A phase II trial of erlotinib monotherapy for pretreated elderly patients with advanced EGFR wild-type non-small cell lung cancerReportar como inadecuado

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BMC Research Notes

, 8:220



BackgroundErlotinib is an epidermal growth factor receptor EGFR tyrosine kinase inhibitor, which is an effective treatment for patients with non-small cell lung cancer NSCLC, especially those harboring activating EGFR mutations. A previous phase III trial suggested that patients with EGFR wild-type EGFR-wt NSCLC or elderly patients with disease progression after cytotoxic chemotherapy might benefit from erlotinib monotherapy. However, few studies have prospectively evaluated the efficacy and safety of second- or third-line erlotinib monotherapy for elderly patients with EGFR-wt advanced or recurrent NSCLC.

MethodsPretreated patients aged ≥70 years with EGFR-wt stage IIIB-IV NSCLC or those with postoperative recurrence were enrolled and received oral erlotinib at a dose of 150 mg-day until disease progression. Primary outcome was the objective response rate ORR. Secondary end points included the disease control rate DCR, progression-free survival PFS, overall survival OS, and toxicity profile.

ResultsThis study was terminated early because of the results from a Japanese phase III trial DELTA trial. Sixteen patients were enrolled between April 2010 and May 2013. The median age was 78 years range 70–84 years. Six patients were female. Five patients had an Eastern Cooperative Oncology Group performance status of 0. Eleven 69% patients had adenocarcinoma. Fifteen 94% patients were treated with erlotinib as a second-line therapy. The ORR was 0% 95% confidence interval CI 0–17.1. DCR was 56.3% 95% CI 33.2–76.9. The median PFS and OS were 1.7 months 95% CI 1.3–2.2 and 7.2 months 95% CI 5.6–8.7, respectively. The most commonly occurring adverse events included acneiform eruption 31.3% and skin rash 25.0%. One patient developed grade 3 interstitial lung disease, which improved following steroid therapy.

ConclusionsIn pretreated elderly patients with advanced or recurrent EGFR-wt NSCLC, daily oral erlotinib was well tolerated; however, administration of the drug should not be considered as a second line therapy.

Trial registration: University Hospital Medical Information Network UMIN Clinical Trials Registry UMIN000004561 Date of registration: November 15th, 2010

KeywordsNon-small cell lung cancer Erlotinib Elderly EGFR wild-type PCR-invader Electronic supplementary materialThe online version of this article doi:10.1186-s13104-015-1214-9 contains supplementary material, which is available to authorized users.

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Autor: Hiroyuki Minemura - Hiroshi Yokouchi - Keisuke Azuma - Ken-ichiro Hirai - Satoko Sekine - Kengo Oshima - Kenya Kanazawa - Y

Fuente: https://link.springer.com/

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