KEY POINTS
- NEOTRAC was a phase 2 randomized controlled trial in women with newly diagnosed, inoperable, HER2-positive stage III locally advanced breast cancer; 126 patients were randomized and 118 were included in the modified intention-to-treat analysis.
- Standard treatment was neoadjuvant chemotherapy plus trastuzumab followed by surgery and sequential radiotherapy; the intervention arm received concurrent neoadjuvant chemoradiotherapy plus trastuzumab, with 46 Gy in 23 fractions before mastectomy.
- Pathological complete response was not significantly improved: 50.9% with NACCRT versus 46.6% with standard NACT, risk difference 4.4%, 95% CI −14.0 to 22.7, p = 0.64.
- Three-year outcomes were similar: event-free survival 76.8% vs 79.8%, p = 0.89, and overall survival 87.4% vs 88.7%, p = 0.63, for NACCRT versus standard treatment.
- Treatment duration was significantly shorter with NACCRT: 193.1 ± 28.6 days versus 262.9 ± 38.9 days, p < 0.0001; grade 3 radiation dermatitis occurred in 5.5%, surgical wound morbidity in 16.4% vs 6.9%, and no cardiac toxicity was observed.
CLINICAL TAKEAWAY
NEOTRAC supports the feasibility of moving radiotherapy into the neoadjuvant phase with trastuzumab for selected patients with initially inoperable HER2-positive locally advanced breast cancer, especially when shortening the total treatment course is clinically important. But the strategy did not improve pathological complete response, event-free survival, or overall survival, and wound morbidity was numerically higher. This is useful randomized feasibility evidence, not a practice-changing replacement for standard sequencing.
SOURCE
International Journal of Radiation Oncology, Biology, Physics