NEW YORK (Reuters Health) - Carboplatin plus vinorelbine (CV) may be safer and more effective than erlotinib in elderly patients with untreated advanced non-small cell lung cancer (NSCLC), researchers say.
Their non-inferiority trial failed to show that erlotinib was at least as good as standard chemo with carboplatin and vinorelbine.
The erlotinib group had poorer progression-free survival and response rates, although both groups had similar overall survival, according to a report online February 3 in Lung Cancer.
The authors say erlotinib, a tyrosine-kinase inhibitor of epidermal growth factor receptor (EGFR-TKI), should not be used in previously untreated patients with EGFR-unknown or wild-type status in first-line treatment.
"Chemotherapy is better, and is tolerable in this group," said lead author Dr. David F. Heigener of LungenClinic Grosshansdorf in Grosshansdorf, Germany, in an email to Reuters Health.
As to future clinical trials in their elderly patients, he said, "there will be no phase 3."
Dr. Yi-long Wu of the Guangdong Lung Cancer Institute in Guangdong, China, who was not involved in the study, agreed in an email, saying, "No, I think we do not need any more clinical trials."
The multicenter trial by Dr. Heigener and his colleagues involved 284 unselected patients age 70 and older who had untreated metastatic NSCLC. The median age was 76, about a third were female, and both groups were similar in age and gender. Except for one Asian patient, all were Caucasian.
Half the patients received 150mg of oral erlotinib daily until disease progression or inacceptable toxicity; and 140 received intravenous carboplatin AUC 5 (area under the curve 5) on day 1 plus vinorelbine (25 mg per square meter) on days 1 and 8 of a 21-day cycle for a maximum of six cycles.
The progression-free survival was significantly lower with erlotinib than with CV, with medians of 2.4 vs 4.6 months (hazard ratio 1.6; p=0.0005). The response rate was also lower with erlotinib (7.8% vs 28.3%; p=0.0001).
But the overall survival in both groups was similar, with a median 7.3 months for erlotinib and 8.4 months for CV (hazard ratio 1.24).
The researchers saw more skin toxicity and diarrhea with erlotinib and more neurotoxicity, myelotoxicity, and constipation with CV.
"As seen in other trials, the superiority of platinum-based chemotherapy compared with an EGFR-TKI in an unselected mostly wild-type EGFR population of NSCLC patients has been confirmed," said principal investigator Dr. Martin Reck of LungenClinic Grosshansdorf in Grosshansdorf, Germany, in an email. "Furthermore, the feasibility and efficacy of a platinum-based chemotherapy in a selected population of elderly patients in good performance status could be shown."
"This is important because in most guidelines, the standard of care for chemotherapy in elderly patients with advanced NSCLC still comprises a mono chemotherapy," he said.
"To my knowledge, this study is the first of its kind," Dr. Heigener said in an email. "The point is that age itself is not a good discrimination factor. Performance status matters! The question is whether patients in Eastern Cooperative Oncology Group (ECOG) performance status 2 might benefit from erlotinib in the sense of noninferiority in efficacy and better tolerability, compared with combination chemo."
SOURCE: http://bit.ly/1qghjtR
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