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Early phase III results for rituximab In October, 2005, the European Organisation for Research and Treatment of Cancer (EORTC) reported that rituximab, a therapeutic antibody to treat non-Hodgkin lymphoma (NHL) has shown positive results in a phase III study much earlier than expected. “This trial is important because it is the first one showing that maintenance treatment with rituximab is not only useful for NHL after chemotherapy induction but also after induction with chemoimmunotherapy”, says Marinus van Oers, lead investigator of the trial (University of Amsterdam, Netherlands). The trial was done in 18 countries and recruited 465 patients with relapsed indolent NHL. Patients were randomly assigned to six cycles of rituximab in combination with cyclophosphamide, doxorubicin, vincristine, and prednisone (CHOP), or to CHOP chemotherapy alone. Patients
who responded to initial treatment were randomly assigned to rituximab maintenance treatment (one infusion every 3 months for 2 years) or to no further treatment. Full trial results will be released in December, 2005, but van Oers reports that the trial has shown that maintenance treatment, given over 2 years, lengthens progression-free survival by about 2·5 years—a significant survival advantage. “These findings will certainly have a profound effect on the treatment of patients with (relapsed) follicular lymphoma”, he predicts. Barry Hancock (University of Sheffield, UK) welcomes the trial results but warns that “although progression-free survival is extended, it remains to be proved whether there is any affect on overall survival”. Rituximab is already a first-line primary treatment for follicular lymphoma: in the future, patients who relapse will
probably have already had rituximab. “We can’t assume that the response in these patients is going to be the same as in those who have never had [the drug]”, he says. Rituximab is non-toxic in the short term, but whether longterm use leads to persistent depression of B-cell immunity with consequent predisposition to chronic or recurrent infections is unknown. “It seems unlikely that maintenance therapy with rituximab will become available as a standard until these issues are resolved. The UK National Institute for Health and Clinical Excellence will have to adjudicate, and providers [or] commissioners will need to debate the pros and cons based on published evidence in peer-reviewed journals, which will, by then, include the EORTC and other relevant studies”, Hancock concludes.
Kathryn Senior
Cervical cancer: tailored prevention programmes fit best
http://oncology.thelancet.com Vol 6 December 2005
to show in a randomised trial, good efficacy of HPV screening, and some efficacy of VIA”, explains study investigator Thomas Wright (Columbia University, New York, NY, USA). A separate analysis (N Engl J Med 2005; 353: 2158–68) showed that this and similar schemes in four other countries are cost effective, and could reduce deaths from cervical cancer by up to half if implemented fully. The US study, by Wendy Brewster and colleagues (University of California Irvine, CA, USA), aimed to improve the low rate of follow-up of abnormal Pap smears in women on lower incomes. When women were offered test results and initial treatment for high-grade abnormalities at the screening visit, 88% completed treatment in 6 months compared with 53% of the group who received their results by post later. Both studies aim to reduce the barriers to prevention, says Paul
Blumenthal (Johns Hopkins University, Baltimore, MD, USA), author of an accompanying editorial. Although testing at-risk women is essential and feasible, Blumenthal says, “the test by itself, whatever it is, has no preventive value unless you can give treatment. Both these studies show that linking tests to treatment in an expeditious way enhances prevention”.
Pat McCaffrey
© Peter Menzel/Science Photo Library
Two randomised clinical trials in South Africa and Southern California, USA, show that new approaches to prevention of cervical cancer can improve outcomes for women on lower incomes in poor and affluent nations (JAMA 2005; 294: 2173–81 and 2182–87). Cervical cancer is largely preventable through early detection and treatment, but the disease still kills 250 000 women per year, 80% of whom live in less developed countries where Pap tests are unavailable. Women in the South-African study were given non-Pap screens including DNA testing for human papillomavirus (HPV) and visual inspection of the cervix after acetic-acid treatment (VIA). Positive results were followed up directly with cryotherapy and no additional diagnostic testing. The “screen and treat” procedure resulted in significantly fewer high-grade neoplasias and cancer after 6 and 12 months. “We were able
Linking tests to treatment could enhance prevention
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