Identifying drivers of first-line HR+/HER2- metastatic breast cancer treatment choices.

Aim: Assess factors associated with first-line (1L) treatment for HR+/HER2- metastatic breast cancer. Materials & methods: A cross-sectional survey of 250 US oncologists was conducted. Correlations were calculated between treatment class and demographics, treatment perceptions and other clinical/nonclinical characteristics. Results: Efficacy and safety/tolerability were critical in oncologists' 1L decision-making. CDK4/6i use positively correlated with proportion of Medicare and postmenopausal patients (r = 0.54-0.67). Chemotherapy use demonstrated positive correlations with perimenopausal and premenopausal patients and symptom burden (r = 0.31-0.42). Aromatase inhibitor (AI) monotherapy correlated positively with anticipated treatment compliance (r = 0.42). Conclusion: Efficacy and safety/tolerability were most important to 1L decision-making. Clinical characteristics corresponded with CDK4/6i and chemotherapy use. Anticipated compliance was associated with AI monotherapy use.

Patients in the USA with a certain type of metastatic breast cancer (mBC, i.e., HR+/HER2−) might get chemotherapy or hormone therapy alone instead of new and potentially better medicines called cyclin-dependent kinase 4/6 inhibitors (CDK4/6i) as their first treatment.Researchers wanted to understand how US cancer specialists decided the first treatment for this type of mBC. In a survey of 250 cancer specialists, researchers looked at different factors that might influence decision-making, including patient characteristics, doctors' opinions about the treatments and other medical and non-medical features. This study also examined the connections between these factors and the cancer specialists' choice of first treatment.Researchers found that cancer specialists care most about how well a treatment works and how safe it is when choosing the first treatment for HR+/HER2− mBC. They are more likely to use CDK4/6i if their patients have Medicare coverage or are older (i.e., women who have been through menopause). Chemotherapy is chosen if their patients are younger (i.e., women who are near and before menopause) or have more symptoms. Cancer specialists tend to choose first treatment with hormone therapy alone if they think their patients have a hard time following their treatment plan. The results showed that patient characteristics, doctors' opinions of treatments and other medical and non-medical factors play a role in choosing treatment for HR+/HER2− mBC. By understanding these factors, researchers can work toward improving treatment choices for patients with this type of mBC.

Impact of COVID-19 on patients with metastatic breast cancer: REthink Access to Care and Treatment survey results.

Aim: Patients with metastatic breast cancer (MBC) may be vulnerable to changes in healthcare management, safety standards and protocols that occurred during the COVID-19 pandemic. Materials & methods: The REthink Access to Care & Treatment (REACT) survey assessed USA-based patient perspectives on COVID-19-related impacts to their MBC treatment experience between 27 April 2021 and 17 August 2021. Results: Participants (n = 341; 98.5% females, mean age 50.8 years) reported that overall oncology treatment quality was maintained during the pandemic. Delayed/canceled diagnostic imaging was reported by 44.9% of participants while telemedicine uptake was high among participants (80%). Conclusion: Overall, MBC care was minimally affected by the pandemic, possibly due to the expanded use of telemedicine, informing MBC management for future public health emergencies.

The COVID-19 pandemic has forced healthcare providers to change the way that healthcare is delivered. These changes could particularly affect people with metastatic breast cancer (MBC), an advanced stage of cancer that has spread to other parts of the body. The authors of this study used a web-based survey to ask 341 volunteers with MBC how the pandemic has affected their cancer treatment. The authors found that people with MBC thought that the quality of their care stayed the same during the pandemic. Most people (80%) surveyed were able to use telemedicine, the remote delivery of care by phone or computer, to replace in-person visits to their doctor. However, almost half of people surveyed reported delays or cancellation of their diagnostic imaging appointments. Overall, this study shows that the COVID-19 pandemic did not affect peoples' opinions of their MBC care. Increased use of telemedicine may have contributed to the lack of disruption in care. These findings will help guide MBC care during future public health emergencies.

Psychosocial Wellbeing among Patients with Breast Cancer during COVID-19.

