Bisphosphonates are bone-building drugs used to treat osteoporosis, which is a condition characterized by low bone mass and deterioration of bone structure. Each year, roughly 1.5 million Americans experience an osteoporosis-related bone fracture. These fractures commonly involve the wrist, hip, or spine, but can affect any part of the body. Bisphosphonates are widely prescribed for osteoporosis and there are a number of them on the market, including Fosamax® [alendronate], Actonel® [risedronate], Boniva® [ibandronate], Reclast® [zoledronic acid]), Prolia® (denosumab), calcitonin, estrogen, Evista® (raloxifene), and Forteo® (teriparatide).

The FDA review of bisphosphonates was prompted by concerns over long-term use of the drugs. The drugs have been shown to be effective in clinical trials lasting 3 to 4 years; however, the pharmacologic effects of bisphosphonate activity continue long after patients stop taking the medication. There is a concern that after many years of use, the drugs may actually lead to weaker bones in some women. There have been some rare but serious adverse events, including unusual femur fractures, esophageal cancer, and osteonecrosis of the jaw, a painful and disfiguring crumbling of the jawbone. One study showed that use of a bisphosphonate for five years or longer was linked with a more than two-fold increase in risk of subtrochanteric or femoral shaft fracture.[2] These fractures occur lower down on the femur than hip fractures.

The FDA review focused on two long-term studies of bisphosphonates—a ten-year study of Fosamax and a six-year study of Reclast. Both studies showed significant reductions in fracture risks during the first three to four years of use, but little or no benefit with long-term use. The FDA’s opinion is that the meaningful endpoint of osteoporosis therapy is the rate of fracture. While bisphosphonates offer an advantage over placebo in the first several years of use, after five years, the advantage narrows—leading the FDA to conclude that long-term use may not provide benefit.

Bisphosphonates are currently labeled with an “Important Limitation of Use” statement that reads: “The optimal duration of use has not been determined. All patients on bisphosphonate therapy should have the need for continued therapy re-evaluated on a periodic basis.”

The report did not provide specific guidelines for use—instead leaving it up to physicians and patients to decide on an individualized basis. For low-risk patients, three to five years of bisphosphonate therapy may be sufficient, whereas older patients may benefit from longer use of the therapy. An accompanying article offers evidence that women who continue to have very low bone density after three to five years of treatment might benefit from long-term use of the drugs.[3] More specifically, they say that women with a T score lower than -2.5, a history of spinal fracture, or an existing fracture are most likely to benefit from long-term use of the drugs. However, women who have moderate to low bone density—meaning a diagnosis of osteopenia rather than osteoporosis—are not likely to benefit from long-term use of bisphosphonates.

The bottom line—caution is warranted with long-term use of bisphosphonates. The optimal duration of use depends on individual characteristics. Patients who take bisphosphonates should be closely monitored to assess the risks and benefits of continued therapy.

References:

Copyright © 2012 CancerConsultants. All Rights Reserved.

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.

Copyright © 2012 CancerConnect Last updated 05/12.

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.

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.

Copyright © 2012 CancerConnect Last updated 05/12.

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.

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.

Copyright © 2012 CancerConnect Last updated 05/12.

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.

Multiple myeloma is a cancer of plasma cells, which are a special type of white blood cell that are part of the body’s immune system. Patients with multiple myeloma have increased numbers of abnormal plasma cells that may produce increased quantities of dysfunctional antibodies detectable in the blood and/or urine.

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 been associated with an increased risk of new cancers and the FDA recently made a safety announcement regarding the drug.[1]

Despite the increased risk of new cancers, Revlimid continues to be studied for its use as maintenance therapy in multiple myeloma. Three double-blind, phase 3, multi-center, randomized trials evaluated Revlimid maintenance therapy. Two studies randomly assigned patients to Revlimid or placebo after stem-cell transplantation. The third study included patients who were ineligible for stem-cell transplantation; these patients were randomly assigned to Revlimid or placebo after oral induction therapy. In all three studies, study-drug assignments were unblended early after Revlimid maintenance showed significant benefit.

In the first study, researchers assigned 614 patients under age 65 to Revlimid or placebo after transplantation.[2] They found that maintenance therapy with Revlimid improved progression-free survival, with a progression-free survival of 41 months in the Revlimid group compared to 23 months in the placebo group. After a median follow-up of 45 months, more than 70 percent of patients in both groups were alive at 4 years. There was an increased rate of new cancers in the Revlimid group, with 32 new cancers in the Revlimid group and 12 in the placebo group. However, the researchers concluded that the benefit of Revlimid outweighed the risk of new cancers.

In the second study, 460 patients age 71 or younger were randomly assigned to Revlimid or placebo after transplantation.[3] Patients in the Revlimid group had a significantly longer time to disease progression compared to those in the placebo group—the median time to progression was 46 months in the Revlimid group and 27 months in the placebo group. Patients in the Revlimid group experienced more grade 3 and 4 adverse events and 18 (8%) patients in the Revlimid group had second primary cancers, compared with 6 (3%) in the placebo group. A total of 35 patients who received Revlimid (15%) and 53 patients who received placebo (23%) died.

