Trial reportClinical cancer research : an official journal of the American Association for Cancer Research2009
A multi-institutional phase II study of the efficacy and tolerability of lapatinib in patients with advanced hepatocellular carcinomas.
Trial report in Clinical cancer research : an official journal of the American Association for Cancer Research, 2009. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT00107536 (A Phase II Study of Efficacy and Tolerability of GW572016 in Patients With Advanced Hepatocellular and Biliary Carcinomas), which is not on this map. Cited by 45 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.
A Phase II Study of Efficacy and Tolerability of GW572016 in Patients With Advanced Hepatocellular and Biliary Carcinomas
Who cites it
45 citing papers in PubMed, 2 syntheses or guidelines pooled it, 114 citations in OpenAlex.
- Pruritus in patients treated with targeted cancer therapies: systematic review and meta-analysis.Journal of the American Academy of Dermatology · 2013Pooled it
- Hemorrhagic events in hepatocellular carcinoma patients treated with antiangiogenic therapies.Hepatology (Baltimore, Md.) · 2013Pooled it
- Targeting AFP-RARβ complex formation: a potential strategy for treating AFP-positive hepatocellular carcinoma.Molecular diversity · 2025Article
- Mechanisms and therapeutic targets of ErbB family receptors in hepatocellular carcinoma: a narrative review.Translational cancer research · 2024Review
- New and Old Key Players in Liver Cancer.International journal of molecular sciences · 2023Review
- Article
- Synthesis and Anticancer Evaluation of 4-Anilinoquinolinylchalcone Derivatives.International journal of molecular sciences · 2023Article
- Small Molecule Inhibitors for Hepatocellular Carcinoma: Advances and Challenges.Molecules (Basel, Switzerland) · 2022Review
- Major Hepatectomy En Bloc with Cava Vein Resection for Locally Invasive Caudate Lobe Hepatocarcinoma.Healthcare (Basel, Switzerland) · 2021Article
- Insights into Growth Factors in Liver Carcinogenesis and Regeneration: An Ongoing Debate on Minimizing Cancer Recurrence after Liver Resection.Biomedicines · 2021Review
- Screening potential prognostic biomarkers for portal vein emboli in patients with hepatocellular carcinoma.Journal of gastrointestinal oncology · 2021Article
- Acquired resistance to third-generation EGFR-TKIs and emerging next-generation EGFR inhibitors.Innovation (Cambridge (Mass.)) · 2021Review
- Salmonella-innovative targeting carrier: Loading with doxorubicin for cancer treatment.Saudi pharmaceutical journal : SPJ : the official publication of the Saudi Pharmaceutical Society · 2020Article
- Molecular Targets, Pathways, and Therapeutic Implications for Hepatocellular Carcinoma.International journal of molecular sciences · 2020Review
- ErBb Family Proteins in Cholangiocarcinoma and Clinical Implications.Journal of clinical medicine · 2020Review
- Molecular targeted and immune checkpoint therapy for advanced hepatocellular carcinoma.Journal of experimental & clinical cancer research : CR · 2019Review
- The future is now: beyond first line systemic therapy in hepatocellular carcinoma.Translational cancer research · 2019Review
- INPP4B inhibits cell proliferation, invasion and chemoresistance in human hepatocellular carcinoma.OncoTargets and therapy · 2019Article
- Mathematical modeling identifies optimum lapatinib dosing schedules for the treatment of glioblastoma patients.PLoS computational biology · 2018Article
- An investigation of the role of gene copy number variations in sorafenib sensitivity in metastatic hepatocellular carcinoma patients.Journal of Cancer · 2017Article
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
19 authors at 7 institutions in 1 country.
Funding
Abstract
backgroundHepatocellular carcinoma (HCC) is on the rise worldwide. HCC responds poorly to chemotherapy. Lapatinib is an inhibitor of epidermal growth factor receptor and HER2/NEU both implicated in hepatocarcinogenesis. This trial was designed to determine the safety and efficacy of lapatinib in HCC.
methodsA Fleming phase II design with a single stage of 25 patients with a 90% power to exclude a true response rate of <10% and detect a true response rate of > or =30% was used. The dose of lapatinib was 1,500 mg/day administered orally in 28-day cycles. Tumor and blood specimens were analyzed for expression of HER2/NEU/CEP17 and status of downstream signal pathway proteins.
resultsTwenty-six patients with HCC enrolled on this study. Nineteen percent had one prior therapy. Most common toxicities were diarrhea (73%), nausea (54%), and rash (42%). No objective responses were observed. Ten (40%) patients had stable disease as their best response including six (23%) with stable disease lasting >120 days. Median progression-free survival was 1.9 months and median overall survival was 12.6 months. Patients who developed a rash had a borderline statistically significant longer survival. Tissue and blood specimens were available on >90% of patients. No somatic mutations in EGFR (exons 18-21) were found. In contrast to our previous findings, we did not find evidence of HER2/NEU somatic mutations. PTEN, P-AKT, and P70S6K expression did not correlate with survival.
conclusionsLapatinib is well-tolerated but seems to benefit only a subgroup of patients for whom predictive molecular or clinical characteristics are not yet fully defined.
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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.