Randomized Phase II Placebo-Controlled Trial of Maintenance Therapy Using the Oral Triple Angiokinase Inhibitor BIBF 1120 After Chemotherapy for Relapsed Ovarian Cancer
| العنوان: | Randomized Phase II Placebo-Controlled Trial of Maintenance Therapy Using the Oral Triple Angiokinase Inhibitor BIBF 1120 After Chemotherapy for Relapsed Ovarian Cancer |
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| المؤلفون: | Michael Merger, Gordon J. S. Rustin, Timothy J. Perren, Jonathan A. Ledermann, Helena M. Earl, Allan Hackshaw, Iain A. McNeish, Stan B. Kaye, Graham Temple, Malcolm Adams, Martin Gore, Hani Gabra, LE James, M. Persic, Gordon C Jayson |
| المصدر: | Journal of Clinical Oncology. 29:3798-3804 |
| بيانات النشر: | American Society of Clinical Oncology (ASCO), 2011. |
| سنة النشر: | 2011 |
| مصطلحات موضوعية: | Adult, Oncology, Cancer Research, medicine.medical_specialty, Indoles, Nausea, medicine.medical_treatment, Placebo-controlled study, Angiogenesis Inhibitors, Placebo, Disease-Free Survival, Maintenance Chemotherapy, law.invention, Placebos, Double-Blind Method, Maintenance therapy, Randomized controlled trial, law, Internal medicine, Antineoplastic Combined Chemotherapy Protocols, medicine, Humans, Adverse effect, Protein Kinase Inhibitors, Aged, Ovarian Neoplasms, Chemotherapy, business.industry, Middle Aged, Protein-Tyrosine Kinases, Surgery, Clinical trial, Female, Neoplasm Recurrence, Local, medicine.symptom, business |
| الوصف: | Purpose Inhibiting angiogenesis is one of the most promising avenues for new therapies for ovarian cancer. We investigated the efficacy and safety of a novel agent, BIBF 1120, a triple angiokinase inhibitor, after chemotherapy for relapsed disease. Patients and Methods We conducted a randomized, double-blind, controlled phase II trial in 83 patients who had just completed chemotherapy for relapsed ovarian cancer, with evidence of response, but at high risk of further early recurrence. The patients were randomly assigned to receive maintenance therapy using BIBF 1120 250 mg or placebo, twice per day, continuously for 36 weeks. End points were progression-free survival (PFS), toxicity, and overall survival. Results Thirty-six–week PFS rates were 16.3% and 5.0% in the BIBF 1120 and placebo groups, respectively (hazard ratio, 0.65; 95% CI, 0.42 to 1.02; P = .06). Four patients continued on BIBF 1120, including two patients for another year or more. The proportion of patients with any grade 3 or 4 adverse events was similar between the groups (34.9% for BIBF 1120 v 27.5% for placebo; P = .49; mostly grade 3). However, more patients on BIBF 1120 experienced diarrhea, nausea, or vomiting (mainly grade 1 or 2 and no grade 4). There was a higher rate of grade 3 or 4 hepatotoxicity in patients on BIBF 1120 (51.2%) compared with patients on placebo (7.5%; P < .001), but this was rarely of clinical significance, and patients continued with the trial treatment. A single-level dose reduction to 150 mg was made in 15 patients, all on active drug. Conclusion BIBF 1120 is well tolerated and associated with a potential improvement in PFS. The observed treatment effect is sufficient to justify further study within a large phase III trial. |
| تدمد: | 1527-7755 0732-183X |
| DOI: | 10.1200/jco.2010.33.5208 |
| URL الوصول: | https://explore.openaire.eu/search/publication?articleId=doi_dedup___::d5d1abe4df039182cceaa0aadc1b0f2e https://doi.org/10.1200/jco.2010.33.5208 |
| رقم الانضمام: | edsair.doi.dedup.....d5d1abe4df039182cceaa0aadc1b0f2e |
| قاعدة البيانات: | OpenAIRE |
| تدمد: | 15277755 0732183X |
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| DOI: | 10.1200/jco.2010.33.5208 |