S-1 plus radiotherapy shows promise in elderly NSCLC patients
medwireNews: Concurrent administration of S-1 chemotherapy and radiotherapy has a favourable impact on survival in elderly patients with locally advanced non-small-cell lung cancer (NSCLC), a phase II trial has found.
Results of the Okayama Lung Cancer Study Group Trial 0801, which are published in the European Journal of Cancer, also indicate that S-1 given alongside radiotherapy is well tolerated in this poor-prognosis population.
Thoracic irradiation is the standard therapy for elderly patients with NSCLC but treatment outcomes are poor. The present study was undertaken to evaluate the incremental benefit of giving S-1, an oral 5-fluorouracil derivative, concurrently with radiation.
Thirty patients aged 76 years or older were included in the study. All had performance status of 0 or 1 and locally advanced disease (stage IIIA/IIIB) with no prior treatment. They were treated with twice-daily S-1 40 mg/m2 on days 1 to 14 and 29 to 42 together with thoracic radiotherapy.
The patients’ median age was 79 years and the median Charlson score was 1. The actual doses of chemotherapy and radiotherapy delivered relative to the planned doses were 95% and 98%, respectively.
The primary endpoint was the response rate. Nineteen patients had a partial response, 10 had stable disease and one had progressive disease. The overall response rate was 63%, which did not meet the predefined criteria for treatment utility.
The most common toxicity was myelosuppression; grade 3 or higher neutropenia occurred in five (17%) patients while thrombocytopenia and anaemia occurred in two (7%) and four (13%) patients, respectively.
Nonhaematological adverse events were generally mild; pneumonitis, febrile neutropenia and oral mucositis were most common grade 3 events, occurring in three (10%), two (7%) and two (7%) patients, respectively.
There were no treatment-related deaths. At a median follow-up of 23.7 months, the median progression-free survival was 13.0 months and the 2-year rate was 30.0%. At the time of the final analysis, 80% of patients had experienced disease recurrence.
Katsuyuki Hotta (Okayama University Hospital, Japan) and study co-authors say that although the trial failed to meet its primary endpoint, S-1 with concurrent radiotherapy exhibited favourable efficacy with acceptable toxicity.
“Further investigations are needed to confirm the utility of this regimen in a phase III trial”, they write.
medwireNews (www.medwirenews.com) is an independent clinical news service provided by Springer Healthcare Limited. © Springer Healthcare Ltd; 2014
By Joanna Lyford, Senior medwireNews Reporter