ESMO 2021

[Palex80]

Interesting talks in the upcoming ESMO 2021 Congress - 17.09-21.09.21

1170O - An international randomized trial, comparing post-operative conformal radiotherapy (PORT) to no PORT, in patients with completely resected non-small cell lung cancer (NSCLC) and mediastinal N2 involvement: Characterisation of PORT efficacy in lung ART (IFCT-0503, UK NCRI, SAKK)
Cécile Le Pechoux (Villejuif, CEDEX, France)

1171MO - PACIFIC-R real-world study: Treatment duration and interim analysis of progression-free survival in unresectable stage III NSCLC patients treated with durvalumab after chemoradiotherapy
Nicolas Girard (Paris, France)

LBA4_PR - Abiraterone acetate plus prednisolone (AAP) with or without enzalutamide (ENZ) added to androgen deprivation therapy (ADT) compared to ADT alone for men with high-risk non-metastatic (M0) prostate cancer (PCa): Combined analysis from two comparisons in the STAMPEDE platform protocol
Gerhardt Attard (London, United Kingdom)

LBA35 - Avelumab-cetuximab-radiotherapy versus standards of care in patients with locally advanced squamous cell carcinoma of head and neck (LA-SCCHN): Randomized phase III GORTEC-REACH trial
Jean Bourhis (Lausanne, Switzerland)

121MO - Acute toxicity associated with a 3-week versus a standard 5-week regimen for locoregional breast radiotherapy delivered in the UNICANCER HypoG-01 phase III trial
Presentation Number
Sofia Rivera (Villejuif, France)



There are also a few other abstracts on the 18th and 19th which will be announced at short notice.

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[Radonky]

Interesting talks in the upcoming ESMO 2021 Congress - 17.09-21.09.21

1170O - An international randomized trial, comparing post-operative conformal radiotherapy (PORT) to no PORT, in patients with completely resected non-small cell lung cancer (NSCLC) and mediastinal N2 involvement: Characterisation of PORT efficacy in lung ART (IFCT-0503, UK NCRI, SAKK)
Cécile Le Pechoux (Villejuif, CEDEX, France)

1171MO - PACIFIC-R real-world study: Treatment duration and interim analysis of progression-free survival in unresectable stage III NSCLC patients treated with durvalumab after chemoradiotherapy
Nicolas Girard (Paris, France)

LBA4_PR - Abiraterone acetate plus prednisolone (AAP) with or without enzalutamide (ENZ) added to androgen deprivation therapy (ADT) compared to ADT alone for men with high-risk non-metastatic (M0) prostate cancer (PCa): Combined analysis from two comparisons in the STAMPEDE platform protocol
Gerhardt Attard (London, United Kingdom)

LBA35 - Avelumab-cetuximab-radiotherapy versus standards of care in patients with locally advanced squamous cell carcinoma of head and neck (LA-SCCHN): Randomized phase III GORTEC-REACH trial
Jean Bourhis (Lausanne, Switzerland)

121MO - Acute toxicity associated with a 3-week versus a standard 5-week regimen for locoregional breast radiotherapy delivered in the UNICANCER HypoG-01 phase III trial
Presentation Number
Sofia Rivera (Villejuif, France)

What is the purpose of PACIFIC-R? It seems like it is sponsored by AstraZeneca...maybe I am jaded, but after a positive trial what is their rationale for doing this?

 

[Palex80]

What is the purpose of PACIFIC-R? It seems like it is sponsored by AstraZeneca...maybe I am jaded, but after a positive trial what is their rationale for doing this?

I presume that they want to see if the PACIFIC-results can be reproduced in clinical practice.
What I'd like to see would be subcohorts based on PD-L1 status.

 

[seper]

Avelumab failed in a large US trial

 

[Lamount]

I presume that they want to see if the PACIFIC-results can be reproduced in clinical practice.
What I'd like to see would be subcohorts based on PD-L1 status.

and EGFR/ALK/ROS etc...

