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Objective:Tumor-treating fields (TTFields) is a kind of non-invasive anti-mitotic tumor therapy, which has been approved for patients with newly diagnosed and recurrent glioblastoma. This study aims to explore the efficacy and safety of TTFields in high-grade gliomas in clinical practice settings.Methods:The clinical data of 15 patients with recurrent glioma and 9 patients with newly diagnosed high-grade glioma admitted to our center from April 2019 to January 2021 were retrospectively analyzed. All patients accepted TTFields≥1 month. Follow-up was performed for 5.3 months (ranged from 2.3 to 10.7 months); Response Assessment in Neuro-Oncology Working Group (RANO) criteria was used to evaluate the glioma responses. The progression-free survival (PFS) and overall survival (OS) were calculated according to Kaplan-Meier method. Common Terminology Criteria for Adverse Events v5.0 (CTCAE v5.0) and TTFields related skin adverse reaction (dAE) criteria were used to evaluate the adverse events. Quality of life questionnaire-core 30 (QLQ-C30) and QLQ-brain cancer module (QLQ-BN20) questionnaires were used to evaluate the health-related quality of life (HRQoL). Treatment compliance was evaluated by data on the use of NovoTTF-200A devices, and calculated as a percentage of daily TTFields usage.Results:The median duration of TTFields was 4.2 months (ranged from 1.0 to 10.7 months), with a median compliance rate of 91.5% (67.0%-97.0%). TTFields was used alone in 2 patients and used with combination of chemotherapy in 22 patients. From follow-up to April 2021, 14 patients had stable symptoms and 10 had disease progression (8 died). The median PFS and OS of recurrent patients were 5.9 months ( 95%CI: 3.3-8.6 months) and 8.5 months ( 95%CI: 3.2-13.8 months), respectively; and the median PFS and OS of newly diagnosed patients were both 10.7 months (without 95%CI). The common adverse events included grading 1 dAE (58.3%) and grading 2 dAE (12.5%), without grading 3 or 4 dAE, manifested as contact or allergic dermatitis, erosion, folliculitis and ulcers. And 87.5% patients had stable HRQoL. Conclusions:The preliminary results showed that the survival of recurrent high-grade glioma patients treated by TTFields is similar to that reported in foreign literature; and the newly diagnosed patients need further survival follow-up. The patients' treatment compliance and safety are good. The dAE incidence (grading 1-2) is higher than that reported in the literature, and the toxicity was acceptable.
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Objective To explore the feasibility of employing a risk category system in evaluating the treatment outcome of locoregionally advanced nasopharyngeal carcinoma (NPC) treated by intensitymodulated radiation therapy (IMRT) alone,and offering evidence for relevant perspective studies.Methods Totally 185 locoregionally advanced NPC patients were divided into high-risk and low-risk groups for evaluation and comparison.The patients who met at least one of the following criteria were defined as high-risk group and others as low-risk group:GTVnx ＞ 30 cm3;Clinical stage T4N2M0;multiple neck node metastases with 1 node size ＞4 cm,and N3 with any T stage.Results With a median follow up of 110.9 months (6.7-152.4 months),the 5-year overall survival,locoregional relapse-free survival,distant metastasis-free survival for the high-risk group vs.the low-risk group were 61.0％ vs.90.5％ (x2 =30.298,P＜0.05),78.3％ vs.91.5％ (x2 =6.352,P＜0.05)and 71.6％ vs.92.0％ (x2 =16.346,P ＜0.05).Conclusions As a simple and practicable method,the risk category system is helpful for discriminating locoregionally advanced nasopharyngeal carcinoma with different risk-group of treatment failure and in further perspective clinical research.
