Ann Oncol. 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. strong class=”kwd-title” Keywords: nasopharyngeal carcinoma, nimotuzumab, chemoradiotherapy, induction chemotherapy INTRODUCTION Concurrent chemoradiation(CCRT) is the standard combinational treatment modality for locoregionally advanced nasopharyngeal carcinoma(LA NPC).With the addition of platinum-based concurrent chemotherapy, a significant survival benefit has been achieved compared with radiotherapy alone [1, 2].However, up to 30% of patients still die of distant metastasis, while 10%-20% of patients will develop local and regional recurrences [3C5].The optimum sequence and combination of chemoradiotherapy for the treatment of LA NPC remains controversial. Newer treatment modalities, including different sequences and combinations of chemoradiotherapy are explored. On the other hand, overexpression of EGFR can be found in more than NSC139021 80% of patients with LA NPC [6]. High EGFR expression was associated with radiotherapy and chemotherapy resistance, and increased risks of locoregional recurrence, distant metastasis, and poor prognosis [7, 8]. Cetuximab, the most commonly used anti-EGFR antibody, has received considerable attention and achieved encouraging progress for the treatment of head and neck squamous cell carcinoma(HNSCC) [9C11]. The schedule of CCRT with cetuximab in LA NPC [12C15] has also demonstrated promising preliminary results. However, the incidence of acne-like rash and radiotherapy-related acute skin and mucosal toxic effects was significantly increased, thus its clinical application was greatly limited. Distinct from cetuximab, nimotuzumab is usually a humanized MLLT7 EGFR monoclonal antibody with a unique safety profile [16]. However, there is little research focusing on the use of CCRT in combination with nimotuzumab in LA NPC. In the phase II single-arm trial presented here, we adopted a combinational treatment modality of NSC139021 induction chemotherapy, followed by concurrent chemoradiation and nimotuzumab for the treatment of LA NPC (Physique ?(Figure1).1). The main purpose of the study is usually to evaluate the safety and treatment compliance of this treatment regimen. Here, we present the preliminary results of our study. Open in a separate window Physique 1 Multidisciplinary management of LA NSC139021 NPC in our studyAbbreviations: LA NPC, Locoregionally advanced nasopharyngeal carcinoma; RT, Radiotherapy; IMRT, Intensity-modulated radiotherapy; NSC139021 ICT, Induction chemotherapy; CCRT, Concurrent chemotherapy; ACT, Adjuvant chemotherapy; N, Nimotuzumab RESULTS Patients and treatment compliance From November 2011 to April 2016, 23 patients with a NSC139021 median age of 53 years (range, 23-73 years) were recruited into the study, baseline characteristics are listed in Table ?Table1.1. All patients received one cycle of induction chemotherapy and a full course of intensity-modulated radiotherapy (IMRT) (Table ?(Table2).2). IMRT was interrupted in two patients who experienced severe side effects of grade 4 stomatitis (n = 1) and grade 3 dermatitis(n = 1). Nineteen(82.6%)patients completed the scheduled concurrent chemotherapy. In terms of compliance to nimotuzumab, 22 (95.7%) patients received 6 weeks of nimotuzumab, 19(82.6%)patients received 8 weeks of nimotuzumab. Nimotuzumab was discontinued in 4 patients due to refusal by patient (n = 3) and anaphylaxis (n = 1). Adjuvant chemotherapy was administered in 20(87%) patients: 18 received four cycles of adjuvant chemotherapy, 1 received three cycles, and another received two cycles. Table 1 Baseline characteristics of patients thead th align=”center” valign=”middle” rowspan=”1″ colspan=”1″ Characteristic /th th align=”center” valign=”middle” rowspan=”1″ colspan=”1″ Number of patients /th /thead Total23GenderMale18Female5Age,yearsMedian53Range23-73WHO histologic typeII18III5Clinical T categoryT11T27T313T42Clinical N categoryN01N15N211N36UICC stageII3III12IVa2IVb6 Open in a separate windows Abbreviations: WHO, World Health Business; UICC, Union for International Cancer Control; T, tumor; N, lymph node Table 2 Treatment compliance thead th align=”center” valign=”middle” rowspan=”1″ colspan=”1″ Treatment compliance /th th align=”center” valign=”middle” rowspan=”1″ colspan=”1″ Number of patients(%) /th /thead Induction chemotherapyreceived one cycle of induction chemotherapy23(100)Concurrent chemoradiationRadiotherapyreceived total dose of radiotherapy23(100)radiotherapy interruptions2(8.7)radiotherapy discontinuation0(0)Chemotherapyreceived one cycle of concurrent chemotherapy19(82.6)did not receive concurrent chemotherapy4(17.4)Nimotuzumabreceived eigtht weeks of nimotuzumab19(82.6)did not receive eigtht weeks of nimotuzumab4(17.4)received 7 weeks of nimotuzumab1(4.3)received 6 weeks of nimotuzumab2(8.7)received 1 weeks of nimotuzumab1(4.3)Adjuvant chemotherapynot scheduled to receive adjuvant chemotherapy3(13.0)scheduled to receive adjuvant chemotherapy20(87.0)received 4 cycles of adjuvant chemotherapy18(78.4)received 3 cycles of adjuvant chemotherapy1(4.3)received 2 cycles of adjuvant chemotherapy1(4.3) Open in a separate window Toxicity No grade 3-4 toxicities occurred in the neoadjuvant setting. Adverse events from concurrent chemoradiation and nimotuzumab were listed in Table ?Table3.3. The most common side effects were oral mucositis and neutropenia..