Lymphoma & Plasma Cell Disorders

Routine surveillance with computed tomography scans add little to the surveillance of patients in remission from diffuse large B-cell lymphoma, a large epidemiologic study shows.

Planned CT scans detected diffuse large B-cell lymphoma (DLBCL) relapse prior to clinical symptoms or signs in only 8 of the 537 (1.5%) patients who entered post-treatment surveillance.

The vast majority (62%) of relapses were detected by patients who contacted their provider because of symptoms before their planned visit, according to lead author Dr. Carrie A. Thompson, a hematologist at Mayo Clinic, Rochester, Minn.

"The take-home point is that the majority of relapses occur outside of planned follow-up visits and are accompanied by symptoms, exam or lab abnormalities," she said. "In this study, scheduled scans added little to patients who had none of the above."

She noted that DLBCL patients in remission in the United States undergo a median of 2.5 CT or positron emission tomography scans per year during surveillance, according to a recent study (Leuk. Lymphoma 2012;53:1113-6). Moreover, only 4.2% of patients in the series received no imaging.

DLBCL is the most common form of non-Hodgkin lymphoma, with about 20,000 new cases diagnosed each year in the United States. It is an aggressive lymphoma, but is potentially curable with chemotherapy. Post-treatment surveillance is necessary, but the optimal strategy is unclear, she explained at a press briefing highlighting studies at the upcoming American Society of Clinical Oncology (ASCO) meeting.

The National Comprehensive Cancer Network recommends that patients be evaluated every 3-6 months for 5 years, with a CT scan no more often than every 6 months for the first 2 years after treatment completion, and then as clinically indicated.

The investigators enrolled 644 patients with biopsy-proven DLBCL treated with anthracycline-based chemotherapy in the University of Iowa/Mayo Clinic SPORE (Specialized Programs of Research Excellence) Molecular Epidemiology Resource, a prospective cohort of newly diagnosed lymphoma patients. Their median age was 63 years (range 18-92), 54% were men, and median follow-up was 59 months (range 8-116). Overall disease management and follow-up was at the discretion of their hematologist/oncologist.

Of the 537 patients who entered surveillance, 109 (20%) relapsed. Medical records were available in 100 patients.

Of the 38 patients with relapse detected at a planned visit, 26 had an abnormal physical exam and/or labs, Dr. Thompson said. The remaining 12 patients were asymptomatic, and their relapses were detected solely by CT scan. "It is noteworthy that four of these relapses turned out to be another form of lymphoma, not diffuse B-cell lymphoma," she added.

Although the data show that scans detected relapses in a minority of patients, it is too early to say definitively how many scans are needed or how often they should be done, Dr. Thompson told reporters.

"I think it’s very interesting, it’s very provocative, but what I would like to see is a randomized study to determine just what the best surveillance strategy is in this disease," she said. "Is it scheduled scans, as we currently do, or clinically directed scans, where we only do a scan when a patient has new symptoms or abnormal findings on clinical exam or laboratory findings?"

Incoming ASCO president Clifford Hudis, chief of the breast cancer medicine service at Memorial Sloan-Kettering Cancer Center in New York, observed that the low 1.5% rate of CT-detected relapse mirrors what has been observed in other common malignancies.

"These findings will help physicians develop guidelines for following patients who are in remission from DLBCL and will spare patients from the costs and excessive radiation exposure of unnecessary CT scans, not to mention the impact of false-positive findings on such scans," Dr. Hudis said.

Dr. Thomson reported having no financial disclosures.

[email protected]

Routine surveillance with computed tomography scans add little to the surveillance of patients in remission from diffuse large B-cell lymphoma, a large epidemiologic study shows.

Planned CT scans detected diffuse large B-cell lymphoma (DLBCL) relapse prior to clinical symptoms or signs in only 8 of the 537 (1.5%) patients who entered post-treatment surveillance.

The vast majority (62%) of relapses were detected by patients who contacted their provider because of symptoms before their planned visit, according to lead author Dr. Carrie A. Thompson, a hematologist at Mayo Clinic, Rochester, Minn.

"The take-home point is that the majority of relapses occur outside of planned follow-up visits and are accompanied by symptoms, exam or lab abnormalities," she said. "In this study, scheduled scans added little to patients who had none of the above."

She noted that DLBCL patients in remission in the United States undergo a median of 2.5 CT or positron emission tomography scans per year during surveillance, according to a recent study (Leuk. Lymphoma 2012;53:1113-6). Moreover, only 4.2% of patients in the series received no imaging.

DLBCL is the most common form of non-Hodgkin lymphoma, with about 20,000 new cases diagnosed each year in the United States. It is an aggressive lymphoma, but is potentially curable with chemotherapy. Post-treatment surveillance is necessary, but the optimal strategy is unclear, she explained at a press briefing highlighting studies at the upcoming American Society of Clinical Oncology (ASCO) meeting.

The National Comprehensive Cancer Network recommends that patients be evaluated every 3-6 months for 5 years, with a CT scan no more often than every 6 months for the first 2 years after treatment completion, and then as clinically indicated.

The investigators enrolled 644 patients with biopsy-proven DLBCL treated with anthracycline-based chemotherapy in the University of Iowa/Mayo Clinic SPORE (Specialized Programs of Research Excellence) Molecular Epidemiology Resource, a prospective cohort of newly diagnosed lymphoma patients. Their median age was 63 years (range 18-92), 54% were men, and median follow-up was 59 months (range 8-116). Overall disease management and follow-up was at the discretion of their hematologist/oncologist.

Of the 537 patients who entered surveillance, 109 (20%) relapsed. Medical records were available in 100 patients.

Of the 38 patients with relapse detected at a planned visit, 26 had an abnormal physical exam and/or labs, Dr. Thompson said. The remaining 12 patients were asymptomatic, and their relapses were detected solely by CT scan. "It is noteworthy that four of these relapses turned out to be another form of lymphoma, not diffuse B-cell lymphoma," she added.

Although the data show that scans detected relapses in a minority of patients, it is too early to say definitively how many scans are needed or how often they should be done, Dr. Thompson told reporters.

"I think it’s very interesting, it’s very provocative, but what I would like to see is a randomized study to determine just what the best surveillance strategy is in this disease," she said. "Is it scheduled scans, as we currently do, or clinically directed scans, where we only do a scan when a patient has new symptoms or abnormal findings on clinical exam or laboratory findings?"

Incoming ASCO president Clifford Hudis, chief of the breast cancer medicine service at Memorial Sloan-Kettering Cancer Center in New York, observed that the low 1.5% rate of CT-detected relapse mirrors what has been observed in other common malignancies.

"These findings will help physicians develop guidelines for following patients who are in remission from DLBCL and will spare patients from the costs and excessive radiation exposure of unnecessary CT scans, not to mention the impact of false-positive findings on such scans," Dr. Hudis said.

Dr. Thomson reported having no financial disclosures.

[email protected]

Routine surveillance with computed tomography scans add little to the surveillance of patients in remission from diffuse large B-cell lymphoma, a large epidemiologic study shows.

