User login
Jennifer Smith is the editor of Oncology Practice, part of MDedge Hematology/Oncology. She was previously the editor of Hematology Times, an editor at Principal Investigators Association, and a reporter at The Oneida Daily Dispatch. She has a BS in journalism.
Polatuzumab outperforms pinatuzumab in non-Hodgkin lymphoma
Favorable results from a phase 2 trial have prompted further development of polatuzumab vedotin in non-Hodgkin lymphoma.
In the ROMULUS trial, polatuzumab vedotin plus rituximab (R-pola) produced more durable responses than did pinatuzumab vedotin plus rituximab (R-pina) in patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL) or follicular lymphoma (FL).
Researchers also observed a more favorable benefit-risk profile with R-pola.
Franck Morschhauser, MD, of Centre Hospitalier Régional Universitaire de Lille, France, and his colleagues described these findings in the Lancet Haematology.
The ROMULUS trial included 81 DLBCL patients and 42 FL patients. They were randomized to receive R-pola or R-pina (rituximab at 375 mg/m2 plus either antibody-drug conjugate at 2.4 mg/kg) every 21 days until disease progression or unacceptable toxicity for up to 1 year.
Among DLBCL patients, the median age was 69 years in the R-pina arm and 68 years in the R-pola arm. Among FL patients, the median age was 59 years in the R-pina arm and 67 years in the R-pola arm.
Seventy-six percent of DLBCL patients randomized to R-pina were refractory to their last treatment, as were 80% of DLBCL patients assigned to R-pola, 52% of FL patients assigned to R-pina, and 35% of FL patients assigned to R-pola.
The median number of prior systemic therapies was three in the R-pina DLBCL arm, the R-pola DLBCL arm, and the R-pina FL arm. The median number of prior therapies was two in the R-pola FL arm.
Response and survival
Among the DLBCL patients, R-pina produced an objective response rate (ORR) of 60% and a complete response (CR) rate of 26%. R-pola produced an ORR of 54% and a CR rate of 21%. The median duration of response was 6.2 months in the R-pina arm and 13.4 months in the R-pola arm.
The median progression-free survival in the DLBCL cohort was 5.4 months for the R-pina arm and 5.6 months for the R-pola arm. The median overall survival was 16.5 months and 20.1 months, respectively.
In the FL cohort, R-pina produced an ORR of 62% and a CR rate of 5%. R-pola produced an ORR of 70% and a CR rate of 45%. The median duration of response was 6.5 months in the R-pina arm and 9.4 months in the R-pola arm.
The median progression-free survival in the FL cohort was 12.7 months for the R-pina arm and 15.3 months for the R-pola arm. The 2-year overall survival rate was 90.5% and 87.8%, respectively. The median overall survival was not reached in either arm.
“Patients treated with R-pola tended to have longer durations of response than those receiving R-pina (particularly those with relapsed or refractory diffuse large B-cell lymphoma), and the results for R-pola compared favorably with other novel antilymphoma agents,” Dr. Morschhauser and his colleagues wrote.
Safety
Among DLBCL patients, serious adverse events (AEs) occurred in 50.0% of those in the R-pina arm and 35.9% of those in the R-pola arm. Among FL patients, serious AEs occurred in 28.6% of those the R-pina arm and 35.0% of those in the R-pola arm.
Ten grade 5 AEs occurred in nine DLBCL patients who received R-pina (21.4%). These events included two cases of sepsis, influenza and pneumonia in the same patient, general physical health deterioration including one death attributed to disease progression, and one case each of Clostridium difficile sepsis, respiratory failure, urosepsis, and sudden death.
There was one grade 5 AE in a FL patient who received R-pola. The 84-year-old patient died of pulmonary congestion 64 days after the last of 12 cycles of treatment.
There were no fatal AEs in the other arms.
“These findings make pola a promising novel candidate for further clinical evaluation in combination regimens in treatment-refractory patients and also in a first-line setting in B-cell non-Hodgkin lymphoma,” Dr. Morschhauser and his colleagues wrote.
Polatuzumab vedotin was chosen by the study funder for further development in non-Hodgkin lymphoma, partly because of longer durations of response, compared with pinatuzumab vedotin.
Polatuzumab vedotin is currently under investigation in the phase 3 POLARIX study. The drug is being combined with rituximab, cyclophosphamide, doxorubicin, and prednisone and compared to rituximab-cyclophosphamide, doxorubicin, vincristine, and prednisone (R-CHOP) in patients with DLBCL.
The ROMULUS study was funded by F Hoffmann-La Roche. The study authors reported relationships with Roche and other companies.
SOURCE: Morschhauser F et al. Lancet Haematol. 2019 Mar 29. doi: 10.1016/S2352-3026(19)30026-2.
Favorable results from a phase 2 trial have prompted further development of polatuzumab vedotin in non-Hodgkin lymphoma.
In the ROMULUS trial, polatuzumab vedotin plus rituximab (R-pola) produced more durable responses than did pinatuzumab vedotin plus rituximab (R-pina) in patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL) or follicular lymphoma (FL).
Researchers also observed a more favorable benefit-risk profile with R-pola.
Franck Morschhauser, MD, of Centre Hospitalier Régional Universitaire de Lille, France, and his colleagues described these findings in the Lancet Haematology.
The ROMULUS trial included 81 DLBCL patients and 42 FL patients. They were randomized to receive R-pola or R-pina (rituximab at 375 mg/m2 plus either antibody-drug conjugate at 2.4 mg/kg) every 21 days until disease progression or unacceptable toxicity for up to 1 year.
Among DLBCL patients, the median age was 69 years in the R-pina arm and 68 years in the R-pola arm. Among FL patients, the median age was 59 years in the R-pina arm and 67 years in the R-pola arm.
Seventy-six percent of DLBCL patients randomized to R-pina were refractory to their last treatment, as were 80% of DLBCL patients assigned to R-pola, 52% of FL patients assigned to R-pina, and 35% of FL patients assigned to R-pola.
The median number of prior systemic therapies was three in the R-pina DLBCL arm, the R-pola DLBCL arm, and the R-pina FL arm. The median number of prior therapies was two in the R-pola FL arm.
Response and survival
Among the DLBCL patients, R-pina produced an objective response rate (ORR) of 60% and a complete response (CR) rate of 26%. R-pola produced an ORR of 54% and a CR rate of 21%. The median duration of response was 6.2 months in the R-pina arm and 13.4 months in the R-pola arm.
The median progression-free survival in the DLBCL cohort was 5.4 months for the R-pina arm and 5.6 months for the R-pola arm. The median overall survival was 16.5 months and 20.1 months, respectively.
In the FL cohort, R-pina produced an ORR of 62% and a CR rate of 5%. R-pola produced an ORR of 70% and a CR rate of 45%. The median duration of response was 6.5 months in the R-pina arm and 9.4 months in the R-pola arm.
The median progression-free survival in the FL cohort was 12.7 months for the R-pina arm and 15.3 months for the R-pola arm. The 2-year overall survival rate was 90.5% and 87.8%, respectively. The median overall survival was not reached in either arm.
“Patients treated with R-pola tended to have longer durations of response than those receiving R-pina (particularly those with relapsed or refractory diffuse large B-cell lymphoma), and the results for R-pola compared favorably with other novel antilymphoma agents,” Dr. Morschhauser and his colleagues wrote.
Safety
Among DLBCL patients, serious adverse events (AEs) occurred in 50.0% of those in the R-pina arm and 35.9% of those in the R-pola arm. Among FL patients, serious AEs occurred in 28.6% of those the R-pina arm and 35.0% of those in the R-pola arm.
Ten grade 5 AEs occurred in nine DLBCL patients who received R-pina (21.4%). These events included two cases of sepsis, influenza and pneumonia in the same patient, general physical health deterioration including one death attributed to disease progression, and one case each of Clostridium difficile sepsis, respiratory failure, urosepsis, and sudden death.
There was one grade 5 AE in a FL patient who received R-pola. The 84-year-old patient died of pulmonary congestion 64 days after the last of 12 cycles of treatment.
There were no fatal AEs in the other arms.
“These findings make pola a promising novel candidate for further clinical evaluation in combination regimens in treatment-refractory patients and also in a first-line setting in B-cell non-Hodgkin lymphoma,” Dr. Morschhauser and his colleagues wrote.
Polatuzumab vedotin was chosen by the study funder for further development in non-Hodgkin lymphoma, partly because of longer durations of response, compared with pinatuzumab vedotin.
Polatuzumab vedotin is currently under investigation in the phase 3 POLARIX study. The drug is being combined with rituximab, cyclophosphamide, doxorubicin, and prednisone and compared to rituximab-cyclophosphamide, doxorubicin, vincristine, and prednisone (R-CHOP) in patients with DLBCL.
The ROMULUS study was funded by F Hoffmann-La Roche. The study authors reported relationships with Roche and other companies.
SOURCE: Morschhauser F et al. Lancet Haematol. 2019 Mar 29. doi: 10.1016/S2352-3026(19)30026-2.
Favorable results from a phase 2 trial have prompted further development of polatuzumab vedotin in non-Hodgkin lymphoma.
In the ROMULUS trial, polatuzumab vedotin plus rituximab (R-pola) produced more durable responses than did pinatuzumab vedotin plus rituximab (R-pina) in patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL) or follicular lymphoma (FL).
Researchers also observed a more favorable benefit-risk profile with R-pola.
Franck Morschhauser, MD, of Centre Hospitalier Régional Universitaire de Lille, France, and his colleagues described these findings in the Lancet Haematology.
The ROMULUS trial included 81 DLBCL patients and 42 FL patients. They were randomized to receive R-pola or R-pina (rituximab at 375 mg/m2 plus either antibody-drug conjugate at 2.4 mg/kg) every 21 days until disease progression or unacceptable toxicity for up to 1 year.
Among DLBCL patients, the median age was 69 years in the R-pina arm and 68 years in the R-pola arm. Among FL patients, the median age was 59 years in the R-pina arm and 67 years in the R-pola arm.
Seventy-six percent of DLBCL patients randomized to R-pina were refractory to their last treatment, as were 80% of DLBCL patients assigned to R-pola, 52% of FL patients assigned to R-pina, and 35% of FL patients assigned to R-pola.
The median number of prior systemic therapies was three in the R-pina DLBCL arm, the R-pola DLBCL arm, and the R-pina FL arm. The median number of prior therapies was two in the R-pola FL arm.
Response and survival
Among the DLBCL patients, R-pina produced an objective response rate (ORR) of 60% and a complete response (CR) rate of 26%. R-pola produced an ORR of 54% and a CR rate of 21%. The median duration of response was 6.2 months in the R-pina arm and 13.4 months in the R-pola arm.
The median progression-free survival in the DLBCL cohort was 5.4 months for the R-pina arm and 5.6 months for the R-pola arm. The median overall survival was 16.5 months and 20.1 months, respectively.
In the FL cohort, R-pina produced an ORR of 62% and a CR rate of 5%. R-pola produced an ORR of 70% and a CR rate of 45%. The median duration of response was 6.5 months in the R-pina arm and 9.4 months in the R-pola arm.
The median progression-free survival in the FL cohort was 12.7 months for the R-pina arm and 15.3 months for the R-pola arm. The 2-year overall survival rate was 90.5% and 87.8%, respectively. The median overall survival was not reached in either arm.
“Patients treated with R-pola tended to have longer durations of response than those receiving R-pina (particularly those with relapsed or refractory diffuse large B-cell lymphoma), and the results for R-pola compared favorably with other novel antilymphoma agents,” Dr. Morschhauser and his colleagues wrote.
Safety
Among DLBCL patients, serious adverse events (AEs) occurred in 50.0% of those in the R-pina arm and 35.9% of those in the R-pola arm. Among FL patients, serious AEs occurred in 28.6% of those the R-pina arm and 35.0% of those in the R-pola arm.
Ten grade 5 AEs occurred in nine DLBCL patients who received R-pina (21.4%). These events included two cases of sepsis, influenza and pneumonia in the same patient, general physical health deterioration including one death attributed to disease progression, and one case each of Clostridium difficile sepsis, respiratory failure, urosepsis, and sudden death.
There was one grade 5 AE in a FL patient who received R-pola. The 84-year-old patient died of pulmonary congestion 64 days after the last of 12 cycles of treatment.
There were no fatal AEs in the other arms.
“These findings make pola a promising novel candidate for further clinical evaluation in combination regimens in treatment-refractory patients and also in a first-line setting in B-cell non-Hodgkin lymphoma,” Dr. Morschhauser and his colleagues wrote.
Polatuzumab vedotin was chosen by the study funder for further development in non-Hodgkin lymphoma, partly because of longer durations of response, compared with pinatuzumab vedotin.
Polatuzumab vedotin is currently under investigation in the phase 3 POLARIX study. The drug is being combined with rituximab, cyclophosphamide, doxorubicin, and prednisone and compared to rituximab-cyclophosphamide, doxorubicin, vincristine, and prednisone (R-CHOP) in patients with DLBCL.
The ROMULUS study was funded by F Hoffmann-La Roche. The study authors reported relationships with Roche and other companies.
SOURCE: Morschhauser F et al. Lancet Haematol. 2019 Mar 29. doi: 10.1016/S2352-3026(19)30026-2.
FROM LANCET HAEMATOLOGY
Combo could replace standard conditioning regimen for myeloma
Busulfan plus melphalan could replace melphalan alone as the standard conditioning regimen for multiple myeloma patients undergoing autologous hematopoietic cell transplant, according to researchers.
In a phase 3 trial, patients who received conditioning with busulfan plus melphalan had significantly longer median progression-free survival compared with patients who received melphalan alone – 64.7 months versus 43.5 months (P = .022).
However, there was no overall survival advantage with busulfan plus melphalan, and adverse events were more common with this regimen, reported Qaiser Bashir, MD, of the University of Texas MD Anderson Cancer Center in Houston, and his colleagues. The report is in The Lancet Haematology.
To their knowledge, the researchers wrote, this was the first randomized, phase 3 trial showing a significant progression-free survival benefit for busulfan plus melphalan versus the standard of care of melphalan 200 mg/m2 pretransplantation conditioning. “These data suggest that busulfan plus melphalan conditioning can serve as a useful platform for further improvement of transplant outcomes in patients with myeloma.”
The current trial (NCT01413178) enrolled 205 multiple myeloma patients who were eligible for transplant. They were randomized to conditioning with melphalan alone or busulfan plus melphalan.
