Treatment Patterns and Clinical Outcomes Among Patients with Metastatic Non-small Cell Lung Cancer Without Actionable Genomic Alterations Previously Treated with Platinum-Based Chemotherapy and Immunotherapy.

BACKGROUND: For patients with metastatic non-small cell lung cancer, timely molecular testing is essential to determine the appropriate course of therapy. Initial treatment with platinum chemotherapy and/or an immune checkpoint inhibitor (ICI) is the standard of care for patients without actionable genomic alterations. OBJECTIVE: We aimed to assess treatment patterns and clinical outcomes among patients with metastatic non-small cell lung cancer, no actionable genomic alterations, and with prior ICI and platinum-based chemotherapy in a community oncology setting. METHODS: This retrospective observational study examined electronic health records from adult patients with an initial metastatic non-small cell lung cancer diagnosis without actionable genomic alterations from 2017 to 2019. Patients had received a subsequent line of therapy (LOT) [index] after discontinuing platinum-based chemotherapy plus an ICI in the previous one or two LOTs. Patient demographics and clinical characteristics were analyzed descriptively. Clinical outcomes were evaluated using Kaplan-Meier analyses. RESULTS: Among the study population (n = 961), the most common index LOT regimens were non-platinum-based chemotherapies (57.3%), platinum-based chemotherapies (12.9%), ICI-based chemotherapies (12.7%), platinum + ICI-based chemotherapies (9.4%), and other (7.7%). The most common post-index LOT regimens were non-platinum based (61.2%), ICI based (15.3%), platinum based (10.7%), platinum + ICI based (3.2%), and other (2.5%). Median time to treatment discontinuation, time to next treatment, and overall survival were numerically longest with index LOT ICI-based regimens (6.5, 9.9, and 18.9 months, respectively) and shortest with platinum-based regimens (2.8, 5.3, and 8.0 months, respectively) and non-platinum-based regimens (2.6, 5.0, and 7.8 months, respectively). CONCLUSIONS: Among patients with metastatic non-small cell lung cancer without actionable genomic alterations previously treated with platinum + ICIs, non-platinum chemotherapy agents were most commonly prescribed in the index LOT. Clinical outcomes including time to treatment discontinuation, time to next treatment, and overall survival were short, highlighting the unmet need for more effective later-line treatments.

Characteristics, healthcare utilization, and outcomes of patients with HER2-low breast cancer.

PURPOSE: Treatment for HER2-low [defined as ImmunoHistoChemistry (IHC) 1 + or 2 + and negative/normal in Situ Hybridization (ISH)] breast cancer patients is rapidly evolving, yet we lack critical information about the HER2-low population. METHODS: We conducted a retrospective cohort study of women aged 18 years or older diagnosed with breast cancer between 2010 and 2016 in North Carolina. Analyses were conducted for the overall cohort and a stage IV sub-cohort. We examined demographic and clinical characteristics, and characterized prevalence of HER2-low disease and healthcare utilization. We estimated adjusted rate ratios for the association between HER2 classifications and utilization outcomes, and hazard ratios for 3-year all cause mortality (stage IV only). RESULTS: The overall and stage IV cohorts included 12,965 and 635 patients, respectively. HER2-low patients represented more than half of both cohorts (59% overall, 53% stage IV). HER2-low patients were more likely than IHC 0 patients to have hormone receptor (HR)-positive disease. In the stage IV cohort, HER2-low patients were more likely to be Black (26% vs. 16% IHC 0, p = 0.0159). In both cohorts, rates of hospitalizations were slightly higher among HER2-low patients. There were no survival differences between HER2-low and IHC 0 among stage IV patients. CONCLUSION: New treatment options for HER2-low breast cancer may have potential for significant impact at the population level particularly for patients with stage IV disease. In light of racial differences between HER2-low and IHC 0 patients observed in our cohort, research- and practice-based efforts to ensure equitable adoption of new treatment guidelines for patients with HER2-low metastatic breast cancer will be essential.

Validation of the revised Patient Perception of Migraine Questionnaire: measuring satisfaction with acute migraine treatment.

