My CO-1686 The Six-Minute Speech

Okay, folks! Let’s prepare for the water works. Get the tissues and handkerchiefs out. A tearjerker of a speech is just ahead.

First, for the speech writing class, here’s a small background. My handler emailed me the following outline for the speech:

You name and age

·         A brief sentence to share that Clovis support your travel – “Clovis Oncology supported my travel here today.”

·         A few sentences about yourself – your family, what you do for a living, connections with your community, etc. – all to give a picture of your life before your diagnosis

·         When you were diagnosed and your diagnosis – details you feel comfortable sharing about the severity of your diagnosis

·         A few sentences about what treatments you received prior to rociletinib and the success or failures of those treatments

·         Your experience with rociletinib and what adjustments and decisions you made with your physician – adjusting dose to manage glucose levels, any issues with rash but stayed on product as it was manageable

·         Your life since rociletinib – what you have returned to doing

·         Why you traveled to be at the meeting to share your story, what you want the committee to remember about your story as they consider their decision – e.g., The issue of resistance and need for additional therapies for patients with T790M mutation

I thought, OMG, how am I going to squeeze all that information in a written six-minute speech, actually shorter than that because I’d have to gasp for air after a comma, a longer gasp after a period?  That’s what my grade school teacher had drilled in my head. And since we’re talking about a senior babe whose age encompasses a huge chunk of a century, how will I condense an autobiography the size of War and Peace into a 4-1/2 minute piece of literature and still keep the essence of the story? Such a monumental task!  Enter the caped Inner Genius to whom nothing is insurmountable. Voila! The speech:

My name is Celia Ruiz Tomlinson. I am a 75-year-old lung cancer patient.

First of all, I thank the Board for allowing me to share my experience with lung cancer, and Clovis Oncology for making my trip possible.

I am a retired engineer/entrepreneur, a published author and a professional motivational speaker.

Growing up in a Manila slum awash with rotting trash and human waste, I transcended numbing poverty and became a civil engineer in the mid 1960’s when female engineers were unheard of. Buoyed by that success, I came to the United States in 1968 legally, alone with only $300 and my engineer’s diploma.  To my rude awakening, the American engineers confronted me with fierce resistance.  Through sheer tenacity, I gained acceptance.

In 1983 I founded an engineering company with $2000 from my own pocket. As its President and CEO, I grew the firm and received national entrepreneurial leadership awards. Twenty-five years later, in 2008, I sold the business and retired.

Four years into retirement, in the summer of 2012, I had a cough that didn’t seem to go away.  A visit to my doctor led to an image of a golf-ball-sized tumor at the bottom of my left lung and tiny nodules too many to count in both lungs.  Biopsy followed.  The diagnosis:  Non-small cell lung cancer, Stage Four. Prognosis:  8 months to live – a year at most.

True to character, I faced the dire prognosis with aplomb. But spunk alone can’t fight cancer. Drugs are needed.  At that time, FDA had just approved Tarceva for first-line treatment of my type of cancer.  My oncologist put me on Tarceva 150 milligrams daily.  No immediate side effects for one week.  On the eighth day, rash blanketed my face and chest.  The dosage was cut in half and the rash went away. After 100 days on Tarceva, the main tumor shrank 80%.  Subsequent CTscans showed stability.  My quality of life was good.

After 20 months on Tarceva, my oncologist suspected resistance and suggested that I participate in the rociletinib clinical trials.  Having qualified, I was accepted.

I took 1500 milligrams of rociletinib daily.  For four months, no side effects. My quality of life was great.  On the fifth month my blood sugar elevated. My oncologists and I worked with Metformin to control the hyperglycemia. Later we reduced the rociletinib dosage to 1000 milligrams.  One day I went on a 3-day drug vacation. When I resumed medication, the hyperglycemia mysteriously disappeared.

I have been on rociletinib now for two years, stable, with zero side effects the last twelve months. My awesome quality of life allows me to blog, inform and inspire other cancer patients.

Today is a far cry from that summer day of 2012 when the first oncologist sort of declared me “dead woman walking.” I implore the Board to please remember my story when deciding on the fate of rociletinib.  A cancer drug affects each patient differently.  It has been very good to me and other patients.  Therefore having more approved drugs is better than having less.