Planned CT scans detected diffuse large B-cell lymphoma (DLBCL) relapse prior to clinical symptoms or signs in only 8 of the 537 (1.5%) patients who entered post-treatment surveillance.

The vast majority (62%) of relapses were detected by patients who contacted their provider because of symptoms before their planned visit, according to lead author Dr. Carrie A. Thompson, a hematologist at Mayo Clinic, Rochester, Minn.

"The take-home point is that the majority of relapses occur outside of planned follow-up visits and are accompanied by symptoms, exam or lab abnormalities," she said. "In this study, scheduled scans added little to patients who had none of the above."

She noted that DLBCL patients in remission in the United States undergo a median of 2.5 CT or positron emission tomography scans per year during surveillance, according to a recent study (Leuk. Lymphoma 2012;53:1113-6). Moreover, only 4.2% of patients in the series received no imaging.

DLBCL is the most common form of non-Hodgkin lymphoma, with about 20,000 new cases diagnosed each year in the United States. It is an aggressive lymphoma, but is potentially curable with chemotherapy. Post-treatment surveillance is necessary, but the optimal strategy is unclear, she explained at a press briefing highlighting studies at the upcoming American Society of Clinical Oncology (ASCO) meeting.

The National Comprehensive Cancer Network recommends that patients be evaluated every 3-6 months for 5 years, with a CT scan no more often than every 6 months for the first 2 years after treatment completion, and then as clinically indicated.

The investigators enrolled 644 patients with biopsy-proven DLBCL treated with anthracycline-based chemotherapy in the University of Iowa/Mayo Clinic SPORE (Specialized Programs of Research Excellence) Molecular Epidemiology Resource, a prospective cohort of newly diagnosed lymphoma patients. Their median age was 63 years (range 18-92), 54% were men, and median follow-up was 59 months (range 8-116). Overall disease management and follow-up was at the discretion of their hematologist/oncologist.

Of the 537 patients who entered surveillance, 109 (20%) relapsed. Medical records were available in 100 patients.

Of the 38 patients with relapse detected at a planned visit, 26 had an abnormal physical exam and/or labs, Dr. Thompson said. The remaining 12 patients were asymptomatic, and their relapses were detected solely by CT scan. "It is noteworthy that four of these relapses turned out to be another form of lymphoma, not diffuse B-cell lymphoma," she added.

Although the data show that scans detected relapses in a minority of patients, it is too early to say definitively how many scans are needed or how often they should be done, Dr. Thompson told reporters.

"I think it’s very interesting, it’s very provocative, but what I would like to see is a randomized study to determine just what the best surveillance strategy is in this disease," she said. "Is it scheduled scans, as we currently do, or clinically directed scans, where we only do a scan when a patient has new symptoms or abnormal findings on clinical exam or laboratory findings?"

Incoming ASCO president Clifford Hudis, chief of the breast cancer medicine service at Memorial Sloan-Kettering Cancer Center in New York, observed that the low 1.5% rate of CT-detected relapse mirrors what has been observed in other common malignancies.

"These findings will help physicians develop guidelines for following patients who are in remission from DLBCL and will spare patients from the costs and excessive radiation exposure of unnecessary CT scans, not to mention the impact of false-positive findings on such scans," Dr. Hudis said.

Dr. Thomson reported having no financial disclosures.

[email protected]

BUENOS AIRES – Incidences of certain cancers, particularly lymphomas, have been shown to be higher in people with systemic lupus erythematosus, while hormone-influenced breast, ovarian, and endometrial cancers have recently been found to occur less often in SLE patients than in the general population.

At the 10th International Congress on SLE, the researchers responsible for these findings discussed their implications for clinical practice.

Dr. Ann Clarke of McGill University, Montreal, coauthor of a large case-cohort study that found neither immunosuppressant drug use nor disease activity correlated with lymphoma risk as hypothesized (Ann. Rheum. Dis. 2013 Jan. 8 [doi:10.1136/annrheumdis-2012-202099]), said that clinicians should nonetheless consider a history of malignancies when deciding whether to prescribe immunosuppressants.

The study by Dr. Clarke and her colleagues, led by Dr. Sasha Bernatsky of McGill, enrolled 75 SLE patients with lymphoma and 4,961 cancer-free controls with SLE, seeking to determine associations between lymphoma risk and exposures to cyclophosphamide, azathioprine, methotrexate, mycophenolate, antimalarials, or steroids. The team also looked at Sjögren’s syndrome, disease duration, and disease activity as potential indicators of risk.

Although cyclophosphamide use was seen more frequently among the lymphoma cases (20%) than in the controls (16.8%), this difference did not reach statistical significance. "There isn’t a strong signal that the drugs are responsible," Dr. Clarke said, but she nonetheless argued for caution in the clinic.

"If there is a remote history of malignancy – more than 5 years, certainly more than 10 – I would proceed [with immunosuppressants]," she said. "If there is a recent history, I would try to avoid them, using rituximab or belimumab as appropriate."

Dr. Clarke’s team, again led by Dr. Bernatsky, also conducted research that examined the incidence of specific cancers in an international cohort of 16,409 patients with SLE (J. Autoimmun. 2013 Feb. 11 [doi:10.1016/j.jaut.2012.12.009]).

This study showed that lupus patients had a threefold higher risk for hematological cancers, especially non-Hodgkin’s lymphoma, and a slightly elevated risk for cancer overall, but saw fewer hormone-sensitive cancers than expected, with the standardized incidence ratio of 0.73 for breast cancers (95% confidence interval [CI], 0.61-0.88), 0.44 for endometrial cancers (95% CI, 0.23-0.77), and 0.64 for ovarian cancers (95% CI, 0.34-1.10).

"There certainly seems to be a convincing signal that female hormone-sensitive cancers appear to be decreased in patients with lupus," said Dr. Clarke, who is also codirector of the lupus clinic at Montreal General Hospital. She said that there are various hypotheses as to why, including animal models that suggest that anti-DNA antibodies could have antitumor effects against certain cancer cell lines (Sci. Transl. Med. 2012;4:157ra142).

"I don’t think this should give us a false sense of reassurance," Dr. Clarke said of the findings, noting that vulvar cancers, likely resulting from HPV infection, were seen as increased in lupus patients and that cervical dysplasia was known to be increased as well.

"I think we still have to screen for breast cancer. And I think that this risk for dysplasia calls us to be even more vigilant than current recommendations," she said.

In a related talk, Dr. Murray B. Urowitz, director of the Centre for Prognosis Studies in the Rheumatic Diseases at Toronto Western Research Institute and a coauthor on both studies, praised Dr. Clarke and colleagues’ malignancy findings as "very important."

"The expected numbers of malignancy in this tremendous number of patients was 561," Dr. Urowitz said at the meeting, referring to the large cohort study. "And the observed number was 644, with the driver being hematologic malignancies." He noted that only age and male gender were found to be predictive factors.

The lower-than expected incidence of hormone-sensitive cancers in the same cohort study, Dr. Urowitz said, was yet another mystery. "Is there a hormonal factor favoring the lupus patient – less total estrogen over her lifetime, less likely to get hormone replacement? Maybe, but the decreased risk seen in SLE is evident in both pre- and postmenopausal lupus. Could it be genetic? It’s unclear. There [are] some very exciting data that anti-DNA antibody may actually be protective, but that’s still in the very early phases."

