Prostate Cancer-5

Basic Information
This is routine information to identify the patient. It is, in essence, name, rank, and serial number. It is very basic data that often fall into administrative details, for example, age, birthdate, full address information, spouse or significant other's name, and the names of physicians with their specialty and contact information. It should also include any medical diagnoses that are likely to have some interactive role with PC.


Prediagnostic HistoryWhen we talk about the diagnosis of any kind of cancer, we refer to the microscopic diagnosis obtained after a biopsy or sampling of tissue. Data in the prediagnostic category relate information about biological expressions of PC that precede the diagnosis of PC. Such information might include the dates and PSA values prior to a diagnosis of PC. It might also include results of the free PSA percentage, calculations of PSA velocity (PSAV), and PSA doubling time (PSADT).


Diagnosis and Staging
This movement relates key baseline information of prognostic significance. This includes the baseline PSA and PAP, the Gleason score, gland volume, core involvement, and clinical stage. The Gleason score must be validated by an expert in PC pathology. This section of the medical record also contains the critical biologic expressions that are used in the algorithm section. Examples of various medical inputs in this category are shown below in Table 3.

Therefore, to assess the reality of the military campaign, a good intelligence officer will gather information crucial to understanding the reality of the battle being faced. This part of the winning strategy overlaps with early recognition of the enemy and assessment of enemy strength (and weakness).

For example, in the clinical data shown in Table 3, the patient's baseline PSA (bPSA) of 35 already suggests that we have a minimal chance that the PC is confined to the prostate. The high level of PSA is equivalent with a large tumor volume. These findings are unfortunately reinforced by those of the DRE where the clinical stage was T3a (indicating extracapsular extension on one side of the prostate), along with the findings showing that of the six biopsy cores taken, all six showed PC. Moreover, the percentage of individual core involvement was also very high with one core showing 100% involvement of PC and the remaining five cores having a total of 220% involvement, for an average core involvement of these five cores of 44%.72 Again, this is indicative of a large tumor volume.

The Narayan stage assesses whether the microscopic findings of PC were limited to one side of the prostate gland (B1) versus both sides (B2). Again, the B2 Narayan stage reinforces our understanding of the enemy insofar as a larger tumor volume.73 This is clearly not going to be a situation where watchful waiting is a rational consideration or one where the first tactic would involve surgery, radiation therapy, or cryosurgery. The PAP blood test is above 3.0, and this finding would point to a high risk of failure from RP74 or of progression after radiation therapy, even with newer advances involving 3D Conformal Radiation Therapy (3DCRT) or Intensity Modulated Radiation Therapy (IMRT) with or without seed implantation.75

The gland volume (GV) has relevance to what therapy is selected, as does the American Urologic Association (AUA) symptom index--an objective scoring system that quantifies lower urinary tract symptoms.

The gathering of this medical informationallows a clearer understanding of what the patient's outcomeis. In a situation that is far more favorable than this one, a patient at the time of diagnosis of PC presents with a PSA of 9 ng/mL with a Gleason score of (3,3) that has been read by an expert in PC pathology. His clinical stage based on the DRE reveals nothing to suggest PC, i.e., T1c clinical stage. Moreover, he has a favorable percentage of PC core involvement with less than 50% of the biopsy cores sampled showing cancer.76

However, his GV is extremely large at 80 cc. Too often, at the time of the patient's diagnosis via transrectal ultrasound of the prostate, the GV is not recorded by the urologist. The patient's assessment is incomplete because the GV is a critical issue in PC diagnosis and management.77-80 The large GV in this example would adversely affect the outcome of the patient undergoing treatment with radiation therapy (external beam and/or brachytherapy) or cryosurgery.81-85 This would be especially true in the setting of an AUA symptom index greater than 20, a maximum urine flow of 10 mL per second or less, and even a GV greater than 40 grams or cc.86 However, controversy in this area does still remain.87

These data inputs are evolving as we understand more and more about the biological story and what is most important for a successful clinical outcome.


Data Used for Algorithms and Nomograms
The gathering of this medical information is important to supply at baseline prior to any treatment. This information is critical in the treatment strategy selected by the PPP team. The calculations involved in such algorithms have been simplified by the use of software programs such as PC Tools I and II on websites such as the PCRI (Prostate Cancer Research Institute) website at www.pcri.org and the Kattan nomogram site at http://www.mskcc.org.

