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  1. Kezza2

    Now for Docetaxel

    Well gentlemen, The time has come. I was on abiraterone + apelutimide trial for two years until that failed, and swapped to enzalutimide (Xtandi) but that only lasted three months, and now my PSA has more than doubled from 17 to 38 in 6 weeks, so it seems that docetaxel is next on the list. Having not had docetaxel previously I am not a candidate for the Lu177 trial unfortunately, so I am scheduled to start docetaxel in two weeks. I would appreciate any words of wisdom from the wise who have already been through this on side effects and how to avoid or minimise them, and what I may expect.
  2. Jim Marshall (not a doctor) said ... If you have castrate-resistant prostate cancer, common treatments that your doctor may add to your regular ADT treatment include: Docetaxel (Taxotere) Enzalutamide (Xtandi) or Abiraterone (Zytiga) Cabazitaxel (Jevtana). But what are your doctor's drug choices when the cancer is no longer under control after all three options? If you responded to docetaxel, your doctor knows you may well respond again to another dosing of docetaxel. But this increases your risk of side effects - especially peripheral neuropathy or nail disorders. Thibault and her colleagues looked at the possibility of giving cabazitaxel another go. They report a benefit to men - 34.3% improved, and 47.8% remained stable. Peripheral neuropathy: nerve damage to hands and feet. Castrate-resistant prostate cancer: PSA going up, even though testosterone is very low. ... end Jim The full article can be found in the European Journal of Cancer 2018: http://www.ejcancer.com/article/S0959-8049(18)30725-1/fulltext which reported the following Results and Conclusions: Results A total of 69 of 562 patients (Eastern Cooperative Oncology Group performance status 0–1 69%) were rechallenged with CABA (25 mg/m2 q3w, 58%; 20 mg/m2 q3w, 27.5%; other, 14.5%) for 1–10 (median 6) cycles; 76.8% received prophylactic granulocyte colony-stimulating factor. Median radiological or clinical PFS with CABA rechallenge was 7.8 months and 11.9 months with initial CABA therapy. OS was 13.7 months (95% confidence interval [CI]: 9.3–15.7) from the first CABA rechallenge cycle, 59.9 months (47.8–67.1) from the first life-extending therapy in mCRPC and 78.3 months (66.4–90.7) from mCRPC diagnosis. Best clinical benefit was improved (34.3%) or stable (47.8%). Lack of response to rechallenge occurred in 17.9% of patients (3.1% with initial CABA). The level of prostate-specific antigen decreased by ≥ 50% in 24% of patients at rechallenge (71% with initial CABA). There was no grade ≥III peripheral neuropathy or nail disorders. Conclusions CABA rechallenge may be a treatment option without cumulative toxicity in heavily pretreated patients with mCRPC who are still fit and had a progression >3 months after the last CABA injections.
  3. Jim Marshall (not a doctor) said ... How many doses of the chemotherapy drug Taxotere (Docetaxel) will give longest survival? The number of doses you get depends on how your cancer is responding, and how your body is dealing with it. Six doses of Docetaxel seems to be a common aim (as in the CHARTED trial): But doctors give as many as 10 or more Docetaxel doses in a row (and may repeat that in the future if the first sessions gave a good result). No one has done a study to see if giving more than six doses in a row gives longer survival. But as part of another study, some men got more than six doses: 10 or more doses, half were still alive at 33.0 months 8 to 10 doses, half were still alive at 26.9 months 5 to 7 doses, half were still alive at 22.8 months Warning about evidence This is not evidence. It is just a hint. Researchers were looking back at what happened in a failed trial of another drug plus Docetaxel. An actual trial would be needed to provide evidence. But if your doctor keeps you on Docetaxel chemo longer, you know there is a hint it may work better. Warning one about survival numbers These men had very advanced disease - metastatic castrate resistant. Docetaxel is often given earlier in treatment, and survival figures are much higher than here. Warning two about survival numbers Doctors speak of the median survival - when half the men are still alive. That half is the men who respond to the treatment. They don't all suddenly die soon after the median time. A few may, but the survival of the others will be spread out over months and years. ... end Jim Abstract JAMA Oncol. 