A whole host of new data on drugs like sipuleucel-T, enzalutamide, abiraterone, and others was available in the poster sessions at the Genitourinary Cancers Ssympisum in Orlando today.
Much of this new data is based on re-analysis of data subsets from trials already reported and so is of limited clinical significance. It would be impossible to comment in detail on all these studies, so … What we have done below is to try to provide a complete listing of most of the relevant posters with links to the abstracts. In just a very few cases we have added some specific comment.
Be warned. … There is a long list below! And it is by no means a complete list of all the drug trial data presented at this meeting. We have simply tried to pick the data on drugs patients are likely to have most interest in.
Posters about abiraterone acetate (Zytiga):
- Rathkopf et al.: “Updated interim analysis (IA) of COU-AA-302, a randomized phase III study of abiraterone acetate (AA) in patients (pts) with metastatic castration-resistant prostate cancer (mCRPC) without prior chemotherapy.“
- Goodman et al.: “Exploratory analysis of the visceral disease (VD) patient subset in COU-AA-301, a phase III study of abiraterone acetate (AA) in metastatic castration-resistant prostate cancer (mCRPC).“
- Schnadig et al.: “Sequencing of cabazitaxel and abiraterone acetate following docetaxel in metastatic castration-resistant prostate cancer (mCRPC).“
- Albiges et al.: “Is there a withdrawal syndrome with abiraterone acetate (AA)?“
- Clayton et al.: “A multicenter population-based experience with abiraterone acetate (AA) in patients with metastatic castration resistant prostate cancer (mCRPC).“
- Autio et al.: “A randomized phase II, open-label study of sipuleucel-T with concurrent or sequential abiraterone acetate (AA) in metastatic castrate-resistant prostate cancer (mCRPC).“
- Peer et al.: “Comparison of abiraterone acetate (Abi) versus ketoconazole (Keto) in patients (pts) with metastatic castration-resistant prostate cancer (mCRPC) refractory to docetaxel (D).“
- Reuter et al.: “Effectiveness of abiraterone as salvage therapy in patients with docetaxel- and castration-resistant prostate cancer (mDCPC) that progressed during second-line chemotherapy with carboplatin plus weekly docetaxel (DC).“
- Chopra et al.: “Comparative effective analysis between enzalutamide and abiraterone in the treatment of metastatic castration-resistant prostate cancer.“
- Fackrell et al.: “Postdocetaxel treatment for castrate-resistant prostate cancer: The sequential use of abiraterone and cabazitaxel.“
Posters about enzalutamide (Xtandi):
- Scher et al.: “Impact of on-study corticosteroid use on efficacy and safety in the phase III AFFIRM study of enzalutamide (ENZA), an androgen receptor inhibitor.“
- Sternberg et al.: “Outcomes in elderly patients with metastatic castration-resistant prostate cancer (mCRPC) treated with the androgen receptor inhibitor enzalutamide: results from the phase III AFFIRM trial.“
- Miller et al.: “Effect of enzalutamide on health-related quality of life (HRQoL) in men with metastatic castration-resistant prostate cancer (mCRPC) following docetaxel-based therapy: results from the AFFIRM study.“
- Tombal et al.: “Enzalutamide monotherapy: Phase II study results in patients with hormone-naive prostate cancer.” This is an important new report that we have commented on separately already.
- Fleming et al.: “Long-term responders to enzalutamide (ENZA) during the phase III AFFIRM trial: baseline characteristics and efficacy outcomes.“
- Chopra et al.: “Comparative effective analysis between enzalutamide and abiraterone in the treatment of metastatic castration-resistant prostate cancer.“
Posters about sipuleucel-T (Provenge):
- Sartor et al.: “Real-world experience with sipuleucel-T in patients (pts) with metastatic castration-resistant prostate cancer (mCRPC) who received prior docetaxel (D): data from PROCEED.“
- Antonarakis et al.: “Randomized phase II trial evaluating the optimal sequencing of sipuleucel-T and androgen-deprivation therapy (ADT) in patients (pts) with biochemically recurrent prostate cancer (BRPC).“
- Hepgur et al.: “Changes in circulating tumor cells (CTC) and markers of inflammation after sipuleucel-T treatment.“
- Small et al.: “Relationship of sipuleucel-T with time to first use of opioid analgesics (TFOA) in patients (pts) with asymptomatic or minimally symptomatic metastatic castration-resistant prostate cancer (mCRPC) on the IMPACT trial.“
- Autio et al.: “A randomized phase II, open-label study of sipuleucel-T with concurrent or sequential abiraterone acetate (AA) in metastatic castrate-resistant prostate cancer (mCRPC).“
- Nabhan et al.: “Real-world experience with sipuleucel-T in patients (pts) ≥80 years old with metastatic castration-resistant prostate cancer (mCRPC): data from PROCEED.“
- Beer et al.: “P10-1 open-label, multicenter study of sipuleucel-T in metastatic castrate-resistant prostate cancer (mCRPC) patients (pts) previously treated with sipuleucel-T: Evaluation of antigen-presenting cell (APC) activation.“
- Gardner et al.: “Immune response with sipuleucel-T in patients (pts) with metastatic castration-resistant prostate cancer (mCRPC): Phase II ProACT study.“
Posters about cabazitaxel (Jevtana):
- Schnadig et al.: “Sequencing of cabazitaxel and abiraterone acetate following docetaxel in metastatic castration-resistant prostate cancer (mCRPC).“
- Bahl et al.: “Cabazitaxel for metastatic castration-resistant prostate cancer (mCRPC): final quality-of-life (QOL) results with safety data from the United Kingdom (UK) Early Access Programme (EAP) (NCT01254279).“
- Oudard et al.: “Efficacy of cabazitaxel and its relationship with predictors of poor response to second hormonal therapies (2d HT) in metastatic castration-resistant prostate cancer (mCRPC).“
- Pezaro et al.: “Response to cabazitaxel in CRPC patients previously treated with docetaxel and abiraterone acetate.“
- Sella et al.: “Activity of cabazitaxel following docetaxel and abiraterone acetate in patients with castration-resistant prostate cancer.“
- Bracarda et al.: “Which data for cabazitaxel (Cbz) from the real world? The safety experience from the Italian centres participating in the Expanded Access Programme (EAP).“
- Kelly et al.: “Cabazitaxel in patients with metastatic castrate-resistant prostate cancer previously treated with a docetaxel-containing regimen: a single U.K. cancer center’s experience using Early Access Programme and Cancer Drugs Fund.“
- Fackrell et al.: “Postdocetaxel treatment for castrate-resistant prostate cancer: The sequential use of abiraterone and cabazitaxel.“
Posters about ARN-509:
- Smith et al.: “ARN-509 in men with high-risk nonmetastatic castration-resistant prostate cancer (CRPC).” We have already (separately) provided a full commentary on this poster.