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Objective To investigate the long-term outcome and prognostic factors of patients with nasopharyngeal carcinoma treated with intensity-modulated radiation therapy (IMRT). Methods From February 2001 to December 2006, 419 patients with nasopharyngeal carcinoma in Cancer Center of Sun yatsen University received IMRT. The number of patients with stage Ⅰ,Ⅱ,Ⅲ and Ⅳ disease was 28, 113, 202 and 76, respectively. In all, 182 and 237 patients received radiotherapy alone and chemoradiotherapy. The prescription doses were as follows:66-70 Gy/25 -30 f to GTV_(nx), 60 -64 Gy/25 -30 f to GTV_(nd), 55 -62 Gy/25 -30 f to CTV_1, and 42 -54 Gy/25 -30 f to CTV_2. Results The median follow-up time was 49 months (6 -94 months). The number of patients with follow-up of 1-, 3-, and 5-year were 419,360 and 166, respectively. Twenty-one, 13 and 57 patients had local recurrence, regional recurrence and distant metastasis, respectively. The 5-year local control (LC) rate, regional control (RC) rate and free from distant metastasis survival rate was 92.7%, 95.8% and 85.5%, respectively. The 5-year disease-free survival (DFS) and disease-specific survival (DSS) was 76. 3% and 84.4%, respectively. In univariate analysis, T stage, primary tumor volume, N stage and volume of cervical nodes before treatment were significant predictors of DFS and DSS, favoring the patients with early T stage (84. 1% vs. 67.6% ,Χ~2 = 12. 16, P = 0. 000 : 92. 1% vs. 75. 1% ,Χ~2 = 14. 86 . P = 0. 000) , primary tumor volume less than 20 cm~3 (89. 1% vs. 62. 9% ,Χ~2 =14. 13,P=0.000;96.2% vs. 72. 1% ,Χ~2 =38. 76,P=0.000), early N stage (81.1% vs. 64. 5%, Χ~2 = 15.49, P = 0. 000; 87. 8% vs. 76. 1%, Χ~2 = 10. 89, P = 0. 001) and volume of cervical nodes less than 5 cm~3 (83. 3% vs. 68. 8%, Χ~2 = 14. 13, P = 0. 000 ; 90. 0% vs. 78. 1%, Χ~2 = 10. 71 ,P =0. 001). Multivariate analysis showed that primary tumor volume (Χ~2 = 26. 81, P = 0. 000 and Χ~2 = 28. 47, P = 0. 000) and N stage (Χ~2 = 4. 92, P = 0. 026 and Χ~2 = 9.50, P = 0. 002) were independent predictive factors for both DFS and DSS. No grade 4 acute and late toxicities were observed. In 243 patients with follow-up time more than 3 years, only 2. 8% suffered from grade 3 late toxicifies. Conclusions IMRT with or without chemotherapy can improve the long-term survival of patients with nasopharyngeal carcinoma, especially in LC and RC. Distant metastasis becomes the main treatment failure. Primary tumor volume and N stage are significant prognostic factors. Acute and late toxicities are acceptable.
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Objective To evaluate the value of L-(methyl-11C)-labeled methionine positron emissions tomography (MET PET) and MRI in target volume delineation for postoperative radiotherapy for brain high grade glioma (HGG).Methods Thirty-seven patients with supratentorial HGG were included.Both MRI and MET PET scan were performed in the same treatment position for all patients.The consistency to determine residual tumor between MRI and MET PET was analyzed.Imaging data of MET PET and MRI were coregistered using the BrainLAB image fusion software.The extension of the volume with high uptake (VMET) on MET PET were compared quantitately with the enhancing area on MRI T1W gadolinium enhancement (VGd) and the hyperintensity area on MRI T2W (VT2).Results Both MET PET and MRI were positive for 19 patients and negative for 7 patients.The consistency between these two scans was 70.3%.MET PET was integrated with MRI in 30 patients with positive MET uptake.VMET were partially or entirely outside VGd in 29 patients and VT2 in 17 patients, whereas VGd and VT2 were partially or entirely outside VMET in all patients.The maximal distance from the margin of VMET to VGd was ≥ 2.0 cm in 50%patients and the corresponding distance of VMET to VT2 was ≥ 1.0 cm in 33% patients.Conclusions The differences are existing between MET PET and MRI in determination and identification of the location and extension of residual tumor for patients with HGG.The integration of MET PET and MRI can accurately delineate radiation target volume.
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Objective To evaluate the effect of intensity-modulated radiation therapy(IMRT) on parotid function in nasopharyngeal carcinoma(NPC). Methods Eighty-three NPC patients received prima-ry IMRT between 2001 and 2003. Xerostomia before radiotherapy, at the end of radiotherapy, at 6-month, 1-,2-,3-,4- and 5-year after radiotherapy were investigated, respectively. The relation between xerostomia and parotid dose distribution was analyzed. Results Of all the patients,4,31,31 and 17 had stage Ⅰ,Ⅱ,Ⅲ and ⅣA disease, respectively. Sixteen patients received chemo-radiotherapy. The median followed-up time was 65 months. The 5-year local control and regional control rate were 96% and 95% ,respectively. The 5-year overall survival rate was 80%. The mild xerostomia rate at the seven time points was 42%, 51%, 71%, 77%, 58%, 38% and 26%. The corresponding moderate xerostomia rate was 52%, 53%, 21%,8%, 3%, 2% and 2%, respectively. No serious xerostomia was observed. The mean dose of the bilateral parotid glands was 34.34 Gy. Xerostomia at 6-month after radiotherapy was positively correlated with the mean dose of the parotid glands, and D50 was the independent factor in predicting the xerostomia. Parotid function was well protected when the mean dose and D50 were no more than 33 Gy and 29 Gy,respectively. Conclusions IMRT can improve the local-regional control of NPC and protect the parotid glands from radiation-induced in-jury.
