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WASHINGTON-A federal court has invalidated the FDA’s "Pediatric Rule" after concluding that its requirement that drug companies test the safety of adult drugs in children is contrary to the intent of Congress.

ORLANDO, Florida-Updateddata from two separate studiesratify earlier results showing thatfollowing CHOP (cyclophosphamide[Cytoxan, Neosar], doxorubicinHCl, vincristine [Oncovin],prednisone) with radiation improvesresults for patients with early-or limited-stage non-Hodgkin’slymphoma (NHL), according todata reported at the 43rd AnnualMeeting of the American Society ofHematology (abstract 3023) .

PALO ALTO, California-Varian Medical Systems, Inc. has received 510(k) clearance from the FDA for Acuity, a new digital imaging product that integrates planning, simulation, and verification software for treating cancer with radiation therapy. It works with Varian’s RPM Respiratory Gating System to track tumor motion during simulation and verification. It is intended to accelerate adoption of intensity modulated radiation therapy (IMRT). By performing patient set-up and treatment plan verification, Acuity frees the linear accelerator to be used exclusively for treatment delivery, Varian said in a press release announcing the new product.

WASHINGTON-President Bush has proposed policy changes to restrict the ability of drug companies to extend their patents past their expiration date. Mr. Bush said current federal laws and regulations try to balance the goals of innovation and accessibility.

NEW ORLEANS-Having a previous pregnancy improves the prognosis for women who develop early-stage breast cancer later in life, according to a study presented at the 44th Annual Meeting of the American Society for Therapeutic Radiology and Oncology (abstract 152). The findings suggest that a more aggressive treatment approach should be considered for those patients who have not had a pregnancy.

Plastic surgical reconstruction extends the capabilities of surgical and radiation therapy for cancer patients. Resection defects that are large, involve functional structures, aesthetically sensitive areas, and/or are at increased risk for wound healing complications are successfully reconstructed with a wide variety of techniques. Cancer and the complications of cancer treatment can involve virtually any area of the body, and to address every potential circumstance, the breadth of oncologic reconstruction must be extensive. A multidisciplinary team approach is the optimal method of cancer treatment, and plastic surgical reconstruction has become a critical component of that treatment, with the ability to restore form and function to the involved areas.

This article underscores what I believe is an important concept in the current state of the art of cancer therapy-namely that reconstructive plastic surgery is a key component in the treatment of many cancer patients. Clearly, the treatment of advanced-stage malignancies is now interdisciplinary, multimodal, and comprehensive. Chemotherapy and radiation therapy are becoming increasingly complementary modalities in the treatment of patients with more advanced disease.

Drs. Konner and O’Reilly have provided a thorough review of current perspectives on pancreatic cancer. The disease is lethal, difficult to diagnose in its early stages, and resistant to standard chemotherapy regimens. Surgery can be curative if performed when the tumor is small (< 2 cm), but only a minority of patients have small tumors.

LUGANO, Switzerland-Forlow-grade lymphomas, fludarabine(Fludara)-based combination therapymay have greater efficacy thansingle-agent fludarabine, especiallywhen a monoclonal antibody is partof the combination, a series of recentEuropean investigations suggest.The investigations, presentedat the Eighth International Conferenceon Malignant Lymphoma(ICML), show that various combinationtherapies hold promise, althougha lack of coordinationamong non-US study groups hashampered progress somewhat.

ORLANDO-In a phase IIIstudy, imatinib mesylate (Gleevec),formerly known as STI-571, produceda 96% complete hematologicresponse rate and a 68% completecytogenetic response rate in newly diagnosedchronic myeloid leukemia(CML) patients, Brian Druker, MD,said on behalf of the IRIS (InternationalRandomized Interferon vs STI-571) Study Group at the 38th AnnualMeeting of the American Societyof Clinical Oncology (abstract 1).

The past year hasseen a number of excitingadvances in the managementof patients withhematologic malignancies.The principal developmentshave beenthose focused on the conceptof targeted therapy.Though this conceptis not new, continuedevolution in therapeuticstrategies and advancesin knowledge of the biologyof various cellulartargets more than everare bringing about thepotential for new therapieswith additive or synergisticpotential and minimal additional toxicity.

This special “Annual Highlights” supplement to Oncology NewsInternational is a compilation of the major advances in the managementof the lymphomas and leukemias during 2002, as reported in ONI.Commentaries by the editors, Drs. Gregory Bociek, James Armitage,and Michael Keating, provide perspective and prediction as to howthese developments may affect clinical practice.

The American Cancer Society has estimated that 23,300 women will develop ovarian cancer in 2002, and 13,900 women will die from the disease.[1] The 5-year survival rate is about 80% for women with stage I disease, 50% for women with stage II disease, 25% for women with stage III disease, and 15% for women with stage IV disease. Among women with advanced-stage disease, optimal debulking surgery, as well as platinum/taxane-based adjuvant therapy prolongs disease-free and median survival.[2,3] Population-based data suggest that guidelines for therapy are not uniformly followed in community practice.[4] In addition, older patients appear to receive less aggressive treatment than younger patients.

The review by Drs. Konner and O’Reilly addresses a number of important issues in pancreatic cancer. Adenocarcinoma of the pancreas is a devastating disease,[1] not only because it will occur in approximately 30,000 Americans this year, and perhaps 200,000 people worldwide, but also because of its high associated mortality. Pancreatic adenocarcinoma is one of the least treatable and, therefore, most lethal of all cancers. Fully 95% of all patients with an established diagnosis of adenocarcinoma of the pancreas will die of their disease.

