Mary Jo M. Dales

A first-in-class investigative drug targeted to the P13K pathway was active in a phase-I study of 54 heavily pretreated patients with chronic lymphocytic leukemia.

The new oral drug, called idelalisib (GS-1101), selectively blocks PI3K-delta and produced "rapid and long-lasting tumor shrinkage in half (2 complete responses and 28 partial responses) of the patients treated with single-agent therapy, stalling disease progression for 17 months, on average. The activity of the drug is noteworthy, given that the patients had already undergone an average of five prior therapies," Dr. Jennifer R. Brown reported during a press conference sponsored by the American Society of Clinical Oncology that featured key research to be presented at its upcoming annual meeting.

Most symptomatic patients with chronic lymphocytic leukemia (CLL) experience a relapse at some point after initial chemoimmunotherapy. About 20% of them relapse within 6 months or do not respond to initial treatment and need better treatments, noted Dr. Brown of the Dana-Farber Cancer Institute, Boston.

"While this research is still early and ongoing, we hope this drug, along with others like it, will lead to prolonged survival and eventually help turn CLL into a condition that is treated like high blood pressure, where a patient can take a couple of pills every day. In the shorter term, these drugs may also provide an alternative to chemotherapy in elderly patients who tend not to tolerate chemotherapy well," she said.

Phase-III trials of idelalisib are under way with a 150-mg, twice-daily dosing schedule, Dr. Brown said.

She reported that the current trial included 54 patients (9 women and 45 men, ranging from 37 to 82 years of age) with bulky lymphadenopathy (80%), refractory disease (70%), and a median of 5 prior treatments (range, 2-14). They were treated continuously with single-agent oral idelalisib at doses ranging from 50 to 350 mg/dose on either a once- or twice-daily schedule for an average duration of 9 months (range, 0-42).

The objective response rate was 56% (2 complete responses and 28 partial responses). At least a 50% reduction in the nodal SPD (sum of the products of the greatest perpendicular diameters) was seen in 44 (81%). Splenomegaly resolved in 14 of 20 affected patients (70%) and cytopenias normalized in 17 of 25 (68%) with anemia, 27 of 34 (79%) with thrombocytopenia, and all 15 patients with neutropenia (100%), Dr. Brown reported.

The most common adverse events of grade 3 or higher, independent of causality, included fatigue (2%), diarrhea (6%), pyrexia (4%), pneumonia (19%), and ALT/AST elevation (2%). Treatment was discontinued because of adverse events in 15% (7% potentially treatment related). There were no dose-limiting toxicities.

The research was supported by Gilead Sciences.

[email protected]

On Twitter @maryjodales

A first-in-class investigative drug targeted to the P13K pathway was active in a phase-I study of 54 heavily pretreated patients with chronic lymphocytic leukemia.

The new oral drug, called idelalisib (GS-1101), selectively blocks PI3K-delta and produced "rapid and long-lasting tumor shrinkage in half (2 complete responses and 28 partial responses) of the patients treated with single-agent therapy, stalling disease progression for 17 months, on average. The activity of the drug is noteworthy, given that the patients had already undergone an average of five prior therapies," Dr. Jennifer R. Brown reported during a press conference sponsored by the American Society of Clinical Oncology that featured key research to be presented at its upcoming annual meeting.

Most symptomatic patients with chronic lymphocytic leukemia (CLL) experience a relapse at some point after initial chemoimmunotherapy. About 20% of them relapse within 6 months or do not respond to initial treatment and need better treatments, noted Dr. Brown of the Dana-Farber Cancer Institute, Boston.

"While this research is still early and ongoing, we hope this drug, along with others like it, will lead to prolonged survival and eventually help turn CLL into a condition that is treated like high blood pressure, where a patient can take a couple of pills every day. In the shorter term, these drugs may also provide an alternative to chemotherapy in elderly patients who tend not to tolerate chemotherapy well," she said.

Phase-III trials of idelalisib are under way with a 150-mg, twice-daily dosing schedule, Dr. Brown said.

She reported that the current trial included 54 patients (9 women and 45 men, ranging from 37 to 82 years of age) with bulky lymphadenopathy (80%), refractory disease (70%), and a median of 5 prior treatments (range, 2-14). They were treated continuously with single-agent oral idelalisib at doses ranging from 50 to 350 mg/dose on either a once- or twice-daily schedule for an average duration of 9 months (range, 0-42).

The objective response rate was 56% (2 complete responses and 28 partial responses). At least a 50% reduction in the nodal SPD (sum of the products of the greatest perpendicular diameters) was seen in 44 (81%). Splenomegaly resolved in 14 of 20 affected patients (70%) and cytopenias normalized in 17 of 25 (68%) with anemia, 27 of 34 (79%) with thrombocytopenia, and all 15 patients with neutropenia (100%), Dr. Brown reported.

The most common adverse events of grade 3 or higher, independent of causality, included fatigue (2%), diarrhea (6%), pyrexia (4%), pneumonia (19%), and ALT/AST elevation (2%). Treatment was discontinued because of adverse events in 15% (7% potentially treatment related). There were no dose-limiting toxicities.

The research was supported by Gilead Sciences.

[email protected]

On Twitter @maryjodales

A first-in-class investigative drug targeted to the P13K pathway was active in a phase-I study of 54 heavily pretreated patients with chronic lymphocytic leukemia.

The new oral drug, called idelalisib (GS-1101), selectively blocks PI3K-delta and produced "rapid and long-lasting tumor shrinkage in half (2 complete responses and 28 partial responses) of the patients treated with single-agent therapy, stalling disease progression for 17 months, on average. The activity of the drug is noteworthy, given that the patients had already undergone an average of five prior therapies," Dr. Jennifer R. Brown reported during a press conference sponsored by the American Society of Clinical Oncology that featured key research to be presented at its upcoming annual meeting.

Most symptomatic patients with chronic lymphocytic leukemia (CLL) experience a relapse at some point after initial chemoimmunotherapy. About 20% of them relapse within 6 months or do not respond to initial treatment and need better treatments, noted Dr. Brown of the Dana-Farber Cancer Institute, Boston.

"While this research is still early and ongoing, we hope this drug, along with others like it, will lead to prolonged survival and eventually help turn CLL into a condition that is treated like high blood pressure, where a patient can take a couple of pills every day. In the shorter term, these drugs may also provide an alternative to chemotherapy in elderly patients who tend not to tolerate chemotherapy well," she said.

Phase-III trials of idelalisib are under way with a 150-mg, twice-daily dosing schedule, Dr. Brown said.

She reported that the current trial included 54 patients (9 women and 45 men, ranging from 37 to 82 years of age) with bulky lymphadenopathy (80%), refractory disease (70%), and a median of 5 prior treatments (range, 2-14). They were treated continuously with single-agent oral idelalisib at doses ranging from 50 to 350 mg/dose on either a once- or twice-daily schedule for an average duration of 9 months (range, 0-42).

The objective response rate was 56% (2 complete responses and 28 partial responses). At least a 50% reduction in the nodal SPD (sum of the products of the greatest perpendicular diameters) was seen in 44 (81%). Splenomegaly resolved in 14 of 20 affected patients (70%) and cytopenias normalized in 17 of 25 (68%) with anemia, 27 of 34 (79%) with thrombocytopenia, and all 15 patients with neutropenia (100%), Dr. Brown reported.

The most common adverse events of grade 3 or higher, independent of causality, included fatigue (2%), diarrhea (6%), pyrexia (4%), pneumonia (19%), and ALT/AST elevation (2%). Treatment was discontinued because of adverse events in 15% (7% potentially treatment related). There were no dose-limiting toxicities.

The research was supported by Gilead Sciences.

[email protected]

On Twitter @maryjodales

Hitting metastatic melanoma with two immunotherapies, each targeted to a different metabolic pathway, has shown some preliminary success in an early study.

Ipilimumab (Yervoy) used in combination with the investigational drug nivolumab shrank stage-III and -IV melanomas in approximately half of 37 evaluable patients in a phase-I study. Tumor reductions of at least 80% were seen at 12 weeks in 11 of 37 (30%) of patients and 90% of all patients who have responded continue to respond to therapy, Dr. Jedd D. Wolchok said at a press briefing sponsored by the American Society of Clinical Oncology highlighting research to be presented at its annual meeting.

Phase-I trials are conducted to examine drug safety and give indications of dose ranges; they do not allow conclusions about efficacy. A randomized phase-III trial of the nivolumab/ipilimumab combination as first-line therapy for patients with advanced melanoma is scheduled to begin in June.

Ipilimumab is a CTLA-4 inhibitor approved for the treatment of metastatic melanoma. Nivolumab is an investigational PD-1 inhibitor that has shown activity when used alone against melanoma and other cancers.

"The rapidity and magnitude of the responses are what’s so striking," Dr. Wolchok said. "We were particularly impressed that the drugs work together so well" and show that two immunotherapies offer a promising strategy for advanced melanoma.

For the trial, patients who had inoperable stage-III and stage-IV melanoma and had undergone up to three prior therapies were assigned to one of six treatment arms. Dr. Wolchok of Memorial Sloan-Kettering Cancer Center, New York, presented results on 37 evaluable patients in three completed treatment arms, in which patients received concurrent treatment with the two drugs.

In the phase-I study, nivolumab and ipilimumab were given every 3 weeks for four doses, followed by nivolumab alone every 3 weeks for four doses. At week 24, patients began to receive one concurrent combination treatment every 3 months.

The first arm of 14 patients received 3 mg/kg of ipilimumab plus 0.3 mg/kg of nivolumab, the second arm of 17 patients received 3 mg/kg of ipilimumab plus 1 mg/kg of nivolumab, and the third arm of 6 patients received 3 mg/kg of ipilimumab plus 3 mg/kg of nivolumab. In those three arms, tumor shrinkage rates were 21%, 47%, and 50%, respectively. Tumor reductions of at least 80% were seen in 29%, 41%, and 0%, respectively.

The responses to therapy were rapid for an immunotherapy – three out of four patients who responded to the concurrent treatment experienced tumor reduction within the first 3 months, which is faster than with single-agent ipilimumab, according to Dr. Wolchok.

Two of the remaining three arms of the study enrolled patients who had undergone prior ipilimumab treatment. Those patients received only nivolumab every 2 weeks for up to 48 treatments. Although the data are still preliminary, 4 of 16 evaluable patients in the study arm given nivolumab at 1 mg/kg had at least 80% tumor shrinkage after 8 weeks, even though they initially had little benefit from ipilimumab.

In the concurrently treated patients, grade 3-4 side effects – primarily due to asymptomatic lipase, AST, and ALT abnormalities – occurred in 28 of 53 patients (53%).

With sequenced treatment, grade 3-4 side effects occurred in 6 of 33 patients (18%).

Side effects were managed using standard protocols and no treatment-related deaths were reported.

The nivolumab/ipilimumab combination also is being investigated in non–small cell lung cancer and renal cell carcinoma.

The research was supported by Bristol-Myers Squibb. Dr. Wolchok serves in consultant or advisory roles with, and receives research funding from, Bristol-Meyers Squibb.

[email protected]

Hitting metastatic melanoma with two immunotherapies, each targeted to a different metabolic pathway, has shown some preliminary success in an early study.

Ipilimumab (Yervoy) used in combination with the investigational drug nivolumab shrank stage-III and -IV melanomas in approximately half of 37 evaluable patients in a phase-I study. Tumor reductions of at least 80% were seen at 12 weeks in 11 of 37 (30%) of patients and 90% of all patients who have responded continue to respond to therapy, Dr. Jedd D. Wolchok said at a press briefing sponsored by the American Society of Clinical Oncology highlighting research to be presented at its annual meeting.

Phase-I trials are conducted to examine drug safety and give indications of dose ranges; they do not allow conclusions about efficacy. A randomized phase-III trial of the nivolumab/ipilimumab combination as first-line therapy for patients with advanced melanoma is scheduled to begin in June.

Ipilimumab is a CTLA-4 inhibitor approved for the treatment of metastatic melanoma. Nivolumab is an investigational PD-1 inhibitor that has shown activity when used alone against melanoma and other cancers.

"The rapidity and magnitude of the responses are what’s so striking," Dr. Wolchok said. "We were particularly impressed that the drugs work together so well" and show that two immunotherapies offer a promising strategy for advanced melanoma.

For the trial, patients who had inoperable stage-III and stage-IV melanoma and had undergone up to three prior therapies were assigned to one of six treatment arms. Dr. Wolchok of Memorial Sloan-Kettering Cancer Center, New York, presented results on 37 evaluable patients in three completed treatment arms, in which patients received concurrent treatment with the two drugs.

In the phase-I study, nivolumab and ipilimumab were given every 3 weeks for four doses, followed by nivolumab alone every 3 weeks for four doses. At week 24, patients began to receive one concurrent combination treatment every 3 months.

The first arm of 14 patients received 3 mg/kg of ipilimumab plus 0.3 mg/kg of nivolumab, the second arm of 17 patients received 3 mg/kg of ipilimumab plus 1 mg/kg of nivolumab, and the third arm of 6 patients received 3 mg/kg of ipilimumab plus 3 mg/kg of nivolumab. In those three arms, tumor shrinkage rates were 21%, 47%, and 50%, respectively. Tumor reductions of at least 80% were seen in 29%, 41%, and 0%, respectively.