The key baseline data necessary for many of the standard algorithms/nomograms currently in use include the data inputs mentioned in the Diagnosis and Staging section. Other data that may become available during the PC patient's course are applicable to additional algorithms involving PSA recurrence after surgery or radiation. This would involve Gleason score at radical prostatectomy (RP), ploidy (DNA analysis) at RP, presence or absence of lymph node involvement at RP, PSA velocity and PSA doubling time after RP, time to PSA recurrence after RP, history of use of ADT (androgen deprivation therapy), dose of RT employed, and other data. The risk assessment provided by the use of algorithms and nomograms is discussed in more detail in Section 5, Risk Assessment of the PC Patient.


A Detailed Clinical Chronological Review (DCCR)In my opinion, this is the most important part of the medical record for the PC patient. This is because the DCCR represents an incorporation of all prior information into a medical story that is clear to the physician, the patient, and his partner (PPP). The DCCR uses a combination of a timeline and information relating to major events to present the key crossroads in the patient's history as it relates to PC. Treatments are designated as "Rx" and are bolded for emphasis.

Ideally, the patient and his partner as well as the physician add information to this part of the PC medical record, encouraging its use as an important navigational tool for the entire team. Using the DCCR as a means of conveying medical information focuses energy on areas of concern. This avoids generic suggestions, for example, operate, radiate, or do nothing, and thus it engenders the need for substantial evidence to support the choice(s) of particular evaluations and/or treatments. Such an approach would help to improve the outcome of the patient and ease his path to that outcome. This is the essence of good treatment strategy. You must do your homework. All of this is illustrated in the Primer.


Flow Sheets (A Powerful Graphic Tool that Warrants Emphasis)
Flow sheets are the Rosetta Stone in understanding the patient's response to treatment. Flow sheets, compulsively maintained, detail the treatment strategy and its response. The flow sheet, accurately kept by the physician, and ideally understood by the patient and his partner, is the nitty-gritty worksheet that conveys the success or lack of success of Treatment.

Flow sheets are critical to the management of any patient, no matter what illness the PPP may encounter. Unfortunately, the concepts involved with flow sheets although simple, are often totally missed by many doctors. The flow sheet employs the concept of time in relation to treatment and correlates this with parameters (indicators) of response.

Simply put, the flow sheet gives a timetable of the patient's medications and correlates them with laboratory and radiological studies (response parameters) to point out any changes reflecting either the presence or absence of the desired biological effect. At the same time, body system functions are monitored using laboratory tests. This monitors any developing drug toxicity or tissue damage that may be due to the treatment and/or the disease. An example of this would be John Doe treated with Flutamide and Lupron for metastatic PC. An example of his flow sheet is shown in part in Tables 4A and 4B (and in full on page F37 of the Primer).

The Flow Sheet Objectifies Medical Intel
This is a hypothetical example of a flow sheet that should be employed in the care of all patients, whether or not they have PC. This objective approach to care presents the variables of TIME and MEDICATIONS or other TREATMENTS used in the context of PARAMETERS OF OUTCOME. Such an objective correlation enables us to better decide whether or not the treatment is a success. The inclusion of critical laboratory data that reflect whether the medical campaign is going as planned is shown in Part A of this form. Additional parameters to tell us about outcomes that might relate to radiological and/or pathology studies are shown in Table 4B.

Month/day 2/1 2/28 3/28 4/25 5/23
Flutamide 250mgTID 3 3 Hole Resume
Lupron 7.5 mg 7.5mg 7.5mg 7.5 mg 7.5 mg
Proscar 5mg BID 3 3 3 3
Fosamax 70mg/wk 3 3
Procrit 10K qWK 3 Hold 3 3
Vasotec 5 mgQD 3 3 3 3
Prilosec 20mgQD 3 3 3 3
Silymarin 200mgQD

WBC 5.5 5.9 5.7 6.3 6.0
PMN'SLYMPHS | | | | |
HCT% 37 36 39 37 35
PLATELETS 180 212 188 234 177
Na+|K+ | | | | |
BUN|CREAT | | | | |
GLUCOSE/ LDH
CA++|PHOS-- | | | | |
Albumin| | | | | |
Globulin
Bilirubin| |456 |245 |188 |143 |92
AlkPHOS
SGOT|SGPT 18|18 20|24 26|33 55|78 35|40
PSA|PAP 122|29 60|12 14|2.5 0.5|2.2 <0.05|2.0
TESTO|SHBG 345| <20| <20| | |
PYRILINKS-D (Dpd) 4.3 6.5 4.0
DHEA-S| 89|125 | | | |
Androstenedione

