Minimally invasive surgery was adopted as an alternative to laparotomy (open surgery) for radical hysterectomy in patients with early-stage cervical cancer before high-quality evidence regarding its ...effect on survival was available. We sought to determine the effect of minimally invasive surgery on all-cause mortality among women undergoing radical hysterectomy for cervical cancer.
We performed a cohort study involving women who underwent radical hysterectomy for stage IA2 or IB1 cervical cancer during the 2010-2013 period at Commission on Cancer-accredited hospitals in the United States. The study used inverse probability of treatment propensity-score weighting. We also conducted an interrupted time-series analysis involving women who underwent radical hysterectomy for cervical cancer during the 2000-2010 period, using the Surveillance, Epidemiology, and End Results program database.
In the primary analysis, 1225 of 2461 women (49.8%) underwent minimally invasive surgery. Women treated with minimally invasive surgery were more often white, privately insured, and from ZIP Codes with higher socioeconomic status, had smaller, lower-grade tumors, and were more likely to have received a diagnosis later in the study period than women who underwent open surgery. Over a median follow-up of 45 months, the 4-year mortality was 9.1% among women who underwent minimally invasive surgery and 5.3% among those who underwent open surgery (hazard ratio, 1.65; 95% confidence interval CI, 1.22 to 2.22; P=0.002 by the log-rank test). Before the adoption of minimally invasive radical hysterectomy (i.e., in the 2000-2006 period), the 4-year relative survival rate among women who underwent radical hysterectomy for cervical cancer remained stable (annual percentage change, 0.3%; 95% CI, -0.1 to 0.6). The adoption of minimally invasive surgery coincided with a decline in the 4-year relative survival rate of 0.8% (95% CI, 0.3 to 1.4) per year after 2006 (P=0.01 for change of trend).
In an epidemiologic study, minimally invasive radical hysterectomy was associated with shorter overall survival than open surgery among women with stage IA2 or IB1 cervical carcinoma. (Funded by the National Cancer Institute and others.).
Breast cancer is the second leading cause of cancer deaths among US women. Mammography screening may be associated with reduced breast cancer mortality but can also cause harm. Guidelines recommend ...individualizing screening decisions, particularly for younger women.
We reviewed the evidence on the mortality benefit and chief harms of mammography screening and what is known about how to individualize mammography screening decisions, including communicating risks and benefits to patients.
We searched MEDLINE from 1960-2014 to describe (1) benefits of mammography, (2) harms of mammography, and (3) individualizing screening decisions and promoting informed decision making. We also manually searched reference lists of key articles retrieved, selected reviews, meta-analyses, and practice recommendations. We rated the level of evidence using the American Heart Association guidelines.
Mammography screening is associated with a 19% overall reduction of breast cancer mortality (approximately 15% for women in their 40s and 32% for women in their 60s). For a 40- or 50-year-old woman undergoing 10 years of annual mammograms, the cumulative risk of a false-positive result is about 61%. About 19% of the cancers diagnosed during that 10-year period would not have become clinically apparent without screening (overdiagnosis), although there is uncertainty about this estimate. The net benefit of screening depends greatly on baseline breast cancer risk, which should be incorporated into screening decisions. Decision aids have the potential to help patients integrate information about risks and benefits with their own values and priorities, although they are not yet widely available for use in clinical practice.
To maximize the benefit of mammography screening, decisions should be individualized based on patients' risk profiles and preferences. Risk models and decision aids are useful tools, but more research is needed to optimize these and to further quantify overdiagnosis. Research should also explore other breast cancer screening strategies.
Abstract Context Whether androgen deprivation therapy (ADT) for men with prostate cancer (PCa) increases the risk of cardiovascular disease (CVD) remains controversial. Pooled analyses using data ...from randomised controlled trials suggest no increased risk of fatal CVD following ADT, but no pooled analyses exist for observational studies. Objective To perform a meta-analysis using observational data on ADT and risk of CVD events in men with PCa. Evidence acquisition PubMed and Embase were searched using predefined inclusion criteria to perform meta-analyses on associations between types of ADT and nonfatal and fatal CVD outcomes using information from observational studies. Random effects meta-analyses were conducted to estimate relative risks (RRs) and 95% confidence intervals (CIs). Evidence synthesis A total of eight observational studies were identified studying at least one type of ADT and a nonfatal or fatal CVD outcome. The RR for risk of any type of nonfatal CVD was 1.38 (95% CI, 1.29–1.48) for men with PCa on gonadotropin-releasing hormone (GnRH) agonists, compared with men not treated with ADT. When analysing nonfatal ischemic heart disease only, the RR was 1.39 (95% CI, 1.26–1.54). The associations between GnRH agonists and nonfatal or fatal myocardial infarction or stroke were even stronger: RR: 1.57 (95% CI, 1.26–1.94) and RR: 1.51 (95% CI, 1.24–1.84), respectively. The results for other types of ADT in relation to the risk of any nonfatal CVD were RR: 1.44 (95% CI, 1.28–1.62) for orchiectomy and RR: 1.21 (95% CI, 1.07–1.367) for antiandrogens. Conclusions Observational data show a consistent positive association between ADT and the risk of CVD. This finding supports the need for future randomised trials of PCa patients that include older patients and men with multiple comorbidities to better reflect the general population. Patient summary We investigated all the available data from observational studies on hormonal treatment for prostate cancer and its possible cardiovascular adverse effects. We found consistent evidence that this treatment may increase the risk of cardiovascular disease.
