Richard D. Gelber

Quality-of-life-adjusted survival analysis of interferon alfa-2b adjuvant treatment of high-risk resected cutaneous melanoma: an Eastern Cooperative Oncology Group study.

PURPOSE To evaluate the quality-of-life effects of adjuvant high-dose interferon alfa-2b (IFN alpha 2b) treatment of high-risk melanoma. PATIENTS AND METHODS A quality-of-life-adjusted survival analysis (Quality-Adjusted Time Without Symptoms, and Toxicity [Q-TWiST]) was applied to the Eastern Cooperative Oncology Group Trial E1684, which compared high-dose IFN alpha 2b treatment for 1 year versus observation in 280 high-risk patients. IFN alpha 2b was administered at a dosage of 20 mU/m2 intravenously daily for 5 days per week for 4 weeks, and then three times weekly at 10 mU/m2 subcutaneously for 48 weeks. RESULTS After 84 months of median follow-up time, the IFN alpha 2b group gained a mean of 8.9 months without disease relapse (P = .03) and 7.0 months of overall survival (P = .07) as compared with the observation group, but had severe treatment-related toxicity for 5.8 months, on average. The IFN alpha 2b group had more quality-of-life-adjusted time than the observation group regardless of the relative valuations placed on time with toxicity (Tox) and time with relapse (Rel). This gain was significant (P < .05) for patients who consider Tox to have a high relative value and Rel to have a low relative value. In contrast, for patients who value Tox about the same as Rel, the quality-adjusted gain for IFN alpha 2b was not statistically significant. An analysis stratified according to tumor burden indicated that the benefit of IFN alpha 2b was greatest in the node-positive strata. CONCLUSION For patients with high-risk melanoma, the clinical benefits of high-dose IFN alpha 2b can offset the toxic effects. The optimal treatment for an individual patient depends on the patients tumor burden and preferences regarding toxicity and disease relapse.

Adjuvant therapy of breast cancer IV

An up-to-date survey of current, mainly clinical research on the treatment of primary breast cancer is summarized in these papers stemming from the 4th Intemational Conference on Adjuvant Therapy of Primary Breast Cancer held in St. Gallen, Switzerland, in 1992. The papers cover relevant topics from biological mechanisms on cell kUl and overcoming drug resistance to new aspects of breast conserving surgery and adjuvant endocrine as well as cytotoxic therapies. They update the results of most of the important intenational trials on adjuvant therapy of breast cancer. The closing summary reporting the common opinions of an intenational consensus on risk-adapted adjuvant therapy of breast cancer, which sets the stage for optimal treatment of breast cancer patients both clinically and psycho-socially, is particularly timely.

Adjuvant therapy of breast cancer V

The Control of Breast Cancer: A Look into the Future.- I. Epidemiology and Genetics of Breast Cancer.- Familial Breast Cancer.- The Food-Derived Heterocyclic Amines and Breast Cancer: A 1995 Perspective.- Menstrual Cycle Timing of Breast Cancer Resection.- Summary.- II. Biology of Breast Cancer.- Peptide Growth Factors and Breast Cancer Treatment: Recent Translational Research.- Single-Chain Fusion Toxins for the Treatment of Breast Cancer: Antitumor Activity of BR96 sFv-PE40 and Heregulin-PE40.- Tamoxifen and Endometrial Cancer: From Experiment to Patient.- Summary.- III. Prognosis of Response and Tumor Markers.- Review of Known Prognostic Variables.- Prognostic Variables and Future Predictors of Behaviour and Response.- Serum (Circulating) Tumor Markers for Breast Cancer.- Summary.- IV. Screening for Breast Cancer and Treatment of Early Lesions (Ductal Carcinoma In Situ).- A Critical Review of Screening for Breast Cancer.- Ductal Carcinoma In Situ.- Intraductal Breast Carcinoma: Experiences from The Breast Center in Van Nuys, California.- Summary.- V. Surgery for Breast Cancer: Special Issues.- Surgical Treatment of Breast Cancer Relapse.- Primary and Secondary Breast Reconstruction with Special Emphasis on the Use of Prostheses.- The Primary Use of Chemotherapy for Operable Breast Cancer: Does Systemic Therapy Make Surgery Superfluous?.- Summary.- VI. Adjuvant Systemic Therapy.- The Role of Anthracyclines in Adjuvant Chemotherapy of Breast Cancer: A Critical Appraisal.- Adjuvant Systemic Therapy: The Issues of Timing and Sequence.- Current and Future Roles of Adjuvant Endocrine Therapy in the Management of Early Carcinoma of the Breast.- Future Developments in Adjuvant Systemic Therapy for High-Risk Breast Cancer.- Summary.- VII. Radiation Therapy as Part of Primary Treatment.- Radiation Therapy in the Primary Management of Early-Stage Breast Cancer.- Quality Assurance in Early Breast Cancer Treatment: Clinical Aspects of Postoperative, External, Whole Breast Irradiation.- How To Predict the Risk of Local Relapse in the Preserved Breast.- Summary.- VIII. Womens Health Perception and Breast Cancer: Issues of Fertility, Hormone Substitution, and Cancer Prevention.- Reproductive Potential After Adjuvant Chemotherapy for Breast Cancer.- Sex Hormones and Breast Cancer: The Issue of Hormone Replacement.- The Womens Health Initiative: Will It Resolve the Issues?.- The Womens Health Initiative: The Road to Scientific Clarity?.- Design and Current Status of the NSABP Breast Cancer Prevention Trial.- Summary.- IX. International Consensus Conference on Primary Treatment of Breast Cancer.- Summary.

Evaluation of Quality of Life in Cancer Clinical Trials

Quality of life is an important consideration when making treatment decisions [1–3]. The choice of one treatment option over another for an individual patient may hinge on how the treatments affect quality of life. Therefore, it is important that the practicing oncologist has a thorough understanding of the potential impacts that treatments can have on quality of life in general as well as an understanding of the individual patient’s needs and preferences. To help address these issues, the evaluation of quality of life is taking on an increasingly larger role in cancer clinical research. In particular, patient-oriented quality-of-life assessments are frequently being included in clinical trials as study endpoints for treatment comparisons. The purpose of this chapter is to provide an overview of the most common methods used in cancer clinical trials for the evaluation of quality of life.

Breast Cancer Trials of the Ludwig and International Breast Cancer Study Group

In early 1977 a meeting was convened by the Ludwig Institute for Cancer Research in Switzerland to plan international participation in adjuvant breast cancer trials. The group of international participants have now completed an initial series of four trials (studies I–IV) from July 1, 1978, to August 31, 1981 [1–7]. A fifth trial (study V) involving perioperative therapy completed accrual of 2,517 patients in December 1985 and will be analyzed initially in late 1986. The initial participants group conducting the trials, the Ludwig Breast Cancer Study Group, has now been renamed the International Breast Cancer Study Group (IBCSG), and this group has planned two new adjuvant protocols for commencement during 1986 (studies VI and VII).