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Uracil/Tegafur Plus Oral Calcium Folinate in Advanced Breast CancerUracil and tegafur (in a molar ratio of 4:1 [UFT]) has proven activity against breast cancer and is delivered in an easy-to-administer oral formulation. Orzel, which combines UFT with the oral biomodulator, calcium folinate, may
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Myelodysplastic SyndromesMyelodysplastic syndromes (MDS) are a group of hematologic malignancies of the pluripotent hematopoietic stem cells. These disorders are characterized by ineffective hematopoiesis, including abnormalities in proliferation, differentiation, and apoptosis.
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Immune Targeting in Gastrointestinal Malignancies: Finding the Right Combination for the Right SiteAdvanced gastrointestinal malignancies are a major oncologic challenge for which successful durable personalized therapies are currently lacking.
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Controversies in the Management of Stage I SeminomaCurrent controversies in the treatment of stage I seminoma center on the relative roles of surveillance, adjuvant radiotherapy (RT), and adjuvant single-agent chemotherapy. Surveillance has been studied in over 800 patients,
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Routine 3D Treatment Planning: Opportunities, Challenges, and HazardsThree-dimensional (3D) treatment planning refers to the use of software and hardware tools to design and implement more accurate and conformal radiation therapy. This is a major advance in oncology that should lead to
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Reassessments of ESAs for Cancer Treatment in the US and EuropeAnemia is a widely prevalent complication among cancer patients. At the time of diagnosis, 30% to 40% of patients with non-Hodgkin lymphoma or Hodgkin lymphoma and up to 70% of patients with multiple myeloma are anemic; rates are higher among persons with myelodysplastic syndromes. Among patients with solid cancers or lymphomas, up to half develop anemia following chemotherapy. For almost 2 decades, erythropoiesis-stimulating agents (ESAs) were the primary treatment for cancer-related anemia. However, reassessments of benefits and risks of ESAs for cancer-associated anemia have occurred internationally. We reviewed guidelines and notifications from regulatory agencies and manufacturers, reimbursement policies, and utilization for ESAs in the cancer and chronic kidney disease settings within the United States, Europe, and Canada. In 2008 the US Food and Drug Administration (FDA) restricted ESAs from cancer patients seeking cure. Reimbursement is limited to hemoglobin levels < 10 g/dL. In the United States, ESA usage increased 340% between 2001 and 2006, and decreased 60% since 2007. The European Medicines Agency (EMEA) recommended that ESA benefits do not outweigh risks. In Europe between 2001 and 2006, ESA use increased 51%; since 2006, use decreased by 10%. In 2009, Canadian manufacturers recommended usage based on patient preferences. In Canada in 2007, approximately 20% of anemic cancer patients received ESAs, a 20% increase since 2004. In contrast to Europe, where ESA use has increased over time, reassessments of ESA-associated safety concerns in the United States have resulted in marked decrements in ESA use among cancer patients.
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Bevacizumab Plus Chemo in Early Stage HER2-Negative Breast CancerDr. Gunter von Minckwitz discusses the recent paper he authored that showed that bevacizumab in addition to neoadjuvant chemotherapy significantly increased the rate of pathological complete response in patients with early stage HER2-negative breast cancer.
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Neoadjuvant Therapy With Gemcitabine in Breast CancerPrimary systemic therapy (ie, preoperative or neoadjuvant) increasesthe possibility for breast-conserving surgery in patients with primarybreast cancer. Patients with pathologic complete response to primarysystemic therapy have improved survival compared with those with persistenttumors. Several phase II trials have evaluated gemcitabine-containingdoublet or triplet regimens as primary systemic therapy for breastcancer, results of which have shown promising clinical and pathologicresponse rates with manageable toxicity. Results of a phase I/II studyof gemcitabine (Gemzar)/epirubicin (Ellence)/docetaxel (Taxotere), orGEDoc, with prophylactic filgrastim (Neupogen), as primary systemictherapy in 77 evaluable patients with primary breast cancer are reportedherein. Dose-limiting toxicities were grade 3 febrile neutropenia(n = 1) and grade 3 diarrhea (n = 2) at the fourth dose level ofGEDoc tested (gemcitabine at 800 mg/m2 days 1 and 8, epirubicin at90 mg/ m2 day 1, and docetaxel at 75 mg/m2 day 1). As assessed byultrasound, 92% of patients responded overall (22% complete response),and 79% of patients could undergo breast-conserving surgery. Thepathologic complete response rate in resected breast tissue was 26%.
