Sequential induction chemotherapy plus intensity-modulated radiotherapy versus concurrent chemoradiotherapy in locoregionally advanced nasopharyngeal carcinoma: the three-year report of a phase II, single center, randomized, non-inferiority trial

Cancer Med. 2021 Jun;10(12):3886-3895. doi: 10.1002/cam4.3936. Epub 2021 May 6.

Abstract

To compare the efficacy and safety of induction chemotherapy (IC) followed by intensity-modulated radiotherapy (IMRT) alone versus concurrent CCRT in locoregionally advanced nasopharyngeal carcinoma (LA-NPC). Patients with newly diagnosed stage III to IVB nasopharyngeal carcinoma (NPC) were randomized to receive IC plus IMRT (IC+RT arm), or concurrent chemotherapy plus IMRT (CCRT arm), using a random number table. Both treatment arms received the same chemotherapy regimen. The primary endpoint was progression-free survival (PFS). Secondary end points included overall survival (OS), locoregional recurrence-free survival (LRRFS), distant metastasis-free survival (DMFS), treatment response, and acute treatment toxicities. From June 2013 to September 2018, a total of 204 patients histologically diagnosed with LA-NPC were enrolled in the study, with 102 patients randomly assigned to each arm. After a median follow-up duration of 45 months (range 4 to 84 months), the 3-year PFS, OS, LRRFS and DMFS were 72.2%, 87.8%, 92.3%, and 82.7% in the IC+RT arm, compared with 82.6%, 92.8%, 94.7%, and 88.2% in the CCRT arm. No statistical difference for PFS, OS, LRRFS, DMFS, or treatment response was observed between the two arms (p > 0.05). The incidences of leukopenia (p = 0.008) and anemia (p = 0.015) were significantly higher in patients in the CCRT arm than those in the IC+RT arm. Compared to CCRT, IC plus IMRT alone provided similarly favorable treatment outcomes in terms of PFS, OS, LRRFS, and DMFS for patients with LA-NPC, but resulted in fewer incidences of leukopenia and anemia.

Keywords: cancer management; chemotherapy; clinical trials; nasopharyngeal carcinoma; neoadjuvant chemotherapy; radiotherapy.

Publication types

  • Clinical Trial, Phase II
  • Equivalence Trial
  • Randomized Controlled Trial
  • Research Support, Non-U.S. Gov't

MeSH terms

  • Adult
  • Aged
  • Anemia / epidemiology
  • Antineoplastic Combined Chemotherapy Protocols / therapeutic use
  • Chemoradiotherapy* / adverse effects
  • Chemoradiotherapy* / mortality
  • Disease-Free Survival
  • Female
  • Follow-Up Studies
  • Humans
  • Incidence
  • Induction Chemotherapy* / adverse effects
  • Induction Chemotherapy* / mortality
  • Leukopenia / epidemiology
  • Male
  • Middle Aged
  • Nasopharyngeal Carcinoma / mortality
  • Nasopharyngeal Carcinoma / pathology
  • Nasopharyngeal Carcinoma / therapy*
  • Nasopharyngeal Neoplasms / mortality
  • Nasopharyngeal Neoplasms / pathology
  • Nasopharyngeal Neoplasms / therapy*
  • Neoplasm Staging
  • Progression-Free Survival
  • Radiotherapy Dosage
  • Radiotherapy, Intensity-Modulated* / adverse effects
  • Radiotherapy, Intensity-Modulated* / mortality
  • Time Factors
  • Young Adult