The third study involved patients who were ineligible for transplantation.[4] In this study, patients were randomly assigned to one of three groups:152 patients received oral melphalan-prednisone-Revlimid induction followed by Revlimid (MPR-R); 153 patients patients received oral melphalan-prednisone-Revlimid followed by placebo (MPR); and 154 patients received melphalan-prednisone followed by placebo (MP). The median progression-free survival was significantly longer with Revlimid maintenance therapy—the MPR-R group had a median progression-free survival of 31 months, compared to 14 months for the MPR group and 13 months for the MP group. The rate of new cancers was 7% with MPR-R, 7% with MPR, and 3% with MP.

In an accompanying editorial, Ashraf Badros notes that while Revlimid appears to offer benefit as maintenance therapy for multiple myeloma, it does come with risks, namely the increased risk of second primary cancers.[5] Furthermore, he questions whether progression-free survival is the optimal endpoint for maintenance therapy and whether it is the most cost-effective treatment.

References:

Copyright © 2012 CancerConsultants. All Rights Reserved.

Multiple myeloma is a cancer of plasma cells, which are a special type of white blood cell that are part of the body’s immune system. Patients with multiple myeloma have increased numbers of abnormal plasma cells that may produce increased quantities of dysfunctional antibodies detectable in the blood and/or urine.

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 been associated with an increased risk of new cancers and the FDA recently made a safety announcement regarding the drug.[1]

Despite the increased risk of new cancers, Revlimid continues to be studied for its use as maintenance therapy in multiple myeloma. Three double-blind, phase 3, multi-center, randomized trials evaluated Revlimid maintenance therapy. Two studies randomly assigned patients to Revlimid or placebo after stem-cell transplantation. The third study included patients who were ineligible for stem-cell transplantation; these patients were randomly assigned to Revlimid or placebo after oral induction therapy. In all three studies, study-drug assignments were unblended early after Revlimid maintenance showed significant benefit.

In the first study, researchers assigned 614 patients under age 65 to Revlimid or placebo after transplantation.[2] They found that maintenance therapy with Revlimid improved progression-free survival, with a progression-free survival of 41 months in the Revlimid group compared to 23 months in the placebo group. After a median follow-up of 45 months, more than 70 percent of patients in both groups were alive at 4 years. There was an increased rate of new cancers in the Revlimid group, with 32 new cancers in the Revlimid group and 12 in the placebo group. However, the researchers concluded that the benefit of Revlimid outweighed the risk of new cancers.

In the second study, 460 patients age 71 or younger were randomly assigned to Revlimid or placebo after transplantation.[3] Patients in the Revlimid group had a significantly longer time to disease progression compared to those in the placebo group—the median time to progression was 46 months in the Revlimid group and 27 months in the placebo group. Patients in the Revlimid group experienced more grade 3 and 4 adverse events and 18 (8%) patients in the Revlimid group had second primary cancers, compared with 6 (3%) in the placebo group. A total of 35 patients who received Revlimid (15%) and 53 patients who received placebo (23%) died.

The third study involved patients who were ineligible for transplantation.[4] In this study, patients were randomly assigned to one of three groups:152 patients received oral melphalan-prednisone-Revlimid induction followed by Revlimid (MPR-R); 153 patients patients received oral melphalan-prednisone-Revlimid followed by placebo (MPR); and 154 patients received melphalan-prednisone followed by placebo (MP). The median progression-free survival was significantly longer with Revlimid maintenance therapy—the MPR-R group had a median progression-free survival of 31 months, compared to 14 months for the MPR group and 13 months for the MP group. The rate of new cancers was 7% with MPR-R, 7% with MPR, and 3% with MP.

In an accompanying editorial, Ashraf Badros notes that while Revlimid appears to offer benefit as maintenance therapy for multiple myeloma, it does come with risks, namely the increased risk of second primary cancers.[5] Furthermore, he questions whether progression-free survival is the optimal endpoint for maintenance therapy and whether it is the most cost-effective treatment.

References:

Copyright © 2012 CancerConsultants. All Rights Reserved.

Multiple myeloma is a cancer of plasma cells, which are a special type of white blood cell that are part of the body’s immune system. Patients with multiple myeloma have increased numbers of abnormal plasma cells that may produce increased quantities of dysfunctional antibodies detectable in the blood and/or urine.

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 been associated with an increased risk of new cancers and the FDA recently made a safety announcement regarding the drug.[1]

Despite the increased risk of new cancers, Revlimid continues to be studied for its use as maintenance therapy in multiple myeloma. Three double-blind, phase 3, multi-center, randomized trials evaluated Revlimid maintenance therapy. Two studies randomly assigned patients to Revlimid or placebo after stem-cell transplantation. The third study included patients who were ineligible for stem-cell transplantation; these patients were randomly assigned to Revlimid or placebo after oral induction therapy. In all three studies, study-drug assignments were unblended early after Revlimid maintenance showed significant benefit.

