June 15, 2017
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Adjuvant chemotherapy shows no benefit in advanced nasopharyngeal carcinoma

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CHICAGO — Adjuvant chemotherapy with cisplatin and gemcitabine failed to extend survival in high-risk patients with nasopharyngeal carcinoma who had residual Epstein–Barr virus DNA following curative radiotherapy or chemoradiation, according to a randomized controlled trial presented at the ASCO Annual Meeting.

Plasma Epstein–Barr virus (EBV) DNA predicts poor survival in patients with nasopharyngeal cancer and may be the most significant prognostic biomarker of subclinical residual disease.

Anthony T.C. Chan, MD, professor of clinical oncology at The Chinese University of Hong Kong, and colleagues used EBV DNA levels as a biomarker after curative radiation therapy to select high-risk patients for adjuvant chemotherapy while sparing low-risk patients from unnecessary toxicity.

Eligible patients had stage IIb to stage IVb disease, detectable EBV DNA 6 to 8 weeks following radiotherapy, no persistent locoregional disease or distant metastasis, ECOG performance status of 0 or 1, and adequate organ function.

In total, 789 patients underwent EBV DNA screening, 218 (27.6%) of whom had detectable EBV DNA.

Researchers randomly assigned 104 patients — 52 patients to receive six cycles of adjuvant 40 mg/m2 cisplatin and 1,000 mg/m2 gemcitabine and 52 patients to follow-up (arm B) from September 2006 to July 2015. The two arms had well-balanced baseline characteristics — all patients received curative radiotherapy, and 84.6% received prior neoadjuvant and/or concurrent chemotherapy.

RFS served as the primary endpoint.

In arm A, 69% of patients completed three cycles of adjuvant cisplatin and gemcitabine, and 50% completed six cycles.

After median follow-up of 6.5 years, researchers reported rate of RFS did not change from 3 to 5 years in either arm. In total, 58.2% of patients in arm A and 57.3% of patients in arm B achieved 3- and 5-year RFS (HR = 0.92; 95% CI, 0.51-1.68).

Patients in arm A did not demonstrate higher rates of OS compared with arm B at 3 years (70.6% vs. 80.1%) and 5 years (66.2% vs. 67.6%; 1.04; 95% CI, 0.53-2.01)

Researchers also reported no difference in loco-regional failure–free survival (78% vs. 83.6%; HR = 1.42; 95% CI, 0.56-3.59) and distant failure–free survival (74.2% vs. 68.9%; HR – 0.72; 95% CI, 0.34-1.51), rates of which also did not change for either arm from 3 to 5 years. – by Chuck Gormley

References:

Chan ATC, et al. Abstract 6002. Presented at: ASCO Annual Meeting; June 2-6, 2017; Chicago.

Disclosure: Chan reports a consultant/advisory role with Celgene, and honoraria, research funding or travel expenses from Boehringer Ingelheim, Bristol-Myers Squibb, Celgene Merck Sharp & Dohme, Pfizer and Roche.