المؤلفون: Jeffrey M. Clarke, MD, Lin Gu, MS, Xiaofei F. Wang, PhD, Thomas E. Stinchcombe, MD, Marvaretta M. Stevenson, MD, Sundhar Ramalingam, MD, Afreen Shariff, MD, Jennifer Garst, MD, Andrew B. Nixon, PhD, Scott J. Antonia, MD, Jeffrey Crawford, MD, Neal E. Ready, MD, PhD

المصدر: JTO Clinical and Research Reports, Vol 3, Iss 6, Pp 100337- (2022)

مصطلحات موضوعية: Non–small cell lung cancer, Immunotherapy, Nivolumab, Ipilimumab, Chemotherapy, Clinical trial, Neoplasms. Tumors. Oncology. Including cancer and carcinogens, RC254-282

الوصف: Introduction: Most patients with advanced NSCLC will experience disease progression and death within 2 years. Novel approaches are needed to improve outcomes. Methods: We conducted an open-label, nonrandomized, phase 2 trial in patients with treatment-naive, advanced NSCLC to assess the safety and efficacy of nivolumab 360 mg every 3 weeks, ipilimumab 1 mg/kg every 6 weeks, and four to six cycles of paclitaxel 80 mg/m2 on days 1 and 8 of every 21-day treatment. The primary end point of the study was median progression-free survival (PFS), with secondary end points of safety, objective response rate, and median overall survival (OS). Results: A total of 46 patients underwent consent and received treatment. The median age was 66 (range: 48–82) years, most had adenocarcinoma (63%), and 50% (23) had programmed death-ligand 1 greater than or equal to 1%. The median follow-up on the study as of October 2021 was 19 months. The primary end point of median PFS was 9.4 months (95% confidence interval [CI]: 5.9–16.6) in all patients regardless of programmed death-ligand 1 expression. The objective response rate for patients in the study was 47.8% (95% CI: 33.4–62.3). The 12-month OS rate was 69.5% (95% CI: 53%–81%), and median OS was not yet reached. Treatment-related grade greater than or equal to 3 adverse events was found in 54.3% of the patients. Conclusions: The toxicity observed was consistent with other reported chemo-immunotherapeutic combinations and was manageable. The primary end point of exceeding median PFS of 9 months was achieved with nivolumab, ipilimumab, and weekly paclitaxel and should be evaluated further in a randomized trial.

وصف الملف: electronic resource

العلاقة: http://www.sciencedirect.com/science/article/pii/S2666364322000613Test; https://doaj.org/toc/2666-3643Test

الوصول الحر: https://doaj.org/article/4e8e10cbb46b4c6b9961babf7e012e44Test

المؤلفون: Frances A. Shepherd, Tal Z. Zaks, Lance Leopold, Kimberly E. Allen, Habib Hassani, Michael Smylie, James R. Rigas, Jennifer Garst, Afshin Dowlati, Nevena Damjanov, Joseph Aisner, George R. Blumenschein, Helen J. Ross

الوصف: Purpose: This randomized phase II study was initially designed to test the activity of two dose schedules of lapatinib (GW572016H), an oral, reversible, dual tyrosine kinase inhibitor of epidermal growth factor receptor (EGFR) and human EGFR-2 (HER2/neu; HER2), in chemotherapy-naive patients with non–small cell lung cancer (NSCLC); it was later amended to target patients with bronchioloalveolar carcinoma or no smoking history.Experimental Design: Patients with good performance status and recurrent or metastatic NSCLC were randomized to lapatinib (orally, 1,500 mg once daily or 500 mg twice daily) until progression or intolerance. Patients could have had a maximum of one prior systemic therapy (chemotherapy or biological therapy) for NSCLC. Safety and activity were assessed every 4 and 8 weeks, respectively. Tumors were analyzed for EGFR and HER2 mutations and/or amplifications.Results: Of 75 patients in the nontargeted population, 1 (1.3%) had partial response and 16 (21%) had stable disease of ≥24 weeks. No complete or partial responses were observed in 56 patients in the targeted population; 14 (25%) had stable disease of ≥24 weeks. No responses were seen in three patients with EGFR mutations and five with EGFR gene amplification. No mutations in HER2 were found. One of two patients with HER2 amplification had a 51% decrease in tumor size; however, this response was unconfirmed. The most common adverse events were grade 1 or 2 diarrhea, rash, fatigue, nausea, and anorexia. Adverse events were similar across dosing regimens.Conclusions: Lapatinib was well tolerated, with no notable difference in toxicity between treatment groups. Lapatinib monotherapy did not induce a significant number of tumor regressions in NSCLC. Further studies may be warranted to determine whether lapatinib is active in combination with other agents in the treatment of NSCLC. Clin Cancer Res; 16(6); 1938–49

