Squamous - IV, Substantial Tumor Shrinkage, Trial Drug, Nivolumab, BMS-936558 - 1255664

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chucksan
Squamous - IV, Substantial Tumor Shrinkage, Trial Drug, Nivolumab, BMS-936558 - 1255664

First post. My wife was diagnosed July 2012 with possible NSCLC after 6 weeks of back pain while in Japan. Returned to Seattle for further diagnosis with severe pain. Opiates and Ibuprofen work. Initial consultations with primary care doctor and general oncologist, neg brain MRI and stage 2-3. PET scan ordered. She wanted second opinion.

Referred to a cancer center in Seattle. We asked to see their best lung cancer oncologist. He found stage 4 squamous, L lung tumor + spine/rib/lymph. Shocked but extremely impressed with his academic credentials and liked his personable but very disciplined professional demeanor. Cisplatin/Gemzar and then Carboplatin/Gemzar chemo during August, September and early October. After a CT showed little improvement, strong fatigue, nausea and low blood counts he discontinued the chemo. Three choices for a third line approach, none of which she was enthused about. He mentioned a new trial drug soon to be out in phase three, showing promise.

She opted to wait on the trial drug and visit her family in Japan for 2.5 months. We consulted with a top cancer MD there for future care in Japan. He also thought this trial drug was the best chance for positive results. She was off cancer drugs for three months. We returned to Seattle in mid January and her pain level was very high. 180mg of Oxycontin/day plus ibuprofen very helpful.

She applied for the trial, was accepted and randomized (50/50) for the trial drug versus the comparison drug, Docetaxel. She has been on the trial anti-PD-1 drug, Nivolumab/BMS-936558, every two weeks. She just finished #6. Right after #1 (Jan 28) the pain started down quickly. The last 8 weeks or so she has had no pain, no nausea and no side effects! Recent CT between #4 and #5 showed very substantial tumor shrinkage and no spread.

Thank you to the Swedish Cancer Institute, the trial nurses and our oncologist, Dr. Jack West for your wonderful and loving care! Arigato!

catdander
Reply To: Squamous – IV, Substantial Tumor Shrinkage, Trial Drug

chucksan, How absolutely fabulous your wife is doing so well! As you can tell from my signature I have more than a passing interest in this treatment.

Thank you for sharing your story and so glad to hear from one of Dr. West's patients (yea, you're a patient too in another manner of speaking).

Looong may the results last.

Congratulations,
Janine

tikicat
Reply To: Squamous – IV, Substantial Tumor Shrinkage, Trial Drug

So glad your wife is responding. I had similar symptoms and diagnosis, and I am having the same kind of results with MK 3475, another anti-PD-1 drug. I have started an anti-PD-1 email group if you or your wife would like to join.

chucksan
Reply To: Squamous – IV, Substantial Tumor Shrinkage, Trial Drug

Thanks Janine and FeistyD for your kind responses and all the best to you.

I write for us as English is my wife's second language. Even though she was a long time smoker who quit about 8 years ago, this was still a shock and we were devastated at the stage 4 diagnosis at age 55. Although she has retained as positive an attitude as possible the future wasn't overly rosey. I have been the online cancer research student and her 24 hour nurse as we are in this as a team. She still cooks (she is a marvelous Japanese and American chef) and talks daily to her 84 year old cancer survivor mother who still works 6 days a week in Japan at the family shop.

We feel very blessed and fortunate to have found such a brilliant oncologist as Dr. Jack West and our lucky timing to qualify for and draw the trial drug. Noriko has found hope for the future and feels like a young woman again. We plan on returning soon to Japan during our 2 week break to visit family and Musashi (the lovable family long haired Dachshund).

We hope her good progress continues. The care at the Swedish Cancer Institute has been so friendly and professional she has been very pleased.

Bless All At Grace,
Chuck

Dr West
Reply To: Squamous – IV, Substantial Tumor Shrinkage, Trial Drug

Chuck,

Thanks so much for your kind words. I'm thrilled for you and Noriko, and I'm very gratified myself to see what is possible. As much as I "knew" from what it could do based on academic presentations and discussions with colleagues, it's more impressive to see with your own eyes and learn of the impact on patients you come to care about. And it's exciting to know that this can help more people over time as well.

May it be remarkably helpful for a very, very long time. I look forward to continuing to work with you both!

