Maintenance treatment with capecitabine prolongs progression-free survival (PFS) in patients with metastatic nasopharyngeal carcinoma (NPC) who achieve disease control with induction chemotherapy, according to the results of a phase 3 trial published in JAMA Oncology.

The trial (ClinicalTrials.gov Identifier: NCT02460419) included 104 patients with metastatic NPC who were randomly assigned to receive maintenance capecitabine plus best supportive care (BSC) or BSC alone. All patients had achieved disease control with 4 to 6 cycles of first-line paclitaxel, cisplatin, and capecitabine.

At baseline, the median age was 47 years, and 80.8% of patients were men. Most patients had nonkeratinizing disease that was undifferentiated (type III). Primary metastases were present in 59% of patients and asynchronous metastases in 41%. The majority of patients received all 6 cycles of first-line chemotherapy (85.6%), with the remaining patients receiving 4 to 5 cycles.


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The primary endpoint was PFS, and secondary endpoints included objective response rate (ORR), duration of response (DOR), overall survival, and safety.

PFS was significantly prolonged with the addition of capecitabine to BSC. The median PFS was 35.9 months in the capecitabine arm and 8.2 months in the BSC-alone arm (hazard ratio, 0.44; 95% CI, 0.26-0.74; P =.002).

The ORR was 25.0% with capecitabine and 11.5% with BSC alone. The median DOR was 40.0 months and 13.2 months, respectively.

Treatment-emergent adverse events occurred more frequently in the capecitabine arm, with the most common grade 3-4 events being anemia (12%) and hand-foot syndrome (10%). Adverse events resulted in 1 treatment discontinuation and 6 dose modifications. There were no treatment-related deaths.

“This trial provides evidence that capecitabine maintenance therapy may be a promising alternative treatment modality for patients with metastatic NPC who achieved disease control after capecitabine-containing induction chemotherapy, with a manageable safety profile,” the researchers concluded.

Reference

Liu GY, Li WZ, Wang DS, et al. 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: a phase 3 randomized clinical trial. JAMA Oncol. Published online February 17, 2022. doi:10.1001/jamaoncol.2021.7366