CLINICAL STUDIES

Recruitment into clinical trials from all USC/Norris Comprehensive Cancer Center affiliated hospitals has increased substantially with more than 1,622 cases being recruited. Patient recruitment is represented by study type as follows: Cooperative Group - 7.5%, Industry - 11.5%, NIH or other peer reviewed - 45%, USC investigator initiated - 36%. The clinical structure of the Division emphasizes a team approach. Drs. Russell, Spicer, and Daniels undertake breast cancer treatment and research, with an expansion of clinical trials and an increased focus on chemoprevention strategies for breast cancer. Dr. Cathie Chung has been recruited to that group to begin in August 2004. The GI team is developing strategies of clinical research for gastrointestinal cancers (Drs. Lenz, Iqbal and El-Khoueiry), with an emphasis on molecular correlates of tumor responsiveness and of the familial clustering of gastrointestinal cancer. An active program of research and treatment of genitourinary cancers was initiated by Drs. Quinn, Aparicio and Pinski with specific programs of new drug development and multidisciplinary management. Each of these teams has been developed to allow maximum synergy with staff members from other clinical units, including surgical oncology, radiation oncology, and urology, as well as an expanded translational interface with the scientists of the Cancer Center and the School of Pharmacy. Multidisciplinary management has been a governing theme in the clinical trial programs that have been developed for lung cancer, head and neck malignancies and melanoma.

LAC+USC MEDICAL CENTER

Major components of the clinical activities of the Division were undertaken at LAC+USC Medical Center. Traditionally, an inpatient unit and adjoining walk-in clinic provide the bulk of treatment to hospitalized patients, and to outpatients requiring specialized daily treatment or daily visits. In view of escalating drug costs, treatment protocols with industry support have been initiated that have provided some of the cytotoxic agents and marrow stimulating agents used in cancer treatment. A high inpatient census was maintained on our Oncology Ward, with increased efficiency and an average length of stay of 7.7 days, with patients being managed efficiently by the two clinical teams (tumor-type specific) which integrate ward management and extradivisional consultative care.

All faculty participated actively in inpatient and outpatient consultative and direct patient care services. The two teams saw 924 inpatient consults and 2,313 follow-up consults and 1,077 chart consults. As Oncology has evolved towards an outpatient service, a greater proportion of the clinical census has been managed in the Outpatient Clinics, with inpatient care predominantly directed towards patients that are less robust, with intercurrent medical disorders, more advanced tumors or requiring more complex and lengthy treatment regimens. Faculty members staffed three clinics per week, with allocation of patients being predicated on tumor type. This specialization has allowed a greater focus of resources and concentration of areas of clinical expertise. During the review period, staff of the Division saw 7,821 patients in clinic and 6,994 patients at the Infusion Center at LAC+USC Medical Center. Particular emphasis was placed on treatment programs for breast cancer (integrating programs of the Southwest Oncology Group, availability of new anticancer agents, and development of novel therapeutic strategies), gastrointestinal malignancy (with a more recent emphasis on biochemical targeting of anticancer therapy, and in particular strategies directed towards thymidylate synthase) and lung cancer (with particular emphasis on the assessment and development of the role of novel taxane compounds and other new cytotoxics). Because of the specific nature of modern oncological practice and the absence of accepted standards of care for many advanced malignancies (traditionally with poor prognosis), the application of novel treatment strategies has been crucial to the successful management of patients with metastatic cancer, thus achieving total integration of clinical and clinical research practice. Funds generated from clinical trials and from the USC/Norris Comprehensive Cancer Center have covered costs of correlative laboratory testing programs fully, and have allowed a clearer understanding of the mechanisms of success and failure of therapy. A particularly important program, directed towards improving the care of Hispanic patients, has addressed a previously undescribed metabolic abnormality that appears to correlate with enhanced toxicity from certain cytotoxic agents. Similarly, in association with the routine clinical management programs for testicular cancer, a program of assessment has been initiated (sponsored by the Cancer Center) to investigate an unusual pattern of failure of chemotherapy for Hispanic patients with testicular cancer. An interactive research and treatment program for the development of new anticancer agents, funded by the National Cancer Institute, and conducted by a consortium of USC, City of Hope National Medical Center and University of California-Davis, has made novel compounds available to the patients treated in the hospitals of the USC Health Sciences Campus. This program has included components of Phase I testing (assessment of correct dose and definition of toxicity profiles of new compounds) and Phase II trials (assessing the anticancer effectiveness of these agents). Specific attempts have been made to expand the utilization of the GCRC for Phase I and pharmacologic studies of novel anticancer agents.

Division member Dr. David Quinn has been a key individual in the Los Angeles County Hospital Oncology Outpatient Practice Review Working Party. The Working Party is a multidisciplinary group formed with the support of Dr. David Altman and directed at improving the delivery of health care in the outpatient clinic. It was established with the aim to build on efforts at coordinated interdisciplinary health care delivery in Breast, Genitourinary and Gastrointestinal Oncology already in place at the instigation of Division of Oncology members in concert with colleagues from Radiation Oncology and Surgical Services. During 2003-2004, this was expanded to include head and neck and lung cancers with the USC/Norris Cancer Center recruitment of Dr. Barbara Gitlitz. These multidisciplinary groups have evolved to full tumor board status in 2004 with the guidance of the LAC Cancer Committee. After a consultative period, the working party has sought to galvanize Health Information Management, Information Services, Radiology and Pathology into provision of optimal service. In seeking to improve time and motion of patient movement within the clinic, the working party has generated templates for a time-based appointment system to reduce waiting times and eliminating redundant visits where a patient comes for review but has not had ordered investigations completed or delivered. After circumventing several obstacles related to LAC resource and structure, the project is now in pilot implementation phase and should result in improved service delivery. It is hoped that this practice model can provide a framework for subsequent similar initiatives in non-oncology services.

USC UNIVERSITY HOSPITAL

The clinical activities of the Division at UH continue to be limited to consultative functions. There is no facility for the delivery of cytotoxic treatment. However, attending faculty provided consultative services upon request for the full gamut of tumor types, interacting with clinical services from the full range of other disciplines. Seamless transfer of patients between UH and the USC/Norris Cancer Hospital has been effected, allowing full access to services of chemotherapy and radiotherapy for patients with cancer at UH. Similarly, the Transitional Care Center of UH has been used to assist in the rehabilitation and postacute care management of patients from the USC/Norris Cancer Hospital.

USC/NORRIS CANCER HOSPITAL

The faculty of the Division have also been actively engaged in practice at the USC/Norris Cancer Hospital. Eleven current faculty members participated in the increase in clinical outpatient practice at USC/Norris Cancer Hospital during 2003-2004, supervising 857 admissions and 5,253 inpatient days with a median length of stay of 6.14 days. A total of 10,956 outpatient visits, 4,297 day hospital visits and 225 outpatient short-stay visits were conducted.