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Interpretation of Genome-Wide Association Study ResultsAs genome-wide association studies (GWAS) have opened the door to systematic discovery of genetic factors for complex diseases, including cancers, the clinical utility of the findings remains to be determined. This is elegantly discussed in the article in this issue of ONCOLOGY by Stadler et al. The authors rightfully caution against the use of “personal genomic tests” based on cancer GWAS results for personal cancer risk prediction.
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Cetuximab-Associated Infusion Reactions: Pathology and ManagementCetuximab (Erbitux), a chimeric antiepidermal growth factor receptor monoclonal antibody currently used to treat metastatic colorectal cancer, is in clinical development for several other solid tumors. Although cutaneous manifestations are the most common toxicities associated with cetuximab, they are rarely life-threatening. Cetuximab-related infusion reactions are less common, but they may become severe and cause fatal outcomes if not managed appropriately. Little about the specific etiology of these events is known; however, an overview of infusion reactions observed with other compounds may shed some light and help characterize cetuximab-related reactions. For physicians administering cetuximab, familiarity with acute reaction treatment protocols and preparedness to identify and manage symptoms promptly and effectively are most important to minimize potential risks.
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Epothilones: Clinical Update and Future DirectionsThis article reviews recent findings from clinical trials of epothilones and discusses future directions for the use of these agents in cancer therapy, with a focus on the two most-studied epothilones to date: ixabepilone and patupilone.
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The Oral Fluorouracil ProdrugsDiscussed herein are selected oral fluorinated pyrimidines that are converted to 5-fluorouracil (5-FU) in vivo to exert antitumor activity. These agents include capecitabine (Xeloda), tegafur-uracil (UFT) plus leucovorin (Orzel), and S-1 (BMS247616). These agents offer the convenience of an orally administered therapy with potentially fewer toxic effects than conventional bolus regimens of 5-FU plus leucovorin. These oral agents provide prolonged 5-FU exposure at lower peak concentrations than observed with bolus intravenous administration of 5-FU and may confer pharmacoeconomic advantages by reducing administration costs and toxicity-related hospitalizations. These regimens also have the potential for improved therapeutic activity by achieving higher 5-FU concentrations in the tumor or by biochemically modulating 5-FU. Phase III trials in patients with advanced colorectal carcinomas are comparing the antitumor activity of these agents with that of intravenous 5-FU plus leucovorin. [ONCOLOGY 12(Suppl 7):48-51, 1998]
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Social Well-Being and Cancer SurvivorshipBill, 53 years old and a 3-year survivor of non-Hodgkin’s lymphoma, reflects on his ongoing journey as a cancer survivor: “I was very sick and treatment was very rough, complete with a severe allergic reaction that was difficult to diagnose for a long time. But I made it through to the other shore…remission. Since then, I’ve been trying to rebuild a new life…Living with an 18-year-old [son], I can see how in some ways I’m in a parallel universe…Both of us are looking out at the world before us, at all the many possible options...trying to figure out what we want tomorrow to look like.
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Commentary (Bodurka-Bevers/Gershenson): Gynecologic Malignancies in Older WomenThe diagnosis and management of cancer in older women is becoming an increasingly common and challenging issue. Women who reach age 65 can expect to live an additional 17 years.[1] Age is an important risk factor for developing cancer. Epidemiologic data from 1992 to 1994 reveal that invasive cancer develops in 1 of 5 women aged 60 to 79 years.[2]
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Caring for Cancer Patients in the Future: A Perfect Storm on the Horizon?This timely manuscript by Bunnell and Shulman highlights critical issues that challenge our ability to provide care to cancer patients in the next 20 years. Each of the concerns the authors identify has a momentum of its own. In combination, they have the makings of a perfect health care storm. The time to further address these matters is now.
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Commentary (Meier): Improving Palliative and Supportive Care in Cancer PatientsThe field of palliative care hasgrown rapidly in recent yearsin response to patient need andclinician interest in effective approachesto managing chronic andlife-threatening illness. The article byKhatcheressian et al reviews the datathat make the case for palliative careas a core component of modern oncologypractice. They point out thatthe issue is not whether we have aquality problem here-it is clear thatwe do. Rather, the focus of this articleis on how best to address that problemin the context of the very real time andfinancial constraints in which we nowpractice oncology in the United States.
