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MA01 - Oligometastatic Disease (ID 114)
- Event: WCLC 2019
- Type: Mini Oral Session
- Track: Oligometastatic NSCLC
- Presentations: 1
- Now Available
- Moderators:Anne Marie Clasina Dingemans, Matthias Guckenberger
- Coordinates: 9/08/2019, 10:30 - 12:00, Copenhagen (1980)
MA01.01 - Safety of Pembrolizumab Combined with Stereotactic Ablative Body Radiotherapy (SABR) for Pulmonary Oligometastases (Now Available) (ID 2187)
10:30 - 12:00 | Author(s): Shahneen Sandhu
Pembrolizumab has demonstrated safety and efficacy in a broad range of tumors. However, safety concerns exist around the combination of pembrolizumab and high dose radiotherapy to the lung, particularly as both have independent risk of pneumonitis. In this interim analysis we assess the safety profile of combination pembrolizumab and SABR to pulmonary oligometastases.Method
As part of the ongoing prospective dual-institutional RAPPORT clinical trial (clinicaltrials.gov ID NCT02855203), patients with 1-5 oligometastases from renal cell carcinoma were enrolled between Nov 2016- April 2019. All participants had ECOG performance status 0-1, and signed informed consent. Patients with at least 1 lung oligometastasis were included in this analysis. All patients were planned for a single fraction of 20Gy SABR to each lung oligometastasis, followed 5 days (+/-3 days) later by 8 cycles of 200mg i.v. 3-weekly pembrolizumab (total 24 weeks). When SABR dose constraints were not achievable, conventional hypofractionated radiotherapy could be delivered. At least 1 oligometastasis needed to receive SABR. Adverse events (AEs) were recorded using CTCAE V4.03 until 30 days post last dose of pembrolizumab, and late AEs atrributable to SABR for 24 months after SABR.Result
20 patients with a combined total of 41 lung oligometastases were included in this analysis. The mean age was 61 years, with 15 (75%) male. The number of lung oligometastases were 1 in 9 (45%), 2 in 3 (15%), 3 in 6 (30%), 4 in 2 (10%) patients. SABR was delivered to 39 lung oligometastases (95%) and conventional radiotherapy to 2 oligometastases (5%) using 10 fractions of 3Gy. Twelve patients have completed all eight cycles of pembrolizumab, with five patients having ongoing treatment. Three patients ceased treatment early due to grade 3 pneumonitis (15%) after 3, 6 and 7 cycles of pembrolizumab respectively. These patients had 1, 2 and 1 lung oligometastases, respectively. The worst grade of any treatment related AEs was grade 3 in 4 pts (20%), with 3 attributed to both SABR and pembrolizumab, and 1 atributed to pembrolizumab alone. Three of the four grade 3 events were pneumonitis. A further 3 patients had grade 2 AEs(15%), and 8 patients had grade 1 AEs(40%). There were no grade 4 or 5 adverse events, and five patients (25%) had no treatment related adverse events.Conclusion
SABR to lung oligometastases in combination with pembrolizumab was well tolerated, with clinically acceptable rates of grade 3 pneumonitis compared to historical rates reported with pembrolizumab monotherapy.
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