The responses to therapy were rapid for an immunotherapy – three out of four patients who responded to the concurrent treatment experienced tumor reduction within the first 3 months, which is faster than with single-agent ipilimumab, according to Dr. Wolchok.

Two of the remaining three arms of the study enrolled patients who had undergone prior ipilimumab treatment. Those patients received only nivolumab every 2 weeks for up to 48 treatments. Although the data are still preliminary, 4 of 16 evaluable patients in the study arm given nivolumab at 1 mg/kg had at least 80% tumor shrinkage after 8 weeks, even though they initially had little benefit from ipilimumab.

In the concurrently treated patients, grade 3-4 side effects – primarily due to asymptomatic lipase, AST, and ALT abnormalities – occurred in 28 of 53 patients (53%).

With sequenced treatment, grade 3-4 side effects occurred in 6 of 33 patients (18%).

Side effects were managed using standard protocols and no treatment-related deaths were reported.

The nivolumab/ipilimumab combination also is being investigated in non–small cell lung cancer and renal cell carcinoma.

The research was supported by Bristol-Myers Squibb. Dr. Wolchok serves in consultant or advisory roles with, and receives research funding from, Bristol-Meyers Squibb.

[email protected]

Hitting metastatic melanoma with two immunotherapies, each targeted to a different metabolic pathway, has shown some preliminary success in an early study.

Ipilimumab (Yervoy) used in combination with the investigational drug nivolumab shrank stage-III and -IV melanomas in approximately half of 37 evaluable patients in a phase-I study. Tumor reductions of at least 80% were seen at 12 weeks in 11 of 37 (30%) of patients and 90% of all patients who have responded continue to respond to therapy, Dr. Jedd D. Wolchok said at a press briefing sponsored by the American Society of Clinical Oncology highlighting research to be presented at its annual meeting.

Phase-I trials are conducted to examine drug safety and give indications of dose ranges; they do not allow conclusions about efficacy. A randomized phase-III trial of the nivolumab/ipilimumab combination as first-line therapy for patients with advanced melanoma is scheduled to begin in June.

Ipilimumab is a CTLA-4 inhibitor approved for the treatment of metastatic melanoma. Nivolumab is an investigational PD-1 inhibitor that has shown activity when used alone against melanoma and other cancers.

"The rapidity and magnitude of the responses are what’s so striking," Dr. Wolchok said. "We were particularly impressed that the drugs work together so well" and show that two immunotherapies offer a promising strategy for advanced melanoma.

For the trial, patients who had inoperable stage-III and stage-IV melanoma and had undergone up to three prior therapies were assigned to one of six treatment arms. Dr. Wolchok of Memorial Sloan-Kettering Cancer Center, New York, presented results on 37 evaluable patients in three completed treatment arms, in which patients received concurrent treatment with the two drugs.

In the phase-I study, nivolumab and ipilimumab were given every 3 weeks for four doses, followed by nivolumab alone every 3 weeks for four doses. At week 24, patients began to receive one concurrent combination treatment every 3 months.

The first arm of 14 patients received 3 mg/kg of ipilimumab plus 0.3 mg/kg of nivolumab, the second arm of 17 patients received 3 mg/kg of ipilimumab plus 1 mg/kg of nivolumab, and the third arm of 6 patients received 3 mg/kg of ipilimumab plus 3 mg/kg of nivolumab. In those three arms, tumor shrinkage rates were 21%, 47%, and 50%, respectively. Tumor reductions of at least 80% were seen in 29%, 41%, and 0%, respectively.

The responses to therapy were rapid for an immunotherapy – three out of four patients who responded to the concurrent treatment experienced tumor reduction within the first 3 months, which is faster than with single-agent ipilimumab, according to Dr. Wolchok.

Two of the remaining three arms of the study enrolled patients who had undergone prior ipilimumab treatment. Those patients received only nivolumab every 2 weeks for up to 48 treatments. Although the data are still preliminary, 4 of 16 evaluable patients in the study arm given nivolumab at 1 mg/kg had at least 80% tumor shrinkage after 8 weeks, even though they initially had little benefit from ipilimumab.

In the concurrently treated patients, grade 3-4 side effects – primarily due to asymptomatic lipase, AST, and ALT abnormalities – occurred in 28 of 53 patients (53%).

With sequenced treatment, grade 3-4 side effects occurred in 6 of 33 patients (18%).

Side effects were managed using standard protocols and no treatment-related deaths were reported.

The nivolumab/ipilimumab combination also is being investigated in non–small cell lung cancer and renal cell carcinoma.

The research was supported by Bristol-Myers Squibb. Dr. Wolchok serves in consultant or advisory roles with, and receives research funding from, Bristol-Meyers Squibb.

[email protected]

An investigational drug that targets the PD-L1 pathway was associated with tumor shrinkage in about 20% of patients who had a wide array of incurable or metastatic solid cancers in a phase I study.

MPDL3280A, a PD-L1 targeted antibody with an Fc-domain designed to optimize efficacy and safety, shrank tumors by at least 50% in 29 of 140 patients, for an overall response rate of 21%. Further, there have been additional delayed responses, and the treatment responses are ongoing, with 26 of 29 patients continuing to respond at follow-ups of 3-15 months.

"We are impressed with the frequency and duration of the responses in these patients with very difficult-to-treat tumors," especially given that this is a phase I study designed to assess the drug’s safety and guide selection of dosing for phase II study, lead investigator Dr. Roy S. Herbst said May 15 during a presscast sponsored by the American Society of Clinical Oncology in advance of its annual meeting,

The drug also met safety measures, with no maximum tolerated dose, dose-limiting toxicities, or treatment-related deaths in an analysis of 171 patients. One patient discontinued MPDL3280A because of an immune-related adverse event; importantly, no cases of grade 3-5 pneumonitis occurred. The most common grade 3-4 adverse events, each seen in 3%-5% of patients, were hyperglycemia, fatigue, increased ALT, dyspnea, and hypoxia. These included all adverse events, irrespective of whether they were from disease, the drug, or other factors, reported Dr. Herbst, Ensign Professor of medical oncology at Yale Cancer Center and chief of medical oncology at Smilow Cancer Hospital at Yale, both in New Haven, Conn.

PD-L1 is a protein that can essentially hide cancer cells from the immune system, When MPDL3280A attaches to the protein PD-L1, it essentially reveals the cancer cell to T cells, eliciting an immune response. MPDL3280A was specifically engineered for enhanced safety and efficacy, compared with earlier PD-L1 or PD-1 targeted agents.

Based on diagnostic testing for PD-L1 expression in archived tumor tissue from 103 patients, tumor shrinkage occurred after MPDL3280A treatment in 13 of 36 (36%) of patients with PD-L1–positive tumors and in 9 of 67 (13%) of patients with PD-L1–negative tumors. The diagnostic test for PD-L1 is still evolving, so a negative result on the PD-L1 test could simply mean that tumors have less PD-L1 than the test currently detects, according to Dr. Herbst.

The study has been expanded to include more than 275 patients to date. Phase II and phase III studies are planned to confirm MPDL3280A’s anticancer activity and to validate the PD-L1 diagnostic test.

For the phase I study, MPDL3280A was administered intravenously 3 times weekly. Administered doses included 1 mg/kg or less (9 patients), 3 mg/kg (3 patients), 10 mg/kg (35 patients), 15 mg/kg (57 patients), and 20 mg/kg (67 patients). Responses were observed in multiple tumor types, including non–small cell lung cancer, renal cell carcinoma melanoma, colorectal cancer, and gastric cancer. The 24-week progression-free survival was 44%. No maximum tolerated dose was identified, and patients received MPDL3280A for a median duration of 127 days (range 1-330 days). Pharmacokinetics supports thrice-weekly dosing at 15 mg/kg or a fixed-dose equivalent.

The study was supported by Genentech. Dr. Herbst receives research support from Genentech.

[email protected]

An investigational drug that targets the PD-L1 pathway was associated with tumor shrinkage in about 20% of patients who had a wide array of incurable or metastatic solid cancers in a phase I study.

MPDL3280A, a PD-L1 targeted antibody with an Fc-domain designed to optimize efficacy and safety, shrank tumors by at least 50% in 29 of 140 patients, for an overall response rate of 21%. Further, there have been additional delayed responses, and the treatment responses are ongoing, with 26 of 29 patients continuing to respond at follow-ups of 3-15 months.

"We are impressed with the frequency and duration of the responses in these patients with very difficult-to-treat tumors," especially given that this is a phase I study designed to assess the drug’s safety and guide selection of dosing for phase II study, lead investigator Dr. Roy S. Herbst said May 15 during a presscast sponsored by the American Society of Clinical Oncology in advance of its annual meeting,

The drug also met safety measures, with no maximum tolerated dose, dose-limiting toxicities, or treatment-related deaths in an analysis of 171 patients. One patient discontinued MPDL3280A because of an immune-related adverse event; importantly, no cases of grade 3-5 pneumonitis occurred. The most common grade 3-4 adverse events, each seen in 3%-5% of patients, were hyperglycemia, fatigue, increased ALT, dyspnea, and hypoxia. These included all adverse events, irrespective of whether they were from disease, the drug, or other factors, reported Dr. Herbst, Ensign Professor of medical oncology at Yale Cancer Center and chief of medical oncology at Smilow Cancer Hospital at Yale, both in New Haven, Conn.

PD-L1 is a protein that can essentially hide cancer cells from the immune system, When MPDL3280A attaches to the protein PD-L1, it essentially reveals the cancer cell to T cells, eliciting an immune response. MPDL3280A was specifically engineered for enhanced safety and efficacy, compared with earlier PD-L1 or PD-1 targeted agents.

Based on diagnostic testing for PD-L1 expression in archived tumor tissue from 103 patients, tumor shrinkage occurred after MPDL3280A treatment in 13 of 36 (36%) of patients with PD-L1–positive tumors and in 9 of 67 (13%) of patients with PD-L1–negative tumors. The diagnostic test for PD-L1 is still evolving, so a negative result on the PD-L1 test could simply mean that tumors have less PD-L1 than the test currently detects, according to Dr. Herbst.

The study has been expanded to include more than 275 patients to date. Phase II and phase III studies are planned to confirm MPDL3280A’s anticancer activity and to validate the PD-L1 diagnostic test.

For the phase I study, MPDL3280A was administered intravenously 3 times weekly. Administered doses included 1 mg/kg or less (9 patients), 3 mg/kg (3 patients), 10 mg/kg (35 patients), 15 mg/kg (57 patients), and 20 mg/kg (67 patients). Responses were observed in multiple tumor types, including non–small cell lung cancer, renal cell carcinoma melanoma, colorectal cancer, and gastric cancer. The 24-week progression-free survival was 44%. No maximum tolerated dose was identified, and patients received MPDL3280A for a median duration of 127 days (range 1-330 days). Pharmacokinetics supports thrice-weekly dosing at 15 mg/kg or a fixed-dose equivalent.

The study was supported by Genentech. Dr. Herbst receives research support from Genentech.

[email protected]

An investigational drug that targets the PD-L1 pathway was associated with tumor shrinkage in about 20% of patients who had a wide array of incurable or metastatic solid cancers in a phase I study.

MPDL3280A, a PD-L1 targeted antibody with an Fc-domain designed to optimize efficacy and safety, shrank tumors by at least 50% in 29 of 140 patients, for an overall response rate of 21%. Further, there have been additional delayed responses, and the treatment responses are ongoing, with 26 of 29 patients continuing to respond at follow-ups of 3-15 months.

"We are impressed with the frequency and duration of the responses in these patients with very difficult-to-treat tumors," especially given that this is a phase I study designed to assess the drug’s safety and guide selection of dosing for phase II study, lead investigator Dr. Roy S. Herbst said May 15 during a presscast sponsored by the American Society of Clinical Oncology in advance of its annual meeting,

The drug also met safety measures, with no maximum tolerated dose, dose-limiting toxicities, or treatment-related deaths in an analysis of 171 patients. One patient discontinued MPDL3280A because of an immune-related adverse event; importantly, no cases of grade 3-5 pneumonitis occurred. The most common grade 3-4 adverse events, each seen in 3%-5% of patients, were hyperglycemia, fatigue, increased ALT, dyspnea, and hypoxia. These included all adverse events, irrespective of whether they were from disease, the drug, or other factors, reported Dr. Herbst, Ensign Professor of medical oncology at Yale Cancer Center and chief of medical oncology at Smilow Cancer Hospital at Yale, both in New Haven, Conn.

PD-L1 is a protein that can essentially hide cancer cells from the immune system, When MPDL3280A attaches to the protein PD-L1, it essentially reveals the cancer cell to T cells, eliciting an immune response. MPDL3280A was specifically engineered for enhanced safety and efficacy, compared with earlier PD-L1 or PD-1 targeted agents.

Based on diagnostic testing for PD-L1 expression in archived tumor tissue from 103 patients, tumor shrinkage occurred after MPDL3280A treatment in 13 of 36 (36%) of patients with PD-L1–positive tumors and in 9 of 67 (13%) of patients with PD-L1–negative tumors. The diagnostic test for PD-L1 is still evolving, so a negative result on the PD-L1 test could simply mean that tumors have less PD-L1 than the test currently detects, according to Dr. Herbst.

The study has been expanded to include more than 275 patients to date. Phase II and phase III studies are planned to confirm MPDL3280A’s anticancer activity and to validate the PD-L1 diagnostic test.

