From the surgical point of view it may be helpful to adopt the following guidelines in the treatment of patients with metastatic or locally recurrent colorectal cancer: 1. A gastroenterologist concerned with oncological patients should initiate adequate resectional treatment of the primary tumor. 2. In case of locoregional recurrences, every diagnostic effort (endoscopy, intraluminal ultrasound, angiogram, CT-scan, MRI) should be made to select patients with limited and resectable disease. 3. In patients with liver metastases amenable to surgical resection it is mandatory to rule out extrahepatic disease preoperatively as far as possible. 4. Prognostic factors deriving from tumor-biological data, extent of recurrent disease, and laboratory findings (CEA) must be taken into consideration when the decision whether to operate is to be made. These arguments should also be used to support non-operative treatment in patients with a type of recurrence that cannot be cured by surgery. 5. Postoperatively, all information (intraoperatively detected extrahepatic disease, tumor infiltrated resection margins, CEA not returning to normal levels) should be combined to classify patients according to whether they carry a high risk for a second tumor recurrence and should thus undergo additional treatment. In a "low-risk situation", further follow-up seems to be adequate.

Surgery followed by appropriate postoperative chemotherapy is the most significant component of treatment of ovarian malignancies. Five-year actuarial (no evidence of disease) survival rates reported in the literature for ovarian epithelial cancer vary: stage I, 60-90%; stage II, 39-67%; stage III, 4-13%; and stage IV, 0-4% (1,18-20). Although more aggressive investigation of adnexal masses, thorough surgical exploration, complete tumor resection, and combination chemotherapy may improve these results, the ability to diagnose ovarian cancer at an earlier stage is required if dramatic improvement in survival is to be seen.

The National Cancer Institute (NCI)-sponsored Chronic Lymphocytic Leukemia (CLL) Working Group was convened to develop a set of standardized eligibility, response, and toxicity criteria for clinical trials. We recognized the previous efforts in 1967 (published again in 1973 as the report of the Chronic Leukemia-Myeloma Task Force [1] and 1978 of Cancer and Leukemia Group B (CALGB) [2]). We have used these reports for guidance during the current effort. Several noteworthy developments in the past few years have made it necessary to modify the previous guidelines. First, the diagnostic criteria for CLL and its clinical staging have been developed and well defined. Second, although staging systems facilitated entry of comparable and relatively homogeneous groups of patients in clinical trials, the definitions of response (CR) and partial response (PR) were not uniformly adopted from the previous guidelines in the clinical trials (Tables IA, IB); therefore, comparisons of results obtained in different studies became difficult. Third, there has been an improvement in our understanding of the immunology and biology of CLL. Finally, we are witnessing the emergence of several chemotherapy agents that promise impressive activity in CLL (e.g., 2'-deoxycoformycin [3], fludarabine monophosphate [4, 5]), and thereby offer the potential for improving survival time in this disease. To best identify regimens worthy of continued pursuit in large comparative trials, standardized guidelines for evaluation are essential. A number of laboratory investigations are also presented for which scientific interest is high yet relevance remains to be determined; thus, they are presented as companion studies to the clinical trials. This mechanism allows for flexibility in the testing of these questions and for additional ideas in the future without requiring modification of an entire treatment protocol. The following guidelines were developed to be used as a form of standardization for clinical trials, incorporating current technologies, yet remaining relevant to the general hematology/oncology community. Based on the membership of the Working Group, it is expected that these guidelines will serve as the criteria for most clinical trials in the near future.