Health-related quality of life in patients with relapsed or refractory multiple myeloma: treatment with daratumumab, lenalidomide, and dexamethasone in the phase 3 POLLUX trial.

In the phase 3 POLLUX trial, daratumumab in combination with lenalidomide and dexamethasone (D-Rd) significantly improved progression-free survival in patients with relapsed/refractory multiple myeloma (RRMM) compared with lenalidomide and dexamethasone (Rd) alone. Here, we present patient-reported outcomes (PROs) from POLLUX, assessed using the validated European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire Core 30-item (EORTC QLQ-C30) and the EuroQol 5-dimensional descriptive system (EQ-5D-5L) questionnaires. Changes from baseline are presented as least-squares mean changes with 95% confidence intervals (CIs) derived from a mixed-effects model. PRO assessment compliance rates were high and similar in both D-Rd and Rd groups through cycle 40 (week 156). In this on-treatment analysis, mean changes from baseline were significantly greater in EORTC QLQ-C30 global health status, physical functioning, and pain scores in the D-Rd group versus the Rd group at multiple time points; however, magnitude of changes was low, suggesting no meaningful impact on health-related quality of life (HRQoL). Subgroup results were similar to those in the overall population. In the POLLUX study, baseline HRQoL was maintained with prolonged D-Rd treatment. These findings complement the sustained and significant improvement in progression-free survival observed with D-Rd and supports its use in patients with RRMM. Clinical trial registration: NCT02076009.

The principle of salvage in the context of COVID-19.

The prioritisation of scarce resources has a particular urgency within the context of the COVID-19 pandemic crisis. This paper sets out a hypothetical case of Patient X (who is a nurse) and Patient Y (who is a non-health care worker). They are both in need of a ventilator due to COVID-19 with the same clinical situation and expected outcomes. However, there is only one ventilator available. In addressing the question of who should get priority, the proposal is made that the answer may lie in how the pandemic is metaphorically described using military terms. If nursing is understood to take place at the 'frontline' in the 'battle' against COVID-19, a principle of military medical ethics-namely the principle of salvage-can offer guidance on how to prioritise access to a life-saving resource in such a situation. This principle of salvage purports a moral direction to return wounded soldiers back to duty on the battlefield. Applying this principle to the hypothetical case, this paper proposes that Patient X (who is a nurse) should get priority of access to the ventilator so that he/she can return to the 'frontline' in the fight against COVID-19.

[Limb salvage or amputation after severe trauma to the lower extremities : Evidence from the LEAP Study]. / Gliedmaßenerhalt oder Amputation nach schwerem Trauma der unteren Extremität : Evidenz aus der LEAP-Studie.

Deciding between reconstruction and primary amputation after severe high-energy trauma to the lower extremities is difficult and consequential. The Lower Extremity Assessment Project (LEAP) prospectively included and investigated patients with severe, limb-threatening injuries below the femur, with third-grade open fractures, defined soft-tissue damage and amputation wounds. This paper aims to review the key results of the LEAP study, which were published in several parts, in due consideration of the newer relevant literature, and to deduce the consequences for clinical practice. The main results are as follows: No score is sufficiently reliable to predict the success of reconstruction. Loss of muscle seems to be more momentous than loss of bone. Any accompanying injuries that should be taken into account in the individual treatment concepts are crucial to the results, in addition to comorbidities and other individual patient-related factors, such as alcoholism, smoking, insurance, and social background. Psychological impairment is frequent after these injuries and should therefore be addressed regularly with regard to rehabilitation.

The Effect of Salvage Radiotherapy and its Timing on the Health-related Quality of Life of Prostate Cancer Patients.