For the phase I study, MPDL3280A was administered intravenously 3 times weekly. Administered doses included 1 mg/kg or less (9 patients), 3 mg/kg (3 patients), 10 mg/kg (35 patients), 15 mg/kg (57 patients), and 20 mg/kg (67 patients). Responses were observed in multiple tumor types, including non–small cell lung cancer, renal cell carcinoma melanoma, colorectal cancer, and gastric cancer. The 24-week progression-free survival was 44%. No maximum tolerated dose was identified, and patients received MPDL3280A for a median duration of 127 days (range 1-330 days). Pharmacokinetics supports thrice-weekly dosing at 15 mg/kg or a fixed-dose equivalent.

The study was supported by Genentech. Dr. Herbst receives research support from Genentech.

[email protected]

The genetic fingerprints of cancer continue to be elaborated in basic research.

A study published in Nature details genetic profiles that permit endometrial cancers to be re-classed into one of four categories: POLE ultramutated, microsatellite instability hypermutated, copy-number low, and copy-number high that might prove useful for guiding post-surgical adjuvant therapy for women with aggressive tumors. There were 48 genes with differential mutation frequencies across the four groups.

The researchers also found that uterine serous carcinomas share genomic features with ovarian serous and basal-like breast carcinomas. 

Photo credit: cancergenome.nih.gov

A second study of acute myeloid leukemia published in the New England Journal of Medicine analyzed the genomes of 200 adults with newly diagnosed acute myeloid leukemia (AML) via whole-genome sequencing (50 cases) or whole-exome sequencing (150 cases), along with RNA and microRNA sequencing and DNA-methylation analysis.

At least one potential driver mutation was detected in nearly all of the AML samples, although a complex interplay of genetic events appears to contribute to AML pathogenesis in individual patients, according to researchers for The Cancer Genome Atlas Research Network, who also conducted the endometrial cancer gene study.

They concluded that the databases from these gene studies will be a foundation for research into pathogenesis, classification, and risk stratification.

The comprehensive data that have been generated by The Cancer Genome Atlas Research Network are freely available through the TCGA Data Portal and the Cancer Genomics Hub (CGHub).

The genetic fingerprints of cancer continue to be elaborated in basic research.

A study published in Nature details genetic profiles that permit endometrial cancers to be re-classed into one of four categories: POLE ultramutated, microsatellite instability hypermutated, copy-number low, and copy-number high that might prove useful for guiding post-surgical adjuvant therapy for women with aggressive tumors. There were 48 genes with differential mutation frequencies across the four groups.

The researchers also found that uterine serous carcinomas share genomic features with ovarian serous and basal-like breast carcinomas. 

Photo credit: cancergenome.nih.gov

A second study of acute myeloid leukemia published in the New England Journal of Medicine analyzed the genomes of 200 adults with newly diagnosed acute myeloid leukemia (AML) via whole-genome sequencing (50 cases) or whole-exome sequencing (150 cases), along with RNA and microRNA sequencing and DNA-methylation analysis.

At least one potential driver mutation was detected in nearly all of the AML samples, although a complex interplay of genetic events appears to contribute to AML pathogenesis in individual patients, according to researchers for The Cancer Genome Atlas Research Network, who also conducted the endometrial cancer gene study.

They concluded that the databases from these gene studies will be a foundation for research into pathogenesis, classification, and risk stratification.

The comprehensive data that have been generated by The Cancer Genome Atlas Research Network are freely available through the TCGA Data Portal and the Cancer Genomics Hub (CGHub).

The genetic fingerprints of cancer continue to be elaborated in basic research.

A study published in Nature details genetic profiles that permit endometrial cancers to be re-classed into one of four categories: POLE ultramutated, microsatellite instability hypermutated, copy-number low, and copy-number high that might prove useful for guiding post-surgical adjuvant therapy for women with aggressive tumors. There were 48 genes with differential mutation frequencies across the four groups.

The researchers also found that uterine serous carcinomas share genomic features with ovarian serous and basal-like breast carcinomas. 

Photo credit: cancergenome.nih.gov

A second study of acute myeloid leukemia published in the New England Journal of Medicine analyzed the genomes of 200 adults with newly diagnosed acute myeloid leukemia (AML) via whole-genome sequencing (50 cases) or whole-exome sequencing (150 cases), along with RNA and microRNA sequencing and DNA-methylation analysis.

At least one potential driver mutation was detected in nearly all of the AML samples, although a complex interplay of genetic events appears to contribute to AML pathogenesis in individual patients, according to researchers for The Cancer Genome Atlas Research Network, who also conducted the endometrial cancer gene study.

They concluded that the databases from these gene studies will be a foundation for research into pathogenesis, classification, and risk stratification.

The comprehensive data that have been generated by The Cancer Genome Atlas Research Network are freely available through the TCGA Data Portal and the Cancer Genomics Hub (CGHub).

A compounding pharmacy has issued a nationwide voluntary recall of all of its products after mold was discovered in one of its intravenous solutions. To date, no injuries or illnesses have been reported in association with the contaminated product: magnesium sulfate 2 g in dextrose 5% in water, 50 mL for injection.

The compounding pharmacy, Med Prep Consulting Inc., announced in a statement that it has voluntarily recalled all lots of all products compounded at its facility after clinicians at a Connecticut hospital notified the company that visible particulate contaminants were observed in five 50-mL bags of the product. These were unique and distinct lots compounded and dispensed by the pharmacy to the Connecticut hospital, according to the company.

The contaminants were subsequently confirmed to be mold; the pharmacy then decided to voluntarily recall all of its compounded products because of lack of sterility assurance.

Injectable steroids contaminated with mold and produced by a different compounding pharmacy were discovered last October and resulted in numerous infections and deaths nationwide. The issue also was part of a recent Institute of Medicine report on drug quality concerns.

Products produced by Med Prep Consulting are used for a wide range of therapeutic purposes in hospitals, outpatient facilities, and physicians’ offices. None are dispensed directly to patients for either self-administration or nursing administration. All products are packaged in plastic infusion bags, plastic infusion devices, plastic syringes, or glass vials.

Recalled products packaged in plastic infusion bags, plastic infusion devices, plastic syringes, and glass vials were distributed directly to regional hospital pharmacies in New Jersey, Pennsylvania, Connecticut, and Delaware.

Recalled products packaged in plastic syringes were distributed nationwide to physician office practice facilities and clinics. All of these products were distributed through March 17, 2013, from Tinton Falls, N.J., to both regional and nationwide locations.

All recipients of products compounded by Med Prep Consulting have been notified by telephone, fax, e-mail, and regular mail of the recall and have been instructed to remove and return the product to the pharmacy. Facilities with questions may contact the company at 732-493-3390. The company has asked that product complaints related to this recall be reported to the same number.

Adverse events that may be related to the use of these products should be reported to FDA’s MedWatch Adverse Event Reporting Program.

[email protected]

A compounding pharmacy has issued a nationwide voluntary recall of all of its products after mold was discovered in one of its intravenous solutions. To date, no injuries or illnesses have been reported in association with the contaminated product: magnesium sulfate 2 g in dextrose 5% in water, 50 mL for injection.

The compounding pharmacy, Med Prep Consulting Inc., announced in a statement that it has voluntarily recalled all lots of all products compounded at its facility after clinicians at a Connecticut hospital notified the company that visible particulate contaminants were observed in five 50-mL bags of the product. These were unique and distinct lots compounded and dispensed by the pharmacy to the Connecticut hospital, according to the company.

The contaminants were subsequently confirmed to be mold; the pharmacy then decided to voluntarily recall all of its compounded products because of lack of sterility assurance.

Injectable steroids contaminated with mold and produced by a different compounding pharmacy were discovered last October and resulted in numerous infections and deaths nationwide. The issue also was part of a recent Institute of Medicine report on drug quality concerns.

Products produced by Med Prep Consulting are used for a wide range of therapeutic purposes in hospitals, outpatient facilities, and physicians’ offices. None are dispensed directly to patients for either self-administration or nursing administration. All products are packaged in plastic infusion bags, plastic infusion devices, plastic syringes, or glass vials.

Recalled products packaged in plastic infusion bags, plastic infusion devices, plastic syringes, and glass vials were distributed directly to regional hospital pharmacies in New Jersey, Pennsylvania, Connecticut, and Delaware.

Recalled products packaged in plastic syringes were distributed nationwide to physician office practice facilities and clinics. All of these products were distributed through March 17, 2013, from Tinton Falls, N.J., to both regional and nationwide locations.

All recipients of products compounded by Med Prep Consulting have been notified by telephone, fax, e-mail, and regular mail of the recall and have been instructed to remove and return the product to the pharmacy. Facilities with questions may contact the company at 732-493-3390. The company has asked that product complaints related to this recall be reported to the same number.

Adverse events that may be related to the use of these products should be reported to FDA’s MedWatch Adverse Event Reporting Program.

[email protected]

A compounding pharmacy has issued a nationwide voluntary recall of all of its products after mold was discovered in one of its intravenous solutions. To date, no injuries or illnesses have been reported in association with the contaminated product: magnesium sulfate 2 g in dextrose 5% in water, 50 mL for injection.

The compounding pharmacy, Med Prep Consulting Inc., announced in a statement that it has voluntarily recalled all lots of all products compounded at its facility after clinicians at a Connecticut hospital notified the company that visible particulate contaminants were observed in five 50-mL bags of the product. These were unique and distinct lots compounded and dispensed by the pharmacy to the Connecticut hospital, according to the company.

The contaminants were subsequently confirmed to be mold; the pharmacy then decided to voluntarily recall all of its compounded products because of lack of sterility assurance.

Injectable steroids contaminated with mold and produced by a different compounding pharmacy were discovered last October and resulted in numerous infections and deaths nationwide. The issue also was part of a recent Institute of Medicine report on drug quality concerns.

Products produced by Med Prep Consulting are used for a wide range of therapeutic purposes in hospitals, outpatient facilities, and physicians’ offices. None are dispensed directly to patients for either self-administration or nursing administration. All products are packaged in plastic infusion bags, plastic infusion devices, plastic syringes, or glass vials.

Recalled products packaged in plastic infusion bags, plastic infusion devices, plastic syringes, and glass vials were distributed directly to regional hospital pharmacies in New Jersey, Pennsylvania, Connecticut, and Delaware.

Recalled products packaged in plastic syringes were distributed nationwide to physician office practice facilities and clinics. All of these products were distributed through March 17, 2013, from Tinton Falls, N.J., to both regional and nationwide locations.

All recipients of products compounded by Med Prep Consulting have been notified by telephone, fax, e-mail, and regular mail of the recall and have been instructed to remove and return the product to the pharmacy. Facilities with questions may contact the company at 732-493-3390. The company has asked that product complaints related to this recall be reported to the same number.

Adverse events that may be related to the use of these products should be reported to FDA’s MedWatch Adverse Event Reporting Program.

[email protected]

CHICAGO – Bendamustine-rituximab continues to outshine CHOP-rituximab for indolent and mantle cell lymphomas, based on the updated results of the StiL NHL1 study.

With a twofold higher rate of progression-free survival and several-fold reductions in the rates of associated toxicities, "bendamustine-rituximab could be considered the preferred first-line treatment for patients with these disease entities," Dr. Mathias J. Rummel said during a press conference at the annual meeting of the American Society of Clinical Oncology.

Bendamustine is marketed in the United States as Treanda (Cephalon). Bendamustine was developed 50 years ago in East Germany, Dr. Rummel said. Only after the reunification of Germany did physicians in the West learn about the drug and begin to conduct clinical trials and to publish the results.

A large randomized trial of 514 evaluable patients treated in community and hospital-based oncology groups in Germany, StiL NHL1 compared progression-free survival for the two regimens in patients with follicular, Waldenstrom’s, marginal zone, small lymphocytic, or mantle cell lymphomas.

Patients in the bendamustine-rituximab group had a median of 69.5 months of progression-free survival compared with 31.2 months with CHOP-rituximab. The benefit with bendamustine-rituximab was maintained in all histological subtypes except marginal zone lymphoma.

In patients with normal levels of lactic dehydrogenase (62%), progression-free survival was significantly prolonged with bendamustine-rituximab compared with CHOP-rituximab (P less than .001). In those with elevated levels of LDH (38%), progression-free survival was numerically, but not significantly, increased with bendamustine-rituximab (P = .118).

In patients with follicular lymphoma, follicular lymphoma international prognostic index (FLIPI) subgroups defined by 0-2 factors (favorable) and 3-5 factors (unfavorable) had longer progression-free survival with bendamustine-rituximab than with CHOP-rituximab. The longer progression-free survival was significant for both the favorable (P = .043) and unfavorable (P = .068) FLIPI subgroups.

Patients in the study were randomized for a maximum of six cycles to either bendamustine (90 mg/m² on day 1 and 2) and rituximab (375 mg/m² on day 1) or to CHOP-rituximab (cyclophosphamide 750 mg/m² on day 1, doxorubicin 50 mg/m² on day 1, vincristine 1.4 mg/m² on day 1, and prednisone 100 mg on days 1-5), and rituximab (375 mg/m² on day 1), according to Dr. Rummel of the University Hospital Giessen (Germany).

