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Published on: February 12, 2017
Durvalumab With Radiation Therapy in Patients With Inoperable Locally Advanced Non-Small Cell Lung Cancer Ineligible
Andreas Rimner1,2, Emily S Lebow1,3, Kelly J Fitzgerald1,4
1Department of Radiation Oncology, Memorial Sloan Kettering Cancer Center, New York, NY.
Summary
Concurrent chemoradiotherapy (CRT) is standard for locally advanced non-small cell lung cancer (LA-NSCLC). This study shows thoracic radiation therapy with durvalumab offers improved progression-free survival for patients ineligible for CRT.
Area of Science:
- Oncology
- Immunotherapy
- Radiation Oncology
Background:
- Concurrent platinum-based chemotherapy and radiation therapy (cCRT) followed by durvalumab is the standard of care for fit patients with locally advanced non-small cell lung cancer (LA-NSCLC).
- A significant unmet need exists for a standard of care (SoC) for patients with LA-NSCLC who are ineligible for cCRT due to age, comorbidities, or frailty.
Purpose of the Study:
- To investigate the efficacy and safety of concurrent and consolidative durvalumab with definitive radiation therapy (RT) without chemotherapy in cCRT-ineligible patients with LA-NSCLC.
- To compare the 2-year progression-free survival (PFS) against historical controls of sequential CRT.
Main Methods:
- A multicenter, single-arm, prospective phase II study.
- Patients received conventionally fractionated RT plus concurrent and consolidative durvalumab (1,500 mg every 4 weeks) for up to 12 months.
- Primary end point: 2-year PFS. Secondary end points: overall survival (OS) and cancer-specific survival (CSS).
Main Results:
- The study met its primary end point with a 2-year PFS of 39% (vs. historical 20%).
- 2-year OS was 54%.
- Grade 3/4 treatment-related adverse events (AEs) occurred in 21% of patients; 7% experienced Grade 5 AEs. Durvalumab was discontinued early due to AEs in 31% of patients.
Conclusions:
- Thoracic RT with concurrent and consolidative durvalumab is a promising treatment option for cCRT-ineligible patients with LA-NSCLC.
- This approach demonstrated improved PFS with a favorable safety profile compared to historical controls.
