الفهرس 
Vinorelbine Plus Platinum Compared to Vinorelbine Plus Capecitabine In Treatment of Patients with Metastatic Triple Negative Breast Cancer Previously Treated with Anthracycline and Taxane. A Prospective Randomized Study.
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Abstract
Patients with mTNBC have a poor prognosis. As most patients with mTNBC have been treated with Anthracyclines and/or Taxanes, the effect of re-treatment by Anthracyclines and Taxanes may be unsatisfactory due to drug resistance. Platinum agents may be active in TNBC
Patient and methods: This is an open-labeled randomized prospective study that held at the National Cancer Institute (NCI), Cairo University. The study included 50 patients who received chemotherapy for metastatic triple negative breast cancer in the period between 1st July, 2016 and 1st July, 2017 and were previously treated with Anthracycline and Taxane. Patients were randomized to either Vinorelbine combined with Cisplatin (NP); Vinorelbine was administered at the dose of 25 mg/m2 I.V on days 1 and 8, Cisplatin 75 mg/m2 I.V over one hour on day 1 of the cycle. Vinorelbine combined with Capecitabine (NX); Vinorelbine was administered at the dose of 25 mg/m 2 I.V on days 1 and 8 and Capecitabine P.O (1,000 mg/m2 b.i.d., days 1-14), or The two regimen were repeated every 3 weeks for up to 6 cycles, until disease progression or unacceptable toxicity
Results: Median age of patients was 49 (30- 64) and 50 (30-64) years of NP and NX, respectively. Lung was the most frequent site of metastasis and was involved in 31 patients (62%), followed by liver in 24 patients (48%), non- regional lymph nodes in 16 patients (32%), bone in 13 patients (26%), chest wall in 12 patients (24%), and pleura in 7 patients (14%). Regarding the number of metastatic sites, 13 patients (26%) had one metastatic site, 29 patients (58%) had two metastatic sites, 8 patients (16%) had three or more metastatic sites. 22 patients (44%) had visceral metastasis, 8 patients (16%) had non-visceral metastasis, included bone, non-regional lymph nodes and chest wall metastasis and 20 patients (40%) had both visceral and non-visceral metastasis. 13 patients (26%) was previously treated with first line chemotherapy for metastatic disease. Median time to progression was 1.9 months longer in (NP) arm, than (NX) arm, 9.9 months (95% CI, 6.4- 13.3) vs. 8 months (95% CI, 5.2- 10.7), but not statistically significant (P. =0.22). Also, median survival was 1.5 months longer in (NP) arm, than (NX) arm, 12.5 months (95% CI, 10- 14.9) vs. 11 months (95% CI 8.8-13.2) but not statistically significant (P. =0.46). Best response rates (CR+ PR) were 40% the (NP) arm, included 1 complete response (CR) and 9 partial responses (PR), compared with the (NX) arm of 36% included 9 PR (P. =0.77). Stable disease was detected in 8 patients (32%) and 6 patients (24%) and progressive disease in 7 patients (28%) and 10 patients (40%) of NP and NX group, respectively. Both (NX) and (NP) regimens were tolerable, grade >3 adverse events reported in > 20% of patients, included nausea/ vomiting in 32 vs. 36 % (p=0.76), neutropenia grade 3 in 44 vs. 52% (P=0.57), neutropenia grade 4 in 4 vs. 12%, in (NX) and (NP) arms respectively, other grade 3 adverse events reported in < 20% of patients were anemia 16 vs. 12%, thrombocytopenia 12 vs. 4%, neuropathy 4 vs. 12%, anorexia 4 vs. 0%, diarrhea 0 vs. 4%, hypocalcemia 0 vs. 4% and creatinine increase 0 vs. 4%, in the (NX) and (NP) arms, respectively. A higher numerical incidence of thrombocytopenia, anemia, hypocalcemia and tinnitus were reported in the NP arm. Higher incidence of diarrhea, oral mucositis, hand-foot syndrome and elevation of transaminases were reported in the NX arm.