Dr. Urowitz, Dr. Clarke, and Dr. Bernatsky did not disclose financial relationships bearing on their studies.

BUENOS AIRES – Incidences of certain cancers, particularly lymphomas, have been shown to be higher in people with systemic lupus erythematosus, while hormone-influenced breast, ovarian, and endometrial cancers have recently been found to occur less often in SLE patients than in the general population.

At the 10th International Congress on SLE, the researchers responsible for these findings discussed their implications for clinical practice.

Dr. Ann Clarke of McGill University, Montreal, coauthor of a large case-cohort study that found neither immunosuppressant drug use nor disease activity correlated with lymphoma risk as hypothesized (Ann. Rheum. Dis. 2013 Jan. 8 [doi:10.1136/annrheumdis-2012-202099]), said that clinicians should nonetheless consider a history of malignancies when deciding whether to prescribe immunosuppressants.

The study by Dr. Clarke and her colleagues, led by Dr. Sasha Bernatsky of McGill, enrolled 75 SLE patients with lymphoma and 4,961 cancer-free controls with SLE, seeking to determine associations between lymphoma risk and exposures to cyclophosphamide, azathioprine, methotrexate, mycophenolate, antimalarials, or steroids. The team also looked at Sjögren’s syndrome, disease duration, and disease activity as potential indicators of risk.

Although cyclophosphamide use was seen more frequently among the lymphoma cases (20%) than in the controls (16.8%), this difference did not reach statistical significance. "There isn’t a strong signal that the drugs are responsible," Dr. Clarke said, but she nonetheless argued for caution in the clinic.

"If there is a remote history of malignancy – more than 5 years, certainly more than 10 – I would proceed [with immunosuppressants]," she said. "If there is a recent history, I would try to avoid them, using rituximab or belimumab as appropriate."

Dr. Clarke’s team, again led by Dr. Bernatsky, also conducted research that examined the incidence of specific cancers in an international cohort of 16,409 patients with SLE (J. Autoimmun. 2013 Feb. 11 [doi:10.1016/j.jaut.2012.12.009]).

This study showed that lupus patients had a threefold higher risk for hematological cancers, especially non-Hodgkin’s lymphoma, and a slightly elevated risk for cancer overall, but saw fewer hormone-sensitive cancers than expected, with the standardized incidence ratio of 0.73 for breast cancers (95% confidence interval [CI], 0.61-0.88), 0.44 for endometrial cancers (95% CI, 0.23-0.77), and 0.64 for ovarian cancers (95% CI, 0.34-1.10).

"There certainly seems to be a convincing signal that female hormone-sensitive cancers appear to be decreased in patients with lupus," said Dr. Clarke, who is also codirector of the lupus clinic at Montreal General Hospital. She said that there are various hypotheses as to why, including animal models that suggest that anti-DNA antibodies could have antitumor effects against certain cancer cell lines (Sci. Transl. Med. 2012;4:157ra142).

"I don’t think this should give us a false sense of reassurance," Dr. Clarke said of the findings, noting that vulvar cancers, likely resulting from HPV infection, were seen as increased in lupus patients and that cervical dysplasia was known to be increased as well.

"I think we still have to screen for breast cancer. And I think that this risk for dysplasia calls us to be even more vigilant than current recommendations," she said.

In a related talk, Dr. Murray B. Urowitz, director of the Centre for Prognosis Studies in the Rheumatic Diseases at Toronto Western Research Institute and a coauthor on both studies, praised Dr. Clarke and colleagues’ malignancy findings as "very important."

"The expected numbers of malignancy in this tremendous number of patients was 561," Dr. Urowitz said at the meeting, referring to the large cohort study. "And the observed number was 644, with the driver being hematologic malignancies." He noted that only age and male gender were found to be predictive factors.

The lower-than expected incidence of hormone-sensitive cancers in the same cohort study, Dr. Urowitz said, was yet another mystery. "Is there a hormonal factor favoring the lupus patient – less total estrogen over her lifetime, less likely to get hormone replacement? Maybe, but the decreased risk seen in SLE is evident in both pre- and postmenopausal lupus. Could it be genetic? It’s unclear. There [are] some very exciting data that anti-DNA antibody may actually be protective, but that’s still in the very early phases."

Dr. Urowitz, Dr. Clarke, and Dr. Bernatsky did not disclose financial relationships bearing on their studies.

BUENOS AIRES – Incidences of certain cancers, particularly lymphomas, have been shown to be higher in people with systemic lupus erythematosus, while hormone-influenced breast, ovarian, and endometrial cancers have recently been found to occur less often in SLE patients than in the general population.

At the 10th International Congress on SLE, the researchers responsible for these findings discussed their implications for clinical practice.

Dr. Ann Clarke of McGill University, Montreal, coauthor of a large case-cohort study that found neither immunosuppressant drug use nor disease activity correlated with lymphoma risk as hypothesized (Ann. Rheum. Dis. 2013 Jan. 8 [doi:10.1136/annrheumdis-2012-202099]), said that clinicians should nonetheless consider a history of malignancies when deciding whether to prescribe immunosuppressants.

The study by Dr. Clarke and her colleagues, led by Dr. Sasha Bernatsky of McGill, enrolled 75 SLE patients with lymphoma and 4,961 cancer-free controls with SLE, seeking to determine associations between lymphoma risk and exposures to cyclophosphamide, azathioprine, methotrexate, mycophenolate, antimalarials, or steroids. The team also looked at Sjögren’s syndrome, disease duration, and disease activity as potential indicators of risk.

Although cyclophosphamide use was seen more frequently among the lymphoma cases (20%) than in the controls (16.8%), this difference did not reach statistical significance. "There isn’t a strong signal that the drugs are responsible," Dr. Clarke said, but she nonetheless argued for caution in the clinic.

"If there is a remote history of malignancy – more than 5 years, certainly more than 10 – I would proceed [with immunosuppressants]," she said. "If there is a recent history, I would try to avoid them, using rituximab or belimumab as appropriate."

Dr. Clarke’s team, again led by Dr. Bernatsky, also conducted research that examined the incidence of specific cancers in an international cohort of 16,409 patients with SLE (J. Autoimmun. 2013 Feb. 11 [doi:10.1016/j.jaut.2012.12.009]).

This study showed that lupus patients had a threefold higher risk for hematological cancers, especially non-Hodgkin’s lymphoma, and a slightly elevated risk for cancer overall, but saw fewer hormone-sensitive cancers than expected, with the standardized incidence ratio of 0.73 for breast cancers (95% confidence interval [CI], 0.61-0.88), 0.44 for endometrial cancers (95% CI, 0.23-0.77), and 0.64 for ovarian cancers (95% CI, 0.34-1.10).

"There certainly seems to be a convincing signal that female hormone-sensitive cancers appear to be decreased in patients with lupus," said Dr. Clarke, who is also codirector of the lupus clinic at Montreal General Hospital. She said that there are various hypotheses as to why, including animal models that suggest that anti-DNA antibodies could have antitumor effects against certain cancer cell lines (Sci. Transl. Med. 2012;4:157ra142).

