Blood & Cancer

In this episode, Stefan Barta, MD, of the University of Pennsylvania, joins David Henry, MD, to discuss the treatment and diagnosis of lymphoma in patients with HIV.

And in this week’s Clinical Correlation, Ilana Yurkiewicz, MD, has Part 2 of her discussion on informed consent in cancer. Dr. Yurkiewicz is a fellow in hematology and oncology at Stanford (Calif.) University and is also a columnist for Hematology News. More from Dr. Yurkiewicz here.

Subscribe to Blood & Cancer here:

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Show notes
 

By Emily Bryer, DO
Resident in the department of internal medicine, University of Pennsylvania Health System

Immunosuppression in patients with HIV, especially with low CD4 counts, is associated with the development of lymphomas.

Diffuse large B-cell lymphoma is the most common lymphoma in patients with HIV followed by Burkitt lymphoma and Hodgkin lymphoma.

Extra-nodal manifestations of lymphoma are more common in patients with HIV, especially with lower CD4 counts.

Following pathologic diagnosis, staging of lymphoma should include:
- CT scan, PET scan, evaluation of CNS (MRI brain and LP), bone marrow biopsy, and evaluation for hepatitis B and C co-infection.
- Fluorescence in situ hybridization (FISH) is a molecular technique that identifies portions of DNA and helps to identify translocations and rearrangements.
- cMYC, BCL2, and BCL6 are all pro-proliferative genes and commonly implicated in lymphoma.
- cMYC rearrangement poses higher risk of CNS involvement and CNS relapse.
- cMYC rearrangement (as opposed to cMYC translocation) requires therapy that is more aggressive therapy than R-CHOP.


Treatment of high grade diffuse large B-cell lymphoma:
- R-EPOCH
- Ibrutinib plus R-EPOCH

Resources:AIDS Malignancy ConsortiumBlood. 2004;103:275-82.
Blood. 2010 Apr 15; 115(15): 3008–16.
NCT03220022: Ibrutinib, Rituximab, Etoposide, Prednisone, Vincristine Sulfate, Cyclophosphamide, and Doxorubicin Hydrochloride in Treating Patients With HIV-Positive Stage II-IV Diffuse Large B-Cell Lymphomas






 

In this episode, Stefan Barta, MD, of the University of Pennsylvania, joins David Henry, MD, to discuss the treatment and diagnosis of lymphoma in patients with HIV.

And in this week’s Clinical Correlation, Ilana Yurkiewicz, MD, has Part 2 of her discussion on informed consent in cancer. Dr. Yurkiewicz is a fellow in hematology and oncology at Stanford (Calif.) University and is also a columnist for Hematology News. More from Dr. Yurkiewicz here.

Subscribe to Blood & Cancer here:

Apple Podcasts
Google Podcasts

Show notes
 

By Emily Bryer, DO
Resident in the department of internal medicine, University of Pennsylvania Health System

Immunosuppression in patients with HIV, especially with low CD4 counts, is associated with the development of lymphomas.

Diffuse large B-cell lymphoma is the most common lymphoma in patients with HIV followed by Burkitt lymphoma and Hodgkin lymphoma.

Extra-nodal manifestations of lymphoma are more common in patients with HIV, especially with lower CD4 counts.

Following pathologic diagnosis, staging of lymphoma should include:
- CT scan, PET scan, evaluation of CNS (MRI brain and LP), bone marrow biopsy, and evaluation for hepatitis B and C co-infection.
- Fluorescence in situ hybridization (FISH) is a molecular technique that identifies portions of DNA and helps to identify translocations and rearrangements.
- cMYC, BCL2, and BCL6 are all pro-proliferative genes and commonly implicated in lymphoma.
- cMYC rearrangement poses higher risk of CNS involvement and CNS relapse.
- cMYC rearrangement (as opposed to cMYC translocation) requires therapy that is more aggressive therapy than R-CHOP.


Treatment of high grade diffuse large B-cell lymphoma:
- R-EPOCH
- Ibrutinib plus R-EPOCH

Resources:AIDS Malignancy ConsortiumBlood. 2004;103:275-82.
Blood. 2010 Apr 15; 115(15): 3008–16.
NCT03220022: Ibrutinib, Rituximab, Etoposide, Prednisone, Vincristine Sulfate, Cyclophosphamide, and Doxorubicin Hydrochloride in Treating Patients With HIV-Positive Stage II-IV Diffuse Large B-Cell Lymphomas






 

In this episode, Stefan Barta, MD, of the University of Pennsylvania, joins David Henry, MD, to discuss the treatment and diagnosis of lymphoma in patients with HIV.

