Adjuvant chemotherapy in patients with locoregionally advanced nasopharyngeal carcinoma: Long-term results of a phase 3 multicentre randomised controlled trial

Chen, Lei; Hu, Chao; Chen, Xiao Zhong; Hu, Guo Qing; Cheng, Zhi; Sun, Yan; Li, Wei Xiong; Chen, Yuan Yuan; Xie, Fang; Liang, Shumin; Chen, Yong; Xu, Ting; B, Li; Long, Guo; Wang, Si Yang; Zheng, Bao Min; Guo, Ying; Sun, Ying; Mao, Yan Ping; TANG, Ling; Chen, Yu Ming; Liu, Meng Zhong

doi:10.1016/j.ejca.2017.01.002

Cited by 119 publications

(114 citation statements)

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“…The 5‐year FFS and OS rates of the CCRT alone group were 66.4% and 77.7%, respectively, which were lower to those (71% and 80%, respectively) reported by Chen et al probably due to a higher percentage of patients with stage IVA‐B disease (44.4% vs . 34%) . Both LR‐FFS and D‐FFS were significantly improved in this report; this new finding indicated that the positive effects of TPF IC on FFS and OS could be related to combined effects on local and distant control.…”

Section: Discussionsupporting

confidence: 64%

“…The 5-year FFS and OS rates of the TPF IC plus CCRT group were 77.4% and 85.6%, respectively, which were comparable to those (74.4% and 87%, respectively) reported by Kong et al 9 The 5-year FFS and OS rates of the CCRT alone group were 66.4% and 77.7%, respectively, which were lower to those (71% and 80%, respectively) reported by Chen et al probably due to a higher percentage of patients with stage IVA-B disease (44.4% vs. 34%). 25 Both LR-FFS and D-FFS were significantly improved in this report; this new finding indicated that the positive effects of TPF IC on FFS and OS could be related to combined effects on local and distant control. Moreover, we developed two nomograms to provide individualized estimates of potential FFS and OS benefit from TPF IC for patients with locoregionally advanced NPC.…”

Section: Discussionsupporting

confidence: 62%

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Concurrent chemoradiotherapy with/without induction chemotherapy in locoregionally advanced nasopharyngeal carcinoma: Long‐term results of phase 3 randomized controlled trial

Chen

Zhang

et al. 2019

Intl Journal of Cancer

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To report long‐term results of a randomized controlled trial that compared cisplatin/fluorouracil/docetaxel (TPF) induction chemotherapy (IC) plus concurrent chemoradiotherapy (CCRT) with CCRT alone in locoregionally advanced nasopharyngeal carcinoma (NPC). Patients with stage III–IVB (except T3–4 N0) NPC were randomly assigned to receive IC plus CCRT (n = 241) or CCRT alone (n = 239). IC included three cycles of docetaxel (60 mg/m2 d1), cisplatin (60 mg/m2 d1), and fluorouracil (600 mg/m2/d civ d1–5) every 3 weeks. Patients from both groups received intensity‐modulated radiotherapy concurrently with three cycles of 100 mg/m2 cisplatin every 3 weeks. After a median follow‐up of 71.5 months, the IC plus CCRT group showed significantly better 5‐year failure‐free survival (FFS, 77.4% vs. 66.4%, p = 0.019), overall survival (OS, 85.6% vs. 77.7%, p = 0.042), distant failure‐free survival (88% vs. 79.8%, p = 0.030), and locoregional failure‐free survival (90.7% vs. 83.8%, p = 0.044) compared to the CCRT alone group. Post hoc subgroup analyses revealed that beneficial effects on FFS were primarily observed in patients with N1, stage IVA, pretreatment lactate dehydrogenase ≥170 U/l, or pretreatment plasma Epstein–Barr virus DNA ≥6000 copies/mL. Two nomograms were further developed to predict the potential FFS and OS benefit of TPF IC. The incidence of grade 3 or 4 late toxicities was 8.8% (21/239) in the IC plus CCRT group and 9.2% (22/238) in the CCRT alone group. Long‐term follow‐up confirmed that TPF IC plus CCRT significantly improved survival in locoregionally advanced NPC with no marked increase in late toxicities and could be an option of treatment for these patients.

