A Phase II Trial of Erlotinib Monotherapy in Pretreated Patients with Advanced Non-small Cell Lung Cancer Who Do Not Possess Active EGFR Mutations: Okayama Lung Cancer Study Group Trial 0705

Yoshioka, Hiroshige; Hotta, Katsuyuki; Kiura, Katsuyuki; Takigawa, Nagio; Hayashi, Hidetoshi; Harita, Shingo; Kuyama, Shoichi; Segawa, Yoshihiko; Kamei, Haruhito; Umemura, Shigeki; Bessho, Akihiro; Tabata, Masahiro; Tanimoto, Mitsune

doi:10.1097/jto.0b013e3181c20063

Cited by 60 publications

(39 citation statements)

References 14 publications

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“…First, the BR.21 study showed a survival benefit of erlotinib in NSCLC patients in all statuses, including patients with wild-type EGFR [45]. A phase-II trial showed that the overall survival after erlotinib treatment was 9.2 months in patients with wild-type EGFR who had received chemotherapy previously [46]. The present study showed that the median overall survival after EGFR-TKI treatment was 8.3 months (95% CI 4.3-12.3 months) in patients with wildtype EGFR, which is compatible with previous reports [46].…”

Section: Discussionmentioning

confidence: 99%

“…A phase-II trial showed that the overall survival after erlotinib treatment was 9.2 months in patients with wild-type EGFR who had received chemotherapy previously [46]. The present study showed that the median overall survival after EGFR-TKI treatment was 8.3 months (95% CI 4.3-12.3 months) in patients with wildtype EGFR, which is compatible with previous reports [46]. Secondly, in the present study, patients with wild-type EGFR and no EGFR-TKI therapy were more likely to be smokers and to have brain metastasis and adrenal gland metastasis than those with wild-type EGFR and EGFR-TKI therapy.…”

Section: Discussionmentioning

confidence: 99%

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Survival of lung adenocarcinoma patients with malignant pleural effusion

Tsai

et al. 2012

Eur Respir J

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In the era of targeted therapy, the association between lung adenocarcinoma patient survival and malignant pleural effusions (MPEs) remains unclear. This study investigated the clinical characteristics, survival and epidermal growth factor receptor (EGFR) gene (EGFR) mutation status of lung adenocarcinoma patients with MPE.From June 2005 to December 2010, consecutive pleural effusions were collected prospectively. Patient clinical characteristics, EGFR mutation status, and overall survival were analysed.We collected MPEs from 448 patients in stage IV lung adenocarcinoma at initial diagnosis. Median overall survival for patients with MPEs at initial diagnosis and following disease progression were 14.3 months and 21.4 months, respectively (p50.001). There were 296 (66.1%) patients harbouring EGFR mutations, the mutation rates among patients with an MPE at initial diagnosis and one following disease progression were 68.2% and 56.6%, respectively (p50.044); the L858R mutation rate was also higher among the former (32.6% versus 18.1%; p50.009). Multivariate analysis revealed that patients who: developed MPEs following disease progression, harboured EGFR mutations, and received EGFR-tyrosine kinase inhibitor therapy, had longer overall survival. Patients in stage IV lung adenocarcinoma with MPEs at initial diagnosis have shorter overall survival and higher EGFR mutation rate, especially for L858R, than patients who develop MPEs following disease progression.

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Section: Discussionmentioning

confidence: 99%

Section: Discussionmentioning

confidence: 99%

Survival of lung adenocarcinoma patients with malignant pleural effusion

Tsai

et al. 2012

Eur Respir J

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“…All except one patient had wildtype EGFR [30] . The RR (11.1%), DCR (63.0%), median PFS (2.8 months) and median OS (15.8 months) of our study were superior to those (3.3%, 63.3%, 2.1 months and 9.2 months, respectively) of Okayama Lung Cancer Study Group trial 0705, a Japanese phase II trial of second to fourth line chemotherapy of erlotinib in patients with EGFR wild-type advanced NSCLC [32] . However, our results were similar to those of the previous two subgroup analyses of pemetrexed monotherapy in patients with pretreated advanced non-squamous NSCLC and unknown EGFR mutation status.…”

Section: Phase II Studies Of Combination Of Erlotinib With Pemetrexedmentioning

confidence: 66%

Dose erlotinib add beneficial effect on cytotoxic agent for patients with pretreated advanced non-small cell lung cancer?