And in this week’s Clinical Correlation, Ilana Yurkiewicz, MD, has Part 2 of her discussion on informed consent in cancer. Dr. Yurkiewicz is a fellow in hematology and oncology at Stanford (Calif.) University and is also a columnist for Hematology News. More from Dr. Yurkiewicz here.

Subscribe to Blood & Cancer here:

Apple Podcasts
Google Podcasts

Show notes
 

By Emily Bryer, DO
Resident in the department of internal medicine, University of Pennsylvania Health System

Immunosuppression in patients with HIV, especially with low CD4 counts, is associated with the development of lymphomas.

Diffuse large B-cell lymphoma is the most common lymphoma in patients with HIV followed by Burkitt lymphoma and Hodgkin lymphoma.

Extra-nodal manifestations of lymphoma are more common in patients with HIV, especially with lower CD4 counts.

Following pathologic diagnosis, staging of lymphoma should include:
- CT scan, PET scan, evaluation of CNS (MRI brain and LP), bone marrow biopsy, and evaluation for hepatitis B and C co-infection.
- Fluorescence in situ hybridization (FISH) is a molecular technique that identifies portions of DNA and helps to identify translocations and rearrangements.
- cMYC, BCL2, and BCL6 are all pro-proliferative genes and commonly implicated in lymphoma.
- cMYC rearrangement poses higher risk of CNS involvement and CNS relapse.
- cMYC rearrangement (as opposed to cMYC translocation) requires therapy that is more aggressive therapy than R-CHOP.


Treatment of high grade diffuse large B-cell lymphoma:
- R-EPOCH
- Ibrutinib plus R-EPOCH

Resources:AIDS Malignancy ConsortiumBlood. 2004;103:275-82.
Blood. 2010 Apr 15; 115(15): 3008–16.
NCT03220022: Ibrutinib, Rituximab, Etoposide, Prednisone, Vincristine Sulfate, Cyclophosphamide, and Doxorubicin Hydrochloride in Treating Patients With HIV-Positive Stage II-IV Diffuse Large B-Cell Lymphomas






 

In this episode, Alok Khorana, MD, of the Cleveland Clinic, joins David H. Henry, MD, to discuss results from the CASSINI trial and what it means for anticoagulation in cancer patients.
And Ilana Yurkiewicz, MD, begins part 1 of her look at informed consent. Dr. Yurkiewicz is a fellow in hematology and oncology at Stanford (Calif.) University and is also a columnist for Hematology News. More from Dr. Yurkiewicz here.
Subscribe to Blood & Cancer here:
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In this episode, Alok Khorana, MD, of the Cleveland Clinic, joins David H. Henry, MD, to discuss results from the CASSINI trial and what it means for anticoagulation in cancer patients.
And Ilana Yurkiewicz, MD, begins part 1 of her look at informed consent. Dr. Yurkiewicz is a fellow in hematology and oncology at Stanford (Calif.) University and is also a columnist for Hematology News. More from Dr. Yurkiewicz here.
Subscribe to Blood & Cancer here:
Apple Podcasts

Google Podcasts

In this episode, Alok Khorana, MD, of the Cleveland Clinic, joins David H. Henry, MD, to discuss results from the CASSINI trial and what it means for anticoagulation in cancer patients.
And Ilana Yurkiewicz, MD, begins part 1 of her look at informed consent. Dr. Yurkiewicz is a fellow in hematology and oncology at Stanford (Calif.) University and is also a columnist for Hematology News. More from Dr. Yurkiewicz here.
Subscribe to Blood & Cancer here:
Apple Podcasts

Google Podcasts

In this episode, Charles E. Geyer, MD, of Virginia Commonweath University joins guest host Jame Abraham, MD, of the Cleveland Clinic to discuss the KATHERINE trial and its impact on the treatment of HER2-positive breast cancer.

And Ilana Yurkiewicz, MD, talks about whether it’s better for physicians to be vague about prognosis. Dr. Yurkiewicz is a fellow in hematology and oncology at Stanford (Calif.) University and is also a columnist for Hematology News. More from Dr. Yurkiewicz here.

