Maintenance intervention to improve survival in patients with metastatic nasopharyngeal carcinoma who benefit from first-line treatment: A prospective multicenter randomized controlled clinical study.

2021 ◽  
Vol 39 (15_suppl) ◽  
pp. 6035-6035
Author(s):  
Ying Lu ◽  
Haixin Huang ◽  
Hui Yang ◽  
Xiaohua Hu ◽  
Xianbing Feng ◽  
...  
Keyword(s):  
Nasopharyngeal Carcinoma ◽  
Maintenance Therapy ◽  
Poor Prognosis ◽  
Observation Group ◽  
First Line ◽  
Metastatic Nasopharyngeal Carcinoma ◽  
Ebv Dna ◽  
Maintenance Intervention ◽  
First Line Treatment

6035 Background: The role of drug maintenance intervention in improving survival outcomes remains controversial.To investigate the safety and effect of Tegafur(S1) maintenance intervention in patients with metastatic nasopharyngeal carcinoma who benefit from the first-line treatment in a multicenter randomized controlled study, and to identify the related biological prognostic factors and guide the individualized treatment choice. Methods: Patients with metastatic nasopharyngeal carcinoma in the Fourth Affiliated Hospital of Guangxi Medical University and other cancer centers who met the inclusion criteria were randomly divided into maintenance therapy group: S1 maintenance therapy until disease progression or intolerance; Observation group: follow-up to disease progression. PFS, overall survival (OS) and adverse reactions of S1 maintenance therapy were compared between the two groups. The correlation between EBV-DNA, human serum amyloid A (SAA) and prognosis was evaluated. Results: Follow-up was conducted to May 2020, with a median follow-up of 19.8 months (6.1-51.3 months), 183 cases were evaluable (88 cases in S1 maintenance treatment group, 95 cases in observation group). Compared with the observation group, the S1 maintenance treatment group significantly increased patients' median PFS (16.2 months vs. 8.7 months, P < 0.001) and median OS (32.1 months vs. 18.2 months, P < 0.001). Reduced the risk of poor prognosis for PFS and OS (PFS: HR 0.305, 95%CI 0.211-0.441, < 0.001; OS: HR 0.363, 95%CI 0.238-0.553, P < 0.001). In the maintenance treatment group, the median S1 treatment lasted for 14 courses (4-58 courses), and the main adverse reactions were grade 1 skin pigmentation, oral mucositis, hand-foot syndrome, nausea, etc. No grade 4 toxic reaction occurred, and it was well tolerated. Compared with observation patients with negative EBV-DNA, observation patients with positive EBV-DNA had a higher risk of poor prognosis for PFS (HR 1.764, 95%CI 1.078-2.887, P = 0.024). The risk of poor prognosis in patients with positive EBV-NDA was significantly reduced by 61.1% ( < 0.001) for PFS and 65.5% (P = 0.001) for OS (P = 0.001). Compared with the observation group with stable SAA expression, S1 maintenance therapy significantly improved the prognosis of patients. Patients with continuous decline in SAA had a 61.9% lower risk of poor prognosis in PFS (P < 0.001) and a 60.2% lower risk of poor prognosis in OS (P = 0.007). Conclusions: For patients with metastatic nasopharyngeal carcinoma who benefit from first-line treatment, maintenance therapy of S1 can significantly improve the survival prognosis and is well tolerated. Patients with positive EBV-DNA and continuous decline in SAA may benefit more from maintenance intervention. Clinical trial information: ChiCTR-IOR-16007939.

scholarly journals DOP54 Real-world effectiveness of thiopurine monotherapy in Crohn’s Disease: Is there still a place for thiopurines in the biological era?