Prior authorization requirements are increasing but little is known about their effects on access to care. We examined the association of a new prior authorization policy with delayed or discontinued ...prescription fills for oral anticancer drugs among Medicare Part D beneficiaries.
Using Medicare part D claims data from 2010 to 2020, we studied beneficiaries regularly filling one of 11 oral anticancer drugs, defined as three 30-day fills in 120 days preceding the plan's prior authorization policy change on that drug and continuously enrolled in the same plan for 120 days before and after the policy change at the start of a new year. The control group consisted of beneficiaries meeting the same utilization criteria, but who were enrolled in plans at the same time that did not implement a prior authorization policy change. The outcomes of interest were discontinuation of the drug within 120 days (analyzed with regression analyses) and time (in days) to next fill after a prior authorization policy change (analyzed using a quasi-experimental difference-in-differences event study).
The introduction of a new prior authorization on an established drug increased the odds of discontinuation within 120 days (adjusted odds ratio, 7.1 95% CI, 6.0 to 8.5;
< .001) and increased time to next fill by 9.7 days (95% CI, 8.2 to 11.2;
< .001), relative to patients whose plans did not have a prior authorization policy change.
Introduction of a new prior authorization policy on an established drug regimen is associated with increased probability of discontinued and delayed care. For some conditions, this may represent a clinically consequential barrier to access. Waiving prior authorization for patients already established on a drug may improve adherence.
Chemotherapy for metastatic lung or colorectal cancer can prolong life by weeks or months and may provide palliation, but it is not curative.
We studied 1193 patients participating in the Cancer Care ...Outcomes Research and Surveillance (CanCORS) study (a national, prospective, observational cohort study) who were alive 4 months after diagnosis and received chemotherapy for newly diagnosed metastatic (stage IV) lung or colorectal cancer. We sought to characterize the prevalence of the expectation that chemotherapy might be curative and to identify the clinical, sociodemographic, and health-system factors associated with this expectation. Data were obtained from a patient survey by professional interviewers in addition to a comprehensive review of medical records.
Overall, 69% of patients with lung cancer and 81% of those with colorectal cancer did not report understanding that chemotherapy was not at all likely to cure their cancer. In multivariable logistic regression, the risk of reporting inaccurate beliefs about chemotherapy was higher among patients with colorectal cancer, as compared with those with lung cancer (odds ratio, 1.75; 95% confidence interval CI, 1.29 to 2.37); among nonwhite and Hispanic patients, as compared with non-Hispanic white patients (odds ratio for Hispanic patients, 2.82; 95% CI, 1.51 to 5.27; odds ratio for black patients, 2.93; 95% CI, 1.80 to 4.78); and among patients who rated their communication with their physician very favorably, as compared with less favorably (odds ratio for highest third vs. lowest third, 1.90; 95% CI, 1.33 to 2.72). Educational level, functional status, and the patient's role in decision making were not associated with such inaccurate beliefs about chemotherapy.
Many patients receiving chemotherapy for incurable cancers may not understand that chemotherapy is unlikely to be curative, which could compromise their ability to make informed treatment decisions that are consonant with their preferences. Physicians may be able to improve patients' understanding, but this may come at the cost of patients' satisfaction with them. (Funded by the National Cancer Institute and others.).
National guidelines recommend that discussions about end-of-life (EOL) care planning happen early for patients with incurable cancer. We do not know whether earlier EOL discussions lead to less ...aggressive care near death. We sought to evaluate the extent to which EOL discussion characteristics, such as timing, involved providers, and location, are associated with the aggressiveness of care received near death.
We studied 1,231 patients with stage IV lung or colorectal cancer in the Cancer Care Outcomes Research and Surveillance Consortium, a population- and health system-based prospective cohort study, who died during the 15-month study period but survived at least 1 month. Our main outcome measure was the aggressiveness of EOL care received.
