xi; Zhao, Chong; Xiang, Yan‐Qun; Guo, Xiang

doi:10.1016/s1470-2045(21)00075-9

Cited by 47 publications

(48 citation statements)

References 32 publications

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“… 24 In addition, Pong et al 25 found that the overall median noninferiority margin was an absolute risk difference of 10% (IQR, 7.5%-13.8%) in oncologic trials. Two recently published studies 26 , 27 on NPC also adopted 10% as the noninferiority margin. This margin of reduced efficacy of cisplatin was regarded as clinically acceptable in view of the expected reduced toxic effects, increased quality of life, and more convenient schedules of administration of nedaplatin.…”

Section: Discussionmentioning

confidence: 99%

Effect of Concurrent Chemoradiotherapy With Nedaplatin vs Cisplatin on the Long-term Outcomes of Survival and Toxic Effects Among Patients With Stage II to IVB Nasopharyngeal Carcinoma

Tang

Liu

et al. 2021

JAMA Netw Open

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IMPORTANCE Nedaplatin-based concurrent chemoradiotherapy (CCRT) regimen at 2 years was noninferior to cisplatin-based regimen in patients with locoregional, stage II to IVB nasopharyngeal carcinoma (NPC) and was associated with fewer late adverse events, but longer-term outcomes and toxicity are unclear. OBJECTIVE To evaluate the 5-year outcomes and late toxicity profile of nedaplatin-based CCRT in patients with locoregional, stage II to IVB NPC. DESIGN, SETTINGS, AND PARTICIPANTS This 5-year follow-up secondary analysis of an openlabel, noninferiority, multicenter randomized clinical trial enrolled patients with nonkeratinizing stage

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Section: Discussionmentioning

confidence: 99%

Effect of Concurrent Chemoradiotherapy With Nedaplatin vs Cisplatin on the Long-term Outcomes of Survival and Toxic Effects Among Patients With Stage II to IVB Nasopharyngeal Carcinoma

Tang

Liu

et al. 2021

JAMA Netw Open

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“…In addition, grade 3 or worse adverse events of leucopenia, neutropenia and thrombocytopenia were more frequently observed in nedaplatin-treated patients than in cisplatin-treated ones ( 36 ). Likewise, lobaplatin was reported to result in more severe thrombocytopenia than cisplatin ( 13 ). In fact, during the course of lobaplatin-radiotherapy of locally advanced nasopharyngeal carcinoma, main grade 3/4 acute adverse events included thrombocytopenia, leucopenia, neutropenia, anemia ( 10 , 37 ).…”

Section: Discussionmentioning

confidence: 99%

“…Lobaplatin is another platinum compound showing anti-tumor activity in multiple solid tumors such as breast cancer, small-cell lung cancer, and hepatocellular carcinoma (10)(11)(12). Lobaplatinbased induction chemotherapy followed by lobaplatin-radiotherapy showed comparable survival outcomes but less acute toxicities than cisplatin-based concurrent chemoradiotherapy in locally advanced nasopharyngeal carcinoma and might be a promising alternative to cisplatin-based treatment (13). Importantly, leucopenia, neutropenia, and gastrointestinal toxicities were more documented in cisplatin-treated patients (14).…”

Section: Introductionmentioning

confidence: 99%

Hematological Toxicities of Concurrent Chemoradiotherapies in Head and Neck Cancers: Comparison Among Cisplatin, Nedaplatin, Lobaplatin, and Nimotuzumab

Zhu

Zhang

et al. 2021

Front. Oncol.

