Sep 13 2012
By Liam Davenport, medwireNews Reporter
Gefitinib improves progression-free survival (PFS), overall response, and health-related quality of life over carboplatin/paclitaxel for first-line advanced non-small-cell lung cancer (NSCLC) treatment, a study indicates.
The team observes that efficacy by epidermal growth factor receptor (EGFR) biomarker status was difficult to interpret due to low numbers of patients with a known biomarker status They write: "PFS was not constant over time, initially favoring carboplatin/paclitaxel and then gefitinib, most likely driven by differences in outcomes for patients with EGFR mutation-positive and mutation-negative tumors."
They add in the Asia-Pacific Journal of Clinical Oncology: "The association… suggests that the EGFR mutation status of a patient's tumor should be determined wherever possible prior to the initiation of first-line treatment."
The results concern 372 NSCLC patients from the Chinese mainland taking part in the IRESSA Pan-Asia Study who were randomly assigned to receive gefitinib 250 mg/day or carboplatin/paclitaxel (area under the curve 5/6; 200 mg/m²) for a median 6.0 months and 4.1 months, respectively.
At the time of analysis, 69.9% patients had progressed. The difference in the duration of PFS was not significant between the gefitinib and carboplatin/paclitaxel groups. The objective response rate was significantly higher with gefitinib than with carboplatin/paclitaxel, at 44.6% versus 29.8%, corresponding to an odds ratio of 1.88.
Overall survival was similar between the two treatments.. Health-related quality of life improved significantly with gefitinib versus carboplatin/paclitaxel on the Trial Outcome Index, at an odds ratio of 2.46. Symptom improvement rates were similar between the treatment groups.
Gefitinib was associated with a better tolerability profile than carboplatin/paclitaxel, with significantly fewer treatment-related adverse events at 83.2% versus 96.1% and fewer adverse events of Common Terminology Criteria grade 3 or 4, at 19.6% versus 66.3%.
Of 84 patients with known biomarker status, 44.8% were positive for EGFR mutations, and PFS favored carboplatin/paclitaxel over gefitinib among patients with known EGFR mutation status, at a hazard ratio of 1.60.
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