More chemo?

[Basil]

Well, I'm annoyed and a bit apprehensive. Per my signature line, I had a complete response to six rounds FOLFOX. Still had a LAR and am sporting a temp ostomy. My surgeon, who is also my PCP at MDAnderson, told me directly that I am "low risk" for recurrence and, not only do I not need further chemo, I won't even need a surveillance scan for a year. My reversal is already scheduled for next month. I got that info on August 2 and have been - relatively speaking - on cloud nine since then.

Then today I received a message that my surgeon and oncologist have talked and I need to come in to discuss further treatment, i.e., further chemo. I don't imagine he wants to see me to pat me on the back and reiterate that I don't need any further treatments. I already have neuropathy, which has gotten slightly worse since my last infusion in June and it's going to put me in a tough spot if the onc recommends more FOLFOX. I know I'll do it but really don't want to.

I guess cancer is the gift that just keeps on giving.

[Hopefulprayers79]

Are you in Jacksonville, Florida?

[Tdubz]

Sorry to hear that basil. Is it normal for surgeons to make decisions regarding chemo? My personal experience has been the surgeon just handled the surgery and the oncologist handled everything else, but I did not go to a major cancer center like mda so my experience could be different. It's pretty standard to get adjuvant chemo for us stage 3's right?

[Basil]

My surgeon is definitely running the show but I do not think that is the norm. He's a research dr., listed as my primary doctor and is much more involved than just doing the cutting. I think the confusion has to do with the recent study that found 6 rounds of chemo was nearly as effective as 12 for certain stage iii folks. Months ago, when the study was released, I asked my onc about it and he said standard of care would remain 12 rounds for him but he would feel much better about discontinuing early.

When my path report came back, my surgeon cancelled further chemo and set my reversal early (it would have to be months later if FOLFOX was in my future). Now they want to bring me in to talk about it and my fear is I'll hear some variation of, "We think you are good to go as is but would recommend adjuvant chemo just to be sure." If so, I'll do it because it's cancer and needs to be dead. But it will suck and I'm at risk for long-term neuropathy.

I'm in Houston, BTW.

My surgeon

[Lee]

Basil,

So sorry this happened to you. Through the years I've learned a surgeon should call the shots regarding surgery and not oncology and an Onc should call the shots regarding chemo and stay clear of surgery type calls.

I'm sure your surgeon is top notch (MD Anderson says a lot), butt if Onc says chemo, do the chemo.

Lee

[Basil]

Thanks - I will almost certainly do what the onc says but the surgeon, who has a slew of titles and credentials in addition to being a cutter, appears to be the Godfather of this whole operation. If push were to come to shove (and it won't) I'd probably do what he says.

I had one medical provider at MDA tell me that dr. [surgeon] isn't a brain doctor but if she got brain cancer, he's who she's calling to take it out. Not a direct reflection of his onc skills but certainly a vote of confidence in his overall skill!

[prs]

Basil, I don't know anything about the PROSPCT trial you were in. Is it possible they are starting to get results from the trial that are leading them to re-evaluate the treatment?

[Basil]

That's very unlikely. PROSPECT results have been very good from what I've been told.

More importantly, the path complete response I had was statistically only about 4% likely and (obviously) the best result you can get from a post-surgery path report. Bottom line is they could never find evidence of cancer outside the primary and one LN. After chemo, there was no tumor and all 42 LN were negative. They biopsied other specimens (which I cannot now recall) and they were all negative as well.

I'm happy and grateful for my overall situation but still do not like the prospect of further oxi. Any adjuvant treatment at this point would be "mop up" or "just to make sure." If it's in my best interest, I'll tolerate it but I was very optimistic when further chemo was initially cancelled. Just sucks to get the "not so fast" message.

[TXLiz]

Sorry for the (probably) continued chemo. If MDA told me to do it though, I'd probably do it.

How do they calculate your risk for long term neuropathy?

[JJH]

Basil -
I have a rather different interpretation about your situation there, but before I go into a long discourse about this I would like to ask whether you are, in fact, a registered patient in the PROSPECT trial and,if so, did they ask you to sign an Informed Consent document for that particular trial? The alternative might be that you were treated off-the-record according to the PROSPECT trial protocol but were not actually registered as one of their patients.

The difference is that if you are registered as an official member of that trial, then they are obligated to follow the protocol for that trial, but if you are just an ordinary, unregistered, patient for whom they decided to try the PROSPECT protocol, then they are not required to follow the protocol to the letter.

In my opinion, there are two documents that are particularly relevant in your case.

• The first document of importance is the protocol for the PROSPECT trial, which can be reviewed here:
  https://clinicaltrials.gov/show/NCT01515787
  
• The second document of importance (if you are in fact a registered patient in that clinical trial) is Federal Law 21CFR50.25 concerning Informed Consent and the rights of patients who are registered in clinical trials:
  https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm?FR=50.25

The particular paragraphs of interest in these two documents are the following:

• From the PROSPECT trial protocol, Arm 1, it says:
  

  Experimental: Group 1
  
  Patients will receive FOLFOX chemotherapy once every two weeks for 6 cycles total over a period of 12 weeks. After completing FOLFOX chemotherapy, the patient will have an MRI scan or endorectal ultrasound (ERUS) to examine the tumor. If the tumor has not decreased in size by at least 20%, the patient will receive 5FUCMT (radiation with chemotherapy). If the tumor has decreased in size by 20%, then the patient will proceed directly to surgery.
  