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BackgroundCisplatin-based concurrent chemoradiotherapy is standard of care for locally advanced head and neck cancers (LAHNC). Nedaplatin, lobaplatin and nimotuzumab have shown anti-cancer effect with less gastrointestinal toxicity and nephrotoxicity. However, the profile of hematological toxicities of these agents in combination with radiotherapy has not been fully illustrated.MethodsWe retrospectively collected the clinical data of consecutive LAHNC patients treated by cisplatin-, nedaplatin-, lobaplatin-, and nimotuzumab-based concurrent chemoradiotherapy. Routine blood cell counts were obtained every 4 to 7 days. Hematological toxicities were graded according to the Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0.ResultsA total of 181 eligible LAHNC patients were assigned to nimotuzumab group (n = 34), cisplatin group (n = 52), nedaplatin group (n = 62) or lobaplatin group (n = 33). Among the four groups, nimotuzumab group displayed lightest hematological toxicities, followed by cisplatin group, nedaplatin group, and lobaplatin group. Lobaplatin was more likely to produce grade 3/4 leukopenia compared with cisplatin (48.5% vs 25.0%). Compared with cisplatin, nedaplatin and lobaplatin were more likely to cause grade 3/4 thrombocytopenia (nedaplatin 19.4% vs cisplatin 3.8%; lobaplatin 30.3% vs cisplatin 3.8%). Similarly, nimotuzumab group showed highest nadir levels among the four groups, followed by cisplatin, nedaplatin, and lobaplatin group. Moreover, concurrent platinum treatment and induction chemotherapy were risk factors of developing grade 3/4 hematological toxicities.ConclusionNimotuzumab-based concurrent chemoradiotherapy in head and neck cancers produced the lightest hematological toxicities, followed by cisplatin, nedaplatin, and lobaplatin. Patients should be given specific attention during concurrent chemoradiotherapy, particularly in the presence of previous induction chemotherapy.

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“…conducted a phase III study that evaluated the treatment efficacy between lobaplatin-based and cisplatin-based induction therapy in the treatment of locoregional advanced NPC. The results showed that lobaplatin-based induction therapy could achieve similar survival (5-year PFS: HR = 0.98, 95% CI = 0.69–1.39) and fewer toxic effects than cisplatin-based therapy ( 72 ).…”

Section: Additional Induction Chemotherapy Followed By Ccrt For Locoregionally Advanced Npcmentioning

confidence: 99%

Nasopharyngeal Carcinoma: Clinical Achievements and Considerations Among Treatment Options

et al. 2021

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Nasopharyngeal carcinoma (NPC) is a severe malignancy arising from the nasopharyngeal epithelium and is southern China’s third most common cancer. With the advancement of treatment methods, early-stage NPC patients usually have a better prognosis and more prolonged survival period than those with other malignant tumors. Most treatment failures are due to distant metastasis or a locally advanced stage of NPC in the initial diagnosis. In addition, approximately 10% of patients develop local recurrence, and 10%–20% of patients experience distant metastasis after treatment. These patients have a poor prognosis, with a median survival of only approximately 10–15 months. In the rapid development of treatment options, the efficacy and safety of some treatments have been validated and approved for first-line treatment, while those of other treatments remain unclear. The present study aims to provide a comprehensive overview of recent advances in NPC treatment and explain the various therapeutic possibilities in treating locally advanced, recurrent, and metastatic NPC patients.

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Induction chemotherapy with lobaplatin and fluorouracil versus cisplatin and fluorouracil followed by chemoradiotherapy in patients with stage III–IVB nasopharyngeal carcinoma: an open-label, non-inferiority, randomised, controlled, phase 3 trial

Cited by 47 publications

References 32 publications

Effect of Concurrent Chemoradiotherapy With Nedaplatin vs Cisplatin on the Long-term Outcomes of Survival and Toxic Effects Among Patients With Stage II to IVB Nasopharyngeal Carcinoma

Effect of Concurrent Chemoradiotherapy With Nedaplatin vs Cisplatin on the Long-term Outcomes of Survival and Toxic Effects Among Patients With Stage II to IVB Nasopharyngeal Carcinoma

Hematological Toxicities of Concurrent Chemoradiotherapies in Head and Neck Cancers: Comparison Among Cisplatin, Nedaplatin, Lobaplatin, and Nimotuzumab

Nasopharyngeal Carcinoma: Clinical Achievements and Considerations Among Treatment Options

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