medwireNews: Older patients with non-small-cell lung cancer (NSCLC) who have not progressed on platinum-based doublet therapy do not gain an overall survival (OS) advantage if treated with switch maintenance therapy rather than observation, study findings show.
Switch maintenance therapy was associated with a progression-free survival (PFS) benefit, but “the higher toxicity in the maintenance arm jeopardized this small PFS advantage,” say Elisabeth Quoix (University Hospital of Strasbourg, France) and fellow researchers. They therefore advise against considering this strategy for older NSCLC patients.
The IFCT-1201 MODEL trial included 328 patients aged 70–89 years who had not progressed after four cycles of monthly carboplatin and weekly paclitaxel and were randomly assigned to receive switch maintenance treatment (n=162) or observation (n=166).
Patients with nonsquamous cell carcinoma received a maintenance regimen of pemetrexed 500 mg/m2 every 3 weeks, while those with squamous cell carcinoma received gemcitabine 1150 mg/m2 on days 1 and 8 of each 3-week cycle.
Over the median 39.7 months of follow-up, patients who received switch maintenance therapy had a significantly better median PFS than those who were observed, at 5.7 versus 2.7 months.
However, this did not translate to an OS benefit; median OS was comparable between the two treatment arms, at 14.0 months for the patients given switch maintenance treatment and 14.1 months for those under observation.
“Switch maintenance therapy significantly prolonged PFS but not OS and, thus, should not be proposed to elderly patients with advanced NSCLC,” say the researchers.
Moreover, the incidence of toxicities was higher among those receiving switch maintenance therapy than those who underwent observation, with adverse events of any grade experienced by 94.7% and 52.4%, respectively. Two deaths were linked to pemetrexed, one from sepsis and one from febrile neutropenia.
Quoix et al note that fewer patients given switch maintenance treatment relative to observation were able to receive a second-line therapy, at 63.6% versus 81.1%.
Among those who did receive second-line treatment, response rates favored the patients in the switch maintenance arm, at 9.4% versus 7.8% for those in the observation arm. But, again, this did not translate to an OS benefit, as the median OS was shorter – albeit not significantly – among patients who received switch maintenance therapy at 9.2 months versus 11.7 months for those in the observation arm.
The researchers conclude in the European Journal of Oncology that the “‘stop and go’ attitude appears more appropriate in elderly [patients] with advanced NSCLC, as more patients without maintenance can undergo [second-line treatment], which results in a similar survival rate with less toxicity.”
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