Introduction / Welcome

Nikole –

I am being treated by Dr. Davendra Sohal (he is treating 15-20 patients with CC and similar liver cancers) at the Cleveland Clinic. I also met once with Dr. Bassam Estfan from the Clinic. Both are very dry, almost removed emotionally, but I have good feelings about them. They strike me as very knowledgeable. My previous onc was at the Seidman Cancer Center in Mentor, OH. She specializes in women’s breast cancer. That Center has seen only 4 CC patients in the last 3 years. She has run out of treatment options and nothing else to offer. Dr. Sohal had a possible trial (my platelets were too low to get into it) but also two more chemo options, one of which I am using now.

I never got the info I requested about University Hospitals and their CC experience.

I would not rule out Mayo in Mn or MDA in Tx (Dr. Javle) as places for second opinions.

Duke

Here is a lot of boring tech information but I wanted to capture it for anyone who might want more details or in case your onc uses the terms without explaining them or just to refresh your memory. Between chemo brain and plain old CRS this just doesn’t stick with me.

It discusses “trial phases”, “cancer grades”, and “imaging terms”. They are cut-and-paste from others.

From Cancer.gov (as a reminder of what the different “trial phases” are):
“What does a trial’s “phase” mean?
New interventions are often studied in a stepwise fashion, with each step representing a different “phase” in the clinical research process. The following phases are used for cancer treatment trials:
Phase 0. These trials represent the earliest step in testing new treatments in humans. In a phase 0 trial, a very small dose of a chemical or biologic agent is given to a small number of people (approximately 10-15) to gather preliminary information about how the agent is processed by the body (pharmacokinetics) and how the agent affects the body (pharmacodynamics). Because the agents are given in such small amounts, no information is obtained about their safety or effectiveness in treating cancer. Phase 0 trials are also called micro-dosing studies, exploratory Investigational New Drug (IND) trials, or early phase I trials. The people who take part in these trials usually have advanced disease, and no known, effective treatment options are available to them.
Phase I (also called phase 1). These trials are conducted mainly to evaluate the safety of chemical or biologic agents or other types of interventions (e.g., a new radiation therapy technique). They help determine the maximum dose that can be given safely (also known as the maximum tolerated dose) and whether an intervention causes harmful side effects. Phase I trials enroll small numbers of people (20 or more) who have advanced cancer that cannot be treated effectively with standard (usual) treatments or for which no standard treatment exists. Although evaluating the effectiveness of interventions is not a primary goal of these trials, doctors do look for evidence that the interventions might be useful as treatments.

Phase II (also called phase 2). These trials test the effectiveness of interventions in people who have a specific type of cancer or related cancers. They also continue to look at the safety of interventions. Phase II trials usually enroll fewer than 100 people but may include as many as 300. The people who participate in phase II trials may or may not have been treated previously with standard therapy for their type of cancer. If a person has been treated previously, their eligibility to participate in a specific trial may depend on the type and amount of prior treatment they received. Although phase II trials can give some indication of whether or not an intervention works, they are almost never designed to show whether an intervention is better than standard therapy.
Phase III (also called phase 3). These trials compare the effectiveness of a new intervention, or new use of an existing intervention, with the current standard of care (usual treatment) for a particular type of cancer. Phase III trials also examine how the side effects of the new intervention compare with those of the usual treatment. If the new intervention is more effective than the usual treatment and/or is easier to tolerate, it may become the new standard of care.

Phase III trials usually involve large groups of people (100 to several thousand), who are randomly assigned to one of two treatment groups, or “trial arms”: 1) a control group, in which everyone in the group receives usual treatment for their type of cancer, or 2) an investigational or experimental group, in which everyone in the group receives the new intervention or new use of an existing intervention. The trial participants are assigned to their individual groups by characteristics. This balance is necessary so the researchers can have confidence that any differences they observe in how the two groups respond to the treatments they receive are due to the treatments and not to other differences between the groups.

Randomization is usually done by a computer program to ensure that human choices do not influence the assignment to groups. The trial participants cannot request to be in a particular group, and the researchers cannot influence how people are assigned to the groups. Usually, neither the participants nor their doctors know what treatment the participants are receiving.
People who participate in phase III trials may or may not have been treated previously. If they have been treated previously, their eligibility to participate in a specific trial may depend on the type and the amount of prior treatment they received. In most cases, an intervention will move into phase III testing only after it has shown promise in phase I and phase II trials.

Phase IV (also called phase 4). These trials further evaluate the effectiveness and long-term safety of drugs or other interventions. They usually take place after a drug or intervention has been approved by the FDA for standard use. Several hundred to several thousand people may take part in a phase IV trial. These trials are also known as post-marketing surveillance trials. They are generally sponsored by drug companies.