BACKGROUND: The impact of salvage radiotherapy (SRT) and its timing on health-related quality of life (HRQoL) in prostate cancer patients is still unclear. OBJECTIVE: To compare the HRQoL of patients who underwent SRT with that of patients who underwent radical prostatectomy (RP) only and to investigate whether SRT timing is associated with HRQoL. DESIGN, SETTING, AND PARTICIPANTS: All SRT patients (n=241) and all RP-only patients (n=1005) were selected from a prospective database (2004-2015). The database contained HRQoL and prostate problem assessments up to 2 yr after last treatment. OUTCOME MEASUREMENT AND STATISTICAL ANALYSIS: Mixed effects growth modelling adjusting for significant differences in patient characteristics and baseline HRQoL was used to analyze the association between: (1) "treatment" (RP-only vs SRT) and (2) "timing of SRT" with changes in HRQoL. RESULTS AND LIMITATIONS: SRT patients showed significantly (p<0.05) poorer recovery from urinary, bowel, and erectile function after their last treatment (clinically meaningful difference for urinary and erectile function). Patients with a longer interval (≥ 7 mo) between RP and SRT reported significantly better sexual satisfaction after SRT (p=0.02), and a better urinary function recovery (p=0.03). Limitations of the study include the nonrandom design and the variability in timing of HRQoL measurements. CONCLUSIONS: Up to 2 yr after treatment, SRT patients reported poorer HRQoL in several HRQoL domains compared with RP-only patients, but not in overall HRQoL. Delaying the start of SRT after RP may limit the incidence and duration of urinary and sexual problems. Nevertheless, decisions regarding SRT timing should also be based on the potential benefits in disease recurrence. PATIENT SUMMARY: Patients who receive radiotherapy after surgery may experience poorer urinary, bowel, and erectile function compared with patients who undergo surgery only. Although more research is needed, delaying radiotherapy seems to limit its impact on urinary and sexual functioning.

Socioeconomic and psychological impact of treatment for unilateral intraocular retinoblastoma.

PURPOSE: To identify the socioeconomic and psychosocial impacts of clinical treatment decisions for advanced unilateral intraocular retinoblastoma. DESIGN: Retrospective observational case series. SETTING: institutional study at Alexandria Main University Hospital. STUDY POPULATION: records of 66 unilateral retinoblastoma cases treated from May 2005 to May 2013 were retrospectively reviewed. Sixty cases were eligible (International Intraocular Retinoblastoma Classification [IIRC] group C, D or E). PROCEDURES: two treatment groups were compared: enucleation vs. salvage treatment. Salvage treatment eyes were further subdivided based on IIRC group. Six socioeconomic parameters (financial burden, financial impact, psychological, social, medical and tumor impacts) were scored. Parameter scores ranged from 0 to 3, for overall score range 0 (no adverse impact) to 18 (severe adverse impact). MAIN OUTCOME MEASURES: derived Socioeconomic scores were correlated with treatment and outcomes. RESULTS: The enucleation group (28 eyes) had a median overall Socioeconomic score of 4/18, significantly lower than the salvage treatment group (32 eyes), median score 11/18 (P<0.01). Socioeconomic score varied with IIRC group. Attempted eye salvage failed in 25 children, due to uncontrolled tumor (44%) and socioeconomic impact of cumulative therapies (56%). Treatment duration and Socioeconomic score were higher for the 5 children in the salvage treatment group who developed metastatic disease compared to those without metastasis (P<0.01). CONCLUSIONS: The socioeconomic and psychosocial impacts of attempted ocular salvage for unilateral intraocular retinoblastoma are severe, in comparison to primary enucleation. Primary enucleation is a good treatment for unilateral retinoblastoma.

Physician beliefs and practices for adjuvant and salvage radiation therapy after prostatectomy.

