Capecitabine maintenance extends PFS in newly diagnosed metastatic nasopharyngeal carcinoma
Capecitabine maintenance therapy significantly prolonged PFS among patients with newly diagnosed metastatic nasopharyngeal carcinoma who achieved disease control after capecitabine-containing induction chemotherapy, according to a study.
Results of the randomized phase 3 trial, published in JAMA Oncology, also showed manageable toxic effects with capecitabine maintenance.
“Prospective studies are needed to define the optimal duration of capecitabine maintenance and identify the individuals who might benefit more from maintenance therapy,” Guo-Ying Liu, MD, researcher in the department of nasopharyngeal carcinoma at Sun Yat-sen University Cancer Center’s State Key Laboratory of Oncology in South China, and colleagues wrote.
Background and methodology
Liu and colleagues knew capecitabine maintenance therapy improved survival outcomes in various cancer types, but limited data existed on its efficacy and safety in metastatic nasopharyngeal carcinoma.
Their analysis included 104 patients (median age, 47 years; interquartile range, 38-54; 80.8% men) with newly diagnosed metastatic nasopharyngeal carcinoma at Sun Yat-sen University Cancer Center from May 16, 2015, to Jan. 9, 2020.
Researchers randomly assigned patients 1:1 to capecitabine maintenance plus best supportive care (n = 52; median age, 45; range, 38-51; 82.7% men) or best supportive care alone (n = 52; median age, 49; range, 38-55; 78.8% men). Patients in the capecitabine maintenance group received 1,000 mg/m2 capecitabine orally twice a day on days 1 to 14 every 3 weeks plus best supportive care; the other group received best supportive care after four to six cycles of induction chemotherapy.
PFS served as the primary outcome; secondary endpoints included objective response rate, duration of response, OS and safety.
Key findings
Results showed 23 patients in the capecitabine maintenance group (44.2%) experienced disease progression or died compared with 37 (71.2%) in the best supportive care group at median follow-up of 33.8 months (interquartile range, 22.9-50.7).
Researchers reported significantly longer median PFS in the capecitabine maintenance group (35.9 months; 95% CI, 20.5 to not reached) vs. the best supportive care (8.2 months; 95% CI, 6.4-10), with an HR of 0.44 (95% CI, 0.26-0.74).
Additionally, Liu and colleagues observed a higher ORR (25% vs. 11.5%) and longer median duration of response (40 months vs. 13.2 months) in the capecitabine maintenance group.
The most common grade 3 or grade 4 adverse events during maintenance therapy included anemia (12%), hand-foot syndrome (10%), nausea and vomiting (6%), fatigue (4%) and mucositis (4%). No treatment-related deaths occurred in the maintenance group.
Implications
Liu and colleagues concluded the randomized phase 3 trial “provides evidence that capecitabine maintenance therapy may be a promising alternative treatment modality for patients with metastatic nasopharyngeal carcinoma who achieved disease control after capecitabine-containing induction chemotherapy, with a manageable safety profile.”
The results also "exemplify the progress the field has made in this disease within such a short time," Wai-Tong Ng, MD, of the Clinical Oncology Centre at University of Hong Kong-Shenzhen Hospital in Shenzhen, China, and colleagues wrote in a related editorial.
“Together with the incorporation of radiation therapy or ablative therapy to eradicate locoregional and metastatic disease, all these strategies will mark the dawn of a new era of never giving up on patients with recurrent or metastatic nasopharyngeal carcinoma, whose life expectancy was, at one point, perceived to be grossly limited,” Ng and colleagues wrote.
References:
Liu G-Y, et al. JAMA Oncol. 2022;doi:10.1001/jamaoncol.2021.7366.
Ng, W-T, et al. JAMA Oncol. 2022;doi:10.1001/jamaoncol.2021.7365.
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