Prognostic variables in newly diagnosed children and adolescents with acute myeloid leukemia: Children's Cancer Group Study 213.

The objective of this study was to identify biologic parameters that were associated with either exceptionally good or poor outcome in childhood acute myeloid leukemia (AML). Among the children with AML who entered Children's Cancer Group trial 213, 498 patients without Down syndrome or acute promyelocytic leukemia (APL) comprise the basis for this report. Univariate comparisons of the proportion of patients attaining complete remission after induction (CR) indicate that, at diagnosis, male gender, low platelet count (< or =20 000/microl), hepatomegaly, myelodysplastic syndrome (MDS), French-American- British (FAB) category M5, high (>15%) bone marrow (BM) blasts on day 14 of the first course of induction, and +8 are associated with lower CR rates, while abnormal 16 is associated with a higher CR rate. Multivariate analysis suggests high platelet count at diagnosis (>20 000/microl), absence of hepatomegaly, < or =15% day 14 BM blast percentage, and abnormal 16 are independent prognostic factors associated with better CR. Univariate analysis demonstrated a significant favorable relationship between platelet count at diagnosis (>20 000/microl), absence of hepatomegaly, low percentage of BM blasts (< or =15%), and abnormal 16 with overall survival. Absence of hepatomegaly, < or =15% day 14 BM blast percentage, and abnormal 16 were determined to be independent prognostic factors associated with better survival.

History of the development of antiemetic guidelines at Mayo Clinic Rochester.

This article describes the historic experience of the development of antiemetic guidelines for patients taking chemotherapy drugs at Mayo Clinic Rochester. The initial guidelines for the use of serotonin (5-hydroxytryptamine3) receptor antagonists for the prevention of chemotherapy-induced nausea and vomiting were developed in early 1995 and implemented in September 1995. In February 1997, the guidelines were reviewed and modified. In the spring of 1998, major changes were made based on new data from the literature and discussions with antiemetic authorities in the United States. These guidelines were implemented in July 1998. The guidelines were again reviewed and modified in December 1998. In addition, we compared costs associated with the 1997 guidelines and the December 1998 guidelines. The developed guidelines, utilizing clinically available agents, seem to provide high-quality patient care at a reasonable cost.

An evaluation of the impact of a self-care coping intervention on psychological and clinical outcomes in adolescents with newly diagnosed cancer.

The demands of cancer treatment are particularly challenging for newly diagnosed adolescents. If attempts to cope with these demands are unsuccessful, adolescents may not comply with or may refuse treatment. As a result, their chances of survival are decreased. The purpose of this study, guided by the Adolescent Self-Sustaining Model, was to determine the effects of a three-part educational intervention designed to facilitate copying on psychological (hopefulness, hopelessness, self-esteem, self-efficacy and symptom distress) and clinical outcomes (treatment toxicity) among adolescents newly diagnosed with cancer. This two-site study used a longitudinal experimental two-group design with adolescents randomly assigned to the intervention or control group. Four measurement points spanning the first 6 months of treatment were included in the design. Of 93 eligible adolescents, 78 (46 females and 32 males) agreed to participate. No statistically significant differences between the intervention and control groups, or between male and female participants, were detected at any measurement point. Differences in scores over time within groups were noted. Explanations for the lack of group differences are offered, as are recommendations for strengthening the intervention and design for future testing.

Hopefulness and its characteristics in adolescents with cancer.

Hopefulness in adolescents with cancer serves critical functions related to the adolescents' sense of well-being and commitment to treatment. Given these critical functions, it is important to determine the essential characteristics of hopefulness, which include the degree and dynamism of hopefulness and the nature and attributes of hoped-for objects. The purposes of this two-site study were to describe the degree and dynamism of hopefulness at four time points during the first 6 months of adolescents' treatment for newly diagnosed cancer, to identify and describe the adolescents' hoped-for objects, and to evaluate potential relationships between the characteristics of hopefulness and patient gender, age, diagnosis, and time point in treatment. Seventy-eight adolescents completed the Hopefulness Scale for Adolescents, the Hopelessness Scale, and the Hopefulness Interview Question at each time point. Hopefulness scores were higher and hopelessness scores substantially lower than reported in other tested samples. Adolescents identified a total of 57 different hopes. Differences by age, gender, and diagnosis were found.

Treatment of nonmetastatic osteosarcoma of the extremity with preoperative and postoperative chemotherapy: a report from the Children's Cancer Group.

