The appointment this past week went well. Dad’s tumor markers are down from 3,735 to 1,750. That is a drop of more than 50% which is good news. At some point we should see this number level out but until then, we like it going down.

Dad is experiencing more side effects from the Tarceva than he did/does from the Gemzar. There are quite a few side effects listed on Tarceva’s website and so we are keeping our eyes on what is happening. The most obvious is the rash that is on his torso and face. He has been given something for that rash and it is expected to dissipate within 2-3 weeks.

His next appointment in next Wed morning, a little over 12 hours from when the Hong Kong contingent of the family arrives. Hopefully we see improvement. He has also been experiencing greater fatigue and wait to see if that will dissipate as well or is this typical of 12 weeks of chemo.

Once again, thank you for your prayers. We’ll keep you in the loop.

Round one goes to Gemzar!

The second scan shows an incredible improvement in every aspect. His tumor marker plummeted (147,000 to 3700), many of the spots on his liver were either gone or smaller, and the mass on his pancreas is smaller. I asked how often Dr. Dugan gets to share this good news with patients after round one, and he said only 25% of the time. From this point on, his treatment schedule will be three weeks on, one week off. They took him in for a treatment today in order to give him next week off so I am not sure when the 3/1 schedule will start.

At this point we are waiting for the insurance information to tell us if they will cover Tarceva. Tarceva is an oral chemotherapy drug that has shown good statistics when used with patients who have responded to Gemzar positively. He will be receiving a tumor marker check, which is a simple blood test, every month. His next scan will be in three months.

As you can imagine, we are happy with the results and look forward to sharing this news with many people. We do not have any info as to how this changes the prognosis however, we can assume it only helps.

Keep up the November support. There are pictures floating around of a large group of people wearing purple and as soon as I get a cpoy…hint hint…cough cough..hint…I will post that here.

FAIL! I have not updated nearly as well as I said I would. There are many reasons for that, but nothing worth trying to convince you with!

Last Tuesday was Dad’s 7th week of chemo which completes his initial round with the drugs. So far He has clearly won. He is up and about every day and is still doing most everything he was doing before. Today he had the 2nd head to toe scan as was planned. The scan went well and we pray that the results are clear and easily interpreted. We have a meeting scheduled next Friday the 20th in the am so you can be in prayer for that meeting. The plan is to have Deanne and Jon join us on a conference call from the office.

Right now, depending on the scan and the final decision by Dad, Dr. Dugan suggests that we add a drug called Tarceva to his regimen of Gemzar. This same website has some great videos explaining cancer and the treatment. Take a look if you have a few minutes.

 Thanks again for all of your comments. Mom and Dad read them regularly.

One of the beautiful things about living in the United States is that with 50 states, we can compare and contrast varying policies to see how well they work or how miserably they fail. We can also predict how national policy will play out by observing how a similar policy affects a particular state.

Oregon is a state that has Universal Health Care. According to KVAL of Eugene, Oregon:

So, why was it not approved by a state that promised Universal Care?

And here is the real kicker:

There is a sinlge word to describe the above situation: RATIONING.

You can access the complete article on-line here:

Health Plan Covers Assisted Suicide But Not New Cancer Treatment
Susan Harding
KVAL.com
July 31, 2008

It’s been four weeks since my last chemo. I’ve been working a lot lately and then last week, took time off to join Ken on a work trip to Shanghai. We had a great time. I always enjoy traveling with him. He always sees so much more than I do. He has such a sharp eye and I with all he shares I enjoy a much richer experience. Of course he had to work most of the time. But we were lucky to have all the evenings and an group outing together. A cold and fever put me out of circulation for a day.  It gave me a chance to read and relax. I picked up a book Ken had brought along, Lone Survivor. It’s a fast read about a SEAL teams’ experience in Afghanistan. The cough is still with me.

Monday Ken accompanied me to my routine CT. In the evening we celebrated our 1st wedding anniversary with a special dinner at Mr A’s. It was wonderful to remember our incredible day and all those that shared it with us.

Today we saw Dr B for the results. It was not anything I expected. The Taxotere quit working and my tumors have grown and there are new ones. The main one is about 2″ in diameter. My cough (which started a few days before we left for China) was attributed to the tumor blocking one of my airways. It’s given me a “Darth Vader” sound when breathing. It is leaving me short of breath. I’ve got an inhaler to help. This problem will be treated with radiation. The plan is to shrink it dramatically and hope it will stay small for quite a while. It can then be retreated as needed.