Thank you.

It was the quietest event in my platform speaking history. There was no laughter, no applause, nothing but the sound of my voice through the microphone and eerie silence.  It was a somber occasion, a plea for approval of a cancer drug.

Where’s the tearjerker? Just before blog post time, reliable sources informed me that the drug sponsor made a business decision to discontinue the pursuit of FDA approval of rociletinib, stop recruitment of participants for the trials, and focus its resources on the ongoing development of another more promising drug.  Rociletinib will never see commercialization. The cancer medicine brand “Poksceva” (that’s what my blog buddies and I named it!) will never be an option for non-small cell cancer patients with T790M mutation.

What about me?! I asked in horror. At this point, this is all about me. Your latest CTscans and blood work are still good. You’ll continue to be given the pills, my contact assured me. In other words, the program will be shut down through attrition. The pills contained in a silo somewhere in the Rockies are there for me.  Henceforth, it’s me and my CO-1686 against the world.  Okay, that’s just a touch of drama. I’m sure there are others out there in my situation.

Let’s conclude the post on an upbeat note. During the speech delivery, there were no stumbles. The word “rociletinib” tumbled from my lips perfectly enunciated at every mention, I toed the earnest line, and finished the speech under the allotted time.  The official timer, the noose man in the ceiling, never had a chance. A Blue Ribbon performance at Toastmasters Club! It’s time for a self-award.  Let me retrieve the calligraphy pen from the bequest box. Now, that definitely calls for a celebration.

Happy dance, Feisty Heifer!

 

 

My CO-1686: Speech! Speech!

Early last January, one top honcho of the CO-1686 trial sent me an email in which he swore me to secrecy. I was intrigued. My imagination immediately propelled me into the thick of a clandestine operation, the focus of endless conspiracy theories, and the stuff of  espionage. It happens when the blogger was, in the days of yore, delusional about being the next Bond girl opposite Sean Connery.

The subject of said email is now public knowledge, therefore the secrecy thing is so totally moot. However, while irreverence is a trait that I’m hell-bent to perpetuate through my DNA, I do respect privacy. The email went as follows, as is, punctuation marks or lack thereof, except as noted and edited for brevity.  Names of persons and places are fictionalized.

SUBJECT: A question for the diva

I have a question – well several questions I guess. 

First thing – how are you doing

Second thing – how are you doing on CO-1686 – side effects, any progression yet, and where are you getting treated now (I’m not sure what you call a patient who keeps changing doctors a polymedicinalist?)  I wanted to pick your brain re your general thoughts on the drug as company is contemplating FDA submission.  Let me know answers to above and maybe we could chat on phone as needed

——————————–

My response:

Hello, (mild expletive and term of endearment deleted)!
Nice hearing from you. What a pleasant surprise! 
First thing – I am fine. It’s scary.
Second thing – CO-1686 has been very good to me. Except for the four months in 2014 that I had the trial-induced hyperglycemia, I have had zero side effects. And the hyperglycemia resolved off Metformin. There has been no progression so far. I will start Cycle 32 this coming Tuesday, 26 January. I’m still under the care of Dr. Brevity at Club Med. 
I am the self-proclaimed Poster Senior Babe of CO-1686! 
I’ll be glad to answer any questions.   

—————————-

His Response:

Thanks

That’s great

The drug will go to something called ODAC (oncology drugs advisory committee) of the FDA – they will issue an opinion that FDA will consider re approving it on breakthrough status ………. hence the committee review. 

Company will present the efficacy and safety – academics will present the background and the risk/benefit overview.

And then they have an open session – it is not unheard of for patients to speak then – I was thinking about opening invitation both to someone who had a mess of side effects but benefit and conceivably you who had little side effects and benefit.

Despite your famed sense of humor – its vmery serious at the time and very tight timelines. Afterwards you can joke all you like : ) 

Interested?

—————————————

My Response

I’d be glad to help out! 

