Low-dose nivolumab with neoadjuvant chemotherapy and oral metronomic therapy in borderline resectable oral cavity squamous cell carcinoma: a phase II trial.
1/5 보강
PICO 자동 추출 (휴리스틱, conf 3/4)
유사 논문P · Population 대상 환자/모집단
34 patients, all except one completed planned neoadjuvant therapy.
I · Intervention 중재 / 시술
surgery; 25 achieved R0 resection (25/33-75·7% conversion)
C · Comparison 대조 / 비교
추출되지 않음
O · Outcome 결과 / 결론
[INTERPRETATION] The NeoLOCUS regimen offers an affordable, outpatient chemo-immunotherapy approach that improves surgical conversion and pathological response in borderline resectable OSCC. [FUNDING] Fluid Research Grant- Christian Medical College, Vellore, India.
[BACKGROUND] Non-surgical management of oral cavity squamous cell carcinoma (OSCC) has poorer outcomes compared to surgery.
APA
Marimuthu PK, Renukaradhya C, et al. (2026). Low-dose nivolumab with neoadjuvant chemotherapy and oral metronomic therapy in borderline resectable oral cavity squamous cell carcinoma: a phase II trial.. The Lancet regional health. Southeast Asia, 47, 100743. https://doi.org/10.1016/j.lansea.2026.100743
MLA
Marimuthu PK, et al.. "Low-dose nivolumab with neoadjuvant chemotherapy and oral metronomic therapy in borderline resectable oral cavity squamous cell carcinoma: a phase II trial.." The Lancet regional health. Southeast Asia, vol. 47, 2026, pp. 100743.
PMID
41810147 ↗
Abstract 한글 요약
[BACKGROUND] Non-surgical management of oral cavity squamous cell carcinoma (OSCC) has poorer outcomes compared to surgery. In borderline resectable tumors, historical neoadjuvant chemotherapy achieves surgical conversion in only about 40%. Combining low-dose immunotherapy and oral metronomic therapy (OMT) with chemotherapy may enhance resection rate and survival.
[METHODS] Between April 2023 and April 2024, patients deemed 'borderline resectable' OSCC based on predefined criteria by a multidisciplinary tumor board were prospectively offered this Phase II single-arm interventional trial setting. Patients received two 21-day cycles of carboplatin, nab-paclitaxel, low-dose nivolumab, and six weeks of erlotinib, methotrexate, celecoxib, with additional cycle(s) if needed. Primary endpoint was R0 resection rate. Secondary endpoints were objective response rate, pathologic response, safety, event-free survival (EFS), and overall survival (OS). Immune biomarkers and Volumetric assessment were exploratory endpoints. The trial was prospectively registered in the Clinical Trial Registry of India (CTRI/2023/04/051617).
[FINDINGS] Of 34 patients, all except one completed planned neoadjuvant therapy. After 2 cycles, 22 (66·6%) had partial response and 11 had stable disease; none progressed. Twenty six underwent surgery; 25 achieved R0 resection (25/33-75·7% conversion). Four of seven remaining patients received additional cycle(s); three subsequently achieved R0 resection. Overall conversion rate was 90·3% (28/31) excluding 2 patients who refused further treatment. Major pathological response occurred in 12 patients (41·4%), including four with pathological complete response. Grade ≥3 toxicities occurred in 5 of 34 patients (14·7%), with no treatment-related deaths. One patient had grade 4 diarrhea with grade 4 acute kidney injury.
[INTERPRETATION] The NeoLOCUS regimen offers an affordable, outpatient chemo-immunotherapy approach that improves surgical conversion and pathological response in borderline resectable OSCC.
[FUNDING] Fluid Research Grant- Christian Medical College, Vellore, India.
[METHODS] Between April 2023 and April 2024, patients deemed 'borderline resectable' OSCC based on predefined criteria by a multidisciplinary tumor board were prospectively offered this Phase II single-arm interventional trial setting. Patients received two 21-day cycles of carboplatin, nab-paclitaxel, low-dose nivolumab, and six weeks of erlotinib, methotrexate, celecoxib, with additional cycle(s) if needed. Primary endpoint was R0 resection rate. Secondary endpoints were objective response rate, pathologic response, safety, event-free survival (EFS), and overall survival (OS). Immune biomarkers and Volumetric assessment were exploratory endpoints. The trial was prospectively registered in the Clinical Trial Registry of India (CTRI/2023/04/051617).
[FINDINGS] Of 34 patients, all except one completed planned neoadjuvant therapy. After 2 cycles, 22 (66·6%) had partial response and 11 had stable disease; none progressed. Twenty six underwent surgery; 25 achieved R0 resection (25/33-75·7% conversion). Four of seven remaining patients received additional cycle(s); three subsequently achieved R0 resection. Overall conversion rate was 90·3% (28/31) excluding 2 patients who refused further treatment. Major pathological response occurred in 12 patients (41·4%), including four with pathological complete response. Grade ≥3 toxicities occurred in 5 of 34 patients (14·7%), with no treatment-related deaths. One patient had grade 4 diarrhea with grade 4 acute kidney injury.
[INTERPRETATION] The NeoLOCUS regimen offers an affordable, outpatient chemo-immunotherapy approach that improves surgical conversion and pathological response in borderline resectable OSCC.
[FUNDING] Fluid Research Grant- Christian Medical College, Vellore, India.
🏷️ 키워드 / MeSH 📖 같은 키워드 OA만
🏷️ 같은 키워드 · 무료전문 — 이 논문 MeSH/keyword 기반
- Successful Treatment of Paranasal Sinus Metastasis From Renal Cell Carcinoma With Immune Checkpoint Inhibitors and Radiotherapy: A Case Report.
- Nanoparticle Albumin-Bound Paclitaxel and Nivolumab for PD-1 Inhibitor-Refractory Recurrent or Metastatic Head and Neck Squamous-Cell Carcinoma.
- Efficacy and safety of nivolumab plus chemotherapy in patients with advanced gastric cancer with massive ascites.
- [Update on the regression grading of non-small cell lung cancer].
- Combined Impact of Neoadjuvant Therapy and Preoperative Cachexia in Patients Undergoing Pancreatoduodenectomy: Is There a "Double Jeopardy"? A National Cohort Study Investigating the Association with Short- and Long-Term Outcomes.
- Artificial Intelligence in Triple-Negative Breast Cancer: Applications in Diagnosis, Treatment Response, and Prognosis.