Subscribe to Blood & Cancer here:

Apple PodcastsGoogle Podcasts

In this episode, Charles E. Geyer, MD, of Virginia Commonweath University joins guest host Jame Abraham, MD, of the Cleveland Clinic to discuss the KATHERINE trial and its impact on the treatment of HER2-positive breast cancer.

And Ilana Yurkiewicz, MD, talks about whether it’s better for physicians to be vague about prognosis. Dr. Yurkiewicz is a fellow in hematology and oncology at Stanford (Calif.) University and is also a columnist for Hematology News. More from Dr. Yurkiewicz here.

Subscribe to Blood & Cancer here:

Apple PodcastsGoogle Podcasts

In this episode, Charles E. Geyer, MD, of Virginia Commonweath University joins guest host Jame Abraham, MD, of the Cleveland Clinic to discuss the KATHERINE trial and its impact on the treatment of HER2-positive breast cancer.

And Ilana Yurkiewicz, MD, talks about whether it’s better for physicians to be vague about prognosis. Dr. Yurkiewicz is a fellow in hematology and oncology at Stanford (Calif.) University and is also a columnist for Hematology News. More from Dr. Yurkiewicz here.

Subscribe to Blood & Cancer here:

Apple PodcastsGoogle Podcasts

In this episode, Daniel G. Haller, MD, of the University of Pennsylvania joins David H. Henry, MD, to talk about the best ways to read and review scientific literature.
And Ilana Yurkiewicz, MD, talks about chaos and opportunity. Dr. Yurkiewicz is a fellow in hematology and oncology at Stanford (Calif.) University and is also a columnist for Hematology News. More from Dr. Yurkiewicz here.

Subscribe to Blood & Cancer here:

Apple Podcasts
Google Podcasts

Show notes
By Hitomi Hosoya, MD, PhD,
Resident in the department of internal medicine, University of Pennsylvania Health System

- If you are a peer reviewer of a manuscript submitted to a journal, you should be unbiased, consistent, constructive, and focused on the research. COPE guideline is a good resource.

- If you are a reader of a published article, it is important to ensure that the abstract has the same conclusion as the body of the article. 

- If you are a clinical practitioner and wondering how to apply findings of published data, the editorial section is a good source.

- If you are a trainee and wondering how to stay up-to-date, Oxford Textbook of Oncology or ASCO University are recommended.

Reference:

https://publicationethics.org/resources/guidelines-new/cope-ethical-guidelines-peer-reviewers

In this episode, Daniel G. Haller, MD, of the University of Pennsylvania joins David H. Henry, MD, to talk about the best ways to read and review scientific literature.
And Ilana Yurkiewicz, MD, talks about chaos and opportunity. Dr. Yurkiewicz is a fellow in hematology and oncology at Stanford (Calif.) University and is also a columnist for Hematology News. More from Dr. Yurkiewicz here.

Subscribe to Blood & Cancer here:

Apple Podcasts
Google Podcasts

Show notes
By Hitomi Hosoya, MD, PhD,
Resident in the department of internal medicine, University of Pennsylvania Health System

- If you are a peer reviewer of a manuscript submitted to a journal, you should be unbiased, consistent, constructive, and focused on the research. COPE guideline is a good resource.

- If you are a reader of a published article, it is important to ensure that the abstract has the same conclusion as the body of the article. 

- If you are a clinical practitioner and wondering how to apply findings of published data, the editorial section is a good source.

- If you are a trainee and wondering how to stay up-to-date, Oxford Textbook of Oncology or ASCO University are recommended.

Reference:

https://publicationethics.org/resources/guidelines-new/cope-ethical-guidelines-peer-reviewers

In this episode, Daniel G. Haller, MD, of the University of Pennsylvania joins David H. Henry, MD, to talk about the best ways to read and review scientific literature.
And Ilana Yurkiewicz, MD, talks about chaos and opportunity. Dr. Yurkiewicz is a fellow in hematology and oncology at Stanford (Calif.) University and is also a columnist for Hematology News. More from Dr. Yurkiewicz here.

Subscribe to Blood & Cancer here:

Apple Podcasts
Google Podcasts

Show notes
By Hitomi Hosoya, MD, PhD,
Resident in the department of internal medicine, University of Pennsylvania Health System

- If you are a peer reviewer of a manuscript submitted to a journal, you should be unbiased, consistent, constructive, and focused on the research. COPE guideline is a good resource.