الوصول الحر: https://explore.openaire.eu/search/publication?articleId=doi_dedup___::b46e80103841eec566f7a61b9767a06eTest
https://doi.org/10.1158/1078-0432.c.6517636.v1Test

المؤلفون: Frances A. Shepherd, Tal Z. Zaks, Lance Leopold, Kimberly E. Allen, Habib Hassani, Michael Smylie, James R. Rigas, Jennifer Garst, Afshin Dowlati, Nevena Damjanov, Joseph Aisner, George R. Blumenschein, Helen J. Ross

الوصف: Supplementary Data from Randomized Phase II Multicenter Trial of Two Schedules of Lapatinib as First- or Second-Line Monotherapy in Patients with Advanced or Metastatic Non–Small Cell Lung Cancer

الوصول الحر: https://explore.openaire.eu/search/publication?articleId=doi_dedup___::7fd3bdd182ae6ad75ba8f901111516c9Test
https://doi.org/10.1158/1078-0432.22440286.v1Test

المؤلفون: Jeffrey M. Clarke, Jeffrey Crawford, Scott J. Antonia, Xiaofei Wang, Afreen Shariff, Tom Stinchcombe, Jennifer Garst, Sundhar Ramalingam, Neal Ready, Marvaretta Stevenson, Lin Gu

المصدر: Journal of Clinical Oncology. 38:e21683-e21683

مصطلحات موضوعية: Oncology, Cancer Research, medicine.medical_specialty, Taxane, business.industry, non-small cell lung cancer (NSCLC), Ipilimumab, medicine.disease, Immune checkpoint, Blockade, Clinical trial, Internal medicine, medicine, In patient, Nivolumab, business, medicine.drug

الوصف: e21683 Background: Combination chemo-immunotherapy is a well-established frontline therapeutic option for treatment naïve NSCLC. Dual immune checkpoint blockade (ICB) with nivolumab (nivo) and ipilimumab (ipi) has demonstrated improved clinical outcomes compared with chemotherapy alone in this setting. Combination dual ICB with low-dose chemotherapy may have advantages of preventing early disease progression and potentiating immunogenic response to treatment. Methods: We are conducting a single arm phase II clinical trial of nivo 360 mg IV Q3 weeks, ipi 1 mg/kg IV Q6 weeks, and weekly paclitaxel 80 mg/m2 IV on d1 and d8 of a 21 day cycle in ECOG 0-1 patients (pts) with treatment naïve NSCLC. Paclitaxel is stopped after a total of 4-6 cycles. The primary endpoint of the trial is progression free survival (PFS) with secondary endpoints of safety and objective response rate (ORR) by independent radiologic review. Interim results are presented from the first 23 evaluable pts, of a planned sample size of 49. Results: 23 pts were enrolled and evaluable with a mean age 63.8 years, 56.5% ECOG 0, 87% current/previous smoking history, and 70% adenocarcinoma. PDL1 score for < 1%, 1-49%, ³ 50% was seen in 9 (39.1%), 4 (17.4%), and 10 (43.5%) pts, respectively. Median time of follow up was 6.5 months (range 1.4–15.0). Partial response was observed in 14 pts, stable disease was seen in 8 pts, and 1 pt progressed during cycle 1, resulting in an ORR of 61%. Grade 3 or higher toxicity at least possibly attributed to study treatment was seen in 47.8% of 23 AE evaluable patients, of which included 4 cases of secondary adrenal insufficiency. Other toxicity rates were as expected for the respective agents. Conclusions: This is the first trial to evaluate weekly paclitaxel with nivo plus ipi in pts with untreated NSCLC. This regimen has demonstrated highly encouraging clinical activity with a manageable toxicity profile. The study is ongoing and updated results will be presented at the annual meeting. Clinical trial information: NCT03573947.

