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In this issue of Oncology, Dr. Schilsky has provided a comprehensive yet concise review of the pharmacology of the fluoropyrimidines and, in particular, capecitabine (Xeloda).

In order to derive maximum benefit from treatment with chemotherapeutic agents, adherence to the established chemotherapy dose and schedule is imperative.

Preclinical studies have shown that rhIL-11, also known as oprelvekin (Neumega), stimulates early and later stages of megakaryocytopoiesis (including proliferation and differentiation of megakaryocyte precursors and maturation of megakaryocytes), to

Safety data from two randomized phase II and one abbreviated phase III placebo-controlled, double-blind clinical studies in adult patients with nonmyeloid malignancies indicate that recombinant human interleukin-11 (rhIL-11, also known as oprelvekin [Neumega]) has an acceptable toxicity profile as therapy for the mitigation of chemotherapy-induced thrombocytopenia.

PHILADELPHIA-“Most people would agree that standard-of-care for frontline treatment of advanced colorectal cancer (CRCA) should now be irinotecan (Camptosar) plus 5-fluorouracil/leucovorin (5-FU/LV),” stated Daniel G. Haller, MD, at an investigators’ workshop sponsored by the University of Texas M. D. Anderson Cancer Center and Pharmacia Oncology. As the basis for this assessment, Dr. Haller of the University of Pennsylvania Cancer Center in Philadelphia, cited presentations made earlier this year.

ROCHESTER, Minn-Standard adjuvant therapy for stage III colorectal cancer (CRCA) should be 6 months of 5-flourouracil (5-FU) plus either high-dose or low-dose leucovorin (LV), but new agents “offer the promise of less toxicity and possibly improved survival,” Henry C. Pitot, MD, reported. A consultant in the Division of Medical Oncology at the Mayo Clinic in Rochester, Minnesota, Dr. Pitot described several of these new regimens at a clinical investigators’ workshop sponsored by the University of Texas M. D. Anderson Cancer Center and Pharmacia Oncology.

CHICAGO-No overall gain was seen with ranpirnase (Onconase) compared with doxorubicin in unresectable malignant mesothelioma, but there was a trend toward ranpirnase benefit in good-prognosis patients.

Ever since the first phase II study of paclitaxel (Taxol) began, there has been ongoing controversy about the optimal dose and schedule of administration of this drug. The initial reports of marked antitumor activity against metastatic breast cancer were obtained using 250 mg/m² administered by 24-hour continuous IV infusion. This schedule was originally developed in an attempt to reduce the incidence and severity of anaphylactic reactions. Subsequent to the determination that this dose and schedule was effective and safe, there were multiple attempts to develop more convenient schedules, and dose/schedules associated with an improved side-effect profile.

The Southwest Oncology Cooperative Group (SWOG) conducted a study in which single-agent docetaxel (Taxotere) was used as “consolidation” therapy following concurrent chemoradiotherapy (abstract #1916). A previous SWOG study (S90-19) (Proc Am Soc Clin Oncol 16: 446a [abstract 1600], 1997) established that chemotherapy with cisplatin (Platinol)/etoposide could be given concurrently with definitive thoracic irradiation both safely and effectively. In this earlier trial, following the completion of irradiation, two additional cycles of cisplatin/etoposide were given.

Gómez-Bernal et al (abstract #341) report the results of a docetaxel (Taxotere)/vinorelbine (Navelbine) combination as second-line therapy for metastatic breast cancer. Both agents were administered on the same day and repeated every 14 days. The 52% objective response rate is impressive, since vinorelbine alone would be expected to produce a 20%–30% response rate in this setting, with docetaxel projected to achieve a 40% complete and partial remission rate. Therefore, the results suggest an additive interaction between the two agents.

Over the past 5 years it has become evident that the administration of taxanes on a weekly schedule dramatically changes their toxicity profile, compared to the standard 3-weekly schedule. Weekly docetaxel (Taxotere) is markedly less

Evidence generated by controlled clinical trials over the past 4 decades indicated that combination chemotherapy produced superior results to single-agent cytotoxic therapy. Response rates and times to progression were superior with combination chemotherapy, and survival was also favorably altered by this approach. This paradigm has been recently challenged on the basis of the Norton-Simon hypothesis and by the development of more effective, new cytotoxic agents, specifically the taxanes.

Before the introduction of the taxanes into the management of breast cancer, the anthracyclines (and doxorubicin and epirubicin [Ellence] in particular) were considered the most active agents against this malignancy. The marked activity of single-agent taxanes suggested that their antitumor efficacy might match and perhaps exceed that of the anthracyclines. Several prospective randomized trials have confirmed these initial impressions. At intermediate doses (60 mg/m²), the activity of doxorubicin and paclitaxel (Taxol) was similar; at higher doses (75 mg/m²), doxorubicin appeared more effective. Conversely, docetaxel (Taxotere) was reported to be more active than doxorubicin in one trial.

WASHINGTON-The House voted to allow the Justice Department to tap funds from three other federal departments to help pay for pursuing a lawsuit against the tobacco industry. Attorney General Janet Reno had said that without funds from the Departments of Health and Human Services, Defense, and Veterans’ Affairs, the government would be unable to go forward with the suit to recover $20 billion in federal funds spent on treating tobacco-related illnesses.

