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Original Article
- Phase II Trial of Neoadjuvant Docetaxel/Cisplatin/5-Fluorouracil Combined with Pegteograstim for Unresectable, Locally Advanced Sinonasal Squamous Cell Carcinoma: KCSG HN18-07
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Bhumsuk Keam1
, Ho Jung An2
, Seong Hoon Shin3, Min Kyoung Kim4, Jung Hae Cho5, Seyoung Seo6, Sung-Bae Kim6 -
DOI: https://doi.org/10.4143/crt.2024.1025 [Accepted]
Published online: December 16, 2024
1Department of Internal Medicine, Seoul National University Hospital, Seoul, Korea
2Division of Oncology, Department of Internal Medicine, St. Vincent’s Hospital, College of Medicine, The Catholic University of Korea, Suwon, Korea
3Department of Internal Medicine, Kosin University Gospel Hospital, Busan, Korea
4Division of Hematology-Oncology, Department of Internal Medicine, Yeungnam University College of Medicine, Daegu, Korea
5Department of Otolaryngology-Head and Neck Surgery, St. Vincent’s Hospital, College of Medicine, The Catholic University of Korea, Suwon, Korea
6Department of Oncology, Asan Medical Center, University of Ulsan College of Medicine, Seoul, Korea
2Division of Oncology, Department of Internal Medicine, St. Vincent’s Hospital, College of Medicine, The Catholic University of Korea, Suwon, Korea
3Department of Internal Medicine, Kosin University Gospel Hospital, Busan, Korea
4Division of Hematology-Oncology, Department of Internal Medicine, Yeungnam University College of Medicine, Daegu, Korea
5Department of Otolaryngology-Head and Neck Surgery, St. Vincent’s Hospital, College of Medicine, The Catholic University of Korea, Suwon, Korea
6Department of Oncology, Asan Medical Center, University of Ulsan College of Medicine, Seoul, Korea
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Corresponding author:
Ho Jung An
Tel: 82-31-881-8893 Fax: 82-31-244-7983 Email: meicy@catholic.ac.kr
Received: 24 October 2024 • Accepted: 13 December 2024
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Abstract
Purpose
The role of neoadjuvant chemotherapy in locally advanced sinonasal squamous cell carcinoma (SNSCC) has not been established prospectively. We conducted a phase II trial of neoadjuvant chemotherapy (NAC) with docetaxel/cisplatin/5-fluorouracil (TPF) in this population.
Materials and Methods
Eligible patients had unresectable, locally advanced SNSCC, defined as T3/4 stage or potential compromise of critical organ function on surgery. Three TPF (docetaxel 75 mg/m2 and cisplatin 75 mg/m2 on day 1, 5-fluorouracil 1,000 mg/m2 on days 1–4 every 3 weeks) cycles were administered with prophylactic pegteograstim. The primary outcome was the overall response rate (ORR); the secondary outcomes included 2-year progression-free survival (PFS), eyeball preservation rate, and safety.
Results
Among 28 patients screened, 25 were evaluable for efficacy (one screen-failure; two evaluable for safety only). The confirmed ORR was 72.0%. The definitive post-NAC treatment comprised chemoradiotherapy (n=15) and surgery (n=10). With a median follow-up of 25.5 months, median PFS was not reached and the 2-year PFS rate was 60.4%. Response to NAC was related to prolonged PFS (p=0.038). No patient underwent eyeball exenteration at the data cutoff point. Treatment-related adverse events of grade ≥3 were neutropenia (48.1%) including febrile neutropenia (14.8%), followed by acute kidney injury (22.2%), nausea/vomiting (11.1%), anemia (7.4%), thrombocytopenia (7.4%), and enterocolitis (3.7%).
Conclusion
TPF NAC showed a promising efficacy and might help preserve critical structures in this population, which needs to be validated in a large prospective trial (KCT0003377).
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