Oncology NEWS International Vol 12 No 3

Elevated Serum HER2/neu Linked to Lower Response to Hormone Therapy

March 01, 2003

HERSHEY, Pennsylvania-Elevated levels of common serum biomarkers, including HER2/neu, predict response to hormone therapy among women with advanced breast cancer, according to a study reported by Kim Leitzel, MS, senior research associate in the Experimental Oncology Research Lab, directed by Allan Lipton, MD, at Penn State/Hershey Medical Center, Hershey, Pennsylvania.

Chemotherapy Does Not Add to the Benefits of Tamoxifen in Node-Negative, ER-Positive Older Breast Cancer Patients

March 01, 2003

PITTSBURGH-Long-term follow-up data from National Surgical Adjuvant Breast and Bowel Project (NSABP) trials of tamoxifen plus chemotherapy in node-negative, estrogen receptor (ER)-positive breast cancer patients suggest that chemotherapy does not add to the benefits of tamoxifen among women aged 60 or older. Bernard Fisher, MD, distinguished service professor at the University of Pittsburgh and past chairman and scientific director of the NSABP, reviewed the results of several trials, beginning with NSABP B-20. That trial established the value of combining cyclophosphamide (Cytoxan, Neosar), methotrexate, and fluorouracil (CMF) with tamoxifen in node-negative, estrogen receptor-positive women.

Are We Closing in on a Blood Test for Breast Cancer?

March 01, 2003

NORFOLK, Virginia-Using an innovative technique called protein chip mass spectrometry, researchers at Eastern Virginia Medical School in Norfolk have identified specific serum protein profiles that may enhance the detection of breast cancer. Lori Wilson, MD, previously research associate at Eastern Virginia Medical School and now surgical oncology fellow at John Wayne Cancer Institute in Santa Monica, California, reported that in early testing, the biomarker profiles have shown a specificity and sensitivity that approaches that of mammography.

Trial Lays Groundwork for All-Oral Capecitabine/Vinorelbine

March 01, 2003

ANN ARBOR, Michigan-Giving oral capecitabine (Xeloda) plus IV vinorelbine (Navelbine) in flat doses unadjusted for body surface area (BSA) is a feasible, convenient strategy that has good activity in previously treated metastatic breast cancer, according to results of a phase I/II study. The findings lay the groundwork for investigating a potential flat-dosed, all-oral regimen, according to Anne F. Schott, MD, assistant professor of internal medicine with the University of Michigan Comprehensive Cancer Center at Ann Arbor.

Vinorelbine/Capecitabine Can Be Used in Patients Pretreated With Anthracyclines or Taxanes

March 01, 2003

ESSEN, Germany-The combination of capecitabine (Xeloda) plus vinorelbine (Navelbine) is feasible and has a favorable toxicity profile in anthracycline-pretreated or taxane-pretreated advanced breast cancer, according to results of a recent phase I/II study. "The response rate over 50% is very promising," noted Udo Vanhoefer, MD, professor of medicine at University of Essen Medical School in Germany. "We had no alopecia, the incidence of hand-foot syndrome is very low, and the dose density is very high at 90% and very acceptable for this combination."

Idarubicin Paired With Capecitabine as Entirely Oral First-Line Treatment

March 01, 2003

EDINBURGH-Idarubicin (Idamycin) paired with capecitabine (Xeloda) and administered orally is well tolerated and active as a first-line treatment for older women with breast cancer, according to results of a recent dose-finding study. The oral idarubicin/capecitabine regimen was associated with 8 responses among 16 postmenopausal women who had chemotherapy-naive locally advanced or metastatic breast cancer, according to David Cameron, MD, senior lecturer in oncology at Western General Hospital, University of Edinburgh.