Nearly half of patients received at least one marker of aggressive EOL care, including chemotherapy in the last 14 days of life (16%), intensive care unit care in the last 30 days of life (9%), and acute hospital-based care in the last 30 days of life (40%). Patients who had EOL discussions with their physicians before the last 30 days of life were less likely to receive aggressive measures at EOL, including chemotherapy (P = .003), acute care (P < .001), or any aggressive care (P < .001). Such patients were also more likely to receive hospice care (P < .001) and to have hospice initiated earlier (P < .001).
Early EOL discussions are prospectively associated with less aggressive care and greater use of hospice at EOL.
The introduction of imatinib, a tyrosine kinase inhibitor (TKI), has greatly increased survival for patients with chronic myeloid leukemia (CML). Conversely, nonadherence to imatinib and other TKIs ...undoubtedly results in disease progression and treatment resistance. We examined trends in imatinib expenditures from 2002 to 2011 and assessed the association between copayment requirements for imatinib and TKI adherence.
We used MarketScan health plan claims from 2002 to 2011 to identify adults (age 18 to 64 years) with CML who initiated imatinib therapy between January 1, 2002, and June 30, 2011, and had insurance coverage for at least 3 months before through 6 months after initiation (N = 1,541). Primary outcomes were TKI discontinuation and nonadherence. The primary independent variable was out-of-pocket cost for a 30-day supply of imatinib. By using a propensity-score weighted sample, we estimated the risk of discontinuation and nonadherence for patients with higher (top quartile) versus lower copayments.
Monthly copayments for imatinib averaged $108; median copayments were $30 (range, $0 to $4,792). Mean total monthly expenditures for imatinib nearly doubled between 2002 and 2011, from $2,798 to $4,892. Approximately 17% of patients with higher copayments and 10% with lower copayments discontinued TKIs during the first 180 days following initiation (adjusted risk ratio aRR, 1.70; 95% CI, 1.30 to 2.22). Similarly, patients with higher copayments were 42% more likely to be nonadherent (aRR, 1.42; 95% CI, 1.19 to 1.69).
Patients with higher copayments are more likely to discontinue or be nonadherent to TKIs. Given the importance of these therapies for patients with CML, our data suggest a critical need to reduce patient costs for these therapies.
Patients with advanced-stage cancer are receiving increasingly aggressive medical care near death, despite growing concerns that this reflects poor-quality care.
To assess the association of ...aggressive end-of-life care with bereaved family members' perceptions of the quality of end-of-life care and patients' goal attainment.
Interviews with 1146 family members of Medicare patients with advanced-stage lung or colorectal cancer in the Cancer Care Outcomes Research and Surveillance study (a multiregional, prospective, observational study) who died by the end of 2011 (median, 144.5 days after death; interquartile range, 85.0-551.0 days).
Claims-based quality measures of aggressive end-of-life care (ie, intensive care unit ICU admission or repeated hospitalizations or emergency department visits during the last month of life; chemotherapy ≤2 weeks of death; no hospice or ≤3 days of hospice services; and deaths occurring in the hospital).
Family member-reported quality rating of "excellent" for end-of-life care. Secondary outcomes included patients' goal attainment (ie, end-of-life care congruent with patients' wishes and location of death occurred in preferred place).
Of 1146 patients with cancer (median age, 76.0 years interquartile range, 65.0-87.0 years; 55.8% male), bereaved family members reported excellent end-of-life care for 51.3%. Family members reported excellent end-of-life care more often for patients who received hospice care for longer than 3 days (58.8% 352/599) than those who did not receive hospice care or received 3 or fewer days (43.1% 236/547) (adjusted difference, 16.5 percentage points 95% CI, 10.7 to 22.4 percentage points). In contrast, family members of patients admitted to an ICU within 30 days of death reported excellent end-of-life care less often (45.0% 68/151) than those who were not admitted to an ICU within 30 days of death (52.3% 520/995) (adjusted difference, -9.4 percentage points 95% CI, -18.2 to -0.6 percentage points). Similarly, family members of patients who died in the hospital reported excellent end-of-life care less often (42.2% 194/460) than those who did not die in the hospital (57.4% 394/686) (adjusted difference, -17.0 percentage points 95% CI, -22.9 to -11.1 percentage points). Family members of patients who did not receive hospice care or received 3 or fewer days were less likely to report that patients died in their preferred location (40.0% 152/380) than those who received hospice care for longer than 3 days (72.8% 287/394) (adjusted difference, -34.4 percentage points 95% CI, -41.7 to -27.0 percentage points).
Among family members of older patients with fee-for service Medicare who died of lung or colorectal cancer, earlier hospice enrollment, avoidance of ICU admissions within 30 days of death, and death occurring outside the hospital were associated with perceptions of better end-of-life care. These findings are supportive of advance care planning consistent with the preferences of patients.
PDF
