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Approximately 16% of Worldwide Cancers Caused By Preventable Infections

Thu, 17 May 2012 00:01:53 +0000

Two million cancer cases each year—or roughly 16 percent of cancers worldwide—are the result of preventable and treatable infections such as human papillomavirus (HPV) and Hepatitis C (HCV), according to the results of a study published in The Lancet Oncology.[1]

Infections with certain viruses, bacteria, and parasites have been identified as strong risk factors for specific cancers. To examine the link between infections and cancer, researchers performed a systematic analysis of the proportion of cancer cases attributable to infection in 2008. They used data on cancer incidence from the GLOBOCAN project along with epidemiological data regarding the causal effects of infection on cancer. The data included information on 27 types of cancer from 182 countries.

They found that of the 12.7 million new cancer cases that occurred worldwide in 2008, 16 percent—or roughly two million—were attributable to infections. The rate of infection-related cancer was about three times higher in developing countries. For example, 3.3 percent of cancers in Australia and New Zealand were infection related, whereas 32.7 percent of cancers in sub-Saharan Africa were attributable to infections. The four main infections associated with cancer were human papillomavirus, hepatitis C, hepatitis B, and Helicobacter pylori. These infections were responsible for approximately 1.9 million cancer cases in 2008, mainly gastric, liver, and cervical cancers.

Cervical cancer accounted for about half of the infection-related cancers in women. Liver and gastric cancers accounted for more than 80 percent of the infection-related cancers in men. About 30 percent of infection-related cancers occurred in people younger than 50 years. It’s important to note that it takes decades of chronic infection before an infection progresses to cancer.

Based on the statistics, the researchers noted that approximately two million cancer cases each year might be preventable with better public health methods for preventing infection. In an accompanying editorial, Dr. Goodarz Danaei, an assistant professor of global health at Harvard School of Public Medicine in Boston, noted that vaccines for HPV and hepatitis B are effective and that increasing their availability should be a priority for higher risk countries.[2] He suggests that increasing vaccine coverage could reduce the global burden of cancer.

References:

[1] de Martel C, Ferlay J, Franceschi S, et al. Global burden of cancers attributable to infections in 2008: a review and synthetic analysis. The Lancet Oncology. Published early online May 9, 2012. doi:10.1016/S1470-2045(12)70137-7

[2] Danaei G. Global burden of infection-related cancer revisited. The Lancet Oncology. Published early online May 9, 2012. doi:10.1016/S1470-2045(12)70176-6

Provenge®

Wed, 16 May 2012 16:01:38 +0000

Class: Biological Therapy

Generic Name: Sipuleucel-T

Trade Name: Provenge®

How is this drug used? Provenge is used for the treatment of prostate cancer that has few or no symptoms, but has spread to other parts of the body and does not respond to hormone therapy (metastatic, hormone-refractory prostate cancer).

What is the mechanism of action? Provenge mixes your own immune cells with a protein that prompts an immune response against cancer cells.

How is Provenge given (administered)? Provenge is given as an intravenous (IV) infusion. You will receive a total of three infusions about two weeks apart. Approximately three days before each infusion, a sample of your immune cells will be collected through a process known as leukapheresis; the cells are used to produce Provenge.

How are patients monitored? Patients will usually have scheduled meetings with their healthcare provider while they are being treated with Provenge. Patients may undergo physical examinations, lab tests, or imaging to assess side effects and response to therapy.

What are the most common side effects of treatment with Provenge?

Chills
Fatigue
Fever
Back pain
Nausea
Joint ache
Headache

This is not a complete list of side effects. Some patients may experience other side effects that are not listed here. Patients may wish to discuss with their physician the other less common side effects of this drug, some of which may be serious.

Some side effects may require medical attention. Other side effects do not require medical attention and may go away during treatment. Patients should check with their physician about any side effects that continue or are bothersome.
What can patients do to help alleviate or prevent discomfort and side effects?

Pay careful attention to the physician’s instructions, and discuss side effects with your physician.

Are there any special precautions patients should be aware of before starting treatment?

Patients should inform their physician about all medical conditions, including heart problems, lung problems, and history of stroke.
Patients should inform their physician of any other medication or supplement they are taking (whether prescription or over-the-counter).

When should patients notify their physician?