-Dr. West

+++++++++++++++++++++++++
Dr. Howard (Jack) West
Associate Clinical Professor
Medical Oncology
City of Hope Cancer Center
Duarte, CA

Founder & President
Global Resource for Advancing
Cancer Education

certain spring
Reply To: Squamous – IV, Substantial Tumor Shrinkage, Trial Drug

That's fantastic news, chucksan.
Could someone just confirm, as it might be useful information for others, that this is the trial in question?
http://www.clinicaltrials.gov/ct2/show/study/NCT01673867
If that's the right one, it's Phase 3 and there are multiple locations around the world.

chucksan
Reply To: Squamous – IV, Substantial Tumor Shrinkage, Trial Drug

Hi Certain Spring, to the best of my knowledge the study you link is a slightly different trial. It says:

"Subjects with histologically or cytologically-documented locally advanced non-squamous cell NSCLC who present with Stage IIIB/IV disease or recurrent disease following radiation therapy or surgical resection"

I believe there are a number of different trials by BMS using this same drug. The specific study trial that Noriko is on is for squamous cell, NSCLC. The title of her study is:

An Open-label Randominzed Phase III Trial of BMS-936558 versus Docetaxel in Previously Treated Advacned or Metastic Squamous Cell Non-small Cell Lung Cancer (NSCLC)

Protocol NO: CA209017
WIRB Protocal #20121428
5322W-12

BMS-936558 is now also called Nivolumab and was previously known as MDX-1106 (Medarex, US) and ONO-4538 (in Japan, Korea and Taiwan). BMS (Brystol-Meyers Squibb has the worldwide rights for lung cancer except for Japan, Korea and Taiwan. ONO pharmeceutical is mainly testing this drug for melanoma and renal cancer.

I believe this below link is to the correct trial that Noriko is on. Note, some of the other trials with BMS-936558 are very similar with a few differences like squamous or non-squamous and Phase I, II or III, etc.

http://www.clinicaltrials.gov/ct2/show/NCT01642004?term=bms-936558+nsclc...

Worldwide study locations here:

http://www.clinicaltrials.gov/ct2/show/study/NCT01642004?term=bms-936558...

Hope this helps and all the best to you Certain Spring!

Chuck

:-D

chucksan
Reply To: Squamous – IV, Substantial Tumor Shrinkage, Trial Drug

Dr. West, we both decided right after the first visit that you are Noriko's certified permanent oncologist. You are stuck with us both for a very long time.

Thank You, Arigato Gozaimasu! C & N :mrgreen:

certain spring
Reply To: Squamous – IV, Substantial Tumor Shrinkage, Trial Drug

Great, thanks for explaining about the two different trials. Best to you and your wife.

Dr West
Reply To: Squamous – IV, Substantial Tumor Shrinkage, Trial Drug

They are parallel trials with the same design and eligibility except that one is for patients with a squamous NSCLC, while the other is for patients with a non-squamous NSCLC. I suspect that most participating centers are offering the pair, so that they can essentially enroll appropriate patients irrespective of their particular NSCLC histology.

-Dr. West

+++++++++++++++++++++++++
Dr. Howard (Jack) West
Associate Clinical Professor
Medical Oncology
City of Hope Cancer Center
Duarte, CA

Founder & President
Global Resource for Advancing
Cancer Education

b-1 83
Reply To: Squamous – IV, Substantial Tumor Shrinkage, Trial Drug

Great to see new stuff coming out and folks responding! It's only a matter of time until we beat this terrible disease.

certain spring
Reply To: Squamous – IV, Substantial Tumor Shrinkage, Trial Drug

Good to hear from you, B-1 83, and hope you are doing OK.

chucksan
Reply To: Squamous – IV, Substantial Tumor Shrinkage, Trial Drug

UPDATE, May 27, 2014

Noriko started on Nivolumab, PD-1 Immune Checkpoint Inhibitor, in late Jan, 2013. All went very well thru early Summer of 2013. She had significant shrinkage of the lung tumor and no pain or side effects. Then over several months she started to experience inflammation of the axillary underarm lymph nodes and daily fevers. Her symptoms seemed similar to those of Kikuchi's Disease (histiocytic necrotizing lymphadenitis). In July 2013, Dr. West started her on steroids and discontinued the Nivolumab. A biopsy eliminated the possibility of lymphoma. The last day of August with a high fever she went to the ER and ICU for three days. By release day her fever was gone and treatment with steroids and anti/biotic/fungal/viral (for several weeks) her fever did not return and the lymph issues slowly subsided. Dr. West put her on Celebrex, 200mg, 2X day and started her back on Nivolumab in October after she went off the steroids.

She continues to have no pain or side effects. She has an Xgeva shot very 8 weeks for the mets in her spine and ribs. A CT scan every 6 weeks shows continued shrinkage of the tumor from about 8cm x 7.5cm in Jan 2013 to presently about 1.4cm x 1.0cm in May 2014 (approx 85% reduction). There are no indications of new metastasis or inflammation. With the 3 month break, she's had about 12 months of Nivolumab, 28 bi-weekly infusions. Her labs are good and she feels very well. Dr. West (bless him) has allowed her to travel home to Japan for a family visit several times during her two week infusion breaks.

