Top Line: Does adjuvant capecitabine improve outcomes for patients receiving chemoradiation for locoregionally advanced NPC?
The Study: Induction chemotherapy followed by concurrent chemoradiation is now the NCCN preferred approach for patients with locoregionally advanced NPC. With gem/cis, 5-year OS was improved from 78.8→ 87.9%. In patients who don’t receive induction therapy, the use of adjuvant chemotherapy has been a subject of debate. The MAC-NPC meta-analysis concluded that, while induction and adjuvant chemotherapy improve survival, concurrent chemo provides the most significant survival benefit and CRT is considered the backbone of treatment. A challenge with adjuvant chemo (particularly multi-drug regimens) is tolerance in patients who have been through head and neck chemoradiation. In this randomized phase 3 trial, 180 patients with high risk NPC were randomized to receive definitive chemoradiation with or without adjuvant capecitabine (1000 mg/m2 BID for 14 days every 3 weeks for 8 cycles). High risk criteria were any of the following: cT3-4N2, cT1-4N3, plasma EBV DNA >20,000, primary tumor >30 cc, FDG-PET maximum SUV >10, or multiple positive nodes and any node >4 cm. Of note, >80% of patients had 2 or more high risk features. An impressive 79% of patients completed all 8 cycles of adjuvant capecitabine. At 3 years, adjuvant capecitabine significantly improved the primary endpoint of failure-free survival from 72 → 83%. The rate of locoregional recurrence free survival was also higher (98% v 84%). There were numeric but not statisitical improvements in OS (93% v 88%) and DMFS (86% v 80%). The FFS outcomes were very similar to another recent randomized trial of adjuvant metronomic capecitabine (3-year FFS 85% v 76%).
TBL: Adjuvant capecitabine is a tolerable adjuvant chemotherapy regimen for locoregionally advanced NPC. Without improving OS, though, this would be a less preferred option in patients who don’t receive induction therapy. | Miao, JAMA Oncol 2022