March 3, 2011 — The practicalities of molecular testing, the "revamped" treatment of castration-resistant metastatic prostate cancer, and negotiating the goals of advanced cancer care are among the notable topics at the National Comprehensive Cancer Network (NCCN) 16th Annual Conference: Clinical Practice Guidelines & Quality Cancer Care, being held March 9 to 13 in Hollywood, Florida.
The meeting also includes sessions that will update NCCN guidelines for the following cancers: breast, head and neck, nonsmall-cell lung cancer, multiple myeloma, non-Hodgkin's lymphoma, chronic myelogenous leukemia G, melanoma, sarcoma, prostate, and ovarian.
Other sessions include presentations on newer techniques in radiation oncology and hepatitis B screening and chemotherapy.
The meeting will feature, for the sixth consecutive year, a roundtable discussion led by veteran ABC News journalist Sam Donaldson, who is a cancer survivor. This year's topic is "The Many Faces and Challenges of Caregivers."
The roundtable kicks off the conference and is one of the hallmarks of the annual event, as it brings together an eclectic group of people to discuss a cancer topic, often in a highly personal way. The session always features celebrities, whose public lives seem to provide a unifying sense of collective experience.
This year's roundtable panelists are:
In one of the meeting's roundtable discussions, a group of experts will discuss molecular testing in oncology.
"The intent of the session is to discuss how we are moving further along the path of individualized medicine," said panel member Michael Kolodziej, MD, from Innovent Oncology, a division of US Oncology in Woodlands, Texas.
Dr. Kolodziej reported that he will play the role of the skeptic in the discussion. "The value of molecular testing has yet to proven," he told Medscape Medical News.
Dr. Kolodziej is also a community-based clinician at New York Hematology-Oncology in Albany, and will bring that perspective to the table.
He believes that the promise of molecular testing currently does not jive with its practicalities for community-based clinicians.
He offered the example of one of his patients — a female nonsmoker diagnosed with nonsmall-cell lung cancer. Because she fit the profile of patients who have tumors that might have a rearrangement of the ALK gene, and therefore might benefit from the investigational drug crizotinib (Pfizer), the woman was a candidate for genotyping of her lung tumor tissue.
The patient could not go to Memorial Sloan-Kettering Cancer Center in New York City for the genotyping process, so Dr. Kolodziej needed a commercial lab for the job. "There are only 1 or 2 commercial labs in the whole country that do the test," he said.
There were also "regulatory hurdles" (the state of New York restricts the types of medical tests that can be done) and insurance problems (insurance companies do not recognize some tests, especially ones related to investigational agents), Dr. Kolodziej noted.
"It took weeks to get this sorted out," he said. In the end, the patient did not have the genotype suited for treatment with crizotinib.
Similar problems with timing exist for a gene test in lung cancer that looks for a mutation of the epidermal growth-factor receptor (EGFR), which indicates potential benefit from targeted therapy with an EGFR inhibitor — a problem that Medscape Medical News has previously reported.
Prostate Cancer Notes
"We have completely revamped systemic therapy for castration-resistant metastatic prostate cancer," said James Mohler, MD, chair of the NCCN prostate cancer panel. The revamping includes 2 new treatments and a new agent for the prevention of skeletal-related events, said Dr. Mohler, who is from Roswell Park Cancer Institute in Buffalo, New York.
One of the new treatments is an immunotherapy — sipuleucel-T (Provenge, Dendreon) — which, according to the NCCN, should be considered for asymptomatic men with castration-resistant metastatic prostate cancer.
These men should have a good performance status, an estimated life expectancy of more than 6 months, and no visceral disease.
Sipuleucel-T has been shown in a phase 3 trial to extend survival; mean survival was 21.7 months in the control group and 25.8 months in the treatment group (a 22% reduction in mortality risk).
Symptomatic men in this setting should still first be considered for chemotherapy (docetaxel and prednisone every 3 weeks), according to the guideline.
For a man who fails docetaxel, there is a new second-line option — cabazitaxel (Jevtana, Sanofi-Aventis).
Cabazitaxel has been shown in a phase 3 trial to prolong overall survival; median survival was 15.1 months in the cabazitaxel group and 12.7 months in the mitoxantrone group.
There are limitations to who can be prescribed cabazitaxel, according to the NCCN; patients selected for treatment should be without severe neuropathy and have adequate liver, kidney, and bone marrow function, "given the high risk of neutropenia and other side effects in this population."
Finally, for men with castration-resistant metastatic prostate cancer, the NCCN panel now recommends denosumab as an alternative to zoledronic acid for the prevention of skeletal-related events. A phase 3 study showed denosumab to be the superior agent in some regards, said Dr. Mohler. However, all patients on denosumab should be treated with vitamin D and calcium and undergo periodic monitoring of serum calcium levels because of the risk for hypocalcemia.
