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We report here the preliminary results of a large phase II multicenter study done in the community setting, using paclitaxel (Taxol) (given by 1-hour infusion) plus carboplatin (Paraplatin) to treat patients with advanced non-small-cell lung cancer (NSCLC). In this study, 155 chemotherapy-naive patients with stage IIIB, stage IV, or recurrent metastatic non-small-cell lung cancer received the two drugs in 21-day cycles. Paclitaxel 225 mg/m² was given by 1-hour intravenous infusion followed immediately by carboplatin at a targeted area under the concentration-time curve of 6.0 (calculated according to the Calvert formula). Colony-stimulating factors were not used routinely. Objective responses occurred in 53 of 155 patients (34%) (53 of 144 [36%] evaluable patients) including three complete responses and 50 partial responses. Fifty-two other patients had stable disease at initial reevaluation. The median survival among all 155 patients was 8 months; the 1-year survival rate was 42%, and the 2-year survival rate was 20%. Leukopenia and cumulative peripheral neuropathy occurred consistently but rarely were severe or affected the course of therapy. One patient died due to sepsis. Other grade 3 and grade 4 toxicities were uncommon. This paclitaxel-carboplatin combination chemotherapy appears to be a relatively convenient, safe, and active regimen in advanced non-small-cell lung cancer.[ONCOLOGY 12(Suppl 2):71-73, 1998]

Although the need to combine thoracic radiotherapy with systemic chemotherapy in the curative treatment of limited small-cell lung cancer is now widely acknowledged, there is substantial disagreement on how best to do this. This paper reviews radiotherapeutic factors but also highlights the important interactions that occur with some classes of chemotherapeutics. Studies examining variables like dose and volume are clearly in order. Concurrent therapy given early has been adopted throughout most of the world, except Europe. The reasons for this are explored. Multiple studies are now showing excellent results with fewer total cycles of chemotherapy. Integrationof newer drugs is another challenge for clinical investigators at the close of this century. [ONCOLOGY 12(Suppl 2):15-18, 1998]

For more than 25 years, chemotherapy has been the cornerstone of treatment for small-cell lung cancer. Many studies have tested a wide variety of drugs in different combinations, resulting in a number of standard

Rituximab (Rituxan) has been cleared for marketing by the FDA. Previously known as the C2B8 antibody, rituximab, is a single-agent monoclonal antibody therapy for relapsed or refractory, low-grade or follicular, CD20-positive, B-cell non-

Newer chemotherapy drugs have shown encouraging activity in advanced non-small-cell lung cancer. Based on these improved outcomes, as well as the high rate of distant relapse in patients with locally advanced disease, several recent studies have evaluated the use of systemic therapy in patients with earlier-stage disease.

DUBLIN-Preliminary results suggest that the use of single-agent topotecan (Hycamtin) as second-line therapy for small-cell lung cancer (SCLC) in patients who failed after an initial response to first-line therapy provides efficacy similar to that of the commonly used regimen of cyclophosphamide, doxorubicin (Adriamycin), and vincristine (CAV).

SAN FRANCISCO-About 4,000 human diseases have a genetic cause, and many such diseases are untreatable or poorly treated by conventional medicine, said R. Michael Blaese, MD, chief of the Clinical Gene Therapy Branch at the NIH National Center for Human Genome Research. In theory, many of these diseases could be treated by adding, deleting, or altering genes.

BETHESDA, Md-The Food and Drug Administration’s Oncologic Drugs Advisory Committee (ODAC) has recommended approval of QLT Photo-Therapeutics’ Photofrin (porfimer sodium) for use as photodynamic therapy (PDT) of T1 stage endobronchial carcinoma in patients with non-small-cell lung cancer (NSCLC) for whom surgery and radiotherapy are not indicated.

This study compared the activity and toxicity of fluorouracil (5-FU)/cisplatin with the combination tegafur and uracil (UFT)/cisplatin in the neoadjuvant treatment of locally advanced-stage III or IV (M0)-head and neck

Squamous cell carcinoma of the head and neck is a potentially curable neoplasm. Historically, the standard approach to treatment has been either surgery or radiation therapy, or a combination of the two. Over the past

Treatment of patients with unresectable stage IIIA and IIIB non-small-cell lung cancer with conventionally-fractionated radiation therapy (ie, total doses of 50 to 60 Gy, using one fraction per day), which was standard

SEATTLE-Targeted Genetics Corporation’s tumor suppressor gene product, tgDCC-E1A, is currently being tested in two phase I trials.

SAN FRANCISCO-Investigations into the cellular basis of the anticancer activity of recombinant interleukin-2 (IL-2, Proleukin) may lead to immunization against some cancers. That was the prospect suggested by Steven A. Rosenberg, MD, head of the NCI’s Surgery Branch and professor of surgery at George Washington University School of Medicine and Health Sciences, and the Uniformed Services University of the Health Sciences, Bethesda, Md.

Drs. Enright and McGlave succinctly review the biology of chronic myelogenous leukemia (CML) and highlight the therapeutic role of allogeneic stem-cell transplantation. Two points, however, warrant further discussion. The first is that a regimen containing interferon-alfa (Intron A, Roferon-A) is optimal front-line therapy for the great majority of CML patients.[1] The second is that use of an interferon-alfa-based regimen prior to allogeneic stem-cell transplantation does not adversely affect post-transplant mortality, morbidity, or anti-CML efficacy.

BETHESDA, Md-The Biological Response Modifiers Advisory Committee has recommended that the FDA usher cancer therapy into a new era by approving IDEC Pharamceutical’s Rituxan (rituximab) for patients with relapsed or refractory low-grade or follicular B-cell non-Hodgkin’s lymphoma.