In all, 98 patients received melphalan alone, given at 200 mg/m2 on day –2. The 104 patients who received busulfan plus melphalan started with a test dose of busulfan at 32 mg/m2, which was followed by pharmacokinetically adjusted doses on days –7, –6, –5, and –4 to achieve a target daily area under the curve of 5,000 mmol/minute. These patients received melphalan at 70 mg/m2 per day on days –2 and –1.
The median age at transplant was 57.9 years (range, 31.7-70.9 years) in the busulfan group and 57.6 years (range, 34.3-70.6 years) in the melphalan-alone group.
The most common induction regimen used was bortezomib, lenalidomide, and dexamethasone, which was given to 60% of the busulfan group and 57% of the melphalan-alone group.
Most patients responded to induction – 96% of patients in the busulfan group and 94% of those in the melphalan-alone group.
There was no treatment-related mortality within 100 days of transplant.
At 90 days after transplant, the response rate was 98% in the busulfan group and 97% in the melphalan-alone group. The rate of complete remission/stringent complete remission was 27% and 34%, respectively.
Most patients received posttransplant maintenance. The most common maintenance regimen consisted of lenalidomide monotherapy, which was given to 57% of the busulfan group and 58% of the melphalan-alone group.
Patients continued maintenance until disease progression or unacceptable toxicity. The median duration of maintenance was 16.0 months in the busulfan group and 10.1 months in the melphalan-alone group.
The median follow-up was 22.6 months in the busulfan group and 20.2 months in the melphalan-alone group.
Progression-free survival was superior in the busulfan group. Median progression-free survival was 64.7 months in the busulfan group and 43.5 months in the melphalan-alone group (hazard ratio = 0.53; P = .022). The 3-year progression-free survival rate was 72% and 50%, respectively.
The median overall survival was not reached in either group. The 3-year overall survival rate was 91% in the busulfan group and 89% in the melphalan-alone group.
There were 10 deaths in the busulfan group, 7 due to progression and 3 due to infection. All 7 deaths in the melphalan-alone group were due to progression.
Grade 3-4 nonhematologic toxicity was more common in the busulfan group, occurring in 84% of that group and 33% of the melphalan-alone group (P less than .0001).
Grade 2-3 mucositis occurred in 74% of the busulfan group and 14% of the melphalan-alone group. There were no cases of grade 4 mucositis.
One patient in the busulfan group had grade 4 cardiac toxicity, an acute myocardial infarction, and ventricular fibrillation. However, the patient recovered and was in remission at last follow-up.
Two patients in the busulfan group developed second primary malignancies. One patient developed squamous cell skin cancer and rectal adenocarcinoma, and the other developed melanoma and basal cell skin carcinoma.
Three patients in the melphalan-alone group developed second primary malignancies. Two patients had squamous cell skin cancers and one had myelodysplastic syndrome.
Dr. Bashir and his colleagues noted that this study has limitations, including insufficient data to assess minimal residual disease and its impact on survival. It is a single-center study and induction and maintenance therapies were not prespecified.
“These results should be verified in a cooperative group or a multicenter, randomized study to assess the generalizability of our findings,” the researchers wrote.
Dr. Bashir and his colleagues reported having no competing financial interests. The trial was sponsored by MD Anderson Cancer Center in collaboration with Otsuka Pharmaceutical Development & Commercialization. The work was funded in part by the National Institutes of Health.
SOURCE: Bashir Q et al. Lancet Haematol. 2019 Mar 22. doi: 10.1016/S2352-3026(19)30023-7.
Busulfan plus melphalan could replace melphalan alone as the standard conditioning regimen for multiple myeloma patients undergoing autologous hematopoietic cell transplant, according to researchers.
In a phase 3 trial, patients who received conditioning with busulfan plus melphalan had significantly longer median progression-free survival compared with patients who received melphalan alone – 64.7 months versus 43.5 months (P = .022).
However, there was no overall survival advantage with busulfan plus melphalan, and adverse events were more common with this regimen, reported Qaiser Bashir, MD, of the University of Texas MD Anderson Cancer Center in Houston, and his colleagues. The report is in The Lancet Haematology.
To their knowledge, the researchers wrote, this was the first randomized, phase 3 trial showing a significant progression-free survival benefit for busulfan plus melphalan versus the standard of care of melphalan 200 mg/m2 pretransplantation conditioning. “These data suggest that busulfan plus melphalan conditioning can serve as a useful platform for further improvement of transplant outcomes in patients with myeloma.”
The current trial (NCT01413178) enrolled 205 multiple myeloma patients who were eligible for transplant. They were randomized to conditioning with melphalan alone or busulfan plus melphalan.
In all, 98 patients received melphalan alone, given at 200 mg/m2 on day –2. The 104 patients who received busulfan plus melphalan started with a test dose of busulfan at 32 mg/m2, which was followed by pharmacokinetically adjusted doses on days –7, –6, –5, and –4 to achieve a target daily area under the curve of 5,000 mmol/minute. These patients received melphalan at 70 mg/m2 per day on days –2 and –1.
The median age at transplant was 57.9 years (range, 31.7-70.9 years) in the busulfan group and 57.6 years (range, 34.3-70.6 years) in the melphalan-alone group.
The most common induction regimen used was bortezomib, lenalidomide, and dexamethasone, which was given to 60% of the busulfan group and 57% of the melphalan-alone group.
Most patients responded to induction – 96% of patients in the busulfan group and 94% of those in the melphalan-alone group.
There was no treatment-related mortality within 100 days of transplant.
At 90 days after transplant, the response rate was 98% in the busulfan group and 97% in the melphalan-alone group. The rate of complete remission/stringent complete remission was 27% and 34%, respectively.
Most patients received posttransplant maintenance. The most common maintenance regimen consisted of lenalidomide monotherapy, which was given to 57% of the busulfan group and 58% of the melphalan-alone group.
Patients continued maintenance until disease progression or unacceptable toxicity. The median duration of maintenance was 16.0 months in the busulfan group and 10.1 months in the melphalan-alone group.
The median follow-up was 22.6 months in the busulfan group and 20.2 months in the melphalan-alone group.
Progression-free survival was superior in the busulfan group. Median progression-free survival was 64.7 months in the busulfan group and 43.5 months in the melphalan-alone group (hazard ratio = 0.53; P = .022). The 3-year progression-free survival rate was 72% and 50%, respectively.
The median overall survival was not reached in either group. The 3-year overall survival rate was 91% in the busulfan group and 89% in the melphalan-alone group.
There were 10 deaths in the busulfan group, 7 due to progression and 3 due to infection. All 7 deaths in the melphalan-alone group were due to progression.
Grade 3-4 nonhematologic toxicity was more common in the busulfan group, occurring in 84% of that group and 33% of the melphalan-alone group (P less than .0001).
Grade 2-3 mucositis occurred in 74% of the busulfan group and 14% of the melphalan-alone group. There were no cases of grade 4 mucositis.
One patient in the busulfan group had grade 4 cardiac toxicity, an acute myocardial infarction, and ventricular fibrillation. However, the patient recovered and was in remission at last follow-up.
Two patients in the busulfan group developed second primary malignancies. One patient developed squamous cell skin cancer and rectal adenocarcinoma, and the other developed melanoma and basal cell skin carcinoma.
Three patients in the melphalan-alone group developed second primary malignancies. Two patients had squamous cell skin cancers and one had myelodysplastic syndrome.
Dr. Bashir and his colleagues noted that this study has limitations, including insufficient data to assess minimal residual disease and its impact on survival. It is a single-center study and induction and maintenance therapies were not prespecified.
“These results should be verified in a cooperative group or a multicenter, randomized study to assess the generalizability of our findings,” the researchers wrote.
Dr. Bashir and his colleagues reported having no competing financial interests. The trial was sponsored by MD Anderson Cancer Center in collaboration with Otsuka Pharmaceutical Development & Commercialization. The work was funded in part by the National Institutes of Health.
SOURCE: Bashir Q et al. Lancet Haematol. 2019 Mar 22. doi: 10.1016/S2352-3026(19)30023-7.
Busulfan plus melphalan could replace melphalan alone as the standard conditioning regimen for multiple myeloma patients undergoing autologous hematopoietic cell transplant, according to researchers.
In a phase 3 trial, patients who received conditioning with busulfan plus melphalan had significantly longer median progression-free survival compared with patients who received melphalan alone – 64.7 months versus 43.5 months (P = .022).
However, there was no overall survival advantage with busulfan plus melphalan, and adverse events were more common with this regimen, reported Qaiser Bashir, MD, of the University of Texas MD Anderson Cancer Center in Houston, and his colleagues. The report is in The Lancet Haematology.
To their knowledge, the researchers wrote, this was the first randomized, phase 3 trial showing a significant progression-free survival benefit for busulfan plus melphalan versus the standard of care of melphalan 200 mg/m2 pretransplantation conditioning. “These data suggest that busulfan plus melphalan conditioning can serve as a useful platform for further improvement of transplant outcomes in patients with myeloma.”
The current trial (NCT01413178) enrolled 205 multiple myeloma patients who were eligible for transplant. They were randomized to conditioning with melphalan alone or busulfan plus melphalan.
In all, 98 patients received melphalan alone, given at 200 mg/m2 on day –2. The 104 patients who received busulfan plus melphalan started with a test dose of busulfan at 32 mg/m2, which was followed by pharmacokinetically adjusted doses on days –7, –6, –5, and –4 to achieve a target daily area under the curve of 5,000 mmol/minute. These patients received melphalan at 70 mg/m2 per day on days –2 and –1.
The median age at transplant was 57.9 years (range, 31.7-70.9 years) in the busulfan group and 57.6 years (range, 34.3-70.6 years) in the melphalan-alone group.
The most common induction regimen used was bortezomib, lenalidomide, and dexamethasone, which was given to 60% of the busulfan group and 57% of the melphalan-alone group.
Most patients responded to induction – 96% of patients in the busulfan group and 94% of those in the melphalan-alone group.
There was no treatment-related mortality within 100 days of transplant.
At 90 days after transplant, the response rate was 98% in the busulfan group and 97% in the melphalan-alone group. The rate of complete remission/stringent complete remission was 27% and 34%, respectively.
Most patients received posttransplant maintenance. The most common maintenance regimen consisted of lenalidomide monotherapy, which was given to 57% of the busulfan group and 58% of the melphalan-alone group.
Patients continued maintenance until disease progression or unacceptable toxicity. The median duration of maintenance was 16.0 months in the busulfan group and 10.1 months in the melphalan-alone group.
The median follow-up was 22.6 months in the busulfan group and 20.2 months in the melphalan-alone group.
Progression-free survival was superior in the busulfan group. Median progression-free survival was 64.7 months in the busulfan group and 43.5 months in the melphalan-alone group (hazard ratio = 0.53; P = .022). The 3-year progression-free survival rate was 72% and 50%, respectively.
The median overall survival was not reached in either group. The 3-year overall survival rate was 91% in the busulfan group and 89% in the melphalan-alone group.
There were 10 deaths in the busulfan group, 7 due to progression and 3 due to infection. All 7 deaths in the melphalan-alone group were due to progression.
Grade 3-4 nonhematologic toxicity was more common in the busulfan group, occurring in 84% of that group and 33% of the melphalan-alone group (P less than .0001).
Grade 2-3 mucositis occurred in 74% of the busulfan group and 14% of the melphalan-alone group. There were no cases of grade 4 mucositis.
One patient in the busulfan group had grade 4 cardiac toxicity, an acute myocardial infarction, and ventricular fibrillation. However, the patient recovered and was in remission at last follow-up.
Two patients in the busulfan group developed second primary malignancies. One patient developed squamous cell skin cancer and rectal adenocarcinoma, and the other developed melanoma and basal cell skin carcinoma.
Three patients in the melphalan-alone group developed second primary malignancies. Two patients had squamous cell skin cancers and one had myelodysplastic syndrome.
Dr. Bashir and his colleagues noted that this study has limitations, including insufficient data to assess minimal residual disease and its impact on survival. It is a single-center study and induction and maintenance therapies were not prespecified.
“These results should be verified in a cooperative group or a multicenter, randomized study to assess the generalizability of our findings,” the researchers wrote.
Dr. Bashir and his colleagues reported having no competing financial interests. The trial was sponsored by MD Anderson Cancer Center in collaboration with Otsuka Pharmaceutical Development & Commercialization. The work was funded in part by the National Institutes of Health.
SOURCE: Bashir Q et al. Lancet Haematol. 2019 Mar 22. doi: 10.1016/S2352-3026(19)30023-7.
FROM LANCET HAEMATOLOGY
Cancer researchers take home AACR honors
The American Association for Cancer Research (AACR) has granted 14 awards and lectureships to cancer researchers and plans to recognize the recipients at the annual meeting of the American Association for Cancer Research.
Emil J. Freireich, MD, of the University of Texas MD Anderson Cancer Center in Houston, has won the 16th AACR Award for Lifetime Achievement in Cancer Research. AACR cited Dr. Freireich’s contributions related to leukocyte and allogeneic platelet transfusions, engraftment of peripheral blood stem cells, and combination chemotherapy approaches in the treatment of childhood leukemia. Dr. Freireich will receive the award during the opening ceremony of the meeting on March 31.
Another award to be given at the opening ceremony is the 13th Margaret Foti Award for Leadership and Extraordinary Achievements in Cancer Research. Raymond N. DuBois, MD, PhD, of the Medical University of South Carolina in Charleston, will receive the award for his contributions to the “early detection, interception, and prevention of colorectal cancer.” This includes elucidating the role of prostaglandins and cyclooxygenase in colon cancer tumorigenesis and pioneering the use of nonsteroidal anti-inflammatory mediators for cancer prevention. Dr. DuBois will deliver the lecture “Inflammation and Inflammatory Mediators as Potential Targets for Cancer Prevention or Interception” on April 1.
Jennifer R. Grandis, MD, of the University of California, San Francisco, has won the 22nd AACR–Women in Cancer Research Charlotte Friend Memorial Lectureship. Dr. Grandis characterized the role of EGFR, STAT3, and other signaling pathways in head and neck squamous cell carcinoma and used the findings to uncover new treatment options. Dr. Grandis will deliver her award lecture, “Leveraging Biologic Insights to Prevent and Treat Head and Neck Cancer,” on March 30.
