In January, the Food and Drug Administration (FDA) approved sunitinib (Sutent) for treating gastrointestinal stromal tumor (GIST) in patients who develop resistance to or cannot tolerate primary treatment with imatinib (Gleevec). Final results from the trial that led to the approval appear in the October 14 issue of The Lancet.
The multicenter, randomized trial, led by Dr. George Demetri of the Dana-Farber Cancer Institute, was terminated early after a scheduled assessment of the data clearly favored sunitinib over placebo. The median time the disease took to progress for the sunitinib group was 27.3 weeks compared with 6.4 weeks for the placebo group. Patients in the sunitinib group had longer overall survival, even though the drug was available to all patients once GIST had progressed.
After the trial began, evidence emerged to suggest that discontinuing imatinib in patients with GIST may increase the risk of disease progression. But in the absence of a trial to directly compare sunitinib with the continuation of imatinib, "no definitive conclusion about the superiority of switching to sunitinib can be reached," the authors wrote. They point out, however, that progression-free survival obtained with sunitinib in this study (24.6 weeks) compared favorably with the overall benefits reported with escalation of imatinib (11.6 weeks).
"We can conclude that sunitinib is more effective than placebo in the treatment of imatinib-resistant GIST," wrote Dr. Heikki Joensuu of Helsinki University Central Hospital, Finland, in an accompanying editorial. "The benefits of sunitinib are, however, only moderate in this setting, and might have been less if imatinib had been continued in the control arm." Dr. Joensuu noted that several promising agents are being evaluated for treating GIST when the tumor no longer responds to imatinib, and these studies might bring further good news in the near future for patients with GIST.
Posttreatment fatigue is a common and debilitating side effect faced by many cancer survivors. A new study published in the October 20 Journal of Clinical Oncology reports that cognitive behavior therapy (CBT), a form of psychotherapy, can be an effective tool for fighting persistent posttreatment fatigue. This randomized, controlled trial was the first such trial to look at the management of postcancer fatigue.
Ninety-eight eligible patients 65 years of age or younger who had persistent fatigue with no discernable physiologic cause and who had completed cancer treatment at least 1 year before the start of the study were randomly assigned to receive either CBT or assignment to a wait-list control group. CBT was tailored for each patient based on six identified perpetuating factors for postcancer fatigue: insufficient coping with the experience of cancer, fear of disease recurrence, dysfunctional cognitions concerning fatigue, dysregulation of sleep, dysregulation of activity, and low social support and negative social interactions.
Fatigue severity, functional impairment, and psychological stress were measured before and after therapy. Patients in the CBT group received an average of 12.5 sessions of therapy and experienced both statistically and clinically significant reductions in fatigue, functional impairment, and stress compared with the control group.
"The results show that CBT is successful in treating fatigue in cancer survivors," wrote the authors. Further studies are needed, they noted, to determine the usefulness of CBT in older survivors and in patients with tumor types not represented in this study, to control for the lack of human contact experienced by patients in the control group, and to quantify the long-term effects of CBT.
African American women with breast cancer who underwent a mastectomy and received either adjuvant or neoadjuvant systemic therapy were more likely to have larger, later stage tumors and lower survival rates than Hispanic and Caucasian women who received the same treatment, according to study results published online October 23 in Cancer.
Researchers at the University of Texas M.D. Anderson Cancer Center retrospectively analyzed data from two cohorts of patients who were treated prospectively in clinical trials at that institution between 1975 and 2000. The cohorts consisted of 1,456 women who were treated with doxorubicin-based chemotherapy following mastectomy (adjuvant therapy) and 684 women who were treated with doxorubicin-based chemotherapy before mastectomy (neoadjuvant therapy).
African American women treated with adjuvant chemotherapy had a 10-year overall survival rate of 52 percent, while Hispanic and Caucasian women had a survival rate of 62 percent. Similarly, African American women treated with neoadjuvant chemotherapy had a 10-year survival rate of 40 percent, compared with 56 percent for Hispanic and 50 percent for Caucasian women. More African American women treated with either adjuvant or neoadjuvant chemotherapy entered the clinical trials with later stage disease, tumors greater than 5 centimeters, and estrogen receptor-negative disease, which is considered more difficult to treat.
"These findings should prompt additional research on how we can improve outcomes for African American patients by understanding and addressing tumor biology," said lead author Dr. Wendy Woodward. "It's important to identify unique features in different populations and subgroups of all women with breast cancer so we can understand a woman's risk and factors that affect her care on an individual level."