This is only tumor that is practical to treat this way. Chemo treatment is needed for the rest. The problem is which one. I’ve now exhausted 3 of the 6 traditional available treatments. Dr B advises I check into clinical trials available at the City of Hope and USC Norris. I am more likely to be eligible now than if I wait and use the other treatments now. We’ll be using the time while going through radiation treatment to meet with the oncologists and see which, I am eligible for. Then we’ll discuss the choices with Dr B.

I hope it will go quickly. With the tumor growth I’ve had with Taxotere, I don’t like getting no treatment at all for even a short while.

It was such an unexpected setback – and such a big one. For now, Ken and I are too stunned by the news and busy with all the new plans and appointments to be fully hit by it. At times we both struggle not to cry.

Today we’ve already met with a radiologist at the Cancer Center, had a preparation session (for my marker tattoos), and had my first treatment. I have treatments scheduled for the next two weeks – daily except for weekends. It only takes about 20 minutes and there is no pain at all. The most common side effects are  fatigue and, due to the area treated, a sore throat. My cough and shortness of breath will possibly get worse for a few days before it starts to improve.

The Federal Coordinating Council for Comparative Effectiveness Research, created to manage the $1.1-billion designated to support the comparative effectiveness research outlined in Obama’s American Recovery and Reinvestment Act of 2009, named 15 members on March 26th 2009. Those named are primarily clinicians attached to government departments, including the US Department of Health and Human Services, the National Institutes of Health and Food and Drug Administration.

While the council is not expected to make any recommendations concerning clinical guidelines for payment, coverage or treatment, it is to examine the needs of populations served by federal programmes and to build and expand on current investments and priorities. A strong emphasis of the Council is to ensure the interests of the diverse population are met. To this end the Council includes members with expertise in Medicare and Medicaid, minority health, disability and veteran health. On April 14th the Council is holding its first public meeting to gauge the impact comparative effectiveness measures could have on subpopulations.

Whatever the outcome of the public meeting, many within the pharmaceutical industry will be watching the Council carefully, keen to understand how its recommendations might affect their business. Critics of Obama’s Recovery Act have argued the drive for comparativeness effectiveness could hinder effective patient care and stifle drug innovation. Fears are also being aroused about the impact it could have on the overall profitability of new drugs on the market. As the journalist Jonathan Carey points out the push for comparative effectiveness could erode the high revenue stream Roche could inherit from Genentech’s portfolio of new cancer drugs, such as Avastin and Tarceva, whose comparative effectiveness against older and less expensive drugs remain unclear.

With the demand for comparative effectiveness of drugs and medical devices gaining increasing popularity, alliances with innovative biotechnology companies will likely become an increasingly attractive strategy for pharmaceutical companies needing to source innovative science that passes the comparative effectiveness hurdle.

On Tuesday I learned that I won’t be getting the trial drug. I qualified for the trial but lost the toss for the new treatment. I will be in the control group. I will be getting the standard of care, Taxotere. I don’t know how many cycles. But, it’s two weeks on, then one week off.

This makes my trial results 50-50. I got it the last time and missed out this one. Once I start a program, I will be disqualified from others. Hopefully, this will be effective on it’s own. It will at least be good to be getting treatment again. I am getting an occasional cough. My chest pains and back aches are easing. My earache and headaches continue. I will go through another brain MRI. It been about 3 months since the last one. It would be nice to know what’s going on.

So much has changed since last Tuesday. So much it feels like it’s been weeks since we got the bad news.

I’d expected to get about another year on Tarceva. Time I’d begun to count on has been snatched away. It’s devastating. We’ve now been through this a few times but it doesn’t get much easier. Lots of tears. More uncertainty. Another crossroads.

Since getting the news, I’ve been either working late or exhausted or both. No opportunity to blog. And there have been the new pains. Because of severe back pains several days in a row, I had MRI of my spine last Saturday. But, the results weren’t definitive. That can happen with most of these tests from time to time.

Then over the weekend I started getting more intense chest pains. By Monday morning it was constant and I was referred to the ER. I doubted it could be a heart issue, but I have been on a lot of different drugs with various side effects. There was also pulmonary emboli to rule out. For this, I had another chest CT. No PE. But, there is further noticeable disease progression – and in just two weeks. Not good – but I guess not entirely unexpected. So it’s pain management for now. And wait. The day at the ER was exhausting and aggravating. It was the entire day! I felt ignored and forgotten much of the time. Ken would have come in an instant. But, I insisted he get through his meetings. We were in phone contact as much as possible which helped. But, I learned my lesson. I won’t go it alone again. 

