Local Consolidative Therapy Boosts Oligometastatic NSCLC PFS

Non-small-cell lung cancer patients with a maximum of three metastatic lesions derive a progression-free survival benefit from local consolidation treatment involving radiotherapy or resection

medwireNews: Aggressive local consolidation therapy after first-line systemic treatment could help delay disease progression in patients with oligometastatic non-small-cell lung cancer (NSCLC), suggests a phase II trial.

Progression-free survival (PFS) was a median of 11.9 months for patients who received local consolidative therapy, with or without subsequent maintenance, and 3.9 months for those given maintenance treatment alone, equating to a hazard ratio of 0.35. The corresponding 1-year PFS rates were 48% and 20%.

In view of the significant advantage afforded by localised consolidation treatment, recruitment to the trial was terminated early on recommendation of the Data Safety Monitoring Committee.

The team led by Daniel Gomez, from The University of Texas MD Anderson Cancer Center in Houston, USA, writes in The Lancet Oncology that the results “suggest that aggressive local therapy should be further explored in phase 3 trials as a standard treatment option in this clinical scenario.”

In a related comment, Dirk De Ruysscher, from Maastricht University Medical Center in the Netherlands, agrees that “a randomised phase 3 trial is needed.” He believes that the current study “gives a signal, but not a proof, that local treatment might be of benefit.”

The commentator writes: “At present, it should be emphasised that except for solitary brain metastases, the radical local treatment of synchronous oligometastases of NSCLC is still an unproven treatment with regard to the long-term survival benefit.”

At the time of termination, the trial included 48 evaluable patients with stage IV NSCLC who had achieved a partial response or stable disease after first-line platinum-based chemotherapy or targeted therapy. Included patients had no more than three metastatic lesions, and were randomly assigned to receive either local consolidative therapy (surgery, radiotherapy or both) or a maintenance regimen selected from a predefined set of standard options, which included observation.

After a median follow-up of 12.39 months, the time to appearance of a new lesion was longer in the local consolidative versus maintenance therapy arm, at 11.9 and 5.7 months, respectively.

This indicates that “local consolidative therapy could be changing the natural history of the disease, either by limiting the potential for later spread or possibly by altering systemic anticancer immune responses to facilitate longer control of subclinical disease”, say the researchers.

However, they point out that the analysis was exploratory in nature, and that further investigation is needed.

Local consolidation was well tolerated, with no grade 4 adverse events or toxicity-related deaths. Five patients experienced a grade 3 side effect, of which two cases of oesophagitis and one case each of anaemia and pneumothorax were considered related to treatment, while one episode of abdominal pain was not.

References

Gomez DR, Blumenschein GR, Jr, Lee JJ, et al. Local consolidative therapy versus maintenance therapy or observation for patients with oligometastatic non-small-cell lung cancer without progression after first-line systemic therapy: a multicentre, randomised, controlled, phase 2 study. Lancet Oncol; Advance online publication 24 October 2016. doi: http://dx.doi.org/10.1016/S1470-2045(16)30532-0

De Ruysscher D. Radical treatment of synchronous oligometastases from NSCLC. Lancet Oncol; Advance online publication 24 October 2016. doi: http://dx.doi.org/10.1016/S1470-2045(16)30533-2

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