The impact of coronavirus disease 2019 (COVID-19) on the wellbeing of breast cancer (BC) patients is not well understood. This study described psychosocial problems among these patients in the United States (US) during the COVID-19 pandemic. Data were collected from BC patients via an online self-report survey between 30 March-6 July 2021 to assess the prevalence of COVID-19 diagnosis history and potential depression, health-related quality of life, COVID-related stress, and financial toxicity. Patients with early-stage (eBC) and metastatic (mBC) disease were compared. Of 669 patients included in the analysis, the prevalence of COVID-19 diagnosis history (10.9% versus 7.7%) and potential depression (33.7% versus 28.3%) were higher in mBC than eBC patients. Patients with eBC (versus mBC) had higher scores on nearly all Functional Assessment of Cancer Therapy-Breast scales (all, p < 0.001). For the Psychological Impact of Cancer subscales measuring negative coping strategies, the emotional distress score was the highest (9.1 ± 1.8) in the overall sample. Comprehensive Score for Financial Toxicity scores were higher in eBC than in mBC patients (24.2 ± 11.3 vs. 21.3 ± 10.2, p < 0.001). Overall, the COVID-19-related stress score was highest for danger/contamination fears (8.2 ± 5.6). In conclusion, impairments to psychosocial wellbeing among patients during the pandemic were observed, particularly financial toxicity and poor mental health and emotional functioning, with greater problems among mBC patients.

Palbociclib Adherence and Persistence in Patients with Hormone Receptor Positive/Human Epidermal Growth Factor Receptor 2 Negative (HR+/HER2-) Metastatic Breast Cancer.

Purpose: To assess adherence and persistence with palbociclib therapy in patients with HR+/HER2- metastatic breast cancer (mBC) in a US real-world setting. Methods: This retrospective study evaluated palbociclib dosing, adherence, and persistence using commercial and Medicare Advantage with Part D claims data from the Optum Research Database. Adult patients with mBC who had continuous enrollment 12 months prior to mBC diagnosis and initiated first-line palbociclib with aromatase inhibitor (AI) or fulvestrant between 02/03/2015 and 12/31/2019 were included. Demographic and clinical characteristics, palbociclib dosing and dose changes, adherence (medication possession ratio [MPR]), and persistence were measured. Adjusted logistic and Cox regression models were used to examine demographic and clinical factors associated with adherence and discontinuation. Results: Patients (n = 1066) with a mean age of 66 years were included; 76.1% received first-line palbociclib+AI and 23.9% palbociclib+fulvestrant. Most patients (85.7%) initiated palbociclib at 125 mg/day. Of the 34.0% of patients with a dose reduction, 82.6% reduced from 125 to 100 mg/day. Overall, 80.0% of patients were adherent (MPR), and 38.3% discontinued palbociclib during a mean (SD) follow-up of 16.0 (11.2) and 17.4 (13.4) months, for palbociclib+fulvestrant and palbociclib+AI, respectively. Annual income below $75,000 was significantly associated with poor adherence. Older age (age 65-74 years (hazard ratio [HR] 1.57, 95% CI, 1.06, 2.33), age ≥75 years (HR 1.61, 95% CI: 1.08, 2.41)) and bone-only metastatic disease (HR 1.37, 95% CI, 1.06, 1.76) were significantly associated with palbociclib discontinuation. Conclusion: In this real-world study, >85% of patients started palbociclib at 125 mg/day and 1 in 3 had dose reductions during the follow-up. Patients were generally adherent and persistent with palbociclib. Older age, bone-only disease, and low-income levels were associated with early discontinuation or non-adherence. Further studies are needed to understand the associations of clinical and economic outcomes with palbociclib adherence and persistence.

Work productivity among patients with metastatic breast cancer in the United States.

OBJECTIVE: To characterize workplace productivity measures in patients with metastatic breast cancer (mBC) using line of therapy (LOT) and first line (1 L) regimen. METHODS: A retrospective cohort study was conducted using IBM's MarketScan Commercial Claims and Encounters (CCAE) and Health and Productivity Management (HPM) databases. The cohort included patients diagnosed with mBC who initiated 1 L treatment between 2/3/2015 and 6/30/2018. Productivity was measured using days absent from work and short- and long-term disability (STD, LTD) claims by LOT and 1 L regimen (any cyclin-dependent kinase 4/6 inhibitor [CDK4/6i], endocrine monotherapy, chemotherapy only, or other anti-cancer therapy [OACT]). LOT was defined using regimen-based progression. RESULTS: Overall, 548 patients were included; 148, 129, 145, and 126 received endocrine monotherapy, CDK4/6i, chemotherapy only, and OACT, respectively. The rate of LTD increased significantly by 3.1 and 2.6 times from 1 L to second line (2 L) and from 2 L to subsequent lines, respectively. Patients receiving 1 L chemotherapy had 2.4- and 2.7-times odds of using STD and LTD compared to patients receiving 1 L CDK4/6i. CONCLUSIONS: Regimen-based disease progression is associated with increased use of STD and LTD. Patients with a 1 L regimen of chemotherapy have significantly higher odds of using STD or LTD than patients using 1 L CDK4/6i.