PURPOSE: Despite results of randomized trials that support adjuvant radiation therapy (RT) after radical prostatectomy (RP) for prostate cancer with adverse pathologic features (APF), many clinicians favor selective use of salvage RT. This survey was conducted to evaluate the beliefs and practices of radiation oncologists (RO) and urologists (U) regarding RT after RP. METHODS AND MATERIALS: We designed a Web-based survey of post-RP RT beliefs and policies. Survey invitations were e-mailed to a list of 926 RO and 591 U. APF were defined as extracapsular extension, seminal vesicle invasion, or positive surgical margin. Differences between U and RO in adjuvant RT recommendations were evaluated by comparative statistics. Multivariate analyses were performed to evaluate factors predictive of adjuvant RT recommendation. RESULTS: Analyzable surveys were completed by 218 RO and 92 U (overallresponse rate, 20%). Adjuvant RT was recommended based on APF by 68% of respondents (78% RO, 44% U, p <0.001). U were less likely than RO to agree that adjuvant RT improves survival and/or biochemical control (p < 0.0001). PSA thresholds for salvage RT were higher among U than RO (p < 0.001). Predicted rates of erectile dysfunction due to RT were higher among U than RO (p <0.001). On multivariate analysis, respondent specialty was the only predictor of adjuvant RT recommendations. CONCLUSIONS: U are less likely than RO to recommend adjuvant RT. Future research efforts should focus on defining the toxicities of post-RP RT and on identifying the subgroups of patients who will benefit from adjuvant vs. selective salvage RT.

Salvage reconstructive surgery in an adult patient with failed previous repair of an extrophy-epispadias complex: an operation with a functional and aesthetic purpose

Salvage surgical procedures after failed reconstruction for an extrophy-epispadias complex are extremely challenging. The goals are to restore continence and improve aesthetic appearance in order to provide quality of life and an improved body image to the patient. We describe the surgical steps in an adult patient who presented anal urinary incontinence and a poor body image due to the absence of an umbilicus and the presence of hypertrophic scars. He underwent a modified Mainz II reconstruction of the lower urinary tract at childhood for an extrophy-epispadias complex. Restoration of continence was achieved by the construction of a modified Mainz I pouch with a continent stoma in a neo-umbilicus. Body image improved dramatically by the construction of a neo-umbilicus, a surgical revision of the hypertrophic abdominal scars and an abdominoplasty. It is mandatory that such demanding surgery should only be attempted as a combined multidisciplinary effort with urologists and plastic/reconstructive surgeons.

Salvage reconstructive surgery in an adult patient with failed previous repair of an extrophy-epispadias complex. An operation with a functional and aesthetic purpose.

Salvage surgical procedures after failed reconstruction for an extrophy-epispadias complex are extremely challenging. The goals are to restore continence and improve aesthetic appearance in order to provide quality of life and an improved body image to the patient. We describe the surgical steps in an adult patient who presented anal urinary incontinence and a poor body image due to the absence of an umbilicus and the presence of hypertrophic scars. He underwent a modified Mainz II reconstruction of the lower urinary tract at childhood for an extrophy-epispadias complex. Restoration of continence was achieved by the construction of a modified Mainz I pouch with a continent stoma in a neo-umbilicus. Body image improved dramatically by the construction of a neo-umbilicus, a surgical revision of the hypertrophic abdominal scars and an abdominoplasty. It is mandatory that such demanding surgery should only be attempted as a combined multidisciplinary effort with urologists and plastic/reconstructive surgeons.

Quality of life 2 years after salvage cryosurgery for the treatment of local recurrence of prostate cancer after radiotherapy.

PURPOSE: Previous research has raised concerns that although salvage cryosurgery may be an effective treatment to prevent the progression of prostate cancer after radiotherapy failure, the quality of life cost many be so severe as to prevent its acceptance as a viable treatment. The present study's purpose was to further the understanding of the quality of life outcomes of salvage cryosurgery. MATERIALS AND METHODS: A total of 46 men with locally recurrent prostate cancer after radiotherapy were recruited to participate in a prospective Phase II clinical trial using salvage cryosurgery. There were 2 questionnaires (i.e., the European Organization of Research and Treatment of Cancer QLQ C30 and the Prostate Cancer Index) administered before cryosurgery, and at 1.5, 3, 6, 12, 18, and 24 months after treatment. RESULTS: Quality of life returned to preoperative levels by 24 months after cryosurgery in all domains, with the exception of urinary and sexual functioning. At 24 months, 29% of men reported urinary bother as a moderate-to-big problem, and 56% reported sexual bother as a moderate-to-big problem. CONCLUSIONS: To our knowledge, this is the first study to evaluate prospectively men's quality of life for 2 years after salvage cryosurgery for locally recurrent prostate cancer after radiotherapy. Long-term impairments in quality of life appear to be limited to the sexual and urinary function domains. Overall quality of life appears to be high. These results support salvage cryosurgery as a viable treatment option.