Prolactin| 8.9|55 | |<30 | |
DHT
CEA CGA 2.0 4.8 7.8 | | | |
NSE
Weight 160 162 163 168 170

The Flow Sheet (Back Side)
The reverse side of the flow sheet is shown in part. It reflects the same concept of using a parameter--a biological endpoint--as a measuring stick to gauge the results of the selected therapy. Again, this objectifies what is being done and reduces personal bias. The flow sheets, if attended to correctly and diligently, answer this question: "Is the treatment being used on me working?"
Chest X-Rays
1/23/01: normal
9/17/01: normal
Endorectal MRI + Spectroscopy; Plain MRI, CT (Specify)
CT HEAD:
CT CHEST:
CT Abdomen/ Pelvis: 9/17/01 no lymph node enlargement in pelvis or abdomen; liver normal
ENDORECTAL MRI + SPECTROSCOPY: 1/15/01: gland volume 24 cc, no ECE, concordant MRI and MRS abnormalities in R and L base, R midgland and R apex. No regional nodes seen.
Ultrasound (Including TRUSP)
12/22/99: gland volume 30 cc; hypoechoic lesions in R and L base; capsule intact, no SV involvement
Nuclear Medicine (BS = bone scan; PS = ProstaScint scan; PET = positron emission tomography)
BS #1: 1/22/01: no abnormal uptake in bones, normal scan
Pathology Reports (Include Pathology Number)

Note how the flow sheet acts as a treatment record and how the columns show the time-related effects of therapy on the CBC (hematocrit dropping), which was due to androgen deprivation therapy (ADT). The desired therapeutic effect on the PSA is also clearly shown. The worsening liver function test (SGPT, a liver enzyme) is forecasting problems secondary to liver toxicity, which may be due to Flutamide. The flow sheet is declaring this in advance because the physician or the patient can see the test result going from low normal to high normal before entering the flagged abnormal range. Alkaline phosphatase (due to bone metastases) is showing a response to ADT and is falling from the initial 456 toward the normal range (= 125). Even after reaching the normal range, the alkaline phosphatase continues to drop lower. The concepts here relate to baseline, trends, the issue of changes within the normal range, and treatment versus response parameter.

The empowered patient and partner obtain hard copies of any laboratory data generated in the physician's office along with copies of any flow sheets. The team is encouraged to carefully review and to understand these forms. A true physician welcomes such a request. The same applies to all consultation reports.


Summary/Surveillance Sheets
Lastly, as part of medical event recording, an overall assessment of the patient's total health is needed. While the patient may be having a great response to his PC treatment, his bone mineral density may be worsening.88 If the medical campaign is to be successful, the battle needs to be won on all fronts.

Table 5 is an example of what I have used in medical practice to monitor patients. It makes little sense to put a patient through intensive treatment for PC if his cardiovascular status is deteriorating89 or if he has a second malignancy90 that has gone undiagnosed because of a tunnel-vision approach to the patient's care. Table 5 presents this concept of surveillance and reminds the PPP when the last such test was performed. The patient's flow sheets would show the actual results of such examinations.



Summary/Surveillance Form
Procedure Date Date Date
Physical Exam
DRE
Past/Fam/Soc Hx
Chest X-ray
EKG
Urine analysis
OB X 3
Colonoscopy
Pyrilinks-D
Bone density
ProstaScint
Bone Scan
Stress EKG
Eye Exam
Skin Exam
US-TSH
Homocysteine
Ferritin
Flu Vaccine
Pneumovax

What Does This Mean for Patients?
To win the battle against PC, you must obtain information that is highly important in deciding the outcome of this biological interaction. Medical intelligence (Intel) is as important to the survival of the patient as military intelligence is to the survival of the soldier and the success of the campaign.
The PC patient and partner must again act as a team, reinforcing each other with their growing knowledge. In time, for the paradigm to be fulfilled, they must share this newfound knowledge with the community of other PC patients and partners.
Being aware of the importance of medical Intel gathering and how it is organized, the patient and partner can work together with their fellows to extend influence that will affect the nature of information gathering and record keeping done by physicians.
In an enlightened world, and certainly in a society with today's technological advances, physicians should be graded on their care of patients. This should be carried out by an on-site task force that surveys the medical records and the actual hands-on care delivered by physicians to their patients in the medical office and in the hospital.