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Oral Maintenance Chemotherapy Using S-1/Capecitabine in Metastatic Nasopharyngeal Carcinoma Patients After Systemic Chemotherapy: A Single-Institution Experience.

ABSTRACT: Background:In this study, we retrospectively evaluated a series of metastatic nasopharyngeal carcinoma (mNPC) patients who received oral maintenance chemotherapy using S-1/capecitabine after systemic chemotherapy and local radiation therapy, and aimed to explore potential efficient treatment strategies for this subset of patients. Patients and Methods:Thirty-seven patients with mNPC (19 newly diagnosed metastatic patients and 18 metastatic cases after definitive chemoradiotherapy) who received the treatment strategies mentioned above were analyzed. Results:After a median follow-up time of 37 months, the 3-year progression-free survival and overall survival (OS) rates were 47.6% and 87.7%, respectively. The median time to progression was 27.6 months, while the median OS was not reached at time of last follow-up. The most common acute adverse events were hematological and gastrointestinal toxicity, and all were tolerable and curable. Conclusion:Oral maintenance chemotherapy using S-1/capecitabine in mNPC patients after systemic chemotherapy could yield a superb outcome. Further multicenter prospective clinical trials are warranted.

SUBMITTER: Guo Q

PROVIDER: S-EPMC7049279 | biostudies-literature | 2020

REPOSITORIES: biostudies-literature

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Oral Maintenance Chemotherapy Using S-1/Capecitabine in Metastatic Nasopharyngeal Carcinoma Patients After Systemic Chemotherapy: A Single-Institution Experience.

Guo Qiaojuan Q Chen Mengwei M Xu Hanchuan H Lu Tianzhu T Zhou Han H Chen Yanyan Y Zong Jingfeng J Xu Yun Y Chen Bijuan B Wang Bingyi B Zhu Lili L Pan Jianji J Lin Shaojun S

Cancer management and research 20200225

<h4>Background</h4>In this study, we retrospectively evaluated a series of metastatic nasopharyngeal carcinoma (mNPC) patients who received oral maintenance chemotherapy using S-1/capecitabine after systemic chemotherapy and local radiation therapy, and aimed to explore potential efficient treatment strategies for this subset of patients.<h4>Patients and methods</h4>Thirty-seven patients with mNPC (19 newly diagnosed metastatic patients and 18 metastatic cases after definitive chemoradiotherapy) ...[more]

PMID: 32158270

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Project description:BackgroundThe majority of published studies in recurrent or metastatic nasopharyngeal carcinoma (RM-NPC) are single-arm trials. Reliable modelling of progression-free survival (PFS) and overall survival (OS) outcomes, therefore, is difficult. This study aim to analyse existent literature to estimate the relative efficacy of available systemic regimens in RM-NPC, as well as provide estimates of aggregate OS and PFS.MethodsWe conducted a systematic search of MEDLINE, EMBASE and the Cochrane Library to March 2015. Clinical trials (in English only) investigating cytotoxic and molecularly targeted agents in adult patients with RM-NPC were included. All relevant studies were assessed for quality using Downs and Blacks (DB) checklist (maximum quality score of 27). Aggregate data analysis and Student's t-test were performed for all identified studies (model A). For studies that published analysable Kaplan-Meier curves, survival data were extracted and marginal proportional hazards models were constructed (model B).ResultsA total of 56 studies were identified and included in model A, 26 of which had analysable Kaplan-Meier curves and were included in model B. The 26 studies in model B had significantly higher mean DB scores than the remaining 30 (17.3 vs 13.7, P=0.002). For patients receiving first line chemotherapy, the estimated median OS was 15.7 months by model A (95% CI, 12.3-19.1), and 19.3 months by model B (95% CI, 17.6-21.1). For patients undergoing second line or higher therapies (2nd+), the estimated median OS was 11.5 months by model A (95% CI 10.1-12.9), and 12.5 months by model B (95% CI 11.9-13.4). PFS estimates for patients undergoing first-line chemotherapy by model A was 7.6 months (95% CI, 6.2-9.0), and 8.0 months by model B (95% CI, 7.6-8.8). For patients undergoing therapy in the 2nd+ setting, the estimated PFS by model A was 5.4 months (95% CI, 3.8-7.0), and 5.2 months by model B (95% CI, 4.7-5.6).ConclusionsWe present the first aggregate estimates of OS and PFS for RM-NPC patients receiving first and second-line or higher treatment settings, which could inform the design of future clinical trials in this disease setting.