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Gemcitabine and Irinotecan in Locally Advanced or Metastatic Biliary Cancer: Preliminary ReportChemotherapy has had limited success in biliary tract cancer. Of thenewer agents, gemcitabine (Gemzar) and irinotecan (CPT-11, Camptosar)both have single-agent activity in patients with advanced disease.We conducted a phase II trial to study the efficacy and toxicity of thecombination of gemcitabine plus irinotecan in patients with locallyadvanced or metastatic biliary tract cancer. The study has enrolled 14patients with histologically or cytologically documented cancer of thebiliary tract or gallbladder with bidimensionally measurable disease,Eastern Cooperative Oncology Group performance status 0 or 1,decompressed biliary tree, and no prior exposure to chemotherapy.Gemcitabine at 1,000 mg/m2 and irinotecan at 100 mg/m2 were bothadministered on days 1 and 8, every 21 days. In patients who had lessthan grade 3 hematologic and less than grade 2 nonhematologic toxicityfollowing cycle 1, the dose of irinotecan was increased to 115 mg/m2 forsubsequent cycles. A total of 65 cycles of chemotherapy have beenadministered, with an average of 4.5 cycles per patient (range: 1 to 11cycles). The median treatment duration was 3 months (range: 0.75 to 8months). An objective partial response was determined radiographicallyin two patients (14%) while stable disease for periods ranging from 4to 11.5 months was noted in six patients (43%). Toxicity consisted ofgrade 3/4 neutropenia in seven patients (50%) with no episodes offebrile neutropenia, grade 3/4 thrombocytopenia in four (28%), grade3 diarrhea in two (14%), and grade 3 nausea in one patient. Thecombination of gemcitabine plus irinotecan appears to possess modestclinical activity, and it is well tolerated in patients with advanced biliarycancer. Patient accrual is ongoing to this study.
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Diane M. Simeone, MD “Thrilled” To Be UCSD Moores Cancer Center DirectorDiane M. Simeone, MD highlights the importance of multidisciplinary care, surgical practices, and early detection in pancreatic cancer care.
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NCCS Briefing Paper on Quality Cancer CareThe National Coalition for Cancer Survivorship (NCCS) recently surveyed health providers, government officials, professional and advocacy organizations, scientists, and others regarding a critical issue facing this nation's 8 million cancer survivors: quality cancer care. The responses were illuminating as they portrayed a system in flux. The United States is moving away from a health care system where fee for service insurance plans predominate to one where market-based alternatives are quickly gaining favor among employers, consumers, and other purchasers of health care coverage. What this fundamental transition will mean for survivors and individuals with other serious or life-threatening diseases and the people who care for them is an open question with important public policy implications
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Every-2-Week Darbepoetin Alfa Is Comparable to rHuEPO in Treating Chemotherapy-Induced AnemiaThe safety and efficacy of darbepoetin alfa (Aranesp) at 3.0 µg/kg administered every 2 weeks and recombinant human erythropoietin (rHuEPO) given as 40,000 U weekly or 150 U/kg three times weekly were evaluated by
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Docetaxel/Doxorubicin/Cyclophosphamide in the Treatment of Metastatic Breast CancerPreliminary results from phase I trials suggest that the use of docetaxel (Taxotere) and doxorubicin (Adriamycin) is a well tolerated and highly active combination regimen for
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Unmet Needs and Future Perspectives in Multiple MyelomaA panel of experts discuss unmet needs in multiple myeloma and offer perspectives on the future treatment landscape.
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Natural History and Treatment of Malignant ThymomaThymomas are rare, slow-growing neoplasms that are considered to be malignant because of their potential invasiveness. The most widely used staging system is that of Masaoka and colleagues, which takes into account
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Renal Cancer Management in a Patient With Chronic Kidney DiseaseA 69-year-old man presented in the urology clinic for evaluation of bilateral renal masses, discovered incidentally during routine exams for follow-up of his chronic kidney disease.
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The Variegated Morphology of HPV-Related Neoplasms of the PenisOur commentary aims to expand on the evolution and present state of the art in the pathology of HPV in penile cancer and precancerous lesions.
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Revisiting Induction Chemotherapy for Head and Neck CancerSquamous cell carcinomas of the head and neck are highly responsiveto induction chemotherapy. However, randomized trials have failedto demonstrate a survival advantage with the addition of induction chemotherapyto locoregional therapy consisting of surgery and/or radiationtherapy. Currently, concomitant radiation and chemotherapy hasemerged as a standard and has optimized locoregional control in headand neck cancer. In this setting, the addition of induction chemotherapymay further improve outcome by enhancing both locoregional and distantcontrol. As interest in induction regimens is renewed, we elected toconduct a systematic review of trials of induction chemotherapy forlocoregionally advanced head and neck cancer. The most studied combination-cisplatin plus fluorouracil (5-FU)-achieves objective responserates of about 80%. In a meta-analysis, induction with platinum/5-FU resulted in a small survival advantage over locoregionaltherapy alone. The introduction of a taxane into induction chemotherapyregimens has produced promising results. Induction chemotherapyshould be the subject of further clinical research in head andneck cancer. Randomized clinical trials in which the control arm isconcurrent chemoradiotherapy and the experimental arm is inductionchemotherapy followed by concurrent chemoradiotherapy are planned.Platinum/taxane combinations are the preferred regimens for furtherstudy in the induction setting and a suitable platform with which toinvestigate the addition of novel targeted agents.
