-Dr. West
magbag November 11, 2008 – 10:00 pm
-Dr. West
Posted in: Current Clinical Trials, Immune/Vaccine-based therapies, Lung Cancer, Treatment email to a friend Print This Post 6 Comments Login (Must Be Logged In To Comment) Username:
Password:
September 27, 2008 – 11:18 am
I’m not participating in the trial, so I don’t have all of the details. It is meant for people to start immediately after chemo, and I think there is essentially no chance that someone would be able to be on other standard anti-cancer therapies, such as tarceva and/or avastin, at the same time.
Advanced NSCLC
alimta
Anti-angiogenic agents
avastin
Bronchioloalveolar Carcinoma (BAC)
Chemotherapy
clinical variables
Core Concepts
Current Clinical Trials
early stage NSCLC
ED-SCLC
EGFR
EGFR Based Therapy
EGFR inhibitor
EGFR mutation
EGFR therapy
EGFR TKI
erbitux
erlotinib
First-line treatment
Imaging and Response Measurement
Iressa
locally advanced NSCLC
lung cancer evaluation
Lung Cancer Issues
lung cancer subtypes
lung cancer work-up
maintenance therapy
metastatic NSCLC
molecular marker
Never-smoker lung cancer
NSCLC
older patients with lung cancer
Radiation therapy
Resectable locally advanced NSCLC
SCLC
Second-line treatment
Side Effects
Special Populations in Lung Cancer
Surgery Issues
tarceva
targeted therapy
Third-line therapy and beyond
Treatment
Unresectable locally advanced NSCLC
Dr. West
This work was first reported at an oral presentation at ASCO in 2006 (abstract here) and then published in the Journal of Clinical Oncology, one of our leading journals, that same year (abstract here). It included 75 patients with anywhere from stage II to IV NSCLC, although nearly all had stage IIIB or IV disease, and most had received prior therapy. Patients were then randomized into three different dose levels of the vaccine, which was administered into the skin (intradermal) once every 1-2 months. Not surprisingly, the vaccine was associated with minimal side effects. While fatigue, pain, and pulmonary symptoms were reported, there was no real indication that this was from the treatment and not the cancer itself. Two patients had significant issues felt possibly or probably related to the vaccine: one had fairly significant pain and swelling around the injection site on one occasion, and another developed chronic myelogenous leukemia (CML) 5 months after 16 full cycles of the vaccine — it remains unclear if the vaccine caused this or whether this was just a coincidence.
My son is 36 and was diagnosed with nsclc stage 4 in april 2008. He responded well to 6 cycles of cisplatin,ugg bailey button boots,gemzar and avastin. He is still having th avastin 3 weekly. He did not have any surery. He is doing very well. I am interested in the lucanix trial, even though it is a double blind placebo trial. I feel a 50/50 chance of 30-40 months progression free survival is better than an extra 2 months progression free with the avastin. I am interested in your view on this especially what could be our other options. Thankyou for your help. Maggie
I do find it hard to explain why the lower dose would do visibly better than the middle dose, and my honest sense is that this is because the trial involves a small number of patients, so random chance of the particular characteristics of a few patients and their cancers play a large role. I’ve been impressed that some of the most unusually healthy patients with the most indolent lung cancer I’ve ever seen are the ones who jump on a plane to Dallas to enroll on these trials led by Dr. John Nemunaitis at Baylor, who runs multiple vaccine-based trials — because of this, I think it will be very important to rule out selection bias of remarkably unusual patients as a reason that these patients did so much better than we expect to see in large trials of previously treated patients. in fact, the reported “tumor burden” (basically, the size of measured disease) was very low in their responding patients, so I wonder if many of these patients had far less aggressive disease than a more average population that would be reflected in results from larger trials. But perhaps suggesting a real benefit, responses on scans were correlated with better immune responses in patients on the trial.
Quick Resources Glossary of
Terms / Abbreviations Syndication Would you be interested in purchasing a DVD with a collection of GRACE podcasts?
(polls) Lucanix: A Vaccine Being Tested as a “Maintenance” Strategy in Advanced NSCLC September 22, 2008 – 8:32 pm email to a friend Print This Post view / write comments
(No Ratings Yet)
Loading … Dr West
Password:
Survival certainly appeared promising, particularly compared to historical data of what you’d expect for previously treated patients. Median survival was 14.4 months on the trial, and it was actually 15-16 months in the two higher dose cohorts, in which the two year survival was about 40%:
Not yet a member?