John M. Carethers, MD, of the University of Michigan in Ann Arbor, has won the 14th AACR–Minorities in Cancer Research Jane Cooke Wright Memorial Lectureship. Dr. Carethers is being recognized for his work related to DNA mismatch repair, tumor resistance, inflammation, and health disparities in colorectal cancer patients. He will deliver his award lecture, “A Role for Inflammation-Induced DNA Mismatch Repair Deficits in Racial Outcomes from Advanced Colorectal Cancer,” on March 31.
Susan L. Cohn, MD, of the University of Chicago, has won the 24th AACR–Joseph H. Burchenal Memorial Award for Outstanding Achievement in Clinical Cancer Research (supported by Bristol-Myers Squibb). She won this award for her work in refining pediatric cancer risk-group classification, making discoveries that changed treatment strategies, and creating computational frameworks that enabled data collection and sharing. Dr. Cohn will deliver her award lecture, “Advancing Treatment Through Collaboration: A Pediatric Oncology Paradigm,” on April 2.
Another awardee to be recognized at the meeting is Alberto Mantovani, MD, a professor at Humanitas University in Milan, Italy, who won the 22nd Pezcoller Foundation–AACR International Award for Extraordinary Achievement in Cancer Research (supported by the Pezcoller Foundation).
Jeffrey A. Bluestone, PhD, of the University of California, San Francisco, won the 15th AACR–Irving Weinstein Foundation Distinguished Lecture (supported by the Irving Weinstein Foundation).
Andrew T. Chan, MD, of Massachusetts General Hospital in Boston, won the Third AACR–Waun Ki Hong Award for Outstanding Achievement in Translational and Clinical Cancer Research.
Elaine Fuchs, PhD, of Rockefeller University in New York, won the 59th AACR G.H.A. Clowes Memorial Award (supported by Lilly Oncology).
Charles L. Sawyers, MD, of the Memorial Sloan Kettering Cancer Center in New York, won the 13th AACR Princess Takamatsu Memorial Lectureship (supported by the Princess Takamatsu Cancer Research Fund).
Michael E. Jung, PhD, of the University of California, Los Angeles, won the 13th AACR Award for Outstanding Achievement in Chemistry in Cancer Research.
Cornelis J.M. Melief, MD, PhD, of Leiden (the Netherlands) University Medical Center and ISA Pharmaceuticals, also in Leiden, won the Seventh AACR–Cancer Research Institute Lloyd J. Old Award in Cancer Immunology (supported by the Cancer Research Institute).
Edward L. Giovannucci, MD, of the Harvard T.H. Chan School of Public Health in Boston, won the 28th AACR-American Cancer Society Award for Research Excellence in Cancer Epidemiology and Prevention (supported by the American Cancer Society).
Melissa M. Hudson, MD, and 15 other researchers from St. Jude Children’s Research Hospital in Memphis won the 13th AACR Team Science Award (supported by Lilly Oncology).
Movers in Medicine highlights career moves and personal achievements by hematologists and oncologists. Did you switch jobs, take on a new role, climb a mountain? Tell us all about it at [email protected], and you could be featured in Movers in Medicine.
The American Association for Cancer Research (AACR) has granted 14 awards and lectureships to cancer researchers and plans to recognize the recipients at the annual meeting of the American Association for Cancer Research.
Emil J. Freireich, MD, of the University of Texas MD Anderson Cancer Center in Houston, has won the 16th AACR Award for Lifetime Achievement in Cancer Research. AACR cited Dr. Freireich’s contributions related to leukocyte and allogeneic platelet transfusions, engraftment of peripheral blood stem cells, and combination chemotherapy approaches in the treatment of childhood leukemia. Dr. Freireich will receive the award during the opening ceremony of the meeting on March 31.
Another award to be given at the opening ceremony is the 13th Margaret Foti Award for Leadership and Extraordinary Achievements in Cancer Research. Raymond N. DuBois, MD, PhD, of the Medical University of South Carolina in Charleston, will receive the award for his contributions to the “early detection, interception, and prevention of colorectal cancer.” This includes elucidating the role of prostaglandins and cyclooxygenase in colon cancer tumorigenesis and pioneering the use of nonsteroidal anti-inflammatory mediators for cancer prevention. Dr. DuBois will deliver the lecture “Inflammation and Inflammatory Mediators as Potential Targets for Cancer Prevention or Interception” on April 1.
Jennifer R. Grandis, MD, of the University of California, San Francisco, has won the 22nd AACR–Women in Cancer Research Charlotte Friend Memorial Lectureship. Dr. Grandis characterized the role of EGFR, STAT3, and other signaling pathways in head and neck squamous cell carcinoma and used the findings to uncover new treatment options. Dr. Grandis will deliver her award lecture, “Leveraging Biologic Insights to Prevent and Treat Head and Neck Cancer,” on March 30.
John M. Carethers, MD, of the University of Michigan in Ann Arbor, has won the 14th AACR–Minorities in Cancer Research Jane Cooke Wright Memorial Lectureship. Dr. Carethers is being recognized for his work related to DNA mismatch repair, tumor resistance, inflammation, and health disparities in colorectal cancer patients. He will deliver his award lecture, “A Role for Inflammation-Induced DNA Mismatch Repair Deficits in Racial Outcomes from Advanced Colorectal Cancer,” on March 31.
Susan L. Cohn, MD, of the University of Chicago, has won the 24th AACR–Joseph H. Burchenal Memorial Award for Outstanding Achievement in Clinical Cancer Research (supported by Bristol-Myers Squibb). She won this award for her work in refining pediatric cancer risk-group classification, making discoveries that changed treatment strategies, and creating computational frameworks that enabled data collection and sharing. Dr. Cohn will deliver her award lecture, “Advancing Treatment Through Collaboration: A Pediatric Oncology Paradigm,” on April 2.
Another awardee to be recognized at the meeting is Alberto Mantovani, MD, a professor at Humanitas University in Milan, Italy, who won the 22nd Pezcoller Foundation–AACR International Award for Extraordinary Achievement in Cancer Research (supported by the Pezcoller Foundation).
Jeffrey A. Bluestone, PhD, of the University of California, San Francisco, won the 15th AACR–Irving Weinstein Foundation Distinguished Lecture (supported by the Irving Weinstein Foundation).
Andrew T. Chan, MD, of Massachusetts General Hospital in Boston, won the Third AACR–Waun Ki Hong Award for Outstanding Achievement in Translational and Clinical Cancer Research.
Elaine Fuchs, PhD, of Rockefeller University in New York, won the 59th AACR G.H.A. Clowes Memorial Award (supported by Lilly Oncology).
Charles L. Sawyers, MD, of the Memorial Sloan Kettering Cancer Center in New York, won the 13th AACR Princess Takamatsu Memorial Lectureship (supported by the Princess Takamatsu Cancer Research Fund).
Michael E. Jung, PhD, of the University of California, Los Angeles, won the 13th AACR Award for Outstanding Achievement in Chemistry in Cancer Research.
Cornelis J.M. Melief, MD, PhD, of Leiden (the Netherlands) University Medical Center and ISA Pharmaceuticals, also in Leiden, won the Seventh AACR–Cancer Research Institute Lloyd J. Old Award in Cancer Immunology (supported by the Cancer Research Institute).
Edward L. Giovannucci, MD, of the Harvard T.H. Chan School of Public Health in Boston, won the 28th AACR-American Cancer Society Award for Research Excellence in Cancer Epidemiology and Prevention (supported by the American Cancer Society).
Melissa M. Hudson, MD, and 15 other researchers from St. Jude Children’s Research Hospital in Memphis won the 13th AACR Team Science Award (supported by Lilly Oncology).
Movers in Medicine highlights career moves and personal achievements by hematologists and oncologists. Did you switch jobs, take on a new role, climb a mountain? Tell us all about it at [email protected], and you could be featured in Movers in Medicine.
The American Association for Cancer Research (AACR) has granted 14 awards and lectureships to cancer researchers and plans to recognize the recipients at the annual meeting of the American Association for Cancer Research.
Emil J. Freireich, MD, of the University of Texas MD Anderson Cancer Center in Houston, has won the 16th AACR Award for Lifetime Achievement in Cancer Research. AACR cited Dr. Freireich’s contributions related to leukocyte and allogeneic platelet transfusions, engraftment of peripheral blood stem cells, and combination chemotherapy approaches in the treatment of childhood leukemia. Dr. Freireich will receive the award during the opening ceremony of the meeting on March 31.
Another award to be given at the opening ceremony is the 13th Margaret Foti Award for Leadership and Extraordinary Achievements in Cancer Research. Raymond N. DuBois, MD, PhD, of the Medical University of South Carolina in Charleston, will receive the award for his contributions to the “early detection, interception, and prevention of colorectal cancer.” This includes elucidating the role of prostaglandins and cyclooxygenase in colon cancer tumorigenesis and pioneering the use of nonsteroidal anti-inflammatory mediators for cancer prevention. Dr. DuBois will deliver the lecture “Inflammation and Inflammatory Mediators as Potential Targets for Cancer Prevention or Interception” on April 1.
Jennifer R. Grandis, MD, of the University of California, San Francisco, has won the 22nd AACR–Women in Cancer Research Charlotte Friend Memorial Lectureship. Dr. Grandis characterized the role of EGFR, STAT3, and other signaling pathways in head and neck squamous cell carcinoma and used the findings to uncover new treatment options. Dr. Grandis will deliver her award lecture, “Leveraging Biologic Insights to Prevent and Treat Head and Neck Cancer,” on March 30.
John M. Carethers, MD, of the University of Michigan in Ann Arbor, has won the 14th AACR–Minorities in Cancer Research Jane Cooke Wright Memorial Lectureship. Dr. Carethers is being recognized for his work related to DNA mismatch repair, tumor resistance, inflammation, and health disparities in colorectal cancer patients. He will deliver his award lecture, “A Role for Inflammation-Induced DNA Mismatch Repair Deficits in Racial Outcomes from Advanced Colorectal Cancer,” on March 31.
Susan L. Cohn, MD, of the University of Chicago, has won the 24th AACR–Joseph H. Burchenal Memorial Award for Outstanding Achievement in Clinical Cancer Research (supported by Bristol-Myers Squibb). She won this award for her work in refining pediatric cancer risk-group classification, making discoveries that changed treatment strategies, and creating computational frameworks that enabled data collection and sharing. Dr. Cohn will deliver her award lecture, “Advancing Treatment Through Collaboration: A Pediatric Oncology Paradigm,” on April 2.
Another awardee to be recognized at the meeting is Alberto Mantovani, MD, a professor at Humanitas University in Milan, Italy, who won the 22nd Pezcoller Foundation–AACR International Award for Extraordinary Achievement in Cancer Research (supported by the Pezcoller Foundation).
Jeffrey A. Bluestone, PhD, of the University of California, San Francisco, won the 15th AACR–Irving Weinstein Foundation Distinguished Lecture (supported by the Irving Weinstein Foundation).
Andrew T. Chan, MD, of Massachusetts General Hospital in Boston, won the Third AACR–Waun Ki Hong Award for Outstanding Achievement in Translational and Clinical Cancer Research.
Elaine Fuchs, PhD, of Rockefeller University in New York, won the 59th AACR G.H.A. Clowes Memorial Award (supported by Lilly Oncology).
Charles L. Sawyers, MD, of the Memorial Sloan Kettering Cancer Center in New York, won the 13th AACR Princess Takamatsu Memorial Lectureship (supported by the Princess Takamatsu Cancer Research Fund).
Michael E. Jung, PhD, of the University of California, Los Angeles, won the 13th AACR Award for Outstanding Achievement in Chemistry in Cancer Research.
Cornelis J.M. Melief, MD, PhD, of Leiden (the Netherlands) University Medical Center and ISA Pharmaceuticals, also in Leiden, won the Seventh AACR–Cancer Research Institute Lloyd J. Old Award in Cancer Immunology (supported by the Cancer Research Institute).
Edward L. Giovannucci, MD, of the Harvard T.H. Chan School of Public Health in Boston, won the 28th AACR-American Cancer Society Award for Research Excellence in Cancer Epidemiology and Prevention (supported by the American Cancer Society).
Melissa M. Hudson, MD, and 15 other researchers from St. Jude Children’s Research Hospital in Memphis won the 13th AACR Team Science Award (supported by Lilly Oncology).
Movers in Medicine highlights career moves and personal achievements by hematologists and oncologists. Did you switch jobs, take on a new role, climb a mountain? Tell us all about it at [email protected], and you could be featured in Movers in Medicine.
Brachytherapy access may mediate poor cervical cancer survival in blacks
HONOLULU – , according to a speaker at the Society of Gynecologic Oncology’s Annual Meeting on Women’s Cancer.
Stephanie Alimena, MD, of Brigham and Women’s Hospital in Boston, presented a large, retrospective study showing that use of brachytherapy mediated survival differences by race.
In the absence of brachytherapy, black patients had a significantly higher risk of death than did non-black patients (P = .013). However, when brachytherapy was used, black and non-black patients had a similar risk of death (P = .83).
“[W]e know that use of a brachytherapy boost is associated with improved patient outcomes, including improved cancer-specific and overall survival,” Dr. Alimena said. “We also know that African-American women have one of the highest incidences of cervical cancer in the United States and also have worse mortality from cervical cancer.”
“Studies have reached varying conclusions about the impact of race on brachytherapy utilization, with several smaller studies suggesting that minority women may be less likely to receive brachytherapy services compared to white women. No studies have specifically examined the interaction between race, radiation, and survival.”
Dr. Alimena and her colleagues decided to examine the interaction using data from the National Cancer Database. The researchers evaluated 15,411 women diagnosed with cervical cancer from 2004 to 2014. The patients had stage IB2 to IVA disease, their mean age was 54 years (range, 19-90), 58% had received brachytherapy, and 19% were black.
“Race was defined as black or non-black race, given that previous data had shown similar and even increased survival rates for Hispanic and Asian-American women compared to white patients diagnosed with cervical cancer,” Dr. Alimena noted.
Differences by race
The researchers found that black patients were significantly less likely to receive brachytherapy than were non-black patients: 52.5% vs. 59.0%, respectively (P less than .001).
Black patients were significantly more likely to have stage III disease (42.7% vs. 37.6%; P less than .001) and less likely to have stage IVA disease (6.8% vs. 7.3%; P less than .001).
Black patients were significantly more likely to have government insurance (57.0% vs. 49.1%; P less than .001) and less likely to have private insurance (27.6% vs. 36.7%; P less than .001).
And black patients were significantly more likely to have annual incomes below $38,000 (49.4% vs. 22.6%; P less than .001).
