By Laura Cowen, medwireNews Reporter
A treatment strategy designed to minimise the effects of accelerated repopulation using hypofractionated radiotherapy with chemotherapy is feasible for patients with stage III non-small-cell lung cancer (NSCLC), according to UK researchers.
“Although concurrent chemo-radiation is now the international standard of care for patients with inoperable stage III NSCLC and good [performance status], there is no consensus regarding a standard treatment regimen”, explain Joseph Maguire (Clatterbridge Cancer Centre, Wirral) and colleagues.
They add that “[a] strategy designed to limit the detrimental effects of accelerated repopulation by delivering radical radiotherapy with chemotherapy within four weeks might enhance local control and survival.”
To investigate whether such a strategy is feasible, Maguire and team conducted a phase II trial in which patients with inoperable stage III NSCLC and a performance status of 0 or 1 were randomly assigned to receive cisplatinum and vinorelbine with either sequential (n=60) or concurrent (n=70) chemoradiation using the standard UK radical radiotherapy schedule of 55 Gy in 20 fractions over 4 weeks.
The researchers report that the primary study outcome of treatment-related mortality was higher in the concurrent arm than in the sequential arm, but not significantly so, at 2.9% versus 1.7%, giving a relative risk of 1.25.
Toxicity was similar between the arms with 32% and 41% of patients in the concurrent and sequential arms, reporting grade 3 to 5 serious adverse events overall, and 8.8% and 8.5% reporting grade 3 or worse oesophagitis. The only significant differences observed were for grade 3 or higher neutropenia (35 concurrent vs 53% sequential) and fatigue (21 vs 42%).
During a median 35.2 months of follow-up, 87 patients died. The risk of death was nonsignificantly lower in the in the concurrent arm compared with the sequential arm, at an unadjusted hazard ratio of 0.92 and median overall survival times of 24.3 and 18.4 months, respectively.
Patients who received concurrent treatment were slightly less likely to be alive at 1 year but slightly more likely to be alive at 2 years compared with those who received sequential treatment; the respective 1- and 2- year overall survival rates were 70% versus 83% and 50% versus 46%.
The researchers say that this pattern of survival has been observed previously and could be attributed to “an initial detriment from toxicity followed by and improvement in local control.”
Maguire and co-authors conclude that “a schedule of 55 Gy in 20 fractions over four weeks with concurrent cisplatinum and vinorelbine, is safe and effective when delivered within the parameters used in this trial.”
They add that the regimen “is convenient for patients and is likely to be cost effective for health care providers.”
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