In the bendamustine-rituximab group, 74 salvage treatments had been initiated. In the CHOP-rituximab group, 116 salvage treatments were initiated. Of those in the CHOP-rituximab group, 52 patients received bendamustine-rituximab as a salvage regimen. Overall survival did not differ between the treatment arms, with 43 and 45 deaths in the two groups, respectively. Secondary malignancies were observed in 20 patients in the bendamustine-rituximab group compared with 23 in the CHOP-rituximab group, with 1 hematologic malignancy in each group (1 case of myelodysplastic syndrome in the bendamustine-rituximab group and 1 case of acute myelogenous leukemia in the CHOP-rituximab group).

Grade 3/4 hematotoxicities were significantly lower in the 261 patients in the bendamustine-rituximab group than in the 253 in the CHOP-rituximab group (P less than .0001). The percentage of cycles associated with leukopenia was 12% for bendamustine-rituximab patients and 38% for CHOP-rituximab patients. The percentage of cycles associated with neutropenia was nearly 11% with bendamustine-rituximab and more than 46% with CHOP-rituximab. The percentage of cycles that necessitated administration of granulocyte colony-stimulating factor (G-CSF) was 4% with bendamustine-rituximab and 20% with CHOP-rituximab. The rates of anemia and thrombocytopenia were comparable and low (less than 2% of cycles) for both regimens.

Importantly, alopecia did not occur with bendamustine-rituximab but was nearly universal with CHOP-rituximab, Dr. Rummel said. Paresthesias were noted in 18 of 261 bendamustine-rituximab patients and 73 of 253 CHOP-rituximab patients; stomatitis was seen in 16 and 73 patients, respectively. Both differences were significant (P less than .0001).

Conversely, the bendamustine-treated patients had more erythema (42 of 261 bendamustine-rituximab patients vs. 23 of 253 CHOP-rituximab patients) and allergic reactions (40 vs. 15, respectively). These were not dose-limiting toxicities. Infectious complications were frequent, and affected 96 bendamustine and 127 CHOP patients.

Next steps include a new trial called MAINTAIN that will examine rituximab maintenance therapy in 591 patients treated with bendamustine and rituximab. Patients will receive 2 years of rituximab maintenance therapy and will then be randomized to either observation or 2 more years of rituximab.

Dr. Rummel receives honoraria and research funding from Mundipharma and Roche.

CHICAGO – Bendamustine-rituximab continues to outshine CHOP-rituximab for indolent and mantle cell lymphomas, based on the updated results of the StiL NHL1 study.

With a twofold higher rate of progression-free survival and several-fold reductions in the rates of associated toxicities, "bendamustine-rituximab could be considered the preferred first-line treatment for patients with these disease entities," Dr. Mathias J. Rummel said during a press conference at the annual meeting of the American Society of Clinical Oncology.

Bendamustine is marketed in the United States as Treanda (Cephalon). Bendamustine was developed 50 years ago in East Germany, Dr. Rummel said. Only after the reunification of Germany did physicians in the West learn about the drug and begin to conduct clinical trials and to publish the results.

A large randomized trial of 514 evaluable patients treated in community and hospital-based oncology groups in Germany, StiL NHL1 compared progression-free survival for the two regimens in patients with follicular, Waldenstrom’s, marginal zone, small lymphocytic, or mantle cell lymphomas.

Patients in the bendamustine-rituximab group had a median of 69.5 months of progression-free survival compared with 31.2 months with CHOP-rituximab. The benefit with bendamustine-rituximab was maintained in all histological subtypes except marginal zone lymphoma.

In patients with normal levels of lactic dehydrogenase (62%), progression-free survival was significantly prolonged with bendamustine-rituximab compared with CHOP-rituximab (P less than .001). In those with elevated levels of LDH (38%), progression-free survival was numerically, but not significantly, increased with bendamustine-rituximab (P = .118).

In patients with follicular lymphoma, follicular lymphoma international prognostic index (FLIPI) subgroups defined by 0-2 factors (favorable) and 3-5 factors (unfavorable) had longer progression-free survival with bendamustine-rituximab than with CHOP-rituximab. The longer progression-free survival was significant for both the favorable (P = .043) and unfavorable (P = .068) FLIPI subgroups.

Patients in the study were randomized for a maximum of six cycles to either bendamustine (90 mg/m² on day 1 and 2) and rituximab (375 mg/m² on day 1) or to CHOP-rituximab (cyclophosphamide 750 mg/m² on day 1, doxorubicin 50 mg/m² on day 1, vincristine 1.4 mg/m² on day 1, and prednisone 100 mg on days 1-5), and rituximab (375 mg/m² on day 1), according to Dr. Rummel of the University Hospital Giessen (Germany).

In the bendamustine-rituximab group, 74 salvage treatments had been initiated. In the CHOP-rituximab group, 116 salvage treatments were initiated. Of those in the CHOP-rituximab group, 52 patients received bendamustine-rituximab as a salvage regimen. Overall survival did not differ between the treatment arms, with 43 and 45 deaths in the two groups, respectively. Secondary malignancies were observed in 20 patients in the bendamustine-rituximab group compared with 23 in the CHOP-rituximab group, with 1 hematologic malignancy in each group (1 case of myelodysplastic syndrome in the bendamustine-rituximab group and 1 case of acute myelogenous leukemia in the CHOP-rituximab group).

Grade 3/4 hematotoxicities were significantly lower in the 261 patients in the bendamustine-rituximab group than in the 253 in the CHOP-rituximab group (P less than .0001). The percentage of cycles associated with leukopenia was 12% for bendamustine-rituximab patients and 38% for CHOP-rituximab patients. The percentage of cycles associated with neutropenia was nearly 11% with bendamustine-rituximab and more than 46% with CHOP-rituximab. The percentage of cycles that necessitated administration of granulocyte colony-stimulating factor (G-CSF) was 4% with bendamustine-rituximab and 20% with CHOP-rituximab. The rates of anemia and thrombocytopenia were comparable and low (less than 2% of cycles) for both regimens.

Importantly, alopecia did not occur with bendamustine-rituximab but was nearly universal with CHOP-rituximab, Dr. Rummel said. Paresthesias were noted in 18 of 261 bendamustine-rituximab patients and 73 of 253 CHOP-rituximab patients; stomatitis was seen in 16 and 73 patients, respectively. Both differences were significant (P less than .0001).

Conversely, the bendamustine-treated patients had more erythema (42 of 261 bendamustine-rituximab patients vs. 23 of 253 CHOP-rituximab patients) and allergic reactions (40 vs. 15, respectively). These were not dose-limiting toxicities. Infectious complications were frequent, and affected 96 bendamustine and 127 CHOP patients.

Next steps include a new trial called MAINTAIN that will examine rituximab maintenance therapy in 591 patients treated with bendamustine and rituximab. Patients will receive 2 years of rituximab maintenance therapy and will then be randomized to either observation or 2 more years of rituximab.

Dr. Rummel receives honoraria and research funding from Mundipharma and Roche.

CHICAGO – Bendamustine-rituximab continues to outshine CHOP-rituximab for indolent and mantle cell lymphomas, based on the updated results of the StiL NHL1 study.

With a twofold higher rate of progression-free survival and several-fold reductions in the rates of associated toxicities, "bendamustine-rituximab could be considered the preferred first-line treatment for patients with these disease entities," Dr. Mathias J. Rummel said during a press conference at the annual meeting of the American Society of Clinical Oncology.

Bendamustine is marketed in the United States as Treanda (Cephalon). Bendamustine was developed 50 years ago in East Germany, Dr. Rummel said. Only after the reunification of Germany did physicians in the West learn about the drug and begin to conduct clinical trials and to publish the results.

A large randomized trial of 514 evaluable patients treated in community and hospital-based oncology groups in Germany, StiL NHL1 compared progression-free survival for the two regimens in patients with follicular, Waldenstrom’s, marginal zone, small lymphocytic, or mantle cell lymphomas.

Patients in the bendamustine-rituximab group had a median of 69.5 months of progression-free survival compared with 31.2 months with CHOP-rituximab. The benefit with bendamustine-rituximab was maintained in all histological subtypes except marginal zone lymphoma.

In patients with normal levels of lactic dehydrogenase (62%), progression-free survival was significantly prolonged with bendamustine-rituximab compared with CHOP-rituximab (P less than .001). In those with elevated levels of LDH (38%), progression-free survival was numerically, but not significantly, increased with bendamustine-rituximab (P = .118).

In patients with follicular lymphoma, follicular lymphoma international prognostic index (FLIPI) subgroups defined by 0-2 factors (favorable) and 3-5 factors (unfavorable) had longer progression-free survival with bendamustine-rituximab than with CHOP-rituximab. The longer progression-free survival was significant for both the favorable (P = .043) and unfavorable (P = .068) FLIPI subgroups.

Patients in the study were randomized for a maximum of six cycles to either bendamustine (90 mg/m² on day 1 and 2) and rituximab (375 mg/m² on day 1) or to CHOP-rituximab (cyclophosphamide 750 mg/m² on day 1, doxorubicin 50 mg/m² on day 1, vincristine 1.4 mg/m² on day 1, and prednisone 100 mg on days 1-5), and rituximab (375 mg/m² on day 1), according to Dr. Rummel of the University Hospital Giessen (Germany).

In the bendamustine-rituximab group, 74 salvage treatments had been initiated. In the CHOP-rituximab group, 116 salvage treatments were initiated. Of those in the CHOP-rituximab group, 52 patients received bendamustine-rituximab as a salvage regimen. Overall survival did not differ between the treatment arms, with 43 and 45 deaths in the two groups, respectively. Secondary malignancies were observed in 20 patients in the bendamustine-rituximab group compared with 23 in the CHOP-rituximab group, with 1 hematologic malignancy in each group (1 case of myelodysplastic syndrome in the bendamustine-rituximab group and 1 case of acute myelogenous leukemia in the CHOP-rituximab group).

Grade 3/4 hematotoxicities were significantly lower in the 261 patients in the bendamustine-rituximab group than in the 253 in the CHOP-rituximab group (P less than .0001). The percentage of cycles associated with leukopenia was 12% for bendamustine-rituximab patients and 38% for CHOP-rituximab patients. The percentage of cycles associated with neutropenia was nearly 11% with bendamustine-rituximab and more than 46% with CHOP-rituximab. The percentage of cycles that necessitated administration of granulocyte colony-stimulating factor (G-CSF) was 4% with bendamustine-rituximab and 20% with CHOP-rituximab. The rates of anemia and thrombocytopenia were comparable and low (less than 2% of cycles) for both regimens.

Importantly, alopecia did not occur with bendamustine-rituximab but was nearly universal with CHOP-rituximab, Dr. Rummel said. Paresthesias were noted in 18 of 261 bendamustine-rituximab patients and 73 of 253 CHOP-rituximab patients; stomatitis was seen in 16 and 73 patients, respectively. Both differences were significant (P less than .0001).

Conversely, the bendamustine-treated patients had more erythema (42 of 261 bendamustine-rituximab patients vs. 23 of 253 CHOP-rituximab patients) and allergic reactions (40 vs. 15, respectively). These were not dose-limiting toxicities. Infectious complications were frequent, and affected 96 bendamustine and 127 CHOP patients.

Next steps include a new trial called MAINTAIN that will examine rituximab maintenance therapy in 591 patients treated with bendamustine and rituximab. Patients will receive 2 years of rituximab maintenance therapy and will then be randomized to either observation or 2 more years of rituximab.

Dr. Rummel receives honoraria and research funding from Mundipharma and Roche.

CHICAGO – The financial costs of cancer weigh heavily on patients.

Personal bankruptcy is especially a risk for young adult cancer patients with local-stage tumors. Cancer diagnosis patterns indicate patients are likely to delay screening and treatment for less symptomatic cancers during times of recession. Many insured cancer patients report feeling the financial pinch of their out-of-pocket costs, going into debt or forgoing therapies and, in general, becoming less satisfied with their cancer care.

Those were the conclusions from three studies that examined financial implications of a cancer diagnosis and were presented at the annual meeting of the American Society of Clinical Oncology.

Bankruptcies Hit Lung Patients Hardest

First-time bankruptcy filings averaged 0.5% of patients at 1 year after diagnosis and 1.9% at 5 years after diagnosis based on data from 1995-2009, Dr. Scott David Ramsey reported. Average U.S. bankruptcy rates for the entire population are 0.28%.

Based on trend data, the U.S. financial crisis has likely further driven up bankruptcy filings by cancer patients, he added.

Unlike previous studies of personal bankruptcy in cancer patients, which have relied on self-reported data, Dr. Ramsey of the Fred Hutchinson Cancer Research Center, Seattle, and his colleagues looked at actual bankruptcy filings. They married Surveillance, Epidemiology, and End Results (SEER) registry data with federal bankruptcy court records in Western Washington State from 1995-2009.

Bankruptcy filings were compared by cancer type and by bankruptcy type. Time-dependent covariants were used, since filing patterns and types varied after passage of the Bankruptcy Abuse Prevention and Consumer Protection Act (BAPCPA) in 2005. They had no other financial information about patients’ treatment or debt status before their cancer diagnosis.

The researchers found 4,723 SEER registry patients who had filed for bankruptcy and compared them with the other 225,884 cancer patients who did not file for bankruptcy. The five most common cancers associated with bankruptcy filings were lung, thyroid, leukemia/lymphoma, uterine, and colorectal. Those who filed were more likely to be nonwhite, women, younger, and to have local or regional cancers.

