Bloomberg News (5/14, Cortez) reports, "Older women with breast cancer are almost twice a likely to die or suffer a relapse if they are treated with Roche Holding AG's Xeloda [capecitabine] rather than standard chemotherapy after surgery to remove the tumor," according to a study appearing in the New England Journal of Medicine. Researchers found that "the choice of therapy is critical for women aged 65 and older with early-stage breast cancer, a group that is rarely included in clinical trials." During the study, which included 600 women, those given capecitabine "were twice as likely to have the cancer return and die as those assigned to intravenous chemotherapy. After three years, 68 percent of women on Xeloda were alive and hadn't had a cancer relapse, compared to 85 percent of those in the comparison group." Bloomberg notes that the study's "preliminary findings were presented at the American Society of Clinical Oncology meeting in Chicago last year."
Reuters (5/14, Emery) notes that, according to the study, capecitabine does work against breast cancer that has spread, but does not prevent the spread of early-stage breast cancer.
Lead researcher Hyman Muss, MD, a professor of medicine at the University of North Carolina, said, "In this trial, we had hoped that it [capecitabine] would be as good as standard therapy, so we would have a pill treatment with less side effects, but it turned out it wasn't as good," HealthDay (5/13, Reinberg) reports. One variation was "in women whose cancer is hormone receptor-positive." In those patients, researchers found "that standard therapy and capecitabine were pretty similar," Dr. Muss said, adding, "It would be reasonable for these women to select capecitabine over standard chemotherapy, but my bias would still be to pick the standard right now." Medscape (5/13, Chustecka) and MedPage Today (5/13, Bankhead) also covered the story.
May 13, 2009 — One of the first trials specifically conducted in elderly women with early-stage breast cancer has found that standard adjuvant chemotherapy was superior to the oral drug capecitabine (Xeloda, Roche) used alone. Standard chemotherapy halved the risk for death and relapse, compared with capecitabine, but it doubled the rate of moderate to severe adverse events.
The average age at which a woman is diagnosed with breast cancer is 63 years, but older women are underrepresented in clinical trials. "This study is important" because it is one of the first trials specifically targeting the elderly (65 years and older), commented lead author Hyman Muss, MD, professor of medicine at the University of North Carolina in Chapel Hill. It shows that "chemotherapy can make a difference," he said in a statement.
The study, known as the Cancer Leukemia Group B (CALGB) 49907 trial, is published in the May 14 issue of the New England Journal of Medicine.
"Our results provide support for the belief that adjuvant chemotherapy improves survival among older women," the authors write.
Effective Oral Drug Would Be Important
Dr. Muss and colleagues investigated capecitabine because "patients often prefer oral to intravenous chemotherapy," and an effective oral agent would be important for treating older women with breast cancer, they explain.
Capecitabine is approved for use in metastatic breast cancer, and it has shown "substantial" antitumor activity in this setting, the authors state. They note that 1 small randomized trial in metastatic breast cancer suggested activity similar to that seen with cyclophosphamide, methotrexate, and fluorouracil (CMF).
However, in this latest study — which involved a different patient population, one with early-stage breast cancer — capecitabine was inferior to CMF and to the combination of cyclophosphamide and doxorubicin (C&D).
The trial involved 600 women 65 years of age and older, and randomized them to adjuvant therapy with capecitabine alone, or to 1 of 2 standard chemotherapy regimens (CMF or C&D). The choice was left to the treating physician.
After 3 years, the rate of relapse-free survival was 68% in the capecitabine group and 85% in the standard-chemotherapy groups, and the overall survival rate was 86% and 91%, respectively.
Patients receiving capecitabine were twice as likely to have a relapse and nearly twice as likely to die, the authors note. The hazard ratio for disease recurrence or death in the capecitabine group was 2.09 (95% confidence interval, 1.38 - 3.17; P < .001).
Better Results, But Greater Toxicity
However, twice as many patients receiving standard chemotherapy had moderate to severe toxic effects (64% vs 33% with capecitabine), the authors note.
Adverse Effects in the 3 Study Groups: Cyclophosphamide, Methotrexate, and Fluorouracil (CMF); Cyclophosphamide and Doxorubicin (C&D); and Capecitabine Alone
| Adverse Effect | CMF (n = 132) | C&D (n = 183) | Capecitabine (n = 229) |
| Hematologic, % | 52 | 54 | 2 |
| Fatigue, % | 11 | 4 | 5 |
| Nausea and vomiting, % | 13 | 6 | 4 |
| Diarrhea, % | 8 | 3 | 7 |
| Hand–foot skin reaction, % | <1 | 0 | 16 |
| Febrile neutropenia, % | 8 | 9 | 1 |
Most patients receiving standard chemotherapy had substantial adverse effects, the authors comment, even though these patients had excellent performance status and no major organ dysfunction. Toxicity would probably be worse in frail and vulnerable patients, and these regimens "should be administered with caution or not at all in such patients," they add.
Only 62% of patients assigned to CMF managed to complete the planned 6 cycles of therapy, whereas 80% of those receiving capecitabine managed to. And although patients receiving C&D had substantial toxicity, 92% completed the planned 4 cycles of therapy.
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