Clinical triale: phases and goals:

Phase I   ‧To determine the maximally tolerated dose of drug

             ‧To determine the schedule for administration

             ‧To define toxic effect to normal tissue

             ‧To generate data about the clinical pharmacology of the agent

Phase II  ‧To identify antitumor activity in a spectrum of common metastatic

               tumors

‧To explore ability to achieve increased rates or response with changes

                 of dose or schedule

             ‧To extend phase I data on toxicity

Phase III ‧To 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

push chemotherapy時應注意事項

1.  check IV Line通暢後，Full Run。

2.  push時勿反折set讓輸液及藥物一同注入血管。

3.  採slowly push並且push時間要大於十分鐘以上。

4.  病患若主訢疼痛則立即停止，並報告上級醫師。

5.  若發生外漏時，需立即停止IV注射，利用原針頭儘量反抽藥液，並push藥物如下：

當Adriamycin Epirubicin DTIC外漏時，則予push Jusomin & Solucortef。

當Vinblastin Vincristin外漏時，則予push solu-cortef。

6.  外漏患部，予冰敷。

※ 若打前臂時，手肘須放直，以避免血液循環不好

問題：術後寡尿或無尿？

1.    定義：寡尿（oliguria）：尿量24小時內少於400cc或每小時20cc以下。

無尿（anuria）：沒有尿排出。

2.    分類：

腎前（prerenal）：由於流血、腹泄、嘔吐、脫水等造成血容積減少、血壓下降，使腎血流供給不足，而致尿量減少。

腎（renal）：腎本身器質性傷害，可由缺氧或對腎有毒物質所引起。

腎後（post renal）：輸尿管、膀胱、尿道的阻塞，包括外科傷害。

· 尿液分析：

※ 術後或產後的無尿，表腎後阻塞或膀胱無力，而術後或產後幾天，才發生的寡尿，則表腎內部的因素。

3.    處理：術後無尿或寡尿：

(1)         合併血尿，疑ureter injury ® 打Lasix check urine output。

(2)         恥骨上部可摸到漲大的膀胱®foley阻塞。

(3)         噁心、嘔吐造成的腎前寡尿，應補充液體。

(4)         合併血壓下降，疑internal bleeding® check Hb/Hct及Sonar，給IVF challenge並備血。

(5)         OPD手術完，常因塞紗布compression造成無法解尿® remove紗布或intermittent catheterization。

(6) 產後無法解尿，常因neurogenic bladderintermittent catheterization。

問題1：cancer with ascites, complained of abdominal distension, pain.

Adranced stage of ovarian cancer常合併腹水，故產生腹脹不舒服，疼痛等症狀，臨床上處置：

1.    測量AC qd及BW qW1，注意腹圍體重之增加。

2.    monitor I/O q8h，注意每四小時尿量>100cc。

3.    不要只顧著給予Lasix拉出水份，而應評估病人的intracellular fluid量是否足夠：skin turgor, sunken eye. 適時給予輸FFP補充再打Lasix。

4.    測A/G ratio，若Alb £ 2.3 ® 給予Albumin 20% 1BT qd ´ 3天® 再測albumin。

5.    若已為terminal stage，則需要症狀處理。Check abd sona: 定位fluid最多的地方予以皮膚消毒，再用18G大針接bottle真空瓶子做ascite tapping，注意tapping量勿超過2000cc，並觀察病人血壓瞬間hypotension情況。

問題2：post radiation leg edema and swelling

cancer with radiation後術腳腫情形，臨床上要先區別是否因chronic venous insufficiency產生的lymphedema還是產生deep vein thrombosis (DVT)症狀，臨床上處理前者：先將肢體作局部抬高，加強靜脈回流。若是因lymphatic duct obstruction造成lymphedema，就要考慮病人是否已有淋巴轉移。透過影像學的診斷，有需要的話就可排CT-guided lymph node biopsy來做tissue proof。治療方法可能只有期盼chemoradiation therapy能讓腫瘤體積縮小，減少局部淋巴組織受壓機會。要確定DVT：先評估6"P"（¬疼痛­麻痺®蒼白¯感覺異常°溫度改變±無脈膊）之後，予以排deep vein Doppler來偵測深部靜脈血流有否阻塞。若已碓定是DVT須早期治療：Heparin 20000U至25000U in N/S 500cc run 20cc /hr，每次調整上下2cc/hr，來維持1NR ratio keep在1.5X至25X，並每6小時check APTT功能。

問題3：Cervical cancer with vaginal bleeding at ward.

CxCa的病人產生vaginal bleeding在臨床上多見於bulky exophytic tumor（> 4公分）及advanced cervical cancer病人。首先要給病人上婦科台作PV，予以評估bleeders是從哪裏出來的，以及血流速度，需要時給予set IV line並check Hb備血，有需要時甚至要check PT及APTT，需要時可給病人排transvaginal sonography，評估cervical mass大小及壓迫位置。若血流失很快或Hb¯8.0以下，可考慮直接輸P-RBC。對須予活動受限之患者，甚至予以on foley catheter並record I/O q8h來評估尿量

Neutropenia After Chemotherapy – 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)＜1000/uL, accompanied with fever (＞38℃)

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.