"I don’t think this should give us a false sense of reassurance," Dr. Clarke said of the findings, noting that vulvar cancers, likely resulting from HPV infection, were seen as increased in lupus patients and that cervical dysplasia was known to be increased as well.

"I think we still have to screen for breast cancer. And I think that this risk for dysplasia calls us to be even more vigilant than current recommendations," she said.

In a related talk, Dr. Murray B. Urowitz, director of the Centre for Prognosis Studies in the Rheumatic Diseases at Toronto Western Research Institute and a coauthor on both studies, praised Dr. Clarke and colleagues’ malignancy findings as "very important."

"The expected numbers of malignancy in this tremendous number of patients was 561," Dr. Urowitz said at the meeting, referring to the large cohort study. "And the observed number was 644, with the driver being hematologic malignancies." He noted that only age and male gender were found to be predictive factors.

The lower-than expected incidence of hormone-sensitive cancers in the same cohort study, Dr. Urowitz said, was yet another mystery. "Is there a hormonal factor favoring the lupus patient – less total estrogen over her lifetime, less likely to get hormone replacement? Maybe, but the decreased risk seen in SLE is evident in both pre- and postmenopausal lupus. Could it be genetic? It’s unclear. There [are] some very exciting data that anti-DNA antibody may actually be protective, but that’s still in the very early phases."

Dr. Urowitz, Dr. Clarke, and Dr. Bernatsky did not disclose financial relationships bearing on their studies.

Community Oncology editor Dr. David Henry spoke with Dr. Kenneth Anderson at the Oncology Practice Summit in Las Vegas about the antibody elotuzumab in the treatment of relapsed or refractory multiple myeloma. He notes that as a single agent, the anti-CS humanized monoclonal antibody can achieve stable disease and when used in combination with lenalidomide and low-dose dexamethasone early findings suggest a response rate of 80%-90% and a near doubling of progression-free survival.

The Oncology Practice Summit was the 8th annual meeting of Community Oncology, the journal of clinical issues in community practice.  Dr. Henry was a co-chair of the Summit, which was hosted this year by Community Oncology as well as The Journal of Supportive Oncology, and The Oncology Report.

Community Oncology editor Dr. David Henry spoke with Dr. Kenneth Anderson at the Oncology Practice Summit in Las Vegas about the antibody elotuzumab in the treatment of relapsed or refractory multiple myeloma. He notes that as a single agent, the anti-CS humanized monoclonal antibody can achieve stable disease and when used in combination with lenalidomide and low-dose dexamethasone early findings suggest a response rate of 80%-90% and a near doubling of progression-free survival.

The Oncology Practice Summit was the 8th annual meeting of Community Oncology, the journal of clinical issues in community practice.  Dr. Henry was a co-chair of the Summit, which was hosted this year by Community Oncology as well as The Journal of Supportive Oncology, and The Oncology Report.

Community Oncology editor Dr. David Henry spoke with Dr. Kenneth Anderson at the Oncology Practice Summit in Las Vegas about the antibody elotuzumab in the treatment of relapsed or refractory multiple myeloma. He notes that as a single agent, the anti-CS humanized monoclonal antibody can achieve stable disease and when used in combination with lenalidomide and low-dose dexamethasone early findings suggest a response rate of 80%-90% and a near doubling of progression-free survival.

The Oncology Practice Summit was the 8th annual meeting of Community Oncology, the journal of clinical issues in community practice.  Dr. Henry was a co-chair of the Summit, which was hosted this year by Community Oncology as well as The Journal of Supportive Oncology, and The Oncology Report.

Adding rituximab to combination chemotherapy for primary mediastinal B-cell lymphoma yields a high cure rate and may obviate the need for thoracic radiation therapy, a study has shown.

Patients in a single-group, prospective phase II study were treated with dose-adjusted etoposide, doxorubicin, cyclophosphamide with vincristine, prednisone, and rituximab (DA-EPOCH-R). All but 2 of the 51 adults with lymphoma in the study were able to forgo radiotherapy, and there were no recurrences during a median follow-up of 5 years, reported Dr. Kieron Dunleavy of the National Cancer Institute and his colleagues.

"These findings suggest that DA-EPOCH-R is a therapeutic advance for this type of lymphoma," they wrote (N. Engl. J. Med. 2013;368:1408-16 [doi:10.1056/NEJMoa1214561]).

In a previous study, Dr. Dunleavy and his colleagues found that DA-EPOCH yielded an overall survival of 79%. To examine whether the addition of rituximab would further improve outcomes, they enrolled treatment-naive patients who had masses of at least 5 cm and presented over a 13-year period.

The study patients’ median age was 30 years (range, 19-52 years), and 59% were women. Mediastinal B-cell lymphoma was advanced, with a median tumor diameter of 11 cm. Approximately 30% of patients had stage IV disease.

All 51 patients received six to eight cycles of DA-EPOCH-R. Two patients showed persistent focal disease after therapy, and one patient showed disease progression. Two of the patients then underwent mediastinal radiotherapy, and one underwent excisional biopsy. All three were disease free thereafter.

After follow-up, ranging from 3 to 156 months, overall survival was 97% and event-free survival was 93%, with no recurrences of the cancer, the investigators reported.

Primary mediastinal B-cell lymphoma develops in the thymus, "predominantly affects young women, is aggressive, and typically is manifested by a localized, bulky mediastinal mass, often with pleural and pericardial effusions," they noted. There have been few prospective studies of the disease; and the findings have been conflicting, so at present there are no treatment standards. Immunochemotherapy usually does not achieve tumor control. Mediastinal radiotherapy (associated with severe late adverse effects) after aggressive chemotherapy is the current regimen.

The toxic effects of the chemotherapy regimen were similar to other previously reported events. Neutropenia occurred during half of the chemotherapy cycles overall, thrombocytopenia occurred in 6%, and hospitalization was required for fever and neutropenia in 13% of the cycles. There were no significant cardiac toxic effects.

Dr. Dunleavy and his associates also reported the results of DA-EPOCH-R therapy in an independent retrospective cohort of 16 patients treated at Stanford (Calif.) University Medical Center during the past 5 years. All of the Stanford patients were able to forgo radiation therapy, and event-free survival was 100%.

An international trial of DA-EPOCH-R for treating children or adolescents with primary mediastinal B-cell lymphoma is currently underway (clinical trial number NCT01516567).

The study was supported by the National Cancer Institute. Amgen provided filgrastim for the study but had no involvement with study design or with data collection or analysis. The investigators reported having no relevant financial conflicts.

Adding rituximab to combination chemotherapy for primary mediastinal B-cell lymphoma yields a high cure rate and may obviate the need for thoracic radiation therapy, a study has shown.

Patients in a single-group, prospective phase II study were treated with dose-adjusted etoposide, doxorubicin, cyclophosphamide with vincristine, prednisone, and rituximab (DA-EPOCH-R). All but 2 of the 51 adults with lymphoma in the study were able to forgo radiotherapy, and there were no recurrences during a median follow-up of 5 years, reported Dr. Kieron Dunleavy of the National Cancer Institute and his colleagues.