Fulvestrant Is Effective for Patients Failing Other Hormonal Therapy

March 01, 2003

BERN, Switzerland-The antiestrogen fulvestrant (Faslodex) is an effective and well-tolerated treatment option for women with heavily pretreated, hormone-sensitive advanced breast cancer, according to an interim analysis from an ongoing study by the Swiss Group for Clinical Cancer Research (SAKK), based in Bern, Switzerland. All of the patients in the study had failed both tamoxifen and an aromatase inhibitor, but 11 of 32 patients (34%) had prolonged clinical benefit on fulvestrant 250 mg every 28 days.

Conventional Factors Do Not Explain Higher Mastectomy Rate in US Compared to UK

March 01, 2003

EVANSTON, Indiana-Analysis of traditional factors that correlate with choice of mastectomy or breast-conserving surgery failed to explain the significantly higher mastectomy rates in the United States compared to the United Kingdom seen in the international Arimidex (anastrozole), Tamoxifen, Alone or in Combination (ATAC) trial. ATAC investigator Gershon Y. Locker, MD, noted the striking difference "in the mastectomy rates between the two largest accruing nations in ATAC-the United Kingdom with a 42% mastectomy rate and the United States with a 51% mastectomy rate. This is a 21% increased risk of having a mastectomy if enrolled in the United States compared to the United Kingdom."

Cervical Cancer Screening Not Needed for Many Older Women

March 01, 2003

ROCKVILLE, Maryland-Physicians can discontinue cervical cancer screening for many women age 65 and older, and delay screening for some young women until age 21, according to new guidelines developed by the US Preventive Services Task Force (USPSTF).

Adding Carboplatin Step Ups Response in HER2/neu-Positive Breast Cancer Patients

March 01, 2003

FAIRFAX, Virginia-In women with HER2/neu-positive advanced breast cancer, augmenting trastuzu-mab (Herceptin)/paclitaxel with carboplatin (Paraplatin) provides superior response and time to progression, results of a randomized phase III trial suggest. The response rate was 52% for patients who received trastuzu-mab/paclitaxel/carboplatin (TPC), significantly higher (P = .04) than the 36% response rate for trastuzumab/paclitaxel (TP). Time to progression was 11.2 months for TPC, vs 6.9 months for TP (P = .007). Investigator Nicholas J. Robert, MD, chairman of the US Oncology Breast Committee, Fairfax, Virginia, presented the results.

No Benefit for T-Cell Depletion in Unrelated Donor Transplants

March 01, 2003

PHILADELPHIA-T-cell depletion had no clear advantage over immunosuppressive drug therapy in patients receiving a matched, unrelated donor bone marrow transplant, John E. Wagner, MD, reported at the 44th Annual Meeting of the American Society of Hematology (ASH abstract 274).

ZD1839 Provides Some Clinical Benefit in Advanced Breast Cancer

March 01, 2003

CHICAGO-The novel biologic agent ZD1839 (gefitinib; Iressa) provided some clinical benefit, and may have relieved bone pain, in heavily pretreated patients with advanced breast cancer, according to results of a recent phase II trial. Of 63 patients treated, 9 or 14.3% had a partial response or stable disease, and 15% of patients remained on treatment for 4 to 8 months or longer

Nonanthracycline Combination Shows Promise as Neoadjuvant Therapy for Breast Cancer

March 01, 2003

MIAMI-As neoadjuvant therapy for breast cancer, docetaxel (Taxotere) plus cisplatin delivers pathologic complete response rates as good or better than standard anthracycline-containing regimens, results of a nonrandomized study suggest. The study involved 57 patients with locally advanced and inflammatory breast cancer.

Capecitabine/Paclitaxel Safe and Effective as First-Line Therapy for Metastatic Breast Cancer

March 01, 2003

CHICAGO-A capecitabine (Xeloda) plus paclitaxel regimen is effective and safe as first-line treatment of metastatic breast cancer, according to 3-year results of a multicenter, phase II study. Toxicity was manageable, with a relatively low incidence of grade 3/4 adverse events, including hand-foot syndrome. The study, which is among the latest to evaluate the potential for synergy between capecitabine and taxanes, was described by William J. Gradishar, MD, associate professor of medicine at Northwestern University Medical School, Chicago.

