Is the Importance of Achieving Stable Disease Different between Epidermal Growth Factor Receptor Tyrosine Kinase Inhibitors and Cytotoxic Agents in the Second-Line Setting for Advanced Non-small Cell Lung Cancer?

Kurata, Takeshi; Matsuo, Keitaro; Takada, Minoru; Kawahara, Mutsuto; Tsuji, Masahiro; Matsubara, Yutaka; Otani, Nagahiro; Matsuyama, Shigeki; Muraishi, Kenya; Fujita, Tatsuo; Ishikawa, Masato; Koyano, Keita; Okamoto, Isamu; Satoh, Taroh; Tamura, Kenji; Nakagawa, Kazuhiko; Fukuoka, Masahiro

doi:10.1016/s1556-0864(15)30382-8

Cited by 9 publications

(11 citation statements)

References 55 publications

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“…In the validation set, the proteomic classifier successfully distinguished responders (complete response [CR]/PR) from nonresponders (PD). Nevertheless, the model garnered criticism for its neglect of the SD cases since data have shown survival improvement may not be confined exclusively to patients with tumor shrinkage,40 and considering that stabilization of the disease and prolonged OS are important criteria of benefit from treatment. In the present study, we specifically took the response to treatment and PFS/OS together as end points of our classifier.…”

Section: Discussionmentioning

confidence: 99%

Serum proteomic study on EGFR-TKIs target treatment for patients with NSCLC

Wu¹,

Liang²,

Hou³

et al. 2013

OTT

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BackgroundAlthough epidermal growth factor receptor (EGFR)-tyrosine kinase inhibitors (TKIs) are widely used for EGFR mutated non-small-cell lung cancer (NSCLC) patients, tumor sample availability and heterogeneity of the tumor remain challenging for physicians’ selection of these patients. Here, we developed a serum proteomic classifier based on matrix assisted laser desorption ionization time of flight mass spectrometry (MALDI-TOF-MS) to predict the clinical outcome of patients treated with EGFR-TKIs.MethodA total of 68 patients were included in this study. All patients received EGFR-TKIs as second or third line treatment and blood samples were collected before treatment. Using magnetic bead assisted serum peptide capture coupled to MALDI-TOF-MS, pretreatment serum from 24 NSCLC patients was analyzed to develop a proteomic classifier (training set). In a blinded test set with 44 patients, each sample was classified into “good” or “poor” groups using this classifier. Survival analysis of each group was done based on this classification.ResultA 3-peptide proteomic classifier was developed from the training set. In the testing set, the classifier was able to distinguish patients of “good” or “poor” outcomes with 93% accuracy, sensitivity, and specificity. The overall survival and progression free survival of the predicted good group were found to be significantly longer than the poor group, not only in the whole population but also in certain subgroups, such as pathological adenocarcinoma and nonsmokers. With respect to the tumor samples available for EGFR mutation detection, all eight EGFR mutant tumors and three of the 12 wild type EGFR tumors were classified as good while nine of the 12 wild type EGFR tumors were classified as poor.ConclusionThe current study has shown that a proteomic classifier can predict the outcome of patients treated with EGFR-TKIs and may aid in patient selection in the absence of available tumor tissue. Further studies are necessary to confirm these findings.

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Section: Discussionmentioning

confidence: 99%

Serum proteomic study on EGFR-TKIs target treatment for patients with NSCLC

Wu¹,

Liang²,

Hou³

et al. 2013

OTT

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“…This value increases to 21% and 30% if the number of patients is 500 or 250, respectively [40]. In two other studies, each 1% increase in response rate resulted in an improvement in median survival time of 0.26 months in patients receiving TKI [54] or 0.07 months with salvage chemotherapy [51]. When specified, the evaluation criteria for response were most often those of the WHO and RECIST.…”