I feel hesitant to post about her mostly wonderful progress so far since there are folks who have not had such good results and some who have sadly lost the fight. May Noriko's blessings so far be contagious. We hope the good results with the immunology type drug continue.

Thanks to our eminent oncologist, Dr. Jack West and his wonderful staff at the Swedish Cancer Institute.

Chuck & Noriko

JimC
Reply To: Squamous – IV, Substantial Tumor Shrinkage, Trial Drug

Hi Chuck,

Thank you for the update on Noriko. It is always heartening to hear of great responses to treatment, so you should never hesitate to share your good news. During my wife's battle with cancer, I always appreciated such reports for the hope they gave me. I often shared them with Liz, and they did help instill hope in her as well. Of course I wish that some current treatments were available for her, but on the other hand she had access to therapies that didn't exist a short time before her diagnosis, and she received benefit from them. I just want treatments to continue to improve until cancer is at worst a manageable, chronic disease. Patients aren't in competition with each other; the common foe is the disease. We're all in this fight together, and that's why we're here to share knowledge and experience.

Wishing Noriko continued success with Nivolumab.

JimC
Forum moderator

<p>I began visiting GRACE in July, 2008 when my wife Liz was diagnosed with lung cancer, and became a forum moderator in January, 2010. My beloved wife of 30 years passed away Nov. 4, 2011 after battling stage IV lung cancer for 3 years and 4 months</p>

sawyer6
Reply To: Squamous – IV, Substantial Tumor Shrinkage, Trial Drug

Hi Chuck,

I would just like to second what Jim said about great responses -- my dad is only about two and half months into his fight with lung cancer, but information about your wife's treatment gives us much needed hope for what future treatments may bring. Congratulations on your wife's response to the trial drug and I hope your wife continues to have an excellent response.

Best,

Seth

chucksan
Reply To: Squamous – IV, Substantial Tumor Shrinkage, Trial Drug

Thanks Jim and Seth for your kind words ..... yes there is hope! We do feel blessed that Noriko is experiencing such good success with her Nivolumab immunology drug after a rough start with several combos of Gemzar with Cisplatin/Carboplatin.

Up to Jan 2013 she was off chemo for almost 3 months and experiencing very high pain (180mg Oxy per day). BTW, we found that an OTC anti-inflammatory drug like Ibuprofen worked even better than the opiates for her pain which seemed to be the tumor pushing against the spine and ribs which had mets. After one week on the PD-1 drug the pain was gone.

I feel there is some luck involved as in being selected by computer to receive the trial drug itself. Otherwise, I have to give us both credit for lots of research on lung cancer treatment and what we feel is most important. We live in a large metropolitan area and asked for a second opinion after first consulting with a general medical oncologist recommended at our clinic. We both wanted a second opinion and our primary care doctor was very supportive and referred us to the Swedish Cancer Institute. We requested the oncologist that most specialized in lung cancer in the West (pun intended!). In walked Dr. Jack West and we had an immediate bonding with this marvelous oncologist and his very knowledgeable and caring staff. The formula for us was: select one of the best cancer centers in your area + select one of the best lung cancer oncologists at that center + be open to a clinical trial drug if available = the best chance of success.

In July of 2012, Noriko was originally given an estimate for stage 4 squamous NSCLC survival of about 8 months or so. She is now going into her 23rd month while feeling very well.

JimC
Reply To: Squamous – IV, Substantial Tumor Shrinkage, Trial Drug

Hi Chuck,

Those of us who have been active on GRACE for a while (I began using this site in July, 2008) are just a bit biased in our admiration for Dr. West, both as a caring physician and an innovator in cancer education. Your story is a good example of exactly what he wanted to achieve by creating the GRACE site - enabling patients and their caregivers to be informed and empowered, true partners in their own health care decisions. I agree that you and Noriko deserve much credit for her successful treatment.

JimC
Forum moderator

<p>I began visiting GRACE in July, 2008 when my wife Liz was diagnosed with lung cancer, and became a forum moderator in January, 2010. My beloved wife of 30 years passed away Nov. 4, 2011 after battling stage IV lung cancer for 3 years and 4 months</p>

chucksan
Reply To: Squamous – IV, Substantial Tumor Shrinkage, Trial Drug

UPDATE: August 14, 2014

Two Year Survival, stage 4, squamous cell, NSCLC!

Dr. West diagnosed Noriko with stage 4 squamous NSCLC on August 14, 2012. She continues to do very well on her bi-weekly infusions of Nivolumab, BMS 936558. There is no indication of further metastasis and the lung tumor is tiny compared to the original size, maybe 15% or less. She is experiencing no noticeable side effects and her labs are all good.