Last year, the NCCN made news by recommending, for the first time, active surveillance as the sole initial treatment for men with low-risk and very-low-risk prostate cancer. The guideline was "ahead of its time," said Dr. Mohler at the 2010 meeting.
This year, there is a major change to the active surveillance section of the guideline, Dr. Mohler told Medscape Medical News. "Active surveillance monitoring has been made more rigorous," he explained.
The tightening of monitoring includes a number of new recommendations.
The guideline now advises clinicians that, when the initial biopsy is more than 10 cores, repeat biopsy should be performed within 18 months. When the initial biopsy is fewer than 10 cores, a repeat biopsy should be performed within 6 months of diagnosis. However, for all patients, physicians should "consider" a repeat prostate biopsy as often as 12 months as part of ongoing active surveillance, according to the guideline. The guideline also suggests that a prostate-specific antigen test be performed as often as every 3 months, but at least every 6 months. Also, a digital rectal exam should be performed as often as every 6 months, and at least every 12 months.
Dr. Mohler noted that this guidance contains "consensus recommendations" — in other words, they are not based on evidence from trials.
"It's very hard to provide concrete guidance because of the lack of evidence," he admitted. As it currently stands, the guidance for active surveillance has a long way to go, Dr. Mohler said.
"We hope to do more for patients and urologists to establish the best possible schedule to detect prostate cancer progression," he said. Some such evidence will eventually come from the Surveillance Therapy Against Radical Treatment (START) trial, the first-ever North American phase 3 trial comparing active surveillance with mainstay treatments. The trial is still enrolling patients, but the enrolment is going "horribly," said Dr. Mohler, because of patient apprehensions about active surveillance.
For a variety of reasons, active surveillance is not catching on in the United States as well as it is in other countries. For instance, the conversion rate from surveillance to treatment because of patient anxiety is only about 10% among Canadians in a Toronto-based cohort. In the United States, the conversion rate in 2 different programs — in Baltimore, Maryland and San Francisco, California — is roughly 33%, said Dr. Mohler.
The meeting also includes sessions that will update NCCN guidelines for the following cancers: breast, head and neck, nonsmall-cell lung cancer, multiple myeloma, non-Hodgkin's lymphoma, chronic myelogenous leukemia G, melanoma, sarcoma, prostate, and ovarian.
Other sessions include presentations on newer techniques in radiation oncology and hepatitis B screening and chemotherapy.
The meeting will feature, for the sixth consecutive year, a roundtable discussion led by veteran ABC News journalist Sam Donaldson, who is a cancer survivor. This year's topic is "The Many Faces and Challenges of Caregivers."
The roundtable kicks off the conference and is one of the hallmarks of the annual event, as it brings together an eclectic group of people to discuss a cancer topic, often in a highly personal way. The session always features celebrities, whose public lives seem to provide a unifying sense of collective experience.
This year's roundtable panelists are:
- Bill Cowher, former coach of the Pittsburgh Steelers, whose wife Kaye recently died from melanoma
- Suzanne Daulerio, daughter of the late Pat Daulerio, a longtime NCCN staff member
- Jai Pausch, wife of the late Randy Pausch, an academic perhaps best known for his iconic "last lecture," written when he was terminally ill with pancreatic cancer
- Charlie "Chaz" Ebert, wife of Roger Ebert, who has been treated for salivary gland cancer
- Priscilla Mack, breast cancer survivor and wife of Sen. Connie Mack
- Mary Beth Reardon, RN, MS, from the H. Lee Moffitt Cancer Center & Research Institute in Tampa Bay, Florida
- Liz Scott, mother of the late Alex Scott, creator of Alex's Lemonade Stand Foundation, who died from neuroblastoma
- Samuel M. Silver, MD, PhD, from the University of Michigan Comprehensive Cancer Center in Ann Arbor
- Jill Ellen Snow, wife of the late Tony Snow, former White House press secretary who died from colon cancer.
In one of the meeting's roundtable discussions, a group of experts will discuss molecular testing in oncology.
"The intent of the session is to discuss how we are moving further along the path of individualized medicine," said panel member Michael Kolodziej, MD, from Innovent Oncology, a division of US Oncology in Woodlands, Texas.
Dr. Kolodziej reported that he will play the role of the skeptic in the discussion. "The value of molecular testing has yet to proven," he told Medscape Medical News.
Dr. Kolodziej is also a community-based clinician at New York Hematology-Oncology in Albany, and will bring that perspective to the table.
He believes that the promise of molecular testing currently does not jive with its practicalities for community-based clinicians.
He offered the example of one of his patients — a female nonsmoker diagnosed with nonsmall-cell lung cancer. Because she fit the profile of patients who have tumors that might have a rearrangement of the ALK gene, and therefore might benefit from the investigational drug crizotinib (Pfizer), the woman was a candidate for genotyping of her lung tumor tissue.
