Identification of factors limiting patient recruitment into phase I trials: A study from the Royal Marsden Hospital

Karavasilis, Vasilios; Digue, Laurence; Arkenau, Tobias; Eaton, David J.; Stapleton, Sarah; Bono, Johann S. de; Judson, Ian; Kaye, Stan B.

doi:10.1016/j.ejca.2008.02.040

Cited by 29 publications

(23 citation statements)

References 9 publications

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“…1,14 It is generally accepted that only a minority of patients referred to a phase I trials unit go on to be enrolled onto a study. 15,16 Some of the reasons for a patient's nonprogression to a trial are unlikely to be related to individual social factors (not meeting eligibility criteria, lack of trial availability), but in our experience up to 40% of patients are not suitable for trial recruitment because of poor or deteriorating fitness after referral. 17 Other patients prefer not to participate once they learn about the demands of trial participation.…”

Section: Discussionmentioning

confidence: 96%

Effect of Patient Socioeconomic Status on Access to Early-Phase Cancer Trials

Noor

Sarker

Vizor

et al. 2013

JCO

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We show for the first time to our knowledge that socioeconomic status affects early-phase cancer trial referrals. The least-deprived patients are almost twice as likely to be referred compared with the most deprived. This may be because more-deprived patients are less suitable for a trial-as a result of comorbidities, for example-or because of inequalities that could be addressed by patient or referrer education. Once reviewed at the unit, enrollment onto a trial is not affected by deprivation.

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Section: Discussionmentioning

confidence: 96%

Effect of Patient Socioeconomic Status on Access to Early-Phase Cancer Trials

Noor

Sarker

Vizor

et al. 2013

JCO

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“…Physicians may experience problems in initiating conversations about clinical trials with patients. Physician issues have been strongly linked to lack of accrual in phase I trials [16, 17]. Once a physician identifies a patient as an eligible clinical trial candidate and extends the offer to enroll, the patient has the choice to agree or refuse to participate.…”

Section: Introductionmentioning

confidence: 99%

The Bottleneck Effect in Lung Cancer Clinical Trials

et al. 2013

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Clinical trials provide the most promising way to improve treatment outcomes in cancer. This study examined the rate at which eligible patients with lung cancer, at a National Cancer Institutedesignated cancer center in the South, were offered a clinical trial and explored for reasons for ineligibility. We retrospectively reviewed 300 randomly selected lung cancer patients' medical records seen in 2010, to assess clinical trial offers to eligible patients, reasons for not offering an eligible patient a trial, demographic factors associated with eligibility, and reasons for refusal among those offered a trial. Of the 300 patient charts, seven were excluded for lack of confirmed lung cancer diagnosis. Forty-six of the remaining 293 (15.7 %) patients were eligible for a clinical trial. Forty-five of the 46 (97.8 %) were considered for a trial by their oncologist. Thirty-five of the 45 (77.8 %) were offered a trial: 15 agreed (42.9 % of those offered, 5.1 % of patients reviewed), 11 declined, and 9 were undecided at the end of the review window. Patients with poor Eastern Cooperative Oncology Group (ECOG) performance status levels and small cell (SC) diagnoses were significantly less likely to be eligible for a trial. Results suggest that oncologists at the cancer center are effectively presenting all eligible patients with the option of a clinical trial;Correspondence to: Gwendolyn P. Quinn, gwen.quinn@moffitt.org. however, there is a need to increase the number of approved clinical trials for patients with SC or ECOG score greater than 2. HHS Public Access

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“…Whether or not there is clinical benefit for patients included in phase I trials continues to be a concern for many physicians, thus limiting referrals to and recruitment for such trials (15). Here, we show that the clinical outcomes of patients with advanced head and neck tumors that progressed on standard FDA-approved therapies were not inferior to the outcomes of the same patients on their last FDA-approved therapy.…”

Section: Discussionmentioning

confidence: 59%

Patients with Advanced Head and Neck Cancers Have Similar Progression-Free Survival on Phase I Trials and Their Last Food and Drug Administration–Approved Treatment

Garrido‐Laguna

Janků

Falchook

et al. 2010

Clinical Cancer Research

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Results: The most common histology was head and neck squamous cell carcinoma (62%). Median age was 55 years (range, 26-80). Eastern Cooperative Oncology Group performance status was 0 to 1 for 95% of patients. Fifty-nine patients had received FDA-approved drugs as the backbone of their last systemic therapy before inclusion in phase I trials (median, 2 systemic therapies). Progression-free survival (PFS) on phase I trials was not inferior to PFS on their last FDA-approved therapies (12 versus 10.7 weeks, log-rank P = 0.87). Fifty-three patients were evaluable for response by Response Evaluation Criteria in Solid Tumors criteria. Four (7%) had partial responses and 16 (26%) had stable disease for ≥4 months. In univariate analysis, number of metastatic sites, lactate dehydrogenase (LDH) levels at baseline, and Royal Marsden Hospital prognosis scores were significant predictors of survival. Only LDH was significant in multivariate analysis (hazard ratio, 6.35; P ≤ 0.0001).Conclusions: For patients with heavily pretreated advanced head and neck tumors, PFS on phase I trials is not inferior to PFS with their last FDA-approved therapy. The only significant predictor of survival in the multivariate analysis was baseline LDH. Clin Cancer Res; 16(15); 4031-7. ©2010 AACR.

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Identification of factors limiting patient recruitment into phase I trials: A study from the Royal Marsden Hospital

Cited by 29 publications

References 9 publications

Effect of Patient Socioeconomic Status on Access to Early-Phase Cancer Trials

Effect of Patient Socioeconomic Status on Access to Early-Phase Cancer Trials

The Bottleneck Effect in Lung Cancer Clinical Trials

Patients with Advanced Head and Neck Cancers Have Similar Progression-Free Survival on Phase I Trials and Their Last Food and Drug Administration–Approved Treatment

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