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Gemcitabine in combination with capecitabine in metastatic breast carcinoma: A phase I-II study



Gemcitabine in combination with capecitabine in metastatic breast carcinoma: A phase I-II study



Journal of Clinical Oncology 23(16_Suppl): 870-870



NlmCategory="UNASSIGNED">870 Background: Gemcitabine (G) and Capecitabine (C) are both actives in metastatic breast cancer (MBC). To define the maximum tolerated dose of this combination we designed a phase I study with escalating dose of G (from 750 mg/m2 up to 1500 mg/m2 with increments of 250 mg/m2) at day 1 and 8 every 3 weeks combined with C 2000 mg/m2/die on days 1 to 14. To better investigate the activity and toxicity at the recommended doses, a phase II study has been subsequently performed in patients (pts) pre-treated with anthracyclines and taxanes. 12 pts have been enrolled in the phase I study. Dose escalation of G reached the maximum dose planned without observing dose-limiting toxicities. In fact, only 6 pts experienced a grade 2 (WHO) toxicity (anaemia, neutropenia, N/V, mucositis). So far, 21 pts have received G at the recommended dose of 1500 mg/m2 and C 2000 mg/m2/die for a total of 125 cycles with a median of 6 cycles for pt (range1-12). Main characteristics included: median age 51 (range 35-71), median PS 1 (range 0-2) and median sites of metastasis 2 (range 1-4) (14 pts liver, 9 lung, 12 skin/lymphnodes and 14 bone). No G3-4 non-haematological toxicities have been observed except for a G3 dermatitis in one pt. G2 toxicities are diarrhoea, nausea/vomiting and mucositis in 2.4%, 4.8% and 1.6% of cycles, respectively. A reduced dose of G (75% of total dose) was administered at day 8 in 4.8% of cycles because of G3 neutropenia. A G2 neutropenia was observed in 11% of cycles. So far 22 pts are evaluable for response (12 pts in the phase I and 10 in the phase II): 9 pts (41%) obtained an OR (5 CR and 4 PR), 12 (55%) a SD and 1 (4%) progressed. Median duration of response is 5+ months (range 2-13) and median progression-free survival is 7+ months (range 2-16). The combination we used shows a favourable toxicity profile and promising activity in pre-treated MBC. Accrual is continuing to include 39 pts in the phase II study.(Partially supported by Fondazione ARCO) No significant financial relationships to disclose.

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Accession: 057920977

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PMID: 27945236


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