Comparison of results of a pilot study of alternating vincristine/doxorubicin/cyclophosphamide and etoposide/ifosfamide with IRS-IV in intermediate risk rhabdomyosarcoma: a report from the Children's Oncology Group.

BACKGROUND: Over 50% of patients with rhabdomyosarcoma (RMS) have intermediate risk disease, with a 3-year failure-free survival (FFS) of 50%-70% depending on histology. Doxorubicin is active against RMS, but its role in improving outcome remains controversial. Ifosfamide is as active as cyclophosphamide in RMS, with the Fourth Intergroup RMS Study (IRS-IV) showing equivalent outcomes for patients treated with ifosfamide for the first 28 weeks compared to cyclophosphamide. Treatment with alternating cycles of non-cross-resistant chemotherapy has been used in a number of diseases with good results. PROCEDURE: The results of a pilot study utilizing alternating courses of vincristine, doxorubicin, cyclophosphamide, and etoposide/ifosfamide (VDC/IE) were compared for outcome and patient characteristics to a group of similar matched patients treated on IRS-IV. RESULTS: The 5-year FFS for patients with parameningeal (PM) primaries on IRS-IV and the VDC/IE study were 72% and 82%, respectively (P = 0.26); for patients with non-PM primaries, the estimated risk of failure for VDC/IE study versus IRS-IV was 0.54. Combining all disease sites and performing analysis for relative risk of failure for 46 VDC/IE patients and 342 IRS-IV patients, the relative risk of failure for the VDC/IE study compared to the IRS-IV study is 0.5 (P = 0.06). CONCLUSIONS: VDC/IE is as effective therapy for intermediate risk RMS as IRS-IV therapy. It is being explored along with irinotecan in relapsed patients and newly diagnosed high-risk patients.

Complementary and alternative therapies in pediatric oncology.

Evidence on the science of complementary and alternative medicine (CAM) in children with cancer is slowly evolving. Most parents of children with cancer want their children to receive state-of-the-art therapy, which generally includes chemotherapy, radiation, and surgery. Increasingly, they also want the concomitant use of CAM therapies to help effect a cure or to alleviate symptoms. The ideal model of integrative pediatric oncology offers safe and effective CAM therapies in a pediatric hospital or medical center setting which participates in the clinical trials network of a pediatric oncology cooperative group setting.

Surgery for pediatric invasive fungal sinonasal disease.

OBJECTIVES/HYPOTHESIS: To evaluate the management and outcomes of children with invasive fungal sinonasal disease treated with radical surgery. STUDY DESIGN: Retrospective case series. METHODS: From 1994 to 2007, 11 pediatric patients were identified with invasive fungal sinonasal disease treated surgically by the same pediatric otolaryngologist. Collected data included demographics, oncologic diagnoses, absolute neutrophil counts, symptoms, computed tomography scan findings, biopsy and culture results, surgical procedures, concurrent medical therapies, complications, and survival. RESULTS: The studied patient population consisted of four males and seven females with an average age of 10 years (range, 2-14 years). Six patients were diagnosed with acute lymphoblastic leukemia and five with acute myeloid leukemia, which included 10 cases of relapsed disease. The average number of severely neutropenic days prior to diagnosis of an invasive fungal infection was 18 (range, 8-41 days). Culture results demonstrated Alternaria in seven patients and Aspergillus in four. Nine patients underwent an external medial maxillectomy, five of which were bilateral, and six underwent septectomy. All 11 patients (100%) were cured of their invasive fungal sinonasal disease without relapse. Three patients eventually died from unrelated causes. CONCLUSIONS: Invasive fungal sinonasal disease is a life-threatening problem in immunocompromised children, especially with relapsed leukemia. Successful treatment depends on timely and aggressive surgical, antifungal, and supportive therapies. To our knowledge, this study represents the largest series of pediatric patients with invasive fungal sinonasal disease managed via an aggressive surgical approach with the best outcomes to date. LEVEL OF EVIDENCE: 4.

Complementary and alternative medicine use in children with cancer and general and specialty pediatrics.

The objective of this survey is to determine the frequency, reasons, and factors influencing use of complementary and alternative medicine (CAM) in general and specialty pediatrics within the same geographic area. Of the 281 surveys completed, CAM use was higher in children with epilepsy (61.9%), cancer (59%), asthma (50.7%), and sickle cell disease (47.4%) than in general pediatrics (36%). Children most often used prayer (60.5%), massage (27.9%), specialty vitamins (27.2%), chiropractic care (25.9%), and dietary supplements (21.8%). Parents who used CAM for themselves (68.7%) were more likely to access CAM for their child. Most parents (62.6%) disclosed some or all of their child's use of CAM to providers. This study confirms that within the same geographic region, children with chronic and life-threatening illness use more CAM therapies than children seen in primary care clinics. Children with cancer use CAM for different reasons than children with non-life-threatening illnesses.

