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    Chemotherapy  ¤Æ¾ÇªvÀø   

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Clinical triale: phases and goals:

Phase I   ¡ETo determine the maximally tolerated dose of drug

             ¡ETo determine the schedule for administration

             ¡ETo define toxic effect to normal tissue

             ¡ETo generate data about the clinical pharmacology of the agent

Phase II  ¡ETo identify antitumor activity in a spectrum of common metastatic

               tumors

¡ETo explore ability to achieve increased rates or response with changes

                 of dose or schedule

             ¡ETo extend phase I data on toxicity

Phase III ¡ETo compare the investigational therapy against an established form

  of treatment in previously untreated patients

 

Performance Status

Karnofsky performance status

100¡×Normal; no complaints; no evidence of disease

90¡×Able to carry on normal activity; minor signs or symptoms of disease

80¡×Normal activity with effort; some sign or symptoms of disease

70¡×Cares for self but unable to carry on normal activity or do active work

60¡×Requires occasional assistance but is able to care for most personal needs

50¡×Requires considerable assistance and frequent medical care

40¡×Disabled; requires special care and assistance

30¡×Severely disabled; hospitalization indicated, although death not imminent

20¡×Very sick, hospitalization necessary; active support treatment necessary

10¡×Moribund; fatal process progressing rapidly

0¡×Dead

 

Zubrod status

0¡×No symptoms

1¡×Symptoms; fully ambulatory

2¡×Requires nursing assistance or equivalent; bedridden less than 50% of normal day

3¡×Bedridden more than 50% of normal day

4¡×Bedfast

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Neutropenia After Chemotherapy ¡V With or Without Fever

 

Definition

Neutropenia is the most frequent cause of leukopenia.  Neutropenia is termed severe if there are fewer than 500 neutrophils (polymorphonuclear leukocytes and band leukocytes) per microliter, moderate if there are between 500 and 1000 neutrophils per microliter, and mild if there are 1000 to 2000 cells per microliter.

 

Febrile neutropenia is defined as absolute neutrophil count (ANC)¡Õ1000/uL, accompanied with fever (¡Ö38¢J)

 

Virtually all cytotoxic drugs (chemotherapeutic agents) cause a profound transient neutropenia 10 to 14 days after therapy.

 

Symptoms

1.     Mild and moderate neutropenias may be clinically asymptomatic.  When the neutrophil count falls below 1000 cells per microliter, there is a progressively increasing susceptibility to infections with bacterial and fungal pathogens.  Infections are uncommon in patients with absolute neutrophil counts greater than 500.

2.     Symptoms are usually associated with infection.  Common localizing signs of inflammation may be absent.

3.     Common pathogens include gram-negative bacilli, Staphylococcus aureus, S. epidermidis, Candida species, and Aspergillus species.

4.     The most likely source of bacteremia in a neutropenic patient with a fever and without an indwelling line is endogenous flora of the mouth and gut.


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