BETHESDA, Md--Delta-amino-levulinic acid (ALA), a compound found in cells throughout the body, holds potential as an active drug in photodynamic therapy and could provide an alternative to surgery for patients with basal and squamous cell carcinomas, R. Rox Anderson, MD, said at the General Motors Cancer Research Foundation conference.

Studies of hematopoietic stem-cell transplantation as a treatment for severe autoimmune diseases (SADS) are currently in progress. Dr. Burt thoroughly reviews the rationale for these studies. It includes: (1) preclinical studies showing that marrow transplantation is an effective therapy in animal models of autoimmune disease; (2) observations of the effect of stem-cell grafts on SADS in patients transplanted for other indications; and (3) improvements in the safety of the transplant procedure.

Radioimmunotherapy allows for the delivery of systemically targeted radiation to areas of disease while relatively sparing normal tissues. Despite numerous challenges, considerable progress has been made in the application of radioimmunotherapy to a wide variety of human malignancies. The greatest successes have occurred in the treatment of hematologic malignancies. Radioimmunotherapy, with or without stem-cell transplant support, has produced substantial complete remission rates in chemotherapy-resistant B-cell lymphomas. Nonmyeloablative regimens have shown so much promise that they are now being tested as initial therapy for low-grade B-cell lymphomas. Although solid tumor malignancies have been less responsive to radioimmunotherapy, encouraging results have been obtained with locoregional routes of administration, especially when the tumor burden is small. Greater tumor-to-normal tissue ratios are achievable with regional administration. Even with intraperitoneal and intrathecal administration, bone marrow suppression remains the dose-limiting toxicity. Ongoing research into new targeting molecules, improved chelation chemistry, and novel isotope utilization is likely to extend the applications of this strategy to other tumor types. The potential for radioimmunotherapy will be enhanced if this modality can be optimally adapted for integration with other agents and if the administration method can be tailored to the type and distribution of malignancy. [ONCOLOGY 11(7):979-987, 1997]

Docetaxel (Taxotere) hasdemonstrated significant activity as a single agent in the treatment of

SAN DIEGO--So little is known about cell cycling that a new study on a possible mechanism for why cells fail to exit the cell cycle was termed the "most exciting presentation" of the American Association for Cancer Research's 88th annual meeting. Stephen H. Friend, MD, of the Fred Hutchinson Cancer Research Center, made the comment at a press briefing held at the meeting.

Mycobacterial cell wall therapy may be an alternative to BCG in the treatment of carcinoma in situ (CIS) of the bladder, Dr. Alvaro Morales, of Queen's University, Kingston, Ontario, reported at the AUA meeting.

SAN DIEGO--Genetically engineered bacteria have the potential to deliver anticancer genes directly to a tumor site, according to four presentations of preclinical data at the American Association for Cancer Research (AACR) annual meeting.

SAN DIEGO--A therapy for advanced lung cancer patients who have not responded to other treatments is showing promise in studies at M.D. Anderson Cancer Center. In this phase I trial, 18 patients with non-small-cell lung cancer (NSCLC) and missing or defective copies of the tumor-suppressor p53 gene have received injections directly into their tumors of an adenovirus containing the p53 wildtype gene.

Gene therapy for prostate cancer faces hurdles similar to those being encountered for other cancers and nonmalignant processes. The greatest obstacle is the identification of efficient delivery systems, since numerous animal models and cell culture systems have shown potential efficacy when most cells express the introduced genetic material. Early prostate cancers are easily accessible to gene vector introduction, and the predictable metastatic patterns of this cancer may offer additional advantages for gene therapy. This article reviews gene vectors and gene products, as well as ongoing trials of gene therapy that have recently begun in prostate cancer. [ONCOLOGY 11(6):845-856, 1997]

CHICAGO--Cellular tumor bio-markers may be able to identify patients with N1 non-small-cell lung adenocarcin-oma who could achieve better survival and control of metastasis through aggressive adjuvant therapy, Ritsuko Komaki, MD, said at the Radiological Society of North America meeting.

VIENNA--Although the majority of patients with advanced non-small-cell lung cancer (NSCLC) are too ill to tolerate platinum therapy, the more benign safety profile of gemcitabine (Gemzar) is opening up the possibility of palliative chemotherapy for a wider group of NSCLC patients.

Overexpression by the HER2 gene plays a significant role in breast cancer pathogenesis, and the phenomenon is commonly regarded as a predictor of a poor prognosis. HER2 overexpression has been linked to sensitivity and/or resistance to hormone therapy and chemotherapeutic regimens, including CMF (cyclophosphamide, methotrexate, and fluoro-uracil) and anthracyclines. Studies of patients with advanced disease demonstrate that, despite the association of HER2 overexpression with poor prognosis, the odds of HER2-positive patients responding clinically to taxanes were greater than three times those of HER2-negative patients. Further studies in preclinical models used combination therapy for breast cancer cells that overexpress HER2, and the use of agents that interfere with HER2 function plus paclitaxel (Taxol) resulted in significant antitumor effects. [ONCOLOGY 11(Suppl):43-48, 1997]

NASHVILLE-In 1996, delivery difficulties were the major barrier to breast cancer gene therapy, Jeffrey T. Holt, MD, said at a plenary session of the San Antonio Breast Cancer Symposium.

With the increased use of doxorubicin-based chemotherapy, chemoendocrine therapy, and high-dose chemotherapy with autologous bone marrow transplantation or peripheral blood progenitor-cell reinfusion, the role

ST. PETERSBURG, Russia--High doses of the investigational antiestrogen toremifene (Fareston) proved safe and effective as palliative therapy in patients with advanced renal cell carcinoma, say Dr. Michael Gershanovich and colleagues, of the Professor N. N. Petrov Research Institute of Oncology, St. Petersburg, and Orion Corporation, Turku, Finland.