الوصول الحر: https://explore.openaire.eu/search/publication?articleId=doi_________::97fe7966da6adf78144532c7f1c7f1feTest
https://doi.org/10.1200/jco.2020.38.15_suppl.e21683Test

المؤلفون: Pauline Lyna, Francis J. Keefe, Colleen M. McBride, Bercedis L. Peterson, Gerold Bepler, Michael J. Kelley, Lori A. Bastian, Jennifer Garst, Laura J. Fish, Andrea K. Biddle, Stephanie Molner

المصدر: American Journal of Health Promotion. 27:181-190

مصطلحات موضوعية: Counseling, Male, Coping (psychology), medicine.medical_specialty, Lung Neoplasms, Health (social science), medicine.medical_treatment, Motivational interviewing, law.invention, Nicotine, Social support, Telephone counseling, Randomized controlled trial, law, Humans, Medicine, Lung cancer, Motivation, business.industry, Patient Selection, Age Factors, Public Health, Environmental and Occupational Health, Social Support, Middle Aged, medicine.disease, Telephone, Physical therapy, Smoking cessation, Female, Smoking Cessation, business, Program Evaluation, medicine.drug

الوصف: Purpose. When a patient is diagnosed with lung cancer, members of his/her social network may be more likely to engage in smoking cessation efforts. Proactive telephone counseling combined with a tailored self-directed intervention may be more effective at promoting smoking cessation than a tailored self-directed intervention alone. Design. Randomized controlled trial. Setting. Four clinical sites. Subjects. Current smokers who are family members and close friends of patients with lung cancer. Intervention. Six counselor-initiated counseling calls using motivational interviewing techniques and focusing on teaching adaptive coping skills based on the transactional model of stress and coping along with tailored self-directed materials (including nicotine patches, if not contraindicated) (n = 245) vs. tailored self-directed materials (including nicotine patches, if not contraindicated) (n = 251). Measures. Participants were surveyed at baseline and at 2 weeks, 6 months, and 12 months postintervention. The outcome was 7-day point prevalent abstinence. Analysis. The objective of this study was to test for arm differences in smoking cessation rates at 2 weeks and 6 months postintervention (primary) and at 12 months postintervention (secondary). Results. We found no overall effect of the proactive intervention on cessation rates. Among younger participants (age 50), there were no group differences. Conclusion. Proactive telephone counseling focusing on adaptive coping skills was difficult to implement among smokers in lung cancer patients' social network. Although this study did not demonstrate any added benefit to cessation rates, this null finding may be a result of an intervention that was weaker than intended, owing to difficulties in completing the counseling phone calls. We discuss lessons learned and areas for future research in this special population.

الوصول الحر: https://explore.openaire.eu/search/publication?articleId=doi_dedup___::37957bbc052e7de2eb8635c73585021eTest
https://doi.org/10.4278/ajhp.101122-quan-387Test

المؤلفون: Everett E. Vokes, Ramaswamy Govindan, Xiaofei Wang, Timothy Brotherton, Robert A. Kratzke, Jennifer Garst, Lydia Hodgson, Thomas E. Stinchcombe, Jeffrey A. Bogart

المصدر: Journal of Clinical Oncology. 29:3120-3125

مصطلحات موضوعية: Adult, Male, Oncology, Cancer Research, medicine.medical_specialty, Guanine, Lung Neoplasms, Cetuximab, Phases of clinical research, Kaplan-Meier Estimate, Pemetrexed, Antibodies, Monoclonal, Humanized, Carboplatin, chemistry.chemical_compound, Glutamates, Carcinoma, Non-Small-Cell Lung, Internal medicine, Original Reports, Antineoplastic Combined Chemotherapy Protocols, medicine, Humans, Lung cancer, Aged, Neoplasm Staging, Aged, 80 and over, business.industry, Antibodies, Monoclonal, Cancer, Middle Aged, medicine.disease, Combined Modality Therapy, Squamous carcinoma, Regimen, chemistry, Female, business, medicine.drug