Intra-arterial chemotherapy for limb preservation in patients with osteosarcoma: nursing implications.

Osteosarcoma is an aggressive tumor found in children and young adults, originating primarily in the legs or arms. The high-grade tumor grows in a circular, ball-like mass in the bone tissue. Before the 1970s and the advent of chemotherapy use in osteosarcoma, treatment consisted solely of amputation. More recently, a preoperative regimen of intra-arterial (IA) cisplatin and infusional doxorubicin with limb-sparing procedures has provided an effective treatment option and improved survival for many patients with osteosarcoma. IA chemotherapy is administered through a small, temporary, external catheter that rests in the arterial vessel that supplies the tumor. The primary advantage of IA chemotherapy administration is the delivery of a higher chemotherapy concentration directly to the tumor site, Nursing management of patients with IA chemotherapy requires knowledge of treatment side effects and procedure-related assessments. Further implications for practice include instructing patients and families before and after the insertion of the IA line and giving discharge and long-term follow-up education. Oncology nurses are well positioned to assist children and young adult patients through difficulties with adjustment after treatment is completed and a response has been achieved, owing to advanced communication skills and knowledge of developmental stages and survivorship issues,

Ethical issues in pediatric oncology phase I-II trials based on a mother's point of view.

Phase I-II trials are developing in Pediatrics and raise many complex relational, psychological and ethical issues. We present and discuss these based on an interview in a pediatric oncology setting, with a mother who accepted that her daughter be included in such trials and who expressed why she accepted with great sensitivity and profoundness. She explained that after many years of inefficient treatments she had lost all her landmarks and was ready to accept any proposition, even those she would have considered unacceptable earlier. She did not know whether there is a limit to what is acceptable. Her only objective was to gain any time possible in order to continue living with her daughter. She found it important that the research doctor be different from the doctor involved in patient care, and that the latter remains the major decision-maker and correspondent: thus the child's best interests take precedence over that of research. Interviews with the psycho-oncologist can help the parents and the doctors gain a better insight into the various aspects, rational and irrational, conscious and unconscious, involved in the proposition to participate in a clinical trial and in the parents' or the child's acceptance or refusal.

Cost-utility analysis of salvage cardiac extracorporeal membrane oxygenation in children.

BACKGROUND: Indications for extracorporeal membrane oxygenation therapy have expanded to include cardiopulmonary arrest and support after congenital heart surgery. Data from a national registry have reported that cardiac patients have the poorest survival of all extracorporeal membrane oxygenation recipients. Concerns have been raised about the appropriateness of such an aggressive strategy, especially in light of the high costs and potential for long-term neurologic disability. We reviewed our experience with salvage cardiac extracorporeal membrane oxygenation to determine the cost-utility, which accounts for both costs and quality of life. METHODS: Medical records of patients with congenital heart disease receiving salvage cardiac extracorporeal membrane oxygenation between January 2000 and May 2004 were reviewed. Charges for all medical care after the institution of extracorporeal membrane oxygenation were determined and converted to costs by published standards. The quality-of-life status of survivors was determined with the Health Utilities Index Mark II. RESULTS: Salvage cardiac extracorporeal membrane oxygenation was instituted in 32 patients (18 for cardiopulmonary arrest and 14 for cardiac failure after heart surgery) at a median age of 2.0 months (range, 4 days to 5.1 years). Congenital heart disease was present in 27 (84%). The mean duration of extracorporeal membrane oxygenation support was 5.1 +/- 4.1 days. Survival to hospital discharge was 50%, including 1 patient bridged to heart transplantation. Survival to 1 year was 47%. The mean score of the Health Utilities Index for the survivors was 0.75 +/- 0.19 (range, 0.41-1.0). The median cost for hospital stay after the institution of extracorporeal membrane oxygenation was USD 156,324 per patient. The calculated cost-utility for salvage extracorporeal membrane oxygenation in this population was USD 24,386 per quality-adjusted life-year saved, which would be considered within the range of accepted cost-efficacy (< USD 50,000 per quality-adjusted life-year saved). CONCLUSIONS: Salvage cardiac extracorporeal membrane oxygenation results in reasonable survival and is justified on a cost-utility basis.