The bankruptcy rates were highest for lung cancer patients; the rate was 8% among patients who were still alive 5 years after diagnosis.

Thyroid was the second most likely cancer to be associated with bankruptcy. "We were puzzled by this finding ... but noted that most of these are local stage cancers and likelier to occur in younger women with fewer assets." While the treatment is usually straightforward, the costs can still be considerable, he said. A course of radioactive iodine treatment costs around $40,000.

Dr. Ramsey’s study was funded by the National Cancer Institute.

Breast Cancers Untreated in Recessions

During recessions, the incidence and treatment rates for breast cancer decline, but they don’t vary much for pancreatic cancer, reported Dr. Ronald D. Ennis, director of radiation oncology at St. Luke’s-Roosevelt Hospitals in New York.

For every 1% increase in unemployment, there was a 3% decline in cancer incidence, a 9% drop in radiotherapy, and a 12% decline in surgery. For breast cancer, however, the differences were much greater at 7%, 17%, and 24%, respectively. For pancreatic cancer, the relationship was less evident with no significant difference in incidence, less than 2% decline in radiotherapy, and 9% in surgery.

Delayed screening and care are the probable causes of the inverse relationship between breast cancer and recession, said Dr. Ennis of St. Luke’s–Roosevelt Hospital, Continuum Cancer Centers of New York.

Breast cancer symptoms are less evident and incidence can appear to decline as a result of diagnostic delays from declines in screening. In pancreatic cancer, the symptoms are obvious and hard to ignore, he explained. "People likely put off preventive screening in times of recession, increasing the probability that cancers will be detected later and at more advanced stages ... It’s a case of fewer people getting diagnosed and fewer people getting treated."

The findings were noted in a study that compared data from the SEER database with unemployment rates by month from the Bureau of Labor Statistics from 1983-2007. Education, income, and race were considered in the analysis.

Dr. Ennis had no relevant financial disclosures.

Chemo Costs Pinch Insured Patients

"I have had to go without groceries in the house just to get my medicine."

"My parents pay my medical bills, which is humiliating when I worked 27 years as a teacher."

"I became homeless and our entire family has had to live with a friend several times."

These were just a few of the comments taken from surveys of 216 chemotherapy patients, reported by Dr. S. Yousuf Zafar of Duke University Medical Center, Durham, N.C.

Sponsored by the HealthWell Foundation, the study found considerable financial burdens related to chemotherapy. Although 90% of the survey participants had health insurance, most were underinsured with a mean monthly out-of-pocket expense of $712 (median $459). Most said this represented a financial burden that they described as moderate (39%), significant (30%) or catastrophic (11%).

As a result, 70% reduced leisure activities, 48% turned to their savings, and 18% sold possessions. Because of the cost of their drugs, 26% didn’t fill prescriptions.

Among their coping mechanisms for dealing with drug costs, patients asked for samples, requested cheaper drugs, sought out drugs from another country via the Internet, and shopped for lower prescription prices. To pay for their drugs, 43% borrowed money or used credit. When their cancer symptoms brought them to the hospital, many asked their doctors to let them stay for the night in the hopes of ensuring that their insurance would cover the hospital care.

These patients were less happy with their care and reported a reduced quality and standard of living. Most said they had talked to their doctor about costs, but perhaps too late in the course of their care, Dr. Zafar said.

The findings were seen among respondents who kept diaries and completed a monthly survey for 4 months. Most were white women: 76% had breast cancer. The survey was national, but 23% of the respondents resided in North Carolina. Over half were retired, 33% were college educated, and 65% earned less than $20,000 per year.

Dr. Zafar acknowledged that the findings are limited by the size of study, that all participants were on chemotherapy, and that most participants were breast cancer patients. Also, disease outcomes were not assessed.

CHICAGO – The financial costs of cancer weigh heavily on patients.

Personal bankruptcy is especially a risk for young adult cancer patients with local-stage tumors. Cancer diagnosis patterns indicate patients are likely to delay screening and treatment for less symptomatic cancers during times of recession. Many insured cancer patients report feeling the financial pinch of their out-of-pocket costs, going into debt or forgoing therapies and, in general, becoming less satisfied with their cancer care.

Those were the conclusions from three studies that examined financial implications of a cancer diagnosis and were presented at the annual meeting of the American Society of Clinical Oncology.

Bankruptcies Hit Lung Patients Hardest

First-time bankruptcy filings averaged 0.5% of patients at 1 year after diagnosis and 1.9% at 5 years after diagnosis based on data from 1995-2009, Dr. Scott David Ramsey reported. Average U.S. bankruptcy rates for the entire population are 0.28%.

Based on trend data, the U.S. financial crisis has likely further driven up bankruptcy filings by cancer patients, he added.

Unlike previous studies of personal bankruptcy in cancer patients, which have relied on self-reported data, Dr. Ramsey of the Fred Hutchinson Cancer Research Center, Seattle, and his colleagues looked at actual bankruptcy filings. They married Surveillance, Epidemiology, and End Results (SEER) registry data with federal bankruptcy court records in Western Washington State from 1995-2009.

Bankruptcy filings were compared by cancer type and by bankruptcy type. Time-dependent covariants were used, since filing patterns and types varied after passage of the Bankruptcy Abuse Prevention and Consumer Protection Act (BAPCPA) in 2005. They had no other financial information about patients’ treatment or debt status before their cancer diagnosis.

The researchers found 4,723 SEER registry patients who had filed for bankruptcy and compared them with the other 225,884 cancer patients who did not file for bankruptcy. The five most common cancers associated with bankruptcy filings were lung, thyroid, leukemia/lymphoma, uterine, and colorectal. Those who filed were more likely to be nonwhite, women, younger, and to have local or regional cancers.

The bankruptcy rates were highest for lung cancer patients; the rate was 8% among patients who were still alive 5 years after diagnosis.

Thyroid was the second most likely cancer to be associated with bankruptcy. "We were puzzled by this finding ... but noted that most of these are local stage cancers and likelier to occur in younger women with fewer assets." While the treatment is usually straightforward, the costs can still be considerable, he said. A course of radioactive iodine treatment costs around $40,000.

Dr. Ramsey’s study was funded by the National Cancer Institute.

Breast Cancers Untreated in Recessions

During recessions, the incidence and treatment rates for breast cancer decline, but they don’t vary much for pancreatic cancer, reported Dr. Ronald D. Ennis, director of radiation oncology at St. Luke’s-Roosevelt Hospitals in New York.

For every 1% increase in unemployment, there was a 3% decline in cancer incidence, a 9% drop in radiotherapy, and a 12% decline in surgery. For breast cancer, however, the differences were much greater at 7%, 17%, and 24%, respectively. For pancreatic cancer, the relationship was less evident with no significant difference in incidence, less than 2% decline in radiotherapy, and 9% in surgery.

Delayed screening and care are the probable causes of the inverse relationship between breast cancer and recession, said Dr. Ennis of St. Luke’s–Roosevelt Hospital, Continuum Cancer Centers of New York.

Breast cancer symptoms are less evident and incidence can appear to decline as a result of diagnostic delays from declines in screening. In pancreatic cancer, the symptoms are obvious and hard to ignore, he explained. "People likely put off preventive screening in times of recession, increasing the probability that cancers will be detected later and at more advanced stages ... It’s a case of fewer people getting diagnosed and fewer people getting treated."

The findings were noted in a study that compared data from the SEER database with unemployment rates by month from the Bureau of Labor Statistics from 1983-2007. Education, income, and race were considered in the analysis.

Dr. Ennis had no relevant financial disclosures.

Chemo Costs Pinch Insured Patients

"I have had to go without groceries in the house just to get my medicine."

"My parents pay my medical bills, which is humiliating when I worked 27 years as a teacher."

"I became homeless and our entire family has had to live with a friend several times."

These were just a few of the comments taken from surveys of 216 chemotherapy patients, reported by Dr. S. Yousuf Zafar of Duke University Medical Center, Durham, N.C.

Sponsored by the HealthWell Foundation, the study found considerable financial burdens related to chemotherapy. Although 90% of the survey participants had health insurance, most were underinsured with a mean monthly out-of-pocket expense of $712 (median $459). Most said this represented a financial burden that they described as moderate (39%), significant (30%) or catastrophic (11%).

As a result, 70% reduced leisure activities, 48% turned to their savings, and 18% sold possessions. Because of the cost of their drugs, 26% didn’t fill prescriptions.

Among their coping mechanisms for dealing with drug costs, patients asked for samples, requested cheaper drugs, sought out drugs from another country via the Internet, and shopped for lower prescription prices. To pay for their drugs, 43% borrowed money or used credit. When their cancer symptoms brought them to the hospital, many asked their doctors to let them stay for the night in the hopes of ensuring that their insurance would cover the hospital care.

These patients were less happy with their care and reported a reduced quality and standard of living. Most said they had talked to their doctor about costs, but perhaps too late in the course of their care, Dr. Zafar said.

The findings were seen among respondents who kept diaries and completed a monthly survey for 4 months. Most were white women: 76% had breast cancer. The survey was national, but 23% of the respondents resided in North Carolina. Over half were retired, 33% were college educated, and 65% earned less than $20,000 per year.

Dr. Zafar acknowledged that the findings are limited by the size of study, that all participants were on chemotherapy, and that most participants were breast cancer patients. Also, disease outcomes were not assessed.

CHICAGO – The financial costs of cancer weigh heavily on patients.

Personal bankruptcy is especially a risk for young adult cancer patients with local-stage tumors. Cancer diagnosis patterns indicate patients are likely to delay screening and treatment for less symptomatic cancers during times of recession. Many insured cancer patients report feeling the financial pinch of their out-of-pocket costs, going into debt or forgoing therapies and, in general, becoming less satisfied with their cancer care.

Those were the conclusions from three studies that examined financial implications of a cancer diagnosis and were presented at the annual meeting of the American Society of Clinical Oncology.

Bankruptcies Hit Lung Patients Hardest

First-time bankruptcy filings averaged 0.5% of patients at 1 year after diagnosis and 1.9% at 5 years after diagnosis based on data from 1995-2009, Dr. Scott David Ramsey reported. Average U.S. bankruptcy rates for the entire population are 0.28%.

Based on trend data, the U.S. financial crisis has likely further driven up bankruptcy filings by cancer patients, he added.

Unlike previous studies of personal bankruptcy in cancer patients, which have relied on self-reported data, Dr. Ramsey of the Fred Hutchinson Cancer Research Center, Seattle, and his colleagues looked at actual bankruptcy filings. They married Surveillance, Epidemiology, and End Results (SEER) registry data with federal bankruptcy court records in Western Washington State from 1995-2009.

Bankruptcy filings were compared by cancer type and by bankruptcy type. Time-dependent covariants were used, since filing patterns and types varied after passage of the Bankruptcy Abuse Prevention and Consumer Protection Act (BAPCPA) in 2005. They had no other financial information about patients’ treatment or debt status before their cancer diagnosis.

The researchers found 4,723 SEER registry patients who had filed for bankruptcy and compared them with the other 225,884 cancer patients who did not file for bankruptcy. The five most common cancers associated with bankruptcy filings were lung, thyroid, leukemia/lymphoma, uterine, and colorectal. Those who filed were more likely to be nonwhite, women, younger, and to have local or regional cancers.

The bankruptcy rates were highest for lung cancer patients; the rate was 8% among patients who were still alive 5 years after diagnosis.

Thyroid was the second most likely cancer to be associated with bankruptcy. "We were puzzled by this finding ... but noted that most of these are local stage cancers and likelier to occur in younger women with fewer assets." While the treatment is usually straightforward, the costs can still be considerable, he said. A course of radioactive iodine treatment costs around $40,000.

Dr. Ramsey’s study was funded by the National Cancer Institute.

Breast Cancers Untreated in Recessions

During recessions, the incidence and treatment rates for breast cancer decline, but they don’t vary much for pancreatic cancer, reported Dr. Ronald D. Ennis, director of radiation oncology at St. Luke’s-Roosevelt Hospitals in New York.

For every 1% increase in unemployment, there was a 3% decline in cancer incidence, a 9% drop in radiotherapy, and a 12% decline in surgery. For breast cancer, however, the differences were much greater at 7%, 17%, and 24%, respectively. For pancreatic cancer, the relationship was less evident with no significant difference in incidence, less than 2% decline in radiotherapy, and 9% in surgery.

Delayed screening and care are the probable causes of the inverse relationship between breast cancer and recession, said Dr. Ennis of St. Luke’s–Roosevelt Hospital, Continuum Cancer Centers of New York.

Breast cancer symptoms are less evident and incidence can appear to decline as a result of diagnostic delays from declines in screening. In pancreatic cancer, the symptoms are obvious and hard to ignore, he explained. "People likely put off preventive screening in times of recession, increasing the probability that cancers will be detected later and at more advanced stages ... It’s a case of fewer people getting diagnosed and fewer people getting treated."

The findings were noted in a study that compared data from the SEER database with unemployment rates by month from the Bureau of Labor Statistics from 1983-2007. Education, income, and race were considered in the analysis.

Dr. Ennis had no relevant financial disclosures.

Chemo Costs Pinch Insured Patients

"I have had to go without groceries in the house just to get my medicine."

"My parents pay my medical bills, which is humiliating when I worked 27 years as a teacher."