الوصف: Purpose Cancer and Leukemia Group B conducted a randomized phase II trial to investigate two novel chemotherapy regimens in combination with concurrent thoracic radiation therapy (TRT). Patients and Methods Patients with unresectable stage III non–small-cell lung cancer (NSCLC) were randomly assigned to carboplatin (area under the curve, 5) and pemetrexed (500 mg/m2) every 21 days for four cycles and TRT (70 Gy; arm A) or the same treatment with cetuximab administered concurrent only with TRT (arm B). Patients in both arms received up to four cycles of pemetrexed as consolidation therapy. The primary end point was the 18-month overall survival (OS) rate; if the 18-month OS rate was ≥ 55%, the regimen(s) would be considered for further study. Results Of the 101 eligible patients enrolled (48 in arm A and 53 in arm B), 60% were male; the median age was 66 years (range, 32 to 81 years); 44% and 35% had adenocarcinoma and squamous carcinoma, respectively; and more patients enrolled onto arm A compared with arm B had a performance status of 0 (58% v 34%, respectively; P = .04). The 18-month OS rate was 58% (95% CI, 46% to 74%) in arm A and 54% (95% CI, 42% to 70%) in arm B. No significant difference in OS between patients with squamous and nonsquamous NSCLC was observed (P = .667). The toxicities observed were consistent with toxicities associated with concurrent chemoradiotherapy. Conclusion The combination of pemetrexed, carboplatin, and TRT met the prespecified criteria for further evaluation. This regimen should be studied further in patients with locally advanced unresectable nonsquamous NSCLC.

الوصول الحر: https://explore.openaire.eu/search/publication?articleId=doi_dedup___::4897304a7c18c27a927927cd18b50734Test
https://doi.org/10.1200/jco.2010.33.4979Test

المؤلفون: Francis J. Keefe, Pauline Lyna, Colleen M. McBride, Gerold Bepler, Lori A. Bastian, Laura J. Fish, Andrea K. Biddle, Michael J. Kelley, Jennifer Garst, Bercedis L. Peterson, Stephanie Molner

المصدر: Contemporary Clinical Trials. 32:498-504

مصطلحات موضوعية: Adult, Male, medicine.medical_specialty, Lung Neoplasms, medicine.medical_treatment, Friends, Article, medicine, Humans, Family, Pharmacology (medical), Lung cancer, Aged, Aged, 80 and over, Social network, business.industry, Patient Selection, Smoking cessation intervention, Social Support, Cancer, General Medicine, Middle Aged, medicine.disease, respiratory tract diseases, Surgery, Clinical trial, Lung disease, Family medicine, Smoking cessation, Female, Smoking Cessation, business

الوصف: This report describes the characteristics associated with successful enrollment of smokers in the social networks (i.e., family and close friends) of patients with lung cancer into a smoking cessation intervention.Lung cancer patients from four clinical sites were asked to complete a survey enumerating their family members and close friends who smoke, and provide permission to contact these potential participants. Family members and close friends identified as smokers were interviewed and offered participation in a smoking cessation intervention. Repeated measures logistic regression model examined characteristics associated with enrollment.A total of 1062 eligible lung cancer patients were identified and 516 patients consented and completed the survey. These patients identified 1325 potentially eligible family and close friends. Of these, 496 consented and enrolled in the smoking cessation program. Network enrollment was highest among patients who were white and had late-stage disease. Social network members enrolled were most likely to be female, a birth family, immediate family, or close friend, and live in close geographic proximity to the patient.Proactive recruitment of smokers in the social networks of lung cancer patients is challenging. In this study, the majority of family members and friends declined to participate. Enlisting immediate female family members and friends, who live close to the patient as agents to proactively recruit other network members into smoking cessation trials could be used to extend reach of cessation interventions to patients' social networks. Moreover, further consideration should be given to the appropriate timing of approaching network smokers to consider cessation.