PURPOSE: The specific aims of this study were to improve event-free survival (EFS) in patients with newly diagnosed nonmetastatic osteosarcoma of an extremity using the histologic response to neoadjuvant chemotherapy to determine postoperative chemotherapy; to evaluate a uniform histologic grading system that measures tumor response; and to identify patient characteristics that might influence EFS and survival. PATIENTS AND METHODS: Two hundred sixty-eight patients with nonmetastatic osteosarcoma of the extremity were entered between August 1983 and October 1986. Preoperative chemotherapy consisted of four courses of high-dose methotrexate (MTX) and one course of bleomycin, cyclophosphamide, and dactinomycin (BCD). Histologic response to preoperative chemotherapy was determined by morphometric analysis. Good histologic responders (< 5% residual viable tumor) were treated postoperatively with MTX, BCD, and doxorubicin (DOX); poor histologic responders were treated with BCD, DOX, and cisplatin (CDDP). RESULTS: The 8-year EFS and survival rates were 53% and 60%, respectively. Two hundred six patients had their tumors assessed for histologic response: 28% displayed a good histologic response to preoperative chemotherapy. Good histologic responders had an 8-year postoperative EFS rate of 81% and survival rate of 87%; those with a poor histologic response had an 8-year postoperative EFS rate of 46% and survival rate of 52%. A primary tumor site in the proximal humerus or proximal femur and an elevated serum alkaline phosphatase level were associated with an increased risk of an adverse event, whereas the type of surgical procedure was not. CONCLUSION: EFS and survival appear to be directly related to histologic response to neoadjuvant chemotherapy.

Variation in the practice of dose reduction of chemotherapeutic agents after weight loss or amputation.

PURPOSE: Dose reduction of chemotherapeutic agents in response to weight loss or amputation is important in avoiding excessive therapy-related toxicity. Several methods of calculating this dose reduction are currently in use, including dose reduction in proportion to (a) the reduction in body surface area (BSA), (b) the amount of weight lost, and (c) no dose reduction unless toxicity is observed. Each of these methods results in the administration of a different dose, and few guidelines exist as to the preferred method. METHODS: We conducted a survey of a large group of pediatric oncologists, pediatric oncology nurses, and data managers to determine the methods of dose reduction currently in use for patients (a) with weight loss, (b) after amputation, and (c) with further weight loss after amputation. RESULTS: Responses were obtained from 237 of 294 individuals surveyed (80.6%). The most popular method was to dose reduce in proportion to the reduction in BSA in patients with weight loss alone (88%), amputees (60%), and amputees with ongoing weight loss (66%). Other methods were chosen by 7%, 31%, and 24% of participants in each of these clinical settings, respectively. CONCLUSION: The chosen methods result in a discrepancy of administered doses of up to 37%. Our results highlight the need for the standardization of practice, and the determination of the optimal method of dose reduction after weight loss or amputation.

Treatment of newly diagnosed children and adolescents with acute myeloid leukemia: a Childrens Cancer Group study.

PURPOSE: The objectives of this study were to determine if the addition of etoposide, thioguanine, and dexamethasone to daunorubicin and cytarabine (five-drug regimen) during induction would improve remission induction rates and survival of children with acute myeloid leukemia (AML) when compared with the standard regimen of cytarabine and daunorubicin (7 + 3) and whether allogeneic bone marrow transplantation (BMT) or intensive chemotherapy consolidation with or without maintenance would give a superior outcome. PATIENTS AND METHODS: A total of 591 assessable children with AML entered Childrens Cancer Group (CCG) trial 213 between January 1986 and February 1989. The status of patients as of September 1, 1992 forms the basis of this report. The results were compared with previous AML studies. RESULTS: The projected survival rate of all patients at 5 years is 39% (event-free survival [EFS] rate, 31%), which is superior to that of the prior CCG study (P = .01). The induction rate was 79% for 7 + 3 and 76% for the five-drug regimen (not significant). Comparisons of BMT to chemotherapy favored BMT, but these differences do not always reach statistical significance (eg, 5-year disease-free survival [DFS] rate, 46% v 38% [P = .06] with donor available and 54% v 37% [P = .002] if treated according to protocol intent). No benefit for maintenance therapy was found and, in some comparisons, it was inferior to discontinuation of therapy (5-year survival rate, 46% v 68%, P < .01). CONCLUSION: The 5-year EFS rate of patients with AML is 31% and has improved. The five-drug induction regimen is no better than standard induction, BMT appears superior to chemotherapy, and maintenance therapy was not beneficial.

Trial of a topically administered local anesthetic (EMLA cream) for pain relief during central venous port accesses in children with cancer.

Procedure-related pain is a significant problem for many children receiving cytotoxic chemotherapy. In an effort to lessen this toxicity, we studied the efficacy and safety of administering topical local anesthesia using EMLA cream in 47 evaluable children with cancer undergoing implanted central venous port injections. Children (< 21 years old) scheduled to undergo repeated venous access procedures were selected for study. A placebo-controlled, randomized, double-blind, crossover study design was utilized. Statistically significant decreases in pain intensity scores (P < 0.002) were recorded by both children and investigators during the use of EMLA cream as compared with placebo. There was a good correlation between pain scores recorded by both patients and health care providers using both visual analog scales and categorized pain measurement tools. The topical application of EMLA cream 5% provides highly effective superficial anesthesia, and promises to be extremely useful for pain relief during percutaneous access procedures in cancer patients.