Preliminary Results of a Randomized Study on Therapeutic Gain by Concurrent Chemotherapy for Regionally-Advanced Nasopharyngeal Carcinoma: NPC-9901 Trial by the Hong Kong Nasopharyngeal Cancer Study Group

Lee, Anne W.M.; Lau, W.S.; Tung, Stewart Y.; Chua, Daniel T.T.; Chappell, Rick; Xu, Ling; Siu, Lillian L.; Sze, W.M.; Leung, TW; Sham, Jonathan S. T.; Ngan, Roger K.C.; Law, Stephen C.K.; Yau, Tsz‐Kok; Au, Joseph Siu-Kie; O’Sullivan, Brian; Pang, Elizabeth; Au, Gordon K.H.; Lau, Joseph T. F.

doi:10.1200/jco.2004.00.7542

Cited by 407 publications

(312 citation statements)

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“…Our finding was highly consistent with prior reports in [7,8] and out of [16,17] clinical trials. However, age showed no association with survival in another two trials that focused on the effect of concurrent chemotherapy [10] and adjuvant chemotherapy [9] respectively.…”

Section: Discussionsupporting

confidence: 83%

“…Interestingly, prior randomized controlled trials [7,8] hinted at age-specific association with mortality, while others [9,10] observed no association at all. Undoubtedly, strict eligibility criteria make the trial cohort unlikely to www.impactjournals.com/oncotarget represent the general cancer population with respect to cancer histology, stage and other basic characteristics.…”

Section: Introductionmentioning

confidence: 99%

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Age at diagnosis indicated poor prognosis in locoregionally advanced nasopharyngeal carcinoma

Zhang¹,

Qiu²,

OuYang³

et al. 2016

Oncotarget

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Section: Discussionsupporting

confidence: 83%

Section: Introductionmentioning

confidence: 99%

Age at diagnosis indicated poor prognosis in locoregionally advanced nasopharyngeal carcinoma

Zhang¹,

Qiu²,

OuYang³

et al. 2016

Oncotarget

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“…High doses every 3 weeks were the most favorable treatment option for distant metastases but resulted in acute, severe toxicity. 8 Chan et al compared RT alone with chemotherapy (40 mg/m 2 ) weekly during the RT phase, and their results indicated that the regimen of concurrent weekly chemotherapy was a promising standard treatment strategy for patients with locoregionally advanced NPC. 17,18 The scheduled adjuvant chemotherapy dose intensity also was moderately reduced (cisplatin 80 mg/m 2 plus fluorouracil 800 mg/m 2 daily), because many Asian patients cannot tolerate the full chemotherapy dose of the IGS regimen.…”

Section: Discussionmentioning

confidence: 99%

“…8,9 Both the SQNP01 trial and the current trial enrolled patients who had stage III to IVB patients according to the 5th edition of the AJCC cancer staging manual, whereas the HK99-01 trial focused on patients with N2 or N3 disease. Patients who have regionally advanced NPC have a higher distant tumor burden and, thus, poorer OS compared with patients who have locally advanced disease.…”

Section: Discussionmentioning

confidence: 99%

“…5 Surprisingly, 2 randomized trials that were conducted to verify the IGS regimen in endemic NPC patients resulted in opposite outcomes: results from the SQNP01 trial in Singapore indicated that the modified IGS regimen significantly improved 5-year OS compared with RT (67% vs 49%; P 5 .008), 6,7 whereas the HK99-01 trial in Hong Kong did not (68% vs 64%; P 5 .22). 8,9 Therefore, we carried out a randomized trial to verify a modified IGS regimen in patients with stage III to IVB NPC from endemic regions of China. The preliminary results have been published and demonstrate that concurrent adjuvant chemotherapy increases 2-year OS by 10% (P 5 .003).…”

Section: Introductionmentioning

confidence: 99%

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Progress report of a randomized trial comparing long‐term survival and late toxicity of concurrent chemoradiotherapy with adjuvant chemotherapy versus radiotherapy alone in patients with stage III to IVB nasopharyngeal carcinoma from endemic regions of China

Chen

Sun

Liang

et al. 2013

Cancer

150

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BACKGROUND:The objective of this study was to evaluate the long-term survival and late toxicities of concurrent-adjuvant chemotherapy in patients with stage III through IVB nasopharyngeal carcinoma (NPC) from endemic regions of China. METHODS: Patients with stage III to IVB NPC were assigned randomly to receive radiotherapy (RT) alone (the RT group) or RT plus concurrent adjuvant chemotherapy (the CRT group). CRT patients received concurrent cisplatin (40 mg/m 2 ) weekly during RT followed by cisplatin (80 mg/m 2 ) and fluorouracil (800 mg/m 2 daily for 5 days) every 4 weeks for 3 cycles. The primary endpoint was overall survival. RESULTS:In total, 316 patients underwent randomization, with 158 to each group. At a median follow-up of 70 months, the 5-year overall survival rate was 72% for the CRT group and 62% for the RT group (hazard ratio, 0.69; 95% confidence interval, 0.48-0.99; P 5.043). Failure-free survival was significantly higher in the CRT group (P 5.020). Most late toxicities were similar (33% vs 26%; P 5.089), except for cranial neuropathy (P 5.042), peripheral neuropathy (P 5.041), and ear damage (P 5.048), which were significantly increased in the CRT group. CONCLUSIONS: The addition of concurrent adjuvant chemotherapy to RT provides survival benefits to patients with stage III through IVB NPC in endemic regions of China, and it does not increase most late toxicities apart from cranial neuropathy, peripheral neuropathy, and ear damage. Cancer 2013;119:2230-8.

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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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Preliminary Results of a Randomized Study on Therapeutic Gain by Concurrent Chemotherapy for Regionally-Advanced Nasopharyngeal Carcinoma: NPC-9901 Trial by the Hong Kong Nasopharyngeal Cancer Study Group

Cited by 407 publications

References 21 publications

Age at diagnosis indicated poor prognosis in locoregionally advanced nasopharyngeal carcinoma

Age at diagnosis indicated poor prognosis in locoregionally advanced nasopharyngeal carcinoma

Progress report of a randomized trial comparing long‐term survival and late toxicity of concurrent chemoradiotherapy with adjuvant chemotherapy versus radiotherapy alone in patients with stage III to IVB nasopharyngeal carcinoma from endemic regions of China

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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