- If you are a reader of a published article, it is important to ensure that the abstract has the same conclusion as the body of the article. 

- If you are a clinical practitioner and wondering how to apply findings of published data, the editorial section is a good source.

- If you are a trainee and wondering how to stay up-to-date, Oxford Textbook of Oncology or ASCO University are recommended.

Reference:

https://publicationethics.org/resources/guidelines-new/cope-ethical-guidelines-peer-reviewers

In this episode, David Henry, MD, welcomes Daniel G. Haller, MD, to rehash research from ESMO 2018 as well as the way the meeting itself was run.

And Ilana Yurkiewicz, MD, stops by for this week’s Clinical Correlation. Dr. Yurkiewicz is a hematology fellow at Stanford and also is a columnist at MDedge Hematology/Oncology. More from Dr. Yurkiewicz here.

Subscribe to Blood & Cancer here:

Apple Podcasts
Google Podcasts

SHOW NOTES

By Emily Bryer, DO
Resident in the department of internal medicine, University of Pennsylvania Health System

• CheckMate 142: Durable clinical benefit with nivolumab plus low-dose ipilimumab as first-line therapy in microsatellite high (MSI-H) and non-MSI-H colon cancer
  • Phase 2 study included 45 patients with metastatic colorectal cancer
  • Overall response rate (primary end point) was 60% and disease control rate was 84%
  • Almost every patient had some response and the therapy was well-tolerated
  • https://academic.oup.com/annonc/article/29/suppl_8/mdy424.019/5141601?searchresult=1

• Tribe 2: FOLFOXIRI plus bevacizumab followed by reintroduction of FOLFOXIRI plus bevacizumab versus FOLFOX plus bevacizumab followed by FOLFIRI plus bevacizumab
  • Phase 3 study of 654 patients with unresectable metastatic colorectal cancer
  • Progression free survival (primary end point) of FOLFOXIRI regimen was 18.9 months, compared with 16.2 months of the FOLFOX then FOLFIRI regimen
  • Side effects of FOLFOXIRI: febrile neutropenia, neutropenia, GI toxicities
  • https://www.thelancet.com/journals/lanonc/article/PIIS1470-2045(15)00122-9/fulltext

• Trifluridine/tipiracil versus placebo in patients with heavily pretreated metastatic gastric cancer (TAGS): a randomized, double-blind, placebo-controlled, phase 3 trial
  • Phase 3 study included 506 patients with metastatic gastric cancer
  • Trifluridine/tipiracil (oral drug) provided a 2-month overall survival advantage (primary end point), compared with placebo
  • Major side effect: neutropenia
  • https://www.ncbi.nlm.nih.gov/pubmed/30355453

• Safety and clinical activity of 1L atezolizumab plus bevacizumab in a phase 1b study in hepatocellular carcinoma (HCC)
  • Phase 1B study included 100 patients with HCC who had not received prior therapy
  • Disease control rate was high as was duration of response
  • Primary outcomes included safety and efficacy
  • The overall response rate was 34% and the most common side effect was hypertension
  • http://ascopubs.org/doi/abs/10.1200/JCO.2018.36.15_suppl.4074

In this episode, David Henry, MD, welcomes Daniel G. Haller, MD, to rehash research from ESMO 2018 as well as the way the meeting itself was run.

And Ilana Yurkiewicz, MD, stops by for this week’s Clinical Correlation. Dr. Yurkiewicz is a hematology fellow at Stanford and also is a columnist at MDedge Hematology/Oncology. More from Dr. Yurkiewicz here.

Subscribe to Blood & Cancer here:

Apple Podcasts
Google Podcasts

SHOW NOTES

By Emily Bryer, DO
Resident in the department of internal medicine, University of Pennsylvania Health System

• CheckMate 142: Durable clinical benefit with nivolumab plus low-dose ipilimumab as first-line therapy in microsatellite high (MSI-H) and non-MSI-H colon cancer
  • Phase 2 study included 45 patients with metastatic colorectal cancer
  • Overall response rate (primary end point) was 60% and disease control rate was 84%
  • Almost every patient had some response and the therapy was well-tolerated
  • https://academic.oup.com/annonc/article/29/suppl_8/mdy424.019/5141601?searchresult=1