"These findings suggest that DA-EPOCH-R is a therapeutic advance for this type of lymphoma," they wrote (N. Engl. J. Med. 2013;368:1408-16 [doi:10.1056/NEJMoa1214561]).

In a previous study, Dr. Dunleavy and his colleagues found that DA-EPOCH yielded an overall survival of 79%. To examine whether the addition of rituximab would further improve outcomes, they enrolled treatment-naive patients who had masses of at least 5 cm and presented over a 13-year period.

The study patients’ median age was 30 years (range, 19-52 years), and 59% were women. Mediastinal B-cell lymphoma was advanced, with a median tumor diameter of 11 cm. Approximately 30% of patients had stage IV disease.

All 51 patients received six to eight cycles of DA-EPOCH-R. Two patients showed persistent focal disease after therapy, and one patient showed disease progression. Two of the patients then underwent mediastinal radiotherapy, and one underwent excisional biopsy. All three were disease free thereafter.

After follow-up, ranging from 3 to 156 months, overall survival was 97% and event-free survival was 93%, with no recurrences of the cancer, the investigators reported.

Primary mediastinal B-cell lymphoma develops in the thymus, "predominantly affects young women, is aggressive, and typically is manifested by a localized, bulky mediastinal mass, often with pleural and pericardial effusions," they noted. There have been few prospective studies of the disease; and the findings have been conflicting, so at present there are no treatment standards. Immunochemotherapy usually does not achieve tumor control. Mediastinal radiotherapy (associated with severe late adverse effects) after aggressive chemotherapy is the current regimen.

The toxic effects of the chemotherapy regimen were similar to other previously reported events. Neutropenia occurred during half of the chemotherapy cycles overall, thrombocytopenia occurred in 6%, and hospitalization was required for fever and neutropenia in 13% of the cycles. There were no significant cardiac toxic effects.

Dr. Dunleavy and his associates also reported the results of DA-EPOCH-R therapy in an independent retrospective cohort of 16 patients treated at Stanford (Calif.) University Medical Center during the past 5 years. All of the Stanford patients were able to forgo radiation therapy, and event-free survival was 100%.

An international trial of DA-EPOCH-R for treating children or adolescents with primary mediastinal B-cell lymphoma is currently underway (clinical trial number NCT01516567).

The study was supported by the National Cancer Institute. Amgen provided filgrastim for the study but had no involvement with study design or with data collection or analysis. The investigators reported having no relevant financial conflicts.

Adding rituximab to combination chemotherapy for primary mediastinal B-cell lymphoma yields a high cure rate and may obviate the need for thoracic radiation therapy, a study has shown.

Patients in a single-group, prospective phase II study were treated with dose-adjusted etoposide, doxorubicin, cyclophosphamide with vincristine, prednisone, and rituximab (DA-EPOCH-R). All but 2 of the 51 adults with lymphoma in the study were able to forgo radiotherapy, and there were no recurrences during a median follow-up of 5 years, reported Dr. Kieron Dunleavy of the National Cancer Institute and his colleagues.

"These findings suggest that DA-EPOCH-R is a therapeutic advance for this type of lymphoma," they wrote (N. Engl. J. Med. 2013;368:1408-16 [doi:10.1056/NEJMoa1214561]).

In a previous study, Dr. Dunleavy and his colleagues found that DA-EPOCH yielded an overall survival of 79%. To examine whether the addition of rituximab would further improve outcomes, they enrolled treatment-naive patients who had masses of at least 5 cm and presented over a 13-year period.

The study patients’ median age was 30 years (range, 19-52 years), and 59% were women. Mediastinal B-cell lymphoma was advanced, with a median tumor diameter of 11 cm. Approximately 30% of patients had stage IV disease.

All 51 patients received six to eight cycles of DA-EPOCH-R. Two patients showed persistent focal disease after therapy, and one patient showed disease progression. Two of the patients then underwent mediastinal radiotherapy, and one underwent excisional biopsy. All three were disease free thereafter.

After follow-up, ranging from 3 to 156 months, overall survival was 97% and event-free survival was 93%, with no recurrences of the cancer, the investigators reported.

Primary mediastinal B-cell lymphoma develops in the thymus, "predominantly affects young women, is aggressive, and typically is manifested by a localized, bulky mediastinal mass, often with pleural and pericardial effusions," they noted. There have been few prospective studies of the disease; and the findings have been conflicting, so at present there are no treatment standards. Immunochemotherapy usually does not achieve tumor control. Mediastinal radiotherapy (associated with severe late adverse effects) after aggressive chemotherapy is the current regimen.

The toxic effects of the chemotherapy regimen were similar to other previously reported events. Neutropenia occurred during half of the chemotherapy cycles overall, thrombocytopenia occurred in 6%, and hospitalization was required for fever and neutropenia in 13% of the cycles. There were no significant cardiac toxic effects.

Dr. Dunleavy and his associates also reported the results of DA-EPOCH-R therapy in an independent retrospective cohort of 16 patients treated at Stanford (Calif.) University Medical Center during the past 5 years. All of the Stanford patients were able to forgo radiation therapy, and event-free survival was 100%.

An international trial of DA-EPOCH-R for treating children or adolescents with primary mediastinal B-cell lymphoma is currently underway (clinical trial number NCT01516567).

The study was supported by the National Cancer Institute. Amgen provided filgrastim for the study but had no involvement with study design or with data collection or analysis. The investigators reported having no relevant financial conflicts.

Changes in serum alpha-fetoprotein levels over time correlated with the development of hepatocellular carcinoma in hepatitis C patients, wrote Dr. Elliot Lee and his colleagues in the April 1 issue of Clinical Gastroenterology and Hepatology.*

"If confirmed in future studies, these findings could be used to develop individualized risk assessments for clinical use, which could then influence the frequency and type of further testing" in this population, added the researchers (doi:10.1016/j.cgh.2012.11.029).

In what he called "the first large study to demonstrate that patterns of AFP [alpha-fetoprotein] over time are independently associated with HCC [hepatocellular carcinoma] development," Dr. Lee of the University of Michigan, Ann Arbor, looked at patients enrolled in the HALT-C (Hepatitis C Antiviral Long-Term Treatment Against Cirrhosis) trial, in which hepatitis C patients who were nonresponders to prior antiviral therapy were randomized to receive maintenance pegylated interferon or placebo.

According to the trial protocol, patients were screened every 3 months for the first 3.5 years, then every 6 months thereafter on a voluntary basis, with levels of serum alpha-fetoprotein measured at each visit.

Patients who developed hepatocellular carcinoma were matched to controls without HCC in a 1:3 ratio according to the length of follow-up "in order to exclude bias caused by subjects with longer follow-up time having higher cumulative probability of HCC development, as well as more AFP values available," wrote the authors.

Overall, among 967 subjects with hepatitis C, 82 developed HCC during the study period, with a median of 18 (range, 5-22) AFP tests performed.

Dr. Lee then analyzed the association between the development of HCC and three AFP patterns.

First, the researchers assessed the rate of rise, defined as the patient’s final alpha-fetoprotein level (before study conclusion or HCC development, whichever came first) minus the AFP baseline value (on study entry), all over the follow-up duration divided by 90 days.

