Induction chemotherapy followed by concurrent chemoradiation and nimotuzumab for locoregionally advanced nasopharyngeal carcinoma: preliminary results from a phase II clinical trial

Abstract

Overexpression of epidermal growth factor receptor can be found in more than 80% of patients with locoregionally advanced nasopharyngeal carcinoma and is associated with shorter survival. In this work, we evaluated the feasibility of adding nimotuzumab to chemoradiation in locoregionally advanced nasopharyngeal carcinoma. Twenty-three patients with clinically staged T3-4 or any node-positive disease were enrolled. They were scheduled to receive one cycle of induction chemotherapy followed by intensity-modulated radiotherapy, weekly administration of nimotuzumab and concurrent chemotherapy. Results showed that all patients received a full course of radiotherapy, 19(82.6%)patients completed the scheduled neoadjuvant and concurrent chemotherapy, and 22(95.7%) patients received =6 weeks of nimotuzumab. During the period of concurrent chemoradiation and nimotuzumab, grade 3-4 toxicities occurred in 14(60.9%) patients: 8 (34.8%) had grade 3-4 oral mucositis, 6(26.1%) had grade 3 neutropenia, and 1(4.3%) had grade 3 dermatitis. No acne-like rash was observed. With a median follow-up of 24.1 months, the 2-year progression-free survival and overall survival were 83.5% and 95.0%, respectively. In conclusion, concurrent administration of chemoradiation and nimotuzumab was well-tolerated with good compliance. Preliminary clinical outcome data appear encouraging with favorable normal tissue toxicity results comparing with historical data of concurrent chemoradiation plus cetuximab.

Comparing treatment outcomes of concurrent chemoradiotherapy with or without nimotuzumab in patients with locoregionally advanced nasopharyngeal carcinoma

“…A recent retrospective analysis by Liu and colleagues 21 also concluded NTZ could be safely combined with CCRT for treatment of LA-NPC. However, Huang et al 12 reported 34.8% of patients receiving CCRT plus NTZ experienced grade 3 to 4 mucositis. These inconsistencies could be due to obvious differences between chemotherapy regimens, where only patients receiving concurrent chemotherapy consisting of cisplatin (100 mg/ m 2 ) every three weeks or cisplatin (40 mg/m 2 ) weekly were eligible for the current study.…”

“…These inconsistencies could be due to obvious differences between chemotherapy regimens, where only patients receiving concurrent chemotherapy consisting of cisplatin (100 mg/ m 2 ) every three weeks or cisplatin (40 mg/m 2 ) weekly were eligible for the current study. However, the study by Huang et al 12 included patients who received more intensive concurrent chemotherapy regimens (75 mg/m 2 docetaxel and 80 mg/m 2 nedaplatin), which may have increased the incidence of mucositis during radiotherapy.…”

“…IMRT treatment details have been previously reported. 13 Target volumes were delineated according to a previously described treatment protocol by our institution, 12 in agreement with International Commission on Radiation Units (ICRU) and Measurements reports 62 14 and 83. 15 The prescribed radiation dose was defined as follows: a total dose of 68-70 Gy at 2.12-2.27 Gy/fraction to the planning target volume (PTV) of the GTV-P (primary gross tumor volume), 60 Gy to the PTV of CTV-1 (high-risk regions) and 54 Gy to the PTV of CTV-2 (low-risk regions).…”

“…11 A phase II trial found the addition of NTZ to CCRT was associated with encouraging survival outcomes in LA-NPC, though only 23 patients were enrolled to be administered CCRT and NTZ, with a follow-up median of 24.1 months. 12 Considering the absence of randomized controlled trial to determine the efficacy of CCRT plus NTZ vs. CCRT alone in patients with LA-NPC, it remains under debate if patients with LA-NPC benefit from the addition of NTZ for the recommended standard treatment of CCRT.…”

Anti‐epidermal growth factor receptor therapy concurrently with induction chemotherapy in locoregionally advanced nasopharyngeal carcinoma

“…6,7 EGFR is also highly expressed in NPC 8 and numerous studies have evaluated the efficacy of anti-EGFR targeted therapy. [9][10][11][12][13][14][15] Cetuximab (CTX) or nimotuzumab (NTZ) (anti-EGFR monoclonal antibodies) concurrent with RT could achieve comparable outcomes compared with standard cisplatin-RT. 12,14 When combined with CCRT, different results were produced.…”