Factors associated with brachytherapy
In a multivariate analysis, black race was significantly associated with a reduced likelihood of receiving brachytherapy. The odds ratio (OR) was 0.86 (P = .003).
Other factors significantly associated with a reduced likelihood of receiving brachytherapy were:
- Being older than 70 years (OR = 0.59; P less than .001)
- Having government insurance (OR = 0.89; P = .008) or no insurance/unknown insurance status (OR = 0.75; P less than .001)
- Having stage III disease (OR = 0.47; P less than .001) or stage IVA disease (OR = 0.20; P less than .001)
- Being treated in southern states (OR = 0.67; P less than .001) or western states (OR = 0.86; P = .02)
- Having a Charlson/Deyo score of 2 or more (OR = 0.73; P less than .001).
Race, brachytherapy, and survival
“Consistent with prior data, we found that black patients had a significant decrease in overall survival, compared to non-black women,” Dr. Alimena said. “Furthermore, we found survival differences by race were mediated by brachytherapy use.”
The median overall survival was 52.5 months among black patients and 65.3 months among non-black patients (P less than .001).
Among patients who did not receive brachytherapy, black patients had a significantly higher risk of death than non-black patients (adjusted hazard ratio = 1.11; P = .013).
However, among patients who did receive brachytherapy, black and non-black patients had a similar risk of death (adjusted hazard ratio = 1.01; P = .83). The interaction term comparing these survival curves was statistically significant (P = .043).
“This is the first study, to our knowledge, to show such an interaction between race and survival being mediated by one particular treatment modality,” Dr. Alimena said.
“While not directly tested in this study, the most likely hypothesis why black patients may be less likely to receive brachytherapy is having poor access to brachytherapy services. This suggests that reducing racial disparities in survival is possible by increasing access to brachytherapy for black patients.”
Dr. Alimena had no financial disclosures.
SOURCE: Alimena S et al. SGO 2019. Abstract 11.
HONOLULU – , according to a speaker at the Society of Gynecologic Oncology’s Annual Meeting on Women’s Cancer.
Stephanie Alimena, MD, of Brigham and Women’s Hospital in Boston, presented a large, retrospective study showing that use of brachytherapy mediated survival differences by race.
In the absence of brachytherapy, black patients had a significantly higher risk of death than did non-black patients (P = .013). However, when brachytherapy was used, black and non-black patients had a similar risk of death (P = .83).
“[W]e know that use of a brachytherapy boost is associated with improved patient outcomes, including improved cancer-specific and overall survival,” Dr. Alimena said. “We also know that African-American women have one of the highest incidences of cervical cancer in the United States and also have worse mortality from cervical cancer.”
“Studies have reached varying conclusions about the impact of race on brachytherapy utilization, with several smaller studies suggesting that minority women may be less likely to receive brachytherapy services compared to white women. No studies have specifically examined the interaction between race, radiation, and survival.”
Dr. Alimena and her colleagues decided to examine the interaction using data from the National Cancer Database. The researchers evaluated 15,411 women diagnosed with cervical cancer from 2004 to 2014. The patients had stage IB2 to IVA disease, their mean age was 54 years (range, 19-90), 58% had received brachytherapy, and 19% were black.
“Race was defined as black or non-black race, given that previous data had shown similar and even increased survival rates for Hispanic and Asian-American women compared to white patients diagnosed with cervical cancer,” Dr. Alimena noted.
Differences by race
The researchers found that black patients were significantly less likely to receive brachytherapy than were non-black patients: 52.5% vs. 59.0%, respectively (P less than .001).
Black patients were significantly more likely to have stage III disease (42.7% vs. 37.6%; P less than .001) and less likely to have stage IVA disease (6.8% vs. 7.3%; P less than .001).
Black patients were significantly more likely to have government insurance (57.0% vs. 49.1%; P less than .001) and less likely to have private insurance (27.6% vs. 36.7%; P less than .001).
And black patients were significantly more likely to have annual incomes below $38,000 (49.4% vs. 22.6%; P less than .001).
Factors associated with brachytherapy
In a multivariate analysis, black race was significantly associated with a reduced likelihood of receiving brachytherapy. The odds ratio (OR) was 0.86 (P = .003).
Other factors significantly associated with a reduced likelihood of receiving brachytherapy were:
- Being older than 70 years (OR = 0.59; P less than .001)
- Having government insurance (OR = 0.89; P = .008) or no insurance/unknown insurance status (OR = 0.75; P less than .001)
- Having stage III disease (OR = 0.47; P less than .001) or stage IVA disease (OR = 0.20; P less than .001)
- Being treated in southern states (OR = 0.67; P less than .001) or western states (OR = 0.86; P = .02)
- Having a Charlson/Deyo score of 2 or more (OR = 0.73; P less than .001).
Race, brachytherapy, and survival
“Consistent with prior data, we found that black patients had a significant decrease in overall survival, compared to non-black women,” Dr. Alimena said. “Furthermore, we found survival differences by race were mediated by brachytherapy use.”
The median overall survival was 52.5 months among black patients and 65.3 months among non-black patients (P less than .001).
Among patients who did not receive brachytherapy, black patients had a significantly higher risk of death than non-black patients (adjusted hazard ratio = 1.11; P = .013).
However, among patients who did receive brachytherapy, black and non-black patients had a similar risk of death (adjusted hazard ratio = 1.01; P = .83). The interaction term comparing these survival curves was statistically significant (P = .043).
“This is the first study, to our knowledge, to show such an interaction between race and survival being mediated by one particular treatment modality,” Dr. Alimena said.
“While not directly tested in this study, the most likely hypothesis why black patients may be less likely to receive brachytherapy is having poor access to brachytherapy services. This suggests that reducing racial disparities in survival is possible by increasing access to brachytherapy for black patients.”
Dr. Alimena had no financial disclosures.
SOURCE: Alimena S et al. SGO 2019. Abstract 11.
HONOLULU – , according to a speaker at the Society of Gynecologic Oncology’s Annual Meeting on Women’s Cancer.
Stephanie Alimena, MD, of Brigham and Women’s Hospital in Boston, presented a large, retrospective study showing that use of brachytherapy mediated survival differences by race.
In the absence of brachytherapy, black patients had a significantly higher risk of death than did non-black patients (P = .013). However, when brachytherapy was used, black and non-black patients had a similar risk of death (P = .83).
“[W]e know that use of a brachytherapy boost is associated with improved patient outcomes, including improved cancer-specific and overall survival,” Dr. Alimena said. “We also know that African-American women have one of the highest incidences of cervical cancer in the United States and also have worse mortality from cervical cancer.”
“Studies have reached varying conclusions about the impact of race on brachytherapy utilization, with several smaller studies suggesting that minority women may be less likely to receive brachytherapy services compared to white women. No studies have specifically examined the interaction between race, radiation, and survival.”
Dr. Alimena and her colleagues decided to examine the interaction using data from the National Cancer Database. The researchers evaluated 15,411 women diagnosed with cervical cancer from 2004 to 2014. The patients had stage IB2 to IVA disease, their mean age was 54 years (range, 19-90), 58% had received brachytherapy, and 19% were black.
“Race was defined as black or non-black race, given that previous data had shown similar and even increased survival rates for Hispanic and Asian-American women compared to white patients diagnosed with cervical cancer,” Dr. Alimena noted.
Differences by race
The researchers found that black patients were significantly less likely to receive brachytherapy than were non-black patients: 52.5% vs. 59.0%, respectively (P less than .001).
Black patients were significantly more likely to have stage III disease (42.7% vs. 37.6%; P less than .001) and less likely to have stage IVA disease (6.8% vs. 7.3%; P less than .001).
Black patients were significantly more likely to have government insurance (57.0% vs. 49.1%; P less than .001) and less likely to have private insurance (27.6% vs. 36.7%; P less than .001).
And black patients were significantly more likely to have annual incomes below $38,000 (49.4% vs. 22.6%; P less than .001).
Factors associated with brachytherapy
In a multivariate analysis, black race was significantly associated with a reduced likelihood of receiving brachytherapy. The odds ratio (OR) was 0.86 (P = .003).
Other factors significantly associated with a reduced likelihood of receiving brachytherapy were:
- Being older than 70 years (OR = 0.59; P less than .001)
- Having government insurance (OR = 0.89; P = .008) or no insurance/unknown insurance status (OR = 0.75; P less than .001)
- Having stage III disease (OR = 0.47; P less than .001) or stage IVA disease (OR = 0.20; P less than .001)
- Being treated in southern states (OR = 0.67; P less than .001) or western states (OR = 0.86; P = .02)
- Having a Charlson/Deyo score of 2 or more (OR = 0.73; P less than .001).
Race, brachytherapy, and survival
“Consistent with prior data, we found that black patients had a significant decrease in overall survival, compared to non-black women,” Dr. Alimena said. “Furthermore, we found survival differences by race were mediated by brachytherapy use.”
The median overall survival was 52.5 months among black patients and 65.3 months among non-black patients (P less than .001).
Among patients who did not receive brachytherapy, black patients had a significantly higher risk of death than non-black patients (adjusted hazard ratio = 1.11; P = .013).
However, among patients who did receive brachytherapy, black and non-black patients had a similar risk of death (adjusted hazard ratio = 1.01; P = .83). The interaction term comparing these survival curves was statistically significant (P = .043).
“This is the first study, to our knowledge, to show such an interaction between race and survival being mediated by one particular treatment modality,” Dr. Alimena said.
“While not directly tested in this study, the most likely hypothesis why black patients may be less likely to receive brachytherapy is having poor access to brachytherapy services. This suggests that reducing racial disparities in survival is possible by increasing access to brachytherapy for black patients.”
Dr. Alimena had no financial disclosures.
SOURCE: Alimena S et al. SGO 2019. Abstract 11.
REPORTING FROM SGO 2019
Combo shows promise for endometrial, ovarian cancers
HONOLULU – The combination of lenvatinib and paclitaxel was considered active and well tolerated in a phase 1 trial of patients with recurrent endometrial or ovarian cancer.
Daily lenvatinib plus weekly paclitaxel produced an objective response rate of 65% and a clinical benefit rate of 96%.
Most adverse events (AEs) were grade 1 to 2. The most common grade 3 or higher AEs were hypertension, cytopenias, fatigue, and diarrhea.
Floor J. Backes, MD, of the Ohio State University Comprehensive Cancer Center in Columbus presented these results at the Society of Gynecologic Oncology’s Annual Meeting on Women’s Cancer.
The trial (NCT02788708) included 26 patients with a median age of 63 years (range, 45-74). All patients had adequate organ function and measurable disease.
Nineteen patients had ovarian cancer: 13 with high-grade serous, 2 with low-grade serous, 2 clear cell, 1 endometrioid, and 1 carcinosarcoma. Seven patients had endometrial cancer: 4 endometrioid and 3 serous.
The patients must have received at least one prior platinum-based therapy. In all, they had a median of 3 prior therapies (range, 1-5).
The patients received intravenous paclitaxel at 80 mg/m2 on days 1, 8, and 15 of a 28-day cycle. They also received oral lenvatinib daily at doses of 8 mg (n = 4), 12 mg (n = 3), 16 mg (n = 13), or 20 mg (n = 6).
There were no dose-limiting toxicities (DLTs) in the 8-mg or 12-mg dose groups. There was one DLT (mucositis) at the 16-mg dose level, and two DLTs (hypertension and fatigue) occurred at the 20-mg dose level.
“[At 20 mg,] patients were unable to take more than 75% of the study drug during the first cycle, and that was considered a DLT,” Dr. Backes said. “So our recommended phase 2 dose was lenvatinib 16 mg daily and paclitaxel 80 mg.”
Safety
“Toxicities were fairly common,” Dr. Backes noted. “The majority of these were cytopenias, but we also saw some GI toxicity – mucositis, diarrhea, nausea – and the VEGF inhibitor–related toxicities that we’re familiar with – hypertension, proteinuria, epistaxis. Fortunately, the majority of toxicities were grade 1 to 2.”
The most common AEs of any grade were leukopenia (58%), anemia (50%), mucositis (46%), diarrhea (46%), lymphopenia (42%), anorexia (42%), hypertension (42%), fatigue (42%), nausea (35%), proteinuria (27%), epistaxis (27%), and hoarseness (27%).
Grade 3 or higher AEs included hypertension (19%), neutropenia (15%), leukopenia (12%), anemia (12%), lymphopenia (8%), fatigue (8%), diarrhea (8%), mucositis (4%), vomiting (4%), hematuria (4%), rash (4%), and thrombocytopenia (4%).
“There was one patient [4%] who had a bowel perforation – small bowel perforation – at the site of previous stenosis after multiple prior bowel surgeries,” Dr. Backes noted.
Efficacy
In the 23 evaluable patients, the objective response rate was 65%, and the clinical benefit rate was 96%. One patient had a complete response, 14 had partial responses, 7 had stable disease, and 1 progressed.
The median duration of response was 10.9 months, and the median progression-free survival was 14.0 months.
The objective response rate was 71% in patients with ovarian cancer and 50% in patients with endometrial cancer. The median progression-free survival in these groups was 14.0 months and 12.8 months, respectively.
Dr. Backes said these results suggest lenvatinib plus paclitaxel is safe and active in recurrent ovarian and endometrial cancer, but these findings must be confirmed in a larger study.
This was an investigator-initiated study supported by Eisai. Dr. Backes disclosed relationships with Eisai, ImmunoGen, Clovis Oncology, Tesaro, Merck, and Agenus.
SOURCE: Backes FJ et al. SGO 2019, Abstract LBA5.
HONOLULU – The combination of lenvatinib and paclitaxel was considered active and well tolerated in a phase 1 trial of patients with recurrent endometrial or ovarian cancer.
Daily lenvatinib plus weekly paclitaxel produced an objective response rate of 65% and a clinical benefit rate of 96%.
Most adverse events (AEs) were grade 1 to 2. The most common grade 3 or higher AEs were hypertension, cytopenias, fatigue, and diarrhea.
Floor J. Backes, MD, of the Ohio State University Comprehensive Cancer Center in Columbus presented these results at the Society of Gynecologic Oncology’s Annual Meeting on Women’s Cancer.
The trial (NCT02788708) included 26 patients with a median age of 63 years (range, 45-74). All patients had adequate organ function and measurable disease.
Nineteen patients had ovarian cancer: 13 with high-grade serous, 2 with low-grade serous, 2 clear cell, 1 endometrioid, and 1 carcinosarcoma. Seven patients had endometrial cancer: 4 endometrioid and 3 serous.