He found that this metric was associated with an odds ratio for developing HCC of 1.178 (P less than .001) in a simple logistic regression analysis that accounted for baseline risk factors only, with an area under the receiver-operating characteristic (AUROC) of 0.69.

Next, Dr. Lee calculated the standard deviation of AFP, defined as the standard deviation of all AFP values recorded within each patient.

In the same simple logistic regression, the standard deviation calculation was associated with an odds ratio of 1.026 for HCC per unit increase in standard deviation (P less than .001) and an AUROC of 0.76.

Third, Dr. Lee looked at the most recent AFP value on record. In this case, the odds ratio for developing HCC was 1.012 (also with P less than .001) and an AUROC of 0.76.

Finally, the researchers incorporated both standard deviation and rate of rise of AFP along with baseline age, platelet count, and smoking history to create a "history" model, which had an AUROC of 0.81 – an even better predictor than the models that looked only at one of those factors.

In an attempt to explain their findings, the researchers wrote, "it is intuitively evident why the rate of rise of AFP might be associated with risk of HCC development, but what might explain the association with standard deviation?"

They added, "The biologic basis is unknown, but we theorize that fluctuations in AFP may reflect cycles of damage and regeneration within the liver, and that growth factors involved in regeneration could stimulate hepatocarcinogenesis."

The authors acknowledged that the study had several limitations. "From a practical perspective, these metrics will only be useful once a patient has been followed for at least 2 years in order for the patterns to emerge," they wrote.

Additionally, "this study included only patients with hepatitis C; it is unknown whether these associations would be present among patients with other chronic liver diseases."

The authors said they had no relevant financial disclosures. They disclosed grant support from the National Science Foundation Graduate Research Fellowship.

*Correction, 3/25/2013: An earlier version of this story misstated the name of Clinical Gastroenterology and Hepatology.

Changes in serum alpha-fetoprotein levels over time correlated with the development of hepatocellular carcinoma in hepatitis C patients, wrote Dr. Elliot Lee and his colleagues in the April 1 issue of Clinical Gastroenterology and Hepatology.*

"If confirmed in future studies, these findings could be used to develop individualized risk assessments for clinical use, which could then influence the frequency and type of further testing" in this population, added the researchers (doi:10.1016/j.cgh.2012.11.029).

In what he called "the first large study to demonstrate that patterns of AFP [alpha-fetoprotein] over time are independently associated with HCC [hepatocellular carcinoma] development," Dr. Lee of the University of Michigan, Ann Arbor, looked at patients enrolled in the HALT-C (Hepatitis C Antiviral Long-Term Treatment Against Cirrhosis) trial, in which hepatitis C patients who were nonresponders to prior antiviral therapy were randomized to receive maintenance pegylated interferon or placebo.

According to the trial protocol, patients were screened every 3 months for the first 3.5 years, then every 6 months thereafter on a voluntary basis, with levels of serum alpha-fetoprotein measured at each visit.

Patients who developed hepatocellular carcinoma were matched to controls without HCC in a 1:3 ratio according to the length of follow-up "in order to exclude bias caused by subjects with longer follow-up time having higher cumulative probability of HCC development, as well as more AFP values available," wrote the authors.

Overall, among 967 subjects with hepatitis C, 82 developed HCC during the study period, with a median of 18 (range, 5-22) AFP tests performed.

Dr. Lee then analyzed the association between the development of HCC and three AFP patterns.

First, the researchers assessed the rate of rise, defined as the patient’s final alpha-fetoprotein level (before study conclusion or HCC development, whichever came first) minus the AFP baseline value (on study entry), all over the follow-up duration divided by 90 days.

He found that this metric was associated with an odds ratio for developing HCC of 1.178 (P less than .001) in a simple logistic regression analysis that accounted for baseline risk factors only, with an area under the receiver-operating characteristic (AUROC) of 0.69.

Next, Dr. Lee calculated the standard deviation of AFP, defined as the standard deviation of all AFP values recorded within each patient.

In the same simple logistic regression, the standard deviation calculation was associated with an odds ratio of 1.026 for HCC per unit increase in standard deviation (P less than .001) and an AUROC of 0.76.

Third, Dr. Lee looked at the most recent AFP value on record. In this case, the odds ratio for developing HCC was 1.012 (also with P less than .001) and an AUROC of 0.76.

Finally, the researchers incorporated both standard deviation and rate of rise of AFP along with baseline age, platelet count, and smoking history to create a "history" model, which had an AUROC of 0.81 – an even better predictor than the models that looked only at one of those factors.

In an attempt to explain their findings, the researchers wrote, "it is intuitively evident why the rate of rise of AFP might be associated with risk of HCC development, but what might explain the association with standard deviation?"

They added, "The biologic basis is unknown, but we theorize that fluctuations in AFP may reflect cycles of damage and regeneration within the liver, and that growth factors involved in regeneration could stimulate hepatocarcinogenesis."

The authors acknowledged that the study had several limitations. "From a practical perspective, these metrics will only be useful once a patient has been followed for at least 2 years in order for the patterns to emerge," they wrote.

Additionally, "this study included only patients with hepatitis C; it is unknown whether these associations would be present among patients with other chronic liver diseases."

The authors said they had no relevant financial disclosures. They disclosed grant support from the National Science Foundation Graduate Research Fellowship.

*Correction, 3/25/2013: An earlier version of this story misstated the name of Clinical Gastroenterology and Hepatology.

Changes in serum alpha-fetoprotein levels over time correlated with the development of hepatocellular carcinoma in hepatitis C patients, wrote Dr. Elliot Lee and his colleagues in the April 1 issue of Clinical Gastroenterology and Hepatology.*

"If confirmed in future studies, these findings could be used to develop individualized risk assessments for clinical use, which could then influence the frequency and type of further testing" in this population, added the researchers (doi:10.1016/j.cgh.2012.11.029).

In what he called "the first large study to demonstrate that patterns of AFP [alpha-fetoprotein] over time are independently associated with HCC [hepatocellular carcinoma] development," Dr. Lee of the University of Michigan, Ann Arbor, looked at patients enrolled in the HALT-C (Hepatitis C Antiviral Long-Term Treatment Against Cirrhosis) trial, in which hepatitis C patients who were nonresponders to prior antiviral therapy were randomized to receive maintenance pegylated interferon or placebo.

According to the trial protocol, patients were screened every 3 months for the first 3.5 years, then every 6 months thereafter on a voluntary basis, with levels of serum alpha-fetoprotein measured at each visit.

Patients who developed hepatocellular carcinoma were matched to controls without HCC in a 1:3 ratio according to the length of follow-up "in order to exclude bias caused by subjects with longer follow-up time having higher cumulative probability of HCC development, as well as more AFP values available," wrote the authors.

Overall, among 967 subjects with hepatitis C, 82 developed HCC during the study period, with a median of 18 (range, 5-22) AFP tests performed.

Dr. Lee then analyzed the association between the development of HCC and three AFP patterns.

First, the researchers assessed the rate of rise, defined as the patient’s final alpha-fetoprotein level (before study conclusion or HCC development, whichever came first) minus the AFP baseline value (on study entry), all over the follow-up duration divided by 90 days.

