Oral chemotherapy (OCT) represents a step forward in the management of MBC. It has gained an increased importance over the past years. In Egypt, cancer pts living in rural areas are often hours away from the closest treatment center. For these pts, OCT offers a convenient option and seems to be preferred. In first line MBC, oral vinorelbine (OV) with capecitabine (C) is an active full oral combination with response rates (RR) ranging from 48 to 70% in published data. Based on that, we evaluated efficacy and safety of OV-C in first line Her2 negative MBC pts.
26 patients were treated. Eligible pts had no previous treatment for their advanced disease. All pts had measurable disease relapsing after (neo) adjuvant AC ± taxane based treatment, WHO PS ≤ 2. Pts were treated with OV 60 mg/m2 D1, D8 for the first cycle and thereafter 80mg/m2 D1, D8 in combination with (C) 825mg/m2 twice daily from D1 to D14, every 21 days for 6 cycles. Primary endpoint (EP) was Disease Progression Rate (DPR) (%); secondary EPs were RR, 3 year survival (3YS) and safety.
All 26 pts were included in the analysis. Median age was 53.2 years (range 38.8-77.1); median WHO PS 1 (range 0-2). 58% of the pts were post-menopausal. All pts were treated with AC-based therapy in the (neo)adjuvant setting and 61.5% with an AC+taxane based treatment. 21 (81%) pts had 2 or more metastatic sites; liver (39%), bone (31%) and lung (31%) being the most frequent sites. A median of 4 cycles were given (range: 1-6) with a total number of 102 cycles delivered. ORR was achieved in 14 pts (54%), including 1 complete (4%) and 13 partial responses (50%). In pts who received 6 cycles of treatment, DPR was 40%, while 3 YS was 64.3%. G3-4 neutropenia was noted in 2 (8%) of pts. G3 hand-foot syndrome, nausea-vomiting and neuropathy were seen in 1 (4%), 2 (8%) and 1 (4%) respectively. Dose escalation was possible in 83% of the pts.
In addition to all the benefits of OCT including convenience and prolonged infusion-free survival, our results show that OV-C is also an effective and well tolerated regimen, making it an attractive option for our pts. OCT appears to be a valid alternative to I.V treatment especially for pts and countries where accessibility to treatment centers remains an issue.
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All authors have declared no conflicts of interest.