Sometimes clinical trial phases may be combined (e.g., phase I/II or phase II/III trials) to minimize the risks to participants and/or to allow faster development of a new intervention.
Although treatment trials are always assigned a phase, other clinical trials (e.g., screening, prevention, diagnostic, and quality-of-life trials) may not be labeled this way.”

Tumor Grade (from National Cancer Institute):
1. What is tumor grade?
Tumor grade is the description of a tumor based on how abnormal the tumor cells and the tumor tissue look under a microscope. It is an indicator of how quickly a tumor is likely to grow and spread. If the cells of the tumor and the organization of the tumor’s tissue are close to those of normal cells and tissue, the tumor is called “well-differentiated.” These tumors tend to grow and spread at a slower rate than tumors that are “undifferentiated” or “poorly differentiated,” which have abnormal-looking cells and may lack normal tissue structures. Based on these and other differences in microscopic appearance, doctors assign a numerical “grade” to most cancers. The factors used to determine tumor grade can vary between different types of cancer.

Tumor grade is not the same as the stage of a cancer. Cancer stage refers to the size and/or extent (reach) of the original (primary) tumor and whether or not cancer cells have spread in the body. Cancer stage is based on factors such as the location of the primary tumor, tumor size, regional lymph node involvement (the spread of cancer to nearby lymph nodes), and the number of tumors present. More information about staging is in the NCI fact sheet Cancer Staging.

2. How is tumor grade determined?
If a tumor is suspected to be malignant, a doctor removes all or part of it during a procedure called a biopsy. A pathologist (a doctor who identifies diseases by studying cells and tissues under a microscope) then examines the biopsied tissue to determine whether the tumor is benign or malignant. The pathologist also determines the tumor’s grade and identifies other characteristics of the tumor. The NCI fact sheet Pathology Reports describes the type of information that can be found in a pathologist’s report about the visual and microscopic examination of tissue removed during a biopsy or other surgery.

3. How are tumor grades classified?
Grading systems differ depending on the type of cancer. In general, tumors are graded as 1, 2, 3, or 4, depending on the amount of abnormality. In Grade 1 tumors, the tumor cells and the organization of the tumor tissue appear close to normal. These tumors tend to grow and spread slowly. In contrast, the cells and tissue of Grade 3 and Grade 4 tumors do not look like normal cells and tissue. Grade 3 and Grade 4 tumors tend to grow rapidly and spread faster than tumors with a lower grade.
If a grading system for a tumor type is not specified, the following system is generally used (1):
GX: Grade cannot be assessed (undetermined grade)
G1: Well differentiated (low grade)
G2: Moderately differentiated (intermediate grade)
G3: Poorly differentiated (high grade)
G4: Undifferentiated (high grade)

4. What are some of the cancer type-specific grading systems?
Breast and prostate cancers are the most common types of cancer that have their own grading systems.

5. How does tumor grade affect a patient’s treatment options?
Doctors use tumor grade and other factors, such as cancer stage and a patient’s age and general health, to develop a treatment plan and to determine a patient’s prognosis (the likely outcome or course of a disease; the chance of recovery or recurrence). Generally, a lower grade indicates a better prognosis. A higher-grade cancer may grow and spread more quickly and may require immediate or more aggressive treatment.

The importance of tumor grade in planning treatment and determining a patient’s prognosis is greater for certain types of cancer, such as soft tissue sarcoma, primary brain tumors, and breast and prostate cancer. Patients should talk with their doctor for more information about tumor grade and how it relates to their treatment and prognosis.

Simplified explanation of imaging terms (from Marion):
C-T (CAT) Scans – computed or computerized tomography. Can show precise location of tumor, defined shape, solid or hollow; provides clues to a cancerous tumor but not as concrete as biopsy. Not reliable in identifying tumors less than 2 cm in size.

MRI (Magnetic Resonance Imaging) Scans – In many tissues, the image and detail are clearer than those with an MRI than a CT scan. For some tissues, MRI image is less clear than CT. Difficult to distinguish between Inflammation and scar tissue.

PET (Positron Emission Tomography) Scans – picks up cancer activity at a very small level.
Image not as clear as CT and MRI, inflammation can obscure other activities on scan and localizing exact location of tumor. Best suited for higher grade tumors, metastasis. Some insurance carriers won’t cover cost of PET Scan.

CAT/PET Combo Scans – wave of the future, allows for anatomical detail of the CT and detection of small nodules of cancer cells by PET. Not yet widely available in many hospitals.
Insurance coverage: don’t know.

Duke