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Background Industry payments to US cancer centers are poorly understood. Methods US National Cancer Institute (NCI)–designated comprehensive cancer centers were identified (n = 51). Industry payments to NCI–designated comprehensive cancer centers from 2014 to 2021 were obtained from Open Payments and National Institutes of Health (NIH) grant funding from NIH Research Portfolio Online Reporting Tools (RePORT). Given our focus on cancer centers, we measured the subset of industry payments related to cancer drugs specifically and the subset of NIH funding from the NCI. Results Despite a pandemic-related decline in 2020-2021, cancer-related industry payments to NCI–designated comprehensive cancer centers increased from $482 million in 2014 to $972 million in 2021. Over the same period, NCI research grant funding increased from $2 481  million to $2 724  million. The large majority of nonresearch payments were royalties and licensing payments. Conclusion Industry payments to NCI–designated comprehensive cancer centers increased substantially more than NCI funding in recent years but were also more variable. These trends raise concerns regarding the influence and instability of industry payments. [ABSTRACT FROM AUTHOR]

Background Drug manufacturers claim that the purpose of financial payments to physicians is to facilitate education about new drugs. This claim suggests 2 testable hypotheses: payments should not be associated with drug revenue and payments for each drug should decline over time as physicians become educated. Materials and Methods We used open payments data on industry payments. We included payments for cancer drugs without generic/biosimilar competitors and used federal data sources to measure Medicare spending (a proxy for overall drug revenue) and a number of prescribers. We used generalized estimating equations (GEE) to model the drug-level association between industry payments and Medicare spending. Separately, we used GEE to estimate the change in payments with respect to the duration of time since initial FDA approval. Results The sample included 89 drugs and 361 drug-year observations. The total value of industry payments for oncology drugs increased, from $53 333 854 in 2014 to $90 343 731 in 2018. There was no association between log-transformed mean, per-physician industry payments, and per-physician Medicare spending (estimate −0.001, 95%CI, −0.005 to 0.004). Payments for individual drugs decreased over time; estimated payments in the subsequent year for a drug with mean, per-physician payments of $1000 in the index year was: $681* for drugs 0-4 years since approval, $825 for 5-9 years, and $679* for ≥10 years (* P <.05). Conclusions Although industry-sponsored education may also serve marketing purposes, the absence of association between industry payments and Medicare spending and the decline in payments subsequent to approval are consistent with claims that industry payments function to facilitate physician education. [ABSTRACT FROM AUTHOR]

Background: Bone-modifying agent (BMA) therapy is recommended for metastatic castration-resistant prostate cancer but not metastatic castration-sensitive prostate cancer (mCSPC). BMA treatment in mCSPC may therefore constitute overuse.Methods: In this retrospective cohort study using linked Surveillance, Epidemiology, and End Results-Medicare data, we included patients diagnosed with stage IV prostate adenocarcinoma from 2007 to 2015 who were 66 years of age or older at diagnosis and had received androgen-deprivation or antiandrogen therapy. We excluded patients who had previously received BMAs or had existing osteoporosis, osteopenia, hypercalcemia, or prior bone fracture. The primary outcome was receipt of BMA (zoledronic acid or denosumab) within 180 days of diagnosis (emergence of CRPC within this time frame is unlikely). The secondary outcome was receipt of a BMA within 90 days. Exposures of interest included practice location (physician office vs hospital outpatient) and the specialty (medical oncologist vs urologist) of the treating physician.Results: Our sample included 2627 patients, of whom 52.9% were treated by medical oncologists and 47.1% by urologists; 77.7% and 22.3% received care in physician office and hospital outpatient locations, respectively. Overall, 23.6% received a BMA within 180 days; 18.4% did within 90 days. BMA therapy was more common among patients treated by oncologists (odds ratio = 8.23, 95% confidence interval = 6.41 to 10.57) and in physician office locations (odds ratio = 1.33, 95% confidence interval = 1.06 to 1.69). Utilization has increased: 17.3% of patients received BMAs from 2007 to 2009 (17.3% zoledronic acid, 0% denosumab) and 28.1% from 2012 to 2015 (8.4% zoledronic acid, 20.3% denosumab).Conclusions: Among patients with mCSPC who had no evidence of high osteoporotic fracture risk, more than one-quarter have received BMAs in recent years. This overuse may lead to excess costs and toxicity. [ABSTRACT FROM AUTHOR]

