ArticleAnnals of oncology : official journal of the European Society for Medical Oncology2012
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.
Article in Annals of oncology : official journal of the European Society for Medical Oncology, 2012. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT02363647 (Personalized Cancer Therapy for Patients With Metastatic Medullary Thyroid or Metastatic Colon Cancer), which is not on this map. Cited by 11 papers, 2 of them syntheses that pooled it.
What it found
Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.
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.
Personalized Cancer Therapy for Patients With Metastatic Medullary Thyroid or Metastatic Colon Cancer
Who cites it
11 citing papers in PubMed, 2 syntheses or guidelines pooled it.
- Disruption of podocyte cytoskeletal biomechanics by dasatinib leads to nephrotoxicity.Nature communications · 2019Pooled it
- The role of age on dose-limiting toxicities in phase I dose-escalation trials.Clinical cancer research : an official journal of the American Association for Cancer Research · 2014Pooled it
- Randomized phase II trial of sorafenib alone or in combination with carboplatin/paclitaxel in women with recurrent platinum sensitive epithelial ovarian, peritoneal, or fallopian tube cancer.Investigational new drugs · 2014Trial
- Review
- Early-phase clinical trials in the pandemic era: a four-year experience from an academic cancer center.American journal of cancer research · 2025Article
- First-In-Human Phase 1 Clinical Trials - A Single-Center Experience In The Era Of Modern Oncotherapeutics.Scientific reports · 2020Review
- Reprioritizing Risk and Benefit: The Future of Study Design in Early-Phase Cancer Research.Ethics & human research · 2019Article
- Article
- Incidence of infusion reactions to anti-neoplastic agents in early phase clinical trials: The MD Anderson Cancer Center experience.Investigational new drugs · 2017Article
- Doxycycline reverses epithelial-to-mesenchymal transition and suppresses the proliferation and metastasis of lung cancer cells.Oncotarget · 2015Article
- Nomogram to predict cycle-one serious drug-related toxicity in phase I oncology trials.Journal of clinical oncology : official journal of the American Society of Clinical Oncology · 2014Article
Corrections and comments
- Commented on by
Authors and funding
10 authors.
Funding
Abstract
backgroundThis study assessed toxicity in advanced cancer patients treated in a phase I clinic that focuses on targeted agents. PATIENTS AND
methodsAn analysis of database records of 1181 consecutive patients with advanced cancer who were treated in the phase I program starting 1 January 2006 was carried out.
resultsAll patients were treated on at least 1 of the 82 phase I clinical trials. Overall, 56 trials (68.3%) had only targeted agents, 13 (15.9%) only cytotoxics, and 13 (15.9%) targeted and cytotoxic agents. Rates of grade 3 and 4 toxicity that were at least possibly drug related were 7.1% and 3.2%, respectively, and 5 of the 1181 patients (0.4%) died from toxicity that was at least possibly drug related. The most common grade 3 or more toxic effects were neutropenia, thrombocytopenia, anemia, dehydration, infection, altered mental status, bleeding, vomiting, nausea, and diarrhea. Eastern Cooperative Oncology Group (ECOG) performance status greater than zero and use of a cytotoxic agent were selected as independent factors associated with serious toxicity.
conclusionPhase I trials of primarily targeted agents showed low rates of toxicity, with 10.3% of patients experiencing grade 3 or 4 toxicity and a 0.4% rate of death, at least possibly drug related.
Indexed as
Identifiers
What OpenQuestion holds
Registered trials
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.