الوصول الحر: https://explore.openaire.eu/search/publication?articleId=doi_dedup___::83c485c238bc479138c15856ffdaf4f4Test
https://doi.org/10.1016/j.cct.2011.03.006Test

المؤلفون: James R. Rigas, Tal Zaks, Nevena Damjanov, Michael Smylie, Habib Hassani, Frances A. Shepherd, Afshin Dowlati, Lance Leopold, Kimberly E. Allen, Joseph Aisner, Helen J. Ross, Jennifer Garst, George R. Blumenschein

المصدر: Clinical Cancer Research. 16:1938-1949

مصطلحات موضوعية: Adult, Oncology, Cancer Research, medicine.medical_specialty, Pathology, Lung Neoplasms, Receptor, ErbB-2, Population, Phases of clinical research, Salvage therapy, Antineoplastic Agents, Adenocarcinoma, Lapatinib, Carcinoma, Non-Small-Cell Lung, Internal medicine, medicine, Humans, EGFR Gene Amplification, Neoplasm Metastasis, skin and connective tissue diseases, Lung cancer, education, Aged, Aged, 80 and over, Salvage Therapy, education.field_of_study, Performance status, business.industry, Cancer, Adenocarcinoma, Bronchiolo-Alveolar, Middle Aged, medicine.disease, ErbB Receptors, Survival Rate, Treatment Outcome, Drug Resistance, Neoplasm, Carcinoma, Squamous Cell, Quinazolines, Female, Neoplasm Recurrence, Local, business, medicine.drug

الوصف: Purpose: This randomized phase II study was initially designed to test the activity of two dose schedules of lapatinib (GW572016H), an oral, reversible, dual tyrosine kinase inhibitor of epidermal growth factor receptor (EGFR) and human EGFR-2 (HER2/neu; HER2), in chemotherapy-naive patients with non–small cell lung cancer (NSCLC); it was later amended to target patients with bronchioloalveolar carcinoma or no smoking history. Experimental Design: Patients with good performance status and recurrent or metastatic NSCLC were randomized to lapatinib (orally, 1,500 mg once daily or 500 mg twice daily) until progression or intolerance. Patients could have had a maximum of one prior systemic therapy (chemotherapy or biological therapy) for NSCLC. Safety and activity were assessed every 4 and 8 weeks, respectively. Tumors were analyzed for EGFR and HER2 mutations and/or amplifications. Results: Of 75 patients in the nontargeted population, 1 (1.3%) had partial response and 16 (21%) had stable disease of ≥24 weeks. No complete or partial responses were observed in 56 patients in the targeted population; 14 (25%) had stable disease of ≥24 weeks. No responses were seen in three patients with EGFR mutations and five with EGFR gene amplification. No mutations in HER2 were found. One of two patients with HER2 amplification had a 51% decrease in tumor size; however, this response was unconfirmed. The most common adverse events were grade 1 or 2 diarrhea, rash, fatigue, nausea, and anorexia. Adverse events were similar across dosing regimens. Conclusions: Lapatinib was well tolerated, with no notable difference in toxicity between treatment groups. Lapatinib monotherapy did not induce a significant number of tumor regressions in NSCLC. Further studies may be warranted to determine whether lapatinib is active in combination with other agents in the treatment of NSCLC. Clin Cancer Res; 16(6); 1938–49

الوصول الحر: https://explore.openaire.eu/search/publication?articleId=doi_dedup___::e281f6ed0cfb6d1bf9a938eccdb124b6Test
https://doi.org/10.1158/1078-0432.ccr-08-3328Test

المؤلفون: David H. Harpole, Lee W. Jones, Jeffrey Crawford, Jennifer Garst, Pamela S. Douglas, Miranda J. West, Neil D. Eves, William E. Kraus, Stephanie Mabe, Bercedis L. Peterson

المصدر: Cancer. 113:3430-3439

مصطلحات موضوعية: Male, Cancer Research, medicine.medical_specialty, Lung Neoplasms, Pilot Projects, Physical exercise, law.invention, Incremental exercise, Cardiovascular Physiological Phenomena, Oxygen Consumption, Randomized controlled trial, Quality of life, law, Carcinoma, Non-Small-Cell Lung, Internal medicine, medicine, Humans, Aerobic exercise, Lung cancer, Exercise, Aged, business.industry, Cancer, Middle Aged, medicine.disease, Confidence interval, Exercise Therapy, Oncology, Physical Fitness, Quality of Life, Physical therapy, Feasibility Studies, Female, business