 

[Palex80]

Interesting data out today…

Pembro + CarboTaxol/Bev showing OS benefit versus CarboTaxol/Bev in persistent, recurrent & metastatic cervical cancer. The interesting part is, that as subgroup analysis points out, it seems to work only in patients who have had local treatment before (and pretty much everyone had RT/RCT) and not in primary metastatic disease.
This could be a bit like Pacific, where immunotherapy delivered on persistent (in this case also recurrent/metastatic) tumors following RCT works! Eager to see this being incorporated as maintenance post primary RCT.

Tomorrow we expect some good data on GU cancer!

 

[TheWallnerus]

ESMO Congress 2021 | OncologyPRO

OncologyPRO is the home of ESMO’s educational & scientific resources, with exclusive content for ESMO members such as ESMO’s Congresses webcasts,

oncologypro.esmo.org

 

[Palex80]

Ok, nice data today!

Addition of abiraterone with OS benefit in non-metastatic high-risk prostate cancer. Get set to start prescribing more than ADT soon...

 

[evilbooyaa]

Ok, nice data today!

Addition of abiraterone with OS benefit in non-metastatic high-risk prostate cancer. Get set to start prescribing more than ADT soon...

Link to abstract/presentation?

ESMO Congress 2021 | OncologyPRO

OncologyPRO is the home of ESMO’s educational & scientific resources, with exclusive content for ESMO members such as ESMO’s Congresses webcasts,

oncologypro.esmo.org

Interesting strategy to let chemotherapy handle the microscopic disease while doing RT to gross disease alone. I actually like this strategy more than either single agent strategy on it's own.

 

[Palex80]

Link to abstract/presentation?

New Combination of Old Drugs Improves Survival in Patients with Prostate Cancer [ESMO Congress 2021 Press Release]

A novel combination of well-known drugs prolongs survival in patients with hormone/castration-sensitive prostate cancer, according to late breaking...

www.esmo.org

 

[RickyScott]

Ok, nice data today!

Addition of abiraterone with OS benefit in non-metastatic high-risk prostate cancer. Get set to start prescribing more than ADT soon...

I know plenty of urologists who prescribe Zytiga but not a single radonc.

 

[Chartreuse Wombat]

Link to abstract/presentation?



Interesting strategy to let chemotherapy handle the microscopic disease while doing RT to gross disease alone. I actually like this strategy more than either single agent strategy on it's own.

 

[DoctwoB]

Ok, nice data today!

Addition of abiraterone with OS benefit in non-metastatic high-risk prostate cancer. Get set to start prescribing more than ADT soon...

Was having some trouble deciphering the abstract. Is this high risk non metastatic patients that are about to undergo definitive xrt plus adt and they are adding abi? Are they Including patients who didn’t get local therapy? Are surgery patients involved? Did anybody also get brachy?

most urology practices I know offload the Novel hormonal agents to heme onc btw. No money in it beyond routine clinic follow ups which we already have plenty of and a lot of time spent fighting with insurance for approval. Easy to manage though.

 

[DoctwoB]

Link to abstract/presentation?



Interesting strategy to let chemotherapy handle the microscopic disease while doing RT to gross disease alone. I actually like this strategy more than either single agent strategy on it's own.

Interesting. Definitely seems like it would have a better toxicity profile then standard chemo for 2a/b disease. Surgical RPLND also throwing its hat in the ring with the ESMO trial.

https://www.mdedge.com/hematology-oncology/article/235944/genitourinary-cancer/rplnd-deemed-attractive-option-early

 

[DoctwoB]

Ah, thanks for this. Answered most of my questions. Definitely looks like a new SOC, like ADT plus taxotere plus abi for high volume de novo metastatic disease.

one interesting point though, is Mets free survival still a valid surrogate in this setting? Since now patients have been exposed to abi. Presumably professing to Mets despite abi is worse then progressing to mets without seeing abi. Meaning time from Mets to death will likely be different between arms.

 

[communitydoc13]

Ok, nice data today!

Addition of abiraterone with OS benefit in non-metastatic high-risk prostate cancer. Get set to start prescribing more than ADT soon...