Tell your doctor if you experience any side effects that bother you or don’t go away. Watch for signs of serious side effects and report these to your doctor immediately: breathing problems, chest pains, racing heart or irregular heartbeats, dizziness, nausea or vomiting, a fever over 100º F, or redness or pain at the infusion or collection sites.

What is a package insert?
A package insert is required by the FDA and contains a summary of the essential scientific information needed for the safe and effective use of the drug for healthcare providers and consumers. A package insert typically includes information regarding specific indications, administration schedules, dosing, side effects, contraindications, results from some clinical trials, chemical structure, pharmacokinetics and metabolism of the specific drug. By carefully reviewing the package insert, you will get the most complete and current information about how to safely use this drug. If you do not have the package insert for the drug you are using, your pharmacist or physician may be able to provide you with a copy.

Important Limitations of Use

The information provided above on the drug you have selected is provided for your information only and is not a substitute for consultation with an appropriate medical doctor. We are providing this information solely as a courtesy and, as such, it is in no way a recommendation as to the safety, efficacy or appropriateness of any particular drug, regimen, dosing schedule for any particular cancer, condition or patient nor is it in any way to be considered medical advice. Patients should discuss the appropriateness of a particular drug or chemotherapy regimen with their physician.

As with any printed reference, the use of particular drugs, regimens and drug dosages may become out-of-date over time, since new information may have been published and become generally accepted after the latest update to this printed information. Please keep in mind that health care professionals are fully responsible for practicing within current standards, avoiding use of outdated regimens, employing good clinical judgment in selecting drugs and/or regimens, in calculating doses for individual patients, and verifying all dosage calculations.

DISCLAIMER OF WARRANTIES

CANCERCONSULTANTS.COM SPECIFICALLY DISCLAIMS AND EXCLUDES ALL EXPRESSED OR IMPLIED WARRANTIES, INCLUDING ANY IMPLIED WARRANTIES AS TO QUALITY, ACCURACY (INCLUDING TYPOGRAPHICAL ERRORS), MERCHANTABILITY, OR FITNESS FOR ANY PARTICULAR PURPOSE OF THE INFORMATION CONTAINED HEREIN. CANCERCONSULTANTS.COM DISCLAIMS ALL LIABILITY OR DAMAGES ARISING FROM ANY USE OF THE INFORMATION.

The prescribing physician is solely responsible for making all decisions relating to appropriate patient care including, but not limited to, drugs, regimens, dose, schedule, and any supportive care.

Fluorouracil

Wed, 16 May 2012 15:46:48 +0000

Class: Chemotherapy

Generic Name: Fluorouracil (fler-oh-YOO-rah-sil), 5-FU, 5-fluorouracil

For which conditions is this drug approved? Fluorouracil is FDA approved for the treatment of the following conditions: colon cancer, rectal cancer, breast cancer, stomach (gastric) cancer, and pancreatic cancer. Fluorouracil may also come in a topical form that is FDA approved for the treatment of superficial basal cell carcinoma. It is important for patients to remember that physicians have the ability to prescribe medication for conditions other than those for which the drug has been approved by the FDA. Patients who have received a prescription of this drug for a condition other than which it is approved may wish to discuss this issue with their physician.

What is the mechanism of action? Fluorouracil belongs to a class of agents called antimetabolites. Antimetabolites produce their anti-cancer effects by inhibiting the ability of a cell to produce or repair DNA, thereby making the cell unable to replicate or repair itself and ultimately causing cellular death.

How is fluorouracil typically given (administered)? Fluorouracil may be given intravenously (into a vein), and may be applied topically as a skin cream. The information on this sheet mainly covers the intravenous formulation. The dose depends on several factors, including the condition being treated, the size of the patient, the particular regimen being used, and the overall health of the patient.

How are patients typically monitored? Patients will usually have scheduled meetings with their healthcare provider while they are being treated with flourouracil. Typically, blood will be drawn to check levels of blood cells and to monitor functions of some organ systems, such as the kidneys or liver. Patients may also undergo physical examinations, scans or other measures to assess side effects and response to therapy. In addition, patients will have their heart function monitored, as treatment with fluorouracil may produce damage to the heart. Patients should notify their healthcare provider if they notice changes in heart rate or rhythm, or experience chest pain. Patients who are using the topical fluorouracil will also undergo skin assessments.