Pancreatic cancer is a leading cause of cancer-related mortality. Treatment has limited efficacy, and 5-year survival rates remain less than 5%. Insights from epidemiology and discoveries in molecular genetics have laid

HOMBURG, Germany-Afterconducting trials comparingCHOP (cyclophosphamide [Cytoxan,Neosar], doxorubicin HCl,vincristine [Oncovin], prednisone)with and without etoposide andvarying time intervals, the GermanHigh-Grade Non-Hodgkin’s LymphomaStudy Group concluded thatCHOP plus etoposide is the newstandard regimen for younger patientswith low-risk non-Hodgkin’slymphoma (NHL), and CHOP at2-week intervals is the new standardregimen for aggressive NHL in olderpatients.

WASHINGTON-A federal court has invalidated the FDA’s "Pediatric Rule" after concluding that its requirement that drug companies test the safety of adult drugs in children is contrary to the intent of Congress.

WASHINGTON-The blood of the human umbilical cord, although often discarded after childbirth, is a "very rich source" of lymphocytes potentially capable of killing cancer cells, according to Shantaram Joshi, PhD, professor of genetics, cell biology, and anatomy, University of Nebraska Medical Center, Omaha.

This special “Annual Highlights” supplement to Oncology NewsInternational is a compilation of the major advances in the managementof the lymphomas and leukemias during 2002, as reported in ONI.Commentaries by the editors, Drs. Gregory Bociek, James Armitage,and Michael Keating, provide perspective and prediction as to howthese developments may affect clinical practice.

ORLANDO-Allogeneicbone marrow transplant (BMT) significantlyreduced relapse rates andincreased event-free survival (EFS)rates, but not overall survival, inadults with Philadelphia chromosome(Ph)-negative acute lymphoblasticleukemia (ALL) in first completeremission.

ORLANDO-About onethird of “bad prognosis” refractoryB-cell chronic lymphocytic leukemia(B-CLL) patients are salvageablewith alemtuzumab (Campath-1H), according to a compassionateuse study presented at the 43rd AnnualMeeting of the American Societyof Hematology (abstract 1538).

H O U S T O N - A d d i n grituximab (Rituxan) to fludarabine(Fludara)/cyclophosphamide(Cytoxan, Neosar) (FCR) prolongssurvival in patients with relapsedchronic lymphocytic leukemia(CLL), according to GuillermoGarcia-Manero, MD. Dr. Garcia-Manero is assistant professor in theDepartment of Leukemia at TheUniversity of Texas M. D. AndersonCancer Center in Houston. Hepresented updated data on thisstudy in a poster at the 43rd AnnualMeeting of the American Society ofHematology (abstract 2650).

BOSTON-A rare pediatricleukemia, previously thought to bea subset of acute lymphoblastic leukemia(ALL), is actually a distinctform of the disease, according toinvestigators who used gene chipsto create and contrast genetic profilesof cancer cells.

This special “Annual Highlights” supplement to Oncology NewsInternational is a compilation of the major advances in the managementof the lymphomas and leukemias during 2002, as reported in ONI.Commentaries by the editors, Drs. Gregory Bociek, James Armitage,and Michael Keating, provide perspective and prediction as to howthese developments may affect clinical practice.

ORLANDO-Patients withchronic lymphocytic leukemia(CLL) complicated by autoimmunehemolytic anemia (AIHA) usuallyimprove following treatment withhigh-dose steroids but have few optionsif such treatment fail

This special “Annual Highlights” supplement to Oncology NewsInternational is a compilation of the major advances in the managementof the lymphomas and leukemias during 2002, as reported in ONI.Commentaries by the editors, Drs. Gregory Bociek, James Armitage,and Michael Keating, provide perspective and prediction as to howthese developments may affect clinical practice.

This special “Annual Highlights” supplement to Oncology NewsInternational is a compilation of the major advances in the managementof the lymphomas and leukemias during 2002, as reported in ONI.Commentaries by the editors, Drs. Gregory Bociek, James Armitage,and Michael Keating, provide perspective and prediction as to howthese developments may affect clinical practice.

ORLANDO-Despite earlymortality risks, HLA-matched siblingbone marrow transplants(BMTs) offer a greater possibility ofcure for patients with relapsedchronic lymphocytic leukemia(CLL) than does chemotherapy, accordingto a report presented at the43rd Annual Meeting of the AmericanSociety of Hematology (abstract2011). A second report (abstract2013) showed that allogeneic transplantled to better event-free survivalthan autologous transplant.

This special “Annual Highlights” supplement to Oncology NewsInternational is a compilation of the major advances in the managementof the lymphomas and leukemias during 2002, as reported in ONI.Commentaries by the editors, Drs. Gregory Bociek, James Armitage,and Michael Keating, provide perspective and prediction as to howthese developments may affect clinical practice.

This special “Annual Highlights” supplement to Oncology NewsInternational is a compilation of the major advances in the managementof the lymphomas and leukemias during 2002, as reported in ONI.Commentaries by the editors, Drs. Gregory Bociek, James Armitage,and Michael Keating, provide perspective and prediction as to howthese developments may affect clinical practice.