Background: Oncologists who author clinical practice guidelines frequently have financial relationships with the pharmaceutical industry. It is unknown whether participation on clinical practice guideline committees is associated with differences in the amounts of industry money received. Materials and Methods: We conducted a nested case‐control study from August 2013 to December 2018. We manually abstracted membership records of National Comprehensive Cancer Network (NCCN) Guidelines committees for the 20 most common cancers and linked to Open Payments. The study sample included medical oncologists selected to join an NCCN Guidelines committee ("joiners") during the study period. Joiners were matched 1:2 to medical oncologists who had no participation on NCCN committees (controls) by gender, NCCN institution, and medical school graduation year. We performed difference‐in‐differences (DiD) estimation to assess whether selection to an NCCN committee was associated with the dollar value of payments received from industry, using generalized estimating equations to address correlation between matched pairs and between repeated observations of the same pair. Results: During the study period, 54 physicians joined an NCCN Guidelines committee. These physicians received more payments than matched controls in the year prior to joining ($11,259 vs. $3,427; p =.02); this difference did not increase in the year after joining (DiD = $731; p =.45). Conclusion: Medical oncologists selected to NCCN Guidelines committees had greater financial ties to industry than their peers. The potential influence of industry in oncology clinical practice guidelines may be reduced through the selection of committee members with fewer ties to industry. Implications for Practice: Oncologists who author clinical practice guidelines frequently have financial conflicts of interest with the pharmaceutical industry. This creates concern about the potential for industry influence on guidelines. However, it is unknown whether oncologists who author guidelines have greater industry relationships than their peers. This study compared medical oncologists who were newly selected to join a National Comprehensive Cancer Network (NCCN) Guidelines panel with medical oncologists at the same institutions and at similar career stages. At the time they joined, oncologists joining NCCN Guidelines panels had received more than three times the dollar value of industry payments than their peers. The potential for industry influence may be reduced by the selection of less‐conflicted panel members. To assess industry influence on oncologists creating clinical practice guidelines, this study compared medical oncologists who were newly selected to join an NCCN Guidelines panel with medical oncologists at the same institutions and at similar career stages. [ABSTRACT FROM AUTHOR]

Long-standing guidelines against screening high-risk individuals for lung cancer may change following the publication of the randomized National Lung Screening Trial (NLST), which shows a benefit of computed tomography compared with chest x-ray screening. Guideline panels will likely also seek additional information from nonrandomized studies of computed tomography screening, such as the Early Lung Cancer Action Project (ELCAP). However, for the ELCAP findings to be incorporated into new guidelines, some inconsistencies in the published data should first be resolved. Specifically, some of the reports from ELCAP appear to contradict others in terms of important endpoints, and several findings from ELCAP appear to be statistically improbable or outliers when compared with analyses and studies by other research groups. Clarification of both internal and external inconsistencies is a prerequisite for evaluation of the body of work published by ELCAP investigators. [ABSTRACT FROM PUBLISHER]

A letter to the editor about the article "CT Screening for Lung Cancer: Update 2007," by Claudia I. Henschke and D. F. Yankelevitz and a response by the authors to the letter are presented.

Background Medicare managed care may offer enrollees lower out-of-pocket costs and provide benefits that are not available in the traditional fee-for-service Medicare program. However, managed care plans may also restrict provider choice in an effort to control costs. We compared rates of voluntary disenrollment from Medicare managed care to traditional fee-for-service Medicare among Medicare managed care enrollees with and without a cancer diagnosis. Methods We identified Medicare managed care enrollees aged 65 years or older who were diagnosed with a first primary breast (n = 28 331), colorectal (n = 26 494), prostate (n = 29 046), or lung (n = 31 243) cancer from January 1, 1995, through December 31, 2002, in Surveillance, Epidemiology, and End Results (SEER) cancer registry records linked with Medicare enrollment files. Cancer patients were pair-matched to cancer-free enrollees by age, sex, race, and geographic location. We estimated rates of voluntary disenrollment to fee-for-service Medicare in the 2 years after each cancer patient's diagnosis, adjusted for plan characteristics and Medicare managed care penetration, by use of Cox proportional hazards regression. Results In the 2 years after diagnosis, cancer patients were less likely to disenroll from Medicare managed care than their matched cancer-free peers (for breast cancer, adjusted hazard ratio [HR] for disenrollment = 0.78, 95% confidence interval [CI] = 0.74 to 0.82; for colorectal cancer, HR = 0.84, 95% CI = 0.80 to 0.88; for prostate cancer, HR = 0.86, 95% CI = 0.82 to 0.90; and for lung cancer, HR = 0.81, 95% CI = 0.76 to 0.86). Results were consistent across strata of age, sex, race, SEER registry, and cancer stage. Conclusion A new cancer diagnosis between 1995 and 2002 did not precipitate voluntary disenrollment from Medicare managed care to traditional fee-for-service Medicare. [ABSTRACT FROM AUTHOR]

A letter to the editor is presented in response to the article "CT Screening for Lung Cancer: Update 2007" in the January 2008 issue.

