الفهرس 
Epidemiology and PathogenesisOnly 14 pages are availabe for public view
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Abstract
Metastatic breast cancer treatment incorporates the usage of a large magnitude of oncological therapeutics with chemotherapy considered as back bone of MBC management.3
The lack of a curative intent in the treatment of MBC due to absence of significant survival benefit with different chemotherapeutics led to adapting new rationale for selection of the appropriate chemotherapy based on individualized criteria including previous adjuvant therapy, better toxicity profile, QOL and cost effectiveness.222
This prospective phase II study included 40 patients with metastatic breast cancer pretreated with anthracyclines who presented to Radiation Oncology and Nuclear medicine Department, Ain Shams University Hospitals. This study took place during the period from December 2006 to June 2009. All patients had a bi-dimensionally measurable disease and did not receive any chemotherapy for metastatic disease.
All eligible patients fulfilling the inclusion criteria and after pretreatment assessments received gemcitabine 1250 mg/m2 on days 1 & 8 plus Cisplatin 75 mg/m2 on day 1 repeated every 3 weeks. Assessment of the response was done according to the WHO criteria every 2 cycles and the toxicity was assessed using NCI criteria for common toxicities every cycle.
The study objective tumor response was 57.89%, of which only 5.26% of patients (2 patients) achieved Complete Response (CR) and 52.63% of patients (20 patients) achieved Partial Response (PR). While 10.52% of patients (4 patients) showed Stationary Disease (SD) which made the Clinical benefit ratio (CR+PR+SD) equal to 68.41%. On the other hand 31.579% of patients (12 patients) had Progressive Disease (PD).
The regimen mean duration of objective response was 9.93 months + 4.3 months as standard of deviation and the median duration of response was 9.5 months ranging from 3 to 18 months with a 95% confidence interval of (8.07-11.83) months.
The regimen mean time to disease progression among responders was 12.6 months + 4.09 months as standard of deviation and the median time to disease progression was 12.5 months ranging from 5 to 20 months with a 95% confidence interval of (10.85-14.43) months.
The study population estimated mean survival was 17.83 months with 1.21 months as standard of error and a 95% confidence interval of (15.45 to 20.2) months. The estimated median survival was 22 months with 2.88 months as standard of error and a 95% confidence interval of (16.33 to 27.66) months.
The triple negative cancer phenotype and better performance status among the study patients were associated with better survival; however this survival advantage did not reach statistical significance.
The study regimen proved to be quite tolerable with the main hematological toxicities of this protocol were grade III anemia in 10% of patients, grade III/IV neutropenia in 20% of patients and grade III/IV thrombocytopenia in 17.5% of patients.
There were no grade IV non hematological toxicity observed within the study and the only grade III non hematological toxicities recorded in the study were grade III nausea in 25% of patients, grade III vomiting in 17.5% of patients, grade III fatigue in 15% of patients and grade III renal toxicity in 2.5% of patients.
The response and the toxicities of the protocol matched the results of other first line chemotherapeutic combinations which encourage direct comparison with phase III head to head trials.