Impact of Radiation on Survival After Complete Resection of Non Small Cell Lung Cancer: Descriptive Analysis in the Randomized Adjuvant Chemotherapy Trial Anita 1

Reviewer: John P. Plastaras, MD, PhD
Abramson Cancer Center of the University of Pennsylvania
Ultima Vez Modificado: 7 de noviembre del 2006

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Presenter: Jean-Yves Douillard, M.D., Ph.D.
Presenter's Affiliation: Centre Rene Gauducheau, France
Type of Session: Plenary

Background

  • Post-operative radiotherapy ( PORT ) in lung cancer is a controversial topic. The PORT Meta-analysis previously demonstrated that radiotherapy was actually detrimental in certain patients. The PORT Meta-analysis has numerous recognized weaknesses, such as including N0 patients in whom PORT is not generally indicated, as well as the use of outdated radiotherapy techniques. Unfortunately, this study has resulted in decreased overall use of PORT , even for patients in whom PORT has potential clinical benefit (i.e. N2 stage patients).
  • Several retrospective studies have shown that the use of PORT in N2 patients is associated with improved survival.
  • The ANITA trial showed that the addition of chemotherapy following complete resection of Stage IB-IIA NSCLC improved overall survival by 8.6% at 5 year
  • The role of PORT in the era of adjuvant chemotherapy is unknown.

Materials and Methods

  • The ANITA trial was a Phase III, multicenter, randomized trial comparing:
    • Observation
    • Adjuvant navelbine-cisplatin chemotherapy (CT)
  • The use of PORT in lymph node positive disease was NOT randomized or required, but each institution had to decide on an individual policy regarding PORT and adhere to this policy before initiation of the trial.
  • Radiation doses ranged from 45 to 60 Gy in 2 Gy fractions, all delivered using high energy linear accelerators.
  • Since PORT was not randomized, only a descriptive analysis was performed.

Results

  • N0 Patients:
    • Patients with N0 disease in the observation arm who had PORT had a WORSE 5 yr survival: (43.8% PORT vs. 62.3% No RT)
    • Patients with N0 disease in the CT arm who had PORT had a WORSE 5 yr survival: (44% PORT vs. 59.7% No RT)
  • N1 Patients:
    • Patients with N1 disease in the observation arm who had PORT had a better 5 yr survival: (42.6% PORT vs. 31.4% No RT)
    • Patients with N1 disease in the CT arm who had PORT had a WORSE 5 yr survival: (40% PORT vs. 56.3% No RT)
  • N2 Patients:
    • Patients with N2 disease in the observation arm who had PORT had a better 5 yr survival: (21% PORT vs. 17% No RT)
    • Patients with N2 disease in the CT arm who had PORT ALSO had a better 5 yr survival: (47% PORT vs. 34% No RT)

Author's Conclusions

  • Similar to some retrospective studies, PORT appears to be deleterious in N0 patients but beneficial in N2 patients.
  • In N1 patients who do not get chemotherapy, PORT may be beneficial as an alternative adjuvant treatment.
  • These are only descriptive analyses, and thus firm conclusions cannot be drawn because PORT was not randomized. Having said that, the results should certainly be confirmed in a randomized trial, which is currently ongoing.

Clinical/Scientific Implications

  • This analysis adds strength to several retrospective studies (most recently the SEER analysis, Lally et al., published in Journal of Clinical Oncology) that have already suggested the beneficial role of PORT for certain patients with completely resected NSCLC. It is time to move beyond the PORT Meta-analysis when deciding if patients are appropriate for adjuvant radiotherapy.
  • A clear benefit has been observed with PORT in patients with N2 disease. This benefit appears to exist even in the setting of adjuvant chemotherapy. In N1 patients, PORT may not be as beneficial if patients are able to receive and tolerate chemotherapy.
  • This study again demonstrates that N0 patients do worse when receiving PORT . It is logical that this be the case considering the decreased risk of local recurrence in this group, and thus relatively less benefit to be obtained from a local treatment .

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