ROCKVILLE, Md-The FDA and the Cellular Telecommunications Industry Association (CTIA) have joined in a collaborative effort to examine the potential health effects of wireless telephones. FDA will provide research recommendations and oversight. CTIA will fund the studies, which will be done over the next 3 to 5 years by researchers who are not connected with FDA or the industry. Initial studies will focus on whether radiofrequent emissions from wireless phones pose any health threat. They will include both laboratory work and studies of mobile phone users.

NEW ORLEANS-Colorectal cancer appears to be two distinct diseases at the molecular and natural history level, but what exactly does this mean in terms of clinical practice? Steven Gallinger, MD, of the Univesity of Toronto, attempted to answer that question in his overview of Dr. Elsaleh’s presentation on microsatellite instability (MSI).

WASHINGTON-The National Cancer Institute and the National Center for Complementary and Alternative Medicine (NCCAM) at the National Institutes of Health are jointly launching a “Quick Trials” research grants program that will enable more rapid evaluation of promising complementary and alternative medicine (CAM) therapies.

SAN DIEGO-Historically, cancer patients with liver metastases that were bilobar or noncolorectal, or who were simply elderly, have been considered inappropriate candidates for hepatic resection. A new study from the University of Chicago’s Pritzker School of Medicine suggests that these indications for resection should be liberalized.

BETHESDA, Md-The National Cancer Institute (NCI), in collaboration with Searle (Skokie, Illinois, now a part of Pharmacia Corp, Peapack, New Jersey) and Pfizer Inc. (New York), is sponsoring a series of clinical trials testing celecoxib (Celebrex) for the prevention of a variety of cancerous and precancerous conditions.

NEW ORLEANS-An educational intervention for both patients and health care professionals led to significant improvements in pain control at the RUSH Cancer Institute of RUSH-Presbyterian-St. Luke’s Medical Center, Chicago. David Frame, PharmD, reported the results at the 36th Annual Meeting of the American Society of Clinical Oncology (ASCO).

CRETEIL, France-In a study of patients with high-risk aggressive non-Hodgkin’s lymphoma (NHL), those receiving high-dose chemotherapy and autologous bone marrow transplant (ABMT) after induction therapy lived longer than those receiving sequential chemotherapy, said Corinne Haioun, MD, of Hospital Henri Mondor, Créteil, France.

PALO ALTO, Calif–Varian Medical Systems, Inc. has been given the go-ahead to begin marketing the new CT Option for its RPM (Real-time Position Management) Respiratory Gating System. The FDA determined that it is a class 1 device exempt from premarket notification requirements.

SAN DIEGO-A new type of colorectal cancer screening test appears to be as sensitive as fecal occult blood testing (FOBT) with higher specificity, according to a Canadian study. Norman E. Marcon, MD, of the Centre for Therapeutic Endoscopy and Endoscopic Oncology, Toronto, reported results of a study comparing the new test, ColorectAlert, with FOBT at an American Gastroenterological Association research forum held during the Digestive Disease Week conference

BETHESDA, Md-The United States can be proud of its scientific progress against cancer, but the nation has failed to adequately address the equally important issue of access to and delivery of quality cancer care, according to the President’s Cancer Panel (PCP).

NEW ORLEANS-A 3-week radiation schedule after lumpectomy is as effective as the standard 5-week schedule in terms of local control, overall survival, and cosmetic outcomes, Canadian researchers reported in a plenary presentation at the 36th Annual Meeting of the American Society of Clinical Oncology (ASCO).

SAN DIEGO-Based on preliminary test results, researchers at Kaiser Permanente Northern California and the University of California, San Francisco, believe that immunochemical fecal occult blood testing (IFOBT) would be a reasonable addition to a managed care plan’s flexible sigmoidoscopy colorectal cancer screening program, depending on patient preference, the practice setting, and cost constraints.

The initial reaction to President Clinton’s June directive on Medicare payment for patient care costs in clinical trials was extremely positive. Senators Jay Rockefeller (D-WV) and Connie Mack (R-FL), who have long and unsuccessfully pushed a

SAN DIEGO-Wheat bran fiber does not appear to reduce the recurrence of colorectal adenomas, Richard E. Sampliner, MD, said at the American Gastroenterological Association annual meeting, held during the Digestive Disease Week conference. Dr. Sampliner is professor of medicine and chief of gastroenterology, University of Arizona Health Sciences Center, Tucson.

WILMINGTON, Del-AstraZen-eca announced in a news release that the FDA has approved Nolvadex (tamoxifen) to reduce the risk of invasive breast cancer in women with ductal carcinoma in situ (DCIS) following breast surgery and radiation. Nolvadex is the first medication to be approved for DCIS, which accounts for nearly 20% of all newly diagnosed breast cancers, the company said.

ARLINGTON, Va-The National Center for Complementary and Alternative Medicine (NCCAM), a division of the National Institutes of Health, has undertaken the task of making a science out of complementary and alternative medicine (CAM).