Prognostic Value of the Cumulative Cisplatin Dose During Concurrent Chemoradiotherapy in Locoregionally Advanced Nasopharyngeal Carcinoma: A Secondary Analysis of a Prospective Phase III Clinical Trial

Peng, Hao; Chen, Lei; Zhang, Yuan; Li, Wenfei; Mao, Yan‐Ping; Zhang, Fan; Guo, Rui; Liu, Lizhi; Lin, Aihua; Sun, Ying; Ma, Jingfei

doi:10.1634/theoncologist.2016-0105

Cited by 57 publications

(55 citation statements)

References 29 publications

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“…In the present study, 200 mg/m 2 CCD did not yield significant improvements in survival outcomes in patients with locoregionally‐advanced NPC receiving IC plus CCRT, while 160 mg/m 2 CCD might be enough to yield beneficial antitumor effects. This is in accordance with previously published reports . In the combined analyses of 2 prospective trials, NPC‐9901 and NPC‐9902, a total dose of cisplatin during the concurrent phase (>200 mg/m 2 ) had a significant impact on LRFS and OS in the stage III subgroup, but not in the stage IV subgroup.…”

Section: Discussionsupporting

confidence: 91%

“…It is generally recognized that 200 mg/m 2 CCD administered during RT is the optimal cutoff dose to yield survival benefit in NPC patients receiving CCRT . However, with the success of several important large‐scale multi‐centre phase II‐III RCT, an increasing number of patients are receiving IC plus CCRT; and a substantial proportion of patients are unable to tolerate 200 mg/m 2 CCD following IC, due to the increased therapeutic intensity.…”

Section: Discussionmentioning

confidence: 99%

“…The importance of a third planned cisplatin cycle was first questioned by Ang et al, who reviewed the compliance levels of CCRT in RCT, and found that a substantial fraction of patients failed to receive the third cycle, and a cumulative dose of 200 mg/m 2 was sufficient to yield beneficial antitumor effects. Peng et al also demonstrated that CCD >240 mg/m 2 was not prognostic in patients with locoregionally‐advanced NPC, and that 200 mg/m 2 cisplatin may be adequate . Furthermore, Loong and colleagues found that 200 mg/m 2 CCD had prognostic value in patients with stage II and III NPC, but not in patients with the highest risk …”

Section: Introductionmentioning

confidence: 99%

“…Peng et al also demonstrated that CCD >240 mg/m 2 was not prognostic in patients with locoregionally-advanced NPC, and that 200 mg/m 2 cisplatin may be adequate. 11 Furthermore, Loong and colleagues found that 200 mg/m 2 CCD had prognostic value in patients with stage II and III NPC, but not in patients with the highest risk. 12 Accordingly, 200 mg/m 2 has been widely used as the optimal cutoff value in clinical practice, regardless of the specific treatment strategies.…”

Section: Introductionmentioning

confidence: 99%

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Optimal cumulative cisplatin dose in nasopharyngeal carcinoma patients receiving additional induction chemotherapy

Zhou

et al. 2018

Cancer Science

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To clarify the optimal cumulative cisplatin dose (CCD) in locoregionally‐advanced nasopharyngel carcinoma (NPC) patients receiving induction chemotherapy (IC) plus concurrent chemoradiotherapy (CCRT). Using the NPC‐specific database from the established big‐data intelligence platform at Sun Yat‐Sen University Cancer Center, 583 non‐disseminated, locoregionally‐advanced NPC patients receiving IC plus CCRT were enrolled. Propensity score matching (PSM) analysis was conducted to control for confounding factors. The median CCD was 160 mg/m2 after IC (range, 40‐300 mg/m2); only 74 patients (12.7%) achieved CCD >200 mg/m2. Patients receiving >200 mg/m2 CCD did not show significantly improved 5‐year overall survival (OS) (HR = 1.19; 95% confidence intervals [CI] 0.69‐2.06, P = .53) and progression‐free survival (PFS) (HR = 1.03; 95% CI: 0.63‐1.68, P = .92) compared with patients receiving <200 mg/m2 CCD. Further investigations of the potential of median CCD (160 mg/m2) to yield survival benefits revealed that there were no significant differences in survival endpoints between patients receiving CCD >160 mg/m2 and CCD < 160 mg/m2 in both the original and PSM cohorts. In addition, subgroup analysis indicated a favorable PFS, but not OS, with higher cisplatin administration in patients with pretreatment Epstein–Barr virus deoxyribonucleic acid (EBV DNA) <1000 copies/mL (HR = 0.26, 95% CI: 0.07‐0.93, P = .03) and receiving <3 IC cycles (HR = 0.59, 95% CI 0.33‐1.07, P = .08). Our analysis of real world data provided references for the optimal CCD in locoregionally‐advanced NPC receiving additional IC. The causal relationship between 200 mg/m2 CCD and improved survival was not defined; 160 mg/m2 CCD might be enough. However, for patients with EBV DNA <1000 copy/mL and receiving <3 IC cycles, a higher dose might be necessary.

