No Benefit for Post-operative Radiotherapy in Non-small-cell Lung Cancer

Date:20 Sep 2020

LUGANO, Switzerland - Post-operative radiotherapy (PORT) used in patients with non-small-cell lung cancer (NSCLC) following complete resection and after (neo) adjuvant chemotherapy shows no statistically significant difference in 3-year disease-free survival (DFS), according to data presented at ESMO 2020. These results give the oncology community a long-awaited answer. (1)

PORT in completely resected NSCLC patients has been a subject of debate for many years in patients with mediastinal nodal involvement (pN2), since a meta-analysis in 1998 threw doubt on the benefits associated with it. (2)

However, more recent times have seen better selection, (neo)-adjuvant chemotherapy in stage III resected patients, as well as improved radiotherapy and more recent non prospective studies suggested modern PORT could improve outcome. (3,4,5,6,7)

As such, there was a clear need for a large, randomised trial to assess the role of modern mediastinal PORT in adequately staged and surgically treated patients. This study provides more robust data to help clinicians to decide the best course of action for these patients.

The large randomised controlled trial presented at ESMO 2020, explored the role of modern mediastinal PORT in patients with completely resected NSCLC with histo/cytologically proven nodal involvement.

A total of 501 patients were entered into the intention-to-treat analysis, of which 252 received PORT over five weeks, and 249 entered the control arm (no PORT). Safety analysis was carried out in 487 patients.

Disease-free survival was of 47.1% in the PORT arm and 43.8% in the control arm, thus not statistically significant, with a hazard ratio of = 0.85 (95% CI = [0.67;1.07]; p value = 0.16) for patient receiving PORT compared to control.
Overall survival at three years was 66.5% (95% CI = [59;73]) of patients in the PORT arm compared to 68.5% (95% CI = [61;75]) in the control arm.

Study author Dr Cécile Le Pechoux, radiation oncologist from Institut Gustave Roussy, Paris, France, said: “PORT cannot be recommended for all patients with stage II and III NSCLC with mediastinal nodal involvement. Possibly, however, for some patients it might be useful because it does decrease the rate of mediastinal relapse by 50%. This must be put into balance with the risk of over-added cardio-pulmonary toxicity. We need to do further analysis to determine if certain patients, in particular, could benefit from it” she added.

Prof Rafal Dziadziuszko, radiation oncologist from the Medical University of Gdansk, Poland, commented on the findings. “Radiotherapy to the mediastinum after surgery, after adjuvant chemotherapy shouldn’t be recommended as standard of care. This will change the practice of many institutions that adopted standard use of radiotherapy in these patients. We can safely say there is no net benefit from such treatment but there is also potential harm, which we see from this study, so any potential benefits in some patients are offset by the predominantly higher risk of cardiopulmonary toxicities.”

Disclaimer

This press release contains information provided by the author of the highlighted abstract and reflects the content of this abstract. It does not necessarily reflect the views or opinions of ESMO who cannot be held responsible for the accuracy of the data. Commentators quoted in the press release are required to comply with the ESMO Declaration of Interests policy and the ESMO Code of Conduct.

References

  1. Abstract LBA3_PR ‘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 Lung ART (IFCT-0503, UK NCRI, SAKK) NCT00410683.’ will be presented by Cécile Le Pechoux during the Presidential Symposium II, on Sunday, 20 September 2020, 18:30 – 20:25 CEST.  Annals of Oncology, Volume 31 Supplement 4, September 2020

  2. PORT Meta-analysis Trialists Group. Postoperative radiotherapy in non small-cell lung cancer: systematic review and meta-analysis of individual patient data from nine randomised controlled trials. Lancet 1998;352: 257–263
  3. Douillard JY, Rosell R, De Lena M, et al: Impact of postoperative radiation therapy on survival in patients with complete resection and stage I, II, or IIIA non-small-cell lung cancer treated with adjuvant chemotherapy: The adjuvant Navelbine International Trialist Association (ANITA) randomized trial. Int J Radiat Oncol Biol Phys 72:695-701, 2008
  4. Lally BE, Zelterman D, Colasanto JM, et al: Postoperative radiotherapy for stage II or III non–small-cell lung cancer using the Surveillance, Epidemiology, and End Results database. J Clin Oncol 2006; 24:2998-3006.
  5. John L Mikell, Theresa W Gillespie, William A Hall, et al. Postoperative radiotherapy is associated with better survival in non-small cell lung cancer with involved N2 lymph nodes: results of an analysis of the National Cancer Data Base. J Thorac Oncol. 2015;10(3):462-71. doi: 10.1097/JTO.0000000000000411.
  6. Robinson CG, Patel AP, Bradley JD, et al: Postoperative radiotherapy for pathologic N2 non–small-cell lung cancer treated with adjuvant chemotherapy: A review of the National Cancer Data Base. J Clin Oncol 2015; 33:870-876.
  7. Corso CD, Rutter CE, Wilson LD, Kim AW, Decker RH, Husain ZA. Re-evaluation of the role of postoperative radiotherapy and the impact of radiation dose for non-small-cell lung cancer using the National Cancer Database. J Thorac Oncol. 2015; 10(1):148-55. doi: 10.1097/JTO.0000000000000406.

LBA3_PR - 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 Lung ART (IFCT-0503, UK NCRI, SAKK) NCT00410683.

 

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