Jennifer Garst

Overview:

1. Non-small cell and small cell lung cancer - intervention, epidemiology and treatment.
2. Clinical trials of combined modality therapy, cancer drug development, and new treatment approaches and supportive care for lung cancer.
3. Lung cancer as a women's health issue.
4. Supportive care for lung cancer patients including management of taste alteration, weight loss and declining performance status.
5. Clinical research in the Duke Oncology Outreach (DOORS) & DOC affiliate setting.
6. Standardization of management for common oncologic problems.

Clinical Research:

1. Principal Investigator:
TOP 96-02, "A Phase I/II Dose Escalation Study of Concurrent Navelbine and Radiation Inoperable Stage III"
TOP 96-03, "A Phase I/II Study of Weekly Docetaxel and Vinorelbine in Advanced and Relapsed Non-Small Cell Lung Carcinoma"
TOP 97-01, "A Phase I/II Study: Sequential Topotecan and Carboplatin/VP-16 for the Treatment of Small Cell Lung Cancer"
TOP 98-01, "A Phase I/II Study: Weekly CPT-11 with Vinorelbine in Advanced Non-Small Cell Lung Carcinoma"
TOP 98-02, "A Phase I/II Trial of Concurrent Carboplatin and Vinorelbine Chemotherapy with Radiation Followed by Surgery in Patients with Non-Small Cell Lung Carcinoma"
TOP 99-01, "A Feasibility Trial of Filgrastim-SD/01 to Support Carboplatin/ Navelbine (SD/01-CaN) Chemotherapy for the Treatment of Thoracic Malignancies"
TOP 00-03, "Phase II Trial of Gemcitabine and Oxaliplatin in the Treatment of Non-Small Cell Lung Cancer (NSCLC)"
TOP 00-01, "A Pilot Study of the Relative Velocity of Serum Tumor Marker CYFRA 21-1 as an Indicator of Early Chemotherapeutic Response in Advanced Non-Small Cell Lung Cancer"
"Evaluation of Oral Antiemetic Regimens for Moderately-High to Highly Emetogenic Chemotherapy: Pilot Study of Oral Ondansetron in Acute Chemotherapy Inducted Emesis (CIE) and a Randomized Double Blind Comparison of Ondansetron versus Dexamethasone versus Procholorperazine in Delayed CIE"
2. Co-Principal Investigator:
"A Phase I/II Study of Active Immunotherapy with Dexosomes Loaded with
Mage3.A2 and Mage4.A2 Peptides in HLA A2+ Patients with Metastatic
Non-Small Cell Lung Cancer Expressing Mage3 or Mage4 (AP Cells,
Inc.)"
3D 97-01, "A Phase I Dose Escalation Research Study of Radiotherapy Using Three-Dimensional Treatment Planning Following Neoadjuvant Chemotherapy for Stage IIB/III Non-Small Cell Lung Cancer"
"Phase IV Pharmacokinetic Study in Chemonaive Patients with Stage IIIB or IV
Non-Small Cell Lung Cancer (NSCLC) Receiving Gemcitabine and
Cisplatin (Eli Lilly B9E-MC-JHQK)"
3. Initiation, organization and development of the Multidisciplinary Thoracic Oncology clinic
with clinical research at DVAMC, 1996
4. Development of four oncology clinical pathways at Duke University Medical Center, 1997
5. Implementation of 3 clinical research trials at DOORS Asheboro site, Randolph Hospital,
1997

Positions:

Professor of Medicine

Medicine, Medical Oncology
School of Medicine

Member of the Duke Cancer Institute

Duke Cancer Institute
School of Medicine

Education:

M.D. 1990

Medical College of Georgia

Intern, Medicine

University of Texas Southwestern Medical Center, Medical School

Resident, Medicine

University of Texas Southwestern Medical Center, Medical School

Fellow, Hematology, Oncology

Duke University School of Medicine

Grants:

Publications:

A Phase 2 Clinical Trial of Combination Nivolumab, Ipilimumab, and Paclitaxel in Patients With Untreated Metastatic NSCLC: The OPTIMAL Trial.

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.
MLA Citation
Clarke, Jeffrey M., et al. “A Phase 2 Clinical Trial of Combination Nivolumab, Ipilimumab, and Paclitaxel in Patients With Untreated Metastatic NSCLC: The OPTIMAL Trial.Jto Clin Res Rep, vol. 3, no. 6, June 2022, p. 100337. Pubmed, doi:10.1016/j.jtocrr.2022.100337.
URI
https://scholars.duke.edu/individual/pub1524906
PMID
35719867
Source
pubmed
Published In
Jto Clinical and Research Reports
Volume
3
Published Date
Start Page
100337
DOI
10.1016/j.jtocrr.2022.100337

Safety and effectiveness of bevacizumab-containing treatment for non-small-cell lung cancer: final results of the ARIES observational cohort study.

