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Why Give Adjuvant Chemotherapy, and to Which Patients?

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GRACE Cancer Video Library - Lung

GCVL_LU-D12_Why_Adjuvant_Chemotherapy_Which_Patients

 

Dr. Heather Wakelee, Stanford University Medical Center, discusses the purpose of adjuvant chemotherapy, and which patients benefit most from it.

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Adjuvant chemotherapy is chemotherapy given after surgery for early stage non-small cell lung cancer. What is early stage non-small cell lung cancer? That’s lung cancer that has either not spread at all, or spread just to lymph nodes in the lung which would be called stage II, or to lymph nodes in the central part of the chest or mediastinum called stage III.

When a patient is thought to have stage I or II lung cancer, for most people the best treatment is to go to surgery, and with surgery we’re able to cure more than half of patients. However there is still a high chance of the cancer coming back so chemotherapy is given to reduce the chance of the cancer coming back. With stage III lung cancer it’s a bit more complex, and normally if we know it’s stage III beforehand, other treatments are given instead of just going straight to surgery, but sometimes we can’t see the cancer on the imaging studies like PET scans and CT scans and you only find out about it after surgery.

So we end up with patients with stage I, II, and III who have gone to surgery, have recovered from surgery, and now have to face the question of, “what can I do to reduce the chance of the cancer coming back?” It’s in that setting that we offer adjuvant chemotherapy. We know from randomized clinical trials where half the patients got chemotherapy and half didn’t, that we can improve the cure rates by giving chemotherapy.

The benefit is different for the different stages — we know it definitely helps for stage III, we know it definitely helps for stage II where there are lymph nodes in the lung — in stage I it’s a bit more controversial. For patients with stage I lung cancer that’s small, less than 4cm, we don’t think the chemotherapy actually improves the cure rates, and so it’s not usually recommended. For patients with tumors over 4cm, it becomes a discussion between the patient and their providers trying to make that decision because the data is just not as strong. When we look at subset analyses from clinical trials, there was a survival benefit seen in the subset with the larger tumors, but again it was a subset, it wasn’t the primary endpoint of the trial, and so you have to take that cautiously because you don’t know it’s the definite truth.

So it’s always an important discussion to go through that with the patient and with the providers as well.


GRACE Video

Targeted Therapies in a Post-Operative/Adjuvant Setting

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Dr. Nathan Pennell, Cleveland Clinic, reviews the available trial evidence for the use of targeted therapies in the post-operative/adjuvant setting.

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I’d like to talk to you now about adjuvant treatment with molecularly targeted therapies for non-small call lung cancer. We know that early stage patients, so patients with stage I, II, or III non-small cell lung cancer — many patients are cured with surgery, but unfortunately, many patients go on to recur with metastatic disease. The reason this happens is that some of the cancer cells have escaped from the tumor before surgery and spread elsewhere in the body. This is called microscopic metastatic disease, and for this reason, we offer patients at high risk of occurrence adjuvant therapy. Adjuvant just means that we give four cycles of chemotherapy after surgery, and we know that this provides a modest, but significant improvement in cure rates after surgery alone.

Well, what about for patients who have molecularly defined subgroups of cancer, like EGFR mutation-positive cancer, or ALK-positive cancer? We know that, in the advanced setting, targeted therapies like Tarceva or Gilotrif for EGFR-positive cancer, or crizotinib or Xalkori for ALK-positive lung cancer, are better than chemotherapy in terms of inducing tumor responses, delaying the progression of cancer, and potentially even improving overall survival.

Since they work in the advanced setting, wouldn’t it make sense that they might work better in the adjuvant setting as well? Well, it’s not quite that simple. For one thing, we don’t have any evidence for any type of molecular subgroup, other than EGFR mutation-positive patients, but even in that setting, we really don’t have good evidence that adjuvant therapy improves cure rates after surgery alone. We have a little bit of evidence, so we know that the doctors at Memorial Sloan Kettering Cancer Institute in New York have treated several hundred patients with adjuvant Tarceva after surgery and they’ve reported that the patients have probably a lower than expected recurrence rate compared to what we might expect for that risk of patients, and they’ve suggested that maybe even they’re improving cure rates with adjuvant Tarceva.

Unfortunately, you can’t draw conclusions from a retrospective series and not a prospective trial. There have been at least two prospective trials that have been done, including one phase II trial that treated patients with two years of adjuvant Tarceva after surgery and then a subgroup of patients from a phase III trial called the RADIANT trial — so these were not EGFR mutation-positive patients in the overall trial, but there were 160 mutation-positive patients on the trial who were treated with two years of Tarceva, or two years of a placebo. All of these put together have suggested that adjuvant Tarceva does potentially delay the recurrence of cancers, but once the adjuvant treatment stopped, many patients went on to recur at a later time. None of the trials have suggested that patients lived longer or were cured at a higher rate than patients who were treated with standard treatment, including adjuvant chemotherapy.

What we really need is a randomized prospective phase III trial. Luckily, there is one that’s open and enrolling called the ALCHEMIST trial. Patients with stage IB, II, or III non-small cell lung cancer are tested for EGFR mutations or ALK gene fusions, and if those are found, they’re randomly assigned to two years of Tarceva for EGFR, or Xalkori for ALK-positive lung cancer patients, or two years of a placebo. Hopefully, at the end of this trial we’ll know whether patients are cured at a higher rate when treated with these adjuvant target therapies, versus just delaying the recurrence of the cancer.

For now, in 2015, I would not routinely recommend adjuvant therapy with a targeted drug like Tarceva or Xalkori outside of a clinical trial, but would strongly encourage patients to enroll in the ALCHEMIST trial.


GRACE Video

Molecular Testing in Early Stage Non-Small Cell Lung Cancer

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Does it make sense to do molecular testing on early stage lung cancer patients? Dr. Taofeek Owonikoko of Emory University School of Medicine and the Winship Cancer Institute thinks it does in some settings. February 2014


GRACE Video

An Update on ECOG 1505: Will Avastin (Bevacizumab) Become Standard Treatment for Early Stage Lung Cancer Patients?

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Dr. Heather Wakelee of Stanford University Medical Center talks about how studies looking into Avastin (bevacizumab) for early stage lung cancer patients are progressing. February 2014.


Dr West

Modifying Factors: Should Patients with Smaller Resected Node-Negative NSCLC Tumors Receive Adjuvant Chemo?

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While post-operative chemotherapy for early stage NSCLC is a well-established standard for relatively healthy patients with stage II or higher resected cancers, the question of whether adjuvant chemotherapy is more likely to help or hurt a patient remains more a matter of debate.  Much of the debate has focused on a threshold of tumor size, with 4 cm emerging as a cutoff, above which chemotherapy appears more likely to be helpful and is often recommended.  The general concept is that adjuvant chemotherapy confers a benefit that is proportional to the risk of the cancer recurring — a higher risk cancer is more likely to have the risk reduced by chemo more than enough to counterbalance the acute and chronic side effects of adjuvant chemo.  But while tumor size is certainly one of the more readily identifiable factors associated with risk of recurrence and death, it’s not the only relevant factor. The National Comprehensive Cancer Network (NCCN) also includes several other factors in its guidelines for consideration of adjuvant chemotherapy, even for smaller tumors, so let’s review those.  

I covered the issues of tumor histology and pleural invasion in a prior post.  In addition, vascular invasion, or tumor cells invading into blood vessels, is associated with increased risk. In fact, as shown in the figure to the left, T1 (smaller) cancers with vascular invasion have a worse outcome than T2 (larger) cancers that don’t have vascular invasion.

 

 

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