You are here: Home: LCU 1 | 2007: Chandra P Belani, MD

Tracks 1-16

Track 1 Introduction Track 2 Controversies in the adjuvant treatment of Stage IB disease Track 3 Incorporating bevacizumab into adjuvant clinical trials Track 4 Use of bevacizumab in clinical practice Track 5 Use of adjuvant erlotinib in select patients Track 6 Study of bevacizumab with either chemotherapy or erlotinib compared to chemotherapy alone for recurrent or refractory NSCLC Track 7 Treatment of Stage III NSCLC Track 8 New research strategies in Stage III NSCLC Track 9 Bevacizumab with chemoradiation therapy for Stage III NSCLC Track 10 Evaluating biologic agents in the metastatic setting Track 11 Treatment algorithm for metastatic NSCLC Track 12 Potential advantages of nab paclitaxel Track 13 Clinical trial strategies with select patients, targeted agents and tissue correlative studies Track 14 Future directions for clinical research in small cell lung cancer Track 15 IELCAP study of spiral CT screening for patients at high risk for lung cancer Track 16 Biomarker discovery and individualized therapy in lung cancer

Select Excerpts from the Interview

Track 2

DR BELANI: I believe adjuvant therapy has become the standard for patients with resected non-small cell lung cancer. After 2005, it was the standard for patients with Stage IB to IIIA disease. Now we have a brewing controversy regarding whether we should administer adjuvant therapy to patients with Stage IB disease.

One issue in the controversy is whether or not it was carboplatin that caused the failure of the carboplatin and paclitaxel regimen for patients with Stage IB disease in CALGB-9633 (Strauss 2006). At long-term follow-up, the data failed to show an improvement in overall survival because the hazard ratio fell from 0.62 to 0.80 and the p-value was not significant. As a word of caution, that was a small trial, and it is still not completed.

In general, considering the results of the other clinical trials, the JBR.10 study (Winton 2005), the IALT study (Arriagada 2004) and the ANITA trial (Douillard 2006), adjuvant chemotherapy did play a role in Stage IB disease because in those trials the chemotherapy was cisplatin based (2.1).

The CALGB-9633 trial has shown in a subset analysis that among patients who have tumors greater than four centimeters, a benefit still exists (Strauss 2006; [1.3]). But again, we may be reading too much into these subset analyses, which were not clear endpoints of these clinical studies.

In the clinical setting, for Stage IB disease, I offer chemotherapy to patients, informing them that in a small subset it has shown a benefit and in another subset it has not shown a benefit. I let the patient decide whether he or she wants to receive adjuvant chemotherapy. If the tumor is greater than four centimeters in size, then I usually suggest that the patient receive it.

DR LOVE: What about the older patient who has some comorbid conditions but is still healthy enough to consider therapy?

DR BELANI: The older patient should be considered for adjuvant chemotherapy because the JBR.10 trial reported on the elderly subset of patients. About 155 patients in the JBR.10 trial were elderly (Winton 2005; Pepe 2006), and a significant benefit was still evident in that population. The numbers are actually higher than they were in the total patient population: A 20 percent benefit appeared with adjuvant chemotherapy in the elderly population, and a 15 percent benefit appeared in the overall population.

Five-year overall survival was 69 percent in the overall population versus 66 percent in the elderly population. So if the performance status was good and a patient didn’t have any significant problems, I would offer cisplatin-based chemotherapy to an older patient.

Tracks 3-4

DR BELANI: The next adjuvant bevacizumab trial will be ECOG-E1505 (2.2), and it includes three regimens — cisplatin/vinorelbine, cisplatin/docetaxel and cisplatin/gemcitabine — all with or without bevacizumab. Eligible patients will include those with Stage IB disease who have tumors that are greater than four centimeters in size and those with Stage II or Stage IIIA disease without mediastinal nodes.

DR LOVE: What were your thoughts about the ECOG-E4599 study (Sandler 2005) evaluating carboplatin/paclitaxel with or without bevacizumab in patients with metastatic disease?

DR BELANI: That’s an excellent trial that has shown a significant but modest benefit for bevacizumab in combination with carboplatin and paclitaxel. A two-month survival difference appeared, and this is the only trial that has shown a one-year survival greater than 50 percent in a select group of patients with metastatic NSCLC.

DR LOVE: How have those data affected your practice?

DR BELANI: We are using bevacizumab for patients with metastatic nonsquamous cell carcinoma outside of a study. We are still following the ECOG-E4599 criteria. Outside of a study context, I would not recommend its use for patients with squamous cell carcinoma, patients with brain metastases or patients taking anticoagulants.

Track 6

DR BELANI: I consider it a combination worth pursuing further. A Phase III trial is definitely warranted in the second-line setting. A second-line trial (Fehrenbacher 2006) compared chemotherapy to chemotherapy with bevacizumab to erlotinib with bevacizumab. The trial showed that the progression-free survival is superior in the chemotherapy with bevacizumab arm and in the erlotinib with bevacizumab arm by about 50 percent compared to chemotherapy alone (2.4).

Select publications

Table of Contents

Top of Page