Health-Related Quality of Life Among Patients With HR+/HER2- Early Breast Cancer.

PURPOSE: The goal of this study was to characterize health-related quality of life (HRQOL) among patients diagnosed with early-stage, hormone receptor-positive (HR+)/human epidermal growth factor receptor 2 negative (HER2-) breast cancer. METHODS: A multinational (United States, Japan, France, Germany, Italy, Spain, and United Kingdom) study of patients diagnosed with stage I to III HR+/HER2- breast cancer, either receiving adjuvant treatment or under postadjuvant surveillance, was conducted between June and October 2019. Patients were identified by their consulting physician and invited to complete the Functional Assessment of Cancer Therapy-Breast (FACT-B) and the EQ-5D-5L pen and paper questionnaires. EQ-5D-5L index scores were derived by using available country-specific health state value sets, where available, and numerically compared with general population scores derived from published normative and population data. Descriptive summary statistics were reported for FACT-B, Functional Assessment of Cancer Therapy-General (FACT-G) (total and specific subscales), the EQ-5D index scores, and the EQ-VAS scores for each country. Results were stratified according to disease-free treatment status (active adjuvant treatment or postadjuvant surveillance), age (25-44, 45-54, 55-64, or ≥65 years), stage (I, II, or III), and menopausal status at the time of questionnaire completion (pre-/peri-menopausal or postmenopausal). FINDINGS: Overall, 1110 patients completed the HRQOL questionnaires (mean age, 59 years; 79% active adjuvant treatment, and 21% under surveillance postadjuvant treatment at time of questionnaire administration; 31% stage I, 48% stage II, and 20% stage III at diagnosis). Of these, 1102 completed the FACT-B and 1083 completed the EQ-5D-5L questionnaires. The mean (SD) FACT-B total score was 99.0 (21.9). The mean FACT-G total score was 72.5 (17.8), which was comparable to the published normative score. The mean EQ-5D index and EQ-VAS scores for each country were similar to corresponding population means; EQ-5D index scores ranged from 0.842 (0.098) in Japan to 0.916 (0.109) in France, and EQ-VAS scores from 68.0 (18.4) in Germany to 78.6 (16.4) in the United States. In addition, mean scores were comparable between the active adjuvant treatment and postadjuvant surveillance groups for the FACT-B total (99.4 [22.5] and 97.7 [19.7], respectively), FACT-G total (72.8 [18.3] and 71.3 [16.0]), EQ-5D index score (0.868 [0.135] and 0.869 [0.142]), and EQ-VAS (74.9 [17.2] and 74.4 [16.1]). IMPLICATIONS: Patient-reported HRQOL among patients with HR+/HER2- early breast cancer who were disease-free was high, with reported scores comparable to normative scores. These results improve our understanding of HRQOL among patients with early disease and may facilitate future studies examining the potential impact of adjuvant treatment and disease recurrence, including metastasis.

Medical record review of transition to lanreotide following octreotide for neuroendocrine tumors.

