Neoadjuvant Chemotherapy and Surgery versus Surgery for Organ Preservation of T3 and T4a Nasal and Paranasal Sinus Squamous Cell Carcinoma: ECOG-ACRIN EA3163 Journal Article
| Authors: | Saba, N. F.; Flamand, Y.; Lin, D. T.; Chung, C. H.; McDonald, M. W.; Flampouri, S.; Khan, S. A.; Snyderman, C. H.; Hanna, E. Y.; El-Sayed, I. H.; Solares, C. A.; Le, C. H.; Ghaly, M.; Hwang, P. H.; Shin, D. M.; Axelrod, R. S.; Ikpeazu, C. V.; Adkins, D. R.; Duan, F.; Cohen, M.; Samuels, M. A.; Swiecicki, P. L.; Subramaniam, R. M.; Bapsi Chakravarthy, A.; Burtness, B. A. |
| Article Title: | Neoadjuvant Chemotherapy and Surgery versus Surgery for Organ Preservation of T3 and T4a Nasal and Paranasal Sinus Squamous Cell Carcinoma: ECOG-ACRIN EA3163 |
| Abstract: | Purpose: Neoadjuvant chemotherapy for structure preservation (SP) in nasal and paranasal sinus squamous cell carcinoma (NPNSCC) has been described in single-institution studies but not in randomized studies. EA3163 was a randomized study investigating whether cytoreductive neoadjuvant chemotherapy would improve SP or overall survival (OS). Patients and Methods: Patients with T3/T4a and select T4b NPNSCC requiring orbital or base of skull (BOS) resection were randomized to surgery (arm A) versus surgery preceded by docetaxel/cisplatin for three cycles (arm B). The degree of anticipated SP (orbit and BOS) was required preoperatively and after chemotherapy. SP was noted at surgery. Co-primary objectives were the SP rate (orbit/BOS) and OS. Eighty-two patients needed to be accrued for 81% power with a 0.1 one-sided alpha using Fisher’s exact test for SP rate and 83% with a 0.1 one-sided alpha using the log-rank test for OS. Results: Among 23 evaluable patients, the overall SP rate was 30%: 15% in arm A (N = 2/13; 95% confidence interval (CI), 1.9%–45.4%) and 50% in arm B (N = 5/10; 95% CI, 18.7%–81.3%; P = 0.17). Among 18 patients with pathologic T3/T4a disease, the overall SP rate was 39%: 18% in arm A (N = 2/11; 95% CI, 2.3%–51.8%) and 71% in arm B (N = 5/7; 95% CI, 29.0%–96.3%; P = 0.049). Orbit and BOS-specific preservation rates were 38% (95% CI, 8.5%–75.5%) versus 83% (95% CI, 35.9%–99.6%) and 33% (95% CI, 9.9%–65.1%) versus 67% (95% CI, 29.9%–92.5%) in arm A versus B, respectively. The most common grade ≥3 toxicities included mucositis, anemia, nausea and lymphopenia (all >10%). No grade 5 events were reported. Conclusions: These results support neoadjuvant chemotherapy as an effective intervention for SP in T3/T4a NPNSCC and deserve further evaluation. © 2025 American Association for Cancer Research. |
| Keywords: | adult; controlled study; treatment outcome; aged; middle aged; mortality; squamous cell carcinoma; carcinoma, squamous cell; cisplatin; multimodality cancer therapy; combined modality therapy; neoadjuvant therapy; cancer staging; antineoplastic agent; neoplasm staging; randomized controlled trial; antineoplastic combined chemotherapy protocols; pathology; docetaxel; conservative treatment; surgery; drug therapy; paranasal sinus neoplasms; therapy; nose tumor; nose neoplasms; paranasal sinus tumor; organ sparing treatments; humans; human; male; female |
| Journal Title: | Clinical Cancer Research |
| Volume: | 31 |
| Issue: | 12 |
| ISSN: | 1078-0432 |
| Publisher: | American Association for Cancer Research |
| Date Published: | 2025-01-01 |
| Start Page: | 2339 |
| End Page: | 2346 |
| Language: | English |
| DOI: | 10.1158/1078-0432.ccr-24-4085 |
| PUBMED: | 40227186 |
| PROVIDER: | scopus |
| PMCID: | PMC12165817 |
| DOI/URL: | |
| Notes: | Article -- Source: Scopus |
Altmetric
Citation Impact
BMJ Impact Analytics
Related MSK Work