A planned,prospective comparison of short-term quality of life outcomes among older patients with breast cancer treated with standard chemotherapy in a randomized clinical trial vs. an observational study: CALGB #49907 and #369901

ObjectivesPatients ≥ 65 years old (“older”) are often not included in randomized clinical trials (RCT), but when they are, care in an RCT might improve quality of life (QoL). We conducted a prospective comparison of QoL among older women receiving standard chemotherapy from the same cooperative group physicians in an RCT vs. an observational study (“off-trial”).MethodsOlder women with invasive, non-metastatic breast cancer (n = 150 RCT; 530 off-trial) were included. Linear mixed-effects models tested associations between chemotherapy on- vs. off-trial and changes in EORTC (European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire) QoL scores over 24 months, controlling for pre-treatment QoL, age, education, tumor factors, comorbidity, and other covariates.ResultsAnthracycline regimens were used by 58% of women treated on-trial vs. 54% of those treated off-trial. Women in the RCT reported an adjusted mean increase of 13.7 points (95% CI 10.2, 17.1) in global QoL at 24 months (vs. mid-treatment), while women treated off-trial had only an adjusted improvement of 7.0 points (95% CI 3.5, 10.4; p = .007 for difference in mean changes). Women in the RCT had significantly greater improvement in emotional function than those treated off-trial, controlling for baseline; they also had greater reductions in therapy side effects and fatigue at 24 months than women off-trial, controlling for covariates.ConclusionThere may be different QoL trajectories for older women undergoing breast cancer chemotherapy on- vs. off-trial. If confirmed, the results suggest that the extra monitoring and communication within an RCT could provide the infrastructure for interventions to address symptoms and improve QoL for the growing older cancer population.     

“Iatrogenic” Parasitic Myomas: Unusual Late Complication of Laparoscopic Morcellation Procedures

Study ObjectiveTo describe our experience in diagnosing and managing parasitic myomas developing as an unexpected late complication of laparoscopic morcellation.DesignObservational study (Canadian Task Force classification II-3).SettingUniversity hospital.PatientsRetrospective chart review of all patients found to have parasitic myomas that developed after previous morcellation.InterventionLaparoscopic morcellation. Review of the recent literature correlated with clinical, surgical, and pathologic features of our cases.Measurements and Main ResultsFour patients had heterogeneous pelvic masses after morcellation. In 3 patients, symptoms developed between 2 and 16 years after the primary surgery. One patient had no symptoms, and was referred because of a suspect pelvic mass. Vaginal examination revealed painful pelvic masses in the pouch of Douglas in 2 patients, and painless masses fixed to the vaginal vault and anterior vaginal wall, respectively, in the other 2 patients. Laparoscopic examination confirmed the presence of parasitic masses in 3 patients. In 1 patient, the mass was excised vaginally. Histologic analysis confirmed leiomyoma fragments in all patients. A well-differentiated endometrial carcinoma was incidentally found in 1 patient after hysterectomy.ConclusionThese masses probably resulted from growth of missed fragments of uterine tissue after previous morcellation, culminating in development of symptomatic iatrogenic parasitic myomas. If morcellation is anticipated or required, exclusion of malignancy is mandatory. Meticulous inspection of the abdominal cavity is necessary after morcellation. In patients with a history of morcellation who have pelvic masses, iatrogenic parasitic myomas should be considered in the differential diagnosis.     

Histomorphometry of Bone after Intentionally Exposed Non-Resorbable d-PTFE Membrane or Guided Bone Regeneration for the Treatment of Post-Extractive Alveolar Bone Defects with Implant-Supported Restorations: A Pilot Randomized Controlled Trial

Aim: The aim of the present study was to investigate quantitative histological examination of bone reconstructed with non-resorbable high-density polytetrafluoroethylene membrane (d-PTFE), left intentionally exposed in post extraction sockets grafted with anorganic bone material, and removed after four weeks, versus extraction and guided bone regeneration (GBR), performed two months later. Materials and Methods: This study was designed as a multicenter randomized controlled trial of parallel-group design. Patients were selected and consecutively treated in three centers in Italy. Patients randomly received intentionally exposed non-resorbable d-PTFE membrane (group A), or guided bone regeneration (group B), to treat post-extractive alveolar bone defects with implant-supported restorations. Outcomes were: the implant failure, any mechanical and biological complications, patient satisfaction, and qualitative and histomorphometric evaluation of the collected bone samples. Results: Eighteen patients were consecutively enrolled in the trial. Of these, six out of 18 patients were male. All the included patients were treated according to the allocated interventions, and no drop out occurred. No implant failure and no complications were experienced, and all the patients were fully satisfied with the function and aesthetic of their implant-supported restoration, without difference between groups. Morphological analysis revealed no sign of tissue reaction, such as fibrosis or necrosis. Regenerated bone was well mineralized in both groups, but it seemed more mature in group B than in group A. Three samples showed a minimal number of lymphocytes. Several blood vessels of small size occupied the medullary spaces, where the tissue resulted in more maturity, indicating the activity of the tissue in progress. The histomorphometric evaluation showed no statistically significant differences in the tissue volume fractions between the two groups of patients. Conclusions: With the limitation of the present study, buccal plate reconstruction with an intentionally exposed non-resorbable membrane is an effective and easy procedure for regenerating a resorbed buccal bone plate, reducing the need for guided bone regeneration.     

Die Bedeutung der pathogenen Blastomyzeten für die Ätiologie des Karzinoms

Ohne ZusammenfassungHierzu 22 Textfiguren.Bericht auf dem I. internationalen Kongreß für vergleichende allgemeine Pathologie zu Paris, Oktober 1912, wegen Abwesenheit des Verfassers nicht vorgetragen.Übersetzt von Dr. Carl Davidsohn.