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Notes: Abstract Purpose:To assess the antitumor efficacy and safety of avinorelbine and cisplatin combination in patients with metastatic breastcancer previously treated with anthracyclines. Patients and methods:Fifty-three patients with assessablemetastatic breast cancer with previous exposure to anthracyclines (adjuvantn= 6, palliative n= 47) were studied. Cisplatin 75mg/m2 on day 1 was given followed by 25 mg/m2vinorelbine (VNR) on days 1 + 8, in a five-min i.v. infusion. Courses wererepeated every three weeks on an outpatient basis. Treatment continued untildisease progression, excess toxicity or patient refusal. Patients wereclassified according to their response to anthracyclines: anthracyclinerefractory patients were patients who had never responded under ananthracycline regimen. Anthracycline resistant patients were either metastaticpatients who progressed within four months of completing anthracycline-basedchemotherapy or patients who progressed within six months of completion of ananthracycline adjuvant treatment. Patients who progressed four months afterthe end of an anthracycline regimen in metastatic setting or six months afterthe end of an anthracycline regimen in adjuvant setting were considered aspatients previously treated with anthracyclines and were called `relapsed'. Results:Four patients (8%) achieved a complete response(CR) and twenty-two patients (41%) achieved a partial response (PR)with an overall response rate (OR) of 49% (95% confidenceinterval (CI): 35–63). Stable disease (SD) was observed infive patients (9%), twenty-two patients had progressive disease (PD).Responses according to previous sensitivity to anthracycline were as follow:5 refractory patients achieved a PR from 14 patients (36%). Seven ofsixteen resistant patients responded (44%), six with PR and one withCR. Among 23 `relapsed' patients, 14 responses were observed (61%),with 3 CR and 11 PR. There was no statistical difference in RR among the threegroups. The median duration of response for all patients was 7 months, themedian time to progression (TTP) 5 months and median overall survival 12months. All patients were assessed for toxicity. The main toxicity was neutropeniagrade 3 and 4 in 49% of patients. Febrile neutropenia requiringhospitalization was uncommon (2 patients). There were no treatment relateddeaths. Despite potential overlapping neurologic toxicities of the two drugs,only eight patients (15%) developed neuropathy, which was, however,mild (grades 1 and 2). Conclusions:This cisplatin–VNR regimen is well toleratedand active in patients who failed anthracyclines. The response rate, TTP andsurvival data are engouranging and indicate that cisplatin–VNR may havea place as second-line treatment alternative to taxanes or other less activeregimens. If these results can be verified in multi-institution trials, thiscombination of drugs would merit investigation as first-line therapy in thispatient population.