First, what is this vaccine? There are two main types of cancer vaccines. One type is called autologous and is generated from the individual patient’s tumor, which has the advantage of being tailored to the individual, but it requires tumor to be collected from a patient by a separate procedure. Lung cancer tumor tissue isn’t always accessible, so it’s a problem and involves some degree of risk to obtain tissue to generate the vaccine, which is also a time-consuming process. The other type is called allogeneic, which means that it’,ugg cardy boots;s made by other tumor cells, not those from the patient. Lucanix is a vaccine derived from four different lung cancer cell lines (two adeno, one squamous, one large cell), so the immune response would presumably be against proteins on any of a number of different lung cancers. This is combined with an “antisense” gene modification against transforming growth factor-B (or TGF-beta), which is a very complicated idea, but the net result is that this helps reinstate immunity against cancer cells after they had disarmed the body’s surveillance system in the immediate area around the tumor with this protein.
(click to enlarge)
Disclaimer: The information provided at GRACE is for informational purposes only. The faculty of GRACE is not providing medical advice, diagnosis or treatment and cannot replace the medical advice of your doctor or health care provider. (Full Disclaimer)
Remember me
–>
GRACE Home | Forums | About GRACE | Donate | GRACE Website Tutorial | Contact | Disclaimer
I have written about several other treatments that have been tested and are recognized as being potentially effective for patients previously treated for advanced NSCLC. In addition to tarceva, both alimta (at least for patients with non-squamous cancers) and taxotere are widely used and FDA-approved for this setting.
Bookmark to:
I would also say that there is much more buzz about lucanix in the lay media and general public than within the lung cancer/oncology professional community, which is more skeptical. I also think that this trial is going to be extremely difficult to complete, so I’m afraid we may never get a firm answer from it.
Over the past several weeks, coincident with the opening of a new large clinical trial and some publicity associated with that, several people have asked me here about a lung cancer vaccine called Lucanix (full name belagenpumatucel-L, so a near guarantee that nobody will call this anything but Lucanix). My initial response was that I knew essentially nothing about it and more or less implied that there must not be much to it if there was really no buzz about it within the lung cancer community. But that’s a very simplistic view that goes against one of the issues I feel strongly about, namely that hype isn’t the same as promise. There are enough approaches that I’ve been critical of despite “buzz” (RFA, proton beam radiation, celebrex, just to name a few I’ve minimized over the past few weeks) that it would be completely hypocritical for me to suggest that a lack of attention from the media or lung cancer establishment means that a treatment isn’t worth pursuing. I’ve seen over the years that the interest in a treatment is a combination of the favorable findings from early work, the public relations machine and marketing muscle of the sponsor company, how explainable it is (we like a good “story”, so it’s easier to explain that something blocks EGFR or is antiangiogenic than that something is an aurora kinase inhibitor), and certainly some luck about what just happens to catch on. I’ve also been following some treatments that seem to get little traction despite quite encouraging results (talactoferrin alpha, for instance), probably because they’re products of small companies, and/or have been studied by people who don’t immediately attract media attention.
© 2007-2009 GRACE. All rights reserved.
So it was only fair for me to review the available information about Lucanix and provide a more informed opinion. T0 their credit, folks at NovaRx, the company working on Lucanix, saw my comments announcing my intention to write a more educated piece, and they proactively sent me several files with background information about the company, Lucanix, and the trial being conducted now. After several attempts to connect, I spoke earlier today with Ms. Carissa Schumacher, Director of Corporate Development, and Dr. Habib Fakhrai, President; both were eager to discuss the promise and challenges of the early work with Lucanix and the new trial moving forward. I’ve never had the leadership of a company provide more enthusiastic and open communication, so kudos to them for that.
Username:
Related posts brought to you by Yet Another Related Posts Plugin.
–> Lung Cancer
I still think it’s a reasonable option and that the vaccine and trial are promising concepts. I’d be very eager to see the study completed and learn whether the vaccine proves to be another effective tool in treating lung cancer.
WP Cumulus Flash tag cloud by Roy Tanck requires Flash Player 9 or better.