The patient could not go to Memorial Sloan-Kettering Cancer Center in New York City for the genotyping process, so Dr. Kolodziej needed a commercial lab for the job. "There are only 1 or 2 commercial labs in the whole country that do the test," he said.
There were also "regulatory hurdles" (the state of New York restricts the types of medical tests that can be done) and insurance problems (insurance companies do not recognize some tests, especially ones related to investigational agents), Dr. Kolodziej noted.
"It took weeks to get this sorted out," he said. In the end, the patient did not have the genotype suited for treatment with crizotinib.
Similar problems with timing exist for a gene test in lung cancer that looks for a mutation of the epidermal growth-factor receptor (EGFR), which indicates potential benefit from targeted therapy with an EGFR inhibitor — a problem that Medscape Medical News has previously reported.
Prostate Cancer Notes
"We have completely revamped systemic therapy for castration-resistant metastatic prostate cancer," said James Mohler, MD, chair of the NCCN prostate cancer panel. The revamping includes 2 new treatments and a new agent for the prevention of skeletal-related events, said Dr. Mohler, who is from Roswell Park Cancer Institute in Buffalo, New York.
One of the new treatments is an immunotherapy — sipuleucel-T (Provenge, Dendreon) — which, according to the NCCN, should be considered for asymptomatic men with castration-resistant metastatic prostate cancer.
These men should have a good performance status, an estimated life expectancy of more than 6 months, and no visceral disease.
Sipuleucel-T has been shown in a phase 3 trial to extend survival; mean survival was 21.7 months in the control group and 25.8 months in the treatment group (a 22% reduction in mortality risk).
Symptomatic men in this setting should still first be considered for chemotherapy (docetaxel and prednisone every 3 weeks), according to the guideline.
For a man who fails docetaxel, there is a new second-line option — cabazitaxel (Jevtana, Sanofi-Aventis).
Cabazitaxel has been shown in a phase 3 trial to prolong overall survival; median survival was 15.1 months in the cabazitaxel group and 12.7 months in the mitoxantrone group.
There are limitations to who can be prescribed cabazitaxel, according to the NCCN; patients selected for treatment should be without severe neuropathy and have adequate liver, kidney, and bone marrow function, "given the high risk of neutropenia and other side effects in this population."
Finally, for men with castration-resistant metastatic prostate cancer, the NCCN panel now recommends denosumab as an alternative to zoledronic acid for the prevention of skeletal-related events. A phase 3 study showed denosumab to be the superior agent in some regards, said Dr. Mohler. However, all patients on denosumab should be treated with vitamin D and calcium and undergo periodic monitoring of serum calcium levels because of the risk for hypocalcemia.
Last year, the NCCN made news by recommending, for the first time, active surveillance as the sole initial treatment for men with low-risk and very-low-risk prostate cancer. The guideline was "ahead of its time," said Dr. Mohler at the 2010 meeting.
This year, there is a major change to the active surveillance section of the guideline, Dr. Mohler told Medscape Medical News. "Active surveillance monitoring has been made more rigorous," he explained.
The tightening of monitoring includes a number of new recommendations.
The guideline now advises clinicians that, when the initial biopsy is more than 10 cores, repeat biopsy should be performed within 18 months. When the initial biopsy is fewer than 10 cores, a repeat biopsy should be performed within 6 months of diagnosis. However, for all patients, physicians should "consider" a repeat prostate biopsy as often as 12 months as part of ongoing active surveillance, according to the guideline. The guideline also suggests that a prostate-specific antigen test be performed as often as every 3 months, but at least every 6 months. Also, a digital rectal exam should be performed as often as every 6 months, and at least every 12 months.
Dr. Mohler noted that this guidance contains "consensus recommendations" — in other words, they are not based on evidence from trials.
"It's very hard to provide concrete guidance because of the lack of evidence," he admitted. As it currently stands, the guidance for active surveillance has a long way to go, Dr. Mohler said.
"We hope to do more for patients and urologists to establish the best possible schedule to detect prostate cancer progression," he said. Some such evidence will eventually come from the Surveillance Therapy Against Radical Treatment (START) trial, the first-ever North American phase 3 trial comparing active surveillance with mainstay treatments. The trial is still enrolling patients, but the enrolment is going "horribly," said Dr. Mohler, because of patient apprehensions about active surveillance.
For a variety of reasons, active surveillance is not catching on in the United States as well as it is in other countries. For instance, the conversion rate from surveillance to treatment because of patient anxiety is only about 10% among Canadians in a Toronto-based cohort. In the United States, the conversion rate in 2 different programs — in Baltimore, Maryland and San Francisco, California — is roughly 33%, said Dr. Mohler.
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