"I became homeless and our entire family has had to live with a friend several times."

These were just a few of the comments taken from surveys of 216 chemotherapy patients, reported by Dr. S. Yousuf Zafar of Duke University Medical Center, Durham, N.C.

Sponsored by the HealthWell Foundation, the study found considerable financial burdens related to chemotherapy. Although 90% of the survey participants had health insurance, most were underinsured with a mean monthly out-of-pocket expense of $712 (median $459). Most said this represented a financial burden that they described as moderate (39%), significant (30%) or catastrophic (11%).

As a result, 70% reduced leisure activities, 48% turned to their savings, and 18% sold possessions. Because of the cost of their drugs, 26% didn’t fill prescriptions.

Among their coping mechanisms for dealing with drug costs, patients asked for samples, requested cheaper drugs, sought out drugs from another country via the Internet, and shopped for lower prescription prices. To pay for their drugs, 43% borrowed money or used credit. When their cancer symptoms brought them to the hospital, many asked their doctors to let them stay for the night in the hopes of ensuring that their insurance would cover the hospital care.

These patients were less happy with their care and reported a reduced quality and standard of living. Most said they had talked to their doctor about costs, but perhaps too late in the course of their care, Dr. Zafar said.

The findings were seen among respondents who kept diaries and completed a monthly survey for 4 months. Most were white women: 76% had breast cancer. The survey was national, but 23% of the respondents resided in North Carolina. Over half were retired, 33% were college educated, and 65% earned less than $20,000 per year.

Dr. Zafar acknowledged that the findings are limited by the size of study, that all participants were on chemotherapy, and that most participants were breast cancer patients. Also, disease outcomes were not assessed.

CHICAGO – The financial costs of cancer weigh heavily on patients.

Personal bankruptcy is especially a risk for young adult cancer patients with local-stage tumors. Cancer diagnosis patterns indicate patients are likely to delay screening and treatment for less symptomatic cancers during times of recession. Many insured cancer patients report feeling the financial pinch of their out-of-pocket costs, going into debt or forgoing therapies and, in general, becoming less satisfied with their cancer care.

Those were the conclusions from three studies that examined financial implications of a cancer diagnosis and were presented at the annual meeting of the American Society of Clinical Oncology.

Bankruptcies Hit Lung Patients Hardest

First-time bankruptcy filings averaged 0.5% of patients at 1 year after diagnosis and 1.9% at 5 years after diagnosis based on data from 1995-2009, Dr. Scott David Ramsey reported. Average U.S. bankruptcy rates for the entire population are 0.28%.

Based on trend data, the U.S. financial crisis has likely further driven up bankruptcy filings by cancer patients, he added.

Unlike previous studies of personal bankruptcy in cancer patients, which have relied on self-reported data, Dr. Ramsey of the Fred Hutchinson Cancer Research Center, Seattle, and his colleagues looked at actual bankruptcy filings. They married Surveillance, Epidemiology, and End Results (SEER) registry data with federal bankruptcy court records in Western Washington State from 1995-2009.

Bankruptcy filings were compared by cancer type and by bankruptcy type. Time-dependent covariants were used, since filing patterns and types varied after passage of the Bankruptcy Abuse Prevention and Consumer Protection Act (BAPCPA) in 2005. They had no other financial information about patients’ treatment or debt status before their cancer diagnosis.

The researchers found 4,723 SEER registry patients who had filed for bankruptcy and compared them with the other 225,884 cancer patients who did not file for bankruptcy. The five most common cancers associated with bankruptcy filings were lung, thyroid, leukemia/lymphoma, uterine, and colorectal. Those who filed were more likely to be nonwhite, women, younger, and to have local or regional cancers.

The bankruptcy rates were highest for lung cancer patients; the rate was 8% among patients who were still alive 5 years after diagnosis.

Thyroid was the second most likely cancer to be associated with bankruptcy. "We were puzzled by this finding ... but noted that most of these are local stage cancers and likelier to occur in younger women with fewer assets." While the treatment is usually straightforward, the costs can still be considerable, he said. A course of radioactive iodine treatment costs around $40,000.

Dr. Ramsey’s study was funded by the National Cancer Institute.

Breast Cancers Untreated in Recessions

During recessions, the incidence and treatment rates for breast cancer decline, but they don’t vary much for pancreatic cancer, reported Dr. Ronald D. Ennis, director of radiation oncology at St. Luke’s-Roosevelt Hospitals in New York.

For every 1% increase in unemployment, there was a 3% decline in cancer incidence, a 9% drop in radiotherapy, and a 12% decline in surgery. For breast cancer, however, the differences were much greater at 7%, 17%, and 24%, respectively. For pancreatic cancer, the relationship was less evident with no significant difference in incidence, less than 2% decline in radiotherapy, and 9% in surgery.

Delayed screening and care are the probable causes of the inverse relationship between breast cancer and recession, said Dr. Ennis of St. Luke’s–Roosevelt Hospital, Continuum Cancer Centers of New York.

Breast cancer symptoms are less evident and incidence can appear to decline as a result of diagnostic delays from declines in screening. In pancreatic cancer, the symptoms are obvious and hard to ignore, he explained. "People likely put off preventive screening in times of recession, increasing the probability that cancers will be detected later and at more advanced stages ... It’s a case of fewer people getting diagnosed and fewer people getting treated."

The findings were noted in a study that compared data from the SEER database with unemployment rates by month from the Bureau of Labor Statistics from 1983-2007. Education, income, and race were considered in the analysis.

Dr. Ennis had no relevant financial disclosures.

Chemo Costs Pinch Insured Patients

"I have had to go without groceries in the house just to get my medicine."

"My parents pay my medical bills, which is humiliating when I worked 27 years as a teacher."

"I became homeless and our entire family has had to live with a friend several times."

These were just a few of the comments taken from surveys of 216 chemotherapy patients, reported by Dr. S. Yousuf Zafar of Duke University Medical Center, Durham, N.C.

Sponsored by the HealthWell Foundation, the study found considerable financial burdens related to chemotherapy. Although 90% of the survey participants had health insurance, most were underinsured with a mean monthly out-of-pocket expense of $712 (median $459). Most said this represented a financial burden that they described as moderate (39%), significant (30%) or catastrophic (11%).

As a result, 70% reduced leisure activities, 48% turned to their savings, and 18% sold possessions. Because of the cost of their drugs, 26% didn’t fill prescriptions.

Among their coping mechanisms for dealing with drug costs, patients asked for samples, requested cheaper drugs, sought out drugs from another country via the Internet, and shopped for lower prescription prices. To pay for their drugs, 43% borrowed money or used credit. When their cancer symptoms brought them to the hospital, many asked their doctors to let them stay for the night in the hopes of ensuring that their insurance would cover the hospital care.

These patients were less happy with their care and reported a reduced quality and standard of living. Most said they had talked to their doctor about costs, but perhaps too late in the course of their care, Dr. Zafar said.

The findings were seen among respondents who kept diaries and completed a monthly survey for 4 months. Most were white women: 76% had breast cancer. The survey was national, but 23% of the respondents resided in North Carolina. Over half were retired, 33% were college educated, and 65% earned less than $20,000 per year.

Dr. Zafar acknowledged that the findings are limited by the size of study, that all participants were on chemotherapy, and that most participants were breast cancer patients. Also, disease outcomes were not assessed.

CHICAGO – The financial costs of cancer weigh heavily on patients.

Personal bankruptcy is especially a risk for young adult cancer patients with local-stage tumors. Cancer diagnosis patterns indicate patients are likely to delay screening and treatment for less symptomatic cancers during times of recession. Many insured cancer patients report feeling the financial pinch of their out-of-pocket costs, going into debt or forgoing therapies and, in general, becoming less satisfied with their cancer care.

Those were the conclusions from three studies that examined financial implications of a cancer diagnosis and were presented at the annual meeting of the American Society of Clinical Oncology.

Bankruptcies Hit Lung Patients Hardest

First-time bankruptcy filings averaged 0.5% of patients at 1 year after diagnosis and 1.9% at 5 years after diagnosis based on data from 1995-2009, Dr. Scott David Ramsey reported. Average U.S. bankruptcy rates for the entire population are 0.28%.

Based on trend data, the U.S. financial crisis has likely further driven up bankruptcy filings by cancer patients, he added.

Unlike previous studies of personal bankruptcy in cancer patients, which have relied on self-reported data, Dr. Ramsey of the Fred Hutchinson Cancer Research Center, Seattle, and his colleagues looked at actual bankruptcy filings. They married Surveillance, Epidemiology, and End Results (SEER) registry data with federal bankruptcy court records in Western Washington State from 1995-2009.

Bankruptcy filings were compared by cancer type and by bankruptcy type. Time-dependent covariants were used, since filing patterns and types varied after passage of the Bankruptcy Abuse Prevention and Consumer Protection Act (BAPCPA) in 2005. They had no other financial information about patients’ treatment or debt status before their cancer diagnosis.

The researchers found 4,723 SEER registry patients who had filed for bankruptcy and compared them with the other 225,884 cancer patients who did not file for bankruptcy. The five most common cancers associated with bankruptcy filings were lung, thyroid, leukemia/lymphoma, uterine, and colorectal. Those who filed were more likely to be nonwhite, women, younger, and to have local or regional cancers.

The bankruptcy rates were highest for lung cancer patients; the rate was 8% among patients who were still alive 5 years after diagnosis.

Thyroid was the second most likely cancer to be associated with bankruptcy. "We were puzzled by this finding ... but noted that most of these are local stage cancers and likelier to occur in younger women with fewer assets." While the treatment is usually straightforward, the costs can still be considerable, he said. A course of radioactive iodine treatment costs around $40,000.

Dr. Ramsey’s study was funded by the National Cancer Institute.

Breast Cancers Untreated in Recessions

During recessions, the incidence and treatment rates for breast cancer decline, but they don’t vary much for pancreatic cancer, reported Dr. Ronald D. Ennis, director of radiation oncology at St. Luke’s-Roosevelt Hospitals in New York.

For every 1% increase in unemployment, there was a 3% decline in cancer incidence, a 9% drop in radiotherapy, and a 12% decline in surgery. For breast cancer, however, the differences were much greater at 7%, 17%, and 24%, respectively. For pancreatic cancer, the relationship was less evident with no significant difference in incidence, less than 2% decline in radiotherapy, and 9% in surgery.

Delayed screening and care are the probable causes of the inverse relationship between breast cancer and recession, said Dr. Ennis of St. Luke’s–Roosevelt Hospital, Continuum Cancer Centers of New York.

Breast cancer symptoms are less evident and incidence can appear to decline as a result of diagnostic delays from declines in screening. In pancreatic cancer, the symptoms are obvious and hard to ignore, he explained. "People likely put off preventive screening in times of recession, increasing the probability that cancers will be detected later and at more advanced stages ... It’s a case of fewer people getting diagnosed and fewer people getting treated."

The findings were noted in a study that compared data from the SEER database with unemployment rates by month from the Bureau of Labor Statistics from 1983-2007. Education, income, and race were considered in the analysis.

Dr. Ennis had no relevant financial disclosures.

Chemo Costs Pinch Insured Patients

"I have had to go without groceries in the house just to get my medicine."

"My parents pay my medical bills, which is humiliating when I worked 27 years as a teacher."

"I became homeless and our entire family has had to live with a friend several times."

These were just a few of the comments taken from surveys of 216 chemotherapy patients, reported by Dr. S. Yousuf Zafar of Duke University Medical Center, Durham, N.C.

Sponsored by the HealthWell Foundation, the study found considerable financial burdens related to chemotherapy. Although 90% of the survey participants had health insurance, most were underinsured with a mean monthly out-of-pocket expense of $712 (median $459). Most said this represented a financial burden that they described as moderate (39%), significant (30%) or catastrophic (11%).

As a result, 70% reduced leisure activities, 48% turned to their savings, and 18% sold possessions. Because of the cost of their drugs, 26% didn’t fill prescriptions.

Among their coping mechanisms for dealing with drug costs, patients asked for samples, requested cheaper drugs, sought out drugs from another country via the Internet, and shopped for lower prescription prices. To pay for their drugs, 43% borrowed money or used credit. When their cancer symptoms brought them to the hospital, many asked their doctors to let them stay for the night in the hopes of ensuring that their insurance would cover the hospital care.

These patients were less happy with their care and reported a reduced quality and standard of living. Most said they had talked to their doctor about costs, but perhaps too late in the course of their care, Dr. Zafar said.

The findings were seen among respondents who kept diaries and completed a monthly survey for 4 months. Most were white women: 76% had breast cancer. The survey was national, but 23% of the respondents resided in North Carolina. Over half were retired, 33% were college educated, and 65% earned less than $20,000 per year.

Dr. Zafar acknowledged that the findings are limited by the size of study, that all participants were on chemotherapy, and that most participants were breast cancer patients. Also, disease outcomes were not assessed.

CHICAGO – The financial costs of cancer weigh heavily on patients.

Personal bankruptcy is especially a risk for young adult cancer patients with local-stage tumors. Cancer diagnosis patterns indicate patients are likely to delay screening and treatment for less symptomatic cancers during times of recession. Many insured cancer patients report feeling the financial pinch of their out-of-pocket costs, going into debt or forgoing therapies and, in general, becoming less satisfied with their cancer care.