We are both amazed and so thankful for her progress on this clinical trial drug. Perhaps this might offer hope to others for possible treatment in the future with further testing and advancement of immunotherapy cancer drugs.

There are no words that can adequately express our heartfelt thanks to Dr. Jack West, the Seattle Swedish Cancer Institute and staff, and Bristol-Myers Squibb.

Chuck & Noriko :-D

JimC
Reply To: Squamous – IV, Substantial Tumor Shrinkage, Trial Drug

Hi Chuck & Noriko,

Thanks so much for sharing another update with such terrific news! It's always so heartening when someone finds just the right drug, one which works so well for them.

Continued success with Nivolumab, and keep these great updates coming!

JimC
Forum moderator

<p>I began visiting GRACE in July, 2008 when my wife Liz was diagnosed with lung cancer, and became a forum moderator in January, 2010. My beloved wife of 30 years passed away Nov. 4, 2011 after battling stage IV lung cancer for 3 years and 4 months</p>

Dr West
Reply To: Squamous – IV, Substantial Tumor Shrinkage, Trial Drug

I'm very happy for both of you. Nivolumab has been remarkable for Noriko; it's just wonderful, especially how well it has worked, and for as long as it has worked with no suggestion of losing ground.

Congratulations on her important milestone.

-Dr. West

+++++++++++++++++++++++++
Dr. Howard (Jack) West
Associate Clinical Professor
Medical Oncology
City of Hope Cancer Center
Duarte, CA

Founder & President
Global Resource for Advancing
Cancer Education

chucksan
UPDATE ----- Three Year Lung

UPDATE ----- Three Year Lung Cancer Survival! ----- Stage 4, Squamous Cell (NSCLC) Lung Cancer.

I just wanted to update all of the good folks here on Noriko's continued battle with cancer and her three years of survival. We feel so blessed at her amazingly positive results since she started 31 months ago on the clinical trial drug Nivolumab (now brand name Opdivo) from Bristol-Myers Squibb which was FDA approved in March, 2015. She is now off the clinical trial so she can receive the drug on a less frequent commercial prescription basis (now every 4 weeks versus every two weeks before). Of course the frequency of infusion can be adjusted up or down as her oncologist recommends.

She is feeling very well with almost no side effects for the last 4-5 months. Tests show no spread of the cancer and the original tumor is now very small, about 0.9 x 1.6 cm's versus 7.5 x 8.0 cm's 30 months ago. Her oncologist cautions us that it is possible in the future at some time that the drug will cease to give positive results and that we would need to consider alternative drugs. We will keep out fingers crossed that she continues to do well.

Thanks so much for all the continued support, caring comments, thoughts and prayers. Thanks to Bristol-Myers Squibb, Swedish Hospital Seattle Cancer Institute, and especially to Noriko's esteemed lung cancer oncologist Dr. Jack West and his extraordinary crew.

Chuck

chucksan
Stage 4 Squamous Cell Lung

Stage 4 Squamous Cell Lung Cancer IN REMISSION!

11-1-2016, Dr. West ordered a PET/CT scan the morning before Noriko's now every 8 week infusion of Opdivo (Nivolumab). He came into the exam room with the biggest smile I had ever seen on his face. He said:

Good news! The scan shows no sign of cancer and you are in remission.

Noriko and I are of course ecstatic after a 53 month battle since we first knew she had lung cancer and 51 months since Dr. West gave her the Stage IV diagnosis. She had been on Opdivo for 45 months after two failed regimens of chemo. She now only has a few arthritic symptoms in her lower legs, possibly a side effect and we are currently consulting with a rheumatologist.

There is hope for stage 4 lung cancer!

Thanks so much for all the support, caring comments, thoughts and prayers. Thanks to Bristol-Myers Squibb, Swedish Hospital Seattle Cancer Institute, and especially to Noriko’s esteemed lung cancer oncologist Dr. Jack West and his extraordinary crew.

Chuck & Noriko :mrgreen:

JimC
Hi Chuck and Noriko,

Hi Chuck and Noriko,

That is just fantastic news, and we appreciate your sharing it with all of us here on the GRACE site. We love hearing success stories of this kind, and we hope to hear many more good news updates from you in the future!

JimC
Forum moderator

<p>I began visiting GRACE in July, 2008 when my wife Liz was diagnosed with lung cancer, and became a forum moderator in January, 2010. My beloved wife of 30 years passed away Nov. 4, 2011 after battling stage IV lung cancer for 3 years and 4 months</p>

lgg1918
Such wonderful news! Thank

Such wonderful news! Thank you so much for posting this.
And I'm not surprised about your comment re: Dr. West et al. Having read many of his posts, I find his dedication to all patients facing cancer nothing short of remarkable.
May your wife's courage and determination be contagious............!