We are performing a multicentric phase II study to evaluate the activity and the toxicity of the combination regimen EPl + NVB as first line chemotherapy in ABC patients. Treatments: EPI 90 mg/sqm i.v. bolus day 1, NVB 25 mg/sqm i.v. day 1 and 8: the courses are repeated every 21 days. The treatment is administered on day 1 if WBC ≥ 3,500 u/L and/or ANC ≥ 1,500 u/L and PLT ≥ 100,000 u/L. The dose of NVB on day 8 is modified as follows: G 2 neutropenia: 25% dose reduction, G 3 netropenia: 50% dose reduction, G 4 neutropenia: NVB omitted. In case of G 4 neutropenia lasting more than 72 hours or febrile neutropenia, G-CSF (300 ug/die subcutaneously) is administered until recovery and a 25% dose reduction is applied in the subsequent courses. Patient characteristics: so far 30 pts have been enrolled and 63% of the pts had visceral metastases: median age 64 years (range 39–72), PS 0 = 15, PS 1 = 6, PS 2 = 9. A total of 121 courses have been administered, with a median of 5 courses (range 1–7) for each patient. The worst toxicities (WHO grade) observed al nadir are: Table View table in article View Within Article The median duration of G 4 neutropenia is 5 days (range 2–7). The doses on day 1 were reduced at 75% in 30.5% of the courses while the treatment was delayed in 14.8% of the courses. On day 8 NVB was omitted in 14.8% of the courses and reduced as 75% or 50% in 23.1% and 8% of the courses respectively. G-CSF was administered in 15.7% of the courses. Seven episodes of febrile neutropenia not requiring hospitalization have been reported. Results: 25 pts are evaluable for response: the overall response rate is 68% (95% C.I. 46.5%–85%) with 3 CR, 14 PR, 6 SD. and 2 PD. Five pts are not evaluable: 4 pts too early, 1pt worsening PS. Conclusions: EPI + VNR is a very active combination regimen in ABC: however, considering the high pecentage of neutropenia on day 8 requiring NVB dose reduction, we have modified the original schedule and NVB is now administered on day 1 and 5. The study is ongoing
E., B., C., T., M., D.P., A., C., M., D.L., R., T., et al. (1996). Epirubicin (EPI) + navelbine (NVB) as first line chemotherapy in advanced breast cancer (ABC) patients (PTS): a multicentric phase II study. EUROPEAN JOURNAL OF CANCER, 32(1), s17-s17.
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|Titolo:||Epirubicin (EPI) + navelbine (NVB) as first line chemotherapy in advanced breast cancer (ABC) patients (PTS): a multicentric phase II study|
|Citazione:||E., B., C., T., M., D.P., A., C., M., D.L., R., T., et al. (1996). Epirubicin (EPI) + navelbine (NVB) as first line chemotherapy in advanced breast cancer (ABC) patients (PTS): a multicentric phase II study. EUROPEAN JOURNAL OF CANCER, 32(1), s17-s17.|
|Appare nelle tipologie:||1.1 Articolo in rivista|
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