Those were the conclusions from three studies that examined financial implications of a cancer diagnosis and were presented at the annual meeting of the American Society of Clinical Oncology.

Bankruptcies Hit Lung Patients Hardest

First-time bankruptcy filings averaged 0.5% of patients at 1 year after diagnosis and 1.9% at 5 years after diagnosis based on data from 1995-2009, Dr. Scott David Ramsey reported. Average U.S. bankruptcy rates for the entire population are 0.28%.

Based on trend data, the U.S. financial crisis has likely further driven up bankruptcy filings by cancer patients, he added.

Unlike previous studies of personal bankruptcy in cancer patients, which have relied on self-reported data, Dr. Ramsey of the Fred Hutchinson Cancer Research Center, Seattle, and his colleagues looked at actual bankruptcy filings. They married Surveillance, Epidemiology, and End Results (SEER) registry data with federal bankruptcy court records in Western Washington State from 1995-2009.

Bankruptcy filings were compared by cancer type and by bankruptcy type. Time-dependent covariants were used, since filing patterns and types varied after passage of the Bankruptcy Abuse Prevention and Consumer Protection Act (BAPCPA) in 2005. They had no other financial information about patients’ treatment or debt status before their cancer diagnosis.

The researchers found 4,723 SEER registry patients who had filed for bankruptcy and compared them with the other 225,884 cancer patients who did not file for bankruptcy. The five most common cancers associated with bankruptcy filings were lung, thyroid, leukemia/lymphoma, uterine, and colorectal. Those who filed were more likely to be nonwhite, women, younger, and to have local or regional cancers.

The bankruptcy rates were highest for lung cancer patients; the rate was 8% among patients who were still alive 5 years after diagnosis.

Thyroid was the second most likely cancer to be associated with bankruptcy. "We were puzzled by this finding ... but noted that most of these are local stage cancers and likelier to occur in younger women with fewer assets." While the treatment is usually straightforward, the costs can still be considerable, he said. A course of radioactive iodine treatment costs around $40,000.

Dr. Ramsey’s study was funded by the National Cancer Institute.

Breast Cancers Untreated in Recessions

During recessions, the incidence and treatment rates for breast cancer decline, but they don’t vary much for pancreatic cancer, reported Dr. Ronald D. Ennis, director of radiation oncology at St. Luke’s-Roosevelt Hospitals in New York.

For every 1% increase in unemployment, there was a 3% decline in cancer incidence, a 9% drop in radiotherapy, and a 12% decline in surgery. For breast cancer, however, the differences were much greater at 7%, 17%, and 24%, respectively. For pancreatic cancer, the relationship was less evident with no significant difference in incidence, less than 2% decline in radiotherapy, and 9% in surgery.

Delayed screening and care are the probable causes of the inverse relationship between breast cancer and recession, said Dr. Ennis of St. Luke’s–Roosevelt Hospital, Continuum Cancer Centers of New York.

Breast cancer symptoms are less evident and incidence can appear to decline as a result of diagnostic delays from declines in screening. In pancreatic cancer, the symptoms are obvious and hard to ignore, he explained. "People likely put off preventive screening in times of recession, increasing the probability that cancers will be detected later and at more advanced stages ... It’s a case of fewer people getting diagnosed and fewer people getting treated."

The findings were noted in a study that compared data from the SEER database with unemployment rates by month from the Bureau of Labor Statistics from 1983-2007. Education, income, and race were considered in the analysis.

Dr. Ennis had no relevant financial disclosures.

Chemo Costs Pinch Insured Patients

"I have had to go without groceries in the house just to get my medicine."

"My parents pay my medical bills, which is humiliating when I worked 27 years as a teacher."

"I became homeless and our entire family has had to live with a friend several times."

These were just a few of the comments taken from surveys of 216 chemotherapy patients, reported by Dr. S. Yousuf Zafar of Duke University Medical Center, Durham, N.C.

Sponsored by the HealthWell Foundation, the study found considerable financial burdens related to chemotherapy. Although 90% of the survey participants had health insurance, most were underinsured with a mean monthly out-of-pocket expense of $712 (median $459). Most said this represented a financial burden that they described as moderate (39%), significant (30%) or catastrophic (11%).

As a result, 70% reduced leisure activities, 48% turned to their savings, and 18% sold possessions. Because of the cost of their drugs, 26% didn’t fill prescriptions.

Among their coping mechanisms for dealing with drug costs, patients asked for samples, requested cheaper drugs, sought out drugs from another country via the Internet, and shopped for lower prescription prices. To pay for their drugs, 43% borrowed money or used credit. When their cancer symptoms brought them to the hospital, many asked their doctors to let them stay for the night in the hopes of ensuring that their insurance would cover the hospital care.

These patients were less happy with their care and reported a reduced quality and standard of living. Most said they had talked to their doctor about costs, but perhaps too late in the course of their care, Dr. Zafar said.

The findings were seen among respondents who kept diaries and completed a monthly survey for 4 months. Most were white women: 76% had breast cancer. The survey was national, but 23% of the respondents resided in North Carolina. Over half were retired, 33% were college educated, and 65% earned less than $20,000 per year.

Dr. Zafar acknowledged that the findings are limited by the size of study, that all participants were on chemotherapy, and that most participants were breast cancer patients. Also, disease outcomes were not assessed.

CHICAGO – The financial costs of cancer weigh heavily on patients.

Personal bankruptcy is especially a risk for young adult cancer patients with local-stage tumors. Cancer diagnosis patterns indicate patients are likely to delay screening and treatment for less symptomatic cancers during times of recession. Many insured cancer patients report feeling the financial pinch of their out-of-pocket costs, going into debt or forgoing therapies and, in general, becoming less satisfied with their cancer care.

Those were the conclusions from three studies that examined financial implications of a cancer diagnosis and were presented at the annual meeting of the American Society of Clinical Oncology.

Bankruptcies Hit Lung Patients Hardest

First-time bankruptcy filings averaged 0.5% of patients at 1 year after diagnosis and 1.9% at 5 years after diagnosis based on data from 1995-2009, Dr. Scott David Ramsey reported. Average U.S. bankruptcy rates for the entire population are 0.28%.

Based on trend data, the U.S. financial crisis has likely further driven up bankruptcy filings by cancer patients, he added.

Unlike previous studies of personal bankruptcy in cancer patients, which have relied on self-reported data, Dr. Ramsey of the Fred Hutchinson Cancer Research Center, Seattle, and his colleagues looked at actual bankruptcy filings. They married Surveillance, Epidemiology, and End Results (SEER) registry data with federal bankruptcy court records in Western Washington State from 1995-2009.

Bankruptcy filings were compared by cancer type and by bankruptcy type. Time-dependent covariants were used, since filing patterns and types varied after passage of the Bankruptcy Abuse Prevention and Consumer Protection Act (BAPCPA) in 2005. They had no other financial information about patients’ treatment or debt status before their cancer diagnosis.

The researchers found 4,723 SEER registry patients who had filed for bankruptcy and compared them with the other 225,884 cancer patients who did not file for bankruptcy. The five most common cancers associated with bankruptcy filings were lung, thyroid, leukemia/lymphoma, uterine, and colorectal. Those who filed were more likely to be nonwhite, women, younger, and to have local or regional cancers.

The bankruptcy rates were highest for lung cancer patients; the rate was 8% among patients who were still alive 5 years after diagnosis.

Thyroid was the second most likely cancer to be associated with bankruptcy. "We were puzzled by this finding ... but noted that most of these are local stage cancers and likelier to occur in younger women with fewer assets." While the treatment is usually straightforward, the costs can still be considerable, he said. A course of radioactive iodine treatment costs around $40,000.

Dr. Ramsey’s study was funded by the National Cancer Institute.

Breast Cancers Untreated in Recessions

During recessions, the incidence and treatment rates for breast cancer decline, but they don’t vary much for pancreatic cancer, reported Dr. Ronald D. Ennis, director of radiation oncology at St. Luke’s and Roosevelt Hospitals in New York.

For every 1% increase in unemployment, there was a 3% decline in cancer incidence, a 9% drop in radiotherapy, and a 12% decline in surgery. For breast cancer, however, the differences were much greater at 7%, 17%, and 24%, respectively. For pancreatic cancer, the relationship was less evident with no significant difference in incidence, less than 2% decline in radiotherapy, and 9% in surgery.

Delayed screening and care are the probable causes of the inverse relationship between breast cancer and recession, said Dr. Ennis of St. Luke’s–Roosevelt Hospital, Continuum Cancer Centers of New York.

Breast cancer symptoms are less evident and incidence can appear to decline as a result of diagnostic delays from declines in screening. In pancreatic cancer, the symptoms are obvious and hard to ignore, he explained. "People likely put off preventive screening in times of recession, increasing the probability that cancers will be detected later and at more advanced stages ... It’s a case of fewer people getting diagnosed and fewer people getting treated."

The findings were noted in a study that compared data from the SEER database with unemployment rates by month from the Bureau of Labor Statistics from 1983-2007. Education, income, and race were considered in the analysis.

Dr. Ennis had no relevant financial disclosures.

Chemo Costs Pinch Insured Patients

"I have had to go without groceries in the house just to get my medicine."

"My parents pay my medical bills, which is humiliating when I worked 27 years as a teacher."

"I became homeless and our entire family has had to live with a friend several times."

These were just a few of the comments taken from surveys of 216 chemotherapy patients, reported by Dr. S. Yousuf Zafar of Duke University Medical Center, Durham, N.C.

Sponsored by the HealthWell Foundation, the study found considerable financial burdens related to chemotherapy. Although 90% of the survey participants had health insurance, most were underinsured with a mean monthly out-of-pocket expense of $712 (median $459). Most said this represented a financial burden that they described as moderate (39%), significant (30%) or catastrophic (11%).

As a result, 70% reduced leisure activities, 48% turned to their savings, and 18% sold possessions. Because of the cost of their drugs, 26% didn’t fill prescriptions.

Among their coping mechanisms for dealing with drug costs, patients asked for samples, requested cheaper drugs, sought out drugs from another country via the Internet, and shopped for lower prescription prices. To pay for their drugs, 43% borrowed money or used credit. When their cancer symptoms brought them to the hospital, many asked their doctors to let them stay for the night in the hopes of ensuring that their insurance would cover the hospital care.

These patients were less happy with their care and reported a reduced quality and standard of living. Most said they had talked to their doctor about costs, but perhaps too late in the course of their care, Dr. Zafar said.

The findings were seen among respondents who kept diaries and completed a monthly survey for 4 months. Most were white women: 76% had breast cancer. The survey was national, but 23% of the respondents resided in North Carolina. Over half were retired, 33% were college educated, and 65% earned less than $20,000 per year.

Dr. Zafar acknowledged that the findings are limited by the size of study, that all participants were on chemotherapy, and that most participants were breast cancer patients. Also, disease outcomes were not assessed.

Talk to Patients About Costs

According to Dr. Neal J. Meropol, who was the discussant of the papers at the ASCO meeting, these studies drill down from the macroeconomic to the individual cancer patients feeling the burdens of increased insurance costs and more cost sharing for their treatment. Cancer diagnosis is associated with the greatest individual burden for health care costs, with more than 13% of patients spending more than 20% of their income. Additionally, the Kaiser Family Foundation reports 20% of cancer patients use all of their savings on their cancer care.

More 50 million Americans are uninsured, and ample data show that lack of insurance is associated with late diagnosis of cancer. Additionally, every 1% increase in unemployment results in another 1 million citizens losing health insurance, said Dr. Meropol, chief of hematology-oncology, University Hospitals Case Medical Center, Case Western Reserve University, Cleveland. As the numbers of uninsured and underinsured increase, the divide grows between the haves and the have-nots in our society. The disparities will result in more delays in seeking care, decreased access to treatment, and more financial burdens including more personal bankruptcies.

Trends in health care spending threaten our nation’s health. In 2010, the NIH estimates that we spent $264 billion on cancer, $103 billion of that on direct medical costs. We need more patient-physician discussions about the costs of care, as well as educational and support tools to promote effective communication about costs and to guide patients’ evaluations of treatments and their impact on outcomes. We need a better understanding of the factors that drive the costs of cancer care and how the cancer care system can be modified to ensure that all Americans have access to high-quality, cost-effective care.

Dr. Meropol is an advisor or consultant to AstraZeneca, Genentech, Genomic Health, and Helsinn.

CHICAGO – The financial costs of cancer weigh heavily on patients.

Personal bankruptcy is especially a risk for young adult cancer patients with local-stage tumors. Cancer diagnosis patterns indicate patients are likely to delay screening and treatment for less symptomatic cancers during times of recession. Many insured cancer patients report feeling the financial pinch of their out-of-pocket costs, going into debt or forgoing therapies and, in general, becoming less satisfied with their cancer care.

Those were the conclusions from three studies that examined financial implications of a cancer diagnosis and were presented at the annual meeting of the American Society of Clinical Oncology.

Bankruptcies Hit Lung Patients Hardest

First-time bankruptcy filings averaged 0.5% of patients at 1 year after diagnosis and 1.9% at 5 years after diagnosis based on data from 1995-2009, Dr. Scott David Ramsey reported. Average U.S. bankruptcy rates for the entire population are 0.28%.

Based on trend data, the U.S. financial crisis has likely further driven up bankruptcy filings by cancer patients, he added.