About Us GRACE Home About GRACE Mission History Board Faculty Contact Us Disclaimer Support GRACE Donate Ways to Give Create A Tribute View Tributes Our Supporters Matching Gifts Gift of Securities / Planned Giving Find Info About General GRACE News Cancer 101 Treatments & Support Naturopathic Medicine/CAM Coping with Cancer / Social Work Lung Cancer Radiation FAQ FAQ Glossary of Terms / Abbreviations Events & Publications Community Outreach Contact Us Guestbook Contact GRACE Contact Tech Support Suggest A Topic Donate Text Size Recent Posts Dr. Shirish Gadgeel on Managing Locally Advanced NSCLC Who Benefits from Third-line Treatment for Advanced NSCLC? Never-smoker vs. “ever-smoker”? It’s not quite that simple… Dr. Le, Radiation Oncologist from Stanford, on Radiation Options for Early Stage NSCLC Avastin, Radiation, and Tracheoesophageal Fistulas: Yet another Cautionary Tale Recent Comments recce101 on Dr. Shirish Gadgeel on Managing Locally Advanced NSCLCDr Pennell on Who Benefits from Third-line Treatment for Advanced NSCLC?JimC on Who Benefits from Third-line Treatment for Advanced NSCLC?recce101 on Who Benefits from Third-line Treatment for Advanced NSCLC?Dr Pennell on Who Benefits from Third-line Treatment for Advanced NSCLC? Popular Topics
Related posts:Interview with Dr. Suresh Ramalingam on First Line and Maintenance Therapy for Advanced NSCLC ?? The ACombating Nicotine Addiction with a Vaccine Imagine thFirst Line Chemotherapy for Advanced NSCLC: An Introduction This pilotCetuximab (Erbitux) for Advanced NSCLC: Promising Results, But is it Ready for Prime Time? There h
Sections Recent Posts GRACEcasts Subject Archives Monthly Archives GRACE Twitter Other Resources Donate Search
Forums Forums Ask a question about:
Please Select… Cancer 101 Lung Cancer Radiation Coping / Social Work Alternative Medicine Symptoms & Support Archived Onctalk Forums Our SupportersMs. Cheryl HauberMr. Phil ConverseMr. Roger DayMs. Debra Chidester-ClampittMr. Andrew HillMr. Are SorliMr. & Mrs. Wayne FordMr. & Mrs. Robert & Wendy SchwintekMr. John Cromwell IIIMs. Janine ThompsonMrs. Ruth ZimmersMs. Lois CunniffMr. & Mrs. Kenneth & Judith HillMr. John BaldwinMs. Myrtle ChidesterMr. Gary ClucasMs. Bethann FrillmanMr. & Mrs. Harvey & Bernice JanssenMr. Esteban TormenMr. Rob HillMr. William BauerMr. & Mrs. Edward & Sheila Whittington, In memory of Joanne Sampl, dear friend & soul mateMs. Amabelle SandanMr. Arnaz MalhiMr. Jon GordonMr. & Mrs. Anthony & Cindy LiuMrs. Margrit CromwellMs. Christina RackleyMr. & Mrs. Raymond & Elizabeth Landry, for Mrs. Joan Trogden, in memory of Mr. William TrogdenMr Paul WardMr. David OrvosMs. Vikki KramerMs. Rhea RollinsMr. Bruce JacobsMr. & Mrs. Nedra & Ralph KimballMr. Thomas HoltMs. Terisa HawkMs. Myrtle ChidesterMs. Rita HoriguchiMr. Jason BrodskyMing ChenMiriam Arfin and Robert RebitzerGreenheart InvestmentsMs. Colleen Hart-CarboneMs. Kathleen ClaytonMs. Lois HollanderMr. Stephen ConnKelsey Namara, The Capital Group Companies Charitable Foundation, in memory of Golda AzarMs. Jean ShermanMs. Deborah MarkowMs. Teresa ArledgeMs. Catharine LiddicoatMs. Gina MurrinMr. Steven BrowerM.J. FordMs. Nancy EastMr. & Mrs. Ben & Willie MountMr. James CelebuckiMr. & Mrs. Ronald L. TerryMr. Steve KallmanMr. Matthew Peterson, CreatureMrs. Nedra KimballMrs. Ruth ZimmersMs. Anna BowenMr. Michael Sampl, In honor of my wife, Joanne SamplMs. Corinna WongMrs. Jian LiPornchan Chankajorn
Dr. West May 8, 2009 – 9:24 pm
bayrealtor May 9, 2009 – 10:18 am
Hig,
Hig September 27, 2008 – 2:38 pm
I appreciate your thoughts on a 50/50 chance being better than no other option. To me, the bigger issue is that there are other options for patients who have only received first line therapy, so I am concerned that many people would not accept a randomization to potential placebo in this situation.