2016 Aug 25. doi: 10.1001/jamaoncol.2016.3000. [Epub ahead of print] Association of Survival Benefit With Docetaxel in Prostate Cancer and Total Number of Cycles Administered: A Post hoc Analysis of the Mainsail Study. de Morrée ES1, Vogelzang NJ2, Petrylak DP3, Budnik N4, Wiechno PJ5, Sternberg CN6, Doner K7, Bellmunt J8, Burke JM9, Ochoa de Olza M10, Choudhury A11, Gschwend JE12, Kopyltsov E13, Flechon A14, van As N15, Houede N16, Barton D17, Fandi A17, Jungnelius U17, Li S17, Li JS17, de Wit R1. Author information Abstract IMPORTANCE: The optimal total number of docetaxel cycles in patients with metastatic castration resistant prostate cancer (mCPRC) has not been investigated yet. It is unknown whether it is beneficial for patients to continue treatment upon 6 cycles. OBJECTIVE: To investigate whether the number of docetaxel cycles administered to patients deriving clinical benefit was an independent prognostic factor for overall survival (OS) in a post hoc analysis of the Mainsail trial. DESIGN, SETTING, AND PARTICIPANTS: The Mainsail trial was a multinational randomized phase 3 study of 1059 patients with mCRPC receiving docetaxel, prednisone, and lenalidomide (DPL) or docetaxel, prednisone, and a placebo (DP). Study patients were treated until progressive disease or unacceptable adverse effects occurred. Median OS was found to be inferior in the DPL arm compared with the DP arm. As a result of increased toxic effects with the DPL combination, patients on DPL received fewer docetaxel cycles (median, 6) vs 8 cycles in the control group. As the dose intensity was comparable in both treatment arms, we investigated whether the number of docetaxel cycles administered to patients deriving clinical benefit on Mainsail was an independent prognostic factor for OS. We conducted primary univariate and multivariate analyses for the intention-to-treat population. Additional sensitivity analyses were done, excluding patients who stopped treatment for reasons of disease progression and those who received 4 or fewer cycles of docetaxel for other reasons, minimizing the effect of confounding factors. MAIN OUTCOMES AND MEASURES: Total number of docetaxel cycles delivered as an independent factor for OS. RESULTS: Overall, all 1059 patients from the Mainsail trial were included (mean [SD] age, 68.7 [7.89] years). Treatment with 8 or more cycles of docetaxel was associated with superior OS (hazard ratio , 1.909; 95% CI, 1.660-2.194; P < .001), irrespective of lenalidomide treatment (HR, 1.060; 95% CI, 0.924-1.215; P = .41). Likewise, in the sensitivity analysis, patients who received a greater number of docetaxel cycles had superior OS; patients who received more than 10 cycles had a median OS of 33.0 months compared with 26.9 months in patients treated with 8 to 10 cycles; and patients who received 5 to 7 cycles had a median OS of 22.8 months (P < .001). CONCLUSIONS AND RELEVANCE: These findings suggest that continuation of docetaxel chemotherapy contributes to the survival benefit. Prospective validation is warranted. PMID: 27560549 DOI: 10.1001/jamaoncol.2016.3000 [PubMed - as supplied by publisher]
  4. The opportunity There is a chance to have your voice heard on whether the drug Xtandi (enzalutamide) should be available on the PBS BEFORE chemotherapy. Timing Submissions are due Wednesday 8 February 2017, and no late submissions will be accepted. Enzalutamide on the PBS An important drug for men with advanced prostate cancer is Xtandi, also called enzalutamide. The first evidence that enzalutamide worked looked at using enzalutamide AFTER the chemotherapy drug docetaxel. A committee of experts looked at this evidence. They recommended that it was worth spending taxpayer money on. So, now men with advanced prostate cancer can get enzalutamide on the PBS at a low price, AFTER they have had chemotherapy with docetaxel. Some new evidence has arrived showing that enzalutamide works well BEFORE chemotherapy with docetaxel. The same committee of experts is now looking at this evidence to see if it is worth spending taxpayer money to put enzalutamide on the PBS for use BEFORE chemotherapy with docetaxel. This is the second time this has come up for consideration. The first time, the expert committee rejected the application: because the submission was focused on a claim of survival advantage, which was small and uncertain, rather than on outcomes that clinicians and patients considered to be of most value. The purpose of using enzalutamide earlier in the disease pathway would be: 1) to delay symptoms from developing and maintaining a better quality of life for longer in asymptomatic patients for whom placebo, or watchful waiting, is the appropriate comparator; and 2) delaying the toxicities of chemotherapy in symptomatic patients considered suitable for