To update recommendations of the ASCO systemic therapy for hormone receptor (HR)-positive metastatic breast cancer (MBC) guideline.
An Expert Panel conducted a systematic review to identify new, ...potentially practice-changing data.
Fifty-one articles met eligibility criteria and form the evidentiary basis for the recommendations.
Alpelisib in combination with endocrine therapy (ET) should be offered to postmenopausal patients, and to male patients, with HR-positive, human epidermal growth factor receptor 2 (HER2)-negative,
-mutated, ABC, or MBC following prior endocrine therapy with or without a cyclin-dependent kinase (CDK) 4/6 inhibitor. Clinicians should use next-generation sequencing in tumor tissue or cell-free DNA in plasma to detect
mutations. If no mutation is found in cell-free DNA, testing in tumor tissue, if available, should be used as this will detect a small number of additional patients with
mutations. There are insufficient data at present to recommend routine testing for
mutations to guide therapy for HR-positive, HER2-negative MBC. For
or
mutation carriers with metastatic HER2-negative breast cancer, olaparib or talazoparib should be offered in the 1st-line through 3rd-line setting. A nonsteroidal aromatase inhibitor (AI) and a CDK4/6 inhibitor should be offered to postmenopausal women with treatment-naïve HR-positive MBC. Fulvestrant and a CDK4/6 inhibitor should be offered to patients with progressive disease during treatment with AIs (or who develop a recurrence within 1 year of adjuvant AI therapy) with or without one line of prior chemotherapy for metastatic disease, or as first-line therapy. Treatment should be limited to those without prior exposure to CDK4/6 inhibitors in the metastatic setting.Additional information can be found at www.asco.org/breast-cancer-guidelines.
To develop recommendations about endocrine therapy for women with hormone receptor (HR) -positive metastatic breast cancer (MBC).
The American Society of Clinical Oncology convened an Expert Panel to ...conduct a systematic review of evidence from 2008 through 2015 to create recommendations informed by that evidence. Outcomes of interest included sequencing of hormonal agents, hormonal agents compared with chemotherapy, targeted biologic therapy, and treatment of premenopausal women. This guideline puts forth recommendations for endocrine therapy as treatment for women with HR-positive MBC.
Sequential hormone therapy is the preferential treatment for most women with HR-positive MBC. Except in cases of immediately life-threatening disease, hormone therapy, alone or in combination, should be used as initial treatment. Patients whose tumors express any level of hormone receptors should be offered hormone therapy. Treatment recommendations should be based on type of adjuvant treatment, disease-free interval, and organ function. Tumor markers should not be the sole criteria for determining tumor progression; use of additional biomarkers remains experimental. Assessment of menopausal status is critical; ovarian suppression or ablation should be included in premenopausal women. For postmenopausal women, aromatase inhibitors (AIs) are the preferred first-line endocrine therapy, with or without the cyclin-dependent kinase inhibitor palbociclib. As second-line therapy, fulvestrant should be administered at 500 mg with a loading schedule and may be administered with palbociclib. The mammalian target of rapamycin inhibitor everolimus may be administered with exemestane to postmenopausal women with MBC whose disease progresses while receiving nonsteroidal AIs. Among patients with HR-positive, human epidermal growth factor receptor 2-positive MBC, human epidermal growth factor receptor 2-targeted therapy plus an AI can be effective for those who are not chemotherapy candidates.
Patients with cancer suffer from a variety of symptoms associated with both cancer and its treatment. These symptoms may lead to a decreased quality of life for patients and can affect compliance ...with cancer therapies. The importance of adequately treating cancer-related symptoms is gaining more attention but, overall, many symptoms remain underdiagnosed and undertreated. Fatigue, insomnia, neuropathy, and pain are among the most common troublesome symptoms experienced by cancer survivors. This article will focus on the management of these symptoms, including an assessment of the current research and proposed best- management practices.
Objective
To estimate and compare the prevalence of fibromyalgia by 2 different methods in Olmsted County, Minnesota.
Methods
The first method was a retrospective review of medical records of ...potential cases of fibromyalgia in Olmsted County using the Rochester Epidemiology Project (from January 1, 2005, to December 31, 2009) to estimate the prevalence of diagnosed fibromyalgia in clinical practice. The second method was a random survey of adults in Olmsted County using the fibromyalgia research survey criteria to estimate the percentage of responders who met the fibromyalgia research survey criteria.
Results
Of the 3,410 potential patients identified by the first method, 1,115 had a fibromyalgia diagnosis documented in the medical record by a health care provider. The age‐ and sex‐adjusted prevalence of diagnosed fibromyalgia by this method was 1.1%. By the second method, of the 2,994 people who received the survey by mail, 830 (27.6%) responded and 44 (5.3%) met the fibromyalgia research survey criteria. The age‐ and sex‐adjusted prevalence of fibromyalgia in the general population of Olmsted County by this method was estimated at 6.4%.
Conclusion
To the best of our knowledge, this is the first report of the rate at which fibromyalgia is being diagnosed in a community. This is also the first report of prevalence as assessed by the fibromyalgia research survey criteria. Our results suggest that patients, particularly men, who meet the fibromyalgia research survey criteria are unlikely to have been given a diagnosis of fibromyalgia.