Docetaxel/Vinorelbine Among Most Active Regimens Ever Tested in Neoadjuvant Setting

March 01, 2003

CHARLOTTE, North Carolina-Dose-intense, dose-dense neoadjuvant docetaxel (Taxotere) /vinorelbine (Navelbine) produced a pathologic complete response rate of 36% in women with locally advanced breast cancer, making the combination among the most active ever tested in this setting, according to investigator Steven A. Limentani, MD. Preliminary study results also suggest the regimen is safe and well tolerated.

Concept of Running a Clinical Trial Without Genetic Profiling May Soon Be Unthinkable

March 01, 2003

SAN ANTONIO, Texas-The genetic signature of breast tumors seems to be a powerful predictor of aggressiveness and metastatic potential, outperforming the individual clinical parameters that have traditionally been used, according to several presentations at the San Antonio Breast Cancer Symposium.

Capecitabine/Docetaxel Is More Cost Effective Than Docetaxel Alone in Pretreated Disease

March 01, 2003

SYDNEY, Australia-Capecitabine (Xeloda) plus docetaxel (Taxotere) is a cost-saving treatment for patients with advanced breast cancer previously treated with an anthracycline-containing regimen, results of an economic analysis suggest. The combination, shown in a pivotal randomized trial to provide a significant survival benefit over docetaxel alone in advanced breast cancer, is also associated with a decrease in total treatment costs, according to Carlene Todd, health economist with Roche Products Pty. Ltd., Sydney, Australia.

Prior Hormone-Replacement Therapy Linked to Reduced Risk of Metastasis to Bone, Lung, Liver

March 01, 2003

HEIDELBERG, Germany-Breast cancer patients who have received prior hormone-replacement therapy (HRT) have a significantly reduced risk of metastasis to bone, lung, and liver, according to a study reported by Ingo J. Diel, MD, of the Institute for Gynecological Oncology in Mannheim Germany. Dr. Diel was previously affiliated with the Department of Obstetrics and Gynecology at University Hospital in Heidelberg, Germany. The German study supports previous reports of improved outcome for breast cancer patients who have used HRT.

CEF Maintains Advantage Over CMF at 10 Years

March 01, 2003

SAN ANTONIO-A 10-year update of Canada’s MA.5 trial has found a continuing survival advantage for node-positive premenopausal breast cancer patients treated with adjuvant cyclophosphamide/epirubicin (Ellence)/fluorouracil (5-FU) (CEF) vs those given classic cyclophosphamide/methotrexate/5-FU (CMF).

Radiofrequency Ablation Relieves Metastatic Bone Pain

March 01, 2003

CHICAGO-Among patients with intractable and severe pain because of bony metastases, radiofrequency ablation either relieved pain completely or produced a significant reduction in patients’ assessment of pain, according to a study presented at the 88th Scientific Assembly and Annual Meeting of the Radiological Society of North America (RSNA abstract 228VI-p). In this multicenter study of 62 patients with osteolytic metastases, 44% reported they were completely free of pain at some point during the 6 months following radiofrequency ablation, 81% had a 3-point drop in the Brief Pain Inventory (BPI), and 95% had at least a 2-point drop in BPI.

Invasive Local Recurrence in DCIS Can Turn ‘Indolent’ Disease Into Life-Threatening Condition

March 01, 2003

REIMS, France-Results of a French study suggest that oncologists should not underestimate the potential threat posed by local recurrence of ductal carcinoma in situ (DCIS). Reporting on the DCIS experience of 11 French cancer centers, Bruno Cutuli, MD, a radiation oncologist at the Center for Radiotherapy and Oncology at Polyclinique Courlancy in Reims, France, emphasized the importance of optimal initial treatment, close follow-up and definitive treatment after an invasive local recurrence.

