Adjuvant gefitinib could benefit patients with resected stage II–IIIA NSCLC
medwireNews: Adjuvant gefitinib could offer an alternative to cisplatin-based adjuvant chemotherapy for patients with completely resected stage II–IIIA, EGFR-mutant non-small-cell lung cancer (NSCLC), according to the findings of a phase III trial.
“ADJUVANT is—to our knowledge—the first prospective phase 3 study to show that adjuvant EGFR tyrosine kinase inhibitor treatment compared with cisplatin-based chemotherapy can significantly increase disease-free survival [DFS], diminish toxic effects, and improve HRQoL [health-related quality of life]” in these patients, say the researchers.
“Adjuvant gefitinib could be considered a treatment option for this population of patient,” they write, but admit that mature overall survival data are required to confirm a benefit.
Yi-Long Wu (Guangdong Lung Cancer Institute, Guangzhou, China) and colleagues randomly assigned 222 adults at one of 27 Chinese centers to receive either gefitinib 250 mg/day for 24 months or intravenous vinorelbine and cisplatin every 3 weeks for four cycles.
Over a median follow-up of 36.5 months, the primary endpoint of median DFS was significantly longer for patients given gefitinib compared with those using chemotherapy, at 28.7 versus 18.0 months, giving a hazard ratio of 0.60.
However, the DFS rate at 3 years was similar in the two groups, at 34% with gefitinib and 27% with chemotherapy.
“Safety and tolerability in our study favoured gefitinib,” notes the team in The Lancet Oncology, with lower rates than chemotherapy for adverse events of any grade (58 vs 80%) and serious adverse events (7 vs 23%).
Furthermore, patients who received gefitinib reported significant improvements in HRQoL from baseline to week 33 compared with the chemotherapy group, as measured by the Trial Outcome Index of the Functional Assessment of Cancer Therapy—Lung Cancer questionnaire and the Lung Cancer Symptom Scale.
In an accompanying comment, Terry Ng and D Ross Camidge, both from the University of Colorado Cancer Center in Aurora, USA, note: “The findings of ADJUVANT suggest many new avenues for clinical research, centred around an increased understanding that the disease-free survival advantage for adjuvant EGFR tyrosine kinase inhibitors could reflect effective suppression of tumour growth during treatment but ineffective cure of microscopic disease.”
And they add: “The immediate next wave of adjuvant trials should focus on minimal residual disease assessments to best define groups of patients who should either never stop the tyrosine kinase inhibitor or never start it unless their disease recurs.”
By Catherine Booth
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