Survival and prognostic factors in lung cancer patients treated in phase I trials: Japanese experience.

Yamamoto, Naoto; Tamura, Tomohide; Fukuoka, M.; Saijo, Nagahiro

doi:10.3892/ijo.15.4.737

Cited by 23 publications

(29 citation statements)

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“…Alternatively, higher bilirubin or transaminase levels within the normal range could be markers of genetic variation, with reduced hepatic metabolic or excretory capacity leading to greater systemic exposure (AUC) and toxicity for a given dose. Supporting this possibility are the data of Yamamoto et al (5), who found independent correlation of docetaxel clearance with cytochrome P4503A4 activity, serum levels of ␣-1 acid glycoprotein, and baseline transaminase activity in patients with normal total bilirubin and hepatic transaminase levels. Like docetaxel, elevated bilirubin or transaminase levels correlate with reduced clearance of paclitaxel and paclitaxel metabolites, increased AUC, and greater toxic effects (11).…”

Section: Discussionsupporting

confidence: 67%

Patient Characteristics Compete with Dose as Predictors of Acute Treatment Toxicity in Early Phase Clinical Trials

Rogatko¹,

Babb²,

Wang³

et al. 2004

Clinical Cancer Research

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Purpose: The purpose of this study was to identify patient characteristics that may be risk factors or markers of susceptibility to adverse treatment effects in cancer Phase I and II clinical trials.Patients and Methods: A total of 459 patients enrolled in 23 therapeutic Phase I and II studies at the Fox Chase Cancer Center were included in the analysis. Patient-specific characteristics, medical and treatment history, doses of experimental agents, and graded toxicities were extracted from case report forms. We developed a novel summary measure, the toxicity index (TI), to better discriminate patients on the basis of their overall toxicity experiences. Mixed model ANOVA was used to model TI on the basis of data from all trials using a specific agent. Generalized estimating equations in the context of binary logistic regression were used to model dose-limiting toxicity.Results: Seventeen pretreatment factors, including performance status, alkaline phosphatase, total bilirubin, serum creatinine, and tobacco use, emerged as significant predictors of toxicity as defined by dose-limiting toxicity or TI. Unexpectedly, dose was not always a predictor of toxicity. Even for values within the normal range, the TI identified serum bilirubin and alkaline phosphatase as predictors of toxicity after treatment with docetaxel and alkaline phosphatase as a predictor for toxicity after treatment with irinotecan.Conclusions: Independent of dose, certain pretreatment characteristics, including measures of organ function that are in the normal range, were found to be predictors of treatment toxicity. Because of its sensitivity to differences in overall toxicity, the TI should prove to be a useful tool for identifying predictors of chemotherapy-related toxicity.

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Section: Discussionsupporting

confidence: 67%

Patient Characteristics Compete with Dose as Predictors of Acute Treatment Toxicity in Early Phase Clinical Trials

Rogatko¹,

Babb²,

Wang³

et al. 2004

Clinical Cancer Research

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“…5) are 10 to 25 years old now, and differ from our series in the following significant ways: greater proportion of PS 2 patients; phase I trials of predominantly cytotoxic chemotherapy rather than modern molecular targeted agents; fewer prior systemic treatments as well as shorter median OS. In addition, the series reported by Italiano and colleagues (7) excluded patients who discontinued their trial early, and the series from Yamamoto and colleagues (29) included only lung cancer patients, therefore these results were not comparable.…”

Section: Discussionmentioning

confidence: 61%

Baseline Circulating Tumor Cell Counts Significantly Enhance a Prognostic Score for Patients Participating in Phase I Oncology Trials

Olmos

Baird

Yap

et al. 2011

Clinical Cancer Research

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Background: High circulating tumor cell (CTC) counts are associated with poor prognosis in several cancers. Enrollment of patients on phase I oncology trials requires a careful assessment of the potential risks and benefits. Many patients enrolled on such trials using established eligibility criteria have a short life expectancy and are less likely to benefit from trial participation. We hypothesized that the incorporation of CTC counts might improve patient selection for phase I trials.Methods: This retrospective analysis evaluated patients who had baseline CTCs enumerated prior to their starting on a phase I trial. CTCs were enumerated using the CellSearch System.Results: Between January 2006 and December 2009 a total of 128 patients enrolled in phase I trials had CTC counts evaluated. Higher CTC counts as a continuous variable independently correlated with risk of death in this patient population (P ¼ 0.006). A multivariate point-based risk model was generated using CTCs as a dichotomous variable (!3 or <3), and incorporated other established prognostic factors, including albumin <35 g/L, lactate dehydrogenase greater than upper limit of normal, and >2 metastatic sites. Comparison of receiver operating characteristic curves demonstrated that the addition of baseline CTC counts improved the performance of the prospectively validated Royal Marsden Hospital phase I prognostic score, which now identifies three risk groups (P < 0.0001): good prognosis [score 0-1, median overall survival (OS) 63.7 weeks], intermediate prognosis (score 2-3, median OS 37.3 weeks), and poor prognosis (score 4, median OS 13.4 weeks).Conclusion: CTC enumeration improved the performance of a validated prognostic score to help select patients for phase I oncology trials. Clin Cancer Res; 17(15); 5188-96. Ó2011 AACR.

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“…The patients' characteristics are the usual ones in this population [8,17,18]. In previous reports, the median overall survival of cancer patients treated in phase I was estimated to range between 5 to 9 months [8,17,18].…”

Section: Discussionmentioning

confidence: 99%

Prognostic factors among cancer patients with good performance status screened for phase I trials

Penel

Vanseymortier

Bonneterre³

et al. 2007

Invest New Drugs

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Survival and prognostic factors in lung cancer patients treated in phase I trials: Japanese experience.

Cited by 23 publications

References 0 publications

Patient Characteristics Compete with Dose as Predictors of Acute Treatment Toxicity in Early Phase Clinical Trials

Patient Characteristics Compete with Dose as Predictors of Acute Treatment Toxicity in Early Phase Clinical Trials

Baseline Circulating Tumor Cell Counts Significantly Enhance a Prognostic Score for Patients Participating in Phase I Oncology Trials

Prognostic factors among cancer patients with good performance status screened for phase I trials

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