The patients must have received at least one prior platinum-based therapy. In all, they had a median of 3 prior therapies (range, 1-5).
The patients received intravenous paclitaxel at 80 mg/m2 on days 1, 8, and 15 of a 28-day cycle. They also received oral lenvatinib daily at doses of 8 mg (n = 4), 12 mg (n = 3), 16 mg (n = 13), or 20 mg (n = 6).
There were no dose-limiting toxicities (DLTs) in the 8-mg or 12-mg dose groups. There was one DLT (mucositis) at the 16-mg dose level, and two DLTs (hypertension and fatigue) occurred at the 20-mg dose level.
“[At 20 mg,] patients were unable to take more than 75% of the study drug during the first cycle, and that was considered a DLT,” Dr. Backes said. “So our recommended phase 2 dose was lenvatinib 16 mg daily and paclitaxel 80 mg.”
Safety
“Toxicities were fairly common,” Dr. Backes noted. “The majority of these were cytopenias, but we also saw some GI toxicity – mucositis, diarrhea, nausea – and the VEGF inhibitor–related toxicities that we’re familiar with – hypertension, proteinuria, epistaxis. Fortunately, the majority of toxicities were grade 1 to 2.”
The most common AEs of any grade were leukopenia (58%), anemia (50%), mucositis (46%), diarrhea (46%), lymphopenia (42%), anorexia (42%), hypertension (42%), fatigue (42%), nausea (35%), proteinuria (27%), epistaxis (27%), and hoarseness (27%).
Grade 3 or higher AEs included hypertension (19%), neutropenia (15%), leukopenia (12%), anemia (12%), lymphopenia (8%), fatigue (8%), diarrhea (8%), mucositis (4%), vomiting (4%), hematuria (4%), rash (4%), and thrombocytopenia (4%).
“There was one patient [4%] who had a bowel perforation – small bowel perforation – at the site of previous stenosis after multiple prior bowel surgeries,” Dr. Backes noted.
Efficacy
In the 23 evaluable patients, the objective response rate was 65%, and the clinical benefit rate was 96%. One patient had a complete response, 14 had partial responses, 7 had stable disease, and 1 progressed.
The median duration of response was 10.9 months, and the median progression-free survival was 14.0 months.
The objective response rate was 71% in patients with ovarian cancer and 50% in patients with endometrial cancer. The median progression-free survival in these groups was 14.0 months and 12.8 months, respectively.
Dr. Backes said these results suggest lenvatinib plus paclitaxel is safe and active in recurrent ovarian and endometrial cancer, but these findings must be confirmed in a larger study.
This was an investigator-initiated study supported by Eisai. Dr. Backes disclosed relationships with Eisai, ImmunoGen, Clovis Oncology, Tesaro, Merck, and Agenus.
SOURCE: Backes FJ et al. SGO 2019, Abstract LBA5.
HONOLULU – The combination of lenvatinib and paclitaxel was considered active and well tolerated in a phase 1 trial of patients with recurrent endometrial or ovarian cancer.
Daily lenvatinib plus weekly paclitaxel produced an objective response rate of 65% and a clinical benefit rate of 96%.
Most adverse events (AEs) were grade 1 to 2. The most common grade 3 or higher AEs were hypertension, cytopenias, fatigue, and diarrhea.
Floor J. Backes, MD, of the Ohio State University Comprehensive Cancer Center in Columbus presented these results at the Society of Gynecologic Oncology’s Annual Meeting on Women’s Cancer.
The trial (NCT02788708) included 26 patients with a median age of 63 years (range, 45-74). All patients had adequate organ function and measurable disease.
Nineteen patients had ovarian cancer: 13 with high-grade serous, 2 with low-grade serous, 2 clear cell, 1 endometrioid, and 1 carcinosarcoma. Seven patients had endometrial cancer: 4 endometrioid and 3 serous.
The patients must have received at least one prior platinum-based therapy. In all, they had a median of 3 prior therapies (range, 1-5).
The patients received intravenous paclitaxel at 80 mg/m2 on days 1, 8, and 15 of a 28-day cycle. They also received oral lenvatinib daily at doses of 8 mg (n = 4), 12 mg (n = 3), 16 mg (n = 13), or 20 mg (n = 6).
There were no dose-limiting toxicities (DLTs) in the 8-mg or 12-mg dose groups. There was one DLT (mucositis) at the 16-mg dose level, and two DLTs (hypertension and fatigue) occurred at the 20-mg dose level.
“[At 20 mg,] patients were unable to take more than 75% of the study drug during the first cycle, and that was considered a DLT,” Dr. Backes said. “So our recommended phase 2 dose was lenvatinib 16 mg daily and paclitaxel 80 mg.”
Safety
“Toxicities were fairly common,” Dr. Backes noted. “The majority of these were cytopenias, but we also saw some GI toxicity – mucositis, diarrhea, nausea – and the VEGF inhibitor–related toxicities that we’re familiar with – hypertension, proteinuria, epistaxis. Fortunately, the majority of toxicities were grade 1 to 2.”
The most common AEs of any grade were leukopenia (58%), anemia (50%), mucositis (46%), diarrhea (46%), lymphopenia (42%), anorexia (42%), hypertension (42%), fatigue (42%), nausea (35%), proteinuria (27%), epistaxis (27%), and hoarseness (27%).
Grade 3 or higher AEs included hypertension (19%), neutropenia (15%), leukopenia (12%), anemia (12%), lymphopenia (8%), fatigue (8%), diarrhea (8%), mucositis (4%), vomiting (4%), hematuria (4%), rash (4%), and thrombocytopenia (4%).
“There was one patient [4%] who had a bowel perforation – small bowel perforation – at the site of previous stenosis after multiple prior bowel surgeries,” Dr. Backes noted.
Efficacy
In the 23 evaluable patients, the objective response rate was 65%, and the clinical benefit rate was 96%. One patient had a complete response, 14 had partial responses, 7 had stable disease, and 1 progressed.
The median duration of response was 10.9 months, and the median progression-free survival was 14.0 months.
The objective response rate was 71% in patients with ovarian cancer and 50% in patients with endometrial cancer. The median progression-free survival in these groups was 14.0 months and 12.8 months, respectively.
Dr. Backes said these results suggest lenvatinib plus paclitaxel is safe and active in recurrent ovarian and endometrial cancer, but these findings must be confirmed in a larger study.
This was an investigator-initiated study supported by Eisai. Dr. Backes disclosed relationships with Eisai, ImmunoGen, Clovis Oncology, Tesaro, Merck, and Agenus.
SOURCE: Backes FJ et al. SGO 2019, Abstract LBA5.
REPORTING FROM SGO 2019
Perceived cancer risk may improve access to HPV vaccine
HONOLULU – The perceived risk of HPV-related cancer appears to overcome variables that typically impede access to HPV vaccination, according to a speaker at the Society of Gynecologic Oncology’s Annual Meeting on Women’s Cancer.
An analysis showed that adolescents in Alabama are more likely to receive the HPV vaccine if they live below the poverty line and reside in rural areas. The study also revealed a positive association between vaccine uptake and the incidence of HPV-related cancer by county.
These results suggest the perceived risk of HPV-related cancer may outweigh rurality and poverty—factors that might otherwise hinder access to health care, according to Jennifer Y. Pierce, MD, of Mitchell Cancer Institute in Mobile, Ala.
She discussed this idea when presenting the study results at the meeting.
“There are 39,000 preventable cases of HPV-related cancer in the United States,” Dr. Pierce said. “In Alabama, we are [ranked] third for cervical cancer incidence and first for cervical cancer mortality. When we look at vaccination rates in Alabama, unfortunately, we have the opposite problem. We are 45th for HPV vaccination.”
Dr. Pierce also noted that, nationally, adolescents in rural areas are 11% less likely to be vaccinated than their peers in urban areas.
“When we looked in Alabama, that did not exist,” Dr. Pierce said. “So we wanted to know, ‘What are the factors associated with HPV vaccination rate, by county, in the state of Alabama?’ because we had widely disparate rates by county.”
Dr. Pierce and her colleagues looked at data from the U.S. census, county health rankings for Alabama, the Alabama state cancer registry, and other sources. The researchers wanted to determine rates of HPV vaccination in 13- to 17-year-olds as well as rates of HPV-related cancers and variables associated with HPV vaccination by county.
Dr. Pierce said that, of the 67 counties in Alabama, 50%-70% of them are rural. Forty of them have a higher percent poverty level than the state mean. Twenty-three counties have no pediatrician, and four counties have no vaccine provider other than the health department.
By county, cancer rates were positively associated with HPV vaccination in both sexes. Higher cervical cancer rates correlated with higher HPV vaccination rates in females (r = .49; P = .011) and males (r = .46; P = .017). Higher HPV-related cancer rates in males correlated with higher HPV vaccination rates in females (r = .49; P = .001) and males (r = .46; P = .001).
The researchers found no significant association between vaccine uptake and the primary care provider ratio or the number of pediatricians per county. However, private insurance (r = –.40; P = .001) and higher median household income (r = –.40; P = .0007) were associated with lower HPV vaccine uptake. Rurality (r = .27; P = .025) and having a higher percentage of people below the poverty line (r = .39; P = .0011) were associated with higher vaccine uptake.
“How do we explain this paradox?” Dr. Pierce asked. “I think, really, it speaks to the strong commitment of our county public health departments who have, for a long time, been pushing the HPV vaccine and are doing a fairly good job of vaccinating. But I think, even more so, we need to focus on this question of perceived risk.”
“Our poor, rural adolescents in Alabama are being vaccinated at a higher rate than their more affluent peers, and those HPV vaccination rates appear to be directly linked to the cancer incidence rates in those counties.”
Dr. Pierce had no disclosures.
SOURCE: Pierce JY et al. SGO 2019, Abstract 13.
HONOLULU – The perceived risk of HPV-related cancer appears to overcome variables that typically impede access to HPV vaccination, according to a speaker at the Society of Gynecologic Oncology’s Annual Meeting on Women’s Cancer.
An analysis showed that adolescents in Alabama are more likely to receive the HPV vaccine if they live below the poverty line and reside in rural areas. The study also revealed a positive association between vaccine uptake and the incidence of HPV-related cancer by county.
These results suggest the perceived risk of HPV-related cancer may outweigh rurality and poverty—factors that might otherwise hinder access to health care, according to Jennifer Y. Pierce, MD, of Mitchell Cancer Institute in Mobile, Ala.
She discussed this idea when presenting the study results at the meeting.
“There are 39,000 preventable cases of HPV-related cancer in the United States,” Dr. Pierce said. “In Alabama, we are [ranked] third for cervical cancer incidence and first for cervical cancer mortality. When we look at vaccination rates in Alabama, unfortunately, we have the opposite problem. We are 45th for HPV vaccination.”
Dr. Pierce also noted that, nationally, adolescents in rural areas are 11% less likely to be vaccinated than their peers in urban areas.
“When we looked in Alabama, that did not exist,” Dr. Pierce said. “So we wanted to know, ‘What are the factors associated with HPV vaccination rate, by county, in the state of Alabama?’ because we had widely disparate rates by county.”
Dr. Pierce and her colleagues looked at data from the U.S. census, county health rankings for Alabama, the Alabama state cancer registry, and other sources. The researchers wanted to determine rates of HPV vaccination in 13- to 17-year-olds as well as rates of HPV-related cancers and variables associated with HPV vaccination by county.
Dr. Pierce said that, of the 67 counties in Alabama, 50%-70% of them are rural. Forty of them have a higher percent poverty level than the state mean. Twenty-three counties have no pediatrician, and four counties have no vaccine provider other than the health department.
By county, cancer rates were positively associated with HPV vaccination in both sexes. Higher cervical cancer rates correlated with higher HPV vaccination rates in females (r = .49; P = .011) and males (r = .46; P = .017). Higher HPV-related cancer rates in males correlated with higher HPV vaccination rates in females (r = .49; P = .001) and males (r = .46; P = .001).
The researchers found no significant association between vaccine uptake and the primary care provider ratio or the number of pediatricians per county. However, private insurance (r = –.40; P = .001) and higher median household income (r = –.40; P = .0007) were associated with lower HPV vaccine uptake. Rurality (r = .27; P = .025) and having a higher percentage of people below the poverty line (r = .39; P = .0011) were associated with higher vaccine uptake.
“How do we explain this paradox?” Dr. Pierce asked. “I think, really, it speaks to the strong commitment of our county public health departments who have, for a long time, been pushing the HPV vaccine and are doing a fairly good job of vaccinating. But I think, even more so, we need to focus on this question of perceived risk.”
“Our poor, rural adolescents in Alabama are being vaccinated at a higher rate than their more affluent peers, and those HPV vaccination rates appear to be directly linked to the cancer incidence rates in those counties.”
Dr. Pierce had no disclosures.
SOURCE: Pierce JY et al. SGO 2019, Abstract 13.
HONOLULU – The perceived risk of HPV-related cancer appears to overcome variables that typically impede access to HPV vaccination, according to a speaker at the Society of Gynecologic Oncology’s Annual Meeting on Women’s Cancer.
An analysis showed that adolescents in Alabama are more likely to receive the HPV vaccine if they live below the poverty line and reside in rural areas. The study also revealed a positive association between vaccine uptake and the incidence of HPV-related cancer by county.
These results suggest the perceived risk of HPV-related cancer may outweigh rurality and poverty—factors that might otherwise hinder access to health care, according to Jennifer Y. Pierce, MD, of Mitchell Cancer Institute in Mobile, Ala.
She discussed this idea when presenting the study results at the meeting.
“There are 39,000 preventable cases of HPV-related cancer in the United States,” Dr. Pierce said. “In Alabama, we are [ranked] third for cervical cancer incidence and first for cervical cancer mortality. When we look at vaccination rates in Alabama, unfortunately, we have the opposite problem. We are 45th for HPV vaccination.”
Dr. Pierce also noted that, nationally, adolescents in rural areas are 11% less likely to be vaccinated than their peers in urban areas.
“When we looked in Alabama, that did not exist,” Dr. Pierce said. “So we wanted to know, ‘What are the factors associated with HPV vaccination rate, by county, in the state of Alabama?’ because we had widely disparate rates by county.”
Dr. Pierce and her colleagues looked at data from the U.S. census, county health rankings for Alabama, the Alabama state cancer registry, and other sources. The researchers wanted to determine rates of HPV vaccination in 13- to 17-year-olds as well as rates of HPV-related cancers and variables associated with HPV vaccination by county.