BACKGROUND: Octreotide has been used for decades in the United States (US) and Europe to treat patients with advanced neuroendocrine tumors (NETs). Lanreotide was approved in 2014 to improve progression-free survival (PFS) in patients with unresectable, well- or moderately-differentiated, locally advanced or metastatic gastroenteropancreatic NETs. Therefore, clinicians and patients may consider sequencing therapy from octreotide to lanreotide. However, current real-world outcomes data on patients who have made this transition is limited. METHODS: We conducted a multicenter, noninterventional, retrospective medical record review of patients with locally advanced or metastatic gastroenteropancreatic NETs (NCT03112694). Included patients had been treated with long-acting octreotide monotherapy for ≥90 days before transitioning to lanreotide monotherapy and continued on lanreotide for ≥90 days. Abstractors entered patient demographic and clinical data into a customized, web-based case report form. We assessed clinically defined PFS and other tumor-related outcomes while patients were treated with lanreotide. Outcomes were analyzed according to level of response at the time of transition from octreotide to lanreotide: progressive disease, nonprogressive disease, or unknown. Statistical analyses were descriptive. Clinically defined PFS and duration of treatment with lanreotide were estimated using the Kaplan-Meier method. RESULTS: Data were abstracted for 91 patients with gastroenteropancreatic NETs who received long-acting octreotide followed by lanreotide at six US based sites. At initial diagnosis, 71.4% of patients had stage IV disease. Small intestine (63.7%) and pancreas (14.3%) were the most common primary tumor sites. Mean [standard deviation (SD)] duration of follow-up from diagnosis was 70.6 (41.3) months. Patients received long-acting octreotide for a mean (SD) of 38.4 (32.8) months. When patients transitioned to lanreotide, 57.1% had nonprogressive disease on octreotide, 30.8% had progressive disease, and the remainder had unknown disease status. The most common reasons for switching from octreotide to lanreotide were progressive disease (22.0%), formulary change (15.4%), and patient preference (9.9%). Patients received lanreotide for a median (95% CI) duration of 24.7 (16.7-59.9) months. At the end of follow-up, 74% of patients remained on lanreotide monotherapy. Progression occurred in 24.2% of patients during lanreotide treatment. Overall median (95% CI) clinician-defined PFS following the transition to lanreotide was estimated to be 23.7 months [20.2 months-NE (not estimable)]. Patients with nonprogressive disease when they transitioned to lanreotide experienced a median clinician-defined PFS of 24.7 (17.0-NE) months. Among patients reported to have progressive disease when they transitioned to lanreotide, median (95% CI) clinician-defined PFS was estimated to be 15.2 (11.4-NE) months. There were no material differences in adverse events recorded during the long-acting octreotide and lanreotide treatment periods. CONCLUSIONS: Our study suggests that lanreotide monotherapy is well tolerated and may contribute to stabilization of disease in a subset of patients with locally advanced or metastatic gastroenteropancreatic NETs previously treated with long-acting octreotide.

Treatment Patterns and Health Outcomes in Platinum-Refractory or Platinum-Resistant Ovarian Cancer: A Retrospective Medical Record Review.

OBJECTIVE: The objective of this article is to describe real-world treatment patterns and outcomes in patients with platinum-refractory/resistant epithelial ovarian, fallopian tube, or primary peritoneal cancer (PRROC) in the United States, United Kingdom, and Canada. METHODS/MATERIALS: Physicians retrospectively reviewed medical records of women aged 18 years or older who were diagnosed with PRROC between January 2010 and June 2014. Patient characteristics, initial PRROC therapy, and health care utilization were assessed; progression-free survival (PFS) and overall survival were estimated using Kaplan-Meier and Cox proportional hazards methods. RESULTS: Data were obtained on 392 US, 296 UK, and 82 Canadian patients. At initial ovarian cancer diagnosis, 65.8% (United States), 93.3% (United Kingdom), and 82.9% (Canada) of patients had stage III/IV disease; 43.6%, 73.7%, and 56.1%, respectively, had high-grade tumors. At PRROC diagnosis, mean age was 57.2 years (United States), 59.2 years (United Kingdom), and 57.4 years (Canada). Eastern Cooperative Oncology Group performance status was 0/1 at PRROC diagnosis for 57.7% (United States), 80.1% (United Kingdom), and 36.6% (Canada) of patients. Most patients initiated systemic treatment after PRROC diagnosis (United States, 71.4%; United Kingdom, 83.1%; Canada, 81.7%). The most common initial PRROC therapy was pegylated liposomal doxorubicin monotherapy (United States, 18.6%; United Kingdom, 50.0%; Canada, 34.3%). During initial PRROC treatment, 80.7%, 59.8%, and 44.8% of patients had 1 office visit or more and 17.5%, 10.2%, and 14.9% of patients had 1 hospitalization or more in the United States, the United Kingdom, and Canada, respectively. Treatment toxicity was the most common reason for hospitalization (United States, 75.5%; United Kingdom, 64.0%; Canada, 80.0%). Median (95% confidence interval) PFS was 5.6 (4.9-6.2), 8.0 (6.8-9.2), and 6.4 (5.4-9.3) months in the United States, the United Kingdom, and Canada. The Cox proportional hazards model showed that stage III/IV, high-grade tumors, and poorer performance status were associated with shorter survival. CONCLUSIONS: Current treatments for PRROC yield limited PFS and frequent hospitalizations reported to be related to toxicities or procedural complications, suggesting a continued unmet need for more effective and tolerable therapeutic strategies for PRROC.

Treatment Patterns and Outcomes of Patients With Metastatic ER+/HER-2- Breast Cancer: A Multicountry Retrospective Medical Record Review.