• Tribe 2: FOLFOXIRI plus bevacizumab followed by reintroduction of FOLFOXIRI plus bevacizumab versus FOLFOX plus bevacizumab followed by FOLFIRI plus bevacizumab
  • Phase 3 study of 654 patients with unresectable metastatic colorectal cancer
  • Progression free survival (primary end point) of FOLFOXIRI regimen was 18.9 months, compared with 16.2 months of the FOLFOX then FOLFIRI regimen
  • Side effects of FOLFOXIRI: febrile neutropenia, neutropenia, GI toxicities
  • https://www.thelancet.com/journals/lanonc/article/PIIS1470-2045(15)00122-9/fulltext

• Trifluridine/tipiracil versus placebo in patients with heavily pretreated metastatic gastric cancer (TAGS): a randomized, double-blind, placebo-controlled, phase 3 trial
  • Phase 3 study included 506 patients with metastatic gastric cancer
  • Trifluridine/tipiracil (oral drug) provided a 2-month overall survival advantage (primary end point), compared with placebo
  • Major side effect: neutropenia
  • https://www.ncbi.nlm.nih.gov/pubmed/30355453

• Safety and clinical activity of 1L atezolizumab plus bevacizumab in a phase 1b study in hepatocellular carcinoma (HCC)
  • Phase 1B study included 100 patients with HCC who had not received prior therapy
  • Disease control rate was high as was duration of response
  • Primary outcomes included safety and efficacy
  • The overall response rate was 34% and the most common side effect was hypertension
  • http://ascopubs.org/doi/abs/10.1200/JCO.2018.36.15_suppl.4074

In this episode, David Henry, MD, welcomes Daniel G. Haller, MD, to rehash research from ESMO 2018 as well as the way the meeting itself was run.

And Ilana Yurkiewicz, MD, stops by for this week’s Clinical Correlation. Dr. Yurkiewicz is a hematology fellow at Stanford and also is a columnist at MDedge Hematology/Oncology. More from Dr. Yurkiewicz here.

Subscribe to Blood & Cancer here:

Apple Podcasts
Google Podcasts

SHOW NOTES

By Emily Bryer, DO
Resident in the department of internal medicine, University of Pennsylvania Health System

• CheckMate 142: Durable clinical benefit with nivolumab plus low-dose ipilimumab as first-line therapy in microsatellite high (MSI-H) and non-MSI-H colon cancer
  • Phase 2 study included 45 patients with metastatic colorectal cancer
  • Overall response rate (primary end point) was 60% and disease control rate was 84%
  • Almost every patient had some response and the therapy was well-tolerated
  • https://academic.oup.com/annonc/article/29/suppl_8/mdy424.019/5141601?searchresult=1

• Tribe 2: FOLFOXIRI plus bevacizumab followed by reintroduction of FOLFOXIRI plus bevacizumab versus FOLFOX plus bevacizumab followed by FOLFIRI plus bevacizumab
  • Phase 3 study of 654 patients with unresectable metastatic colorectal cancer
  • Progression free survival (primary end point) of FOLFOXIRI regimen was 18.9 months, compared with 16.2 months of the FOLFOX then FOLFIRI regimen
  • Side effects of FOLFOXIRI: febrile neutropenia, neutropenia, GI toxicities
  • https://www.thelancet.com/journals/lanonc/article/PIIS1470-2045(15)00122-9/fulltext

• Trifluridine/tipiracil versus placebo in patients with heavily pretreated metastatic gastric cancer (TAGS): a randomized, double-blind, placebo-controlled, phase 3 trial
  • Phase 3 study included 506 patients with metastatic gastric cancer
  • Trifluridine/tipiracil (oral drug) provided a 2-month overall survival advantage (primary end point), compared with placebo
  • Major side effect: neutropenia
  • https://www.ncbi.nlm.nih.gov/pubmed/30355453

• Safety and clinical activity of 1L atezolizumab plus bevacizumab in a phase 1b study in hepatocellular carcinoma (HCC)
  • Phase 1B study included 100 patients with HCC who had not received prior therapy
  • Disease control rate was high as was duration of response
  • Primary outcomes included safety and efficacy
  • The overall response rate was 34% and the most common side effect was hypertension
  • http://ascopubs.org/doi/abs/10.1200/JCO.2018.36.15_suppl.4074

In this episode, Gary H. Lyman, MD (https://bitly.is/2UJzUly) joins David Henry, MD, (http://bit.ly/2MFDfzm) to talk about biosimilars. 