In the first study, researchers assigned 614 patients under age 65 to Revlimid or placebo after transplantation.[2] They found that maintenance therapy with Revlimid improved progression-free survival, with a progression-free survival of 41 months in the Revlimid group compared to 23 months in the placebo group. After a median follow-up of 45 months, more than 70 percent of patients in both groups were alive at 4 years. There was an increased rate of new cancers in the Revlimid group, with 32 new cancers in the Revlimid group and 12 in the placebo group. However, the researchers concluded that the benefit of Revlimid outweighed the risk of new cancers.

In the second study, 460 patients age 71 or younger were randomly assigned to Revlimid or placebo after transplantation.[3] Patients in the Revlimid group had a significantly longer time to disease progression compared to those in the placebo group—the median time to progression was 46 months in the Revlimid group and 27 months in the placebo group. Patients in the Revlimid group experienced more grade 3 and 4 adverse events and 18 (8%) patients in the Revlimid group had second primary cancers, compared with 6 (3%) in the placebo group. A total of 35 patients who received Revlimid (15%) and 53 patients who received placebo (23%) died.

The third study involved patients who were ineligible for transplantation.[4] In this study, patients were randomly assigned to one of three groups:152 patients received oral melphalan-prednisone-Revlimid induction followed by Revlimid (MPR-R); 153 patients patients received oral melphalan-prednisone-Revlimid followed by placebo (MPR); and 154 patients received melphalan-prednisone followed by placebo (MP). The median progression-free survival was significantly longer with Revlimid maintenance therapy—the MPR-R group had a median progression-free survival of 31 months, compared to 14 months for the MPR group and 13 months for the MP group. The rate of new cancers was 7% with MPR-R, 7% with MPR, and 3% with MP.

In an accompanying editorial, Ashraf Badros notes that while Revlimid appears to offer benefit as maintenance therapy for multiple myeloma, it does come with risks, namely the increased risk of second primary cancers.[5] Furthermore, he questions whether progression-free survival is the optimal endpoint for maintenance therapy and whether it is the most cost-effective treatment.

References:

Copyright © 2012 CancerConsultants. All Rights Reserved.

Multiple myeloma is a cancer of plasma cells, which are a special type of white blood cell that are part of the body’s immune system. Patients with multiple myeloma have increased numbers of abnormal plasma cells that may produce increased quantities of dysfunctional antibodies detectable in the blood and/or urine.

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 been associated with an increased risk of new cancers and the FDA recently made a safety announcement regarding the drug.[1]

Despite the increased risk of new cancers, Revlimid continues to be studied for its use as maintenance therapy in multiple myeloma. Three double-blind, phase 3, multi-center, randomized trials evaluated Revlimid maintenance therapy. Two studies randomly assigned patients to Revlimid or placebo after stem-cell transplantation. The third study included patients who were ineligible for stem-cell transplantation; these patients were randomly assigned to Revlimid or placebo after oral induction therapy. In all three studies, study-drug assignments were unblended early after Revlimid maintenance showed significant benefit.

In the first study, researchers assigned 614 patients under age 65 to Revlimid or placebo after transplantation.[2] They found that maintenance therapy with Revlimid improved progression-free survival, with a progression-free survival of 41 months in the Revlimid group compared to 23 months in the placebo group. After a median follow-up of 45 months, more than 70 percent of patients in both groups were alive at 4 years. There was an increased rate of new cancers in the Revlimid group, with 32 new cancers in the Revlimid group and 12 in the placebo group. However, the researchers concluded that the benefit of Revlimid outweighed the risk of new cancers.

In the second study, 460 patients age 71 or younger were randomly assigned to Revlimid or placebo after transplantation.[3] Patients in the Revlimid group had a significantly longer time to disease progression compared to those in the placebo group—the median time to progression was 46 months in the Revlimid group and 27 months in the placebo group. Patients in the Revlimid group experienced more grade 3 and 4 adverse events and 18 (8%) patients in the Revlimid group had second primary cancers, compared with 6 (3%) in the placebo group. A total of 35 patients who received Revlimid (15%) and 53 patients who received placebo (23%) died.

The third study involved patients who were ineligible for transplantation.[4] In this study, patients were randomly assigned to one of three groups:152 patients received oral melphalan-prednisone-Revlimid induction followed by Revlimid (MPR-R); 153 patients patients received oral melphalan-prednisone-Revlimid followed by placebo (MPR); and 154 patients received melphalan-prednisone followed by placebo (MP). The median progression-free survival was significantly longer with Revlimid maintenance therapy—the MPR-R group had a median progression-free survival of 31 months, compared to 14 months for the MPR group and 13 months for the MP group. The rate of new cancers was 7% with MPR-R, 7% with MPR, and 3% with MP.

In an accompanying editorial, Ashraf Badros notes that while Revlimid appears to offer benefit as maintenance therapy for multiple myeloma, it does come with risks, namely the increased risk of second primary cancers.[5] Furthermore, he questions whether progression-free survival is the optimal endpoint for maintenance therapy and whether it is the most cost-effective treatment.

References:

Copyright © 2012 CancerConsultants. All Rights Reserved.

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:

Copyright © 2012 CancerConsultants. All Rights Reserved.

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.

Copyright © 2012 CancerConnect Last updated 05/12.

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.

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