Just curious — while you’re at it, can you try to ask the company to spring for the airfare of my “assistant” (the one who will drive me to John Wayne Airport and everywhere)? You know me – Miss Daisy.

I am used to speaking within “blocked” time. No worries.
———————————————————————————–

Long story short, the diva did her part toward the advancement of a new cancer drug to the medicine cabinets of oncologists the world over. I spoke and shared my cancer story and positive CO-1686 experience at the ODAC public hearing on April 12, 2016 in Silver Springs, Maryland. I implored ODAC to accelerate the approval of rociletinib, the generic name of the trial drug that has been whipping my lung nasties for two years.

Details! Details! Blow-by-blow account!

Okay. It was a junket full monty.  Octo had been invited but unfortunately couldn’t go.

A spitting image of Downton Abbey’s majordomo Mr Carson emerged from an unstretched limo in front of my condo.  This vehicle would whisk me to John Wayne airport.  Mr Carson dutifully carried my small suitcase. Afterwards, he ushered me to the plush back seat where two bottles of spring water awaited. I secretly agreed that 4:30 a.m. was a tad early for fine wine, the kind with clove bouquet and earthy undertones. Then for the longest time he held the door open.  I looked up at the suited chauffeur whose silver hair made him look distinguished. I asked, Is there a problem? He pointed at the limo floor. There was my jacket, sprawled, half of it hanging over the parking lot pavement. OMG! It was a good thing I wasn’t wearing it! It happens when the perks exclude a lady-in-waiting.  So to the airport, to the next limo to the hotel, and to the event. Dining was awesome. At the end of the whirlwind tour, I was chauffered back to the airport then to my condo door, thus concluding the full-diva pampering.

I must confess:  I struggled to appear coolly unimpressed the whole time.  But I suspect all the subtle nudging assured my handlers that I’d show up at the hearing. Otherwise, I do have a tendency to wander aimlessly.

The ODAC edict allotted each speaker six minutes to read a speech – strictly six minutes or else! Afraid that a noose might drop from the ceiling and drag me by the neck if I spoke past six minutes, I wrote a 4-1/2 minute speech that allowed 1 minute for emotional pauses and 1/2 minute factor of safety.   It’s tough when a Drama Queen’s reputation is at stake. Full text of the stirring speech next post. Otherwise it drags this one.

The ODAC hearing ramrodders did a magnificent job of maintaining solemnity throughout the hearing.  The 500-some audience consisting of FDA bureaucrats, big pharma hot shots, press, speakers, caregivers, advocates, naysayers, students, and noseys behaved collectively like a choir.  It was so quiet that I felt like I was in the middle of a Catholic mass except there was no priest wearing a frock and being followed around by a pre-teen boy.

Bottom line: My speech failed to sway ODAC. They decided to not act on the sponsor’s application for accelerated approval of rociletinib. Instead, the board voted to wait for the results of Phase 3 of the CO-1686 clinical trials. Rociletinib will eventually be approved if I have to bawl and squall at the final ODAC hearing.

I’ve asked my closest followers to contain their enthusiasm to organize an event where I’ll be hoisted on shoulders to celebrate my stab at heroism. Nope. I was only one of the public hearing’s six pro-rociletinib speakers. One woman spoke against us. I memorized her face in case I decide to hold a grudge.

So, my takeaway from the whole experience? I met fellow blogger and Inspire member scifiknitter aka Anita Figueras, her daughter Ana, and son-in-law Michael!  I’m like the kid who informed her teacher about her first time at the zoo the past weekend. What did you see at the zoo? asked the teacher, expecting to hear breathless accounts of sightings of giraffes and camels. The kid happily exclaimed, I saw my Uncle Pedro! Anyway, Anita also spoke at the public hearing.  She posted an impressive summary of the ODAC proceedings.  Very thorough and informative. Here is the link:

http://scifiknitter.blogspot.com/2016/04/anitas-excellent-adventure-i-speak.html

What a tremendous experience it has been so far to be part of an historic event! I have been in on the development of a cancer drug – from qualifying for the trials through the motions of the drug approval process.  And feeling awesome to boot! Do we have some Amens there? This calls for a celebration.

Happy dance, Feisty Heifer!