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Section: Discussionsupporting

confidence: 64%

Section: Discussionsupporting

confidence: 62%

Concurrent chemoradiotherapy with/without induction chemotherapy in locoregionally advanced nasopharyngeal carcinoma: Long‐term results of phase 3 randomized controlled trial

Chen

Zhang

et al. 2019

Intl Journal of Cancer

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192

179

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“…Accordingly, induction chemotherapy is commonly administered before radiotherapy in clinical practice although randomized controlled trials have not yet contributed to a consensus about its survival benefit [4–8]. In addition, there are no effective adjuvant chemotherapy regimens that have been identified for these patients after radiotherapy [9–13]. Although the tumor, node and metastasis (TNM) staging system of the American Joint Committee on Cancer (AJCC)/Union for International Cancer Control (UICC) was the main tool used to identify patients in these clinical trials, however, the findings of these trials advocate that future clinical trials require more effective stratification method for the identification of high-risk patients, instead of enrolling every patient with locoregionally advanced NPC.…”

Section: Introductionmentioning

confidence: 99%

External validity of a prognostic nomogram for locoregionally advanced nasopharyngeal carcinoma based on the 8th edition of the AJCC/UICC staging system: a retrospective cohort study

OuYang

You

Zhang

et al. 2018

Cancer Communications

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BackgroundThe tumor–node–metastasis (TNM) staging system does not perform well for guiding individualized induction or adjuvant chemotherapy for patients with locoregionally advanced nasopharyngeal carcinoma (NPC). We attempted to externally validate the Pan’s nomogram, developed based on the 8th edition of the American Joint Committee on Cancer (AJCC)/Union for International Cancer Control (UICC) staging system, for patients with locoregionally advanced disease. In addition, we investigated the reliability of Pan’s nomogram for selection of participants in future clinical trials.MethodsThis study included 535 patients with locoregionally advanced NPC who were treated between March 2007 and January 2012. The 5-year overall survival (OS) rates were calculated using the Kaplan–Meier method and compared with predicted outcomes. The calibration was tested using calibration plots and the Hosmer–Lemeshow test. Discrimination ability, which was assessed using the concordance index, as compared with other predictors.ResultsPan’s nomogram was observed to underestimate the 5-year OS of the entire cohort by 8.65% [95% confidence interval (CI) − 9.70 to − 7.60%, P < 0.001] and underestimated the 5-year OS of each risk group. The differences between the predicted and observed 5-year OS rates were smallest among low-risk patients (< 135 points calculated using Pan’s nomogram; which predicted minus observed OS, − 6.41%, 95% CI − 6.75 to − 6.07%, P < 0.001) and were largest among high-risk patients (≥ 160 points) (− 13.56%, 95% CI − 15.48 to − 11.63%, P < 0.001). The Hosmer–Lemeshow test suggested that the predicted and observed 5-year OS rates had no ideal relationship (P < 0.001). Pan’s nomogram had better discriminatory ability compared with the levels of Epstein–Barr virus DNA acid (EBV DNA) and the 7th or 8th AJCC/UICC staging system, although not better compared with the combination of EBV DNA and the 8th staging system. Additionally, Pan’s nomogram was marginally inferior to our predictive model, which included the 8th AJCC/UICC N-classification, age, gross primary tumor volume, lactate dehydrogenase, and body mass index.ConclusionsPan’s nomogram underestimated the 5-year OS of patients with locoregionally advanced NPC at our cancer center, and may not be a precise tool for selecting participants for clinical trials.

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“…One unresolved uncertainty is the exact magnitude of the contribution of the adjuvant phase. Results from the randomized trial by Chen et al comparing concurrent‐adjuvant chemotherapy and concurrent chemotherapy showed that the concurrent‐adjuvant group did not achieve a significant increase in estimated 5‐year FFR (HR, 0.88; 95% CI, 0.64‐1.22). However, it should be cautioned that the impact on NPC outcomes could take a prolonged period to manifest (as shown by our study); long‐term follow‐up is needed for definitive conclusions.…”

Section: Discussionmentioning

confidence: 99%

A multicenter, phase 3, randomized trial of concurrent chemoradiotherapy plus adjuvant chemotherapy versus radiotherapy alone in patients with regionally advanced nasopharyngeal carcinoma: 10‐year outcomes for efficacy and toxicity

Lee

Tung

et al. 2017

Cancer

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Adjuvant chemotherapy in patients with locoregionally advanced nasopharyngeal carcinoma: Long-term results of a phase 3 multicentre randomised controlled trial

Cited by 119 publications

References 19 publications

Concurrent chemoradiotherapy with/without induction chemotherapy in locoregionally advanced nasopharyngeal carcinoma: Long‐term results of phase 3 randomized controlled trial

Concurrent chemoradiotherapy with/without induction chemotherapy in locoregionally advanced nasopharyngeal carcinoma: Long‐term results of phase 3 randomized controlled trial

External validity of a prognostic nomogram for locoregionally advanced nasopharyngeal carcinoma based on the 8th edition of the AJCC/UICC staging system: a retrospective cohort study

A multicenter, phase 3, randomized trial of concurrent chemoradiotherapy plus adjuvant chemotherapy versus radiotherapy alone in patients with regionally advanced nasopharyngeal carcinoma: 10‐year outcomes for efficacy and toxicity

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