OBJECTIVE: To evaluate the psychometric properties of the revised Patient Perception of Migraine Questionnaire (PPMQ-R), which measures satisfaction with migraine treatment. BACKGROUND: The original version of the PPMQ was developed prior to the introduction of newer migraine treatments, which may have attributes that influence treatment satisfaction. METHODS: Literature review, patient focus groups, and one-on-one patient interviews guided revisions to the original PPMQ. The revised questionnaire was tested in 200 migraine patients visiting neurologists and primary care clinics. At baseline, all subjects completed the PPMQ-R, a migraine-specific quality-of-life measure, and a migraine experience questionnaire; and 125 subjects completed assessments 24 hours after each migraine attack and within 30 days post-baseline. Factor analysis was performed to inform the development of a scoring algorithm, and reliability, validity, and responsiveness of the PPMQ-R were evaluated. RESULTS: Factor analyses confirmed that the revised questionnaire has five domains measuring satisfaction with efficacy, functionality, ease of use, medication cost, and bothersomeness of medication side effects. A total score can be created by taking the average of efficacy, functionality, and ease of use scores. The PPMQ-R scale scores and Total score demonstrated internal consistency reliability (Cronbach's alpha: 0.80 to 0.98) and test-retest reliability (intra-class correlation coefficient: 0.79 to 0.91). Except for the Cost domain, the PPMQ-R scores discriminated among migraine pain severity levels (all P < .05) and levels of impairment in ability to work and perform usual activities (all P < .05). Except for the Ease of Use and Cost domains, mean PPMQ-R scores were significantly higher among patients with no change in treatment and whose pain improved between two consecutive migraine attacks (all P < .01). CONCLUSION: The PPMQ-R is a reliable and valid measure of patient satisfaction with acute migraine treatment in women with frequent migraine attacks.

The Short-Form Headache Impact Test (HIT-6) was psychometrically equivalent in nine languages.

BACKGROUND AND OBJECTIVE: This study examined the psychometric properties and equivalence of the six-item Headache Impact Test (HIT-6) across 11 languages in 14 countries. METHODS: A multicenter, international cross-sectional study conducted in a primary care setting. Data obtained from 1,171 adults from 14 countries who consulted their primary care physician for headache completed the HIT-6 questionnaire and a headache survey were included in this analysis. Item-level statistics (e.g., range of response choices used by participants), item-scale statistics (e.g., item-total correlations), scale level statistics (e.g., internal consistency reliability), and tests of differential item functioning were conducted to examine the psychometric properties of all HIT-6 translations and their comparability across translations. RESULTS: Across languages, missing data were low, item-scale correlations were high, reliability was adequate, and item-level statistics were generally comparable. We found only minor differential item functioning, suggesting that the HIT-6 translations are equivalent to the U.S. English form. CONCLUSIONS: Psychometric analyses indicate that most HIT-6 translations (Canadian English, French, Greek, Hungarian, UK English, Hebrew, Portuguese, German, Spanish, and Dutch) are comparable to U.S. English. Improvements may be needed in the Finnish and Slovakian translations and the appropriateness of using the HIT-6 in South Africa should be explored further.

Pain-free results with sumatriptan taken at the first sign of migraine pain: 2 randomized, double-blind, placebo-controlled studies.

OBJECTIVE: To evaluate the efficacy and tolerability of sumatriptan, 50-mg and 100-mg tablets, compared with placebo for treatment of migraine at the first sign of pain. PATIENTS AND METHODS: Two identical multicenter randomized, double-blind, placebo-controlled, single-attack studies were conducted from May through November 2000 in adults (aged 18-65 years). Patients treated migraine at the first sign of pain, while pain was mild, but not more than 2 hours after onset with oral sumatriptan, 50 mg or 100 mg, or matching placebo. The primary end point was pain-free relief at 2 hours after treatment with 50 mg of sumatriptan compared with placebo. RESULTS: There were 354 patients in study 1 and 337 patients in study 2. Significantly more patients treated with sumatriptan, 50 mg and 100 mg, were completely free from pain 2 and 4 hours after treatment vs patients treated with placebo (at 2 hours, 50% and 57% vs 29%; at 4 hours, 61% and 68% vs 30%; for both, P < .001). Also, significantly more patients treated with sumatriptan, 50 mg and 100 mg, were migraine-free (no pain or associated symptoms) vs those treated with placebo at 2 and 4 hours after treatment (at 2 hours, 43% and 49% vs 24%; at 4 hours, 54% and 63% vs 28%; for both, P < .001). The incidence of overall adverse events was low with the 50- and 100-mg dose of sumatriptan (placebo, 7%; sumatriptan at 50 mg, 14%; sumatriptan at 100 mg, 16%). CONCLUSIONS: Treatment of migraine at the first sign of pain with sumatriptan, 50-mg and 100-mg tablets, provides superior pain-free relief at 2 and 4 hours after treatment compared with placebo. Results of these studies suggest that sumatriptan at 100 mg may be more efficacious than at 50 mg when used in the early treatment paradigm. Because these studies were not powered to detect statistical differences between active doses, studies to investigate this finding are warranted.