Dr B is recommending my next line of treatment be Taxotere along with another trial drug. It doesn’t have a catchy name yet – just a designation of letters and numbers. To qualify, I have to wait 3 weeks from the time I stopped taking Tarceva. Three weeks without treatment. Three weeks allowing the cancer to progress. The hope is adding the trial drug will squeeze more success out of the treatment than without it.

To make chemo easier I will get a port implanted. This will make treatments, blood draws, and other tests (with IV contrast) much easier. I know it’s the right thing and I am ready for it. But it doesn’t mean I am looking forward to having a foreign object in my chest with a tube resting inside a major artery. The procedure will be done next week. Then, if all goes well, chemo starts on the 17th.

In the meantime, I had a bone scan. It was a routine follow-up to the trial I’d been on. Dr B thinks it might also give some insight into my chest pains. We’ll know tomorrow.

I learned today the Tarceva is no longer working. Several new small tumors have appeared. There is good news. My abdominal tumor has not reappeared and my lymph nodes have not swollen again with cancer cells.

Needless to say, this has been a long, hard day. I am exhausted physically and emotionally. A good night’s sleep will get me up and going again. I will write more later.

Avastin + Tarceva = better results in lung cancer – Genentech said the trial was stopped early after an interim analysis found that combining Avastin, known generically as bevacizumab, and Tarceva, or erlotinib, significantly extended the time patients with non-small cell lung cancer lived without their disease advancing.

Amylin’s leadership under fire from Carl Icahn and others – “While we have not lost faith in the potential of Amylin’s products and pipeline, we have lost confidence in Amylin’s leadership to take this rich product portfolio and execute an operational strategy that is in the best interest of the shareholders…”

Does insulin help protect brains from the development of Alzheimer’s? – Insulin appears to shield the brain from toxic proteins associated with Alzheimer’s disease, U.S. researchers said on Monday, supporting a theory that Alzheimer’s may be a third form of diabetes.

PLUS – the usual rumor mill: blah, blah, blah…Sanofi-Aventis…blah, blah, blah…Bristol Myers-Squibb. You know the drill. And, business advice from the NY Times for navigating through a downturn.

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Dec. 17, 2008

After the CT, an ultrasound was scheduled to learn more about the nodules. This provided some useful information about their size and location, but also other ambiguous information. The next stop was the Endocrinologist. That involved a needle biopsy – actually several of them. And, once again, ambiguous results. This is not unusual for thyroid issues.

The next step is to make a decision to watch it by repeating the ultrasound or to biopsy it by removing it surgically. Next we will meet with a surgeon to learn more and then make a decision. I am not all that worried. The chance it is cancerous is small and, besides, thyroid cancers are not a big deal all things considered. They grow slowly and can be easily monitored and managed.  I have a brain MRI scheduled for next week and the week after, my routine CT for chest, abdomen, etc.

Based on how I am feeling, I think the medications are effective and I am doing well. Of course, it’s always great to get confirmation. The side effects are lessening. The hair loss has slowed to a normal rate plus I’ve become accustomed to having less of it. I am managing infections better and scarcely have rashes. As I try to do more, I notice my fatigue more. I simply can’t do as much as I used to. But, I am hoping that excercise will help to turn that around.

I still worry about each new ache or pain, but this comes with the territory. Dr B and nurse Erin,  are patient and supportive.

This week, I am on vacation. Ken and I are living on board a boat docked at Shelter Island and learning to sail it – all 42′ of it. It’s intimdating, but exciting. The weather is lousy. The rain doesn’t keep us from going out except when it’s too heavy to see. On deck, we get cold and wet with the limited gear we have. We intend to be fairweather sailors and didn’t plan on getting foul-weather gear. We now have bright yellow slickers but nothing to keep our feet dry.

Preliminary results of the PET scan indicate my medications are still working. Yeah!!! This is a HUGE relief. For now, I will continue on Tarceva and the trial medication.