Dr. Pierce said that, of the 67 counties in Alabama, 50%-70% of them are rural. Forty of them have a higher percent poverty level than the state mean. Twenty-three counties have no pediatrician, and four counties have no vaccine provider other than the health department.
By county, cancer rates were positively associated with HPV vaccination in both sexes. Higher cervical cancer rates correlated with higher HPV vaccination rates in females (r = .49; P = .011) and males (r = .46; P = .017). Higher HPV-related cancer rates in males correlated with higher HPV vaccination rates in females (r = .49; P = .001) and males (r = .46; P = .001).
The researchers found no significant association between vaccine uptake and the primary care provider ratio or the number of pediatricians per county. However, private insurance (r = –.40; P = .001) and higher median household income (r = –.40; P = .0007) were associated with lower HPV vaccine uptake. Rurality (r = .27; P = .025) and having a higher percentage of people below the poverty line (r = .39; P = .0011) were associated with higher vaccine uptake.
“How do we explain this paradox?” Dr. Pierce asked. “I think, really, it speaks to the strong commitment of our county public health departments who have, for a long time, been pushing the HPV vaccine and are doing a fairly good job of vaccinating. But I think, even more so, we need to focus on this question of perceived risk.”
“Our poor, rural adolescents in Alabama are being vaccinated at a higher rate than their more affluent peers, and those HPV vaccination rates appear to be directly linked to the cancer incidence rates in those counties.”
Dr. Pierce had no disclosures.
SOURCE: Pierce JY et al. SGO 2019, Abstract 13.
REPORTING FROM SGO 2019
Triplet appears safe, effective for gynecologic cancers
HONOLULU – Pembrolizumab plus bevacizumab and oral metronomic cyclophosphamide can be effective in patients with recurrent epithelial ovarian, fallopian tube, or primary peritoneal cancer, a phase 2 trial suggests.
The tumor response rate observed with the three-drug regimen (40%) was better than response rates previously reported for pembrolizumab monotherapy (8%) and bevacizumab plus cyclophosphamide (24%), according to Emese Zsiros, MD, PhD, of Roswell Park Comprehensive Cancer Center in Buffalo, N.Y.
The combination proved “very safe” and was associated with “excellent quality of life,” she said at the Society of Gynecologic Oncology’s Annual Meeting on Women’s Cancer.
Dr. Zsiros and her colleagues enrolled 40 patients on a phase 2 trial (NCT02853318) of pembrolizumab, bevacizumab, and oral cyclophosphamide in recurrent, advanced-stage epithelial ovarian, fallopian tube, or primary peritoneal cancer. The trial had a safety lead-in cohort of five patients.
At baseline, the mean patient age was 62.2 years (range, 44.9-88.7 years). Most patients (82.5%, n = 33) had high-grade serous histology. The patients had received a mean of 3.2 (range, 1-12) prior lines of chemotherapy. Most patients (75%, n = 30) were platinum resistant, but 10 patients (25%) were platinum sensitive and declined platinum-based therapy.
Study treatment consisted of IV pembrolizumab at 200 mg plus IV bevacizumab at 15 mg/kg every 3 weeks and oral cyclophosphamide at 50 mg every day. Patients were treated until disease progression or unacceptable toxicity.
Results
“The triple regimen was, overall, really well tolerated,” Dr. Zsiros said.
The most common grade 1/2 treatment-related adverse events (AEs) were fatigue (n = 14), diarrhea (n = 13), nausea (n = 9), hypertension (n =7), white blood cell decrease (n = 6), and arthralgia (n = 6).
Grade 3 related AEs included hypertension (n = 5), lymphocyte count decrease (n = 3), and white blood cell decrease (n = 1). There was one grade 4 drug-related AE of decreased lymphocyte count.
The overall response rate was 40%, with all 16 responders having a partial response. The rate of stable disease was 55% (n = 22).
“Only 2 patients out of the 40 progressed after initiation of the treatment, and I would like to point out that both of these patients had a very large disease burden,” Dr. Zsiros said.
She also noted that more than 77% of patients had a decrease in tumor size from baseline.
The disease control rate (partial response plus stable disease) was 95.0% (n = 38) initially and 62.5% (n = 25) at 6 months. However, three patients had not yet reached 6 months follow-up at the data cutoff.
“I would like to point out that 30% of the patients [n = 12] derived an especially long-term clinical benefit over 12 months and 12 cycles of treatment,” Dr. Zsiros said.
She added that quality of life assessment revealed “high physical, emotional, cognitive, and social functioning throughout the clinical trial.” The researchers also observed significantly improved body image from baseline (P less than .002).
Dr. Zsiros reported relationships with Iovance Biotherapeutics and AstraZeneca. The trial was sponsored by Roswell Park Cancer Institute in collaboration with the National Cancer Institute.
SOURCE: Zsiros E et al. SGO 2019, Abstract LBA4.
HONOLULU – Pembrolizumab plus bevacizumab and oral metronomic cyclophosphamide can be effective in patients with recurrent epithelial ovarian, fallopian tube, or primary peritoneal cancer, a phase 2 trial suggests.
The tumor response rate observed with the three-drug regimen (40%) was better than response rates previously reported for pembrolizumab monotherapy (8%) and bevacizumab plus cyclophosphamide (24%), according to Emese Zsiros, MD, PhD, of Roswell Park Comprehensive Cancer Center in Buffalo, N.Y.
The combination proved “very safe” and was associated with “excellent quality of life,” she said at the Society of Gynecologic Oncology’s Annual Meeting on Women’s Cancer.
Dr. Zsiros and her colleagues enrolled 40 patients on a phase 2 trial (NCT02853318) of pembrolizumab, bevacizumab, and oral cyclophosphamide in recurrent, advanced-stage epithelial ovarian, fallopian tube, or primary peritoneal cancer. The trial had a safety lead-in cohort of five patients.
At baseline, the mean patient age was 62.2 years (range, 44.9-88.7 years). Most patients (82.5%, n = 33) had high-grade serous histology. The patients had received a mean of 3.2 (range, 1-12) prior lines of chemotherapy. Most patients (75%, n = 30) were platinum resistant, but 10 patients (25%) were platinum sensitive and declined platinum-based therapy.
Study treatment consisted of IV pembrolizumab at 200 mg plus IV bevacizumab at 15 mg/kg every 3 weeks and oral cyclophosphamide at 50 mg every day. Patients were treated until disease progression or unacceptable toxicity.
Results
“The triple regimen was, overall, really well tolerated,” Dr. Zsiros said.
The most common grade 1/2 treatment-related adverse events (AEs) were fatigue (n = 14), diarrhea (n = 13), nausea (n = 9), hypertension (n =7), white blood cell decrease (n = 6), and arthralgia (n = 6).
Grade 3 related AEs included hypertension (n = 5), lymphocyte count decrease (n = 3), and white blood cell decrease (n = 1). There was one grade 4 drug-related AE of decreased lymphocyte count.
The overall response rate was 40%, with all 16 responders having a partial response. The rate of stable disease was 55% (n = 22).
“Only 2 patients out of the 40 progressed after initiation of the treatment, and I would like to point out that both of these patients had a very large disease burden,” Dr. Zsiros said.
She also noted that more than 77% of patients had a decrease in tumor size from baseline.
The disease control rate (partial response plus stable disease) was 95.0% (n = 38) initially and 62.5% (n = 25) at 6 months. However, three patients had not yet reached 6 months follow-up at the data cutoff.
“I would like to point out that 30% of the patients [n = 12] derived an especially long-term clinical benefit over 12 months and 12 cycles of treatment,” Dr. Zsiros said.
She added that quality of life assessment revealed “high physical, emotional, cognitive, and social functioning throughout the clinical trial.” The researchers also observed significantly improved body image from baseline (P less than .002).
Dr. Zsiros reported relationships with Iovance Biotherapeutics and AstraZeneca. The trial was sponsored by Roswell Park Cancer Institute in collaboration with the National Cancer Institute.
SOURCE: Zsiros E et al. SGO 2019, Abstract LBA4.
HONOLULU – Pembrolizumab plus bevacizumab and oral metronomic cyclophosphamide can be effective in patients with recurrent epithelial ovarian, fallopian tube, or primary peritoneal cancer, a phase 2 trial suggests.
The tumor response rate observed with the three-drug regimen (40%) was better than response rates previously reported for pembrolizumab monotherapy (8%) and bevacizumab plus cyclophosphamide (24%), according to Emese Zsiros, MD, PhD, of Roswell Park Comprehensive Cancer Center in Buffalo, N.Y.
The combination proved “very safe” and was associated with “excellent quality of life,” she said at the Society of Gynecologic Oncology’s Annual Meeting on Women’s Cancer.
Dr. Zsiros and her colleagues enrolled 40 patients on a phase 2 trial (NCT02853318) of pembrolizumab, bevacizumab, and oral cyclophosphamide in recurrent, advanced-stage epithelial ovarian, fallopian tube, or primary peritoneal cancer. The trial had a safety lead-in cohort of five patients.
At baseline, the mean patient age was 62.2 years (range, 44.9-88.7 years). Most patients (82.5%, n = 33) had high-grade serous histology. The patients had received a mean of 3.2 (range, 1-12) prior lines of chemotherapy. Most patients (75%, n = 30) were platinum resistant, but 10 patients (25%) were platinum sensitive and declined platinum-based therapy.
Study treatment consisted of IV pembrolizumab at 200 mg plus IV bevacizumab at 15 mg/kg every 3 weeks and oral cyclophosphamide at 50 mg every day. Patients were treated until disease progression or unacceptable toxicity.
Results
“The triple regimen was, overall, really well tolerated,” Dr. Zsiros said.
The most common grade 1/2 treatment-related adverse events (AEs) were fatigue (n = 14), diarrhea (n = 13), nausea (n = 9), hypertension (n =7), white blood cell decrease (n = 6), and arthralgia (n = 6).
Grade 3 related AEs included hypertension (n = 5), lymphocyte count decrease (n = 3), and white blood cell decrease (n = 1). There was one grade 4 drug-related AE of decreased lymphocyte count.
The overall response rate was 40%, with all 16 responders having a partial response. The rate of stable disease was 55% (n = 22).
“Only 2 patients out of the 40 progressed after initiation of the treatment, and I would like to point out that both of these patients had a very large disease burden,” Dr. Zsiros said.
She also noted that more than 77% of patients had a decrease in tumor size from baseline.
The disease control rate (partial response plus stable disease) was 95.0% (n = 38) initially and 62.5% (n = 25) at 6 months. However, three patients had not yet reached 6 months follow-up at the data cutoff.
“I would like to point out that 30% of the patients [n = 12] derived an especially long-term clinical benefit over 12 months and 12 cycles of treatment,” Dr. Zsiros said.
She added that quality of life assessment revealed “high physical, emotional, cognitive, and social functioning throughout the clinical trial.” The researchers also observed significantly improved body image from baseline (P less than .002).
Dr. Zsiros reported relationships with Iovance Biotherapeutics and AstraZeneca. The trial was sponsored by Roswell Park Cancer Institute in collaboration with the National Cancer Institute.
SOURCE: Zsiros E et al. SGO 2019, Abstract LBA4.
REPORTING FROM SGO 2019
Combo may improve PFS, OS for certain ovarian cancer patients
HONOLULU – Combining avelumab with pegylated liposomal doxorubicin (PLD) may provide a survival benefit in certain patients with platinum-resistant or refractory epithelial ovarian cancer, a phase 3 trial suggests.
In the overall study population, progression-free survival (PFS) and overall survival (OS) rates were not significantly different for patients who received avelumab plus PLD and those who received avelumab or PLD alone.
However, some subgroups did experience survival benefits with the combination, including patients who were positive for programmed death–ligand 1 (PD-L1) and those who had received two or three prior lines of therapy.
Eric Pujade-Lauraine, MD, PhD, of ARCAGY-GINECO in Paris, presented these results from the JAVELIN Ovarian 200 trial at the Society of Gynecologic Oncology’s Annual Meeting on Women’s Cancer.
The trial enrolled 566 patients with platinum-resistant or refractory epithelial ovarian cancer. They were not preselected for PD-L1 expression.
Patients were randomized 1:1:1 to receive avelumab at 10 mg/kg every 2 weeks (n = 188), avelumab plus PLD at 40 mg/m2 every 4 weeks (n = 188), or PLD (n = 190).
Baseline characteristics were similar across the treatment arms. The median age was 61 in the avelumab arm and 60 in the other two arms (range, 26-86 years). In each arm, about 37% of patients had bulky disease, and all but two patients (both in the avelumab arm) had an Eastern Cooperative Oncology Group performance status of 0 or 1.
Nearly half of patients had received one line of prior therapy, and the rest had received two or three prior lines of therapy. About 75% of patients had platinum-resistant disease, and 25% were platinum refractory.
The median duration of study treatment was 10.1 weeks in the avelumab arm and 16.0 weeks in the pegylated liposomal doxorubicin (PLD) arm. In the combination arm, the median treatment duration was 16.9 weeks for avelumab and 16.3 weeks for PLD. In each arm, the most common reason for treatment discontinuation was disease progression.
Safety
Dr. Pujade-Lauraine said no new safety signals were observed with avelumab alone or in combination.
Serious treatment-related adverse events (AEs) occurred in 7.5% of patients in the avelumab arm, 17.6% of patients in the combination arm, and 10.7% of patients in the PLD arm. Discontinuation because of a treatment-related AE occurred in 6.4%, 4.4%, and 7.3% of patients, respectively.
There was one treatment-related AE leading to death in the avelumab arm and one in the PLD arm.
AEs that were more common in the combination arm than in the avelumab and PLD arms (respectively) were fatigue/asthenia (42.3%, 26.7%, and 28.8%), rash (34.1%, 8.0%, and 16.9%), stomatitis (28.0%, 2.1%, and 20.3%), and palmar-plantar erythrodysesthesia syndrome (33.0%, 0.5%, and 22.6%).
Response
The objective response rate was 3.7% in the avelumab arm, 13.3% in the combination arm, and 4.2% in the PLD arm. There were two complete responses; both occurred in the combination arm.
The response rate was significantly higher in the combination arm (odds ratio, 3.458, P = .0018) than in the PLD arm, but there was no significant difference in response rate between the avelumab arm and the PLD arm (OR, 0.890, P = .8280).
The median duration of response was 9.2 months in the avelumab arm, 8.5 months in the combination arm, and 13.1 months in the PLD arm.
