ArticleBritish journal of cancer2003
Comparison of prognostic factors in patients in phase I trials of cytotoxic drugs vs new noncytotoxic agents.
Article in British journal of cancer, 2003. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 20 papers, 2 of them syntheses that pooled it.
What it found
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The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
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.
Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.
Who cites it
20 citing papers in PubMed, 2 syntheses or guidelines pooled it, 52 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
- Prognostic value of pretreatment serum lactate dehydrogenase level in patients with solid tumors: a systematic review and meta-analysis.Scientific reports · 2015Pooled it
- Recruitment, outcomes, and toxicity trends in phase I oncology trials: Six-year experience in a large institution.Cancer reports (Hoboken, N.J.) · 2022Article
- Clinical Predictors of Early Trial Discontinuation for Patients Participating in Phase I Clinical Trials in Oncology.Cancers · 2021Article
- Improved survival among patients enrolled in oncology phase 1 trials in recent decades.Cancer chemotherapy and pharmacology · 2020Article
- Survival in Early Phase Immuno-Oncology Trials: Development and Validation of a Prognostic Index.JNCI cancer spectrum · 2019Article
- Survival outcome and prognostic model of patients with colorectal cancer on phase 1 trials.Investigational new drugs · 2019Article
- Characteristics and outcomes of breast cancer patients enrolled in the National Cancer Institute Cancer Therapy Evaluation Program sponsored phase I clinical trials.Breast cancer research and treatment · 2018Article
- Phase I trial outcomes in older patients with advanced solid tumours.British journal of cancer · 2016Article
- Clinical outcomes in 66 patients with advanced gastric cancer treated in phase I trials: the NCCHE experience.Investigational new drugs · 2015Article
- An inflammation based score can optimize the selection of patients with advanced cancer considered for early phase clinical trials.PloS one · 2014Article
- Phase 1 clinical trials in end-stage cancer: patient understanding of trial premises and motives for participation.Supportive care in cancer : official journal of the Multinational Association of Supportive Care in Cancer · 2013Article
- Prediction of early death among patients enrolled in phase I trials: development and validation of a new model based on platelet count and albumin.British journal of cancer · 2012Article
- Risk of serious toxicity in 1181 patients treated in phase I clinical trials of predominantly targeted anticancer drugs: the M. D. Anderson Cancer Center experience.Annals of oncology : official journal of the European Society for Medical Oncology · 2012Article
- Creatinine clearance is associated with toxicity from molecularly targeted agents in phase I trials.Oncology · 2012Article
- Early mortality and overall survival in oncology phase I trial participants: can we improve patient selection?BMC cancer · 2011Article
- Outcomes of patients with advanced non-small cell lung cancer treated in a phase I clinic.The oncologist · 2011Article
- Development and validation of a model that predicts early death among cancer patients participating in phase I clinical trials investigating cytotoxics.Investigational new drugs · 2010Article
- Clinical outcome and prognostic factors for patients treated within the context of a phase I study: the Royal Marsden Hospital experience.British journal of cancer · 2008Article
- New target-based agents involve new clinical trial designs.Clinical & translational oncology : official publication of the Federation of Spanish Oncology Societies and of the National Cancer Institute of Mexico · 2006Review
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
10 authors at 3 institutions in 2 countries.
Funding
No grant is acknowledged in the PubMed record.
Abstract
The aims of this study were to identify prognostic variables for toxicity and survival in patients with cancer participating in phase I clinical trials and compare characteristics of those treated with cytotoxic chemotherapy (CT) and non-cytotoxic drugs (non-CT). Data were collected from 420 (114 CT, 306 non-CT) patients enrolled in 16 phase I trials (five CT and 11 non-CT trials) in one cancer centre. Analyses of all patients were used to compare treatment groups, identify predictive variables for toxicity and to estimate prognostic factors in overall survival (OS). These were used to develop a prognostic index (PI). Multivariate analysis found those patients with better performance status, fewer sites of metastases, baseline Hb>12 g dl(-1) and WBC or LDH in the normal range had significantly better OS. Male gender, platelet count <450 x 10(9) l(-1), high WBC or treatment with a non-CT phase I agent significantly reduced the chance of grade 3/4 toxicity. Overall survival was not significantly different between the CT and non-CT groups (260 vs 192 days, P=0.47) except for those with liver metastases (228 vs 137 days, P=0.02). Overall tumour response was 4.9% (95% CI: 2.7-7.0%). The PI identified three distinct patient groups with median survival of 321, 257 and 117 days. In conclusion, entry into a phase I trial of a non-CT drug is a safe option for heavily pretreated patients with cancer. The PI generated from these data can estimate the survival probability for patients entering phase I studies.
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Registered trials
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