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More is not better when it comes to radiation therapy administered with concurrent chemotherapy for unresectable stage III non–small cell lung cancer (NSCLC), suggests a long-term update of the RTOG 0617 trial.
Initial results of the phase 3 randomized controlled trial, at a median follow-up of 1.9 years, showed that median overall survival was about 8 months longer with the 60-Gy standard dose of radiation compared with a 74-Gy high dose, each given along with paclitaxel and carboplatin (Lancet Oncol. 2015;16:187-99).
The update, now at a median follow-up of 5.1 years and reported in the Journal of Clinical Oncology, recapitulates that finding, again showing a roughly 8-month longer overall survival with the standard dose of radiation. Results continue to show no benefit of adding the anti-EGFR antibody cetuximab (Erbitux) to treatment.
“The 5-year overall survival estimate for the standard-dose radiation arm of RTOG 0617, regardless of cetuximab delivery, was 32.1%. This is among the highest overall survival results of any phase III trial for patients with stage III NSCLC,” noted the investigators, led by Jeffrey D. Bradley, MD, department of radiation oncology, Emory University, Atlanta.
“These results argue strongly that the current standard-of-care radiation dose should be 60 Gy given in 2-Gy daily fractions to a target volume directed at tumor plus margin on the basis of CT and PET/CT, excluding elective nodal irradiation.”
The RTOG 0617 trial was conducted among 496 patients with unresectable stage III NSCLC in the United States and Canada. They were randomized to receive standard-dose or high-dose radiation in addition to concurrent chemotherapy, and randomized again to receive cetuximab or not.
Median overall survival as of the update was 28.7 months with standard-dose radiation therapy, compared with 20.3 months with high-dose radiation therapy (P = .0072), Dr. Bradley and coinvestigators reported. This survival benefit stood up in multivariate analysis (hazard ratio, 1.30; P = .0315).
The standard dose of radiation also yielded better 5-year overall survival (32.1% vs. 23%; P = .007) and 5-year progression-free survival (18.3% vs. 13%; P = .055). Further analyses suggested that these differences were not due to differential radiation therapy compliance.
The high-dose radiation group had more grade 5 adverse events (nine vs. three events), as well as higher rates of treatment-related grade 3 or worse dysphagia (12.1% vs. 3.2%; P = .0005) and esophagitis (17.4% vs. 5.0%; P less than .0001). Pulmonary toxicity was statistically indistinguishable between groups.
Since the RTOG 0617 results were first reported, the standard of care for unresectable stage III NSCLC has changed, as the PACIFIC trial showed an overall survival advantage of adding the immune checkpoint inhibitor durvalumab (Imfinzi) as maintenance therapy after concurrent chemoradiotherapy (N Engl J Med. 2018;379:2342-50).
However, the 2-year overall survival rate with chemoradiation using the standard radiation dose in the former trial (59.6%) is fairly close to that seen with chemoradiation plus maintenance durvalumab in the latter trial (66.3%), the investigators noted.
Dr. Bradley disclosed having a consulting or advisory role with AstraZeneca. The trial was supported by the National Cancer Institute and Eli Lilly.
SOURCE: Bradley JD et al. J Clin Oncol. 2019 Dec 16. doi: 10.1200/JCO.19.01162.
More is not better when it comes to radiation therapy administered with concurrent chemotherapy for unresectable stage III non–small cell lung cancer (NSCLC), suggests a long-term update of the RTOG 0617 trial.
Initial results of the phase 3 randomized controlled trial, at a median follow-up of 1.9 years, showed that median overall survival was about 8 months longer with the 60-Gy standard dose of radiation compared with a 74-Gy high dose, each given along with paclitaxel and carboplatin (Lancet Oncol. 2015;16:187-99).
The update, now at a median follow-up of 5.1 years and reported in the Journal of Clinical Oncology, recapitulates that finding, again showing a roughly 8-month longer overall survival with the standard dose of radiation. Results continue to show no benefit of adding the anti-EGFR antibody cetuximab (Erbitux) to treatment.
“The 5-year overall survival estimate for the standard-dose radiation arm of RTOG 0617, regardless of cetuximab delivery, was 32.1%. This is among the highest overall survival results of any phase III trial for patients with stage III NSCLC,” noted the investigators, led by Jeffrey D. Bradley, MD, department of radiation oncology, Emory University, Atlanta.
“These results argue strongly that the current standard-of-care radiation dose should be 60 Gy given in 2-Gy daily fractions to a target volume directed at tumor plus margin on the basis of CT and PET/CT, excluding elective nodal irradiation.”
The RTOG 0617 trial was conducted among 496 patients with unresectable stage III NSCLC in the United States and Canada. They were randomized to receive standard-dose or high-dose radiation in addition to concurrent chemotherapy, and randomized again to receive cetuximab or not.