PURPOSE: To describe treatment patterns and clinical outcomes among postmenopausal women with metastatic ER+/HER-2- breast cancer treated with ≥ 2 lines of endocrine therapy or chemotherapy in the metastatic setting. PATIENTS AND METHODS: Retrospective medical record review was conducted in Canada, the United Kingdom, Belgium, the Netherlands, Germany, Spain, and France. Baseline characteristics were assessed at the date of metastatic diagnosis. Time to progression (TTP) and overall survival (OS) were estimated by Kaplan-Meier analyses. Multivariable models were used to evaluate factors associated with disease progression. RESULTS: Among 901 patients, the mean (standard deviation) age at metastatic diagnosis was 62.7 (9.7) years; 67.26% were initially diagnosed with metastatic disease, 66.37% had visceral disease, and 25.86% had bone metastasis only. Two-thirds of patients received endocrine therapy for first-line treatment. Fifty-nine percent received endocrine therapy, and 37.18% received chemotherapy for second-line treatment. The most common reason for stopping treatment was disease progression. Median (95% confidence interval [CI]) TTP on first-line endocrine treatment was 11.3 (10.7-12.2) months and 7.0 (6.3-7.9) months on chemotherapy. Median (95% CI) TTP on second-line endocrine therapy was 8.1 (7.5-9.1) months and 6.1 (5.4-6.8) months on chemotherapy. Median (95% CI) OS was 68.6 (52.2-83.7) months after first-line endocrine therapy and 39.7 (34.5-48.7) months after chemotherapy. CONCLUSION: Patients prescribed endocrine therapy had longer TTP and OS than patients prescribed chemotherapy in the first- and second-line settings. Disease progression was less than a year regardless of treatment type and line of therapy, indicating a need for treatments that delay progression without affecting quality of life among these patients.

A Ten-Year Case-Control Study of Passive Smoke Exposure as a Risk Factor for Pertussis in Children.

The authors conducted a matched case-control study of laboratory-confirmed pertussis cases, occurring from 1/1/1996 to 12/31/2005, in children up to 12 years of age who were members of a large managed care organization. Sixty-five laboratoryconfirmed cases of pertussis were identified. Using multivariable conditional logistic regression analysis, the authors did not detect a statistically significant association between pertussis and household passive exposure to cigarette smoking.

Uptake, coverage, and completion of quadrivalent human papillomavirus vaccine in the vaccine safety Datalink, July 2006-June 2011.

PURPOSE: The Advisory Committee on Immunization Practices recommended quadrivalent human papillomavirus vaccine (HPV4) for use in females in June 2006 and in males in October 2009. The objective of our study was to describe HPV4 uptake, single-dose coverage, and completion of the three-dose series among those 9-26 years of age, after the respective female and male vaccine licensures through June 2011. METHODS: The study population included members of eight managed care organizations participating in the Vaccine Safety Datalink; we abstracted demographic and comprehensive vaccine information from electronic health records. RESULTS: We found one-dose coverage increasing throughout the study period, to a high of 37.7% among females and 1.3% among males in June 2011. Among those receiving at least one HPV4 dose, three-dose series completion was 42% for females and 30.2% for males. CONCLUSIONS: Our results demonstrate low initiation and completion of the HPV4 series among those recommended to receive the vaccine. Although consistent with previous studies, these results highlight the continued need to develop, implement, and monitor strategies to increase HPV4 vaccine initiation and completion in younger adolescents to achieve maximum impact in reducing the burden of cervical cancer and other HPV-related diseases.

Completion and timing of the three-dose human papillomavirus vaccine series among adolescents attending school-based health centers in Oregon.

OBJECTIVE: Many adolescents do not complete the 3-dose human papillomavirus vaccine series in the recommended time frame, or at all. Given the challenges of administering a multi-dose vaccine to adolescents, especially those in vulnerable populations, we evaluated completion of the human papillomavirus vaccine series in 19 of Oregon's school-based health centers. METHODS: Among persons aged 0-17 who initiated the human papillomavirus vaccine series at a study school-based health center in 2007, we identified all subsequent human papillomavirus doses administered at the school-based health centers, or found in Oregon's immunization information system, in 2007-2008. We describe the proportion completing the vaccine series and mean intervals between doses, stratified by age, race, and insurance status. RESULTS: Four hundred fifty persons initiated the human papillomavirus series in 2007. By December 2008, 51% of these had received all 3 doses. Series completion increased significantly with age, differed significantly between race groups (highest among white persons (56%); lowest among black persons (38%)), and did not differ significantly by insurance status. Mean intervals between doses did not differ significantly by race or insurance status. CONCLUSIONS: Even in challenging conditions, school-based health centers provide excellent preventive care to vulnerable youth. These results support the importance of maintaining and expanding school-based health center access in vulnerable adolescent populations.