What are the common (occur in 30% or more of patients) side effects of treatment with fluorouracil?

• Low levels of white blood cells – increases the risk of infection
• Low levels of red blood cells – increases the risk of anemia and blood transfusions
• Low levels of platelets – increases the risk of bleeding
• Mouth sores
• Diarrhea
• Loss of appetite
• Changes in taste, metallic taste in mouth following IV bolus injection
• Reactions of the eyes resulting in watery eyes or sensitivity to sunlight
• Discoloration of vein in which the drug was administered

What are the less common (occur in 10% to 29% of patients) side effects of treatment with fluorouracil?

• Pain, peeling, redness, rash, or swelling of the palms of the hands or soles of the feet (hand-foot syndrome)
• Discoloration of the skin
• Darkening of the skin where previous radiation was administered?
• Rash or itching
• Skin sensitivity to sunlight
• Hair loss
• Discoloration of nails, loss of nails
• Cracking, peeling or excessively dry skin

What are possible late side effects of treatment with fluorouracil? With the use of this drug, there is risk of developing damage to the heart after treatment is completed, although this is uncommon. Patients experiencing chest or jaw pain, difficulty breathing, sweating or noticeable changes in heart rate or rhythm should contact their healthcare provider immediately.

What can patients do to help alleviate or prevent discomfort and side effects?

• Pay careful attention to the physician’s instructions and inform the physician of any side effects.
• Maintain adequate rest and nutrition.
• Wear sunscreen and protective clothing and try to minimize sun exposure.
• Drink plenty of fluids. (Patients should ask their physician about the amount of liquid to consume during a day.)
• If possible, avoid large crowds or people who are sick or not feeling well, as this drug may leave some patients susceptible to infection.
• Wash hands often to reduce the risk of infection.
• Eat small meals frequently to help alleviate nausea.
• If patients have been prescribed an anti-nausea medication, they should be sure to take the prescribed doses.
• Avoid activities that may cause injury or bruising.
• Use a soft toothbrush and an electric razor to prevent cuts on the mouth or skin.
• For mouth sores, patients should rinse their mouth three times a day with a salt and soda solution (8 ounces of water mixed with ½ to 1 tsp baking soda and/or ½ to 1 tsp salt) and brush their teeth with a soft toothbrush to help prevent the development of mouth sores.

Are there any special precautions patients should be aware of before starting treatment?

• Patients should inform their physician if they are pregnant, breastfeeding or planning a family in the near future. This drug may cause birth defects. It is important to use some kind of birth control while undergoing treatment. Also, patients may want to talk to their physician if they are considering having children in the future, since some drugs may cause fertility problems.
• It is important that patients inform their physician of any pre-existing conditions (chicken pox, heart disease, kidney disease, liver disease, lung disease, etc.) as they may worsen with this drug.
• Patients should inform their physician of any other medication they are taking (whether prescription or over-the-counter, including vitamins, herbs, etc.) as they may interfere with treatment.
• Patients should check with their physician before starting any new drug or nutritional supplement.
• Patients should inform their physician of any known drug or food allergies or any reactions to medications they have experienced in the past.

When should patients notify their physician?

• Chest pain or palpitations
• Noticeable changes in heart rate or rhythm
• Excessive pain or peeling of the palms of the hands or soles of the feet
• Excessive peeling or cracking of skin
• Flu or cold-like symptoms: fever, chills, sore throat, cough
• Signs of infection – redness, swelling, pus, tenderness, painful urination
• Persistent or severe fatigue
• Unexplained or pronounced bleeding (nosebleeds, bruising, blood in the urine, black tarry stools, etc.)
• Mouth sores
• Persistant nausea, vomiting or abdominal pain
• Persistant or severe diarrhea
• Vision changes
• Confusion, mental changes
• Allergic reaction including swelling of the mouth, lips, and/or throat, wheezing or difficulty breathing, hives or rash

Important Limitations of Use
The information provided above on the drug you have selected is provided for your information only and is not a substitute for consultation with an appropriate medical doctor. We are providing this information solely as a courtesy and, as such, it is in no way a recommendation as to the safety, efficacy or appropriateness of any particular drug, regimen, dosing schedule for any particular cancer, condition or patient nor is it in any way to be considered medical advice. Patients should discuss the appropriateness of a particular drug or chemotherapy regimen with their physician.

