TY - JOUR T1 - Multicenter randomized, double-blind controlled trial to evaluate the efficacy of laser therapy for the treatment of severe oral mucositis induced by chemotherapy in children: laMPO RCT. JF - Pediatr Blood Cancer Y1 - 2018 A1 - Gobbo, Margherita A1 - Verzegnassi, Federico A1 - Ronfani, Luca A1 - Zanon, Davide A1 - Melchionda, Fraia A1 - Bagattoni, Simone A1 - Majorana, Alessandra A1 - Bardellini, Elena A1 - Mura, Rosamaria A1 - Piras, Alessandra A1 - Petris, Maria Grazia A1 - Mariuzzi, Maria Livia A1 - Barone, Angelica A1 - Merigo, Elisabetta A1 - Decembrino, Nunzia A1 - Vitale, Marina Consuelo A1 - Berger, Massimo A1 - Defabianis, Patrizia A1 - Biasotto, Matteo A1 - Ottaviani, Giulia A1 - Zanazzo, Giulio Andrea AB -

OBJECTIVES: To demonstrate the efficacy of laser photobiomodulation (PBM) compared to that of placebo on severe oral mucositis (OM) in pediatric oncology patients. The primary objective was the reduction of OM grade (World Health Organization [WHO] scale) 7 days after starting PBM. Secondary objectives were reduction of pain, analgesic consumption, and incidence of side effects.

METHODS: One hundred and one children with WHO grade > 2 chemotherapy-induced OM were enrolled in eight Italian hospitals. Patients were randomized to either PBM or sham treatment for four consecutive days (days +1 to +4). On days +4, +7, and +11, OM grade, pain (following a 0-10 numeric pain rating scale, NRS) and need for analgesics were evaluated by an operator blinded to treatment.

RESULTS: Fifty-one patients were allocated to the PBM group, and 50 were allocated to the sham group. In total, 93.7% of PBM patients and 72% of sham patients had OM grade < 3 WHO on day +7 (P = 0.01). A significant reduction of pain was registered on day +7 in the PBM versus sham group (NRS 1 [0-3] vs. 2.5 [1-5], P < 0.006). Reduced use of analgesics was reported in the PBM group, although it was not statistically significant. No significant adverse events attributable to treatment were recorded.

CONCLUSIONS: PBM is a safe, feasible, and effective treatment for children affected by chemotherapy-induced OM, as it accelerates mucosal recovery and reduces pain.

VL - 65 IS - 8 U1 - http://www.ncbi.nlm.nih.gov/pubmed/29727048?dopt=Abstract ER - TY - JOUR T1 - Single-day trimethoprim/sulfamethoxazole prophylaxis for Pneumocystis pneumonia in children with cancer. JF - J Pediatr Y1 - 2014 A1 - Caselli, Désirée A1 - Petris, Maria Grazia A1 - Rondelli, Roberto A1 - Carraro, Francesca A1 - Colombini, Antonella A1 - Muggeo, Paola A1 - Ziino, Ottavio A1 - Melchionda, Fraia A1 - Russo, Giovanna A1 - Pierani, Paolo A1 - Soncini, Elena A1 - DeSantis, Raffaella A1 - Zanazzo, Giulio A1 - Barone, Angelica A1 - Cesaro, Simone A1 - Cellini, Monica A1 - Mura, Rossella A1 - Milano, Giuseppe M A1 - Meazza, Cristina A1 - Cicalese, Maria P A1 - Tropia, Serena A1 - De Masi, Salvatore A1 - Castagnola, Elio A1 - Aricò, Maurizio KW - Anti-Infective Agents KW - Child KW - Dose-Response Relationship, Drug KW - Drug Administration Schedule KW - Follow-Up Studies KW - Hematologic Neoplasms KW - Humans KW - Incidence KW - Italy KW - Pneumocystis carinii KW - Pneumonia, Pneumocystis KW - Prospective Studies KW - Treatment Outcome KW - Trimethoprim, Sulfamethoxazole Drug Combination AB -

OBJECTIVE: To determine whether a simplified, 1-day/week regimen of trimethoprim/sulfamethoxazole is sufficient to prevent Pneumocystis (jirovecii [carinii]) pneumonia (PCP). Current recommended regimens for prophylaxis against PCP range from daily administration to 3 consecutive days per week dosing.

STUDY DESIGN: A prospective survey of the regimens adopted for the PCP prophylaxis in all patients treated for childhood cancer at pediatric hematology-oncology centers of the Associazione Italiana Ematologia Oncologia Pediatrica.

RESULTS: The 20 centers participating in the study reported a total of 2466 patients, including 1093 with solid tumor and 1373 with leukemia/lymphoma (or primary immunodeficiency; n = 2). Of these patients, 1371 (55.6%) received the 3-day/week prophylaxis regimen, 406 (16.5%) received the 2-day/week regimen, and 689 (27.9%), including 439 with leukemia/lymphoma, received the 1-day/week regimen. Overall, only 2 cases of PCP (0.08%) were reported, both in the 2-day/week group. By intention to treat, the cumulative incidence of PCP at 3 years was 0.09% overall (95% CI, 0.00-0.40%) and 0.51% for the 2-day/week group (95% CI, 0.10%-2.00%). Remarkably, both patients who failed had withdrawn from prophylaxis.

CONCLUSION: A single-day course of prophylaxis with trimethoprim/sulfamethoxazole may be sufficient to prevent PCP in children with cancer undergoing intensive chemotherapy regimens. This simplified strategy might have implications for the emerging need for PCP prophylaxis in other patients subjected to the increased use of biological and nonbiological agents that induce higher levels of immune suppression, such as those with rheumatic diseases.

VL - 164 IS - 2 U1 - http://www.ncbi.nlm.nih.gov/pubmed/24252793?dopt=Abstract ER -