Top Line: What is the rate of progression free survival after radiation and immunotherapy for stage III NSCLC?
The Study: Chemoradiation followed by adjuvant durvalumab is the standard of care for locally advanced, unresectable NSCLC. Trials are actively exploring whether adding immunotherapy to concurrent chemoradiation further improves outcomes, but what about concurrent immunotherapy without chemotherapy? In this nonrandomized, phase 2 trial, 35 patients with either unresectable stage III NSCLC (74%) or lymph node recurrent disease after prior resection (26%) were treated with definitive radiation and immunotherapy. Importantly, they had to have PD-L1 positive disease. They received 60 Gy in 30 fractions along with durvalumab given every 2 weeks for up to 12 months. Most patients (70%) were treated with 3D conformal rather than IMRT. The goal of the trial was to determine if PFS at 12 months using radioimmunotherapy was comparable to the 55.9% rate seen with chemoradiation and immunotherapy in PACIFIC. Granted this was a small trial, the actual rate of PFS at 12 months fell well above this mark at 72.1%. The rate of grade 3-4 adverse events was 52.6%, and the rate of grade 5 adverse events was 5.9%. In comparison, those rates were 30.5% and 4.4% in PACIFIC. Grade 3-4 pneumonitis was seen in 11.8% with no grade 5 pneumonitis events. In PACIFIC, 3.4% had grade 3-4 pneumonitis. On the one hand, the DOLPHIN trial showed encouraging response to radioimmunotherapy. On the other hand, it wasn’t clear that this treatment was less toxic than chemoradiation. Furthermore, the trial included healthy patients with good performance status, so it also isn’t clear if similar outcomes could be expected from less healthy patients who aren’t chemotherapy candidates.
TBL: In this nonrandomized phase 2 trial, definitive radiation with concurrent and adjuvant immunotherapy without chemotherapy produced a 72% PFS rate at 12 months. | Tachihara, JAMA Oncol 2023
The Study: Chemoradiation followed by adjuvant durvalumab is the standard of care for locally advanced, unresectable NSCLC. Trials are actively exploring whether adding immunotherapy to concurrent chemoradiation further improves outcomes, but what about concurrent immunotherapy without chemotherapy? In this nonrandomized, phase 2 trial, 35 patients with either unresectable stage III NSCLC (74%) or lymph node recurrent disease after prior resection (26%) were treated with definitive radiation and immunotherapy. Importantly, they had to have PD-L1 positive disease. They received 60 Gy in 30 fractions along with durvalumab given every 2 weeks for up to 12 months. Most patients (70%) were treated with 3D conformal rather than IMRT. The goal of the trial was to determine if PFS at 12 months using radioimmunotherapy was comparable to the 55.9% rate seen with chemoradiation and immunotherapy in PACIFIC. Granted this was a small trial, the actual rate of PFS at 12 months fell well above this mark at 72.1%. The rate of grade 3-4 adverse events was 52.6%, and the rate of grade 5 adverse events was 5.9%. In comparison, those rates were 30.5% and 4.4% in PACIFIC. Grade 3-4 pneumonitis was seen in 11.8% with no grade 5 pneumonitis events. In PACIFIC, 3.4% had grade 3-4 pneumonitis. On the one hand, the DOLPHIN trial showed encouraging response to radioimmunotherapy. On the other hand, it wasn’t clear that this treatment was less toxic than chemoradiation. Furthermore, the trial included healthy patients with good performance status, so it also isn’t clear if similar outcomes could be expected from less healthy patients who aren’t chemotherapy candidates.
TBL: In this nonrandomized phase 2 trial, definitive radiation with concurrent and adjuvant immunotherapy without chemotherapy produced a 72% PFS rate at 12 months. | Tachihara, JAMA Oncol 2023