DISCLAIMER OF WARRANTIES

The prescribing physician is solely responsible for making all decisions relating to appropriate patient care including, but not limited to, drugs, regimens, dose, schedule, and any supportive care.

Provenge®

Wed, 16 May 2012 11:01:38 +0000

Class: Biological Therapy

Generic Name: Sipuleucel-T

Trade Name: Provenge®

What is the mechanism of action? Provenge mixes your own immune cells with a protein that prompts an immune response against cancer cells.

What are the most common side effects of treatment with Provenge?

Chills
Fatigue
Fever
Back pain
Nausea
Joint ache
Headache

Pay careful attention to the physician’s instructions, and discuss side effects with your physician.

Are there any special precautions patients should be aware of before starting treatment?

Patients should inform their physician about all medical conditions, including heart problems, lung problems, and history of stroke.
Patients should inform their physician of any other medication or supplement they are taking (whether prescription or over-the-counter).

When should patients notify their physician?

Important Limitations of Use

DISCLAIMER OF WARRANTIES

The prescribing physician is solely responsible for making all decisions relating to appropriate patient care including, but not limited to, drugs, regimens, dose, schedule, and any supportive care.

Women More Likely to Survive Melanoma Than Men

Wed, 16 May 2012 00:01:07 +0000

Women are 30 percent more likely to survive melanoma than men, according to the results of a study published in the Journal of Clinical Oncology.[1]

Melanoma is a deadly type of skin cancer that arises from melanocytes, which are cells located in the upper layer of the skin that are responsible for producing pigment (skin color). Melanoma is more likely than other types of skin cancer to spread to other parts of the body. According to an editorial that accompanied the study in the Journal of Clinical Oncology, approximately 70,000 Americans were diagnosed with invasive melanoma in 2011, and about 43 percent of those were women.[2] There were approximately 8,800 melanoma-related deaths in 2011, of which only 35 percent were females.

Previous studies have observed that female melanoma patients tend to fare better than their male counterparts. To evaluate this notion, researchers from Europe analyzed follow-up data from nearly 2,700 melanoma patients enrolled in four phase III melanoma treatment trials conducted in Europe. All patients had been diagnosed with either stage I or stage 2 melanoma. Patients were tracked for disease remission, relapse, disease spread, and death.

The results indicated that women consistently had a survival advantage as well as a lower risk of metastasis (spread) when compared to men. Male melanoma patients were found to have worse disease characteristics at diagnosis and worse disease progression. In contrast, women had a 30 percent improved survival—meaning they were 30 percent more likely to survive—as well as a 30 percent lower risk of cancer spread to lymph nodes and other organs. This was true regardless of age, menopausal status, and subtype of cancer—with the only exception being head and neck melanomas, where gender differences disappeared.

The reasons for the gender differences are unclear, but the researchers speculate that their might be a biologic sex difference that causes the cancer to behave differently in men and women. They evaluated a number of possibilities, including estrogen levels, vitamin D metabolism, testosterone levels, and more—but the data could no prove or disprove any of these theories. Part of the gender difference could be the result of a somewhat true gender stereotype—women are more likely than men to detect skin changes early and see a doctor. Because early detection is critical in melanoma, this could mean a significant difference in survival.

Regardless of the reasons, the data remains—men tend to have worse outcomes with melanoma.

Reference:

[1] Joosse A, Collette S, Suciu S, et al. Superior Outcome of Women With Stage I/II Cutaneous Melanoma: Pooled Analysis of Four European Organisation for Research and Treatment of Cancer Phase III Trials. Journal of Clinical Oncology. Published early online: April 30, 2012. doi: 10.1200/JCO.2011.38.0584

[2] Sondak VK, Swetter SM, Berwick MA. Gender disparities in patients with melanoma: Breaking the glass ceiling. Journal of Clinical Oncology. Published early online: April 30, 2012.

Revlimid Increases Risk of Some New Cancers

Tue, 15 May 2012 00:01:30 +0000

Patients with newly diagnosed multiple myeloma who receive Revlimid® (lenalidomide) may be at an increased risk of developing new cancers, according to a safety announcement released by the U.S. Food and Drug Administration (FDA).

