Seminars in oncology
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Seminars in oncology · Aug 2009
Review Randomized Controlled TrialShould intra-cerebrospinal fluid prophylaxis be part of initial therapy for patients with non-Hodgkin lymphoma: what we know, and how we can find out more.
Central nervous system (CNS) involvement is a serious complication of non-Hodgkin lymphoma (NHL), with an extremely poor outcome. In most cases, relapse in the CNS manifests as leptomeningeal disease. The relatively short interval between the initial diagnosis of NHL and CNS involvement implies that seeding of the cerebrospinal fluid occurs early in the natural history of the disease and suggests a role for CNS prophylaxis during initial treatment. ⋯ Risk factors for CNS relapse in patients with aggressive NHL have been identified and may help define a subpopulation of patients for whom CNS prophylaxis is justified. Because of variation in current practice and a paucity of high-quality evidence, well-designed and controlled trials are needed to assess the benefits of prophylactic treatment in such a population. This article reviews the current role of CNS prophylaxis in patients with NHL and discusses issues in the conception, design, and execution of a clinical trial to elucidate the role of CNS prophylaxis in patients with aggressive NHL.
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Seminars in oncology · Apr 2006
Randomized Controlled Trial Multicenter StudyPreventing relapse beyond 5 years: the MA.17 extended adjuvant trial.
For patients with hormone-receptor-positive breast cancer, the risk of relapse remains significant even after successfully completing 5 years of adjuvant tamoxifen. The use of tamoxifen beyond 5 years is not recommended, but the need to protect against relapse following tamoxifen is clear. The third-generation aromatase inhibitors offer a new approach to treating postmenopausal women with receptor-positive early stage breast cancer through the potent and specific systemic inhibition of estrogen synthesis. ⋯ Letrozole showed minimal side effects compared with placebo; adverse effects on bone metabolism of uncertain clinical significance were the most noteworthy side effect. Thus, the updated results from the MA.17 trial support the previous findings and show extended adjuvant therapy with letrozole to be a well-tolerated protection against the continuing risk of breast cancer recurrence for thousands of women currently receiving standard adjuvant tamoxifen. The re-randomization of MA.17 patients to an additional 5 years of letrozole or to no treatment will provide further insights into the benefits and side effects of long-term treatment.
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Seminars in oncology · Apr 2006
Randomized Controlled Trial Multicenter StudyThe use of early adjuvant aromatase inhibitor therapy: contributions from the BIG 1-98 letrozole trial.
Letrozole has proven efficacious in a variety of therapeutic scenarios, including that of extended adjuvant therapy following 5 years of tamoxifen treatment in postmenopausal women with estrogen-receptor-positive early breast cancer. The Breast International Group 1-98 trial (BIG 1-98) is the first to study the efficacy of upfront letrozole treatment and the first to evaluate the benefits of initial versus sequential aromatase inhibitor therapy. At 25.8 months of follow-up, the primary core analysis of BIG 1-98 compared the efficacy of upfront letrozole treatment with that of upfront tamoxifen treatment in 8,010 postmenopausal women with early breast cancer. ⋯ Letrozole has an efficacy advantage over tamoxifen and can now be considered part of standard adjuvant therapy for postmenopausal women with endocrine-responsive breast cancer. Women at increased risk for recurrence may obtain protective benefit from letrozole. Letrozole is generally well tolerated and is associated with a similar frequency of serious side effects, but fewer deaths, than tamoxifen.
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Seminars in oncology · Apr 2005
Randomized Controlled Trial Clinical TrialMutagen sensitivity may predict lung protection by amifostine for patients with locally advanced non-small cell lung cancer treated by chemoradiotherapy.
Amifostine (AMF) has been shown to protect some normal tissues from acute effects of radiation therapy +/- chemotherapy. We enrolled 62 patients in a randomized study investigating the efficacy of AMF: 31 had concurrent chemoradiation for non-small cell lung cancer and 31 had the same treatment + AMF. AMF reduced the frequency and severity of esophagitis, pneumonitis, and neutropenic fever. ⋯ Higher MS was associated with shorter distant metastasis-free survival and more frequent grade 3/4 lung fibrosis. AMF reduced the incidence of grade 3/4 lung fibrosis among higher MS. These data suggest that MS might help identify subgroups of patients who could receive more benefit from AMF with respect to lung damage.
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Seminars in oncology · Dec 2003
Randomized Controlled Trial Clinical TrialAmifostine reduces radiochemotherapy-induced toxicities in patients with locally advanced non-small cell lung cancer.
Radiochemotherapy (RCT) is an effective treatment for locally advanced non-small cell lung cancer, but can be limited by acute and late toxicities (esophagitis, pneumonitis, and myelosuppression). This trial investigated whether pretreatment with amifostine (Ethyol, WR-2721; MedImmune, Inc, Gaithersburg, MD), a radioprotector, could reduce the incidence of RCT-induced acute and late toxicities. Between October 1997 and August 1999, 73 patients with previously untreated stage IIIa-IIIb non-small cell lung cancer were randomized to treatment with RCT alone or RCT plus amifostine (300 mg/m(2) daily intravenous infusion). ⋯ Endoscopic grade >or= 2 esophagitis was observed in eight of 15 patients in the RCT group and in three of 18 patients in the RCT plus amifostine group (P =.061). No significant differences in response rates were noted between patients receiving RCT with or without amifostine (P =.498). Amifostine is effective in reducing the incidence of both acute and late toxicities associated with RCT in patients with locally advanced non-small cell lung cancer without compromising antitumor efficacy.