Purpose Pediatric Oncology Group (POG) studies 9426 and 9425 evaluated dexrazoxane (DRZ) as a cardiopulmonary protectant during treatment for Hodgkin's disease (HD). We evaluated incidence and risk factors of acute myeloid leukemia (AML)/myelodysplastic syndrome (MDS) and second malignant neoplasms (SMNs). Patients and Methods Treatment for low- and high-risk HD with doxorubicin, bleomycin, vincristine, and etoposide (ABVE) or dose-intensified ABVE with prednisone and cyclophosphamide (ABVE-PC), respectively, was followed by low-dose radiation. The number of chemotherapy cycles was determined by rapidity of the initial response. Patients were assigned randomly to receive DRZ (n = 239) or no DRZ (n = 239) concomitantly with chemotherapy to evaluate its potential to decrease adverse cardiopulmonary outcomes. Results Ten patients developed SMN. Six of eight patients developed AML/MDS, and both solid tumors (osteosarcoma and papillary thyroid carcinoma) occurred in recipients of DRZ. Eight patients with SMN were first events. With median 58 months' follow-up, 4-year cumulative incidence rate (CIR) for AML/MDS was 2.55% ± 1.0% with DRZ versus 0.85% ± 0.6% in the non-DRZ group (P = .160). For any SMN, the CIR for DRZ was 3.43% ± 1.2% versus CIR for non-DRZ of 0.85% ± 0.6% (P = .060). Among patients receiving DRZ, the standardized incidence rate (SIR) for AML/MDS was 613.6 compared with 202.4 for those not receiving DRZ (P = .0990). The SIR for all SMN was 41.86 with DRZ versus 10.08 without DRZ (P = .0231). Conclusion DRZ is a topoisomerase II inhibitor with a mechanism distinct from etoposide and doxorubicin. Adding DRZ to ABVE and ABVE-PC may have increased the incidence of SMN and AML/MDS.
Experience reveals that there is significant noncompliance with self‐administered medication, especially in chronic conditions such as cancer. Noncompliance transcends the boundary of disease categories and age group. However, this is most prevalent during the adolescent years when the process of transition from parental dependency to autonomy produces confusion as to who is responsible for administration of medication. Noncompliance can result in the misjudgment of efficacy of a drug or regimen that may necessitate additional tests, alteration of dose, treatment course, and hospitalization. Currently in the United States, a large percentage of pediatric cancer patients are treated according to research protocols. In a research setting, noncompliance can result in erroneous or inconsistent findings, potentially affecting investigational results. With the availability of venous access ports and sophisticated, yet easy‐to‐operate pumps, increasingly, it is possible to administer parenteral medications at home. This adds a new dimension to the self‐administration of medication that previously concerned mainly oral therapy. Various factors concerning the patient, disease, health providers, and treatment characteristics determine how well a given regimen is adhered to. Because a significant number of determinants are involved, it is often not possible, with any degree of certainty, to identify noncompliers or to predict the level of patient adherence to the treatment. Major factors in any successful therapy include the availability of effective medications and compliance with therapy regimen. With the advent of more successful treatments for childhood and adolescent cancer, the compliance factor is gaining greater importance because therapy currently is given with curative, rather than palliative intent. The availability of questionnaires, tests, and devices can help, to some extent, examine the degree of patient compliance. Family and social support, individualized programs, reminders to reduce forgetfulness, personalized needs assessment, and education can reduce noncompliance. Compliance is a complex and multifaceted issue that is still poorly understood and requires further investigation.
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