Outcomes of Research Biopsies in Phase I Clinical Trials: The MD Anderson Cancer Center Experience

El-Osta, Hazem; Hong, David S.; Wheler, Jennifer J.; Fu, Siqing; Naing, Aung; Falchook, Gerald S.; Hicks, Marshall E.; Wen, Sijin; Tsimberidou, Apostolia M.; Kurzrock, Razelle

doi:10.1634/theoncologist.2011-0043

Cited by 63 publications

(60 citation statements)

References 21 publications

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“…This finding is concordant with data from patient surveys [15,16]. It is noteworthy, however, that most studies have suggested research biopsies are safe, with a 0.8%-1.4% major complication rate [4][5][6]17]. For example, of 61 patients who underwent a liver biopsy in a prospective tissue collection study at DFCI, only 1 grade 2 or higher adverse event (grade 2 pain) was noted [7].…”

Section: Discussionsupporting

confidence: 82%

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Variation in the Attitudes of Medical Oncologists Toward Research Biopsies in Patients With Metastatic Breast Cancer

et al. 2015

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Background. Tissue from research biopsies provides access to insights into tumor biology. We aimed to determine medical oncologists' (MOs') attitudes toward research biopsies in patients with metastatic breast cancer (MBC). Materials and Methods. A total of 309 breast MOs from National Cancer Institute (NCI)-designated cancer centers were invited to complete a self-administered survey about their attitudes toward approaching patients for research purposeonly biopsies (RPOBs), performed as a standalone procedure, or additional biopsies, performed with a clinically indicated biopsy. The MOs were asked to predict what proportion of their MBC patients would consider undergoing research biopsies. Results. Of the 309 MOs, 221 (72%) responded. Of these 221 MOs, 30 were ineligible, leaving 191 eligible responders. Nearly all the MOs reported they were comfortable approaching patients regarding research biopsies of blood or skin. One

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Section: Discussionsupporting

confidence: 82%

“…The participation rates in research biopsies are highly variable, between 4% and 97% [4][5][6][7]. Although some of this variability can be explained by differences in study design (i.e., whether it is tied to a therapeutic trial, optional or mandatory biopsies, and the number of biopsy time points), undoubtedly, other factors are at work.…”

Section: Introductionmentioning

confidence: 99%

Variation in the Attitudes of Medical Oncologists Toward Research Biopsies in Patients With Metastatic Breast Cancer

et al. 2015

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“…Some suggest that mandatory biopsies impact on trial accrual and that when given the choice, patients opt not to have biopsies [15,16]. However, Tabernero et al [17] have reported a 60% acceptance rate for sequential tumor biopsies in a phase I trial, while Rojo et al [18] obtained a 93% acceptance rate in baseline tumor biopsies and 50% acceptance in on-treatment biopsies.…”

Section: Discussionmentioning

confidence: 99%

Patients' Perceptions of Research Biopsies in Phase I Oncology Trials

et al. 2014

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Objective: Research biopsies are increasingly incorporated into phase I oncology trials resulting in ethical and logistical challenges for patients and clinicians. Patients' understanding and willingness to undergo these biopsies are crucial. Methods: Over 12 months, we administered a questionnaire comprising three sections: demographics and previous cancer therapy, understanding of phase I trials and personalized medicine, and understanding of biopsies and associated risks. Results: Out of 56 patients approached, 47 patients completed the questionnaire. Overall, the patients were well informed about the concepts of personalized medicine and 89% (n = 42) were aware that early phase clinical trials aim to define a dose and explore side effects of new drugs. Interestingly, 76% (n = 36) expected early phase trials to improve symptoms, quality of life and survival. Offering hope and feeling in control of their treatment were important components for 80% (n = 38) and 57% (n = 27), respectively. The majority of this highly selective patient cohort understood the concept of research biopsies, with 59% (n = 28) willing to have a fresh research biopsy for trial participation. Although 72% (n = 34) felt that research biopsies should be optional, only 19% (n = 9) would not participate in a clinical trial with mandatory biopsies. Compared to diagnostic biopsies, the patients were less likely to accept associated risks with research biopsies. Conclusion: As research biopsies are crucial to many components of the drug development process, our study provides evidence for patients' overall willingness to undergo research biopsies for trial purposes. A consent process tailored to the biopsy site may help patients weigh up the associated risks versus benefits. © 2014 S. Karger AG, Basel

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“…El-Osta and colleagues (11) found that only 4.4% of patients agreed to an optional biopsy when participating in trials, whereas Gomez-Roca and colleagues (12) found that 68% of patients on optional biopsy protocols had at least one biopsy done and 44% had sequential biopsies. …”

Section: Discussionmentioning

confidence: 99%

Methods for Sample Acquisition and Processing of Serial Blood and Tumor Biopsies for Multicenter Diffuse Large B-cell Lymphoma Clinical Trials

Nielsen

Diaz

Christodoulopoulos

et al. 2014

Cancer Epidemiology, Biomarkers &Amp; Prevention

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Increasingly, targeted therapies are being developed to treat malignancies. To define targets, determine mechanisms of response and resistance, and develop biomarkers for the successful investigation of novel therapeutics, high-quality tumor biospecimens are critical. We have developed standard operating procedures (SOPs) to acquire and process serial blood and tumor biopsies from patients with diffuse large B-cell lymphoma enrolled in multicenter clinical trials. These SOPs allow for collection and processing of materials suitable for multiple downstream applications, including immunohistochemistry, cDNA microarrays, exome sequencing, and metabolomics. By standardizing these methods, we control preanalytic variables that ensure high reproducibility of results and facilitate the integration of datasets from such trials. This will facilitate translational research, better treatment selection, and more rapid and efficient development of new drugs.

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Outcomes of Research Biopsies in Phase I Clinical Trials: The MD Anderson Cancer Center Experience

Cited by 63 publications

References 21 publications

Variation in the Attitudes of Medical Oncologists Toward Research Biopsies in Patients With Metastatic Breast Cancer

Variation in the Attitudes of Medical Oncologists Toward Research Biopsies in Patients With Metastatic Breast Cancer

Patients' Perceptions of Research Biopsies in Phase I Oncology Trials

Methods for Sample Acquisition and Processing of Serial Blood and Tumor Biopsies for Multicenter Diffuse Large B-cell Lymphoma Clinical Trials

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