Hypothesis
To explore whether the progression-free survival (PFS) with pemetrexed differs between anaplastic lymphoma kinase (ALK)-positive and other major molecular subtypes of non-small cell lung cancer.
Methods
In an ALK-enriched population, patients with metastatic non-small cell lung cancer were screened by ALK fluorescence in situ hybridization and for epidermal growth factor receptor (EGFR) and KRAS mutations. Triple-tested, pemetrexed-treated patients (monotherapy or combination therapy) were identified and PFS with pemetrexed captured retrospectively.
Results
Eighty-nine eligible cases were identified (19 ALK fluorescence in situ hybridization positive, 12 EGFR mutant, 21 KRAS mutant, and 37 triple negatives). Eighty-three cases (93%) were adenocarcinomas, two were adenosquamous, one squamous, and three had large cell histology. None of the ALK-positive patients had received crizotinib before pemetrexed. Pemetrexed was first-line therapy in 48% (72% as platinum-based combinations). Median PFS (95% confidence interval) data were EGFR mutant (5.5 months; 1–9), KRAS mutant (7 months; 1.5–10), ALK positive (9 months; 3–12), and triple negative (4 months; 3–5). In a multivariate analysis adjusting for line of therapy, mono- versus platinum and nonplatinum combination therapy, age, sex, histology, and smoking status, the only variable associated with prolonged PFS on pemetrexed was ALK+ (hazard ratio = 0.36 [95% confidence interval: 0.17– 0.73], p = 0.0051).
Conclusions
In this exploratory analysis, ALK-positive patients have a significantly longer PFS on pemetrexed compared with triple-negative patients, whereas EGFR or KRAS mutant patients do not. This information should be considered when sizing randomized studies in ALK-positive patients that involve pemetrexed. Pemetrexed should also be prioritized as a cytotoxic to explore further in patients with known ALK-positive disease.
Objective
To develop a feasibility study of a theory-driven telephone counseling program to enhance psychosocial and physical well-being for cancer survivors after treatment.
Methods
Participants (n = 66) were recruited from two Colorado hospitals with self-administered questionnaires at baseline and two weeks post-intervention. The one group, intervention only design included up to six thematic telephone counseling sessions over three months. Topics included nutrition, physical activity, stress management, and medical follow-up. Primary outcomes were cancer-specific distress, self-reported fruit and vegetable consumption and physical activity.
Results
Of 66 subjects, 46 completed at least one counseling module and the follow-up assessment (70% retention rate). Mean satisfaction was 9 out of 10, and all participants would recommend C-STEPS to other survivors. Cancer-specific distress (Impact of Event Scale – Intrusion subscale) decreased for entire study population (p < 0.001) and stress management session participants (p < 0.001). Fruit and vegetable consumption increased for nutrition and exercise session participants (p = 0.02) and the entire sample (p = NS). Physical activity increased in the entire group (p = 0.006) and for nutrition and exercise session participants (p = 0.01).
Conclusion and practice implications
C-STEPS is a feasible telephone counseling program that transcends geographic barriers, demonstrating the potential to decrease distress and promote coping and healthy lifestyles among cancer survivors.
Objective: Over one third of patients with cancer experience elevated psychosocial distress. As screening for distress becomes more common, the number of patients referred for psychosocial care will increase. Psychosocial telephone interventions are recommended as a convenient and exportable alternative to inperson interventions addressing psychosocial distress. This study reviews the efficacy of randomized controlled trials (RCTs) of psychosocial telephone interventions for patients with cancer.Methods: We conducted a systematic review of peer-reviewed RCTs evaluating telephone interventions in adult patients with cancer across the survivorship continuum.Results: Through a database search, 480 articles were identified. After manual review, 13 were included, with 7 additional studies identified by back citation, totaling 20 studies. Participants were largely Caucasian, highly educated, with mean age ranging from 49 to 75 years. Most participants were patients with breast cancer (n = 13 studies). Sample sizes were generally small, with most patients recruited from large medical centers. Only one screened for psychosocial need. Interventions varied greatly in length and intensity. Eight studies reported significant effects post-intervention in the hypothesized direction on at least one psychosocial outcome measure. Of these eight studies, four included more than one follow-up assessment; of these, only one reported significant effects at last follow-up. No clear commonalities were found among studies reporting significant effects.Conclusions: Methodological concerns and lack of consistency in adherence to CONSORT reporting guidelines were identified. This body of research would benefit from well-designed, theory-based RCTs adequately powered to provide more definitive evidence for intervention efficacy. This will probably require multi-institutional collaborations, guided by intervention and research methodology best practices.
We present and describe tailored strategies to address known barriers to minority participation in clinical trial research. The strategies used allowed our team to engage communities and successfully recruit, enroll, and retain a diverse underserved population of Latinos with advanced cancer for this clinical trial. Participants were recruited from 3 urban and 7 rural sites. We identified 4 critical barriers to recruitment for this underserved population: (1) mistrust; (2) language and communication barriers; (3) lack of access to academic cancer center; and (4) inability to participate due to transportation, childcare, or work responsibilities. We developed tailored strategies to engage referring sites and patients to participate in the clinical trial. We identified 318 potentially eligible participants; 34 were found to be ineligible, and 223 consented to participate in the study, representing a 79.0% enrollment rate. All patients (100%) self-identified as Latino, and 47.5% spoke Spanish as their primary language. Patients were socioeconomically disadvantaged: 53.6% had an annual income <$15,000 USD, and 50.2% had less than a high school education. A total of 177 participants completed the 3-month follow-up; 26 died before the 3-month follow interview, and 20 did not complete the follow-up evaluation (9% withdrawal rate). Our community-informed strategies were highly effective for recruiting, enrolling, and retaining an underserved diverse population of Latinos. The barriers we identified and the strategies we used have the potential to inform research to increase minority participation in cancer clinical trials. ClinicalTrials.gov identifier: NCT01695382.
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