I often get questions about the differences between a PET and CT scan. The simplest way I can explain it – as I understand it –  is PET scans indicate tumor activity while CT scans are a series of xrays that show shapes of organs as well as any abnormal objects. These can indicate a tumor, infection, or scar tissue, etc. The abnormalities are compared to sites of high metabolic activity on a PET scan to determine if any might have cancerous activity. ANd, BTW… a CT scan and a CAT scan are the same thing – Computed Tomography. PET stands for Positron Emission Tomography.

Monday, January 5th we saw Dr B for the test results and my routine exam. The brain MRI from the 22nd was clear. Still no explanation for the ache near my ear… but at least it doesn’t look like anything serious. Now for the not-so-good news. My CT results didn’t look good, at least the radiologist’s report was not good. It indicated the tumor is progressing – not a lot – but any progression is not good and reason to discontinue my current treatment. It’s possible it is an error. I will have a PET scan to get more information. The CT will also be formally reviewed for clarification. The PET scan is tomorrow morning. The two scans will be compared. I should know more by Friday.

I expected and hoped to get at least at year and a half from Tarceva and possibly more. It’s been very effective so far. My symptoms remain good. Hopefully, the PET scan will give us great news.

Ken and I got the CT scan results on Wednesday morning. The results are much better than expected. Yeah!! Dr B is now measuring the tumor in millimeters rather than centimeters. It’s not only smaller, it’s once again opaque looking instead of the dense blob it was in early July. It’s unbelievable!!

My hopes were kept in check by various little aches and pains in my chest and neck that come and go. Obviously, this is a poor indicator of my progress since the tumor continues to shrink and my lymph nodes remain normal in size. I am also encouraged because my abdomen remains clear and has since I finished chemo in May.

The tumors in my bones continue to get added treatment with Zometa. The improvement in the main tumor means my bones should be healing just as well. Dr B does not think the neck issues are related to the cancer. But, I’ll go through a neck CT on the 18th to be sure. I think it’s mostly for my peace of mind. Reducing anxiety being a part of treatment. : )

I have been working a lot of hours and haven’t been able to blog for awhile now. I managed to get seriously behind on things. I am doing well with my current medications. My immune system has been on a roller coaster but seems to have stabilized now. In early November I’ll have my next CAT scan and learn how well my current treatment is working. I am optimistic based on how I’ve been feeling. Fewer aches. Some side effects. But easier ones than I’d had before.

February 2008

A new hope lies on the horizon for lung cancer patients, as researchers at the University of California-Los Angeles expand their dual-drug therapy regimen to a larger group, following positive results reported February 1 in the Journal of Thoracic Oncology.

Researcher’s at UCLA’s Jonsson Cancer Center have found a series of significant biomarkers are reduced when a combination of a common anti-inflammatory drug is combined with a compound known to block cancer growth, and could lead to tests that would show a patient could forego the devastating impact of chemotherapy.

Fifty percent of the patients in the study showed either a reduction in tumor size of up to 30%, or no growth when combining Tarceva with Celebrex. In advanced lung cancer, “no growth” is considered a positive outcome.

Celebrex is the brand name for celecoxib, a medication manufactured by Pfizer for the treatment of arthritis, and is in the family of NonSteroidal Anti-Inflammatory Drugs (NSAIDs) such as ibuprofen and naproxen.

The team knew that in previous studies of the growth factor receptor blocker Tarceva, that some patients responded, while others did not, and that tests of blood and urine indicated that their response to the drug seemed to be linked to the amount of cycloxygenase-2 (COX-2) being produced. COX-2 causes inflammation, and is seen in 80% to 85% of lung cancer patients who are suffering from non-small-cell lung cancer.

The team, led by Dr. Steven Dubinett, is hopeful that the second phase of the study will allow oncologists to personalize treatment, prescribing drugs they know patients will respond to and sparing them from therapies that won’t work.

“We need good predictors of response to targeted therapy in lung cancer so individual patients receive the specific therapy that targets the particular molecular abnormalities of their tumors,” said Dubinett in a press release from UCLA.

Source:  Associated Content

[Tracey's Note:  I know this isn't an alternative therapy, per se, Mom.  But, it did seem like very interesting information to talk to your doctor about.  I don't know how toxic either of these substances are on the body, but they do seem to suggest it's much more tolerable than chemotherapy (which doesn't really work anyway) and this *did* show promise for reducing tumor size.  That's why I included it here.]

Phase III trial results show treatment with Avastin/Tarceva in patients with advanced NSCLC did not meet its primary endpoint (overall survival compared to Tarceva). Secondary endpoints of progression-free survival (PFS) and response rate when Avastin was added to Tarceva were however met.