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UFT/Leucovorin Plus Weekly Paclitaxel in the Treatment of Solid TumorsThe palliation of symptoms and improvement of quality of life are important aspects of therapy in patients with incurable metastatic cancer. This article describes the preliminary results of a phase I study of uracil and tegafur, an orally available fluorouracil (5-FU) derivative combined with oral leucovorin plus weekly intravenous paclitaxel.
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Paclitaxel and Epirubicin as First-Line Therapy for Patients With Metastatic Breast CancerPaclitaxel (Taxol) has aroused considerable interest for its high single-agent activity in breast cancer and novel mechanism of action. Epirubicin (Farmorubicin), the 4'epimer of doxorubicin (Adriamycin), also has high activity in
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Cancer Chemotherapy in the Elderly PatientThe management of older patients with cancer is historically challenging because of a lack of prospective data regarding the appropriate management of this population. In this review, we address some of the issues and challenges surrounding the treatment of older cancer patients, including the withholding of medically appropriate treatment based on chronologic age, the historical omission of elderly from clinical trials, and the impact of geriatric assessment, and age-related changes in pharmacokinetics and pharmacodynamics. Finally, we conclude by discussing the existing evidence related to cancer treatment in the elderly, focusing primarily on the malignancies most commonly seen in older patients, and making general treatment recommendations where applicable.
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The Future of Metastatic Urothelial Carcinoma ManagementClosing out their review of metastatic urothelial carcinoma management, panelists share what they most look forward to in the evolving treatment landscape.
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Renal-Cell CarcinomaRenal-cell carcinoma (RCC) is curable only in patients presenting with resectable, early-stage disease. Advanced local or metastatic disease carries an approximate 15% 5-year survival rate. However, the natural history of metastatic RCC is heterogeneous, and aggressive palliative treatment is recommended, especially for patients with a solitary metastatic site and good performance status.
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Perioperative Treatment of Gastrointestinal Stromal TumorsGastrointestinal stromal tumors (GISTs) originate from the interstitial cells of Cajal or a precursor and are the most common mesenchymal neoplasms of the gastrointestinal (GI) tract.[1] Although GISTs often present as localized masses, they are typified by a high risk of metastatic relapse, most commonly in the liver and peritoneum.
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Paclitaxel as First-Line Treatment for Metastatic Breast CancerWhen administered as a single agent in pretreated patients with advanced breast cancer, paclitaxel (Taxol) exhibits remarkable antitumor activity. This trial was undertaken to compare paclitaxel with standard
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Vaccine Therapy for Patients With MelanomaInvestigation into the therapeutic use of vaccines in patients with metastatic melanoma is critically important because of the lack of effective conventional modalities. The most extensively studied melanoma vaccines in clinical trials are whole-cell preparations or cell lysates that contain multiple antigens capable of stimulating an immune response. Unfortunately, in the majority of studies, immune responses to these vaccines have not translated into a survival advantage. Advances in tumor cell immunology have led to the identification of candidate tumor cell antigens that can stimulate an immune response; this, in turn, has allowed for refinements in vaccine design. However, the exact tumor antigens that should be targeted with a specific vaccine are unknown. The univalent antigen vaccines, which have greater purity, ease of manufacturing, and reproducibility compared with polyvalent vaccines, may suffer from poorer efficacy due to immunoselection and appearance of antigen-negative clones within the tumor. Novel approaches to vaccine design using gene transfection with cytokines and dendritic cells are all promising. However, the induction of immune responses does not necessarily confer a therapeutic benefit. Therefore, these elegant newer strategies need to be studied in carefully designed clinical trials so that outcomes can be compared objectively with standard therapy. If survival is improved with these vaccine approaches, their ease of administration and lack of toxicity will firmly entrench active specific vaccine immunotherapy as a standard modality in the treatment of the melanoma patient.[ONCOLOGY 13(11):1561-1574, 1999].
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A 40-Year-Old Woman With a New Triple-Negative Breast Mass, Shown on Biopsy to Be Metaplastic CarcinomaA 40-year-old woman noted a large mass in her right breast. A diagnostic mammogram and ultrasound confirmed a 3.4-cm mass with associated microcalcifications.
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Cancer Treatment for LGBTQ PatientsIn this interview we discuss the approach to treating cancer in lesbian, gay, bisexual, transgender, and queer (LGBTQ) patients.