docetaxel. That committee has asked for public submissions for a new application. Enzalutamide BEFORE chemotherapy The first thing you should understand that enzalutamide is not a miracle cure. About half the men on the PREVAIL clinical trial were still alive three years after they started on enzalutamide. Some of the men who responded will have a much longer survival. I have met a man whose cancer has been kept at bay for 6 years so far on enzalutamide. But survival times pre-chemo and post-chemo are not different enough to convince the experts. What is most important about this drug is the quality of life it makes possible during that two or three years. Docetaxel chemotherapy vs enzalutamide side effects The first thing you should understand is the current first treatment at this stage - docetaxel chemotherapy. Many men report coping quite well with their docetaxel, finding the temporary hair loss and other side effects manageable. But some men have a terrible experience with the side effects. It is so bad for some men that they give up the treatment. And, about one man in four hundred dies from the treatment. On the other hand, enzalutamide treatment has far fewer reported side effects. Fatigue and hypertension were the most common. So, the first benefit of starting enzalutamide BEFORE chemotherapy is that a man can delay the start of the docetaxel chemotherapy. The PREVAIL clinical trial In the PREVAIL clinical trial of enzalutamide before chemotherapy, men had to: have metastatic prostate cancer, be castrate resistant, and have no, or few symptoms (like pain). Metastatic means that their prostate cancer had spread to other parts of their body. Castrate resistant means that the primary hormone therapy, with drugs like Zoladex, Lupron, and Eligard, was no longer able to keep the cancer in check by itself. In other words their PSA was rising, despite the hormone therapy keeping testosterone very low. Men in this trial on enzalutamide did not need to start chemotherapy, on average, for more than two years - 28 months. The control group of men had to start chemotherapy after 11 months. So men on enzalutamide had 17 MORE months at a higher quality of life. After 12 months of treatment, 65% of men treated with enzalutamide had scans which showed no progression of their cancer, compared to 14% of the control group. The trial was finished early when it became clear that the enzalutamide was far more effective. At that stage, 29% fewer men had died in the enzalutamide group. The enzalutamide group also had a longer time until the first skeletal-related event (that is, problems with their bones). Most prostate cancer metastases (about 89%) occur in bones. Of the men with metastases away from their bones, complete or partial soft-tissue response favoured enzalutamide 59% to 5%. Time until PSA started going up again also favoured enzalutamide. So did the number of men whose PSA dropped to at least half - 78% to 3%. Submissions The Prostate Cancer Foundation of Australia (PCFA) is making a submission on behalf of its members. Some individual members have told me that they are going to put in an individual submission. If you also wish to have your say, a couple of points: Firstly, while submission sounds grand, it is as easy as filling in a few boxes on a web page: Click on this sentence for the submission form. OR Here. Notes on the boxes on that page: Medicine to which this submission relates: Enzalutamide Date of PBAC meeting: March 2017 Note: This is when the board meets. It is not the due date for submissions which is Wednesday 8 February 2017. First declaration box: Nil (unless you work for the manufacturer, hold shares in the company, etc.) Second declaration box: Say what you are: man with this disease, partner, friend, doctor, etc. Say where you are in your disease: having the drug, missed out on the drug, expecting to be needing the drug in the future. What comments would you like the PBAC ...? • How does this condition/disease affect quality of life? • What would you most like to see from this treatment? Improved side effects? Slowing disease progression? More mobility? Other benefits? • If you have used or prescribed this new medicine, what was your experience of the beneficial effects? • If you have used or prescribed this new medicine, what side effects or toxicities did you experience or observe? • If you haven't used the new medicine yet, what are your expectations of it? • If you use other currently available therapies or medicines you use to manage your condition (or for prescribers, for your patient’s condition), what are the benefits and/ or the challenges? Where did you obtain the information that helped form your views on this treatment? ◦ I have been a patient on this medicine; ◦ Your doctor; ◦ Other patients stories/experiences ◦ Professional colleagues; ◦ Support networks: PCFA, Australian Advanced Prostate Cancer Support Group, JimJimJimJim ◦ Own research; ◦ Other patient resources; ◦ Direct experience as a health professional or carer; ◦ Other – please provide details. When your entry is complete be Very Careful not to press the wrong button. Tick: Agree to terms and conditions Click: Submit Click on this sentence for the submission form. Lets hope for a good result this time! Jim