Revlimid is an oral medication that can stop or slow the growth of cancerous myeloma cells within the bone marrow. It has been approved in combination with dexamethasone for multiple myeloma patients who have received at least one prior therapy. Revlimid has also been evaluated in combination with other agents for the initial treatment of patients with newly diagnosed myeloma.

Clinical trials have been ongoing since Revlimid was approved and new data indicates that newly diagnosed patients treated with Revlimid have an increased risk of developing acute myelogenous leukemia (AML), myelodysplastic syndromes, and Hodgkin’s lymphoma.

One analysis included three randomized trials in which patients with newly diagnosed multiple myeloma received initial chemotherapy or chemotherapy and blood-stem-cell transplantation followed by treatment with Revlimid or placebo. The FDA reports that there was nearly a three-fold increase in new cancers in the Revlimid group compared to the placebo group, with 65 second primary cancers among 824 Revlimid patients and 19 second primary cancers among 665 placebo patients. The median time from start of Revlimid to a diagnosis of a second primary malignancy was two years.

The safety information has been added to Revlimid’s label to provide up-to-date information to healthcare professionals. The patient information is also being updated.

The FDA has recommended that doctors consider both the potential benefit of Revlimid as well as the risk of new cancers when choosing to treat patients with the drug. Patients must be closely monitored for the development of new cancers.

Reference:

FDA Drug Safety Communication: Safety review update of cancer drug Revlimid (lenalidomide) and risk of developing new types of malignancies [FDA Safety Announcement]. U.S. Food and Drug Administration website. Available at: http://www.fda.gov/Drugs/DrugSafety/ucm302939.htm

Overall Health, Not Just Age, is an Important Factor in Treatment of Non-Small Cell Lung Cancer

Mon, 14 May 2012 00:01:18 +0000

Younger patients with non-small cell lung cancer (NSCLC) are more likely to receive treatment than older patients, regardless of overall health and prognosis, according to the results of a study published in the Journal of Clinical Oncology.

Lung cancer remains the leading cause of cancer death in the United States. Non–small cell lung cancer (NSCLC) accounts for approximately 85% of all lung cancers.

Many NSCLC cases occur in people over the age of 65, but there is limited information about how best to treat older patients coupled with concern that older patients will not be able to tolerate aggressive treatment. As a result older patients sometimes do not receive treatment that might be of benefit; for example, older patients may be treated with single-agent chemotherapy rather than the combination chemotherapy that is commonly used in younger patients.

Previous research has indicated that older patients with NSCLC who are otherwise healthy can benefit from treatment, while those with comorbidities—or other severe illnesses—are more vulnerable to the toxicity of cancer treatments and therefore less likely to tolerate and complete a course of treatment.

To examine the effects of comorbidity and age on treatment outcomes, researchers used data from the Veterans Affairs (VA) Central Cancer Registry to analyze treatment and outcomes from more than 20,000 veterans over age 65 with NSCLC. They found that regardless of stage of cancer, treatment rates decreased more in association with older age than with comorbidity.

Younger patients—those between the ages of 65 to 74—were more likely to receive treatment, regardless of comorbidity status. In other words, those who were severely ill—and thus less likely to benefit and more likely to be harmed—received treatment at approximately the same rate as patients in the same age range who were not severely ill. In contrast, older patients—those between the ages of 75 and 84—were less likely to receive treatment, even if they had no comorbidities and a better prognosis.

The researchers concluded that physicians appear to base treatment strictly on age, while overlooking other factors. A patient’s overall state of health is an important factor when determining treatment. An otherwise healthy 75-year-old may tolerate treatment well, whereas a severely ill 65-year-old may not. In short, treatment decisions must be individualized rather than based strictly on age in order to target NSCLC treatment to older patients who may benefit.

Reference:

Wang S, Wong ML, Hamilton N, et al: Impact of age and comorbidity on non-small-cell lung cancer treatment in older veterans. Journal of Clinical Oncology. 2012; 30(13): 1447-1455.

Vitamin E Supplementation Appears to Increase Risk of Prostate Cancer

Fri, 11 May 2012 00:01:50 +0000

The final analysis of the Selenium and Vitamin E Cancer Prevention Trial (SELECT) indicated that vitamin E increased the risk of developing prostate cancer in otherwise healthy men by 17% when compared to placebo. The results of the study were published in the Journal of the American Medical Association[1] and presented at the 2012 Genitourinary Cancers Symposium.[2]

Prostate cancer is the most commonly diagnosed type of cancer (other than skin cancer) in U.S. men. Although many prostate cancers are diagnosed at an early, curable stage, treatment of prostate cancer can cause urinary, sexual, and bowel problems that have a substantial impact on quality of life. Prevention of prostate cancer, therefore, continues to be an important research priority.