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UFT/Leucovorin Plus Weekly Irinotecan in Advanced or Metastatic Colorectal CancerThis is an open-label, nonrandomized phase I trial to determine the safety and maximum tolerated dose of irinotecan with a fixed dose of UFT plus oral leucovorin in patients with advanced or metastatic colorectal cancer.
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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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The Role of Amifostine as a RadioprotectorEffective radiotherapy for patients with cancer should include maximal tumor cell killing with minimal injury to normal tissue. Radiation doses that can be delivered, without causing severe damage to surrounding normal
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The Role of Adjuvant Radiation in Endometrial CancerEndometrial cancer is the most common gynecologic malignancy, with an estimated 40,100 cases and 7,470 deaths in 2008. This malignancy represents 6% of all cancers, and 3% of cancer deaths in women. Endometrial cancer is more prevalent in older women, with an incidence of 1 in 142 for women 40 to 59 years old, increasing to 1 in 81 women over 70 years old.[1] Median age at diagnosis is 62.[2] The mortality of endometrial cancer has decreased from 4.18 to 4.12 per 100,000 from 1991 to 2004.
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Paclitaxel and Carboplatin as First-Line Chemotherapy for Advanced Breast CancerIn a phase II study, 66 patients with advanced breast cancer (median age 56 years; range, 28 to 75 years) were treated with paclitaxel (Taxol), 175 mg/m² infused over 3 hours, and carboplatin (Paraplatin), dosed to attain an
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The Evolving Landscape of Gastrointestinal Infections in Neutropenic PatientsDiagnosis and management of GI complications in neutropenic patients benefit from the use of collaborative multidisciplinary teams to optimize outcomes.
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Gemcitabine and UFT Plus Oral Calcium Folinate: Phase I StudyGemcitabine (Gemzar) (2-deoxy-2,2-difluorocytidine) is a new antimetabolite being increasingly used in the treatment of solid tumors. It is an analog of deoxycytidine and cytosine arabinoside (Ara-C) (Figure 1) that has shown significant activity
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Anthracycline vs Nonanthracycline Adjuvant Therapy for Breast CancerThe treatment of breast cancer has progressed substantially overthe past 15 years. Data from randomized adjuvant trials have shownthat the risk of disease recurrence and death is significantly reducedwhen adjuvant chemotherapy and/or hormonal therapy is added to treatment.As new strategies are incorporated, one of the continued controversiesin patient management is whether adjuvant anthracyclinesshould be the preferred treatment for all patients. Data from randomizedand translational clinical trials have become available and arehelping to elucidate the proper role of anthracyclines, as well as their acuteand long-term toxicities. In most situations, an anthracycline is currentlypreferred, but other single and combination chemotherapies arecurrently under evaluation and appear promising for use in the adjuvantsetting. Continued breast cancer research using molecular markers(such as topoisomerase II–alpha and gene clusters) as predictors oftreatment response, could help individualize decisions regardingwhether to incorporate anthracyclines into adjuvant therapy regimens.
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Doxorubicin and Paclitaxel (Sequential Combination) in the TreatmentBased on preclinical data, we designed a phase I/II clinical trial to determine the efficacy and toxicity of doxorubicin followed by paclitaxel in the treatment of advanced breast cancer (either untreated or relapsed after
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Oncology Clinical Trials During the COVID-19 PandemicABSTRACT The coronavirus disease 2019 (COVID-19) pandemic has rapidly spread all over the world in the past several months. No effective treatment for COVID-19 has been established. High transmissibility and considerable mortality rates have forced many national governments to implement quarantine measures. Many patients with cancer rely on clinical trials to receive their oncologic care, but the routine conduct of clinical trials has substantially changed because of the COVID-19 pandemic. The oncology research community should implement formal policies based on the guidance given from regulatory agencies, with the goal of minimizing the risks of COVID-19 infection while maintaining appropriate oncologic treatments for patients during this pandemic.
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Chemotherapy-Induced Cardiomyopathy: Clinical Scenarios and ChallengesWe will discuss the deleterious cardiovascular effects of anthracyclines and HER2-targeted agents in a case-based format, as well as specific approaches to prevention and treatment of associated cardiotoxicity.