Roche and Genmab are preparing to initatea phase II trial of IGF-1R MAb R1507 in NSCLC in combination with tarceva

The Sales Force Shuffle, from Pharmaceutical Executive – The last week the pharma atmosphere was abuzz with news about sales force cuts, outsourcing, and overhauls. First, Schering-Plough announced that it had eliminated the 1,000 sales positions it said it would trim in April. This is being done as part of a new sales model called—internally—a productivity transformation program (PTP). The new model, to go into effect next month, will streamline the sales force to take a more customer-centric approach, including targeted and relevant physician calls and a relationship management–oriented business model…more

Alpharma to King: No. – In a filing with the Securities and Exchange Commission, Alpharma calls the $37-a-share offer was inadequate and continues to explore all strategic alternatives, including a possible sale to King or another party for a higher price…more

Lilly CEO to Boston: you’re scaring us away – The ink is barely dry on a new law governing how drugmakers can market to docs, but Lilly’s John Lechleiter isn’t wasting time trying to make lawmakers regret their decision. In remarks to the Associated Industries of Massachusetts Executive Forum, he claims the law will hamper innovation and force companies to reconsider expanding in Massachusetts, The Boston Business Journal reports…more

B-I goes to the shrink – The drugmaker has ended a contract with InVentiv, one of the players in the Rent-A-Rep business, which was promoting its troubled Micardis, an angiotensin receptor blocker, otherwise known as a blood pressure med…more

The needle or the drug? – Acupuncture works as well as Wyeth’s antidepressant to fight hot flashes and other menopausal symptoms caused by breast cancer treatment, and its benefits last longer without causing unwanted side effects, according to new research…more

Pfizer’s Pfuture – The big drugmaker is dramatically stepping up sales efforts in emerging markets, overhauling US business operations and slashing more costs ahead of the 2011 patent loss for cholesterol blockbuster Lipitor, the Associated Press informs us…more Plus, going after emerging markets for growth

Paxil damages sperm? – A group of 35 healthy men who were given Paxil over a five-week period had higher levels of sperm with damaged DNA, according to a report..more

Medicis to re-state numbers; stock plunges.

Tarceva linked to liver damage - Genentech Inc and OSI Pharmaceuticals have alerted doctors about cases of liver damage among patients who took the cancer drug Tarceva in a post-approval study, U.S. regulators said on Tuesday…more

Takeda goes for diabetes combo – Takeda Pharmaceutical Co said on Wednesday it had applied for approval to market in the United States the SYR-322 and the Actos diabetes drugs in a single tablet for the treatment of type 2 diabetes…more

An interesting analysis on adverse event reporting, and social media.

Is the war on cancer really winnable? A realistic and pessimistic analysis from Newsweek.

OSI and Genentech have notified healthcare professionals that cases of hepatic failure and hepatorenal syndrome have been reported during use of Tarceva

Letter – OSI/Genentech; Updated label - OSI/Genentech

As for more info on the CT results… the main tumor is about 50% smaller than in my last scan in early July. It’s also much less dense looking. The lymph nodes in my chest are back to normal size as is the surrounding tissue. The tumors in my vertebra and ribs were not particularly noticeable and are presumed under control. It is all much better than I expected or hoped. I am feel like I can make some plans again… like traveling and taking sailing lessons with Ken. 

I am feeling well other than tiring at the end of the workday. My little aches and pains are minimal. That encourages me, too. I am still not managing my stress levels well or getting much exercise – but working on it. With my medication, Tarceva, working so well I feel more hopeful in many ways. I know I am fortunate to have such great response and with minimal side effects. My rashes are gone, having run their course. It’s possible they may or may not return. The mouth sores are healing and under control. Biotene rinse has helped – a lot. Now have a case of acne reminiscent of high school days. My scalp is pink and tender and, sadly, my hair is thinning. Thankfully, it’s not in the typical chemo way, in clumps. It’s still another challenging thing to cope with. I am also dealing with dry hands and cuticles and tender finger tips. These are all among the typical side effects. It’s hard to complain, since the medicine is working so well.

Local San Diego volunteers are putting together a 5K walk for March 8. It’s about awareness of lung cancer and fund-raising for research. If you are interested in learning more about it, the link is www.SanDiego BreathOfHope.org. Ken and I plan to participate.