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.

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.

Yang Z ，Cai Z ，Cai Q ，Hong Y ，Zhang C ，Huang K ，Lin Z ，Li M ... -  《Cancer Medicine》

Induction chemotherapy plus concurrent chemoradiotherapy versus induction chemotherapy plus volumetric modulated arc therapy alone in the treatment of stage II-IVB nasopharyngeal carcinoma patients: a retrospective controlled study.

Liu L ，Fei Z ，Chen M ，Zhao L ，Su H ，Gu D ，Lin B ，Cai X ，Lu L ，Gao M ，Ye X ，Jin X ，Xie C ... -  《Radiation Oncology》

Final results of a randomized phase III trial of induction chemotherapy followed by concurrent chemoradiotherapy versus concurrent chemoradiotherapy alone in patients with stage IVA and IVB nasopharyngeal carcinoma-Taiwan Cooperative Oncology Group (TCOG)

Hong RL ，Hsiao CF ，Ting LL ，Ko JY ，Wang CW ，Chang JTC ，Lou PJ ，Wang HM ，Tsai MH ，Lai SC ，Liu TW ... -  《-》

Induction chemotherapy plus IMRT alone versus induction chemotherapy plus IMRT-based concurrent chemoradiotherapy in locoregionally advanced nasopharyngeal carcinoma: a retrospective cohort study.

Wei Z ，Zhang Z ，Luo J ，Li N ，Peng X ... -  《-》

Neoadjuvant chemotherapy followed by concurrent chemoradiotherapy versus concurrent chemoradiotherapy alone in locoregionally advanced nasopharyngeal carcinoma: A phase III multicentre randomised controlled trial.

The role of neoadjuvant chemotherapy (NACT) for locoregionally advanced nasopharyngeal carcinoma (NPC) is unclear. We aimed to evaluate the feasibility and efficacy of NACT followed by concurrent chemoradiotherapy (CCRT) versus CCRT alone in locoregionally advanced NPC. Patients with stage III-IVB (excluding T3N0-1) NPC were randomly assigned to receive NACT followed by CCRT (investigational arm) or CCRT alone (control arm). Both arms were treated with 80 mg/m2 cisplatin every 3 weeks concurrently with radiotherapy. The investigational arm received cisplatin (80 mg/m2 d1) and fluorouracil (800 mg/m2 civ d1-5) every 3 weeks for two cycles before CCRT. The primary end-point was disease-free survival (DFS) and distant metastasis-free survival (DMFS). Secondary end-point was overall survival (OS). Survival curves for the time-to-event endpoints were analyzed by the Kaplan-Meier method and compared using the log-rank test. The P value was calculated using the 5-year endpoints. Four hundred seventy six patients were randomly assigned to the investigational (n = 238) and control arms (n = 238). The investigational arm achieved higher 3-year DFS rate (82.0%, 95% CI = 0.77-0.87) than the control arm (74.1%, 95% CI = 0.68-0.80, P = 0.028). The 3-year DMFS rate was 86.0% for the investigational arm versus 82.0% for the control arm, with marginal statistical significance (P = 0.056). However, there were no statistically significant differences in OS or locoregional relapse-free survival (LRRFS) rates between two arms (OS: 88.2% versus 88.5%, P = 0.815; LRRFS: 94.3% versus 90.8%, P = 0.430). The most common grade 3-4 toxicity during NACT was neutropenia (16.0%). During CCRT, the investigational arm experienced statistically significantly more grade 3-4 toxicities (P < 0.001). NACT improved tumour control compared with CCRT alone in locoregionally advanced NPC, particularly at distant sites. However, there was no early gain in OS. Longer follow-up is needed to determine the eventual therapeutic efficacy.

Cao SM ，Yang Q ，Guo L ，Mai HQ ，Mo HY ，Cao KJ ，Qian CN ，Zhao C ，Xiang YQ ，Zhang XP ，Lin ZX ，Li WX ，Liu Q ，Qiu F ，Sun R ，Chen QY ，Huang PY ，Luo DH ，Hua YJ ，Wu YS ，Lv X ，Wang L ，Xia WX ，Tang LQ ，Ye YF ，Chen MY ，Guo X ，Hong MH ... -  《-》