2021 ◽  
Vol 15 (Supplement_1) ◽  
pp. S089-S090
Author(s):  
A Rezazadeh Ardabili ◽  
S F G Jeuring ◽  
Z Mujagic ◽  
M J L Romberg-Camps ◽  
A A van Bodegraven ◽  
...  
Keyword(s):  
Crohn’S Disease ◽  
Maintenance Therapy ◽  
Treatment Option ◽  
Real World ◽  
Population Based ◽  
Line Treatment ◽  
First Line ◽  
First Line Treatment

Abstract Background In current guidelines, thiopurines are still recommended as first-line maintenance therapy for patients with Crohn’s disease (CD). Due to their lack of immunogenicity, oral administration route and low costs, thiopurines are an attractive first-line treatment option. However, in recent studies the position of thiopurine monotherapy in CD has been questioned as a result of relatively lower overall effectiveness rates compared to ulcerative colitis. Real-world long-term effectiveness data substantiating the use and position of thiopurines in CD management remain sparse. We assessed long-term effectiveness of thiopurine monotherapy in CD using the population-based IBD South-Limburg (IBDSL) cohort. Methods All CD patients in the IBDSL cohort starting thiopurine monotherapy as first-line maintenance therapy between 1991–2014 were included. Thiopurine monotherapy was defined effective if either: (1) no escalation to biological treatment, (2) no course of corticosteroids, (3) no resective surgery or, (4) no hospitalization for active disease was required whilst on thiopurine treatment. Patients with early treatment discontinuation (i.e. &lt;3 months) were identified, including reason of discontinuation. Long-term effectiveness was assessed adjusting for differences in follow-up between patients using Kaplan-Meier analysis. Potential risk factors for therapy failure were identified using Cox regression. Results In total, 643/1162 (55.3%) CD patients (median follow-up: 8.5 years IQR 5.0–13.2) received first-line thiopurine monotherapy after a median of 9.7 months (IQR 3.2–31.3) after diagnosis. Therapy was discontinued within three months in 164 patients (25.5%), mainly due to adverse events [Figure 1]. Thiopurine monotherapy was effective for the duration of treatment in 229/479 (35.6%) patients, corresponding to estimated effectiveness rates of 62.9%, 43.9% and 31.2% after 1, 5 and 10 years, respectively [Figure 1–2]. No significant difference in effectiveness was observed after stratifying for era of thiopurine initiation (pre-biological (1991–1998) vs. biological (&gt;1999) era, p=0.84). Factors associated with thiopurine failure were stricturing disease (aHR 1.41, 95%CI 1.01–1.96) and upper GI involvement (aHR 1.52, 95%CI 1.02–2.28) at diagnosis. During follow-up, 40/229 patients with a durable response discontinued treatment due to quiescent disease. Of these, 35 patients (87.5%) remained without treatment 24 months after discontinuation. Conclusion Real-world data from this population-based study demonstrate that thiopurine monotherapy remains an effective and durable first-line treatment option for CD, even in the biological era. These results should be considered in the ongoing discussion regarding the position of thiopurine therapy.

scholarly journals P09.06 Investigating various patient parameters as prognostic markers for patients with advance stage nasopharyngeal carcinoma undergoing induction chemotherapy followed by Epstein-Barr virus cytotoxic T-lymphocyte immunotherapy

2021 ◽  
Vol 9 (Suppl 1) ◽  
pp. A30.2-A31
Author(s):  
A Chu ◽  
S Han ◽  
H Toh
Keyword(s):  
Overall Survival ◽  
Nasopharyngeal Carcinoma ◽  
Median Survival ◽  
Cytotoxic T Lymphocyte ◽  
Survival Outcome ◽  
First Line ◽  
Patient Factors ◽  
Initial Stage ◽  
Ebv Dna