Survival
There was a trend toward improved PFS with avelumab plus PLD, but the significance threshold was not met.
The median PFS was 1.9 months in the avelumab arm, 3.7 months in the combination arm, and 3.5 months in the PLD arm. With the PLD arm as a reference, the stratified hazard ratio was 1.68 for the avelumab arm (P greater than .999) and 0.78 for the combination arm (P = .0301).
The median OS was 11.8 months in the avelumab arm, 15.7 months in the combination arm, and 13.1 months in the PLD arm. The HR was 1.14 for the avelumab arm (P = .8253) and 0.89 for the combination arm (P = .2082).
“[A]velumab plus PLD showed clinical activity, but, in this unselected population, the trial did not meet the primary objective [of improving PFS or OS compared to PLD alone],” Dr. Pujade-Lauraine noted. “However, prespecified analyses indicate a potential role of PD-L1 expression as a predictor of clinical benefit.”
When Dr. Pujade-Lauraine and his colleagues looked at patients who were positive for PD-L1 (57%), the researchers found a significant improvement in PFS, but not OS, with avelumab plus PLD.
The median PFS was 1.9 months in the avelumab arm (HR,1.45, P = .0303), 3.7 months in the combination arm (HR, 0.65, P = .0143), and 3.0 months in the PLD arm.
The median OS was 13.7 months in the avelumab arm (HR, 0.83, P = .3580), 17.7 months in the combination arm (HR, 0.72, P = .0842), and 13.1 months in the PLD arm.
The researchers also found that PFS and OS were better with avelumab plus PLD versus PLD alone among patients who had received two or three prior treatment regimens at baseline. The HR was 0.62 for PFS and 0.64 for OS.
Dr. Pujade-Lauraine said further subgroup analyses are ongoing.
This trial was sponsored by Pfizer. Dr. Pujade-Lauraine reported relationships with AstraZeneca, Clovis Oncology, Incyte, Pfizer, Roche, and Tesaro.
SOURCE: Pujade-Lauraine E et al. SGO 2019, Abstract LBA1.
HONOLULU – Combining avelumab with pegylated liposomal doxorubicin (PLD) may provide a survival benefit in certain patients with platinum-resistant or refractory epithelial ovarian cancer, a phase 3 trial suggests.
In the overall study population, progression-free survival (PFS) and overall survival (OS) rates were not significantly different for patients who received avelumab plus PLD and those who received avelumab or PLD alone.
However, some subgroups did experience survival benefits with the combination, including patients who were positive for programmed death–ligand 1 (PD-L1) and those who had received two or three prior lines of therapy.
Eric Pujade-Lauraine, MD, PhD, of ARCAGY-GINECO in Paris, presented these results from the JAVELIN Ovarian 200 trial at the Society of Gynecologic Oncology’s Annual Meeting on Women’s Cancer.
The trial enrolled 566 patients with platinum-resistant or refractory epithelial ovarian cancer. They were not preselected for PD-L1 expression.
Patients were randomized 1:1:1 to receive avelumab at 10 mg/kg every 2 weeks (n = 188), avelumab plus PLD at 40 mg/m2 every 4 weeks (n = 188), or PLD (n = 190).
Baseline characteristics were similar across the treatment arms. The median age was 61 in the avelumab arm and 60 in the other two arms (range, 26-86 years). In each arm, about 37% of patients had bulky disease, and all but two patients (both in the avelumab arm) had an Eastern Cooperative Oncology Group performance status of 0 or 1.
Nearly half of patients had received one line of prior therapy, and the rest had received two or three prior lines of therapy. About 75% of patients had platinum-resistant disease, and 25% were platinum refractory.
The median duration of study treatment was 10.1 weeks in the avelumab arm and 16.0 weeks in the pegylated liposomal doxorubicin (PLD) arm. In the combination arm, the median treatment duration was 16.9 weeks for avelumab and 16.3 weeks for PLD. In each arm, the most common reason for treatment discontinuation was disease progression.
Safety
Dr. Pujade-Lauraine said no new safety signals were observed with avelumab alone or in combination.
Serious treatment-related adverse events (AEs) occurred in 7.5% of patients in the avelumab arm, 17.6% of patients in the combination arm, and 10.7% of patients in the PLD arm. Discontinuation because of a treatment-related AE occurred in 6.4%, 4.4%, and 7.3% of patients, respectively.
There was one treatment-related AE leading to death in the avelumab arm and one in the PLD arm.
AEs that were more common in the combination arm than in the avelumab and PLD arms (respectively) were fatigue/asthenia (42.3%, 26.7%, and 28.8%), rash (34.1%, 8.0%, and 16.9%), stomatitis (28.0%, 2.1%, and 20.3%), and palmar-plantar erythrodysesthesia syndrome (33.0%, 0.5%, and 22.6%).
Response
The objective response rate was 3.7% in the avelumab arm, 13.3% in the combination arm, and 4.2% in the PLD arm. There were two complete responses; both occurred in the combination arm.
The response rate was significantly higher in the combination arm (odds ratio, 3.458, P = .0018) than in the PLD arm, but there was no significant difference in response rate between the avelumab arm and the PLD arm (OR, 0.890, P = .8280).
The median duration of response was 9.2 months in the avelumab arm, 8.5 months in the combination arm, and 13.1 months in the PLD arm.
Survival
There was a trend toward improved PFS with avelumab plus PLD, but the significance threshold was not met.
The median PFS was 1.9 months in the avelumab arm, 3.7 months in the combination arm, and 3.5 months in the PLD arm. With the PLD arm as a reference, the stratified hazard ratio was 1.68 for the avelumab arm (P greater than .999) and 0.78 for the combination arm (P = .0301).
The median OS was 11.8 months in the avelumab arm, 15.7 months in the combination arm, and 13.1 months in the PLD arm. The HR was 1.14 for the avelumab arm (P = .8253) and 0.89 for the combination arm (P = .2082).
“[A]velumab plus PLD showed clinical activity, but, in this unselected population, the trial did not meet the primary objective [of improving PFS or OS compared to PLD alone],” Dr. Pujade-Lauraine noted. “However, prespecified analyses indicate a potential role of PD-L1 expression as a predictor of clinical benefit.”
When Dr. Pujade-Lauraine and his colleagues looked at patients who were positive for PD-L1 (57%), the researchers found a significant improvement in PFS, but not OS, with avelumab plus PLD.
The median PFS was 1.9 months in the avelumab arm (HR,1.45, P = .0303), 3.7 months in the combination arm (HR, 0.65, P = .0143), and 3.0 months in the PLD arm.
The median OS was 13.7 months in the avelumab arm (HR, 0.83, P = .3580), 17.7 months in the combination arm (HR, 0.72, P = .0842), and 13.1 months in the PLD arm.
The researchers also found that PFS and OS were better with avelumab plus PLD versus PLD alone among patients who had received two or three prior treatment regimens at baseline. The HR was 0.62 for PFS and 0.64 for OS.
Dr. Pujade-Lauraine said further subgroup analyses are ongoing.
This trial was sponsored by Pfizer. Dr. Pujade-Lauraine reported relationships with AstraZeneca, Clovis Oncology, Incyte, Pfizer, Roche, and Tesaro.
SOURCE: Pujade-Lauraine E et al. SGO 2019, Abstract LBA1.
HONOLULU – Combining avelumab with pegylated liposomal doxorubicin (PLD) may provide a survival benefit in certain patients with platinum-resistant or refractory epithelial ovarian cancer, a phase 3 trial suggests.
In the overall study population, progression-free survival (PFS) and overall survival (OS) rates were not significantly different for patients who received avelumab plus PLD and those who received avelumab or PLD alone.
However, some subgroups did experience survival benefits with the combination, including patients who were positive for programmed death–ligand 1 (PD-L1) and those who had received two or three prior lines of therapy.
Eric Pujade-Lauraine, MD, PhD, of ARCAGY-GINECO in Paris, presented these results from the JAVELIN Ovarian 200 trial at the Society of Gynecologic Oncology’s Annual Meeting on Women’s Cancer.
The trial enrolled 566 patients with platinum-resistant or refractory epithelial ovarian cancer. They were not preselected for PD-L1 expression.
Patients were randomized 1:1:1 to receive avelumab at 10 mg/kg every 2 weeks (n = 188), avelumab plus PLD at 40 mg/m2 every 4 weeks (n = 188), or PLD (n = 190).
Baseline characteristics were similar across the treatment arms. The median age was 61 in the avelumab arm and 60 in the other two arms (range, 26-86 years). In each arm, about 37% of patients had bulky disease, and all but two patients (both in the avelumab arm) had an Eastern Cooperative Oncology Group performance status of 0 or 1.
Nearly half of patients had received one line of prior therapy, and the rest had received two or three prior lines of therapy. About 75% of patients had platinum-resistant disease, and 25% were platinum refractory.
The median duration of study treatment was 10.1 weeks in the avelumab arm and 16.0 weeks in the pegylated liposomal doxorubicin (PLD) arm. In the combination arm, the median treatment duration was 16.9 weeks for avelumab and 16.3 weeks for PLD. In each arm, the most common reason for treatment discontinuation was disease progression.
Safety
Dr. Pujade-Lauraine said no new safety signals were observed with avelumab alone or in combination.
Serious treatment-related adverse events (AEs) occurred in 7.5% of patients in the avelumab arm, 17.6% of patients in the combination arm, and 10.7% of patients in the PLD arm. Discontinuation because of a treatment-related AE occurred in 6.4%, 4.4%, and 7.3% of patients, respectively.
There was one treatment-related AE leading to death in the avelumab arm and one in the PLD arm.
AEs that were more common in the combination arm than in the avelumab and PLD arms (respectively) were fatigue/asthenia (42.3%, 26.7%, and 28.8%), rash (34.1%, 8.0%, and 16.9%), stomatitis (28.0%, 2.1%, and 20.3%), and palmar-plantar erythrodysesthesia syndrome (33.0%, 0.5%, and 22.6%).
Response
The objective response rate was 3.7% in the avelumab arm, 13.3% in the combination arm, and 4.2% in the PLD arm. There were two complete responses; both occurred in the combination arm.
The response rate was significantly higher in the combination arm (odds ratio, 3.458, P = .0018) than in the PLD arm, but there was no significant difference in response rate between the avelumab arm and the PLD arm (OR, 0.890, P = .8280).
The median duration of response was 9.2 months in the avelumab arm, 8.5 months in the combination arm, and 13.1 months in the PLD arm.
Survival
There was a trend toward improved PFS with avelumab plus PLD, but the significance threshold was not met.
The median PFS was 1.9 months in the avelumab arm, 3.7 months in the combination arm, and 3.5 months in the PLD arm. With the PLD arm as a reference, the stratified hazard ratio was 1.68 for the avelumab arm (P greater than .999) and 0.78 for the combination arm (P = .0301).
The median OS was 11.8 months in the avelumab arm, 15.7 months in the combination arm, and 13.1 months in the PLD arm. The HR was 1.14 for the avelumab arm (P = .8253) and 0.89 for the combination arm (P = .2082).
“[A]velumab plus PLD showed clinical activity, but, in this unselected population, the trial did not meet the primary objective [of improving PFS or OS compared to PLD alone],” Dr. Pujade-Lauraine noted. “However, prespecified analyses indicate a potential role of PD-L1 expression as a predictor of clinical benefit.”
When Dr. Pujade-Lauraine and his colleagues looked at patients who were positive for PD-L1 (57%), the researchers found a significant improvement in PFS, but not OS, with avelumab plus PLD.
The median PFS was 1.9 months in the avelumab arm (HR,1.45, P = .0303), 3.7 months in the combination arm (HR, 0.65, P = .0143), and 3.0 months in the PLD arm.
The median OS was 13.7 months in the avelumab arm (HR, 0.83, P = .3580), 17.7 months in the combination arm (HR, 0.72, P = .0842), and 13.1 months in the PLD arm.
The researchers also found that PFS and OS were better with avelumab plus PLD versus PLD alone among patients who had received two or three prior treatment regimens at baseline. The HR was 0.62 for PFS and 0.64 for OS.
Dr. Pujade-Lauraine said further subgroup analyses are ongoing.
This trial was sponsored by Pfizer. Dr. Pujade-Lauraine reported relationships with AstraZeneca, Clovis Oncology, Incyte, Pfizer, Roche, and Tesaro.
SOURCE: Pujade-Lauraine E et al. SGO 2019, Abstract LBA1.
REPORTING FROM SGO 2019
Financial toxicity may be common in gynecologic cancer patients
HONOLULU – Financial toxicity may be common among gynecologic cancer patients starting a new line of treatment, based on the results of a survey presented at the Society of Gynecologic Oncology’s Annual Meeting on Women’s Cancer.
More than half of the 121 patients surveyed reported mild, moderate, or severe financial toxicity, Margaret Liang, MD, of University of Alabama at Birmingham, said in presenting the findings.
Younger age and lower income were both risk factors for financial toxicity, and having insurance did not protect patients from financial toxicity. Dr. Liang noted that insurance coverage “was not protective for financial toxicity, as the majority of those who screened positive for financial toxicity were insured.” Specifically, 89% of patients with financial toxicity and 98% of patients without it were insured (P = .07).
“This finding supports financial toxicity screening regardless of insurance status and may favor universal screening,” Dr. Liang said.
She and her colleagues conducted the survey of 121 gynecologic cancer patients who had started a new line of systemic therapy in the previous 8 weeks.
The patients’ mean age was 59 years (range, 33-80), and 58% were starting their first line of systemic therapy. Half of the patients had a household income below $40,000, and about one-third of the patients were employed. Most had private (74%) or public (20%) insurance, and 7% of patients were uninsured.
To assess financial toxicity, the researchers used the Comprehensive Score for Financial Toxicity (COST). A score of less than 26 was used as a threshold of financial toxicity. The severity of financial toxicity was graded on a scale of 1 to 4, with a lower score indicating worse toxicity.
Patients were most concerned about having enough money to cover the cost of treatment. Patients reported the lowest mean score—0.97—in response to the statement, “I know that I have enough money in savings, retirement, or assets to cover the costs of my treatment.”
Patients were least concerned about losing their job or income. They reported the highest mean score—3.29—in response to the statement, “I am concerned about keeping my job and income, including working at home.” However, as Dr. Liang pointed out, only one-third of patients were employed at baseline.
In all, 54% of patients reported financial toxicity—37% mild, 16% moderate, and 1% severe.