Massage therapy for children with cancer.

This pilot study aimed to determine the feasibility of providing massage to children with cancer to reduce symptoms in children and anxiety in parents. Twenty-three children/parent dyads were enrolled; 17 completed all data points. Children with cancer, ages 1 to 18 years, received at least 2 identical cycles of chemotherapy, and one parent, participated in the 2-period crossover design in which 4 weekly massage sessions alternated with 4 weekly quiet-time control sessions. Changes in relaxation (heart and respiratory rates, blood pressure, and salivary cortisol level) and symptoms (pain, nausea, anxiety, and fatigue) were assessed in children; anxiety and fatigue were measured in parents. Massage was more effective than quiet time at reducing heart rate in children, anxiety in children less than age 14 years, and parent anxiety. There were no significant changes in blood pressure, cortisol, pain, nausea, or fatigue. Children reported that massage helped them feel better, lessened their anxiety and worries, and had longer lasting effects than quiet time. Massage in children with cancer is feasible and appears to decrease anxiety in parents and younger children.

Complementary and alternative medicine in pediatric oncology: availability and institutional policies in Canada--a report from the Children's Oncology Group.

Complementary and alternative medicine (CAM) is used frequently by pediatric oncology patients. A survey exploring the institutional practices and policies surrounding CAM use in pediatric oncology patients was completed by 17 pediatric hematology/oncology centers in Canada. We found that CAM was offered in only 18% of the institutions, but 94% of the communities. Only 6% of oncology divisions made direct referrals to community CAM providers, and only 20% of the centers had policies regarding use of CAM therapies for their patients. Despite published widespread use of CAM therapies, our study demonstrates that institutional CAM resources and policies on CAM are present in much lower proportions.

Pediatric ovarian tumors: a review of 67 cases.

BACKGROUND: Ovarian tumors are uncommon but important childhood neoplasms. PROCEDURE: We reviewed records of 67 pediatric patients presenting to three pediatric referral centers from 1980 to 2003. RESULTS: Thirty patients had benign tumors. Thirty-seven patients had malignant tumors: 11 immature teratomas, seven malignant mixed germ cell tumors, seven juvenile granulosa cell tumors, five dysgerminomas, two endodermal sinus tumors, two serous papillary cystadenocarcinomas, one small cell carcinoma, one anaplastic sex-cord tumor, and one undifferentiated sarcoma. More than half presented with abdominal pain. Forty-six percent had an abdominal mass at the time of presentation. Other signs and symptoms included poor appetite (15%), urinary symptoms/urinary infection (9%), menstrual changes (9%), and weight loss (6%). Precocious puberty was noted in seven patients. Torsion was seen more often in patients with benign tumors (23 vs. 8%); two patients had both torsion and acute appendicitis. The neoplasm was an incidental finding in 12 patients. CONCLUSIONS: Fifty-five percent of the 67 ovarian tumors presenting to our centers were malignant. Pain was the most common symptom, although presence of an abdominal mass was frequent, and other symptoms non-specific. Almost all neoplasms presented as unilateral masses and rarely were metastatic at diagnosis. Ovarian tumors must be considered in the differential diagnosis of young girls with abdominal pain, mass, or other non-specific symptoms.

A pharmacoeconomic analysis of pegaspargase versus native Escherichia coli L-asparaginase for the treatment of children with standard-risk, acute lymphoblastic leukemia: the Children's Cancer Group study (CCG-1962).

PURPOSE: The purpose of this pharmacoeconomic analysis was to compare pegaspargase. a newer chemotherapeutic agent used for treating acute lymphoblastic leukemia, with native Escherichia coli L-asparaginase in induction, delayed intensification 1 and delayed intensification 2. MATERIALS AND METHODS: A subset of patients with newly diagnosed, standard-risk, acute lymphoblastic leukemia enrolled in the Children's Cancer Group (CCG) study CCG-1962 at seven participating institutions gave consent and was enrolled in our pharmacoeconomic analysis study. Societal (transportation, lodging, missed workdays, food, babysitter) and payer (frequency of encounters) cost data were collected from diaries (n = 27). Additional payer costs, such as drug costs, cost per clinic visit, and cost per inpatient day stay were collected from patients in CCG-1962 and participating institutions. We considered costs of therapy, including higher pegaspargase costs when comparing regimens of pegaspargase versus native E. coli L-asparaginase in induction, delayed intensification 1, and delayed intensification 2. RESULTS: Our results showed that the costs of the two therapies were similar from the payer perspective, with pegaspargase costing 1.8% more than E. coli L-asparaginase. The difference between groups also was small (<1%) from the societal perspective. Inpatient stay accounted for 88% of pegaspargase payer costs and 91% of the native E. coli L-asparaginase costs. CONCLUSION: We recommend that pegaspargase not be withheld from treatment protocols solely because of its higher pharmacy costs.