Median overall survival as of the update was 28.7 months with standard-dose radiation therapy, compared with 20.3 months with high-dose radiation therapy (P = .0072), Dr. Bradley and coinvestigators reported. This survival benefit stood up in multivariate analysis (hazard ratio, 1.30; P = .0315).
The standard dose of radiation also yielded better 5-year overall survival (32.1% vs. 23%; P = .007) and 5-year progression-free survival (18.3% vs. 13%; P = .055). Further analyses suggested that these differences were not due to differential radiation therapy compliance.
The high-dose radiation group had more grade 5 adverse events (nine vs. three events), as well as higher rates of treatment-related grade 3 or worse dysphagia (12.1% vs. 3.2%; P = .0005) and esophagitis (17.4% vs. 5.0%; P less than .0001). Pulmonary toxicity was statistically indistinguishable between groups.
Since the RTOG 0617 results were first reported, the standard of care for unresectable stage III NSCLC has changed, as the PACIFIC trial showed an overall survival advantage of adding the immune checkpoint inhibitor durvalumab (Imfinzi) as maintenance therapy after concurrent chemoradiotherapy (N Engl J Med. 2018;379:2342-50).
However, the 2-year overall survival rate with chemoradiation using the standard radiation dose in the former trial (59.6%) is fairly close to that seen with chemoradiation plus maintenance durvalumab in the latter trial (66.3%), the investigators noted.
Dr. Bradley disclosed having a consulting or advisory role with AstraZeneca. The trial was supported by the National Cancer Institute and Eli Lilly.
SOURCE: Bradley JD et al. J Clin Oncol. 2019 Dec 16. doi: 10.1200/JCO.19.01162.
More is not better when it comes to radiation therapy administered with concurrent chemotherapy for unresectable stage III non–small cell lung cancer (NSCLC), suggests a long-term update of the RTOG 0617 trial.
Initial results of the phase 3 randomized controlled trial, at a median follow-up of 1.9 years, showed that median overall survival was about 8 months longer with the 60-Gy standard dose of radiation compared with a 74-Gy high dose, each given along with paclitaxel and carboplatin (Lancet Oncol. 2015;16:187-99).
The update, now at a median follow-up of 5.1 years and reported in the Journal of Clinical Oncology, recapitulates that finding, again showing a roughly 8-month longer overall survival with the standard dose of radiation. Results continue to show no benefit of adding the anti-EGFR antibody cetuximab (Erbitux) to treatment.
“The 5-year overall survival estimate for the standard-dose radiation arm of RTOG 0617, regardless of cetuximab delivery, was 32.1%. This is among the highest overall survival results of any phase III trial for patients with stage III NSCLC,” noted the investigators, led by Jeffrey D. Bradley, MD, department of radiation oncology, Emory University, Atlanta.
“These results argue strongly that the current standard-of-care radiation dose should be 60 Gy given in 2-Gy daily fractions to a target volume directed at tumor plus margin on the basis of CT and PET/CT, excluding elective nodal irradiation.”
The RTOG 0617 trial was conducted among 496 patients with unresectable stage III NSCLC in the United States and Canada. They were randomized to receive standard-dose or high-dose radiation in addition to concurrent chemotherapy, and randomized again to receive cetuximab or not.
Median overall survival as of the update was 28.7 months with standard-dose radiation therapy, compared with 20.3 months with high-dose radiation therapy (P = .0072), Dr. Bradley and coinvestigators reported. This survival benefit stood up in multivariate analysis (hazard ratio, 1.30; P = .0315).
The standard dose of radiation also yielded better 5-year overall survival (32.1% vs. 23%; P = .007) and 5-year progression-free survival (18.3% vs. 13%; P = .055). Further analyses suggested that these differences were not due to differential radiation therapy compliance.
The high-dose radiation group had more grade 5 adverse events (nine vs. three events), as well as higher rates of treatment-related grade 3 or worse dysphagia (12.1% vs. 3.2%; P = .0005) and esophagitis (17.4% vs. 5.0%; P less than .0001). Pulmonary toxicity was statistically indistinguishable between groups.
Since the RTOG 0617 results were first reported, the standard of care for unresectable stage III NSCLC has changed, as the PACIFIC trial showed an overall survival advantage of adding the immune checkpoint inhibitor durvalumab (Imfinzi) as maintenance therapy after concurrent chemoradiotherapy (N Engl J Med. 2018;379:2342-50).
However, the 2-year overall survival rate with chemoradiation using the standard radiation dose in the former trial (59.6%) is fairly close to that seen with chemoradiation plus maintenance durvalumab in the latter trial (66.3%), the investigators noted.
Dr. Bradley disclosed having a consulting or advisory role with AstraZeneca. The trial was supported by the National Cancer Institute and Eli Lilly.
SOURCE: Bradley JD et al. J Clin Oncol. 2019 Dec 16. doi: 10.1200/JCO.19.01162.
FROM THE JOURNAL OF CLINICAL ONCOLOGY