  5. Jim Marshall (not a doctor) said ... If you have advanced prostate cancer then chemotherapy with a drug like Taxotere (docetaxel) may be part of your treatment. As your body deals with chemo, there is a risk of serious infection. Back in 2013 we published concise advice from a USA government site about avoiding or dealing with chemotherapy infections. Click on this sentence to read that advice on our site, which also has links to the Prevent Cancer Infections site. ... end Jim
  6. We are all familiar with the concept of intermittent ADT as opposed to continuous ADT. Now researchers are investigating the concept of intermittent chemotherapy as opposed to continuous chemotherapy. If certain criteria are met, there will a break in the chemotherapy treatment and the patient will have a “drug holiday”. In theory intermittent chemotherapy may serve 2 purposes. First, with less constant exposure to the drug, this may potentially delay the development of taxane-refractory disease. Second, breaks in therapy or “drug holidays” may improve the quality of life for patients, allowing them to recover from the cumulative toxicity of chemotherapy during these “drug holidays.” Resolution of drug side effects may also allow taxane therapy to be prolonged, which could also improve outcomes. It is interesting to see that one of the abstracts for the 2016 ASCO (American Society of Clinical Oncologists) meeting in Chicago next week is about “PRINCE: A phase III study comparing intermittent docetaxel therapy versus continuous docetaxel therapy in patients with castration-resistant prostate cancer”. PRINCE which was a study conducted by German researchers found that: “The intermittent docetaxel chemotherapy was non-inferior to a continuous therapy in one-year survival. It was well tolerated and may present a treatment option for patients with CRPC”. Reference: http://abstract.asco.org/176/AbstView_176_170886.html
  7. Some men may experience a PSA flare when starting docetaxel chemotherapy. The occurrence of PSA flare had no effect on treatment duration or outcome. Joel Nowak at Malecare reports on recent research. Click on this link to read his report. PSA flare is where there is a sharp initial increase in PSA following the commencement of treatment.
  8. Cabazitaxel is a chemotherapy treatment which is used when patients become resistant to chemotherapy treatment with Docetaxel. Cabazitaxel improves overall survival in patients with metastatic castration-resistant prostate cancer (mCRPC) previously treated with Docetaxel. Androgen receptor splice variant 7 (AR-V7) in circulating tumuor cells (CTCs) from mCRPC patients was recently demonstrated to be associated with resistance to Abiraterone and Enzalutamide. A group of Dutch and Belgian researchers investigated whether this was also true for Cabazitaxel. They found that Cabazitaxel was effective even if AR-V7 was present. Reference "Efficacy of Cabazitaxel in Castration-resistant prostate cancer is independent of the presence of AR-V7 in Circulating Tumor Cells" Wendy Ostenk et al Article Information DOI: 10.1016/j.eururo.2015.07.007
  9. The New Prostate Cancer Infolink reports Full data on ADT + chemotherapy from the STAMPEDE trial now published The report has links to the full text of articles in the Lancet regarding this research. "For men with metastatic prostate cancer starting [androgen deprivation] therapy for the first time, we found strong evidence to support the addition of docetaxel to androgen deprivation therapy as the new standard of care, and this combination should be offered to men who are fit to receive chemotherapy. " There is no sufficient evidence yet to recommend docetaxel plus androgen deprivation therapy for hormone-naive men men diagnosed with micrometastatic prostate cancer (cancer in the lymph nodes but not yet metastasised to the bone - M0)
