scholarly journals Long-term results of phase II trial of reduced modified clinical target volume in low-risk nasopharyngeal carcinoma treated with intensity modulated radiotherapy

2019 ◽  
Vol 30 ◽  
pp. v463
Author(s):  
J. Miao ◽  
M. Di ◽  
Y. Cao ◽  
L. Wang ◽  
W. Xiao ◽  
...  
Keyword(s):  
Nasopharyngeal Carcinoma ◽  
Phase Ii ◽  
Clinical Target Volume ◽  
Phase Ii Trial ◽  
Intensity Modulated Radiotherapy ◽  
Target Volume ◽  
Low Risk ◽  
Long Term Results ◽  
Intensity Modulated

scholarly journals Individualized Clinical Target Volume Delineation and Efficacy Analysis in Unilateral Nasopharyngeal Carcinoma Treated with Intensity-Modulated Radiotherapy (IMRT): 10-Year Summary and Results

2021 ◽  
Author(s):  
De-Huan Xie ◽  
Zheng Wu ◽  
Wang-Zhong Li ◽  
Wan-Qin Cheng ◽  
Ya-Lan Tao ◽  
...  
Keyword(s):  
Nasopharyngeal Carcinoma ◽  
Clinical Target Volume ◽  
Parapharyngeal Space ◽  
Intensity Modulated Radiotherapy ◽  
Target Volume ◽  
Recurrence Free Survival ◽  
Free Survival ◽  
Intensity Modulated

Abstract Purpose: To evaluate the long-term local control, failure patterns, and toxicities after individualized clinical target volume (CTV) delineation in unilateral nasopharyngeal carcinoma (NPC) treated with intensity-modulated radiotherapy (IMRT).Methods: Unilateral NPC was defined as nasopharyngeal mass confined to one side of nasopharynx and did not significantly exceed the midline of nasopharyngeal apex/posterior wall. From November 2003 to December 2017, 95 patients with long-term follow-up were retrospectively included. All patients received IMRT. The CTVs were determined based on the distance from the gross tumor, the contralateral parapharyngeal space and skull base orifices were spared from irradiation.Results: There were 3 local recurrence and 8 regional recurrences in 10 patients during 84- month follow-up. All local recurrences were PGTVnx-in-field, and no recurrences in traditional high-risk area including contralateral parapharyngeal space and skull base orifices. The 10-year local-recurrence free survival, regional-recurrence free survival and overall survival were 96.2%, 90.5% and 84.7%, respectively. The dosimetry parameters of the tumor-contralateral organs were all lower than the values of the tumor-ipsilateral side (P < 0.05). The late toxicities occurred mainly in the tumor-ipsilateral organs, including radiation-induced temporal lobe injury, impaired visuality, hearing loss and subcutaneous fibrosis.Conclusion: Individualized CTV delineation in unilateral NPC could yield excellent long-term local control with limited out-of-field recurrences, reduced dose to tumor- contralateral organs and mild late toxicities, which is worthy of further exploration.

A phase II randomized, multicentric clinical trail comparing recombinant human endostatin plus intensity-modulated radiotherapy versus concurrent chemoradiotherapy in locally advanced low-risk nasopharyngeal carcinoma.

2017 ◽  
Vol 35 (15_suppl) ◽  
pp. 6063-6063
Author(s):  
Min Kang ◽  
Shaomin Lin ◽  
Haisheng Zhu ◽  
Sihui Liao ◽  
Haixin Huang ◽  
...  
Keyword(s):  
Nasopharyngeal Carcinoma ◽  
Adverse Effects ◽  
Phase Ii ◽  
Concurrent Chemoradiotherapy ◽  
Locally Advanced ◽  
Intensity Modulated Radiotherapy ◽  
Low Risk ◽  
Short Term ◽  
Intensity Modulated ◽  
Term Efficacy