He found that this metric was associated with an odds ratio for developing HCC of 1.178 (P less than .001) in a simple logistic regression analysis that accounted for baseline risk factors only, with an area under the receiver-operating characteristic (AUROC) of 0.69.

Next, Dr. Lee calculated the standard deviation of AFP, defined as the standard deviation of all AFP values recorded within each patient.

In the same simple logistic regression, the standard deviation calculation was associated with an odds ratio of 1.026 for HCC per unit increase in standard deviation (P less than .001) and an AUROC of 0.76.

Third, Dr. Lee looked at the most recent AFP value on record. In this case, the odds ratio for developing HCC was 1.012 (also with P less than .001) and an AUROC of 0.76.

Finally, the researchers incorporated both standard deviation and rate of rise of AFP along with baseline age, platelet count, and smoking history to create a "history" model, which had an AUROC of 0.81 – an even better predictor than the models that looked only at one of those factors.

In an attempt to explain their findings, the researchers wrote, "it is intuitively evident why the rate of rise of AFP might be associated with risk of HCC development, but what might explain the association with standard deviation?"

They added, "The biologic basis is unknown, but we theorize that fluctuations in AFP may reflect cycles of damage and regeneration within the liver, and that growth factors involved in regeneration could stimulate hepatocarcinogenesis."

The authors acknowledged that the study had several limitations. "From a practical perspective, these metrics will only be useful once a patient has been followed for at least 2 years in order for the patterns to emerge," they wrote.

Additionally, "this study included only patients with hepatitis C; it is unknown whether these associations would be present among patients with other chronic liver diseases."

The authors said they had no relevant financial disclosures. They disclosed grant support from the National Science Foundation Graduate Research Fellowship.

*Correction, 3/25/2013: An earlier version of this story misstated the name of Clinical Gastroenterology and Hepatology.

Plasmablastic lymphoma (PBL) is classified by the World Health Organization as a distinct type of diffuse large B-cell non-Hodgkin lymphoma, which is characterized by plasma cell differentiation and immunoblastic cell morphology.¹ PBL usually develops in middle-aged adults, with the age at onset in one large series ranging from 35 to 55 years with male predominance.^2-4 Although PBL has a strong affinity for the oral cavity, especially in HIV-positive patients, extraoral sites have also been reported.^5-10 In this report, we describe an unusual case of PBL presented as multiple masses mostly located at the ileum, which resulted in small bowel obstruction.

*Click on the link to the left for a PDF of the full article.

Plasmablastic lymphoma (PBL) is classified by the World Health Organization as a distinct type of diffuse large B-cell non-Hodgkin lymphoma, which is characterized by plasma cell differentiation and immunoblastic cell morphology.¹ PBL usually develops in middle-aged adults, with the age at onset in one large series ranging from 35 to 55 years with male predominance.^2-4 Although PBL has a strong affinity for the oral cavity, especially in HIV-positive patients, extraoral sites have also been reported.^5-10 In this report, we describe an unusual case of PBL presented as multiple masses mostly located at the ileum, which resulted in small bowel obstruction.

*Click on the link to the left for a PDF of the full article.

Plasmablastic lymphoma (PBL) is classified by the World Health Organization as a distinct type of diffuse large B-cell non-Hodgkin lymphoma, which is characterized by plasma cell differentiation and immunoblastic cell morphology.¹ PBL usually develops in middle-aged adults, with the age at onset in one large series ranging from 35 to 55 years with male predominance.^2-4 Although PBL has a strong affinity for the oral cavity, especially in HIV-positive patients, extraoral sites have also been reported.^5-10 In this report, we describe an unusual case of PBL presented as multiple masses mostly located at the ileum, which resulted in small bowel obstruction.

*Click on the link to the left for a PDF of the full article.

Pomalidomide has been approved for the treatment of patients with multiple myeloma whose disease has progressed after treatment with at least two prior therapies, including lenalidomide and bortezomib, and whose disease did not respond to treatment and progressed within 60 days of the last treatment.

"Pomalyst (pomalidomide) is the third drug in a class of immunomodulatory agents that includes lenalidomide and thalidomide, and is the second drug approved in the past year to treat multiple myeloma," Dr. Richard Pazdur, director of the office of hematology and oncology products at the Food and Drug Administration’s Center for Drug Evaluation and Research, said in a statement. "Today’s approval provides an additional treatment option for patients who have not responded to other drugs,"

Pomalidomide was granted orphan product designation and was approved under the agency’s accelerated approval program, which provides patients earlier access to promising new drugs while the company conducts additional studies to confirm the drug’s clinical benefit and safe use.

The drug’s safety and effectiveness was evaluated in a clinical trial of 221 patients with relapsed or refractory multiple myeloma randomly assigned to receive pomalidomide alone or pomalidomide and low-dose dexamethasone.

Among patients treated with pomalidomide alone, 7.4% achieved an objective response rate. The median duration of response has not yet been reached in these patients. In patients treated with pomalidomide plus low-dose dexamethasone, 29% achieved an objective response rate with a median duration of response exceeding 7 months.

Common side effects include neutropenia, fatigue and weakness, anemia, constipation, diarrhea, thrombocytopenia, upper respiratory tract infections, back pain, and fever.

Pomalidomide carries a boxed warning that the drug can cause blood clots and should not be used in pregnant women because it can cause severe life-threatening birth defects.

Pomalidomide is available only through the Pomalyst Risk Evaluation and Mitigation Strategy (REMS) Program. Prescribers must be certified with the Pomalyst REMS Program by enrolling and complying with the REMS requirements. Pharmacies must be certified with the Pomalyst REMS Program, must only dispense to patients who are authorized to receive the drug and must comply with REMS requirements. Both lenalidomide and thalidomide have similar REMS.

Pomalidomide is marketed by Celgene.

[email protected]

On Twitter @maryjodales

Pomalidomide has been approved for the treatment of patients with multiple myeloma whose disease has progressed after treatment with at least two prior therapies, including lenalidomide and bortezomib, and whose disease did not respond to treatment and progressed within 60 days of the last treatment.

"Pomalyst (pomalidomide) is the third drug in a class of immunomodulatory agents that includes lenalidomide and thalidomide, and is the second drug approved in the past year to treat multiple myeloma," Dr. Richard Pazdur, director of the office of hematology and oncology products at the Food and Drug Administration’s Center for Drug Evaluation and Research, said in a statement. "Today’s approval provides an additional treatment option for patients who have not responded to other drugs,"

Pomalidomide was granted orphan product designation and was approved under the agency’s accelerated approval program, which provides patients earlier access to promising new drugs while the company conducts additional studies to confirm the drug’s clinical benefit and safe use.

The drug’s safety and effectiveness was evaluated in a clinical trial of 221 patients with relapsed or refractory multiple myeloma randomly assigned to receive pomalidomide alone or pomalidomide and low-dose dexamethasone.

Among patients treated with pomalidomide alone, 7.4% achieved an objective response rate. The median duration of response has not yet been reached in these patients. In patients treated with pomalidomide plus low-dose dexamethasone, 29% achieved an objective response rate with a median duration of response exceeding 7 months.