The Bach model was developed to predict the absolute 10-year risk of developing lung cancer among smokers by use of participants in the Carotene and Retinol Efficacy Trial of lung cancer prevention. We assessed the validity of the Bach model among 6239 smokers from the placebo arm of the Alpha-Tocopherol, Beta-Carotene Cancer Prevention (ATBC) Study. The expected numbers of lung cancer cases and deaths without lung cancer were calculated from the Bach model and compared with the observed numbers of corresponding events over 10 years. We found that the risk model slightly underestimated the observed lung cancer risk (number of lung cancers expected/ number observed = 0.89, 95% confidence interval [CI] = 0.80 to 0.99) over 10 years. The competing risk portion of the model substantially underestimated risk of non-lung cancer mortality (number of non-lung cancer deaths expected/ number observed = 0.61, 95% CI = 0.57 to 0.64) over 10 years. The age-specific concordance indices for 10-year predictions were 0.77 (95% CI = 0.70 to 0.84), 0.59 (95% CI = 0.53 to 0.65), 0.62 (95% CI = 0.57 to 0.67), and 0.57 (95% CI = 0.49 to 0.67) for the age groups 50–54, 55–59, 60–64, and 65–69 years, respectively. Periodic radiographic screening in the ATBC Study may explain why slightly more cancers were observed than expected from the Bach model. [ABSTRACT FROM AUTHOR]

Background: Patients diagnosed with superficial bladder cancer who have not undergone total cystectomy are at high risk for recurrence, and bladder surveillance with cystoscopy is recommended for such patients every 3-6 months. We examined the degree to which bladder cancer patients undergo the recommended surveillance procedures and identified patient and primary care provider characteristics associated with nonadherence to these recommendations. Methods: We used information obtained from the Surveillance, Epidemiology, and End Results (SEER) ProgramMedicare-linked database to identify 6717 patients aged 65 years or older who were diagnosed with superficial bladder cancer from 1992 through 1996 and who survived for at least 3 years after diagnosis but did not have a total cystectomy. We used information obtained from Medicare claims forms to examine the frequency with which these patients had a surveillance examination of the bladder during each of five contiguous 6-month intervals from month 7 to month 36 following diagnosis. We examined characteristics of patients and their physicians that were associated with low-intensity surveillance (defined as having an examination during fewer than two of the five possible follow-up intervals). Logistic regression was used to calculate odds ratios (ORs) and 95% confidence intervals (CIs). All statistical tests were twosided. Results: Only 40% of the entire cohort had an examination during all five intervals; 1216 patients (18.1%) had low-intensity surveillance. Patient characteristics that were independently associated with low-intensity surveillance were being age 75 years or older (adjusted OR = 1.54, 95% CI = 1.35 to 1.74), nonwhite (adjusted OR = 1.94, 95% CI = 1.57 to 2.40), and having favorable tumor histology (adjusted OR = 0.59, 95% CI = 0.48 to 0.72 for poorly differentiated versus referent well-differentiated tumor grade) and high comorbidity (adjusted OR = 1.72, 95% CI = 1.30 to 2.27). Residence in an urban... [ABSTRACT FROM AUTHOR]

Background: Although there is no proven benefit associated with screening for lung cancer, screening programs are attracting many individuals who perceive themselves to be at high risk due to smoking. We sought to determine whether the risk of lung cancer varies predictably among smokers. Methods: We used data on 18172 subjects enrolled in the Carotene and Retinol Efficacy Trial (CARET)—a large, randomized trial of lung cancer prevention—to derive a lung cancer risk prediction model. Model inputs included the subject's age, sex, asbestos exposure history, and smoking history. We assessed the model's calibration by comparing predicted and observed rates of lung cancer across risk deciles and validated it by assessing the extent to which a model estimated on data from five CARET study sites could predict events in the sixth study site. We then applied the model to evaluate the risk of lung cancer among smokers enrolled in a study of lung cancer screening with computed tomography (CT). Results: The model was internally valid and well calibrated. Ten-year lung cancer risk varied greatly among participants in the CT study, from 15% for a 68-year-old man who has smoked two packs per day for 50 years and continues to smoke, to 0.8% for a 51-year-old woman who smoked one pack per day for 28 years before quitting 9 years earlier. Even among the subset of CT study participants who would be eligible for a clinical trial of cancer prevention, risk varied greatly. Conclusions: The risk of lung cancer varies widely among smokers. Accurate risk prediction may help individuals who are contemplating voluntary screening to balance the potential benefits and risks. Risk prediction may also be useful for researchers designing clinical trials of lung cancer prevention. [ABSTRACT FROM AUTHOR]

The discussion of value has moved from the philosophical, in which “value” was held out as an amorphous “eye of the beholder” concept, to an operationalized construct that is now directly affecting prescribing decisions. This is appropriate, given the large differences in price that seem disassociated from value. [ABSTRACT FROM AUTHOR]

A letter to the editor is presented in response to the article "Survival of Patients With Stage 1 Lung Cancer Detected on CT Screening," by CI Henschke and colleagues in a 2006 issue.

Focuses on the risk chart for various causes of death for smokers and nonsmokers. Risk of lung cancer death for smokers; Rates of deaths for both groups; Usefulness of the risk chart in clinical practice.