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Section: Discussionsupporting

confidence: 91%

Section: Discussionmentioning

confidence: 99%

Section: Introductionmentioning

confidence: 99%

Section: Introductionmentioning

confidence: 99%

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Optimal cumulative cisplatin dose in nasopharyngeal carcinoma patients receiving additional induction chemotherapy

Zhou

et al. 2018

Cancer Science

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“…In addition, the number of cycles of IC should be optimized; 2 cycles may be sufficient . For concurrent chemotherapy, an overdose of cisplatin should be avoided; 200 mg/m 2 may be adequate to provide a survival advantage …”

Section: Discussionmentioning

confidence: 99%

Prognostic value of nutritional risk screening 2002 scale in nasopharyngeal carcinoma: A large‐scale cohort study

et al. 2018

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Little is known about the value of the nutritional risk screening 2002 (NRS2002) scale in nasopharyngeal carcinoma (NPC). We conducted a large‐scale study to address this issue. We employed a big‐data intelligence database platform at our center and identified 3232 eligible patients treated between 2009 and 2013. Of the 3232 (12.9% of 24 986) eligible patients, 469 (14.5%), 13 (0.4%), 953 (29.5%), 1762 (54.5%) and 35 (1.1%) had NRS2002 scores of 1, 2, 3, 4 and 5, respectively. Survival outcomes were comparable between patients with NRS2002 <3 and ≥3 (original scale). However, patients with NRS2002 ≤3 vs >3 (regrouping scale) had significantly different 5‐year disease‐free survival (DFS; 82.7% vs 75.0%, P < .001), overall survival (OS; 88.8% vs 84.1%, P = .001), distant metastasis‐free survival (DMFS; 90.2% vs 85.9%, P = .001) and locoregional relapse‐free survival (LRRFS; 91.6% vs 87.2%, P = .001). Therefore, we proposed a revised NRS2002 scale, and found that it provides a better risk stratification than the original or regrouping scales for predicting DFS (area under the curve [AUC] = 0.530 vs 0.554 vs 0.577; P < .05), OS (AUC = 0.534 vs 0.563 vs 0.582; P < .05), DMFS (AUC = 0.531 vs 0.567 vs 0.590; P < .05) and LRRFS (AUC = 0.529 vs 0.542 vs 0.564; P < .05 except scale A vs B). Our proposed NRS2002 scale represents a simple, clinically useful tool for nutritional risk screening in NPC.

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Effect of Radiotherapy Alone vs Radiotherapy With Concurrent Chemoradiotherapy on Survival Without Disease Relapse in Patients With Low-risk Nasopharyngeal Carcinoma

Tang

Guo

Zhang

et al. 2022

JAMA

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IMPORTANCE Concurrent chemoradiotherapy has been the standard treatment for stage II nasopharyngeal carcinoma (NPC) based on data using 2-dimensional conventional radiotherapy. There is limited evidence for the role of chemotherapy with use of intensity-modulated radiation therapy (IMRT).OBJECTIVE To assess whether concurrent chemotherapy can be safely omitted for patients with low-risk stage II/T3N0 NPC treated with IMRT. DESIGN, SETTING, AND PARTICIPANTSThis multicenter, open-label, randomized, phase 3, noninferiority clinical trial was conducted at 5 Chinese hospitals, including 341 adult patients with low-risk NPC, defined as stage II/T3N0M0 without adverse features (all nodes <3 cm, no level IV/Vb nodes; no extranodal extension; Epstein-Barr virus DNA <4000 copies/mL), with enrollment between November 2015 and August 2020. The final date of follow-up was March 15, 2022.INTERVENTIONS Patients were randomly assigned to receive IMRT alone (n = 172) or concurrent chemoradiotherapy (IMRT with cisplatin, 100 mg/m 2 every 3 weeks for 3 cycles [n = 169]). MAIN OUTCOMES AND MEASURESThe primary end point was 3-year failure-free survival (time from randomization to any disease relapse or death), with a noninferiority margin of 10%. Secondary end points comprised overall survival, locoregional relapse-free survival, distant metastasis-free survival, adverse events, and health-related quality of life (QOL) measured by the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire (QLQ-C30; range, 0-100 points; minimum clinically important difference Ն10 for physical function, symptom control, or health-related QOL; higher score indicates better functioning and global health status or worse symptoms). RESULTS Among 341 randomized patients (mean [SD] age, 48 [10] years; 30% women), 334 (98.0%) completed the trial. Median follow-up was 46 months (IQR,. Three-year failure-free survival was 90.5% for the IMRT-alone group vs 91.9% for the concurrent chemoradiotherapy group (difference, −1.4%; 1-sided 95% CI, −7.4% to ϱ; P value for noninferiority, <.001). No significant differences were observed between groups in overall survival, locoregional relapse, or distant metastasis. The IMRT-alone group experienced a significantly lower incidence of grade 3 to 4 adverse events (17% vs 46%; difference, −29% [95% CI, −39% to −20%]), including hematologic toxicities (leukopenia, neutropenia) and nonhematologic toxicities (nausea, vomiting, anorexia, weight loss, mucositis). The IMRT-alone group had significantly better QOL scores during radiotherapy including the domains of global health status, social functioning, fatigue, nausea and vomiting, pain, insomnia, appetite loss, and constipation.CONCLUSIONS AND RELEVANCE Among patients with low-risk NPC, treatment with IMRT alone resulted in 3-year failure-free survival that was not inferior to concurrent chemoradiotherapy.

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Prognostic Value of the Cumulative Cisplatin Dose During Concurrent Chemoradiotherapy in Locoregionally Advanced Nasopharyngeal Carcinoma: A Secondary Analysis of a Prospective Phase III Clinical Trial

Cited by 57 publications

References 29 publications

Optimal cumulative cisplatin dose in nasopharyngeal carcinoma patients receiving additional induction chemotherapy

Optimal cumulative cisplatin dose in nasopharyngeal carcinoma patients receiving additional induction chemotherapy

Prognostic value of nutritional risk screening 2002 scale in nasopharyngeal carcinoma: A large‐scale cohort study

Effect of Radiotherapy Alone vs Radiotherapy With Concurrent Chemoradiotherapy on Survival Without Disease Relapse in Patients With Low-risk Nasopharyngeal Carcinoma

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