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Erlotinib as maintenance therapy after concurrent chemoradiotherapy in patients (p) with stage III non-small cell lung cancer (NSCLC): A Galician Lung Cancer Group phase II study

2009; Lippincott Williams & Wilkins; Volume: 27; Issue: 15_suppl Linguagem: Inglês

10.1200/jco.2009.27.15_suppl.7537

1527-7755

José Casal, Sergio Vázquez‐Estévez, Luís León, M. Lázaro, J. L. Fírvida, Margarita Amenedo, Guzmán Alonso, Lucía Santomé, Francisco Javier Afonso Afonso,

Lung Cancer Research Studies

7537 Background: Combination of platinum-based chemotherapy and radiotherapy is the standard treatment for p with unresectable stage III NSCLC, but considering the high rates of recurrence, it is necessary to improve these results. Erlotinib is an EGFR TKI that prolongs survival in p with recurrent and metastatic NSCLC. In this study, we aim to evaluate the role of erlotinib as maintenance therapy after a standard concurrent chemo-radiotherapy regimen in p with stage III NSCLC. Methods: P with unresectable stage IIIA/IIIB—without malignant effusions—NSCLC who had received a standard concurrent chemo-radiotherapy regimen and had no evidence of tumor progression were enrolled in this single arm, open-label phase II study and received erlotinib 150 mg/day po for 6 months. Main eligibility criteria were: PS 0–2, adequate bone marrow, hepatic and renal function and measurable disease by RECIST criteria. Primary endpoint was the percentage of p without evidence of disease progression after 6 months of erlotinib therapy and secondary endpoints were: PFS, OS, ORR and safety profile. Results: 49 p have been included in the study and data from 37 p are presented in this analysis. Baseline characteristics: median age 62 years (range 41–76); male 94.6%; caucasian 100%; smokers/never smokers (%) 97.3/2.7; ECOG PS 0/1/2 (%) 18.9/75.7/2.7; adenocarcinoma/squamous cell carcinoma/large cell carcinoma (%) 16.2/75.7/5.4; stage IIIA/IIIB (%) 16.2/83.8. Most common previous chemo-radiotherapy regimen is cisplatin/docetaxel/RT (83.8%). 27 p were evaluable for tumor response: CR 22.2%; PR 12.8%; SD 55.6%; PD 7.4%. Median TTP was 7.3 months (95% CI 5.8–16.9) and median OS was 18.7 months (95% CI 11.8-NA). Most common adverse events related to erlotinib were rash 30.6% (3 p gr. 3) and diarrhea 16.7%. Conclusions: Erlotinib as maintenance therapy is an active and well tolerated treatment after concurrent chemo- radiotherapy in p with stage III NSCLC. In spite of the majority of patients are caucasian, males, smokers with squamous cell carcinoma, maintenance with single agent erlotinib reached a promising median OS of 18.7 months. Updated data will be presented. No significant financial relationships to disclose.