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Pathologic Responses to Stereotactic Ablative Radiotherapy in Combination With Nivolumab for Early Stage NSCLC: A
Gustavo Schvartsman1, Yasmin M Amirato2, Frederico Monfardini1
1Hospital Israelita Albert Einstein, São Paulo, Brazil.
Neoadjuvant nivolumab combined with stereotactic ablative radiotherapy (SABR) shows high pathologic complete response (pCR) rates in early-stage non-small cell lung cancer (NSCLC) patients eligible for surgery. This combination therapy warrants further investigation for broader NSCLC treatment applications.
Area of Science:
- Oncology
- Radiotherapy
- Immunotherapy
Background:
- Stereotactic ablative radiotherapy (SABR) is standard for early-stage NSCLC unfit for surgery, but recurrence rates remain high.
- Combining SABR with PD-1 inhibitors shows promise, yet its impact on the tumor microenvironment and pathologic response is unclear.
Purpose of the Study:
- To evaluate the efficacy and safety of neoadjuvant nivolumab plus SABR in operable, early-stage NSCLC.
- To determine the pathologic complete response (pCR) rate following this combined neoadjuvant treatment.
Main Methods:
- Phase II, single-arm study of 25 NSCLC patients (≤4 cm, node-negative).
- Three doses of nivolumab (360 mg q21d) concurrently with SABR, followed by surgery 10 weeks post-radiation.
- Primary endpoint: pCR rate; Secondary endpoints: MPR, safety, survival, biomarker analysis.
Main Results:
- A high pCR rate of 79.2% (19/24 patients) was observed.
- Major pathologic response (MPR) was seen in 83.3% of patients.
- 12-month event-free and overall survival rates were 84%; no treatment-related deaths occurred.
Conclusions:
- Neoadjuvant nivolumab and SABR achieve a high pCR rate in stage I NSCLC.
- Further research is needed for medically inoperable NSCLC and to explore omitting surgery in select cases.
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