Section: Question 1: Can the Criteria Of Pfs Ttp And Dfs Be Used To mentioning

confidence: 99%

“…Seven meta-analyses have been published to date that assess, as the primary objective of the study, the relationship between objective response to chemotherapy and survival [40,[49][50][51][52][53][54]. Objective response and/or disease control (objective response plus stable disease) predict improvement in overall survival in the following situations: advanced NSCLC receiving first-line or salvage chemotherapy and extensive disease SCLC treated by first-line chemotherapy (table 5).…”

Section: Question 1: Can the Criteria Of Pfs Ttp And Dfs Be Used To mentioning

confidence: 99%

Surrogate markers predicting overall survival for lung cancer: ELCWP recommendations

Berghmans¹,

Pasleau²,

Paesmans³

et al. 2011

Eur Respir J

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The present systematic review was performed under the auspices of the European Lung Cancer Working Party (ELCWP) in order to determine the role of early intermediate criteria (surrogate markers), instead of survival, in determining treatment efficacy in patients with lung cancer. Initially, the level of evidence for the use of overall survival to evaluate treatment efficacy was reviewed. Nine questions were then formulated by the ELCWP. After reviewing the literature with experts on these questions, it can be concluded that overall survival is still the best criterion for predicting treatment efficacy in lung cancer. Some intermediate criteria can be early predictors, if not surrogates, for survival, despite limitations in their potential application: these include time to progression, progression-free survival, objective response, local control after radiotherapy, downstaging in locally advanced nonsmall cell lung cancer (NSCLC), complete resection and pathological TNM in resected NSCLC, and a few circulating markers. Other criteria assessed in these recommendations are not currently adequate surrogates of survival in lung cancer.

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“…Objective response rate (ORR) may not be a useful parameter since it shows a clear reduction as the number of treatment lines increases; however, the ability to maintain stable disease (SD) could represent an alternative endpoint [18]. Other factors which should be considered are treatment toxicity profile (to favor patient’s treatment compliance) and the maintenance of the best possible PS through the control of clinical symptoms.…”

Section: Third-line Treatment Aimsmentioning

confidence: 99%

“…The INTEREST trial asked the same question as the Japanese trial but in a broader audience and has provided enough data for registering gefitinib worldwide [12,13,14,15,16,17,18,19,20,21,22,23,24,25,26,27,28,29,30,31,32,33,34,35,36]. The INTEREST trial enrolled 1,466 patients, making it the largest trial in pre-treated patients that has ever been conducted.…”

Section: Biologic Agentsmentioning

confidence: 99%

Third-Line Therapy for Advanced Non-Small-Cell Lung Cancer Patients: A Feasible Therapeutic Option?

et al. 2009

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Two decades ago best supportive care was considered a valid therapeutic option for advanced non-small cell lung cancer (NSCLC) patients until the evidence derived from meta-analysis showed symptom improvement and a survival advantage from systemic chemotherapy. A further advantage was reported when docetaxel and pemetrexed were used as second-line treatment after failure of first-line platinum-based chemotherapy. Furthermore, the biologic therapies targeting the epidermal growth factor receptor – erlotinib and gefitinib – have modified the therapeutic approach to second- and third-line treatment of NSCLC patients. In fact, to date, erlotinib is the only drug to be licensed for third-line therapy worldwide. So, third-line represents a new frontier to be assessed in advanced NSCLC patients. Third-line therapy is very hard to define correctly as it is difficult to interpret the currently available evidence-based data. A better knowledge of cellular biology will certainly encourage clinical research and could allow oncologists to best select patients and treatments. Here we review the state of the art of third-line therapy in the treatment of NSCLC patients.

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Is the Importance of Achieving Stable Disease Different between Epidermal Growth Factor Receptor Tyrosine Kinase Inhibitors and Cytotoxic Agents in the Second-Line Setting for Advanced Non-small Cell Lung Cancer?

Cited by 9 publications

References 55 publications

Serum proteomic study on EGFR-TKIs target treatment for patients with NSCLC

Serum proteomic study on EGFR-TKIs target treatment for patients with NSCLC

Surrogate markers predicting overall survival for lung cancer: ELCWP recommendations

Third-Line Therapy for Advanced Non-Small-Cell Lung Cancer Patients: A Feasible Therapeutic Option?

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