|The following article features coverage from the European Society for Medical Oncology 2020 virtual meeting. Click here to read more of Cancer Therapy Advisor‘s conference coverage.|
Postoperative conformal radiotherapy (PORT) administered to patients with stage IIIAN2 NSCLC did not improve disease-free survival (DFS) and was associated with cardiopulmonary toxicities, according to results of a phase 3 trial reported at the European Society for Medical Oncology (ESMO) Virtual Congress 2020.
“Adjuvant PORT has been controversial since publication of a meta-analysis showing PORT could be deleterious especially in pN0 pN1 patients,” Ćecile Lé Pechoux, MD, of Gustave Roussy in France, and presenter of the study, said. She went on to explain that the researcher initiated this trial because much improvement has been made in the management of stage III NSCLC patients since the meta-analysis was published.
The multicenter phase 3 LungART trial (ClinicalTrials.gov Identifier: NCT00410683) randomly assigned 501 patients with stage III NSCLC with N2 involvement after surgery or chemotherapy to undergo PORT or no PORT. The primary endpoint was DFS and secondary endpoints included toxicity, local control, recurrence, overall survival (OS), and prognostic and predictive factors.
At baseline, the median patient age was 61 years and 66% of patients were male. Most tumors were adenocarcinoma (73%) and most patients received neoadjuvant chemotherapy (96%). The total dose of PORT was 54 Gy, with most practitioners using 3-dimensional definitive radiotherapy (89%).
After a median follow-up of 4.8 years, there was no significant difference in PFS, with a median of 30.5 months with PORT compared with 22.8 months with adjuvant chemotherapy (hazard ratio, 0.85; 95% CI, 0.67-1.07; P =.16). The 3-year DFS was 47.1% and 43.8% with PORT or no PORT, respectively.
OS was also similar between arms, with a 3-year OS of 66.5% with PORT compared with 68.5% with no PORT.
Dr Lé Pechoux noted that mediastinal relapse occurred more frequently among patients who did not receive PORT at 46.1% compared with 25.0% in the PORT arm. Although mortality was similar between arms (41.5% with PORT vs 39.6% without PORT), there were differences in causes of death. Cardiopulmonary (16.2% vs 2.0%), second primary (5.1% vs 1.0%), and RT or chemotherapy–related toxicity (3.0% vs. 0%) causes of death were more frequent with PORT compared with no PORT. Progression or recurrence (69.4% vs 86.1%) and other causes (6.1% vs 10.9%) were less frequent in the PORT arm compared with the group that did not undergo PORT.
Early grade 3 to 4 toxicities occurred among 11.6% of patients in the PORT arm compared with 7.7% of patients in the control arm. Late grade 3 to 4 toxicities occurred among 14.6% and 8.9% of patients in the PORT or no PORT arms, respectively, including 10.8% and 4.9% that were of a cardiopulmonary nature. Second cancers were reported in 11.1% of patients in the PORT arm and 7.2% of patients in the no PORT arm.
Dr Lé Pechoux concluded that “conformal PORT then cannot be recommended as standard of care in all completely resected stage IIIAn2 NSCLC patients.” Further analyses are planned.
Disclosures: Multiple authors declared affiliation with industry. Please refer to the original abstract for a full list of disclosures.
Read more of Cancer Therapy Advisor‘s coverage of the ESMO Virtual Congress 2020 by visiting the conference page.
Le Pechoux C, Pourel N, Barlesi F, et al. An international randomized trial, comparing post-operative conformal radiotherapy (PORT) to no PORT, in patients with completely resected non-small cell lung cancer (NSCLC) and mediastinal N2 involvement: Primary end-point analysis of LungART (IFCT-0503, UK NCRI, SAKK) NCT00410683. Presented at: ESMO Virtual Congress 2020. LBA3_PR.