Patients as peer preceptors for orthopedic oncology rehabilitation patients.

This article describes a peer preceptor program that trains patients who have experienced limb preservation surgeries and managed long-term rehabilitative therapy to support and teach newly diagnosed patients through their rehabilitation. This preceptor program was designed to complement the professional counseling and support that rehabilitation staff provide to patients and their families. Training includes communication techniques, practice sessions using videotaped scenes of patients and their families, as well as role-playing. Experienced patients who became preceptors as a result of this program were orthopedic oncology patients who had completed limb preservation surgery, chemotherapy, grafting, and physical therapies. After their training, preceptors exhibited improved communication skills in terms of empathy, listening, and voice expressions. Initiatives designed to make the preceptor program self-sustaining by having staff nurses manage the training still have to be tested.

Patient preferences concerning the trade-off between the risks and benefits of routine radiation therapy after conservative surgery for early-stage breast cancer.

PURPOSE: To assess patients' preferences regarding the trade-off between risks and benefits of radiation therapy after conservative surgery for early-stage breast cancer. PATIENTS AND METHODS: Utilities (measures of preference) of 97 early-stage breast cancer patients treated with conservative surgery and radiation therapy and 20 medical oncology nurses were assessed for five health states using standard gambles. RESULTS: Patients had the highest mean utility for treatment with conservative surgery and radiation therapy without a local recurrence (0.92), intermediate utilities for treatment with conservative surgery alone followed either by no local recurrence or by a local recurrence salvaged by conservative surgery and radiation therapy (0.88 and 0.87, respectively), and the lowest utilities for treatment with or without radiation therapy followed by a local recurrence salvaged by mastectomy and reconstructive surgery (0.82 and 0.81, respectively). All differences between health states' utilities were significant (P < .0001), except between the two intermediate and two lowest rated health states. None of the clinical or sociodemographic factors examined explained more than 5% of the variability in the patients' utilities or their differences. Nurses' utilities were similar to those of the patients. CONCLUSIONS: These results strongly suggest that fear of a local recurrence and an actual local recurrence leading to mastectomy have such a negative impact on quality of life that patients are willing to accept the risks and inconvenience of radiation therapy to avoid them. There is also considerable interpatient variability that was not explained by the clinical or sociodemographic factors examined.

Decision analysis in children with blunt splenic trauma: the effects of observation, splenorrhaphy, or splenectomy on quality-adjusted life expectancy.

The management of blunt splenic trauma in children has remained controversial, with different physicians advocating observation, splenorrhaphy, and splenectomy. Proponents for each position have debated the relative importance of rebleeding (delayed splenic rupture), posttransfusion hepatitis with its sequelae, and overwhelming postsplenectomy sepsis. In an attempt to guide the clinician, a decision analysis was performed. Variables evaluated included the incidence of transfusion, postsplenectomy sepsis, posttransfusion hepatitis, chronic active hepatitis, cirrhosis, and rebleeding. The quality-adjusted life expectancies (QALEs) when the average incidence of the variables were used in the decision analysis were 62.69 years for observation, 62.32 years for splenorrhaphy, and 61.14 years for splenectomy. Sensitivity analysis showed that there was very little difference between observation and splenorrhaphy when the transfusion rate and hepatitis rate were varied. But these treatment options produced longer QALEs than splenectomy. Therefore, in appropriately selected patients, observation is a safe and effective therapeutic option. If an operation is necessary, every effort should be made to preserve the spleen. Splenectomy may still be required in those cases of complete devascularization, persistent hemorrhage, or other associated significant injuries.