+ Resolve Article
+ Follow Us
Follow on FacebookFollow on Facebook
Follow on TwitterFollow on Twitter

+ Translate
+ Subscribe to Site Feed
GeoScience Most Shared ContentMost Shared Content

Phase Ib study of ixabepilone (I) in combination with epirubicin (E) in women with metastatic breast cancer

, : Phase Ib study of ixabepilone (I) in combination with epirubicin (E) in women with metastatic breast cancer. Journal of Clinical Oncology 26(15_suppl): 1058-1058

NlmCategory="UNASSIGNED">1058 Background: Ixabepilone and anthracyclines are effective in the treatment of breast cancer. The primary objective of this phase I trial was to determine the maximum tolerated doses of the combination of epirubicin and ixabepilone. The safety, tolerability, pharmacokinetic and antitumor activity of epirubicin and ixabepilone in combination administered every 3 weeks was assessed in women with advanced breast cancer. Eligible pts with a cumulative dose of ≤ 300 mg/m2 for doxorubicin, ≤ 450 mg/m2 for epirubicin and ≥ 3 months of progression free interval after adjuvant anthracycline were enrolled. Three dose levels were explored in a 3 + 3 dose escalation design: epirubicin/ixabepilone at 75/25, 75/30 and 75/35 mg/m2. PK blood samples were collected during cycle 1 and estimated by non-compartment analysis. Twenty-six pts have been enrolled to date, median age was 54 yrs (33-68). Eight pts received prior chemotherapy in adjuvant setting. Safety data are preliminary and available on 23 pts across the 3 dose levels for a total of 130 cycles (median 6 cycles, range 2-8). Neutropenia was the dose limiting toxicity, occurring in 1/6 pts at 75/25, 1/11 at 75/30 and 2/6 at 75/35 mg/m2. This included 1 pt with febrile neutropenia and 3 pts with grade 4 neutropenia of ≥ 5 days duration. Enrollment at 75/30 mg/m2 dose level is continuing. The most frequent grade 3 or 4 AE was neutropenia (4/23 and 15/23 respectively). Nonhematologic grade 3 and 4 toxicities were infrequent and included 2 pts with grade 3 neuropathy and 3 pts with grade 3 vomiting. No deaths were reported. No pharmacokinetic interaction was observed. Responses were seen at all dose levels tested. Of twelve women with measurable disease 10 achieved a partial response, one stable disease and one progressed. Six pts with non measurable disease had clinical benefit and/or no disease progression. Based on these preliminary data the recommended dose level of epirubicin 75 mg/m2 and ixabepilone 30 mg/m2 has a favourable toxicity and efficacy profile and warrants further investigation. [Table: see text].


PMID: 27951017

Other references

Zhu, D.-Shan.; Iversen, S.A., 1990: Anchovy and other fish resources in the Yellow Sea and East China Sea, November 1984 - April 1988. Marine Fisheries Research (Shandong). Jan; 11: 1-143

Grigoryan, M.G., 1975: Floristic finds in the khosorv reserve ussr. A study of the flora of the Khosrov reserve in the Armenian SSR [USSR] revealed the following rare and new species [marked *] for the Armenian SSR and the USSR: *Micromeria marifolia, *Saxifraga tridactylites, *Paliurus spina-christi, Astragalus g...

Matsuda M.; Haga S.; Fukushima H.; Kitao H.; Sugishita Y.; IIda K.; Ito I.; Koseki S., 1985: Relation between left ventricular wall thickness and hemodynamic responses to isometric exercise in weight lifters. Japanese Circulation Journal 49(8): 876

Kopf, A.W.; Bart, R.S., 1982: Tumor conference #43: penile lentigo. Journal of Dermatologic Surgery and Oncology 8(8): 637-639

Passmore, C.M.; McElnay, J.C.; Rainey, E.A.;, P.F., 1986: Excretion of metronidazole and its hydroxy-metabolite in human milk. Venous blood samples and milk samples were collected on days 3 and 4 of therapy from 12 women receiving metronidazole at 400 mg 3 times daily; blood was collected from the breast-fed infants on day 4 of therapy. Maternal plasma metronidazole peake...

Chen, B.Y.; Jin,; Chen,; Zhu, Y.C.eng; Chi, Z.Q.ang, 2001: Analgesic activity and opioid receptor selectivity of stereoisomers of ohmefentanyl isothiocyanate. Ohmefentanyl is a very potent and highly selective agonist for mu-opioid receptors. We now study analgesia, in vitro activity and opioid receptor affinity of the stereoisomers of ohmefentanyl isothiocyanate. We found that some isomers of ohmefenta...

Bunkers, G.; Strobel, G., 1991: A proposed mode of action for green island induction by the eremophilane phytotoxins produced by Drechslera gigantea. Physiological and molecular plant pathology 38(5): 313-323

Radhakrishnan A.N., 1981: Intestinal absorption of peptides some recent developments. Indian Journal of Biochemistry & Biophysics 18(4): 1

Cros, A.; Mcclanahan, T., 2003: Coral transplant damage under various management conditions in the Mombasa Marine National Park, Kenya. Two coral species, Porites palmata and Porites lutea, were transplanted into three distinct management areas adjacent to the Mombasa Marine National Park, Kenya: A no-fishing MPA; a gear-restricted reserve with no beach seining and a reserve with...

ElGoresy A.; Bell P.M.; England J.L., 1969: Synthesis of beta Cr (sub 2) FeS (sub 4) at 35 kb. Year Book - Carnegie Institution of Washington Pages 197-199