| Tracks 1-10 |
| Track 1 |
Use of adjuvant capecitabine for
patients with lower-risk disease |
| Track 2 |
Disease-free survival as a surrogate endpoint for overall survival |
| Track 3 |
NCCTG N0147: Adjuvant FOLFOX
with or without cetuximab |
| Track 4 |
New research issues in anal cancer |
| Track 5 |
Clinical trial of CAPOX with radiation therapy for anal cancer |
| Track 6 |
RTOG-9811: Use of mitomycin C versus cisplatin chemotherapy for anal cancer |
|
| Track 7 |
Clinical trial of cisplatin, fluorouracil,
cetuximab and radiation
therapy for HIV-associated anal
cancer |
| Track 8 |
Clinical trial of 5-FU/bevacizumab
in combination with radiation
therapy for rectal cancer |
| Track 9 |
Use of neoadjuvant capecitabine
and oxaliplatin for rectal cancer |
| Track 10 |
Prognostic value of the ratio of
sampled-to-positive lymph nodes |
|
|
Select Excerpts from the Interview
Track 1
DR LOVE: The X-ACT trial data have led many oncologists to switch to
capecitabine when using a fluoropyrimidine alone in the adjuvant setting,
when oxaliplatin is not going to be used — for example, in a patient with
a lower-risk, Stage II tumor. Is that a strategy you are using?
DR ENG: I have patients at low risk who are only willing to receive
capecitabine alone. We discuss the side effects of oxaliplatin-based chemotherapy,
which they know will require six months of therapy and is associated
with neuropathy. These patients are supposedly free of disease and are trying
to work full time. I have been surprised that so many patients are willing
to take single-agent capecitabine — they feel that at least they are doing
something.
We use the schedule of 1,000 mg/m2 twice a day on days one through 14
every three weeks. We haven’t been able to utilize the dose used by the Europeans — 2,500 mg/m2 — due to the hand-foot syndrome that occurs.
European patients tolerate the higher dose of capecitabine, even in their
combined chemotherapy regimens with oxaliplatin. I agree with Dan Haller’s
observation that geographic differences exist in the tolerability of capecitabine
(Haller 2006).
DR LOVE: What about using capecitabine in the adjuvant setting along with
oxaliplatin?
DR ENG: I have colleagues who use adjuvant CAPOX. We now know from
the NO16966 study that FOLFOX and CAPOX are equivalent, but that’s
in the metastatic setting (Cassidy 2007). That may apply just as well in the
adjuvant setting. As with any oral chemotherapy, you have to be cautious and
make certain the patient is adherent to your recommendations.
Track 5
DR LOVE: Can you discuss the study you are conducting in anal cancer?
DR ENG: A retrospective study conducted by my colleague Christopher Crane
at MD Anderson evaluated 5-FU/cisplatin in 92 patients, with no induction.
He recorded an impressive five-year survival and disease-free survival rate of
88 percent (Das 2006).
After approval of oxaliplatin and with its use as a radiation sensitizer in
rectal cancer, it seemed appropriate to replace cisplatin with oxaliplatin, thus
forgoing the nephrotoxicity, electrolyte disturbances, nausea and vomiting
associated with cisplatin. Instead of using continuous infusion 5-FU, we
utilized capecitabine as a radiation sensitizer. So we are using a CAPOX
regimen combined with radiation therapy.
Thus far we’ve accrued 13 patients. They receive their chemotherapy for the
first two weeks of treatment on a Monday-through-Friday schedule, and they
take the third week off.
DR LOVE: What are you seeing in terms of side effects and toxicity?
DR ENG: Initially, there were issues with diarrhea. Originally, we administered
the chemotherapy every week during radiation therapy, but as the Phase I/II
trial was developed in rectal cancer, we amended our schedule to follow that
protocol. They didn’t provide oxaliplatin and capecitabine in the third week.
So that’s what we’ve done. We’ve taken it out during the third and sixth weeks.
We believe this regimen will be equivalent to historical data with 5-FU and
cisplatin but with less toxicity, but it’s still early.
Tracks 6-7
DR LOVE: What questions do you receive from doctors in practice
regarding the treatment of anal cancer?
DR ENG: The most common one is, “Do I really need to use mitomycin-C?”
The majority of physicians prefer using cisplatin to mitomycin-C, but due to
the conclusions drawn from the RTOG-98-11 study, they now feel compelled
to use mitomycin-C (Ajani 2006). Many of us don’t like using mitomycin-C
because of its toxicities.
I discuss with them that the design of 9811 makes it difficult to conclude that
mitomycin-C is the best option, and many of them then use cisplatin. A lot of
them have already been using cisplatin but didn’t know whether they needed
to change that practice.
DR LOVE: What about the use of oxaliplatin in the clinical setting for anal
cancer?
DR ENG: I don’t recommend it because it needs to be evaluated as part of
a clinical trial. Physicians do cite my abstract and ask if they can use oxaliplatin
(Eng 2005). I remind them that toxicities occur that haven’t been fully
studied, especially because diarrhea and radiation dermatitis are commonly
observed in the treatment of anal cancer. Oxaliplatin is being investigated, but
I don’t believe physicians should assume that it will replace cisplatin.
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