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So we had a visiting prof awhile back that said the H10 study had been closed by the oversight committee due to high LF in the chemo alone arm. Can anyone confirm this? Thanks.
H10 - closed?
- Thread starter napoleondynamite
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http://www.ascopost.com/issues/june-15-2012/radiotherapy-in-early-stage-hodgkin-lymphoma.aspx
The HD16-trial is still open in Europe and is basically looking into the same question.
Let's wait and see what happens there.
We've had 2 patients registered so far, both came up positive in the PET after 2xABVD and had to be treated with radiation therapy.
The HD16-trial is still open in Europe and is basically looking into the same question.
Let's wait and see what happens there.
We've had 2 patients registered so far, both came up positive in the PET after 2xABVD and had to be treated with radiation therapy.
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Thanks Palex. Seems to me this should be good fodder against use of interim PET..even the earliest favorables with a CR need RT. I know everyone knows this on this board, but that does not stop med oncs from making the argument!
D
deleted4401
What do you mean? Are people giving 2 cycles, PET and if CR, they are done? Or 2 more after PET for a total of 4 cycles? Chemo alone for 4 cycles is an acceptable standard for Favorable I-II HD, if they had a good response on CT, right? Lymphoma is an enigma for me ...
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In other (lymphoma) news:
http://www.redjournal.org/article/S0360-3016(11)03210-X/abstract
Since the Retuximab introduction a lot of patients in Stage I/II DLBCL lymphoma have been treated with only 6x R-CHOP & 2-R without radiation therapy, which seems to be a viable option for Stage I/II-disease without extranodal manifestations. This led to some medical oncologists opting to ommit radiation therapy for primary mediastinal b-cell lymphoma as well.
We already knew from prospective data, that primary mediastinal lymphoma does tend to relapse mainly locally and that's why radiation therapy is important. However we didn't have a randomized trial until now showing, that we should not ommit radiation therapy in this setting.
This study was a great achievement in my opinion, especially since its coming from a developing country like Mexico.
http://www.redjournal.org/article/S0360-3016(11)03210-X/abstract
Since the Retuximab introduction a lot of patients in Stage I/II DLBCL lymphoma have been treated with only 6x R-CHOP & 2-R without radiation therapy, which seems to be a viable option for Stage I/II-disease without extranodal manifestations. This led to some medical oncologists opting to ommit radiation therapy for primary mediastinal b-cell lymphoma as well.
We already knew from prospective data, that primary mediastinal lymphoma does tend to relapse mainly locally and that's why radiation therapy is important. However we didn't have a randomized trial until now showing, that we should not ommit radiation therapy in this setting.
This study was a great achievement in my opinion, especially since its coming from a developing country like Mexico.
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It is because the med oncs have some how gotten it into the literature. All of the data out there from my (possibly warped and misguided) understanding suggests that RFS/LC is poorer in trials where RT was omitted. I.E. There are no trials that have definitively suggested that chemo alone for 4 cycles is the best possible treatment for early-stage favorable HD.
I think that's the reason why NCCN leaves chemo alone as a "2B" recommendation" and 2-4 cycles + IFRT even after a CR as the Category 1 recommendation. It basically boils down to whether we are getting those referrals or not.
And yes, lymphoma is one of those things that mystifies me as well.
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Let me try to shed some light into this...
http://www.ncbi.nlm.nih.gov/pubmed/15837968
updated:
http://www.ncbi.nlm.nih.gov/pubmed/22149921
This trial compared subtotal nodal irradiation to ABVD alone. Nobody does subtotal nodal irradiation any longer, thus any conclusions drawn from this trial cannot be used for daily practice today. This trial is still often quoted by medical oncologists to show that ABVD is a good idea, yet its poor design with an outdated radiotherapy protocol means you can only draw conclusions looking at the ABVD-only arm. Which basically means, that you should look at it as a single-arm Phase II trial.
http://www.asco.org/ascov2/Meetings/Abstracts?&vmview=abst_detail_view&confID=34&abstractID=30245
This trial was never published as a full paper, I don't know why. It shows, that you can't ommit radiation therapy after CR in CT, if you gave 6x EBVP. The question is: Is 6x EBVP as effective as 4x ABVD in Stage I/II-disease. Nobody knows... Limitation: No PET, just CT-defined CR. However in my opinion a CR in CT is "more worth" than a CR in PET, which for example means that a CT-defined PR can in many cases be a PET-defined CR, especially in bulky patients.
http://www.ncbi.nlm.nih.gov/pubmed/17786707
This trial included only bulky patients and treated them either only with chemo or with chemo and RT, if they had a negative PET. RT improved PFS. Limitation: only bulky patients included.
http://www.ncbi.nlm.nih.gov/pubmed/14657226
Indian trial, showing RT is good after ABVD. Major limitation: Indian trial without very clear study design and questionable quality.
http://www.ncbi.nlm.nih.gov/pubmed/15315964
This is a US randomized trial randomizing to RT or no RT after 6x ABVD for Stage I-III hodgkin's lymphoma. No statistical difference in PFS, OS between both arms.