Minami¹,

Kijima²

2014

Cancer Cell Microenviron

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Combination of epidermal growth factor receptor tyrosine kinase inhibitor (EGFR-TKI) with platinumcontaining standard chemotherapy failed to provide better outcomes in the first-line setting for advanced nonsmall cell lung cancer (NSCLC) in several phase III trials. The approved monotherapy of erlotinib, pemetrexed or docetaxel as the second-line regimen still remains unsatisfactory in anti-tumor effects for recurrent NSCLC. Combination of EGFR-TKI with cytotoxic drug seemed a promising strategy to improve therapeutic outcome for pretreated advanced NSCLC, because preclinical studies indicated schedule-dependent administration of EGFR-TKI with a specific cytotoxic drug had synergistic anti-tumor effects against NSCLC cells. Several clinical pharmacokinetic analyses in dose-finding phase I studies revealed that intermittent erlotinib with pemetrexed or docetaxel did not induce any potential antagonism between two drugs when erlotinib and its metabolites were almost completely swept away from plasma at the subsequent pemetrexed or docetaxel dosing. Recently, four phase II studies of combination of erlotinib with pemetrexed or docetaxel in the second-line setting for patients with NSCLC were reported. As a result, additional anti-tumor effects of erlotinib on cytotoxic drug still remain controversial. Three phase II studies showed favorable results and supported combination strategy of erlotinib, but our study failed to demonstrate the benefits from combination of intermittent erlotinib with tri-weekly pemetrexed. Herein, we review whether combination of erlotinib with cytotoxic drug is a promising therapeutic approach as the second-line treatment for advanced NSCLC.

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“…These results are remarkably similar (except for OS; survival is commonly better in Japanese NSCLC patients) (10), and also comparable to results in a phase II trial for EGFR mutation-negative Japanese NSCLC. In the trial, the RR, DCR, median PFS and median OS were 3.3%, 60.0%, 2.1 months and 10.7 months, respectively (18). Similarly, Matsuura et al (19) have reported the efficacy of erlotinib as third-line therapy in advanced NSCLC without EGFR mutations.…”

Section: Discussionmentioning

confidence: 97%

“…In our study, ILD was observed in one (2.4%) of 41 patients, and caused this patient's death. In phase II studies of erlotinib therapy conducted in Japan, the incidences of ILD were reported as 6.5% (4 of 62), 2.5% (1 of 40) and 6.7% (2 of 30) (18,25,26). In a prospective epidemiologic cohort study on gefitinib, a higher incidence of ILD was significantly associated with the following factors: elderly, smoker, pre-existing ILD and poor PS (15,27).…”

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confidence: 99%

Erlotinib for Pretreated Squamous Cell Carcinoma of the Lung in Japanese Patients

Hata

Katakami

Kunimasa

et al. 2011

Japanese Journal of Clinical Oncology

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Objective: Erlotinib has demonstrated survival benefit in patients with not only adenocarcinoma but also squamous cell carcinoma. Epidermal growth factor receptor-tyrosine kinase inhibitors are more effective in Asian populations, including the Japanese than in western populations. However, a higher incidence of interstitial lung disease has been reported as a fatal adverse event in the Japanese population. There is little data on erlotinib for Japanese patients with pretreated squamous cell carcinoma. Methods: Between January 2004 and October 2010, we retrospectively evaluated the efficacy and toxicity of erlotinib administered as the first epidermal growth factor receptortyrosine kinase inhibitors for 41 Japanese patients with pretreated squamous cell carcinoma. Patients with pre-existing interstitial lung disease were carefully excluded by several examinations including high-resolution computed tomography. Results: The response rate and disease control rate were 9.7% [95% confidence interval: 2.7 -23.1%) and 43.9% (95% confidence interval: 28.5 -60.2%], respectively. Median time to treatment failure and overall survival were 2.2 months (95% confidence interval: 1.0 -2.8 months) and 11.0 months (95% confidence interval: 5.7 -15.7 months), respectively. Interstitial lung disease (Grade 5) was observed in one (2.4%) patient. Patients with Grade 0 -1 skin rashes vs. patients with Grades 2 -3 exhibited disease control rates of 28 vs. 83% (P ¼ 0.0017), and median time to treatment failure of 1.2 months vs. 3.4 months (P ¼ 0.0099). Conclusions: Erlotinib has moderate efficacy for pretreated squamous cell carcinoma in Japanese patients. A higher grade of skin rash was associated with clinical benefit. Careful exclusion of pre-existing interstitial lung disease can minimize the occurrence of interstitial lung disease.

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A Phase II Trial of Erlotinib Monotherapy in Pretreated Patients with Advanced Non-small Cell Lung Cancer Who Do Not Possess Active EGFR Mutations: Okayama Lung Cancer Study Group Trial 0705

Abstract: This is the first prospective biomarker study showing that erlotinib therapy for pretreated patients with EGFR-wt tumors seems to have a modest activity with no irreversible toxicity.

Cited by 60 publications

References 14 publications

Survival of lung adenocarcinoma patients with malignant pleural effusion

Survival of lung adenocarcinoma patients with malignant pleural effusion

Dose erlotinib add beneficial effect on cytotoxic agent for patients with pretreated advanced non-small cell lung cancer?

Erlotinib for Pretreated Squamous Cell Carcinoma of the Lung in Japanese Patients

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