ArticleBMC cancer2011
Early mortality and overall survival in oncology phase I trial participants: can we improve patient selection?
Article in BMC cancer, 2011. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 21 papers, 1 of them a synthesis that pooled it.
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Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
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Who cites it
21 citing papers in PubMed, 1 synthesis or guideline pooled it, 33 citations in OpenAlex.
- Outcomes Among Racial and Ethnic Minority Patients With Advanced Cancers in Phase 1 Trials: A Meta-Analysis.JAMA network open · 2024Pooled it
- Safety and efficacy of intratumourally administered INT230-6 in adult patients with advanced solid tumours: results from an open-label phase 1/2 dose escalation study.EBioMedicine · 2025Trial
- Assessment of Multiple Prognostic Scores in Patients With Metastatic Renal Cell Carcinoma Receiving First-Line, Immune-Based Combinations.Cancer reports (Hoboken, N.J.) · 2026Article
- Inclusion of Older Adults in Early-Phase Cancer Clinical Trials: Safety, Efficacy and a Way Forward.Drugs & aging · 2025Review
- Circulating Tumor DNA as a Prognostic Biomarker for Selecting Participants to Early Phase Clinical Trials.Journal of immunotherapy and precision oncology · 2025Article
- Blood-based prognostic scores and early dynamics under immunotherapy to select patients with metastatic solid tumors for continuing immune check-point inhibition: a prospective longitudinal study.Cancer immunology, immunotherapy : CII · 2025Article
- Tumor fraction-based prognostic tool for cancer patients referred to early phase clinical trials.NPJ precision oncology · 2024Article
- Review
- Clinical outcome and prognostic factors for Asian patients in Phase I clinical trials.British journal of cancer · 2023Article
- On-treatment immune prognostic score for patients with relapsed and/or metastatic head and neck squamous cell carcinoma treated with immunotherapy.Journal for immunotherapy of cancer · 2021Article
- First-In-Human Phase 1 Clinical Trials - A Single-Center Experience In The Era Of Modern Oncotherapeutics.Scientific reports · 2020Review
- Cell-free Circulating Tumor DNA Variant Allele Frequency Associates with Survival in Metastatic Cancer.Clinical cancer research : an official journal of the American Association for Cancer Research · 2020Article
- Survival in Early Phase Immuno-Oncology Trials: Development and Validation of a Prognostic Index.JNCI cancer spectrum · 2019Article
- Referrals to a Phase I Clinic and Trial Enrollment in the Molecular Screening Era.The oncologist · 2019Article
- Survival outcome and prognostic model of patients with colorectal cancer on phase 1 trials.Investigational new drugs · 2019Article
- PRognostic factor of Early Death In phase II Trials or the end of 'sufficient life expectancy' as an inclusion criterion? (PREDIT model).BMC cancer · 2016Article
- The neutrophil-lymphocyte ratio and its utilisation for the management of cancer patients in early clinical trials.British journal of cancer · 2015Article
- The role of palliative chemotherapy in hospitalized patients.Current oncology (Toronto, Ont.) · 2014Article
- An inflammation based score can optimize the selection of patients with advanced cancer considered for early phase clinical trials.PloS one · 2014Article
- A first-in-class, first-in-human, phase I trial of p28, a non-HDM2-mediated peptide inhibitor of p53 ubiquitination in patients with advanced solid tumours.British journal of cancer · 2013Article
Corrections and comments
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Authors and funding
8 authors at 3 institutions in 2 countries.
Funding
No grant is acknowledged in the PubMed record.
Abstract
backgroundPatient selection for phase I trials (PIT) in oncology is challenging. A typical inclusion criterion for PIT is 'life expectancy > 3 months', however the 90 day mortality (90DM) and overall survival (OS) of patients with advanced solid malignancies are difficult to predict.
methodsWe analyzed 233 patients who were enrolled in PIT at Princess Margaret Hospital. We assessed the relationship between 17 clinical characteristics and 90DM using univariate and multivariate logistic regression analyses to create a risk score (PMHI). We also applied the Royal Marsden Hospital risk score (RMI), which consists of 3 markers (albumin < 35g/L, > 2 metastatic sites, LDH > ULN).
resultsMedian age was 57 years (range 21-88). The 90DM rate was 14%; median OS was 320 days. Predictors of 90DM were albumin < 35g/L (OR = 8.2, p = 0.01), > 2 metastatic sites (OR = 2.6, p = 0.02), and ECOG > 0 (OR = 6.3, p = 0.001); all 3 factors constitute the PMHI. To predict 90DM, the PMHI performed better than the RMI (AUC = 0.78 vs 0.69). To predict OS, the RMI performed slightly better (RMI ≥ 2, HR = 2.2, p = 0.002 vs PMHI ≥ 2, HR = 1.6, p = 0.05).
conclusionsTo predict 90DM, the PMHI is helpful. To predict OS, risk models should include ECOG > 0, > 2 metastatic sites, and LDH > ULN. Prospective validation of the PMHI is warranted.
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Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.