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Tracks 1, 4-5

DR LOVE: Can you discuss the data from the GOG-0170D trial evaluating the use of bevacizumab for patients with persistent or recurrent epithelial ovarian cancer or primary peritoneal cancer?

DR BURGER: Among 62 patients who had been previously treated with one or two cytotoxic regimens and had measurable disease by RECIST, bevacizumab led to a 21 percent objective response rate and a 40 percent progression-free survival of at least six months (Burger 2007; [3.1]).

A regression analysis performed at the conclusion of the trial factored in variables associated with disease progression in patients enrolled on Phase II trials of traditional cytotoxic agents: number of prior regimens, time from completion of initial therapy to first recurrence, age and performance status.

None of those factors predicted the time to disease progression in patients treated with bevacizumab (Burger 2007).

DR LOVE: Can you compare GOG-0170D to the other recently reported Phase II trial of bevacizumab in patients with platinum-resistant ovarian cancer or peritoneal serous cancer (Cannistra 2007)?

DR BURGER: In GOG-0170D, the patients had received either one or two prior regimens. About 40 of the patients had experienced disease progression within six months of receiving their most recent platinum-containing regimen, and the remainder had a platinum-free interval greater than or equal to six months (Burger 2007). The other single-agent bevacizumab trial required that the patients’ disease be either primarily or secondarily platinum-resistant, and they could have received two to three prior regimens (Cannistra 2007).

So regarding risk of disease progression with any therapy, the patients in the trial reported by Cannistra were at higher risk. In the trial by Cannistra, the objective response rate was 16 percent (Cannistra 2007). In GOG-0170D, the response rate was 21 percent (Burger 2007; [3.1]).

DR LOVE: What was observed in the two studies in terms of side effects and toxicity?

DR BURGER: The differences in toxicity were interesting. It’s hard to compare across trials, but the trial by Cannistra was closed prematurely due to five cases of gastrointestinal perforation, and GOG-0170D had zero cases of gastrointestinal perforation.

In GOG-0170D, the rate of Grade III/IV proteinuria was minimal. Only one patient developed nephrotic syndrome, and it reversed after the discontinuation of bevacizumab. Approximately 10 percent of the patients had clinically relevant hypertension requiring antihypertensive therapy (Burger 2007). In the trial by Cannistra, no patients developed Grade III/IV proteinuria, but a number of patients with hypertension required therapy. Three patients experienced Grade III/IV arterial thrombotic events (Cannistra 2007).

Track 11

DR LOVE: Can you discuss evolving clinical research on the use of bevacizumab in combination with IP therapy?

DR BURGER: IP chemotherapy is considered a standard option for patients with Stage III ovarian cancer, especially those who have undergone optimal cytoreductive surgery. Three Phase III trials have demonstrated a survival advantage with IP regimens in combination with IV chemotherapy compared to standard IV chemotherapy regimens alone (Alberts 1996; Armstrong 2006; Markman 2001).

It’s important to establish the safety and efficacy of these IP cytotoxic regimens in combination with bevacizumab. A Phase III trial is being developed to evaluate modified IP cytotoxic therapy in combination with bevacizumab for patients with Stage III, optimally debulked ovarian cancer.

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Neil Love, MD

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Tate Thigpen, MD
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Ursula A Matulonis, MD
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Robert A Burger, MD
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Bradley J Monk, MD
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