- In patients with previously untreated, nonmetastatic stage III-IVB locoregionally advanced nasopharyngeal carcinoma (NPC), gemcitabine and cisplatin (GP) induction chemotherapy (IC) followed by concurrent chemoradiotherapy (IC+CCRT) was well tolerated and significantly improved recurrence-free survival (RFS) vs CCRT alone.
Why this matters
- This regimen has already demonstrated impressive efficacy in recurrent-metastatic NPC.
- Primary analysis of a phase 3 study to compare IC+CCRT (n=242) vs CCRT (n=238) in 480 patients with previously untreated, nonmetastatic stage III-IVB locoregionally advanced NPC.
- RFS was defined as locoregional/distant metastatic recurrence and/or death.
- Funding: Qilu Pharmaceutical.
- In the IC+CCRT group, 239 patients initiated GP IC, among whom 2.1% received ≥2 cycles of concurrent cisplatin.
- 85.3% 3-year RFS with IC+CCRT vs 76.5% with CCRT (stratified HR, 0.51; 95% CI, 0.34-0.77; P=.001).
- 91.1% 3-year distant RFS with IC+CCRT vs 84.4% with CCRT (stratified HR, 0.43; 95% CI, 0.25-0.73).
- 94.6% 3-year OS with IC+CCRT vs 90.3% with CCRT (stratified HR, 0.43; 95% CI, 0.24-0.77).
- 76% of patients and 56% of patients receiving IC+CCRT or CCRT, respectively, experienced grade 3-4 adverse events; incidence of myelotoxic events and gastrointestinal toxicities was notably higher with IC+CCRT.
- Lower incidence of grade 3-4 late toxicities with IC+CCRT (9%) vs with CCRT (11%) despite higher cumulative cisplatin dose.
- Patients with T3-4 disease without nodal involvement were excluded.
- "A question that is blurred in today’s discussion is that these are intensive regimens, whether you're giving the drugs before or after, so whom should we be selecting out? What are the really high risk patients?" asked A. Dimitrios Colevas, MD, from the Stanford Cancer Institute in California, who was not involved in the study.