  If all borders of the tumor are normal post surgery, then the patient receives six additional cycles of FOLFOX chemotherapy. If all borders of the tumor are not normal then the patient receives chemoradiation therapy for 5.5 weeks after surgery. After chemoradiation, additional cycles of FOLFOX or similar chemotherapy will be recommended for 4 cycles or 8 weeks. Patient observation with follow up evaluations and event monitoring will occur up to 8 years post randomization.

  
  
• From Federal Law 21CFR50.25(a)(8) on Informed Consent it says.
  

  (8) A statement that participation is voluntary, that refusal to participate will involve no penalty or loss of benefits to which the subject is otherwise entitled, and that the subject may discontinue participation at any time without penalty or loss of benefits to which the subject is otherwise entitled.

This could turn out to be a long involved discussion, but to summarize, I think the issue is this:

Your surgeon is Principal Investigator of this clinical trial for 5 MD Anderson hospitals in Texas, and as Principal Investigator he is responsible for conducting the trial according to the protocol and for following the protocol to the letter for each patient that he enrolls in the trial.

Basically, the dilemma is this: If your surgeon lets you off the hook by saying "No more chemo for you" he is violating the protocol. (That's my opinion)

Keep in mind that clinical trials are there for a purpose. They are there to conduct studies under controlled conditions so that the eventual findings are scientifically valid. The controlled conditions mean that if you are assigned to a group that requires post surgery chemo, then all persons in that group will have to have post surgery chemo. This is so that the findings can be scientifically valid.

The other part of the dilemma is that if you are a patient in the trial and you decide to invoke the option of Federal Law Federal Law 21CFR50.25(a)(8) then you are no longer in the trial and your data must be censored when it comes time to do the final statistical analysis -- in other words, if you invoke your right to leave the trial so that you can skip post-surgery chemo, then you become a trial drop-out and the number of patients analyzed in the trial is decreased accordingly.

So, what I'm saying is that there is a certain conflict of interest here: The surgeon is interested, of course, in being a good Principal Investigator, but at the same time he is interested in doing the best for his patient vis-à-vis long-term quality of life.

So, from my point of view the decision is ultimately up to you and your surgeon to resolve this apparent dilemma.

[[Ana & Alex]]

Dear Basil,

I understand your dilema. If I had had a complete response I would also have trouble accepting chemo.

Since the Prospect trial is somewhat new it is difficult to make evidence based decisions. But from what I've read in the forum, through the experiences of others, people who've had chemo and/or radiation prior to surgery and had a complete response will also do adjuvant chemotherapy just to be sure.

Would you consider dropping the Oxi and carrying on with 5-FU or Xeloda only?

After the SCOT Trial I decided with my Oncs that I would only do 4 rounds of oxaliplatin and the rest of the cycles I'm doing Xeloda only. I hated oxaliplatin. Was falling all the time, couldn't drive my car, was getting really bad ass neuropathy and shitty QoL.

With Xeloda its easier. Besides a little fatigue and a little nausea, it is really bearable.

Would this be an option for you?

Good luck with your decision and may you already be in NEDville!

Love,
Ana

[SurvivorsSpouse]

Did the N1 get added before or after surgical pathology?

I don't know of any protocol that doesn't call for adjuvant chemo at T3N1, especially with rectal cancer.

Even the PROSPECT protocol calls for adjuvant therapy.

[peanut_8]

Basil, I think Ana has a good suggestion regarding eliminating the oxi and switching to Xeloda of 5-FU alone. Especially since you're already experiencing some neuropathy.

Best Wishes,
peanut

[Beckster]

Basil, I think Ana has a good suggestion regarding eliminating the oxi and switching to Xeloda of 5-FU alone. Especially since you're already experiencing some neuropathy.

Best Wishes,
peanut

Basil.

I agree with Peanut. If you look at MD Anderson's protocol, you will see that Xeloda is an option. Since they were going to stop chemo because of your good pathology, Xeloda would be the reasonable choice. I am under the care of an MC Anderson dr in NJ. He said that Xeloda mono-therapy is an option for Stage II and III patients. If you would like me to send the PDF of the MD Anderson protocol, let me know and I will email it to you. It is the lastest updated form. Here is the therapy listed on the PDF for Stage II and III....

7. In cases of tumor perforation, combination chemoradiation therapy to the tumor bed may be considered.
8 Capecitabine or 5-fluorouracil (5-FU)/leucovorin or 5-FU/leucovorin/oxaliplatin or capecitabine/oxaliplatin
9. Consider MSI analysis because patient with microsatellite instability (MSI-H) may not derive benefit from single agent 5-FU based therapy.

Copyright 2016 The University of Texas MD Anderson Cancer Center

[susie0915]

I understand your disappointment Basil. After my chemoradiation, the surgeon told me all that was left was scar tissue, and I may not need chemo after surgery. During my post op check, even though margins were clear and no nodes were affected, he said he wanted me to do chemo due to dead cancer cells seen in the pathology report. I was quite disappointed. My oncologist explained that even though recurrence rate is low for me if it did come back you would have no regrets of not doing the clean up chemo. So I went ahead. Chemo was delayed a couple month as I suffered a bowel blockage and needed to have surgery. My surgeon reversed my ileo early since he had to remove scar tissue causing the blockage. I was happy to hear that but it did make chemo tougher with diarrhea. But, I don't regret doing the chemo and won't have to wonder what if in case I do have a recurrence. Good Luck and prayers.

Susie