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Nuances in the Changing Epidemiology of Head and Neck CancerHead and neck squamous cell carcinoma (HNSCC) represents a heterogeneous group of malignancies caused by the traditional risk factors of tobacco, alcohol, and poor oral hygiene, as well as more recently identified roles of human papillomavirus (HPV) and Epstein-Barr virus (EBV).[1-3] We commend Kim and colleagues on their comprehensive review of the epidemiology of HNSCC. There has been a clear change in the epidemiology of HNSCC which has further accentuated differences in etiology, survival, and demographics among HNSCC patients. We will discuss several important nuances of this changing epidemiology, including the role of tobacco, race, sexual behavior, and gender, as well as HNSCC in nonsmokers and nondrinkers.
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C-11 choline PET/CT boosts early prostate ca detectionFindings of a study by researchers in Italy suggest C-11 choline PET/CT could diagnose prostate cancer recurrence sooner than transrectal ultrasound, CT, MRI, or bone scintigraphy in patients who have undergone radical prostatectomy.
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PSA Testing in Prostate Cancer: Early Treatment vs ObservationIn this interview we discuss the role of early treatment, active surveillance, and watchful waiting in patients with PSA-detected early-stage prostate cancer.
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Commentary (Grossman): Age-Specific Reference Ranges for PSA in the Detection of Prostate CancerDr. DeAntoni has carefully reviewed the literature on age-specific reference ranges for prostate-specific antigen (PSA) in the diagnosis of prostate cancer and the controversy surrounding their use. Key to understanding of this debate are two fundamental concepts: (1) the definition of "clinically significant prostate cancer" and (2) the use of sensitivity and specificity, which is frequently obscured by the surrounding rhetoric. The assumption that all readers uniformly interpret the meaning of clinically significant prostate cancer and wish to achieve the same results by manipulating sensitivity and specificity is probably incorrect.
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Anthracycline and Trastuzumab in Breast Cancer TreatmentThis study was designed to evaluate the cardiac safety of the combined treatment of HER2-positive metastaticbreast cancer patients with trastuzumab (Herceptin) plus epirubicin and cyclophosphamide (EC) incomparison with EC alone in HER2-negative metastatic breast cancer patients. Patients included those withmetastatic breast cancer without any prior anti-HER2 treatment, anthracycline therapy, or any other chemotherapyfor metastatic disease. This was a nonrandomized, prospective, dose-escalating, multicenter, openlabel,phase II study in Germany. A control group of 23 patients received EC 90/600 mg/m2 3-weekly for sixcycles (EC90 alone). A total of 26 HER2-positive patients were treated with trastuzumab, or H (2 mg/kg weeklyafter an initial loading dose of 4 mg/kg), and EC 60/600 mg/m2 3-weekly for six cycles (EC60+H); another 25HER2-positive patients received H and EC 90/600 mg/m2 3-weekly for six cycles. Asymptomatic reductions inleft ventricular ejection fraction (LVEF) of more than 10% points were detected in 12 patients (48%) treatedwith EC60 + H and in 14 patients (56%) treated with EC90 + H vs 6 patients (26%) in the EC90 alone cohort.LVEF decreases to < 50% occurred in one patient in the EC60+H cohort and in two patients in the EC90+Hcohort during the H monotherapy. No cardiac event occurred in the cohort with EC90 alone. The overallresponse rates for EC60+H and EC90+H were >60%, vs 26% for EC90 alone. The interim results of this studysuggest the cardiac safety of the combination of H with EC may be greater than that of H with AC (doxorubicin[Adriamycin]/cyclophosphamide); however, studies in larger numbers of patients are warranted. The combinationregimen revealed promising efficacy.
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Anthracycline and Trastuzumab in Breast Cancer TreatmentThis study was designed to evaluate the cardiac safety of the combined treatment of HER2-positive metastaticbreast cancer patients with trastuzumab (Herceptin) plus epirubicin and cyclophosphamide (EC) incomparison with EC alone in HER2-negative metastatic breast cancer patients. Patients included those withmetastatic breast cancer without any prior anti-HER2 treatment, anthracycline therapy, or any other chemotherapyfor metastatic disease. This was a nonrandomized, prospective, dose-escalating, multicenter, openlabel,phase II study in Germany. A control group of 23 patients received EC 90/600 mg/m2 3-weekly for sixcycles (EC90 alone). A total of 26 HER2-positive patients were treated with trastuzumab, or H (2 mg/kg weeklyafter an initial loading dose of 4 mg/kg), and EC 60/600 mg/m2 3-weekly for six cycles (EC60+H); another 25HER2-positive patients received H and EC 90/600 mg/m2 3-weekly for six cycles. Asymptomatic reductions inleft ventricular ejection fraction (LVEF) of more than 10% points were detected in 12 patients (48%) treatedwith EC60 + H and in 14 patients (56%) treated with EC90 + H vs 6 patients (26%) in the EC90 alone cohort.LVEF decreases to < 50% occurred in one patient in the EC60+H cohort and in two patients in the EC90+Hcohort during the H monotherapy. No cardiac event occurred in the cohort with EC90 alone. The overallresponse rates for EC60+H and EC90+H were >60%, vs 26% for EC90 alone. The interim results of this studysuggest the cardiac safety of the combination of H with EC may be greater than that of H with AC (doxorubicin[Adriamycin]/cyclophosphamide); however, studies in larger numbers of patients are warranted. The combinationregimen revealed promising efficacy.