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Objective To evaluate the long-term efficaey of radiotherapy (RT) alone for nasopharyngnal eareinoma(NPC). Methods 934 NPC patients initially treated by conventional RT alone in 1999 were reviewed retrespeetively, including 676 males and 258 females. According to 92' Fuzhou staging system,there were 35 stage Ⅰ,215 stage Ⅱ ,488 stage Ⅲ and 196 stage Ⅳ diseases. All patients were treated by conventional RT alone with two opposing parallel faeio-eervical fields. The total dose delivered to the nasopharynx was 66-88 Gy. The dose to the cervical lymph nodes was 60-70 Gy, while the prophylactic dose to the neck was 50-56 Gy. Results The median follow-up was 67.1 months. The 5- and 8-year overall survival(OS), disease-free sutural, relapse-free survival and metastasis-free survival rates were 68.30%, 67.3% ,64.4% ,72.4% ,and 48.0% ,66.6% ,50.8% ,68.0% (χ2=49.74, P=0.000), respectively. For stage N1patients,the 5-and 8-year overall survival(OS) ,disease-free survival ,relapse-free survival and metastasis-free survival rates were significantly lower than those of stage NO patients [66.0% : 77.4% and 50.3%:59.8%(χ2=33.34,P=0.000);66.8%:76.1% and 66.1%:76.1%(χ2=29.08,P=0.000); 63.4%:72.9% and 48.9% : 58.7% (χ227.65,P=0.000);71.0%:80.8% and 63.4%:68.0%(χ2=26.13,P=0.000)]. And the corresponding rates of stage N<1-2>were significantly higher than stage N3,while no statistical difference was observed between stage N1 and N2. Multivariate analysis showed that sex, age, pathology,T stage and N stage were independent prognisitie factors for OS. Conclusions Radical RT alone could obtain good long-term results in early stage NPC. Tlowever,OS for local-regionally advanced stage NPC was still unsatisfactory because of the high relapse and metastatic rate. Clinical stage and N stage were valuable prognostic factors.
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Objective To evaluate the efficacy and safety of actovegin against acute oral mucositis through a randomized controlled multicenter trial for nasopharyngeal carcinoma(NPC) patients treated by chemo-radiotherapy. Methods From February 2006 to May 2007,a total of 161 patients with newly diagnosed stage Ⅱ-ⅣA(1992 Fuzhou Stage) NPC were randomly assigned to the prevention group,the treatment group and the control group. All patients received current chemo-radiotherapy ± neoadjuvant chemotherapy. Radiation technique and dose were similar among the three groups. Intravenous infusion of aeovegin was started when radiation started in the prevention group and when grade 2 mueositis occurred in the treatment group,which was given 30 ml daily ,5 times per week until the end of radiotherapy. Criteria of NCI CTC 2.0 and VRS were used to evaluate acute oral mueositis and pain degree,respectively. Results 154 patients were eligible for the efficacy analysis,including 49 in the prevention group,53 in the treatment group and 52 in the control group. In the prevention group and the control group, the incidence was 31% and 56% (P=0.011) for grade 3-4 mucositis,59% and 83% (P=0.009) for grade 2-3 pain. In the treatment group and the control group,the corresponding number was 38% and 60% (P=0.023) ,70% and 90%, (P=0.014). The prevention group had a lower incidence(P=0.021) and longer average interval(P=0.009) of grade 2 mucositis when comparing with the control group. No drug-related adverse event was observed. Conclusions Prophylactic or therapeutic use of actovegin by intravenous infusion can significantly reduce the severity of ehemo-radiotherapy induced oral mucositis and pain. The prophylactic use may also postpone and decrease the incidence of grade 2 mucositis,which deserves clinic application.
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Purpose:A phase I trial of radiotherapy concomitantly with weekly paclitaxel was carried out to define the maximal tolerant dose (MTD) by describing the dose limiting toxicity (DLT) of paclitaxel given as a 3 hour Ⅳ infusion in patients with locally advanced nasopharyngeal carcinoma (NPC). Methods:Patients with locally advanced NPC were enrolled into a prospective, dose escalating phase I study. Toxicity was graded according to CTC 2.0. MTD was defined when two out of six patients developed DLT. The starting dose of paclitaxel was 20 mg/m 2 once weekly IV over 3 hours, with a subsequent dose escalation of 10 mg/m 2 in cohorts of three new patients. Radiation therapy was administered with conventional technique over 7 weeks in 2.0 Gy/daily fractions for 5 days/week up to total doses of 68～70 Gy.Results:From December 2000 to June 2001, sixteen patients completed chemoradiotherapy, and all of them were eligible for toxicity evaluation. On the first dose level (20 mg/m 2 ) no patient experienced DLT. On the next dose level with 30 mg/m 2 , one patient experienced DLT with grade Ⅲ mucositis for 5 weeks, and among the additional 3 patients no one developed DLT. On the third dose level with 40 mg/m 2 , one patient developed grade Ⅲ mucositis for 4 weeks and another suffered from grade Ⅲ dermatitis for 4 weeks. In order to make the trial more credible, another 4 patients were added to 30 mg/m 2 level, and no DLT occurred. Thus, the accumulation of patients stopped. After a median follow-up 12 months, one patient died of multiple bone metastases. One patient needed an operation to eradicate the residual right upper cervical lymph node 3 months after radical irradiation. Fourteen patients survived with disease free condition.Conclusions:When paclitaxel is given weekly as a 3 hour infusion concomitant to conventional radiotherapy for locally advanced NPC, MTD is 30 mg/m 2 with mucositis and dermatitis as DLT, and other toxicities are mild.