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Tracks 4-5

DR LOVE: What do you think about the trials that are evaluating the adjuvant use of erlotinib in enriched populations (ie, those with EGFR-positive tumors)?

DR EDELMAN: Erlotinib is a fascinating agent because it has shown efficacy in nonsmokers, never smokers and women with adenocarcinomas and bronchoalveolar carcinoma features. Patients with these characteristics are coming into my office with increasing frequency. I’m seeing two to three never smokers a month in my clinic and an increasing number of patients who smoked for only one year or so. For an enriched population in which you believe that the EGFR marker is present — either because of positive prognostic factors or because you’ve actually tested for it — adjuvant study of erlotinib is reasonable. We need to approach the use of these drugs in a more intelligent fashion, and I believe this is the way to do it.

Obviously in a resected population, you can test for the presence of EGFR by FISH or gene mutations — whatever your favorite method is.

Track 8

DR LOVE: How do you approach the clinical use of bevacizumab in metastatic NSCLC?

DR EDELMAN: I’ve held fairly closely to the ECOG-E4599 eligibility criteria (Sandler 2005; [2.1]). Patients are concerned about the risk of hemoptysis, but again, viewing this in the aggregate, patients fared better with bevacizumab.

They live longer, so if we have patients who would have been eligible for that, we approach them about the use of bevacizumab.

I have used bevacizumab pretty much as it was used on E4599 with carboplatin/ paclitaxel. The only difference is that I tend to use less cytotoxic chemotherapy — I use four cycles, not six, and I base that on my belief that the evidence is pretty compelling that cytotoxics do not aid you after four courses of therapy. I could certainly be criticized, but I believe it’s a reasonable approach and it’s well tolerated.

Track 15

DR LOVE: What chemotherapy regimen do you usually utilize as adjuvant therapy?

DR EDELMAN: Generally, cisplatin and docetaxel because I believe the weight of data supports a cisplatin-based regimen (2.2). If one wants to be completely data driven, cisplatin/vinorelbine is probably the most validated regimen out there, but it’s difficult to administer. In Stage IV disease, cisplatin/docetaxel is at least as good, possibly even superior, and probably better tolerated than cisplatin/vinorelbine, so I consider that a reasonable regimen.

If someone told me that he or she intended to administer cisplatin/vinorelbine, I would not argue. The combination of cisplatin/gemcitabine is also reasonable. The crucial component in this combination is the platinum.

Despite all the controversy, I believe carboplatin/paclitaxel is also reasonable. Another key issue is adjuvant therapy for Stage IB disease. It has been pointed out that to conduct an adequately powered study of patients with Stage IB disease, you’d have to enroll about 2,000 patients.

So the CALGB carboplatin/paclitaxel study (Strauss 2006) that showed an improvement in progression-free survival in Stage IB disease was probably underpowered.

If you consider the subgroup of patients with tumors of four centimeters or greater (Strauss 2006), those patients clearly fared better with the chemotherapy. I don’t believe carboplatin/paclitaxel is inactive in this setting — occasionally we use that. We use it because some patients cannot tolerate cisplatin-based therapy.

It is not unusual for us to start with a cisplatin-based therapy and switch the patient after one or two cycles because he or she cannot tolerate it. So for their final couple of cycles, these patients are switched to a carboplatin-based regimen.

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