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BFBNIB, FZAB, GIS, IJS, KILJ, NLZOH, NUK, OILJ, SAZU, SBCE, SBMB, UL, UM, UPUK
The objectives of this narrative review are to describe (1) the evidence for interventions addressing four key issues affecting female sexual health in cancer populations (ie, low sexual desire, ...vulvovaginal symptoms, negative body image, and sexual partner relationships) that are ready or nearly ready for integration into practice and (2) the current state of patient-provider sexual health communication related to female sexual health as these findings could have implications for integrating sexual health into practice.
A narrative review of recent intervention evidence for female cancer survivors' sexual health was conducted.
Strong evidence was found for behavioral interventions, such as psychosexual counseling and psychoeducation to treat concerns related to sexual health, including desire, body image, and sexual partner relationships. For partnered female survivors, couple-based psychosexual interventions have been found to be effective. There are no proven pharmacologic treatments for sexual-related concerns other than for vulvovaginal atrophy in female cancer survivors. Vaginal nonhormonal and low-dose hormonal agents are effective remedies for vulvovaginal symptoms. Laser treatment has not yet been fully evaluated. Sexual partners are a critical context for sexual health. Despite much need, discussions around this topic continue to be relatively infrequent. Recent technology-based interventions show promise in improving discussions around sexual health.
Effective interventions exist for many sexual health challenges for female survivors although more high-quality intervention research, particularly multimodal interventions, is needed. Many of the effective interventions are nonpharmacologic, and thus, evaluation of the use of digital delivery to improve access to these interventions is needed. Cancer care delivery research is urgently needed to translate existing effective interventions into practice, including strategies to improve patient-provider communication around this topic.
Purpose The adaptation of the Cancer Care Ontario (CCO) guideline Interventions to Address Sexual Problems in People With Cancer provides recommendations to manage sexual function adverse effects ...that occur as a result of cancer diagnosis and/or treatment. Methods ASCO staff reviewed the guideline for developmental rigor and updated the literature search. An ASCO Expert Panel ( Table A1 ) was assembled to review the guideline content and recommendations. Results The ASCO Expert Panel determined that the recommendations from the 2016 CCO guideline are clear, thorough, and based upon the most relevant scientific evidence. ASCO statements and modifications were added to adapt the CCO guideline for a broader audience. Recommendations It is recommended that there be a discussion with the patient, initiated by a member of the health care team, regarding sexual health and dysfunction resulting from cancer or its treatment. Psychosocial and/or psychosexual counseling should be offered to all patients with cancer, aiming to improve sexual response, body image, intimacy and relationship issues, and overall sexual functioning and satisfaction. Medical and treatable contributing factors should be identified and addressed first. In women with symptoms of vaginal and/or vulvar atrophy, lubricants in addition to vaginal moisturizers may be tried as a first option. Low-dose vaginal estrogen, lidocaine, and dehydroepiandrosterone may also be considered in some cases. In men, medication such as phosphodiesterase type 5 inhibitors may be beneficial, and surgery remains an option for those with symptoms or treatment complications refractory to medical management. Both women and men experiencing vasomotor symptoms should be offered interventions for symptomatic improvement, including behavioral options such as cognitive behavioral therapy, slow breathing and hypnosis, and medications such as venlafaxine and gabapentin.Additional information is available at: www.asco.org/survivorship-guidelines and www.asco.org/guidelineswiki .
Purpose This clinimetric analysis was conducted to evaluate the reliability, validity, and responsiveness to changeover time of the QLQ-CIPN20 when used to quantify patient-reported ...chemotherapy-induced peripheral neuropathy (CIPN). Methods Participants recruited to four cooperative group trials were pooled to create two groups (n = 376, 575): those who did versus did not receive neurotoxic chemotherapy. QLQ-CIPN20 internal consistency reliability was assessed using Cronbach's alpha coefficients. Instrument validity was assessed using factor analysis, by evaluating score correlations with other CIPN and pain measures, and by comparing scores between contrasting groups. Cohen's d was used to assess responsiveness to change. Results Alpha coefficients for the sensory, motor, and autonomic scales were 0.88, 0.88, and 0.78, respectively. However, autonomic scale and hearing loss items exhibited low item–item correlations (r ≤ 0.30) and thus were deleted. Moderate correlations were found between QLQ-CIPN20 and Brief Pain Inventory pain severity items (r 0.30–0.57, p ≤ .0001). Correlation between the QLQ-CIPN20 sensory and toxicity grading scale scores was low (r = .20; p ≤ .01). Mean scores were higher (worse) (p ≤ 0.0001) in individuals who did versus did not receive neurotoxic chemotherapy. The sensory and motor scales exhibited moderate-high responsiveness to change (Cohen's d = 0.82 and 0.48, respectively). Factor analysis indicated that the 16-item version formed distinct factors for lower and upper extremity CIPN, delineating typical distal to proximal CIPN progression. Conclusions Results provide support for QLQ-CIPN20 sensory and motor scale reliability and validity. The more parsimonious and clinically relevant 16-item version merits further consideration.