  10. Dr Charles Myers Jnr (nickname Snuffy Myers) is one of the best known medical oncologists specialising solely on prostate cancer in the USA. He produces a free video on prostate cancer treatment each week, and a paid monthly newsletter service. He also writes books. In a recent video (18 September 2014) Dr Myers talked about Taxotere (brand name Docetaxel) and the CHAARTED trial. Whilst the video deals mainly with early Taxotere use in newly diagnosed patients, there are also some interesting comments about Taxotere use in advanced patients. See this Dr Myers Video at: http://askdrmyers.wordpress.com/2014/09/18/early-taxotere-use/?mc_cid=c83f004150&mc_eid=79f1dd2837 OR http://tinyurl.com/qgs7sc5
  11. The U.S. Food and Drug Administration (FDA) has just released a safety warning about the intravenous chemotherapy drug, docetaxel. Docetaxel contains alcohol, which may cause patients to experience intoxication or feel drunk during and after treatment. The FDA suggested that patients should: Avoid driving, operating machinery or doing other activities that are dangerous or require skill one to two hours after you receive treatment with docetaxel. Tell your doctor about all the medicines you are currently taking, as the alcohol in docetaxel may affect other medicines you are using. Notify your doctor immediately if you experience any of the following symptoms while receiving an intravenous infusion of docetaxel and for one to two hours after treatment: symptoms of being drunk, confusion, stumbling, or becoming very sleepy. The FDA suggested to doctors that symptoms of alcohol intoxication may be minimised by: Using a docetaxel formulation with a lower alcohol content ; or Slowing the infusion rate during administration. Source: http://www.fda.gov/Drugs/DrugSafety/ucm401752.htm?
  12. Doctors have been starting to use the newer drugs such as Xtandi (enzalutamide) and Zytiga (abiraterone) before docetaxel. This has moved chemotherapy further back in the sequence of treatment. Now there is evidence for a role for earlier chemotherapy for some men. By moving docetaxel from the castration-resistant stage, when men were not responding to testosterone-lowering agents, to the castration-sensitive state, when they were, the survival benefits were amplified. The evidence comes from a clinical trial, “Chemohormonal Therapy versus Androgen Ablation Randomized Trial for Extensive Disease in Prostate Cancer (CHAARTED)”. The results were presented at the 2014 annual general meeting of the American Society of Clinical Oncology (ASCO). The trial compared “upfront” docetaxel plus hormone therapy with hormone therapy alone in men with metastatic prostate cancer. When patients enrolled in the trial, they were classified by the extent of their metastatic disease as high-volume or low-volume. High volume was defined as visceral metastasis or 4+ bone metastases or both. In men with high volume metastatic prostate cancer, the trial found that docetaxel plus hormone therapy improved survival over hormone therapy alone. Longer follow-up was needed for men with low volume metastatic prostate cancer. Dr Christopher Sweeney, the lead investigator of the trial, said: “This is one of the biggest improvements in survival we have seen in a trial involving patients with an adult metastatic solid tumour.” Dr Michael J. Morris of Memorial Sloan Kettering Cancer Centre commented: “The best therapies reported previously have less than a third of the benefit seen in these patients.” This study will not change the sequence of treatment for all patients. This treatment applies only to men who had high volume metastatic cancer when first diagnosed. Only about 4% of men with prostate cancer have metastatic cancer when first diagnosed. Of that 4% the number of men with high-volume disease is even smaller. Also to receive this treatment, patients must be well enough to receive docetaxel therapy. Dr Sweeney is now involved in a clinical trial looking at the “upfront” treatment of newly diagnosed prostate cancer patients with docetaxel plus hormone therapy plus Xtandi (enzalutamide). There are 2 talks on the internet about “upfront” docetaxel plus hormone therapy. One is by Dr Snuffy Myers on his blog. This talk is designed for patients with prostate cancer. Here is the link to the video by Dr Myers: http://askdrmyers.wordpress.com/2014/06/05/taxotere-lupron-before-adt/ The second is an interview on the Uro Today website with Dr Sweeney. This interview is intended for urologists. It is not suitable for general listeners. Unless you have a detailed knowledge of clinical trials and of the statistical methods used in these trials, you should not listen to this interview. Further information about the CHAARTED trial (including a link to the abstract of the trial) is available on the ASCO website.
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