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Comparative Study Of Patent Versus Locally Manufactured Chemotherapeutic Agents Used In Breast Cancer Patients.

By: Marriam Sharif | Dr. Muhammad Ovais Omer.
Contributor(s): Prof. Dr. Muhammad Ashraf.
Material type: materialTypeLabelBookPublisher: 2011Subject(s): Department of Pharmaoclogy & ToxicologyDDC classification: 1357,T Dissertation note: The pharmaceutical companies produce anticancer drugs after extensive research and development. Number of generics of doxorubicin, fluorouracil and cyclophosphamide has recently been introduced but their clinical efficacy and toxicity has not been documented in comparison to the brand leader product in Pakistan. Objective of this study was to compare the toxicity and efficacy of patent FAC (fluorouracil, doxorubicin and cyclophosphamide) chemotherapy combination versus local FAC manufactured by Pharmedic laborteries Pakistan. Study was conducted on two groups of patients having 15 patients in each group with breast cancer. Median age was 48 years in group "A" and 47 years in group "B". Patients in group "A" received patent FAC while group "B" received locally manufactured FAC. An inclusion and exclusion criterion was used for patient selection or rejection. Pre-treatment evaluation was done before the start of the chemotherapy. The dosage regimen and route of drug administration was same for both groups. A median number of two cycles of FAC chemotherapy was given in each group. Toxicity was evaluated with special reference to hepatic function, renal function, hematological profile and S-T changes in ECG on day 14 after the execution of FAC combination of chemotherapy and on day 21 before the start of second dose of chemotherapy according to Common Terminology Criteria for Adverse Events version 3.0 (CTCAE). Partial response was seen in 83% patients of group "A" and 60% in group "B". Two patients had stable disease in group "A" while three patients had stable disease and one patient had progressive disease in group "B". In this small series of patients group "A" patients treated with patent or branded FAC appeared to have better response rate at higher cost than group "B" patients treated with locally manufactured FAC combination of chemotherapy.
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Item type Current location Collection Call number Status Date due Barcode Item holds
Thesis Thesis UVAS Library
Thesis Section
Veterinary Science 1357,T (Browse shelf) Available 1357,T
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The pharmaceutical companies produce anticancer drugs after extensive research and development. Number of generics of doxorubicin, fluorouracil and cyclophosphamide has recently been introduced but their clinical efficacy and toxicity has not been documented in comparison to the brand leader product in Pakistan.
Objective of this study was to compare the toxicity and efficacy of patent FAC (fluorouracil, doxorubicin and cyclophosphamide) chemotherapy combination versus local FAC manufactured by Pharmedic laborteries Pakistan.
Study was conducted on two groups of patients having 15 patients in each group with breast cancer. Median age was 48 years in group "A" and 47 years in group "B".
Patients in group "A" received patent FAC while group "B" received locally manufactured FAC. An inclusion and exclusion criterion was used for patient selection or rejection. Pre-treatment evaluation was done before the start of the chemotherapy. The dosage regimen and route of drug administration was same for both groups.
A median number of two cycles of FAC chemotherapy was given in each group. Toxicity was evaluated with special reference to hepatic function, renal function, hematological profile and S-T changes in ECG on day 14 after the execution of FAC combination of
chemotherapy and on day 21 before the start of second dose of chemotherapy according to Common Terminology Criteria for Adverse Events version 3.0 (CTCAE).
Partial response was seen in 83% patients of group "A" and 60% in group "B". Two patients had stable disease in group "A" while three patients had stable disease and one patient had progressive disease in group "B".
In this small series of patients group "A" patients treated with patent or branded FAC appeared to have better response rate at higher cost than group "B" patients treated with locally manufactured FAC combination of chemotherapy.

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