I thought this was well known for those who met the inclusion criteria for non-metastatic pts in this Stampede trial (at least 2/3: cT3, PSA 40+, Gleason 8+ (maybe I've got this wrong)). I've routinely pushed for this approach for younger men with very high risk prostate cancer or men with Gleason 9 or 10 (even though not an inclusion criteria).

Is this data anything else other than an update of that trial?

 

[Palex80]

Was having some trouble deciphering the abstract.

It is a terribly written abstract, yes.

Is this high risk non metastatic patients that are about to undergo definitive xrt plus adt and they are adding abi?

Yes.

Are they Including patients who didn’t get local therapy?

Actually no, since almost everyone got RT in Stampede

Are surgery patients involved? Did anybody also get brachy?

No and no.

 

[Palex80]

I am going to try to clear the clouds a bit.

Two trials were presented at ESMO.

A Stampede comparison of the addition of Abiraterone to ADT for M0 (N0+N1) PC patients. M0 patients in Stampede pretty much all got radiotherapy to the prostate (+/- lymphatics too), but that part of the radiotherapy was not part of the trial, so do not expect to get lots of details (Do not mix it up with the 55/2.75 or 36/6 to the prostate for M1 patients in Stampede, that's another arm!).
So patients were randomized to 2 years of Abiraterone or not, while getting RT+ADT for high risk M0 disease in Stampede (defined as at least 2 out of 3 criteria met: a) T3 on MRI, b) PSA >40, c) GS>7 or simply N1) and the addition of Abiraterone apparently resulted into a MFS and OS benefit.

Some results of the PEACE-1 trial which randomized patients in a 2x2 design to ADT +/- Abiraterone +/- RT to the prostate for M1 PC.
During the trial was running, upfront Docetaxel became s.o.c., so the protocol was adapted and patients started getting Docetaxel too. This allowed the comparison of ADT + Docetaxel +/- Abiraterone (+/- RT to the prostate) for M1 PC.
Now, we didn't get to see results of the RT-comparison, but it seems that patients with high-volume metastatic disease benefitted from upfront Abiraterone added to Docetaxel.

Practice changing for us are the results of Stampede. We will need to see who should be getting Aboraterone on top of RT+ADT.
Abiraterone is going to be generic in 2022 in Europe, not sure about US, so it is not going to be that expensive hopefully.

 

[medgator]

I am going to try to clear the clouds a bit.

Two trials were presented at ESMO.

A Stampede comparison of the addition of Abiraterone to ADT for M0 (N0+N1) PC patients M0 patients in Stampede pretty much all got radiotherapy to the prostate (+/- lymphatics too), but that part of the radiotherapy was not part of the trial, so do not expect to get lots of details (Do not mix it up with the 55/2.75 or 36/6 to the prostate for M1 patients in Stampede, that's another arm!).
So patients were randomized to 2 years of Abiraterone or not, while getting RT+ADT for high risk M0 disease in Stampede (defined as at least 2 out of 3 criteria met: a) T3 on MRI, b) PSA >40, c) GS>7 or simply N1) and the addition of Abiraterone apparently resulted into a MFS and OS benefit.

Some results of the PEACE-1 trial which randomized patients in a 2x2 design to ADT +/- Abiraterone +/- RT to the prostate for M1 PC.
During the trial was running, upfront Docetaxel became s.o.c., so the protocol was adapted and patients started getting Docetaxel too. This allowed the comparison of ADT + Docetaxel +/- Abiraterone (+/- RT to the prostate) for M1 PC.
Now, we didn't get to see results of the RT-comparison, but it seems that patients with high-volume metastatic disease benefitted from upfront Abiraterone added to Docetaxel.

Practice changing for us are the results of Stampede. We will need to see who should be getting Aboraterone on top of RT+ADT.
Abiraterone is going to be generic in 2022 in Europe, not sure about US, so it is not going to be that expensive hopefully.