Project description:There is no standard third-line or further systemic treatment for patients with inoperable locoregionally advanced recurrent or metastatic nasopharyngeal carcinoma (NPC). Metronomic oral cyclophosphamide provides an acceptable and cheap option for these heavily pretreated patients who had limited choices. We conducted a prospective phase II single-arm open-label study of metronomic oral cyclophosphamide. Patients with locoregionally advanced recurrent inoperable (rT3/T4, rN2-N3b) or metastatic (rM1) NPC who had Eastern Cooperative Oncology Group (ECOG) performance status (PS) (0-2) and had progressed after at least 2 lines of palliative systemic chemotherapy were eligible. They received oral cyclophosphamide between 50 and 150 mg once daily until progressive disease or unacceptable toxicity. Objective response rate (ORR), disease control rate (DCR), biochemical response (two consecutive declines of plasma EBV DNA after treatment), progression-free survival (PFS), overall survival (OS), and safety profiles were evaluated. A total of 56 patients were recruited. Thirty-three, 13, 6, 3, and 1 patients received cyclophosphamide as 3rd, 4th, 5th, 6th, and 7th line of therapy respectively. After a median follow-up of 9.95 months (range 1.76-59.51 months), the ORR was 8.9% and the DCR was 57.1%. The median PFS and OS were 4.47 and 9.20 months, respectively. Those with PS 1 had longer median PFS (5.49 months) compared to those with PS 2 (3.75 months, P = .011). Besides, those who had locoregionally recurrent disease had better PFS (8.97 months, 95% CI, 0.53-17.41 months) compared to those who had distant metastases (4.14 months, 95% CI, 2.53-5.75 months, P = .020). Multivariable analysis revealed that PS 1 (vs 2) (P = .020) and locoregional recurrence (vs metastasis) (P = .029) were the only significant independent prognostic factors of PFS. Around 16 (28.6%) patients developed grade ≥3 adverse events, including malaise (5.4%), hematological (8.9%), gastrointestinal (3.6%), feverish (3.6%), and hemorrhagic (1.8%) events. The median cost of the whole drug treatment was 51.65 US dollars (USD) (range 4.15-142.75 USD) (1 USD = 7.8 HK dollars [HKD]). Metronomic oral cyclophosphamide is an acceptable third-line or beyond systemic therapy for locoregionally advanced recurrent or metastatic NPC with acceptable toxicity and limited financial burden.

Project description:ImportanceCapecitabine maintenance therapy improves survival outcomes in various cancer types, but data are limited on the efficacy and safety of capecitabine maintenance therapy in metastatic nasopharyngeal carcinoma (NPC).ObjectiveTo investigate the efficacy and safety of capecitabine maintenance therapy in metastatic NPC.Design, setting, and participantsThis randomized phase 3 clinical trial was conducted at Sun Yat-sen University Cancer Center from May 16, 2015, to January 9, 2020, among 104 patients with newly diagnosed metastatic NPC who had achieved disease control after 4 to 6 cycles of induction chemotherapy with paclitaxel, cisplatin, and capecitabine. The final follow-up date was May 30, 2021. All efficacy analyses were conducted in the intention-to-treat population.InterventionsEligible patients were randomly assigned (1:1) to receive either capecitabine maintenance therapy (1000 mg/m2 orally twice daily on days 1-14) every 3 weeks plus best supportive care (BSC) (capecitabine maintenance group) or BSC alone after 4 to 6 cycles of induction chemotherapy.Main outcomes and measuresProgression-free survival (PFS). Secondary end points were objective response rate, duration of response, overall survival, and safety.ResultsThis study included 104 patients (84 men [80.8%]; median age, 47 years [IQR, 38-54 years]), with 52 assigned to the capecitabine maintenance group and 52 assigned to the BSC group. After a median follow-up of 33.8 months (IQR, 22.9-50.7 months), there were 23 events (44.2%) of progression or death in the capecitabine maintenance group and 37 events (71.2%) of progression or death in the BSC group. Median PFS survival was significantly higher in the capecitabine maintenance group (35.9 months [95% CI, 20.5 months-not reached]) than in the BSC group (8.2 months [95% CI, 6.4-10.0 months]), with a hazard ratio of 0.44 (95% CI, 0.26-0.74; P = .002). Higher objective response rates and longer median duration of response were observed in the capecitabine maintenance group (25.0%; 40.0 months) compared with the BSC group (objective response rate, 25.0% [n = 13] vs 11.5% [n = 6]; and median duration of response, 40.0 months [95% CI, not reached-not reached] vs 13.2 months [95% CI, 9.9-16.5 months]). The most common grade 3 or 4 adverse events during maintenance therapy were anemia (6 of 50 [12.0%]), hand-foot syndrome (5 of 50 [10.0%]), nausea and vomiting (3 of 50 [6.0%]), fatigue (2 of 50 [4.0%]), and mucositis (2 of 50 [4.0%]). No deaths in the maintenance group were deemed treatment-related.Conclusions and relevanceIn this phase 3 randomized clinical trial, capecitabine maintenance therapy significantly improved PFS for patients with newly diagnosed metastatic NPC who achieved disease control after capecitabine-containing induction chemotherapy. Capecitabine exhibited manageable toxic effects.Trial registrationClinicalTrials.gov Identifier: NCT02460419.

Dataset Information

Oral Maintenance Chemotherapy Using S-1/Capecitabine in Metastatic Nasopharyngeal Carcinoma Patients After Systemic Chemotherapy: A Single-Institution Experience.

Publications

Oral Maintenance Chemotherapy Using S-1/Capecitabine in Metastatic Nasopharyngeal Carcinoma Patients After Systemic Chemotherapy: A Single-Institution Experience.

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