There is a great deal of interest in the relationship between diet and cancer, and some previous studies suggested that selenium and vitamin E may reduce the risk of certain types of cancer, including prostate cancer.

To further explore the relationship between selenium and vitamin E supplementation and risk of prostate cancer, researchers conducted SELECT, which was a randomized trial that enrolled more than 35,000 men from 400 study sites across the United States, Canada, and Puerto Rico. At the start of the study, all men had normal prostate-specific antigen (PSA) levels and a normal digital rectal examination. Study participants were assigned to one of four groups: selenium supplementation; vitamin E supplementation; selenium and vitamin E supplementation; or placebo.

In 2008, after approximately 5.5 years of follow-up, preliminary results indicated no benefit from supplementation and participants were instructed to stop taking the supplements. Researchers, however, continued to collect information from the men in order to continue to evaluate the long-term effects

After 7 years of follow-up (5.5 years of supplementation), researchers found that vitamin E supplementation was associated with a statistically significant increased risk of prostate cancer, whereas supplementation with selenium was not. Men in the vitamin E group were 17% more likely than men in the placebo group to be diagnosed with prostate cancer.

These results suggest that daily supplementation with vitamin E may increase the risk of prostate cancer among healthy men. It is always important to communicate with your physician about any supplements you may be taking so that you can discuss the risks and benefits.

References:

[1] Klein EA, Thompson IM Jr, Tangen CM, et al: Vitamin E and the risk of prostate cancer: The Selenium and Vitamin E Cancer Prevention Trial (SELECT). JAMA. 2011; 306: 1549-1556.

[2] Klein EA, Thompson I, Tangen CM, et al: Vitamin E and the risk of prostate cancer: Updated results of the Selenium and Vitamin E Cancer Prevention Trial (SELECT). 2012 Genitourinary Cancers Symposium. Abstract 7. Presented February 2, 2012.

A Phase II Study of Pazopanib in the Treatment of Surgically Unresectable or Metastatic Liosarcoma

Thu, 10 May 2012 16:38:35 +0000

Objective

Overview

Eligibility Requirements

Inclusion:
1. Histologically or cytologically confirmed high-or intermediate grade liposarcoma (allowed subtypes include liposarcoma, de-differentiated, myxoid, round cell, pleomorphic, mixed-type, or not otherwise specified)
2. ECOG 0-1
3. Any number of prior treatment lines including naïve subjects is allowed
Exclusion:
1. Well differentiated liposarcoma, prior treatment with TKI

Randomized Phase 3 Study Comparing Standard First-Line Docetaxel/Prednisone to Docetaxel/Prednisone in Combination with Custirsen (OGX-011) in Men with Metastatic Castrate Resistant Prostate Cancer

Thu, 10 May 2012 16:35:57 +0000

Objective

Overview

Eligibility Requirements

Inclusion:
1. Adenocarcinoma of the prostate requiring chemotherapy with metastatic radiographic disease defined as (20% increase in radiographic disease or at least 2 new bone lesions on bone scan or increasing PSA levels with minimum being 5.0 and rising over two consecutive weeks from baseline
2. Willing to not add, delete or change bisphosphonate or denosumab usage during study therapy
3. Subjects receiving more than 10mg of Prednisone per day at screening must be willing to have dose reduced to 10 mg per day for at least 7 days prior to randomization
Exclusion:
1. Received any other cytotoxic chemotherapy at treatment for prostate cancer
2. Received any cycling, intermittent or continuous hormonal treatment 28 days prior to randomization with the exception of lupron
3. Brain metastasis or symptomatic chord compression requiring surgery or radiation therapy
4. Uncontrolled medical conditions such as heart failure, Mi, uncontrolled hypertension, stroke or treatment of a major active infection within 3 months of randomization

Contact Centers

The West Clinic
100 N Humphreys
Memphis
Tennessee
38120
Tracy B. Stewart, RN, BSN, OCN, CCRC
research@westclinic.com
901-683-0055 ext.1236