الوصف: BACKGROUND. A feasibility study examining the effects of supervised aerobic exercise training on cardiopulmonary and quality of life (QOL) endpoints among postsurgical nonsmall cell lung cancer (NSCLC) patients was conducted. METHODS. Using a single-group design, 20 patients with stage I-IIIB NSCLC performed 3 aerobic cycle ergometry sessions per week at 60% to 100% of peak workload for 14 weeks. Peak oxygen consumption (VO2peak) was assessed using an incremental exercise test. QOL and fatigue were assessed using the Functional Assessment of Cancer Therapy–Lung (FACT-L) scale. RESULTS. Nineteen patients completed the study. Intention-to-treat analysis indicated that VO2peak increased 1.1 mL/kg 21 /min 21 (95% confidence interval [CI], 20.3-2.5; P 5 .109) and peak workload increased 9 W (95% CI, 3-14; P 5 .003), whereas FACT-L increased 10 points (95% CI, 21-22; P 5 .071) and fatigue decreased 7 points (95% CI; 2 1t o217; P 5 .029) from baseline to postintervention. Per protocol analyses indicated greater improvements in cardiopulmonary and QOL endpoints among patients not receiving adjuvant chemotherapy. CONCLUSIONS. This pilot study provided proof of principle that supervised aerobic training is safe and feasible for postsurgical NSCLC patients. Aerobic exercise training is also associated with significant improvements in QOL and select cardiopulmonary endpoints, particularly among patients not receiving chemotherapy. Larger randomized trials are warranted. Cancer 2008;113:3430–9. � 2008 American Cancer Society.

الوصول الحر: https://explore.openaire.eu/search/publication?articleId=doi_dedup___::a7eee8c92292f784e94ee66c2095bb04Test
https://doi.org/10.1002/cncr.23967Test

المؤلفون: Colleen M. McBride, Laura S. Porter, Jennifer Garst, Donald H. Baucom, Francis J. Keefe

المصدر: Pain. 137:306-315

مصطلحات موضوعية: Male, medicine.medical_specialty, Lung Neoplasms, Population, Psychological intervention, Comorbidity, Article, Quality of life, Adaptation, Psychological, medicine, Humans, Lung cancer, education, Fatigue, Depression (differential diagnoses), Aged, Depressive Disorder, education.field_of_study, business.industry, Middle Aged, medicine.disease, Anxiety Disorders, Self Concept, Pain, Intractable, Self Care, Distress, Anesthesiology and Pain Medicine, Caregivers, Neurology, Quality of Life, Physical therapy, Anxiety, Female, Neurology (clinical), Analgesia, medicine.symptom, business, Stress, Psychological

الوصف: This study examined self-efficacy for managing pain, symptoms, and function in patients with lung cancer and their caregivers, and associations between self-efficacy and patient and caregiver adjustment. One hundred and fifty-two patients with early stage lung cancer completed measures of self-efficacy, pain, fatigue, quality of life, depression, and anxiety. Their caregivers completed a measure assessing their self-efficacy for helping the patient manage symptoms and measures of psychological distress and caregiver strain. Analyses indicated that, overall, patients and caregivers were relatively low in self-efficacy for managing pain, symptoms, and function, and that there were significant associations between self-efficacy and adjustment. Patients low in self-efficacy reported significantly higher levels of pain, fatigue, lung cancer symptoms, depression, and anxiety, and significantly worse physical and functional well being, as did patients whose caregivers were low in self-efficacy. When patients and caregivers both had low self-efficacy, patients reported higher levels of anxiety and poorer quality of life than when both were high in self-efficacy. There were also significant associations between patient and caregiver self-efficacy and caregiver adjustment, with lower levels of self-efficacy associated with higher levels of caregiver strain and psychological distress. These preliminary findings raise the possibility that patient and caregiver self-efficacy for managing pain, symptoms, and function may be important factors affecting adjustment, and that interventions targeted at increasing self-efficacy may be useful in this population.

الوصول الحر: https://explore.openaire.eu/search/publication?articleId=doi_dedup___::5b41f69e4a8b67afee7762351773a3f3Test
https://doi.org/10.1016/j.pain.2007.09.010Test