Dr. Liang and her colleagues found that younger age and lower income were associated with an increased risk for financial toxicity. The mean age was 57 years in patients with financial toxicity and 62 years in patients without it (P = .02). Household incomes were below $40,000 in 63% of patients with financial toxicity and 34% of those without it (P less than .01).
The researchers also found that patients with financial toxicity were significantly more likely to say their cancer diagnosis resulted in lost wages, borrowed money, altered spending habits, the need to sacrifice other things, and not paying bills on time (P less than .01 for all).
On the other hand, patients with financial toxicity were not significantly more likely to become unemployed, file for bankruptcy, sell their house, or get a second job due to their cancer diagnosis.
However, it’s important to note that these data were collected within 8 weeks of patients starting their new line of therapy. The final survey results will include follow-up at 3 months and 6 months.
Dr. Liang said the fact that more than half of patients reported financial toxicity within 8 weeks of starting a new line of therapy suggests early interventions are needed to prevent or reduce financial toxicity. This may include counseling patients on anticipated costs of care, screening for financial toxicity, and linking patients to available financial resources.
Dr. Liang had no financial disclosures.
SOURCE: Liang M et al. SGO 2019. Abstract 8.
HONOLULU – Financial toxicity may be common among gynecologic cancer patients starting a new line of treatment, based on the results of a survey presented at the Society of Gynecologic Oncology’s Annual Meeting on Women’s Cancer.
More than half of the 121 patients surveyed reported mild, moderate, or severe financial toxicity, Margaret Liang, MD, of University of Alabama at Birmingham, said in presenting the findings.
Younger age and lower income were both risk factors for financial toxicity, and having insurance did not protect patients from financial toxicity. Dr. Liang noted that insurance coverage “was not protective for financial toxicity, as the majority of those who screened positive for financial toxicity were insured.” Specifically, 89% of patients with financial toxicity and 98% of patients without it were insured (P = .07).
“This finding supports financial toxicity screening regardless of insurance status and may favor universal screening,” Dr. Liang said.
She and her colleagues conducted the survey of 121 gynecologic cancer patients who had started a new line of systemic therapy in the previous 8 weeks.
The patients’ mean age was 59 years (range, 33-80), and 58% were starting their first line of systemic therapy. Half of the patients had a household income below $40,000, and about one-third of the patients were employed. Most had private (74%) or public (20%) insurance, and 7% of patients were uninsured.
To assess financial toxicity, the researchers used the Comprehensive Score for Financial Toxicity (COST). A score of less than 26 was used as a threshold of financial toxicity. The severity of financial toxicity was graded on a scale of 1 to 4, with a lower score indicating worse toxicity.
Patients were most concerned about having enough money to cover the cost of treatment. Patients reported the lowest mean score—0.97—in response to the statement, “I know that I have enough money in savings, retirement, or assets to cover the costs of my treatment.”
Patients were least concerned about losing their job or income. They reported the highest mean score—3.29—in response to the statement, “I am concerned about keeping my job and income, including working at home.” However, as Dr. Liang pointed out, only one-third of patients were employed at baseline.
In all, 54% of patients reported financial toxicity—37% mild, 16% moderate, and 1% severe.
Dr. Liang and her colleagues found that younger age and lower income were associated with an increased risk for financial toxicity. The mean age was 57 years in patients with financial toxicity and 62 years in patients without it (P = .02). Household incomes were below $40,000 in 63% of patients with financial toxicity and 34% of those without it (P less than .01).
The researchers also found that patients with financial toxicity were significantly more likely to say their cancer diagnosis resulted in lost wages, borrowed money, altered spending habits, the need to sacrifice other things, and not paying bills on time (P less than .01 for all).
On the other hand, patients with financial toxicity were not significantly more likely to become unemployed, file for bankruptcy, sell their house, or get a second job due to their cancer diagnosis.
However, it’s important to note that these data were collected within 8 weeks of patients starting their new line of therapy. The final survey results will include follow-up at 3 months and 6 months.
Dr. Liang said the fact that more than half of patients reported financial toxicity within 8 weeks of starting a new line of therapy suggests early interventions are needed to prevent or reduce financial toxicity. This may include counseling patients on anticipated costs of care, screening for financial toxicity, and linking patients to available financial resources.
Dr. Liang had no financial disclosures.
SOURCE: Liang M et al. SGO 2019. Abstract 8.
HONOLULU – Financial toxicity may be common among gynecologic cancer patients starting a new line of treatment, based on the results of a survey presented at the Society of Gynecologic Oncology’s Annual Meeting on Women’s Cancer.
More than half of the 121 patients surveyed reported mild, moderate, or severe financial toxicity, Margaret Liang, MD, of University of Alabama at Birmingham, said in presenting the findings.
Younger age and lower income were both risk factors for financial toxicity, and having insurance did not protect patients from financial toxicity. Dr. Liang noted that insurance coverage “was not protective for financial toxicity, as the majority of those who screened positive for financial toxicity were insured.” Specifically, 89% of patients with financial toxicity and 98% of patients without it were insured (P = .07).
“This finding supports financial toxicity screening regardless of insurance status and may favor universal screening,” Dr. Liang said.
She and her colleagues conducted the survey of 121 gynecologic cancer patients who had started a new line of systemic therapy in the previous 8 weeks.
The patients’ mean age was 59 years (range, 33-80), and 58% were starting their first line of systemic therapy. Half of the patients had a household income below $40,000, and about one-third of the patients were employed. Most had private (74%) or public (20%) insurance, and 7% of patients were uninsured.
To assess financial toxicity, the researchers used the Comprehensive Score for Financial Toxicity (COST). A score of less than 26 was used as a threshold of financial toxicity. The severity of financial toxicity was graded on a scale of 1 to 4, with a lower score indicating worse toxicity.
Patients were most concerned about having enough money to cover the cost of treatment. Patients reported the lowest mean score—0.97—in response to the statement, “I know that I have enough money in savings, retirement, or assets to cover the costs of my treatment.”
Patients were least concerned about losing their job or income. They reported the highest mean score—3.29—in response to the statement, “I am concerned about keeping my job and income, including working at home.” However, as Dr. Liang pointed out, only one-third of patients were employed at baseline.
In all, 54% of patients reported financial toxicity—37% mild, 16% moderate, and 1% severe.
Dr. Liang and her colleagues found that younger age and lower income were associated with an increased risk for financial toxicity. The mean age was 57 years in patients with financial toxicity and 62 years in patients without it (P = .02). Household incomes were below $40,000 in 63% of patients with financial toxicity and 34% of those without it (P less than .01).
The researchers also found that patients with financial toxicity were significantly more likely to say their cancer diagnosis resulted in lost wages, borrowed money, altered spending habits, the need to sacrifice other things, and not paying bills on time (P less than .01 for all).
On the other hand, patients with financial toxicity were not significantly more likely to become unemployed, file for bankruptcy, sell their house, or get a second job due to their cancer diagnosis.
However, it’s important to note that these data were collected within 8 weeks of patients starting their new line of therapy. The final survey results will include follow-up at 3 months and 6 months.
Dr. Liang said the fact that more than half of patients reported financial toxicity within 8 weeks of starting a new line of therapy suggests early interventions are needed to prevent or reduce financial toxicity. This may include counseling patients on anticipated costs of care, screening for financial toxicity, and linking patients to available financial resources.
Dr. Liang had no financial disclosures.
SOURCE: Liang M et al. SGO 2019. Abstract 8.
REPORTING FROM SGO 2019
Financial assistance programs may speed treatment for cervical cancer
HONOLULU – Financial assistance programs may help lower-income cervical cancer patients complete treatment in a timely manner, according to research presented at the Society of Gynecologic Oncology’s Annual Meeting on Women’s Cancer.
In a retrospective study, lower-income patients who used financial assistance programs were able to complete treatment for cervical cancer in a similar timeframe as higher-income patients.
Lower-income patients who registered for disability benefits saw a significant improvement in time to treatment completion.
Additionally, there was a trend toward improved time to treatment completion among lower-income patients who registered for federally funded breast and cervical cancer treatment.
“Identification of patients who qualify for disability and/or breast/cervical cancer Medicaid, and providing assistance for registration in these programs may help them complete therapy in a more appropriate timeframe,” said study investigator Jessica Gillen, MD, of The University of Oklahoma in Oklahoma City.
Dr. Gillen and her colleagues conducted this single-center, retrospective study of patients with squamous cell, adenocarcinoma, or adenosquamous cancer of the cervix.
The investigators identified 116 evaluable patients who received chemoradiation from January 1, 2015, to July 31, 2018. Most of these 106 patients completed treatment in 63 days or less.
The patients’ median household income was $45,782 (range, $19,771–$96,222). The investigators defined “high-income” patients as those whose household incomes were at or above the median, and “low-income” patients as those with incomes below the median.
On average, the patients used 1.24 assistance programs, which included financial assistance (primarily help with clinic visit copays), assistance with medication costs, disability benefits, Medicaid, access to emergency funds, low-cost or free lodging, and transportation.
Dr. Gillen noted that 10% of low-income patients did not use any financial assistance programs.
She and her colleagues found that low-income patients who used assistance programs completed treatment in a similar timeframe as the high-income patients. The median time to treatment completion was 56.5 days and 50 days, respectively.
Registering for disability benefits was significantly associated with improved time to treatment completion (P less than .001).
There were no other significant associations between financial assistance programs and time to treatment completion. However, there was a trend toward improved time to treatment completion among patients who registered for federally funded breast and cervical cancer Medicaid (P = .06).
“[I]t was encouraging to see that enrollment in federally and state-funded programs makes a difference in patients’ ability to complete treatment,” Dr. Gillen said.
She and her colleagues said these data suggest financial assistance programs may help cervical cancer patients overcome barriers to care. Dr. Gillen had no financial disclosures.
SOURCE: Gillen J et al. SGO 2019. Abstract 9.
HONOLULU – Financial assistance programs may help lower-income cervical cancer patients complete treatment in a timely manner, according to research presented at the Society of Gynecologic Oncology’s Annual Meeting on Women’s Cancer.
In a retrospective study, lower-income patients who used financial assistance programs were able to complete treatment for cervical cancer in a similar timeframe as higher-income patients.
Lower-income patients who registered for disability benefits saw a significant improvement in time to treatment completion.
Additionally, there was a trend toward improved time to treatment completion among lower-income patients who registered for federally funded breast and cervical cancer treatment.
“Identification of patients who qualify for disability and/or breast/cervical cancer Medicaid, and providing assistance for registration in these programs may help them complete therapy in a more appropriate timeframe,” said study investigator Jessica Gillen, MD, of The University of Oklahoma in Oklahoma City.
Dr. Gillen and her colleagues conducted this single-center, retrospective study of patients with squamous cell, adenocarcinoma, or adenosquamous cancer of the cervix.
The investigators identified 116 evaluable patients who received chemoradiation from January 1, 2015, to July 31, 2018. Most of these 106 patients completed treatment in 63 days or less.
The patients’ median household income was $45,782 (range, $19,771–$96,222). The investigators defined “high-income” patients as those whose household incomes were at or above the median, and “low-income” patients as those with incomes below the median.
On average, the patients used 1.24 assistance programs, which included financial assistance (primarily help with clinic visit copays), assistance with medication costs, disability benefits, Medicaid, access to emergency funds, low-cost or free lodging, and transportation.
Dr. Gillen noted that 10% of low-income patients did not use any financial assistance programs.
She and her colleagues found that low-income patients who used assistance programs completed treatment in a similar timeframe as the high-income patients. The median time to treatment completion was 56.5 days and 50 days, respectively.
Registering for disability benefits was significantly associated with improved time to treatment completion (P less than .001).
There were no other significant associations between financial assistance programs and time to treatment completion. However, there was a trend toward improved time to treatment completion among patients who registered for federally funded breast and cervical cancer Medicaid (P = .06).
“[I]t was encouraging to see that enrollment in federally and state-funded programs makes a difference in patients’ ability to complete treatment,” Dr. Gillen said.
She and her colleagues said these data suggest financial assistance programs may help cervical cancer patients overcome barriers to care. Dr. Gillen had no financial disclosures.
SOURCE: Gillen J et al. SGO 2019. Abstract 9.
HONOLULU – Financial assistance programs may help lower-income cervical cancer patients complete treatment in a timely manner, according to research presented at the Society of Gynecologic Oncology’s Annual Meeting on Women’s Cancer.
In a retrospective study, lower-income patients who used financial assistance programs were able to complete treatment for cervical cancer in a similar timeframe as higher-income patients.
Lower-income patients who registered for disability benefits saw a significant improvement in time to treatment completion.
Additionally, there was a trend toward improved time to treatment completion among lower-income patients who registered for federally funded breast and cervical cancer treatment.
“Identification of patients who qualify for disability and/or breast/cervical cancer Medicaid, and providing assistance for registration in these programs may help them complete therapy in a more appropriate timeframe,” said study investigator Jessica Gillen, MD, of The University of Oklahoma in Oklahoma City.
Dr. Gillen and her colleagues conducted this single-center, retrospective study of patients with squamous cell, adenocarcinoma, or adenosquamous cancer of the cervix.
The investigators identified 116 evaluable patients who received chemoradiation from January 1, 2015, to July 31, 2018. Most of these 106 patients completed treatment in 63 days or less.
The patients’ median household income was $45,782 (range, $19,771–$96,222). The investigators defined “high-income” patients as those whose household incomes were at or above the median, and “low-income” patients as those with incomes below the median.
On average, the patients used 1.24 assistance programs, which included financial assistance (primarily help with clinic visit copays), assistance with medication costs, disability benefits, Medicaid, access to emergency funds, low-cost or free lodging, and transportation.
Dr. Gillen noted that 10% of low-income patients did not use any financial assistance programs.
She and her colleagues found that low-income patients who used assistance programs completed treatment in a similar timeframe as the high-income patients. The median time to treatment completion was 56.5 days and 50 days, respectively.
Registering for disability benefits was significantly associated with improved time to treatment completion (P less than .001).
There were no other significant associations between financial assistance programs and time to treatment completion. However, there was a trend toward improved time to treatment completion among patients who registered for federally funded breast and cervical cancer Medicaid (P = .06).
“[I]t was encouraging to see that enrollment in federally and state-funded programs makes a difference in patients’ ability to complete treatment,” Dr. Gillen said.
She and her colleagues said these data suggest financial assistance programs may help cervical cancer patients overcome barriers to care. Dr. Gillen had no financial disclosures.
SOURCE: Gillen J et al. SGO 2019. Abstract 9.
REPORTING FROM SGO 2019