Dr. Lyman talks about the definition of biosimilars, how they are made, which are approved, and which ones are on the market. 

He also talks about extrapolation and interchangeability as well as where some biosimilars stand in both ASCO and NCCN guidelines for patients who are going into supportive care. 

And Ilana Yurkiewicz, MD (https://stanford.io/2RXPixR), talks about what the word "cure" means to you compared to what it means to patients in a world with OS, PFS, DFS, CR, etc. (26:35). 

Subscribe here:

Apple Podcasts
Google Podcasts

Show Notes

By Hitomi Hosoya, MD, PhD

- Biosimilars are biologic products that are highly similar to the reference products with no clinically meaningful difference in terms of safety, efficacy, purity, and potency.

- Unlike “generic” products, biosimilars are produced in living systems, therefore they cannot be replicated identically. 

- The Food and Drug Administration encourages companies to produce biosimilars as a patent expires on the original product.

- For approval, the FDA requires largely preclinical data; amino acid sequence and molecular structures, pharmacodynamics and pharmacokinetic data in animal models and humans. Also, no greater immunogenicity should be demonstrated.

- Large randomized trials are not usually required for approval of biosimilars as there is already data on the original product. Post-marketing surveillance is important.

- 14 biosimilars have already been approved by the FDA.

- Interchangeable designation of biosimilars is yet to come.

- At this early stage of biosimilar marketing, we see a 10%-11% cost reduction. This is expected to increase as the market expands.

References:

 JAMA Oncol.2018 Feb 1;4(2):241-247

 JCSO 2018;16(6):e283-e289.

Contact us: [email protected]

MDedge Hematology/Oncology Twitter: @MDedgeHemOnc

Ilana Yurkiewicz Twitter: @ilanayurkiewicz

In this episode, Gary H. Lyman, MD (https://bitly.is/2UJzUly) joins David Henry, MD, (http://bit.ly/2MFDfzm) to talk about biosimilars. 

Dr. Lyman talks about the definition of biosimilars, how they are made, which are approved, and which ones are on the market. 

He also talks about extrapolation and interchangeability as well as where some biosimilars stand in both ASCO and NCCN guidelines for patients who are going into supportive care. 

And Ilana Yurkiewicz, MD (https://stanford.io/2RXPixR), talks about what the word "cure" means to you compared to what it means to patients in a world with OS, PFS, DFS, CR, etc. (26:35). 

Subscribe here:

Apple Podcasts
Google Podcasts

Show Notes

By Hitomi Hosoya, MD, PhD

- Biosimilars are biologic products that are highly similar to the reference products with no clinically meaningful difference in terms of safety, efficacy, purity, and potency.

- Unlike “generic” products, biosimilars are produced in living systems, therefore they cannot be replicated identically. 

- The Food and Drug Administration encourages companies to produce biosimilars as a patent expires on the original product.

- For approval, the FDA requires largely preclinical data; amino acid sequence and molecular structures, pharmacodynamics and pharmacokinetic data in animal models and humans. Also, no greater immunogenicity should be demonstrated.

- Large randomized trials are not usually required for approval of biosimilars as there is already data on the original product. Post-marketing surveillance is important.

- 14 biosimilars have already been approved by the FDA.

- Interchangeable designation of biosimilars is yet to come.

- At this early stage of biosimilar marketing, we see a 10%-11% cost reduction. This is expected to increase as the market expands.

References:

 JAMA Oncol.2018 Feb 1;4(2):241-247

 JCSO 2018;16(6):e283-e289.

Contact us: [email protected]

MDedge Hematology/Oncology Twitter: @MDedgeHemOnc

Ilana Yurkiewicz Twitter: @ilanayurkiewicz

In this episode, Gary H. Lyman, MD (https://bitly.is/2UJzUly) joins David Henry, MD, (http://bit.ly/2MFDfzm) to talk about biosimilars. 

Dr. Lyman talks about the definition of biosimilars, how they are made, which are approved, and which ones are on the market. 

He also talks about extrapolation and interchangeability as well as where some biosimilars stand in both ASCO and NCCN guidelines for patients who are going into supportive care. 

And Ilana Yurkiewicz, MD (https://stanford.io/2RXPixR), talks about what the word "cure" means to you compared to what it means to patients in a world with OS, PFS, DFS, CR, etc. (26:35). 

