Effect of Capecitabine Maintenance Therapy Plus Best Supportive Care vs Best Supportive Care Alone on Progression-Free Survival Among Patients With Newly Diagnosed Metastatic Nasopharyngeal Carcinoma Who Had Received Induction Chemotherapy

Author(s): Guo-Ying Liu, MD1,2; Wang-Zhong Li, MD1; De-Shen Wang, MD3; et al Hu Liang, MD1; Xing Lv, MD1; Yan-Fang Ye, MD4; Chong Zhao, MD1; Liang-Ru Ke, MD5; Shu-Hui Lv, MD6; Nian Lu, MD1,5; Wei-Xin Bei, MD1; Zhuo-Chen Cai, MD1; Xi Chen, MD1; Chi-Xiong Liang, MD1; Xiang Guo, MD1; Wei-Xiong Xia, MD1; Yan-Qun Xiang, MD1
Source: JAMA Oncol. Published online February 17, 2022. doi:10.1001/jamaoncol.2021.7366
Lucio Gordan MD

Dr. Gordan's Thoughts

Given relatively low-toxicities of capecitabine, it is reasonable to consider it especially in a population with fewer comorbidities and preserved performance-status. More data pertaining OS differences will be welcome. Study is relatively small but not unusual for this diagnosis.

A Phase 3 Randomized Clinical Trial

ABSTRACT

Importance:  Capecitabine 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).

OBJECTIVE

To investigate the efficacy and safety of capecitabine maintenance therapy in metastatic NPC.

DESIGN, SETTING, AND PARTICIPANTS

This 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.

INTERVENTIONS

Eligible 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 MEASURES

Progression-free survival (PFS). Secondary end points were objective response rate, duration of response, overall survival, and safety.

RESULTS

This 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 RELEVANCE

In 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.

Author Affiliations

1Department of Nasopharyngeal Carcinoma, Sun Yat-sen University Cancer Center, State Key Laboratory of Oncology in South China, Collaborative Innovation Center for Cancer Medicine, Guangdong Key Laboratory of NPC Diagnosis and Therapy, Guangzhou, China 2Department of Radiotherapy, Sun Yat-sen Memorial Hospital, Sun Yat-sen University, Guangzhou, China 3Department of Medical Oncology, Sun Yat-sen University Cancer Center, State Key Laboratory of Oncology in South China, Collaborative Innovation Center for Cancer Medicine, Guangdong Key Laboratory of NPC Diagnosis and Therapy, Guangzhou, China 4Clinical Research Design Division, Sun Yat-sen Memorial Hospital, Guangzhou, China 5Department of Medical Imaging, Sun Yat-sen University Cancer Center, State Key Laboratory of Oncology in South China, Collaborative Innovation Center for Cancer Medicine, Guangdong Key Laboratory of NPC Diagnosis and Therapy, Guangzhou, China 6Medical Affairs Office, The Fifth Affiliated Hospital of Sun Yat-sen University, Guangzhou, China

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