At ASCO a number of studies showed the efficacy data of combining 5-FU or Xeloda with oxaliplatin in combination with radiation therapy in patients with rectal cancer.
Based on a German study published a couple of years ago, chemoradiation became the standard therapy for patients with resectable rectal cancer. The rate of sphincter-sparing surgeries and lower toxicities were the reason to prefer chemoradiation prior to surgery instead of adjuvant treatment after surgery.
Over the last couple of years many studies aimed to improve the efficacy of neoadjuvant chemoradiation therapies by intensifying the chemotherapy. Standard therapy is 5-FU or Xeloda® (capecitabine). By adding oxaliplatin it was hoped that the success rate of chemoradiation could be increased.
Success of neoadjuvant radiation is measured by a complete pathological response rate (complete disappearance of cancer cells). With 5-FU or Xeloda that can be reached in about 10-15% of the cases. Smaller studies have suggested that the addition of oxaliplatin could double the rate.
However the studies presented at ASCO a couple of weeks ago (ACCORD) did not show any significant difference when oxaliplatin was added. However there was interestingly a lower risk of developing metastases in the patients who received the additional oxaliplatin therapy. These findings may question the ongoing R-04 study which compares 5-FU to 5-FU plus oxaliplatin in combination with radiation therapy.
In the Southwest Oncology Group (SWOG) we have choosen another way. In the study just opened, we started with Xeloda, oxaliplatin and Erbitux (kras wild type), then we continue with the chemo and add radiation to have a both powerful systemic effect and a local effect.
July 01, 2009 at 3:35 pm, Your Northern California Fans said:
Thanks for this information!
We have a few questions — if you could elaborate on your comments about these new findings reported at ASCO:
Re. study adding Oxaliplatin to 5FU with neo-adjuvant radiation for Rectal Cancer:
If there were no significant differences found in the eradication of cancer cells with Oxaliplatin pre surgery – what was the statistical difference of lower risk that was found for rate of recurrent metastic disease? And — how long after treatment did the studies findings cover? Was it 2 years? 5 years? We had thought that adding Oxali to post surgery chemotherapy was primarily effective in reducing local recurrence rates? How does this fit with the findings that Oxali with pre-surgery radiation lowered risk of metastic disease? Was the post surgery chemotherapy Folfox 6 months or 4 months?
Last question: re. how this impacts your group (SWOG) study:
Could you explain the pre surgery treatment plan you follow? Do you do chemo for 2 months along with radiation pre-surgery? Then how many months of chemo after surgery?
We are forever grateful for your updates and information.
July 01, 2009 at 9:04 pm, Heinz-Josef Lenz said:
hello Northern California Fans…….pretty easy to answer oxaliplatin seems to not increase the response rate in the rectal area when combined with radiation, however protects more successfully systemic disease (metastases). Regarding the swog trial, here we do chemotherapy first not only xeloda and oxaliplatin but also erbitux and then follow with the same chemo and radiation. when i remember 70 days of chemotherapy (including breaks) after surgery 35 days chemo and 35 days chemo and radiation prior surgery. HJL
July 27, 2009 at 6:21 pm, Jacqueline Getz said:
I’m curious about what you’ve had to say regarding neoadjuvant treatments. I was treated with the 5fu(xeloda) and radiation for tumor reduction prior to surgery. I had a stage III colorectal tumor. I had the illeostomy for approx 10 weeks then had a resection done. My follow-up treatments consisted of the infused 5fu/oaxliplatin. However, after the 4th round the infusion started attacking my liver. We determined that it was probably the Oaxliplatin. So my oncologist decided to go with just the 5fu 3x/day. I did the regimen he prescribed as long as my body would tolerate it. The scaring from the radiation was almost unbearable when I had to take the Xeloda, but I continued any way I could, finally it was just too much. So my oncologist changed the dosage which did help some. I am using lomotil to help control the frequencies that come from having this type of surger.
I guess my question is, since it hadn’t spread to other organs, even though they said it had metastasized, I’ve really tried to be compliant with the routine, but again, I’m tired of the frequecies that hit me and then when they do, after soo many episodes in the bathroom, my skin totally break down and everything becomes inflammed and this tissue in the sphincter area is extremely inflammed. My oncologist finally reduced my dosage down to 2tabs twice a day. I’ve also had to have iron infusions done to bring up my hemoglobin. I’ve been doing chemo now for 5months. My surgeon pulled 12 nodes and found only 4 that were suspicious looking. I want to know do I need to do any more chemo. I can’t get an absolute answer from my oncologist. I want to get to a place where my insides can heal. The damage from radiation has been awful. And I know that can increase risk factors for recurrency. I need to know that I’ve done all I can at this moment in life. I’m a very positive person, but there are just some things you need to know. PLEASE HELP
July 27, 2009 at 6:38 pm, Heinz-Josef Lenz said:
Sorry to hear about all your problems. However you are not alone struggeling with frequencies and urgencies after surgery of rectal cancer. it can be really difficult, some of my patients infact converted to a colostomy bag because they could not handle it. I would recommend to be patient because in most cases it is getting slowly better….lomiltil and immodium can help and make sure you discuss the right doses. regarding time of therapy not exactly clear how much therapy you got. usually we give 6 months of chemo and radiation if chemoradiation was completed prior to surgery over a 2 months interval we usually give 4 months after surgery to complete 6 months but this only means for patients who have no distant metastases meaning that all tumors have been removed including the LN. Hope this helps.
September 11, 2009 at 9:47 am, Bimmer said:
I have a general question with regards to information about expectations after surgery. I had pre-op chemo/raditaion treatment and then resection surgery. All has gone well so far. I have been diagniosed as a T3 N0.
I had last week started my first cycle (of a total of 8) treatments of Oxaliplatin and 5-FU.
My question however is more about where I can access more informatiuon about “after surgery” expectaions and what I can do. The frequencies mention by Jacqueline is a challenge I too am experiencing. I know I have been told that my body has to learn how to operate again. I was told it takes time. Today it is 6 weeks.
The only information I can get about expectations and what I can do for recovery was – special diet for the first 2 weeks and it takes time.
Would you have more inforamtion or know of a resource which provides more information of what to possibly expect and maybe how I can better help my progression. I am going through what I am sure many have also gone through – wondering when things will improve and is what I am going through normal?
It takes time and be paitient seems to be the only answer I am getting.
Thanks