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Rosell, R., Carcereny, E., Gervais, R., Vergnenegre, A., Massuti, B., Felip, E., Palmero, R., Garcia-Gomez, R., Pallares, C., Sanchez, J.M., Porta, R., Cobo, M., Garrido, P., Longo, F., Moran, T., Insa, A., De Marinis, F., Corre, R., Bover, I., Illiano, A., Dansin, E., De Castro, J., Milella, M., Reguart, N., Altavilla, G., Jimenez, U., Provencio, M., Moreno, M.A., Terrasa, J., Munoz-Langa, J., Valdivia, J., Isla, D., Domine, M., Molinier, O., Mazieres, J., Baize, N., Garcia-Campelo, R., Robinet, G., Rodriguez-Abreu, D., Lopez-Vivanco, G., Gebbia, V., Ferrera-Delgado, L., Bombaron, P., Bernabe, R., Bearz, A., Artal, A., Cortesi, E., Rolfo, C., Sanchez-Ronco, M., Drozdowskyj, A., Queralt, C., De Aguirre, I., Ramirez, J.L., Sanchez, J.J., Molina, M.A., Taron, M., Paz-Ares, L. and Spanish Lung Cancer Group in Collaboration with Groupe Francais de Pneumo-Cancérologie and Associazione Italian Oncologia Toracica (2012) Erlotinib versus Standard Chemotherapy as First-Line Treatment for European Patients with Advanced EGFR Mutation-Positive NonSmall-Cell Lung Cancer (EURTAC): A Multicenter, Open-Label, Randomized Phase 3 Trial. Lancet Oncology, 13, 239-246. http://dx.doi.org/10.1016/S1470-2045 (11)70393-X
has been cited by the following article:
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TITLE:
A Phase II Study of Erlotinib in Patients with Previously Treated Non-Small Cell Lung Cancer
AUTHORS:
Tetsuya Kubota, Yoshio Okano, Mizu Sakai, Takashi Yamane, Naoki Shiota, Hiroshi Ohnishi, Hisanori Machida, Nobuo Hatakeyama, Eiji Takeuchi, Tomoyuki Urata, Fumitaka Ogushi, Akihito Yokoyama
KEYWORDS:
Non-Small Cell Lung Cancer; Phase II Study; Erlotinib; Previously Treated
JOURNAL NAME:
Advances in Lung Cancer,
Vol.3 No.1,
February
18,
2014
ABSTRACT:
Background: Erlotinib has
been reported to be effective for the treatment of non-small cell lung cancer
(NSCLC). To evaluate the efficacy and safety of erlotinib under conditions
similar to daily clinical practice, a phase II trial was conducted in Japanese
patients with previously treated NSCLC. Methods: The eligibility criteria were
stage IIIB/IV NSCLC, a performance status (PS) of 0 - 2, and previous treatment with 1 - 2 non-EGFR-TKI regimens. Patients received erlotinib (150 mg/day) orally
until disease progression or intolerable toxicity occurred. The primary
endpoint was the objective response rate (ORR). In addition, the disease
control rate (DCR), progression-free survival (PFS), overall survival (OS),
safety, and EGFR gene mutation status
were evaluated. Results: Thirty-eight patients were enrolled, and 37 patients
were evaluated. The median age was 69 years (range, 50 - 80 years). Patient characteristics were as follows: 26 were male and 11
were female; 12 had a PS of 0, 20 had a PS of 1, and 5 had a PS of 2; and 26
had adenocarcinoma, and 11 had non-adenocarcinoma
histology. The ORR and DCR were 21.6% (95% confidence interval [CI], 11.4% - 37.2%) and 54.1% (95% CI,
35.9% - 66.6%), respectively.
Twenty-seven patients could be evaluated for EGFR gene status (12, mutated; 15, wild-type). The ORR for EGFR-mutated patients was 41.7%, while
that for patients with wild-type EGFR was 13.3%. The median PFS was evaluated as 4.4 months (95% CI, 2.2 - 10.7 months). The median OS was 14.9 months (95% CI, 9.2 months - not reached). Common adverse events were tolerable skin toxicities,
diarrhea, and stomatitis. In addition, interstitial lung disease occurred in
8.1% of patients. Conclusion: As efficacy and safety were similar to previous
studies, erlotinib was found to be effective for Japanese patients with previously treated NSCLC in clinical practice.
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