In terms of responses among patients with measurable disease, 6 were seen among 40 patients, with 5 in the middle or highest dose. A total of 59% had no progression after 16 weeks on treatment. However, looking at several of their highlight responses, I’ve seen far more convincing responses, and I just don’t feel completely confident that these aren’t improving pneumonitis, infection, or some other non-cancer process, at least in some of these patients. Apparently the physicians involved in the trial were convinced that these were true responses, but I’d really like to see a broader array of data to really be convinced that this can lead to tumors shrinking.
That said, this work looks intriguing enough that I really hope I’m wrong, that many patients are interested in enrolling and the trial accrues quickly. I’d be interested to hear whether people here would be willing to enroll on such a trial, or whether they would be unwilling to subject themselves to be randomized to a placebo in the maintenance setting after first line treatment.
Hello Dr. West!
Seems there is a buzz going on right now about lucanix. In previous posts I discussed my wifes case 35, asain non smoker with nscls 1st line was carbo/taxol & avastin, saw good results….changed to alimta due to low white blood cells on carbo, saw progression on alimta /avastin, now
on tarceva for 3 months with “dramatic improvement” in both lungs. Do you think she would qualify for this trail and do you think the vaccine may take away from the tarceva? She also has avastin once every three weeks based on a study showing avastin & tarceva have better results than tarceva alone. Is the avastin considered chemo that would exclude her, how about the tarceva? Would she be able to continue tarceva while on the trail? Lots of questions but again, we trust and hold your opinion in high regard.
Bill & Cathy
Dr. West November 11, 2008 – 9:42 pm
On further review of the data, results seemed best among patients who had achieved stable disease or better on prior treatment (although it’s pretty much this way with every treatment — “responders respond“). Combined with the rest of the findings, this led to development of a phase III clinical trial with up to 700 patients who have received prior chemo for advanced NSCLC and shown stable disease or better after first line treatment to then be randomized to active vaccine or placebo (50% chance of each). This trial is just getting started now (more information here). While I do think this approach is promising enough to be worth testing in a larger setting, and I think the early results desperately need to be compared to a control arm in a randomized trial to separate true treatment effect from the strong possibility of selection bias, I think this will be a very hard trial to complete. First, placebo-controlled trials are the easiest to interpret and “purest” in design, but the fact is that many patients are reluctant to enroll, especially American patients,Sale Ugg Boots, because they express an extreme aversion to being potentially randomized to a placebo. While it is ethically permissible to offer a placebo in a setting of “maintenance” where it’s not yet a standard to do anything but follow a patient who has shown a response or stable disease after first line therapy, I’ve written that I believe that the evidence is compelling enough that I would now be inclined to recommend an immediate transition from first line to second line treatment (see prior post). Finally, I think it will be challenging to get enough patients enrolled who have shown stable disease or responded to first line therapy and are now off of treatment, not yet on second line therapy, and not yet progressing. That’s really threading a needle, and trials that have had such a narrow window for enrollment have had a very difficult time accruing patients.
I think it’s a stretch to presume that there will be a 30-40 month progression-free survival on the lucanix arm. That may have been reported based on a few patients in an early trial, but I’d consider it extremely unlikely that these kind of results will really be seen in a larger, multi-institutional trial. The reason it’s got a placebo control arm is because we think there’s a real chance that the vaccine will actually prove to be no better than a placebo, or even do worse (I wouldn’t consider that likely). Larger trials almost always provide less impressive results than the smaller ones that preceded them.
Five years ago diagnosed with stage III-IV nsclc. Carbo/taxo in late 2003/early 2004; right lobe wedge resections April 2004; NED until Sept 2006; upper left lobe removed Oct 2006; some delay in recovery due to fistula; started Tarceva Mar 2007; some progression Dec 2007; started Carbo/Taxo/Avastin Jan 2008; good results started maintenance Avastin May 2008; PET due soon. Am doing well, still very active, softball, tennis, basketball, hiking, etc. Yet the big question, with all that behind me, is WHAT NEXT? If there were no other viable options (and I don’t know of any) I would be willing to take a 50/50 chance.
Hig
-Dr. West
相关的主题文章：
COMMENTS