I would consider ordering an Oncotype DX test for this patient. If the test result comes back with a high Recurrence Score^®, I will consider adjuvant therapy with FOLFOX. However, if it returns with a low Recurrence Score, I will observe only without any treatment recommendation.

Without any additional testing, I would not recommend adjuvant therapy. For node-negative disease in patients with T3 tumors, I typically discuss with them the limited data we have regarding adjuvant therapy and the fact that no trial has had adequate power to clearly define benefit, but then I discuss the possibility of ordering the Oncotype DX assay, particularly for patients who are 60 or younger.

Ordering an Oncotype DX assay is dependent on the patient. For example, I have some patients who were referred to me and had been told they require adjuvant therapy. Some of these patients are on the cusp and can’t make a good decision. So I ask them if another piece of information about their risk would be helpful in making a decision. For those who’ve answered positively, I’ve ordered the Oncotype DX test. These patients included those with negative nodes for whom I would not have been inclined to consider the test.

If a patient came to me with Recurrence Score results already in hand and the score were high, I would discuss the overall risk profile with my patient, emphasizing that even if the disease is designated as high risk, that doesn’t mean that it will recur. In addition, the designation of the disease is not linked to improved benefit from therapy.

Usually I would not offer a patient such as this adjuvant systemic therapy. However, I may offer patients adjuvant therapy after discussing the associated risks with them. Patients’ choices vary. Some do not want to receive chemotherapy and others do.

The results of the Oncotype DX assay would not change my treatment decision even if I were handed the information that the results revealed disease with a high Recurrence Score. I’d certainly share the test results with the patient. I would tell the patient that the data suggest that it predicts a potentially higher likelihood of cancer recurrence, though it doesn’t necessarily tell us specifically whether adjuvant chemotherapy is more likely to benefit him or her. This is a complicated concept to explain to a patient.

Typically I would make an assessment of the risk factors pathologically or by using the clinical features that the patient might have. If patients have no risk, I certainly talk to them about not considering any adjuvant therapy. I have administered therapy to patients with T3N0 disease. This is partly because these patients understood the absolute benefit of adjuvant therapy and still chose to receive it.

I do not routinely order an Oncotype DX assay. I would inform the patient of the option to perform the test and discuss the implications of the ranges of the Oncotype DX Recurrence Scores. If the patient’s decision to receive treatment were based on the Recurrence Score, I would order an Oncotype DX assay.

Generally my default is not to recommend adjuvant therapy in this setting. I tend not to recommend adjuvant therapy strongly for patients with node-negative disease unless they have T4 tumors, perforation or obstruction, in which case they’re considered to be at higher risk. However, if the patient particularly wants treatment, knowing that there’s a 2% improvement in cure rate, I’m willing to administer it. If the patient strongly desires treatment, I recommend 5-FU alone.

I would not order an Oncotype DX assay. I do not use the test results to make treatment decisions.

I would recommend treatment with capecitabine alone for this patient. The question that often arises is what to do for patients who are in the intermediate risk category. These are the patients with whom we have long discussions about the relative benefit of adjuvant therapy. I could use either no therapy, if patients are comfortable with that, or a fluoropyrimidine alone.

I would order an Oncotype DX assay when the patient had Stage II, T3N0 disease. In this scenario, if I intended to treat the disease I would favor FOLFOX. If the Oncotype DX assay results showed disease with a high Recurrence Score, I would lean toward treatment. If the disease had a low Recurrence Score, I would discuss the implications of the Oncotype DX test results with the patient. A feature that I like about the Oncotype DX assay is that it provides a number that the patient can focus on. As a result, it allows a more informed discussion because the patient is able to visualize the situation much better.

For patients with Grade II, MSS T3N0 disease I don’t necessarily recommend any treatment. I try to lay out the controversy and discuss it with patients in terms of whether they wish to receive treatment based on the chances of a 3% to 5% benefit — 3% benefit with a fluoropyrimidine and about 5% benefit with FOLFOX — and see what they think. I try to put it more in the context of the patient’s willingness to take risks.

Often this would be a good setting in which to order an Oncotype DX assay. My treatment choice will depend on the Recurrence Score. If the test results show a high Recurrence Score, probably within the dynamic range of where it’s going to be, I may decide to treat with capecitabine in about two thirds of the cases and with oxaliplatin in about a third of the cases.

I would observe without treatment in 80% of cases. I would treat with capecitabine alone in 20% of such situations. My treatment decision is patient driven and based on the fitness level, personal assessment of the associated risks and personal risk tolerance level.

I’ve never ordered the Oncotype DX assay. Until the data show that it’s not simply prognostic but that it’s also predictive, I won’t order it. The problem with the Oncotype DX assay Recurrence Score is that it doesn’t do a good job of telling us whether therapy will actually change the outcome. To me, the Recurrence Scores are, in part, a solution looking for a problem. I would want to know whether I should administer adjuvant therapy, not necessarily what the risk is, because those factors may not be linked. This explains why I’ve never ordered the test.

At any rate, if a patient came to me with a high Recurrence Score, I’d certainly talk to the patient about it. It might change the patient’s preferences. However, since I don’t know whether that would give the patient additional benefit, I typically wouldn’t act on it.

I would not administer adjuvant systemic therapy to this patient. In my view, for node-negative, Stage II disease, the conversation needs to start with a recommendation not to treat unless certain high-risk features are present, such as ulceration or obstruction. In general, because the benefit seems to be so small, I don’t treat Stage II disease with adjuvant therapy. However, I do use online support tools to go through some of the statistics with each patient.