Dose-Dense Adjuvant Chemotherapy Reduces Mortality and Recurrence in Node-Positive Breast Cancer

March 01, 2003

SAN ANTONIO, Texas-In women with node-positive breast cancer, shortening the time between adjuvant chemotherapy cycles significantly reduces mortality and risk of recurrence, with no significant increase in toxicity, according to results of a large, randomized cooperative group trial. Interim analysis from Cancer and Leukemia Group B (CALGB) 9741 showed that dose-dense chemotherapy reduced mortality by 31% and risk of recurrence by 26% vs conventional administration.

uPA/PAI-1 Predict Adjuvant Chemo Benefit in Breast Cancer

March 01, 2003

SAN ANTONIO-In women with primary breast cancer, the tumor invasion factors urokinase-type plasminogen activator (uPA) and plasminogen activator inhibitor type 1 (PAI-1) can predict benefit from adjuvant chemotherapy and should support clinical decision making, according to European investigators who for years have been studying the role of these two molecules in breast cancer. Nadia Harbeck, MD, of Technical University, Munich, Germany, described their most recent findings at the 25th Annual San Antonio Breast Cancer Symposium (abstract 7).

Metastasis-Associated Gene Identified and May Prove Useful as Marker for Relapse

March 01, 2003

HOUSTON-A gene that has been labeled metastasis-associated gene appears to be related to poor disease-free survival. Investigators at Baylor College of Medicine in Houston have produced a polyclonal antibody to metastasis-associated tumor antigen (MTA1)-specific isotopes that may prove useful as a prognostic marker for recurrence.

Anastrozole Continues to Outperform Tamoxifen at Each Efficacy Endpoint

March 01, 2003

HOUSTON-The nonsteroidal aromatase inhibitor anastrozole (Arimidex) continues to outperform tamoxifen in every efficacy measurement in the Arimidex, Tamoxifen, Alone or in Combination (ATAC) trial, according to a recent 47-month update. Speaking for the ATAC Trialists’ Group, Aman U. Buzdar, MD, professor of medicine and deputy chairman of the Department of Breast Medical Oncology at The University of Texas M.D. Anderson Cancer Center, Houston, reported that the absolute differences between the two drugs are increasing with time.

Benign Breast Disease May Be Independent Risk Factor for Invasive Breast Cancer

March 01, 2003

PITTSBURGH-Women with benign breast disease were 54% more likely to develop invasive breast cancer than were women without a diagnosis of benign breast disease, according to an analysis of data from Breast Cancer Prevention Trial (BCPT) of the National Surgical Adjuvant Breast and Bowel Project (NSABP). Lead investigator Jiping Wang, MD, a research associate in biostatistics at the University of Pittsburgh and a statistician for the NSABP, reported that the risk associated with benign breast disease was higher among women age 50 and older.

Bevacizumab Boosts Response to Capecitabine in Metastatic Disease

March 01, 2003

INDIANAPOLIS-Adding the antiangiogenesis agent bevacizumab (Avastin) to capecitabine (Xeloda) increases the objective response rate-but not progression-free survival-in women with advanced breast cancer, according to a phase III trial. This was the first randomized trial to report results with an antiangiogenic agent in patients with metastatic disease, according to lead investigator Kathy D. Miller, MD, assistant professor of medicine in the division of hematology/oncology at Indiana University School of Medicine, Indianapolis.

Vinorelbine/Capecitabine Represents Promising Alternative for Metastatic Breast Cancer

March 01, 2003

BEIRUT, Lebanon-Vinorelbine (Navelbine) plus capecitabine (Xeloda) is a highly effective and well tolerated first-line chemotherapy regimen for metastatic breast cancer, according to results of a recent 30-patient multicenter phase II trial. Investigators reported a response rate of 67%, with the main toxicity being grade 3/4 neutropenia in 13% of patients.