Unlike previous studies of personal bankruptcy in cancer patients, which have relied on self-reported data, Dr. Ramsey of the Fred Hutchinson Cancer Research Center, Seattle, and his colleagues looked at actual bankruptcy filings. They married Surveillance, Epidemiology, and End Results (SEER) registry data with federal bankruptcy court records in Western Washington State from 1995-2009.

Bankruptcy filings were compared by cancer type and by bankruptcy type. Time-dependent covariants were used, since filing patterns and types varied after passage of the Bankruptcy Abuse Prevention and Consumer Protection Act (BAPCPA) in 2005. They had no other financial information about patients’ treatment or debt status before their cancer diagnosis.

The researchers found 4,723 SEER registry patients who had filed for bankruptcy and compared them with the other 225,884 cancer patients who did not file for bankruptcy. The five most common cancers associated with bankruptcy filings were lung, thyroid, leukemia/lymphoma, uterine, and colorectal. Those who filed were more likely to be nonwhite, women, younger, and to have local or regional cancers.

The bankruptcy rates were highest for lung cancer patients; the rate was 8% among patients who were still alive 5 years after diagnosis.

Thyroid was the second most likely cancer to be associated with bankruptcy. "We were puzzled by this finding ... but noted that most of these are local stage cancers and likelier to occur in younger women with fewer assets." While the treatment is usually straightforward, the costs can still be considerable, he said. A course of radioactive iodine treatment costs around $40,000.

Dr. Ramsey’s study was funded by the National Cancer Institute.

Breast Cancers Untreated in Recessions

During recessions, the incidence and treatment rates for breast cancer decline, but they don’t vary much for pancreatic cancer, reported Dr. Ronald D. Ennis, director of radiation oncology at St. Luke’s and Roosevelt Hospitals in New York.

For every 1% increase in unemployment, there was a 3% decline in cancer incidence, a 9% drop in radiotherapy, and a 12% decline in surgery. For breast cancer, however, the differences were much greater at 7%, 17%, and 24%, respectively. For pancreatic cancer, the relationship was less evident with no significant difference in incidence, less than 2% decline in radiotherapy, and 9% in surgery.

Delayed screening and care are the probable causes of the inverse relationship between breast cancer and recession, said Dr. Ennis of St. Luke’s–Roosevelt Hospital, Continuum Cancer Centers of New York.

Breast cancer symptoms are less evident and incidence can appear to decline as a result of diagnostic delays from declines in screening. In pancreatic cancer, the symptoms are obvious and hard to ignore, he explained. "People likely put off preventive screening in times of recession, increasing the probability that cancers will be detected later and at more advanced stages ... It’s a case of fewer people getting diagnosed and fewer people getting treated."

The findings were noted in a study that compared data from the SEER database with unemployment rates by month from the Bureau of Labor Statistics from 1983-2007. Education, income, and race were considered in the analysis.

Dr. Ennis had no relevant financial disclosures.

Chemo Costs Pinch Insured Patients

"I have had to go without groceries in the house just to get my medicine."

"My parents pay my medical bills, which is humiliating when I worked 27 years as a teacher."

"I became homeless and our entire family has had to live with a friend several times."

These were just a few of the comments taken from surveys of 216 chemotherapy patients, reported by Dr. S. Yousuf Zafar of Duke University Medical Center, Durham, N.C.

Sponsored by the HealthWell Foundation, the study found considerable financial burdens related to chemotherapy. Although 90% of the survey participants had health insurance, most were underinsured with a mean monthly out-of-pocket expense of $712 (median $459). Most said this represented a financial burden that they described as moderate (39%), significant (30%) or catastrophic (11%).

As a result, 70% reduced leisure activities, 48% turned to their savings, and 18% sold possessions. Because of the cost of their drugs, 26% didn’t fill prescriptions.

Among their coping mechanisms for dealing with drug costs, patients asked for samples, requested cheaper drugs, sought out drugs from another country via the Internet, and shopped for lower prescription prices. To pay for their drugs, 43% borrowed money or used credit. When their cancer symptoms brought them to the hospital, many asked their doctors to let them stay for the night in the hopes of ensuring that their insurance would cover the hospital care.

These patients were less happy with their care and reported a reduced quality and standard of living. Most said they had talked to their doctor about costs, but perhaps too late in the course of their care, Dr. Zafar said.

The findings were seen among respondents who kept diaries and completed a monthly survey for 4 months. Most were white women: 76% had breast cancer. The survey was national, but 23% of the respondents resided in North Carolina. Over half were retired, 33% were college educated, and 65% earned less than $20,000 per year.

Dr. Zafar acknowledged that the findings are limited by the size of study, that all participants were on chemotherapy, and that most participants were breast cancer patients. Also, disease outcomes were not assessed.

Talk to Patients About Costs

According to Dr. Neal J. Meropol, who was the discussant of the papers at the ASCO meeting, these studies drill down from the macroeconomic to the individual cancer patients feeling the burdens of increased insurance costs and more cost sharing for their treatment. Cancer diagnosis is associated with the greatest individual burden for health care costs, with more than 13% of patients spending more than 20% of their income. Additionally, the Kaiser Family Foundation reports 20% of cancer patients use all of their savings on their cancer care.

More 50 million Americans are uninsured, and ample data show that lack of insurance is associated with late diagnosis of cancer. Additionally, every 1% increase in unemployment results in another 1 million citizens losing health insurance, said Dr. Meropol, chief of hematology-oncology, University Hospitals Case Medical Center, Case Western Reserve University, Cleveland. As the numbers of uninsured and underinsured increase, the divide grows between the haves and the have-nots in our society. The disparities will result in more delays in seeking care, decreased access to treatment, and more financial burdens including more personal bankruptcies.

Trends in health care spending threaten our nation’s health. In 2010, the NIH estimates that we spent $264 billion on cancer, $103 billion of that on direct medical costs. We need more patient-physician discussions about the costs of care, as well as educational and support tools to promote effective communication about costs and to guide patients’ evaluations of treatments and their impact on outcomes. We need a better understanding of the factors that drive the costs of cancer care and how the cancer care system can be modified to ensure that all Americans have access to high-quality, cost-effective care.

Dr. Meropol is an advisor or consultant to AstraZeneca, Genentech, Genomic Health, and Helsinn.

CHICAGO – The financial costs of cancer weigh heavily on patients.

Personal bankruptcy is especially a risk for young adult cancer patients with local-stage tumors. Cancer diagnosis patterns indicate patients are likely to delay screening and treatment for less symptomatic cancers during times of recession. Many insured cancer patients report feeling the financial pinch of their out-of-pocket costs, going into debt or forgoing therapies and, in general, becoming less satisfied with their cancer care.

Those were the conclusions from three studies that examined financial implications of a cancer diagnosis and were presented at the annual meeting of the American Society of Clinical Oncology.

Bankruptcies Hit Lung Patients Hardest

First-time bankruptcy filings averaged 0.5% of patients at 1 year after diagnosis and 1.9% at 5 years after diagnosis based on data from 1995-2009, Dr. Scott David Ramsey reported. Average U.S. bankruptcy rates for the entire population are 0.28%.

Based on trend data, the U.S. financial crisis has likely further driven up bankruptcy filings by cancer patients, he added.

Unlike previous studies of personal bankruptcy in cancer patients, which have relied on self-reported data, Dr. Ramsey of the Fred Hutchinson Cancer Research Center, Seattle, and his colleagues looked at actual bankruptcy filings. They married Surveillance, Epidemiology, and End Results (SEER) registry data with federal bankruptcy court records in Western Washington State from 1995-2009.

Bankruptcy filings were compared by cancer type and by bankruptcy type. Time-dependent covariants were used, since filing patterns and types varied after passage of the Bankruptcy Abuse Prevention and Consumer Protection Act (BAPCPA) in 2005. They had no other financial information about patients’ treatment or debt status before their cancer diagnosis.

The researchers found 4,723 SEER registry patients who had filed for bankruptcy and compared them with the other 225,884 cancer patients who did not file for bankruptcy. The five most common cancers associated with bankruptcy filings were lung, thyroid, leukemia/lymphoma, uterine, and colorectal. Those who filed were more likely to be nonwhite, women, younger, and to have local or regional cancers.

The bankruptcy rates were highest for lung cancer patients; the rate was 8% among patients who were still alive 5 years after diagnosis.

Thyroid was the second most likely cancer to be associated with bankruptcy. "We were puzzled by this finding ... but noted that most of these are local stage cancers and likelier to occur in younger women with fewer assets." While the treatment is usually straightforward, the costs can still be considerable, he said. A course of radioactive iodine treatment costs around $40,000.

Dr. Ramsey’s study was funded by the National Cancer Institute.

Breast Cancers Untreated in Recessions

During recessions, the incidence and treatment rates for breast cancer decline, but they don’t vary much for pancreatic cancer, reported Dr. Ronald D. Ennis, director of radiation oncology at St. Luke’s and Roosevelt Hospitals in New York.

For every 1% increase in unemployment, there was a 3% decline in cancer incidence, a 9% drop in radiotherapy, and a 12% decline in surgery. For breast cancer, however, the differences were much greater at 7%, 17%, and 24%, respectively. For pancreatic cancer, the relationship was less evident with no significant difference in incidence, less than 2% decline in radiotherapy, and 9% in surgery.

Delayed screening and care are the probable causes of the inverse relationship between breast cancer and recession, said Dr. Ennis of St. Luke’s–Roosevelt Hospital, Continuum Cancer Centers of New York.

Breast cancer symptoms are less evident and incidence can appear to decline as a result of diagnostic delays from declines in screening. In pancreatic cancer, the symptoms are obvious and hard to ignore, he explained. "People likely put off preventive screening in times of recession, increasing the probability that cancers will be detected later and at more advanced stages ... It’s a case of fewer people getting diagnosed and fewer people getting treated."

The findings were noted in a study that compared data from the SEER database with unemployment rates by month from the Bureau of Labor Statistics from 1983-2007. Education, income, and race were considered in the analysis.

Dr. Ennis had no relevant financial disclosures.

Chemo Costs Pinch Insured Patients

"I have had to go without groceries in the house just to get my medicine."

"My parents pay my medical bills, which is humiliating when I worked 27 years as a teacher."

"I became homeless and our entire family has had to live with a friend several times."

These were just a few of the comments taken from surveys of 216 chemotherapy patients, reported by Dr. S. Yousuf Zafar of Duke University Medical Center, Durham, N.C.

Sponsored by the HealthWell Foundation, the study found considerable financial burdens related to chemotherapy. Although 90% of the survey participants had health insurance, most were underinsured with a mean monthly out-of-pocket expense of $712 (median $459). Most said this represented a financial burden that they described as moderate (39%), significant (30%) or catastrophic (11%).

As a result, 70% reduced leisure activities, 48% turned to their savings, and 18% sold possessions. Because of the cost of their drugs, 26% didn’t fill prescriptions.

Among their coping mechanisms for dealing with drug costs, patients asked for samples, requested cheaper drugs, sought out drugs from another country via the Internet, and shopped for lower prescription prices. To pay for their drugs, 43% borrowed money or used credit. When their cancer symptoms brought them to the hospital, many asked their doctors to let them stay for the night in the hopes of ensuring that their insurance would cover the hospital care.

These patients were less happy with their care and reported a reduced quality and standard of living. Most said they had talked to their doctor about costs, but perhaps too late in the course of their care, Dr. Zafar said.

The findings were seen among respondents who kept diaries and completed a monthly survey for 4 months. Most were white women: 76% had breast cancer. The survey was national, but 23% of the respondents resided in North Carolina. Over half were retired, 33% were college educated, and 65% earned less than $20,000 per year.

Dr. Zafar acknowledged that the findings are limited by the size of study, that all participants were on chemotherapy, and that most participants were breast cancer patients. Also, disease outcomes were not assessed.

Talk to Patients About Costs

According to Dr. Neal J. Meropol, who was the discussant of the papers at the ASCO meeting, these studies drill down from the macroeconomic to the individual cancer patients feeling the burdens of increased insurance costs and more cost sharing for their treatment. Cancer diagnosis is associated with the greatest individual burden for health care costs, with more than 13% of patients spending more than 20% of their income. Additionally, the Kaiser Family Foundation reports 20% of cancer patients use all of their savings on their cancer care.

More 50 million Americans are uninsured, and ample data show that lack of insurance is associated with late diagnosis of cancer. Additionally, every 1% increase in unemployment results in another 1 million citizens losing health insurance, said Dr. Meropol, chief of hematology-oncology, University Hospitals Case Medical Center, Case Western Reserve University, Cleveland. As the numbers of uninsured and underinsured increase, the divide grows between the haves and the have-nots in our society. The disparities will result in more delays in seeking care, decreased access to treatment, and more financial burdens including more personal bankruptcies.

Trends in health care spending threaten our nation’s health. In 2010, the NIH estimates that we spent $264 billion on cancer, $103 billion of that on direct medical costs. We need more patient-physician discussions about the costs of care, as well as educational and support tools to promote effective communication about costs and to guide patients’ evaluations of treatments and their impact on outcomes. We need a better understanding of the factors that drive the costs of cancer care and how the cancer care system can be modified to ensure that all Americans have access to high-quality, cost-effective care.

Dr. Meropol is an advisor or consultant to AstraZeneca, Genentech, Genomic Health, and Helsinn.