Zytiga went generic stateside already iirc

 

[Chartreuse Wombat]

I thought this was well known for those who met the inclusion criteria for non-metastatic pts in this Stampede trial (at least 2/3: cT3, PSA 40+, Gleason 8+ (maybe I've got this wrong)). I've routinely pushed for this approach for younger men with very high risk prostate cancer or men with Gleason 9 or 10 (even though not an inclusion criteria).

Is this data anything else other than an update of that trial?

Previously i think only a DFS endpoint. Now DM and OS (I think)

 

[communitydoc13]

Practice changing for us are the results of Stampede. We will need to see who should be getting Aboraterone on top of RT+ADT.
Abiraterone is going to be generic in 2022 in Europe, not sure about US, so it is not going to be that expensive hopefully.

This trial to me is me the basis for rational therapeutic escalation in very high risk localized patients. The inclusion criteria are pretty stringent (just not that many T3 or PSA>40 pts out there now in the US) but there are a fair number of Gleason 9-10 pts who we know have worse outcomes. I do try to advocate for therapeutic escalation per this trial for healthy pts that don't quite meet the inclusion criteria.

It does drive me crazy that we have trials like NRG-GU009, which now incorporate multiple next generation agents (apalutamide+abiraterone) plus genomic testing, when I would really like to know if abiraterone alone provides a benefit for a more general group of pts. Example of clinical trials not building on each other.

 

[Palex80]

It does drive me crazy that we have trials like NRG-GU009, which now incorporate multiple next generation agents (apalutamide+abiraterone) plus genomic testing, when I would really like to know if abiraterone alone provides a benefit for a more general group of pts. Example of clinical trials not building on each other.

I have doubts if the NRG is going to come out positive. Stampede tested in M1 patients the addition of Enzalutamid (Apalutamide is pretty much Enzalutamide) to ADT + Abiraterone and that trial arm came back negative. If it doesn't work in M1, it's unlikely it will work in M0.

 

[communitydoc13]

I have doubts if the NRG is going to come out positive. Stampede tested in M1 patients the addition of Enzalutamid (Apalutamide is pretty much Enzalutamide) to ADT + Abiraterone and that trial arm came back negative. If it doesn't work in M1, it's unlikely it will work in M0.

Except that GU009 is looking at ADT+Apa/Abiraterone vs ADT alone both with XRT for high risk/high Decipher patients. To me this is classic signal hunting with maximalist pharmaceutical approach.

What will we end up with if positive?

We know from Stampede that Abiraterone added to XRT/ADT beneficial in a specific high risk cohort.

If GU009 positive, for a different high risk cohort, we now escalate therapy even further with combined Abiraterone/Apa without ever knowing if adding abiraterone alone is adequate.

 

[row_RO_row]

It is very likely that abiraterone will be dropped from NRG GU009 based on ACIS and other studies showing lack of meaningful benefit from combo therapy in more advanced disease states (now also somewhat corroborated by the STAMPEDE Abi/Enza outcomes though it's not the ideal design to compare those), so we will end up with data supporting abi plus ADT from STAMPEDE and (maybe) apa plus ADT from GU009.

Abi comes off patent next year. No more industry funded trials.

 

[communitydoc13]

Abi comes off patent next year. No more industry funded trials

Do you think designs of NRG GU008 and GU009 both contaminated by Pharma influence? Neither one made much sense to me (adding 2 agents to ADT when no existing evidence for adding a single agent) and I understand GU008 may also remove an agent. (I just wish abiraterone were the remaining drug.)

 

[Palex80]

Except that GU009 is looking at ADT+Apa/Abiraterone vs ADT alone both with XRT for high risk/high Decipher patients. To me this is classic signal hunting with maximalist pharmaceutical approach.

What will we end up with if positive?

We know from Stampede that Abiraterone added to XRT/ADT beneficial in a specific high risk cohort.

If GU009 positive, for a different high risk cohort, we now escalate therapy even further with combined Abiraterone/Apa without ever knowing if adding abiraterone alone is adequate.

Well indeed, that is one bad trial design.


Perhaps combining chemo with abiraterone would have been wiser than abiraterone with enzalutamide/apalutamide.