Two points to be made here:
1. Why put all different stages together? This is a bad idea. Patients with Stage III hodgkin's lymphoma don't need RT, if they don't have bulky disease or PET-positive residual tumor after chemo. They should have performed the trial in a smaller, better defined population, for example only favorable disease HL. The patterns of recurrence change with stage.
2. Why give 6x ABCD for Stage IA disease? Is that the way to go? 2x ABVD is not very toxic, but 6x ABVD is a totally different situation. 2x ABVD and 20 Gy IF-RT (like in HD10: https://ash.confex.com/ash/2009/webprogram/Paper21388.html ) could very well be less toxic than 6x ABVD alone for early, favorable disease.
Thus the evidence for omission of RT and superiority or at least non-inferiority of a chemo-only approach is quite thin and frankly I find it toubling, that NCCN accepts chemo-only as a viable alternative to RT. We don't actually have the randomized trial to prove this and NCCN recommendations are supposed to be based on Level 2 evidence.
All the randomized trials have been conducted either with outdated radiation therapy techniques or more chemotherapy than the 4x ABVD, which are recommended by NCCN.
In my opinion the only early hodgkin disease, where one could opt for a chemo-only approach is probably nodular paragranuloma AKA lymphocyte-predominant HL. However these subtype is rare and has sometimes been excluded from the randomized trials, so all the evidence comes from retrospective series. There are even reports of paragranulomas never recurring again after surgery.
http://www.ncbi.nlm.nih.gov/pubmed/15837968
updated:
http://www.ncbi.nlm.nih.gov/pubmed/22149921
This trial compared subtotal nodal irradiation to ABVD alone. Nobody does subtotal nodal irradiation any longer, thus any conclusions drawn from this trial cannot be used for daily practice today. This trial is still often quoted by medical oncologists to show that ABVD is a good idea, yet its poor design with an outdated radiotherapy protocol means you can only draw conclusions looking at the ABVD-only arm. Which basically means, that you should look at it as a single-arm Phase II trial.
http://www.asco.org/ascov2/Meetings/Abstracts?&vmview=abst_detail_view&confID=34&abstractID=30245
This trial was never published as a full paper, I don't know why. It shows, that you can't ommit radiation therapy after CR in CT, if you gave 6x EBVP. The question is: Is 6x EBVP as effective as 4x ABVD in Stage I/II-disease. Nobody knows... Limitation: No PET, just CT-defined CR. However in my opinion a CR in CT is "more worth" than a CR in PET, which for example means that a CT-defined PR can in many cases be a PET-defined CR, especially in bulky patients.
http://www.ncbi.nlm.nih.gov/pubmed/17786707
This trial included only bulky patients and treated them either only with chemo or with chemo and RT, if they had a negative PET. RT improved PFS. Limitation: only bulky patients included.
http://www.ncbi.nlm.nih.gov/pubmed/14657226
Indian trial, showing RT is good after ABVD. Major limitation: Indian trial without very clear study design and questionable quality.
http://www.ncbi.nlm.nih.gov/pubmed/15315964
This is a US randomized trial randomizing to RT or no RT after 6x ABVD for Stage I-III hodgkin's lymphoma. No statistical difference in PFS, OS between both arms.
Two points to be made here:
1. Why put all different stages together? This is a bad idea. Patients with Stage III hodgkin's lymphoma don't need RT, if they don't have bulky disease or PET-positive residual tumor after chemo. They should have performed the trial in a smaller, better defined population, for example only favorable disease HL. The patterns of recurrence change with stage.
2. Why give 6x ABCD for Stage IA disease? Is that the way to go? 2x ABVD is not very toxic, but 6x ABVD is a totally different situation. 2x ABVD and 20 Gy IF-RT (like in HD10: https://ash.confex.com/ash/2009/webprogram/Paper21388.html ) could very well be less toxic than 6x ABVD alone for early, favorable disease.
Thus the evidence for omission of RT and superiority or at least non-inferiority of a chemo-only approach is quite thin and frankly I find it toubling, that NCCN accepts chemo-only as a viable alternative to RT. We don't actually have the randomized trial to prove this and NCCN recommendations are supposed to be based on Level 2 evidence.
All the randomized trials have been conducted either with outdated radiation therapy techniques or more chemotherapy than the 4x ABVD, which are recommended by NCCN.
In my opinion the only early hodgkin disease, where one could opt for a chemo-only approach is probably nodular paragranuloma AKA lymphocyte-predominant HL. However these subtype is rare and has sometimes been excluded from the randomized trials, so all the evidence comes from retrospective series. There are even reports of paragranulomas never recurring again after surgery.
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