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Rituximab as a Single Agent and in Combination With Interferon Alfa-2a as Treatment of Untreated and First-Relapse Follicular or Other Low-Grade Lymphomas: A Randomized Phase II Study (M 39035)Rituximab (Rituxan) is approved for use in patients with relapsed and refractory follicular lymphoma. Considering the immune modulating effect of interferon alfa-2a (IFN [Roferon-A]) and its efficacy as a single agent in follicular lymphoma, a
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A Phase II Randomized Study of Doxorubicin Alternated With Docetaxel vs Sequential Administration of Four Cycles of Docetaxel Followed by Four Cycles of Doxorubicin as First-Line Chemotherapy in Metastatic Breast Cancer PatientsFrom March 1996 to March 1998, 106 patients with untreated metastatic breast cancer (MBC) were treated with docetaxel (Taxotere) (100 mg/m²) and doxorubicin (75 mg/m²) on an alternating cycle-by-cycle (doxorubicin, docetaxel, doxorubicin, etc) or sequential (four cycles of docetaxel, then four cycles of doxorubicin) basis, every 3 weeks, for a maximum of eight cycles.
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Dose-Dense and Sequential Strategies in Adjuvant Breast Cancer TherapySeveral attempts have been made to improve the survival rates of breast cancer patients. The benefit of adjuvant chemotherapy was clearly shown, but the absolute difference of 2% to 11% in overall survival, depending on the
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Rituximab as a Single Agent and in Combination With Interferon Alfa-2a as Treatment of Untreated and First-Relapse Follicular or Other Low-Grade Lymphomas: A Randomized Phase II Study (M 39035)Rituximab (Rituxan) is approved for use in patients with relapsed and refractory follicular lymphoma. Considering the immune modulating effect of interferon alfa-2a (IFN [Roferon-A]) and its efficacy as a single agent in follicular lymphoma, a
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Initial Control of Chemotherapy-Induced Nausea and Vomiting in Patient Quality of LifeThe side effects commonly experienced by patients receiving chemotherapy for the treatment of cancer can challenge many aspects of daily life. Nausea and vomiting, the most common side effects reported by patients, affect the ability to continue with usual life activities and, thus have a pronounced impact on quality of life.
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Anthracycline and Trastuzumab in Breast Cancer TreatmentThis study was designed to evaluate the cardiac safety of the combined treatment of HER2-positive metastaticbreast cancer patients with trastuzumab (Herceptin) plus epirubicin and cyclophosphamide (EC) incomparison with EC alone in HER2-negative metastatic breast cancer patients. Patients included those withmetastatic breast cancer without any prior anti-HER2 treatment, anthracycline therapy, or any other chemotherapyfor metastatic disease. This was a nonrandomized, prospective, dose-escalating, multicenter, openlabel,phase II study in Germany. A control group of 23 patients received EC 90/600 mg/m2 3-weekly for sixcycles (EC90 alone). A total of 26 HER2-positive patients were treated with trastuzumab, or H (2 mg/kg weeklyafter an initial loading dose of 4 mg/kg), and EC 60/600 mg/m2 3-weekly for six cycles (EC60+H); another 25HER2-positive patients received H and EC 90/600 mg/m2 3-weekly for six cycles. Asymptomatic reductions inleft ventricular ejection fraction (LVEF) of more than 10% points were detected in 12 patients (48%) treatedwith EC60 + H and in 14 patients (56%) treated with EC90 + H vs 6 patients (26%) in the EC90 alone cohort.LVEF decreases to < 50% occurred in one patient in the EC60+H cohort and in two patients in the EC90+Hcohort during the H monotherapy. No cardiac event occurred in the cohort with EC90 alone. The overallresponse rates for EC60+H and EC90+H were >60%, vs 26% for EC90 alone. The interim results of this studysuggest the cardiac safety of the combination of H with EC may be greater than that of H with AC (doxorubicin[Adriamycin]/cyclophosphamide); however, studies in larger numbers of patients are warranted. The combinationregimen revealed promising efficacy.