Subscribe here:

Apple Podcasts
Google Podcasts

Show Notes

By Hitomi Hosoya, MD, PhD

- Biosimilars are biologic products that are highly similar to the reference products with no clinically meaningful difference in terms of safety, efficacy, purity, and potency.

- Unlike “generic” products, biosimilars are produced in living systems, therefore they cannot be replicated identically. 

- The Food and Drug Administration encourages companies to produce biosimilars as a patent expires on the original product.

- For approval, the FDA requires largely preclinical data; amino acid sequence and molecular structures, pharmacodynamics and pharmacokinetic data in animal models and humans. Also, no greater immunogenicity should be demonstrated.

- Large randomized trials are not usually required for approval of biosimilars as there is already data on the original product. Post-marketing surveillance is important.

- 14 biosimilars have already been approved by the FDA.

- Interchangeable designation of biosimilars is yet to come.

- At this early stage of biosimilar marketing, we see a 10%-11% cost reduction. This is expected to increase as the market expands.

References:

 JAMA Oncol.2018 Feb 1;4(2):241-247

 JCSO 2018;16(6):e283-e289.

Contact us: [email protected]

MDedge Hematology/Oncology Twitter: @MDedgeHemOnc

Ilana Yurkiewicz Twitter: @ilanayurkiewicz

In the first episode of Blood & Cancer, David Henry, MD (http://bit.ly/2MFDfzm), welcomes Richard J. Gralla, MD (http://bit.ly/2ShsxEv), or the Albert Einstein College of Medicine in New York. The topic today centers around antiemetics and ways to use them. And later, Ilana Yurkiewicz, MD (https://stanford.io/2RXPixR), debuts her segment Clinical Correlations all about hematology care.
Subscribe here:

Apple Podcasts

Show Notes

By Emily Bryer, DO

• Highly emetic chemotherapy regimens include cisplatin, dacarbazine, anthracycline, and cyclophosphamide combinations
  • Treatment should include an NK1 receptor antagonist, dexamethasone, and a 5HT3 antagonist
  • All 5HT3 antagonists should be given only once (no evidence that prn or delayed administration is helpful)
  • Olanzapine is an effective antiemetic, although its precise role and dose are undergoing investigation
  • An all-oral regimen for highly emetic could include Netupitant (NK1) and palonosetron (long-acting 5HT3) (NEPA) + Oral Dex + Olanzapine
• Moderately emetic chemotherapy regimens include irinotecan and taxotere
  • Treatment should include 5HT3 antagonist and dexamethasone
• Carboplatin causes more emesis than initially thought
  • Improvement with NK1 antagonist yields a 15% decreased risk of emesis
  • Guidelines now recommending NK1 with carboplatin
• Low emetic chemotherapy regimens include gemcitabine, pemetrexed as single agent
  • Single drug: one dose of corticosteroid or one dose of 5HT3 antagonist
• Minimal emetic chemotherapy regimens include vincristine or bleomycin
  • No drugs are recommended for acute or delayed nausea/emesis
• 20 mg Dexamethasone IV (or 12 mg PO 12 mg) should be administered only on day 1 of chemotherapy. Dexamethasone can be spared after that unless cisplatin (would require 2 days of steroids)
• Marijuana and THC have some antiemetic properties, but are about one quarter as effective as 5HT3 antagonists
• Lorazepam may be used in anticipatory emesis started a few days prior to chemotherapy

References: 

Ann Oncol. 2014 Jul;25(7):1333-9.

JCSO 2015;13(4):128-30.

JCSO 2016;4(1):11-20.

Contact us: [email protected]

MDedge on Twitter: @mdedgehemonc

Dr. Ilana Yurkiewicz on Twitter: @ilanayurkiewicz

Dr. Yurkiewicz on MDedge: http://bit.ly/2DItTAb

In the first episode of Blood & Cancer, David Henry, MD (http://bit.ly/2MFDfzm), welcomes Richard J. Gralla, MD (http://bit.ly/2ShsxEv), or the Albert Einstein College of Medicine in New York. The topic today centers around antiemetics and ways to use them. And later, Ilana Yurkiewicz, MD (https://stanford.io/2RXPixR), debuts her segment Clinical Correlations all about hematology care.
Subscribe here:

Apple Podcasts

Show Notes

By Emily Bryer, DO

• Highly emetic chemotherapy regimens include cisplatin, dacarbazine, anthracycline, and cyclophosphamide combinations
  • Treatment should include an NK1 receptor antagonist, dexamethasone, and a 5HT3 antagonist
  • All 5HT3 antagonists should be given only once (no evidence that prn or delayed administration is helpful)
  • Olanzapine is an effective antiemetic, although its precise role and dose are undergoing investigation
  • An all-oral regimen for highly emetic could include Netupitant (NK1) and palonosetron (long-acting 5HT3) (NEPA) + Oral Dex + Olanzapine
• Moderately emetic chemotherapy regimens include irinotecan and taxotere
  • Treatment should include 5HT3 antagonist and dexamethasone
• Carboplatin causes more emesis than initially thought
  • Improvement with NK1 antagonist yields a 15% decreased risk of emesis
  • Guidelines now recommending NK1 with carboplatin
• Low emetic chemotherapy regimens include gemcitabine, pemetrexed as single agent
  • Single drug: one dose of corticosteroid or one dose of 5HT3 antagonist
• Minimal emetic chemotherapy regimens include vincristine or bleomycin
  • No drugs are recommended for acute or delayed nausea/emesis
• 20 mg Dexamethasone IV (or 12 mg PO 12 mg) should be administered only on day 1 of chemotherapy. Dexamethasone can be spared after that unless cisplatin (would require 2 days of steroids)
• Marijuana and THC have some antiemetic properties, but are about one quarter as effective as 5HT3 antagonists
• Lorazepam may be used in anticipatory emesis started a few days prior to chemotherapy

References: 

Ann Oncol. 2014 Jul;25(7):1333-9.

JCSO 2015;13(4):128-30.

JCSO 2016;4(1):11-20.

Contact us: [email protected]

MDedge on Twitter: @mdedgehemonc

Dr. Ilana Yurkiewicz on Twitter: @ilanayurkiewicz

Dr. Yurkiewicz on MDedge: http://bit.ly/2DItTAb

In the first episode of Blood & Cancer, David Henry, MD (http://bit.ly/2MFDfzm), welcomes Richard J. Gralla, MD (http://bit.ly/2ShsxEv), or the Albert Einstein College of Medicine in New York. The topic today centers around antiemetics and ways to use them. And later, Ilana Yurkiewicz, MD (https://stanford.io/2RXPixR), debuts her segment Clinical Correlations all about hematology care.
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Show Notes

By Emily Bryer, DO

• Highly emetic chemotherapy regimens include cisplatin, dacarbazine, anthracycline, and cyclophosphamide combinations
  • Treatment should include an NK1 receptor antagonist, dexamethasone, and a 5HT3 antagonist
  • All 5HT3 antagonists should be given only once (no evidence that prn or delayed administration is helpful)
  • Olanzapine is an effective antiemetic, although its precise role and dose are undergoing investigation
  • An all-oral regimen for highly emetic could include Netupitant (NK1) and palonosetron (long-acting 5HT3) (NEPA) + Oral Dex + Olanzapine
• Moderately emetic chemotherapy regimens include irinotecan and taxotere
  • Treatment should include 5HT3 antagonist and dexamethasone
• Carboplatin causes more emesis than initially thought
  • Improvement with NK1 antagonist yields a 15% decreased risk of emesis
  • Guidelines now recommending NK1 with carboplatin
• Low emetic chemotherapy regimens include gemcitabine, pemetrexed as single agent
  • Single drug: one dose of corticosteroid or one dose of 5HT3 antagonist
• Minimal emetic chemotherapy regimens include vincristine or bleomycin
  • No drugs are recommended for acute or delayed nausea/emesis
• 20 mg Dexamethasone IV (or 12 mg PO 12 mg) should be administered only on day 1 of chemotherapy. Dexamethasone can be spared after that unless cisplatin (would require 2 days of steroids)
• Marijuana and THC have some antiemetic properties, but are about one quarter as effective as 5HT3 antagonists
• Lorazepam may be used in anticipatory emesis started a few days prior to chemotherapy

References: 

Ann Oncol. 2014 Jul;25(7):1333-9.

JCSO 2015;13(4):128-30.

JCSO 2016;4(1):11-20.

Contact us: [email protected]

MDedge on Twitter: @mdedgehemonc

Dr. Ilana Yurkiewicz on Twitter: @ilanayurkiewicz

Dr. Yurkiewicz on MDedge: http://bit.ly/2DItTAb