Megestrol acetate versus metronomic cyclophosphamide in patients having exhausted all effective therapies under standard care
| Autor: | Marie Vanhuyse, F. Bonodeau, J.L. Cazin, Eric Dansin, Antoine Adenis, Stéphanie Clisant, M. Degardin, Laurent Mortier, Nicolas Penel, Desauw C, C. Fournier |
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| Rok vydání: | 2010 |
| Předmět: |
Male
Oncology Cancer Research medicine.medical_specialty sarcoma Palliative care Antineoplastic Agents Hormonal Cyclophosphamide medicine.medical_treatment complex mixtures Disease-Free Survival Drug Administration Schedule chemistry.chemical_compound Neoplasms Internal medicine Clinical Studies medicine Humans Antineoplastic Agents Alkylating Aged Chemotherapy business.industry Megestrol Acetate randomised phase II trial Palliative Care palliative chemotherapy Middle Aged Metronomic Chemotherapy Nitrogen mustard Surgery Clinical trial metronomic cyclophosphamide chemistry Megestrol acetate Megestrol Disease Progression Drug Evaluation Female business human activities medicine.drug |
| Zdroj: | British Journal of Cancer |
| ISSN: | 1532-1827 0007-0920 |
| Popis: | Background: To evaluate the antitumour activity and safety of metronomic cyclophosphamide vs megestrol acetate in progressive and advanced cancer patients having exhausted all effective therapies under standard care. Methods: Patients were randomly assigned to receive orally metronomic cyclophosphamide (50 mg b.i.d) or megestrol acetate (160 mg only daily) until intolerance or progression (RECIST 1.0). The primary efficacy end point was a 2-month progression-free rate (PFR2m). According to Optimal Simon's design and the following assumptions, namely, P0=5%, P1=20%, α=β=10%, the treatment is considered as effective if atleast 5 out of 44 patients achieved PFR2m. Results: Between September 2006 and January 2009, 88 patients were enrolled. Two patients experienced grade 3–4 toxicities in each arm (4%). One toxic death occurred in the megestrol acetate arm as a consequence of thrombosis. The metronomic cyclophosphamide arm reached the predefined level of efficacy with a PFR2m rate of 9 out of 44 and a PFR4m rate of 5 out of 44. The MA arm failed to achieve the level of efficacy with a PFR2m of 4 out of 44 and a PFR4m of 1 out of 44. The median overall survival was 195 and 144 days in the metronomic cyclophosphamide arm and megestrol acetate arm, respectively. Conclusion: Metronomic cyclophosphamide is well tolerated and provides stable disease in such vulnerable and poor-prognosis cancer patients. This regimen warrants further evaluations. |
| Databáze: | OpenAIRE |
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