BackgroundPrevious prospective phase II study conducted by our research group at the National Cancer Centre Singapore had shown the efficacy of combined induction chemotherapy followed by cytotoxic T-lymphocyte (CTL) immunotherapy as a first-line treatment for advance nasopharyngeal carcinoma (NPC) – i.e. median survival for patients treated with combined therapy was 29.9 months, compared to 17.7 months for patients who received only standard chemotherapy.1 Using the same data set, we further investigate the correlation between various patient factors (Eastern Cooperative Oncology Group (ECOG) score, gender, age, initial stage of cancer, neutrophil-to-lymphocyte ratio (NLR), initial EBV-DNA titre) on overall survival (OS). This is to further validate our hypothesis that the improved OS is due to an effect of treatment and not due to intrinsic patient factors.Materials and MethodsSurvival distribution curves were estimated using the Kaplan-Meier method and differences were compared statistically using log-rank test. IBM SPSS statistics software package (v. 22) was used for the purpose of statistical analysis. Overall survival was defined as time from diagnosis to date of event (date of death/date of last follow-up). For analysis of overall survival, data for patients who were alive or who were lost to follow-up were censored at the end of study period.ResultsIt was revealed that lower ECOG score, a scale used to assess the physical condition of patients, correlated with longer OS while other characteristics such as gender, age, initial stage of cancer, NLR, and initial EBV-DNA titre did not correlate with survival outcomes. ECOG0 patients had a median survival of 146.7 weeks, compared to ECOG1 patients, which had a median survival of 86.6 weeks (hazard ratio: 0.35; 95% CI: 0.14-0.84; P = 0.033).ConclusionsEven though ECOG performance status is found to be statistically associated with survival outcome of patients with advance stage NPC. This result is unsurprising as the prognostic value of ECOG has been well documented in literature, albeit in other cancer types. Other patient parameters such as gender, age, initial stage of cancer, NLR, and initial EBV titre, did not yield significance and did not prognosticate for survival outcome. This finding supports our hypothesis that the improved survival outcomes observed in advance NPC patients treated with chemotherapy followed by EBV CTL-immunotherapy is due to effects of treatment and not because of intrinsic patient factors.ReferenceChia WK, Teo M, Wang WW, Lee B, Ang SF, Tai WM, Chee CL, Ng J, Kan R, Lim WT, Tan SH, Ong WS, Cheung YB, Tan EH, Connolly JE, Gottschalk S, Toh HC. Adoptive T-cell transfer and chemotherapy in the first-line treatment of metastatic and/or locally recurrent nasopharyngeal carcinoma. Mol Ther 2014 Jan;22(1):132–9.Disclosure InformationA. Chu: None. S. Han: None. H. Toh: None.

scholarly journals Plasma Epstein-Barr virus DNA and risk of nasopharyngeal carcinoma in a prospective seropositive population

BMC Cancer ◽  
2021 ◽  
Vol 21 (1) ◽  
Author(s):  
Wen-Jie Chen ◽  
Wen-Na Xu ◽  
Hai-Yun Wang ◽  
Xiao-Xia Chen ◽  
Xue-Qi Li ◽  
...  
Keyword(s):  
Nasopharyngeal Carcinoma ◽  
Epstein Barr Virus ◽  
Screening Program ◽  
Southern China ◽  
Incidence Rates ◽  
Cox Proportional Hazards ◽  
Barr Virus ◽  
Ebv Dna ◽  
Epstein Barr

Abstract Objective Plasma Epstein-Barr virus (EBV) DNA is considered a biomarker for nasopharyngeal carcinoma (NPC). However, its long-term role in NPC development is unclear. Materials and methods A total of 1363 participants seropositive for EBV VCA-IgA and EBNA1-IgA in a community-based NPC screening program in southern China were tested for plasma EBV DNA levels by real-time qPCR between 2008 and 2015. New NPC cases were confirmed by active follow-up approach and linkage to local cancer registry through the end of 2016. Cox proportional hazards regression analysis was performed to calculate the hazard ratios (HRs) for NPC risk with plasma EBV DNA. Results Thirty patients were newly diagnosed during a median 7.5 years follow-up. NPC incidence increased with the plasma EBV DNA load ranging from 281.46 to 10,074.47 per 100,000 person-years in participants with undetectable and ≥ 1000 copies/ml levels; the corresponding cumulative incidence rates were 1.73 and 50%. Furthermore, plasma EBV DNA loads conferred an independent risk for NPC development after adjustment for other risk factors, with HRs of 7.63 for > 3–999 copies/ml and 39.79 for ≥1000 copies/ml. However, the HRs decreased gradually after excluding NPC cases detected in the first 2 to 3 years and became statistically nonsignificant by excluding cases detected during the first 4 years. Conclusion Elevated plasma EBV DNA can predict NPC risk over 3 years. Monitoring plasma EBV DNA can be used as a complementary approach to EBV serological antibody-based screening for NPC.

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