Common side effects include neutropenia, fatigue and weakness, anemia, constipation, diarrhea, thrombocytopenia, upper respiratory tract infections, back pain, and fever.

Pomalidomide carries a boxed warning that the drug can cause blood clots and should not be used in pregnant women because it can cause severe life-threatening birth defects.

Pomalidomide is available only through the Pomalyst Risk Evaluation and Mitigation Strategy (REMS) Program. Prescribers must be certified with the Pomalyst REMS Program by enrolling and complying with the REMS requirements. Pharmacies must be certified with the Pomalyst REMS Program, must only dispense to patients who are authorized to receive the drug and must comply with REMS requirements. Both lenalidomide and thalidomide have similar REMS.

Pomalidomide is marketed by Celgene.

[email protected]

On Twitter @maryjodales

Pomalidomide has been approved for the treatment of patients with multiple myeloma whose disease has progressed after treatment with at least two prior therapies, including lenalidomide and bortezomib, and whose disease did not respond to treatment and progressed within 60 days of the last treatment.

"Pomalyst (pomalidomide) is the third drug in a class of immunomodulatory agents that includes lenalidomide and thalidomide, and is the second drug approved in the past year to treat multiple myeloma," Dr. Richard Pazdur, director of the office of hematology and oncology products at the Food and Drug Administration’s Center for Drug Evaluation and Research, said in a statement. "Today’s approval provides an additional treatment option for patients who have not responded to other drugs,"

Pomalidomide was granted orphan product designation and was approved under the agency’s accelerated approval program, which provides patients earlier access to promising new drugs while the company conducts additional studies to confirm the drug’s clinical benefit and safe use.

The drug’s safety and effectiveness was evaluated in a clinical trial of 221 patients with relapsed or refractory multiple myeloma randomly assigned to receive pomalidomide alone or pomalidomide and low-dose dexamethasone.

Among patients treated with pomalidomide alone, 7.4% achieved an objective response rate. The median duration of response has not yet been reached in these patients. In patients treated with pomalidomide plus low-dose dexamethasone, 29% achieved an objective response rate with a median duration of response exceeding 7 months.

Common side effects include neutropenia, fatigue and weakness, anemia, constipation, diarrhea, thrombocytopenia, upper respiratory tract infections, back pain, and fever.

Pomalidomide carries a boxed warning that the drug can cause blood clots and should not be used in pregnant women because it can cause severe life-threatening birth defects.

Pomalidomide is available only through the Pomalyst Risk Evaluation and Mitigation Strategy (REMS) Program. Prescribers must be certified with the Pomalyst REMS Program by enrolling and complying with the REMS requirements. Pharmacies must be certified with the Pomalyst REMS Program, must only dispense to patients who are authorized to receive the drug and must comply with REMS requirements. Both lenalidomide and thalidomide have similar REMS.

Pomalidomide is marketed by Celgene.

[email protected]

On Twitter @maryjodales

The Food and Drug Administration has approved a generic formulation of doxorubicin hydrochloride liposome injection to address the current shortage of the cancer drug, the agency announced Feb. 4.

The generic formulation is manufactured by Sun Pharma Global FZE and will be available in 20-mg and 50-mg vials.

Doxil, the brand version of doxorubicin that was first approved in 1995 and is marketed by Janssen Products, is on the FDA’s Current Drug Shortages list, with the note that limited supplies are available.

To address the shortage, the FDA announced in February 2012 that it would allow Lipodox, a version of doxorubicin manufactured by Sun that was not approved in the United States, to be imported on a temporary basis to avoid interruption of the supply. The agency also allowed the one lot of the Janssen product manufactured through an unapproved process to be released for use.

"Once supplies of Sun’s generic doxorubicin hydrochloride liposome injection are sufficient to meet projected demand, the FDA expects to stop exercising enforcement discretion for any unapproved doxorubicin HCl liposomal product," an FDA statement said.

"The agency is committed to doing everything we can to address drug shortages so that patients can get the medicines they need when they need them," Capt. Valerie Jensen, R.Ph., director of the Drug Shortage staff at the FDA’s Center for Drug Evaluation and Research, noted in the statement. The agency is giving priority review to generic products on the drug shortage list.

Doxil is approved for treating ovarian cancer, multiple myeloma, and AIDS-related Kaposi’s sarcoma.

[email protected]

The Food and Drug Administration has approved a generic formulation of doxorubicin hydrochloride liposome injection to address the current shortage of the cancer drug, the agency announced Feb. 4.

The generic formulation is manufactured by Sun Pharma Global FZE and will be available in 20-mg and 50-mg vials.

Doxil, the brand version of doxorubicin that was first approved in 1995 and is marketed by Janssen Products, is on the FDA’s Current Drug Shortages list, with the note that limited supplies are available.

To address the shortage, the FDA announced in February 2012 that it would allow Lipodox, a version of doxorubicin manufactured by Sun that was not approved in the United States, to be imported on a temporary basis to avoid interruption of the supply. The agency also allowed the one lot of the Janssen product manufactured through an unapproved process to be released for use.

"Once supplies of Sun’s generic doxorubicin hydrochloride liposome injection are sufficient to meet projected demand, the FDA expects to stop exercising enforcement discretion for any unapproved doxorubicin HCl liposomal product," an FDA statement said.

"The agency is committed to doing everything we can to address drug shortages so that patients can get the medicines they need when they need them," Capt. Valerie Jensen, R.Ph., director of the Drug Shortage staff at the FDA’s Center for Drug Evaluation and Research, noted in the statement. The agency is giving priority review to generic products on the drug shortage list.

Doxil is approved for treating ovarian cancer, multiple myeloma, and AIDS-related Kaposi’s sarcoma.

[email protected]

The Food and Drug Administration has approved a generic formulation of doxorubicin hydrochloride liposome injection to address the current shortage of the cancer drug, the agency announced Feb. 4.

The generic formulation is manufactured by Sun Pharma Global FZE and will be available in 20-mg and 50-mg vials.

Doxil, the brand version of doxorubicin that was first approved in 1995 and is marketed by Janssen Products, is on the FDA’s Current Drug Shortages list, with the note that limited supplies are available.

To address the shortage, the FDA announced in February 2012 that it would allow Lipodox, a version of doxorubicin manufactured by Sun that was not approved in the United States, to be imported on a temporary basis to avoid interruption of the supply. The agency also allowed the one lot of the Janssen product manufactured through an unapproved process to be released for use.

"Once supplies of Sun’s generic doxorubicin hydrochloride liposome injection are sufficient to meet projected demand, the FDA expects to stop exercising enforcement discretion for any unapproved doxorubicin HCl liposomal product," an FDA statement said.

"The agency is committed to doing everything we can to address drug shortages so that patients can get the medicines they need when they need them," Capt. Valerie Jensen, R.Ph., director of the Drug Shortage staff at the FDA’s Center for Drug Evaluation and Research, noted in the statement. The agency is giving priority review to generic products on the drug shortage list.

Doxil is approved for treating ovarian cancer, multiple myeloma, and AIDS-related Kaposi’s sarcoma.

[email protected]