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BFBNIB, CEKLJ, DOBA, EMUNI, FIS, FZAB, GEOZS, GIS, IJS, IMTLJ, INZLJ, IZUM, KILJ, KISLJ, MFDPS, NLZOH, NMLJ, NUK, OILJ, PILJ, PNG, SAZU, SBCE, SBJE, SBMB, SBNM, UILJ, UKNU, UL, UM, UPUK, VKSCE, VSZLJ, ZAGLJ, ZRSKP
Fatigue after hematopoietic stem cell transplantation (HSCT) is a persistent problem that limits activities and causes distress. Complementary therapies have shown promising results in improving ...fatigue in several patient populations. However, it is unknown whether they have the same effect on fatigue in the HSCT population. This integrative review aimed to explore the literature that evaluated complementary therapies for fatigue among HSCT patients. Only eight studies were considered eligible for inclusion in this review. The eight studies evaluated music therapy, relaxation, mindfulness, and massage techniques with mixed results. These studies had major methodological limitations, such as the small sample sizes and not blinding participants to the treatment allocation, introducing possible bias. Furthermore, most of these studies used 'usual care' control groups, leaving it unclear to what extent the observed effects are based on the effects of complementary therapies, or rather on psychosocial factors such as personal attention. More research is needed to more rigorously evaluate these and other complementary therapies for the prevalent problem of fatigue in the HSCT population.
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EMUNI, FIS, FZAB, GEOZS, GIS, IJS, IMTLJ, KILJ, KISLJ, MFDPS, NLZOH, NUK, OILJ, PNG, SAZU, SBCE, SBJE, SBMB, SBNM, UKNU, UL, UM, UPUK, VKSCE, ZAGLJ
Objet : Des données préliminaires ont révélé qu’une intervention autoguidée cognitivocomportementale de gestion de la douleur (PROSPECT) était efficace contre la neuropathie périphérique chronique ...douloureuse induite par chimiothérapie (NPCI), mais le mécanisme d’action demeure inconnu. L’objectif de cette analyse secondaire a consisté à déterminer si les changements par rapport à l’anxiété, à la dépression, aux troubles du sommeil ou à la fatigue diminuaient la douleur après l’utilisation de PROSPECT chez les patients atteints de NPCI. Méthodologie : En tout, 60 participants ont été sélectionnés au hasard pour recevoir soit l’intervention autoguidée cognitivocomportementale contre la douleur (accès pendant huit semaines), soit le traitement habituel. Un journal sur sept jours de suivi de la douleur due à la NPCI et le système PROMIS (Patient Reported Outcomes Measurement Information System) de mesure de l’anxiété, de la dépression, de la fatigue et des troubles du sommeil ont été utilisés avant et après l’étude (huit semaines). L’analyse de la médiation causale a été utilisée pour quantifier les médiateurs d’amélioration quant aux douleurs les plus intenses. Résultats : Aucun des médiateurs hypothétiques n’a eu un effet statistiquement important sur les douleurs les plus fortes (n = 38). Implications : D’autres recherches sont nécessaires pour déterminer les médiateurs potentiels d’intensité de la douleur qui peuvent être ciblés par des stratégies cognitivocomportementales spécifiques afin d’améliorer la gravité de la douleur de la CIPN. Mots clés : Douleur chronique, neuropathie périphérique chimio-induite, intervention cognitivocomportementale, maladie du système nerveux périphérique/chimio-induite
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NUK, OILJ, UL, UM, UPUK, VSZLJ
Safe, effective interventions to improve cancer-related fatigue (CRF) are needed because it remains a prevalent, distressing, and activity-limiting symptom. Based on pilot data, a phase III trial was ...developed to evaluate the efficacy of American ginseng on CRF.
A multisite, double-blind trial randomized fatigued cancer survivors to 2000mg of American ginseng vs a placebo for 8 weeks. The primary endpoint was the general subscale of the Multidimensional Fatigue Symptom Inventory-Short Form (MFSI-SF) at 4 weeks. Changes from baseline at 4 and 8 weeks were evaluated between arms by a two-sided, two-sample t test. Toxicities were evaluated by self-report and the National Cancer Institute's Common Terminology Criteria for Adverse Events (CTCAE) provider grading.
Three hundred sixty-four participants were enrolled from 40 institutions. Changes from baseline in the general subscale of the MFSI-SF were 14.4 (standard deviation SD = 27.1) in the ginseng arm vs 8.2 (SD = 24.8) in the placebo arm at 4 weeks (P = .07). A statistically significant difference was seen at 8 weeks with a change score of 20 (SD = 27) for the ginseng group and 10.3 (SD = 26.1) for the placebo group (P = .003). Greater benefit was reported in patients receiving active cancer treatment vs those who had completed treatment. Toxicities per self-report and CTCAE grading did not differ statistically significantly between arms.
Data support the benefit of American ginseng, 2000mg daily, on CRF over an 8-week period. There were no discernible toxicities associated with the treatment. Studies to increase knowledge to guide the role of ginseng to improve CRF are needed.
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