Long-term follow-up of the Radiation Therapy Oncology Group (RTOG) 0617 trial continues to support a 60-Gy radiation therapy (RT) dose as the standard of care for patients with unresectable stage III non-small cell lung cancer (NSCLC) receiving chemoradiotherapy, according to results published in the Journal of Clinical Oncology.1

The RTOG 0617 trial (ClinicalTrials.gov Identifier: NCT00533949) was a 2 × 2 factorial, phase 3 study in which patients with stage III unresectable NSCLC were randomly assigned in a 1:1:1:1 ratio to receive paclitaxel-carboplatin chemotherapy concurrently with standard-dose (60 Gy) RT or high-dose (74 Gy) RT; paclitaxel-carboplatin with standard-dose RT with cetuximab, or paclitaxel-carboplatin with high-dose RT with cetuximab. Chemoradiotherapy was followed by consolidation chemotherapy with paclitaxel-carboplatin with or without cextuximab depending on study arm. The primary endpoint of the study was overall survival (OS).

Previously published results from that study demonstrated that neither the addition of cetuximab nor the use of high-dose RT improved median OS in these patients.  Median OS for patients in the study arms receiving 60 Gy RT was 28.7 months compared with 20.3 months for those receiving 74 Gy RT (P =.0072).2

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This analysis, performed at a median follow-up of 5.1 years (ie, 2.7 years for all evaluable patients and 5.3 years for surviving patients), included 496 patients.


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Some of the key study findings including the following:

  • 5-year OS rates were 32.1% and 23.0% (P =.007) for patients receiving 60 Gy and 74 Gy RT doses, respectively
  • 5-year progression-free survival (PFS) rates were 18.3% for patients receiving a 60 Gy RT dose and 13.0% for those receiving RT at a dose of 74 Gy (P =.055)
  • Addition of cetuximab did not affect long-term OS
  • 7.3% of patients receiving 60 Gy RT and 20.8% of patients receiving 74 Gy RT experienced grade 3 or higher esophagitis, dysphasia, or both (P <.0001)
  • Treatment-related grade 3 or higher adverse events were experienced by 87.3% and 71.2% receiving treatment with and without cetuximab, respectively (P <.0001)

In their concluding remarks, the study authors commented that a 5-year OS rate of 32.1% was “among the highest reported in the literature for stage III NSCLC” and represented “a new 5-year landmark in long-term OS of patients with unresectable stage III NSCLC.”

Disclosure: Some of the authors disclosed financial relationships with medical companies. For a full list of disclosures, please refer to the original study.

References

  1. Bradley JD, Hu C, Komaki RR, et al. Long-term results of NRG Oncology RTOG 0617: standard- versus high-dose chemoradiotherapy with or without cetuximab for unresectable stage III non-small-cell lung cancer [published online December 16, 2019]. J Clin Oncol. doi: 10.1200/JCO.19.01162
  2. Bradley JD, Paulus R, Komaki R, et al. Standard-dose versus high-dose conformal radiotherapy with concurrent and consolidation  carboplatin plus paclitaxel with or without cetuximab for patients with stage IIIA or IIIB non-small-cell lung cancer (RTOG 0617): A randomised, two-by-two factorial phase 3 study. Lancet Oncol. 2015;16(2):187-199.