- Rathkopf et al.: “ARN-509 in men with metastatic castration-resistant prostate cancer (mCRPC).“
Posters about radium-223 dichoride:
- Vogelzang et al.: “Updated analysis of radium-223 dichloride (Ra-223) impact on skeletal-related events (SRE) in patients with castration-resistant prostate cancer (CRPC) and bone metastases from the phase III randomized trial (ALSYMPCA).” This new paper now suggests that radium-223 provides a 3.6 month overall survival benefit compared to a placebo in men with CRPC (compared to the earlier survival benefit of 2.8 months initially reported.
- Nilsson: “Pain analysis from the phase III randomized ALSYMPCA study with radium-223 dichloride (Ra-223) in patients with castration-resistant prostate cancer (CRPC) with bone metastases.“
Posters about dasatinib (Sprycel):
- Araujo et al.: “Overall survival (OS) and safety of dasatinib/docetaxel versus docetaxel in patients with metastatic castration-resistant prostate cancer (mCRPC): results from the randomized phase III READY trial.” Again, we have already provided a separate, full commentary on this “late breaking” poster.
Posters about aflibercept (Zaltrap):
- Tannock et al.: “Aflibercept versus placebo in combination with docetaxel/prednisone for first-line treatment of men with metastatic castration-resistant prostate cancer (mCRPC): results from the multinational phase III trial (VENICE).” This is the complete report on a negative Phase III trial first announced as negative but not previously reported in full.
Posters about cediranib (AZD2171):
- Heath et al.: Randomized phase II trial of docetaxel (Doc) and prednisone (Pred) with or without AZD2171 (cediranib), in chemotherapy-naive, metastatic castrate-resistant prostate cancer (mCRPC).” This is a negative report on an early clinical trial of cediranib. Further development of this product may be unlikely.
Filed under: Drugs in development, Management, Treatment | Tagged: abiraterone, aflibercept, ARN-509, cabazitaxel, cediranib, dasatinib, enzalutamide, radium-223, sipuleucel-T |
THE "NEW" PROSTATE CANCER INFOLINK 
I have to admit that I don’t understand much of what is contained in these abstracts. I have a hard time with all the abbreviations and the percentages. It would be nice if we had a “Prostate Cancer Research Terms and Abbreviations for Dummies” book! Abbrfeviations like CI, SI, OS, ECOD, etc., give me a headache!
All kidding aside, am I correct in concluding that the already-approved treatments (Provenge, Zytiga, and Xtandi) all have value in terms of overall survival (OS) as do the not-yet-approved Ra-223 and ARN-509 while Sprycel, Zaltrap, and cederinab do not seem to have much benefit? I’m not sure if Jevtana has been FDA-approved or not but it also seems to have some utility.
If I am correct, it is pretty disappointing that there are so few “new” treatments that will help. Even the best of them seem to give you only a few extra months albeit at a very high financial cost. I wonder if those few extra months are worth the financial burden that the survivors are left to contend with.
I meant to say earlier, Mike, thank you for digesting all this and presenting it in such a way that people like me can actually derive some benefit. Even with all your knowledge and expertise, it must be a daunting task! Thanks!
Dear Sitemaster,
Thank you for your excellent information about the Genitourinary Cancer Symposium in Orlando. Since today it seems to be impossible to look on the complete list of the abstracts of the conference. So it is very helpful that you give us direct links. Thank you!
Jake:
(1) Yes, your assessment of the products that have a proven survival benefit and those that don’t is correct.
(2) Cabazitaxel (Jevtana) is an approved drug and has shown a clear but small overall survival benefit when used to treat men who have progressive disease after treatment with docetxel-based chemotherapy.
(3) It would certainly be great if we could come up with drugs that had far greater survival benefits than those available to date … and if they were so cheap that nearly everyone could afford them with ease (like a dozen eggs).
I should point out, however, that just 15 years ago there were no drugs at all that had been proven to extend survival for men with metastatic prostate cancer. We now have half a dozen, and there are several more prominsing ones (like ARN-509 and some new immunotherapeutic agents) in the pipeline. The cost issue is a problem, however
Dear Gunterman:
You should still be able to look at the complete list of abstracts of all the prostate cancer papers being presented at the meeting if you click here.
However, it is really good for the drug companies’ bottom line.