12 months free of disease with clear CT scans: What is next?

I have a similar story. I have been NED for 10 months. Now my markers are going up over the past 16 weeks. CA19-9 is 612--previous in the mid-30s. I wondered if we should treat right away, but there are no tumors on the scan, and he does not believe in treating based on numbers alone. He is extremely qualified and experienced so I believe him. He says the only reasons to treat with chemotherapy is if chemo will either 1) make you feel better or 2) make you live longer. And in my case, neither is true. Like your husband, I feel wonderful with no problems or symptoms. According to the research, he says that early chemo (with nothing solid to treat) would only harm my quality of life and would not increase my longevity. I hope this is helpful. Beth

When I was treated for metastatic disease to my liver from 2012-2014, I was aware that in many instances metastatic disease returned after completing the recommended 12 cycles of Folfirinox. From a professional career in clinical cancer and immunology research, I had an awareness of minimal residual disease (MRD) and what the term NED means. One question I had was why 12 cycles were chosen. Coming from a research background I assumed there were clinical studies done showing the efficacy of doing 12 cycles. Despite a lengthy search, I could not find any scientific paper giving the reason why only 12 cycles was chosen and what the risk is of MRD resurfacing.

My search led to some of the clinicians that did the studies on Folfirinox and comparison studies against Gemzar and Gemzar plus Abraxane. And what I learned surprised me. Twelve cycles was chosen essentially by a consensus of oncologists whose opinion was it being an amount that most could tolerate will having acceptable side effects-namely peripheral neuropathy for a patient to achieve NED.

The term NED can be misconstrued as being “cancer-free”. What it means is that the disease has been knocked down to a point below the detection limit (threshold of sensitivity) that current imaging can not see MRD. There can be circulating tumor cells or disseminated tumor cells that have found a location conducive to surviving. As long as one’s immune system is robust, the hope is that it will keep any of these cells in-check. If the immune system is challenged or weakens, micrometastatic disease that had remained quiescent can resurface and the same or another chemotherapy regimen needs to be implemented.

It was for this reason I advocated with my oncologist to go beyond the 12 cycles-essentially doing as many as I could tolerate in an attempt to destroy any MRD and truly be cancer-free as in cured. No one thought it possible being stage IV and Folfirinox was only FDA approved in 2011…approximately 9 months before I was diagnosed. I was 55 at the time and my physical condition was otherwise excellent. I had no other co-morbidities, never smoked, did not drink and had a healthy diet. My oncologist agreed and he decided rather than get continuous Folfirinox treatments every 15 days, after 6 cycles the Oxaliplatin and Irinotecan would be removed to give my body a rest and hopefully lessen the neurotoxic effects of the oxaliplatin. After six resting cycles, I went back on Folfirinox and this alternating dosing continued for 24 months until a total of 46 cycles were completed (24 of Folfirinox and 22 of 5-Fu with Leucovorin. After a two week wash-out period, I entered a clinical trial for maintenance monotherapy. At almost 4 years I achieved NED and at 10 years was being told by a number of oncologists they consider me cured.

Was it the additional Folfirinox I had, the targeted maintenance monotherapy or a combination of the two that achieved a cure is not certain. What I do know is that going beyond 12 cycles and looking for treatment beyond standard of care likely made the difference. It was challenging going through that length of treatment but my physical condition allowed me to persevere. For those whose objective is long-term progression-free survival and having no significant co-morbidities, they should discuss with one’s oncologist about going beyond standard of care. I am not a datapoint of n=1. I have meet others that we’re dealing with metastatic disease and advocated for doing beyond standard of care. As a result, they have survived 5 or more years without any signs of reoccurrence.

When I was treated for metastatic disease to my liver from 2012-2014, I was aware that in many instances metastatic disease returned after completing the recommended 12 cycles of Folfirinox. From a professional career in clinical cancer and immunology research, I had an awareness of minimal residual disease (MRD) and what the term NED means. One question I had was why 12 cycles were chosen. Coming from a research background I assumed there were clinical studies done showing the efficacy of doing 12 cycles. Despite a lengthy search, I could not find any scientific paper giving the reason why only 12 cycles was chosen and what the risk is of MRD resurfacing.

My search led to some of the clinicians that did the studies on Folfirinox and comparison studies against Gemzar and Gemzar plus Abraxane. And what I learned surprised me. Twelve cycles was chosen essentially by a consensus of oncologists whose opinion was it being an amount that most could tolerate will having acceptable side effects-namely peripheral neuropathy for a patient to achieve NED.

The term NED can be misconstrued as being “cancer-free”. What it means is that the disease has been knocked down to a point below the detection limit (threshold of sensitivity) that current imaging can not see MRD. There can be circulating tumor cells or disseminated tumor cells that have found a location conducive to surviving. As long as one’s immune system is robust, the hope is that it will keep any of these cells in-check. If the immune system is challenged or weakens, micrometastatic disease that had remained quiescent can resurface and the same or another chemotherapy regimen needs to be implemented.

It was for this reason I advocated with my oncologist to go beyond the 12 cycles-essentially doing as many as I could tolerate in an attempt to destroy any MRD and truly be cancer-free as in cured. No one thought it possible being stage IV and Folfirinox was only FDA approved in 2011…approximately 9 months before I was diagnosed. I was 55 at the time and my physical condition was otherwise excellent. I had no other co-morbidities, never smoked, did not drink and had a healthy diet. My oncologist agreed and he decided rather than get continuous Folfirinox treatments every 15 days, after 6 cycles the Oxaliplatin and Irinotecan would be removed to give my body a rest and hopefully lessen the neurotoxic effects of the oxaliplatin. After six resting cycles, I went back on Folfirinox and this alternating dosing continued for 24 months until a total of 46 cycles were completed (24 of Folfirinox and 22 of 5-Fu with Leucovorin. After a two week wash-out period, I entered a clinical trial for maintenance monotherapy. At almost 4 years I achieved NED and at 10 years was being told by a number of oncologists they consider me cured.

Was it the additional Folfirinox I had, the targeted maintenance monotherapy or a combination of the two that achieved a cure is not certain. What I do know is that going beyond 12 cycles and looking for treatment beyond standard of care likely made the difference. It was challenging going through that length of treatment but my physical condition allowed me to persevere. For those whose objective is long-term progression-free survival and having no significant co-morbidities, they should discuss with one’s oncologist about going beyond standard of care. I am not a datapoint of n=1. I have meet others that we’re dealing with metastatic disease and advocated for doing beyond standard of care. As a result, they have survived 5 or more years without any signs of reoccurrence.

That is very helpful- my husband has completed 12 months of gemabraxane with a trial drug and they plan to start Fulforinox next. He is also in great shape going into this and keeping up exercise - gives me hope. Thank you !