6063 Background: A prospective, randomized, and multicentric phase II study was performed to evaluate the short-term efficacy and safety of Endostar plus intensity-modulated radiotherapy (IMRT) versus concurrent chemoradiotherapy(CCRT) in locally advanced low-risk nasopharyngeal carcinoma(NPC). Methods: From September 2014 to August 2016, 120 patients with low-risk NPC at stages III-IVa from 9 centers were randomly divided into experimental group (Endostar plus radiotherapy (ERT); n = 60) and control group (CCRT; n = 60). ERT patients were given Endostar (7.5 mg/m2/day) by continuous intravenous infusion (CIV) from 5 days before radiotherapy for consecutive 10 days for 2 cycles with an interval of 14 days. Then, ERT patients received 2 cycles of 10 days of maintenance treatment with Endostar after radiotherapy. The CCRT patients were given cisplatin (100 mg/m2) on days 1, 22, and 43 for 3 cycles. Immediate and 3-month efficacy and adverse effects were evaluated between the two groups. ClinicalTrials registration number was NCT02237924. Results: All patients were eligible for toxicity and response analysis. Regarding immediate efficacy, the complete response(CR) rates were 45.0% for ERT arm and 33.3% for CCRT arm in nasopharynx (P = 0.190), and 43.3% for ERT arm and 36.7% for CCRT arm in regional nodes (P = 0.456). Three months after RT, the CR rates were 71.2% for ERT arm and 60.0% for CCRT arm in nasopharynx (P = 0.151), and 74.6% for ERT arm and 63.3% for CCRT arm in regional nodes (P = 0.172). The rate and severity of leukopenia, hemoglobin reduction and thrombocytopenia in ERT arm were significantly lower than CCRT arm (P < 0.01). The occurrence rates of Xerostomia, oral mucositis, nausea / vomiting, constipation and weight loss in ERT arm were significantly lower than those in CCRT arm (P < 0.01). Conclusions: The present study demonstrates that ERT has similar short-term efficacy on locally advanced low-risk NPC compared with CCRT, but the acute adverse effects of ERT are fewer, and the compliance and tolerability of patients are better. Clinical trial information: NCT02237924.

Toripalimab plus intensity-modulated radiotherapy for recurrent nasopharyngeal carcinoma: An open-label single-arm, phase II trial.

2021 ◽  
Vol 39 (15_suppl) ◽  
pp. 6023-6023
Author(s):  
Mingyuan Chen ◽  
Yijun Hua ◽  
Rui You ◽  
Zhi-Qiang Wang ◽  
Peiyu Huang ◽  
...  
Keyword(s):  
Nasopharyngeal Carcinoma ◽  
Phase Ii ◽  
Phase Ii Trial ◽  
Intensity Modulated Radiotherapy ◽  
Progression Free Survival ◽  
Free Survival ◽  
Intensity Modulated ◽  
Local Surgery ◽  
Recurrent Nasopharyngeal Carcinoma ◽  
Grade 3

6023 Background: Toripalimab is a humanized immunoglobulin G4 monoclonal antibody against programmed death 1 (PD-1). We aimed to investigate the efficacy and safety of toripalimab in combination with intensity-modulated radiotherapy (IMRT) for recurrent nasopharyngeal carcinoma (rNPC). Methods: We conducted a single-arm, phase II trial with rNPC patients who had biopsy-proven disease and were unsuitable for local surgery. Eligible patients received IMRT in combination with toripalimab administered via intravenous infusion of 240 mg once every 3 weeks for a maximum of seven cycles. The primary endpoint was the objective response rate (ORR). The secondary endpoints included safety profiles, progression-free survival (PFS). Results: Between May 2019 and January 2020, a total of 25 rNPC patients were enrolled (18 men [72.0%] and 7 women [28.0%]; median [IQR] age, 49.0 [43.5-52.5] years). With a median (IQR) follow-up duration of 14.6 months (13.1-16.2) months, 19 patients (79.2%) achieved an overall response, and disease control was achieved in 23 (95.8%) patients at 3 months post radiotherapy. The 12-month progression-free survival was 91.8% (95% CI 91.7% - 91.9%). The incidences of acute (grade ≥3) blood triglyceride elevation, creatine phosphokinase elevation, skin reaction, and mucositis were 1 (4.0%), 1 (4.0%), 2 (8.0%), and 1 (4.0%), respectively. The incidences of late severe (grade ≥3) nasopharyngeal wall necrosis, nasal bleeding, and trismus were 28.0%, 12.0%, and 4.0%, respectively. Conclusions: Toripalimab combined with IMRT was tolerable and showed promising antitumor activity in rNPC patients. Clinical trial information: NCT03854838.

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