with noncumulative granulocytopenia and neurotoxicity as the main dose limiting toxicities. Gemcitabine plus vinorelbine have shown activity in anthracycline and taxane pretreated MBC in previous studies. However, elderly patients only constituted a minority in these trials, which made it difficult to extrapolate the chloroxine results to the whole patient group. Our study aimed to investigate the efficacy and safety of gemcitabine plus vinorelbine in elderly patients with anthracycline and taxane pretreated MBC, and to search for prognostic factors for disease control, PFS, and OS.
Patients and methods Eligibility criteria Eligibility criteria included the following: women, aged C65, histologically proven MBC with evidence of disease progression, at least one measurable lesion, Eastern Cooperative Oncology Group performance status of 0 to 2, normal hepatic, renal and bone marrow functions, expected pi3k life expectancy C3 months, previously treated with anthracycline and taxane based chemotherapy for metastatic disease or as adjuvant/neoadjuvant treatment, no central nervous system metastasis, no serious concurrent medical illness, no history of other malignancies, no simultaneous or previous radiotherapy on the assessable lesion, and no prior exposure to vinorelbine or gemcitabine. Patients had to have discontinued previous treatment for a minimum of 4 weeks. Concomitant radiotherapy or hormone therapy was not permitted. Multidimensional geriatric assessment was also performed at baseline, and only those fit patients were included into this study.
The study was approved by the Ethics Committees of Shandong Tumor Hospital and Institute. BCR-ABL Signaling Pathway Written informed consent was obtained from all patients before their entry into the study, and the study was carried out in accordance with Helsinki Declaration. Treatment plan This was a monoinstitutional, nonrandomized, prospective phase II study. All patients received gemcitabine and vinorelbine on days 1 and 8 every 21 days. All patients received 5 HT3 antagonist for emesis prophylaxis. Patients were scheduled to receive a maximum of 6 cycles, and chemotherapy was stopped in case of disease progression, patient refusal, or unacceptable toxicity. If the disease progressed, it could be treated with other chemotherapy regimens or endocrine therapy at the investigators, discretion.
Assessment of response and toxicity All measurable lesions were evaluated at baseline by spiral computer Everolimus 159351-69-6 tomography scans and were repeated every 2 cycles to document complete response, partial response, stable disease, or progressive disease according to Response Evaluation Criteria in Solid Tumors. Furthermore, specific organ response was also evaluated by RECIST, which only included the metastatic institutionalized lesion in this organ. When multiple lesions were identified, up to ten biggest measurable target lesions were taken to represent all the lesions involved. Tumor response per treatment line was also recorded. Adverse events were classified according to National Cancer Institute Common Toxicity Criteria version 3.0. For each patient and each kind of toxicity, the worst degree of toxicity throughout the treatment was recorded. Complete blood cell counts with differential counts analyses were repeated once to twice a week.