INTRODUCTION: Bevacizumab, a recombinant humanized monoclonal antibody against vascular endothelial growth factor, was approved by the US Food and Drug Administration for the treatment of advanced non-small-cell lung cancer (NSCLC) in combination with carboplatin and paclitaxel. ARIES (Avastin Regimens: Investigation of Effectiveness and Safety), a prospective observational cohort study, evaluated outcomes in a large, community-based population of patients with first-line NSCLC. METHODS: From 2006 to 2009, ARIES enrolled patients with locally advanced or metastatic NSCLC who were eligible for bevacizumab, excluding those with predominantly squamous histology. Patients were required to provide informed consent and to have initiated bevacizumab with chemotherapy within 4 months before enrollment. There were no protocol-defined treatments or assessments. The dosing of bevacizumab and chemotherapy, and the choice of chemotherapy regimen, was at the discretion of the treating physician. RESULTS: ARIES enrolled 1967 patients with first-line NSCLC. At study closure, median follow-up was 12.5 months (range, 0.2-65.5). Median age was 65 years (range, 31-93), and 252 patients (12.8%) identified as never smokers. Median progression-free survival was 6.6 months (95% confidence interval, 6.3-6.9), and median overall survival was 13.0 months (95% confidence interval, 12.2-13.8) with first-line bevacizumab plus chemotherapy. Incidences of bevacizumab-associated adverse events (19.7% overall) were consistent with those in randomized controlled trials of bevacizumab in NSCLC. CONCLUSION: Results from ARIES demonstrate similar outcomes to randomized controlled trials of bevacizumab when added to standard chemotherapy in a real-world patient population with advanced NSCLC.
Authors
Lynch, TJ; Spigel, DR; Brahmer, J; Fischbach, N; Garst, J; Jahanzeb, M; Kumar, P; Vidaver, RM; Wozniak, AJ; Fish, S; Flick, ED; Leon, L; Hazard, SJ; Kosty, MP; ARIES Study Investigators,
MLA Citation
Lynch, Thomas J., et al. “Safety and effectiveness of bevacizumab-containing treatment for non-small-cell lung cancer: final results of the ARIES observational cohort study.J Thorac Oncol, vol. 9, no. 9, Sept. 2014, pp. 1332–39. Pubmed, doi:10.1097/JTO.0000000000000257.
URI
https://scholars.duke.edu/individual/pub1045616
PMID
25122429
Source
pubmed
Published In
J Thorac Oncol
Volume
9
Published Date
Start Page
1332
End Page
1339
DOI
10.1097/JTO.0000000000000257

The impact of induction chemotherapy and the associated tumor response on subsequent radiation-related changes in lung function and tumor response.

PURPOSE: To assess the impact of induction chemotherapy, and associated tumor shrinkage, on the subsequent radiation-related changes in pulmonary function and tumor response. METHODS AND MATERIALS: As part of a prospective institutional review board-approved study, 91 evaluable patients treated definitively with thoracic radiation therapy (RT) for unresectable lung cancer were analyzed. The rates of RT-associated pulmonary toxicity and tumor response were compared in the patients with and without pre-RT chemotherapy. In the patients receiving induction chemotherapy, the rates of RT-associated pulmonary toxicity and tumor response were compared in the patients with and without a response (modified Response Evaluation Criteria in Solid Tumor criteria) to the pre-RT chemotherapy. Comparisons of the rates of improvements in pulmonary function tests (PFTs) post-RT, dyspnea requiring steroids, and percent declines in PFTs post-RT were compared in patient subgroups using Fisher's exact test, analysis of variance, and linear or logistic regression. RESULTS: The use of pre-RT chemotherapy appears to increase the rate of radiation-induced pneumonitis (p = 0.009-0.07), but has no consistent impact on changes in PFTs. The degree of induction chemotherapy-associated tumor shrinkage is not associated with the rate of subsequent RT-associated pulmonary toxicity. The degree of tumor response to chemotherapy is not related to the degree of tumor response to RT. CONCLUSIONS: Additional study is needed to better clarify the impact of chemotherapy on radiation-associated disfunction.
Authors
Mao, J; Kocak, Z; Zhou, S; Garst, J; Evans, ES; Zhang, J; Larrier, NA; Hollis, DR; Folz, RJ; Marks, LB
MLA Citation
Mao, Jingfang, et al. “The impact of induction chemotherapy and the associated tumor response on subsequent radiation-related changes in lung function and tumor response.Int J Radiat Oncol Biol Phys, vol. 67, no. 5, Apr. 2007, pp. 1360–69. Pubmed, doi:10.1016/j.ijrobp.2006.11.003.
URI
https://scholars.duke.edu/individual/pub782636
PMID
17276621
Source
pubmed
Published In
International Journal of Radiation Oncology, Biology, Physics
Volume
67
Published Date
Start Page
1360
End Page
1369
DOI
10.1016/j.ijrobp.2006.11.003

Routine use of approximately 60 Gy once-daily thoracic irradiation for patients with limited-stage small-cell lung cancer.

PURPOSE: To review the outcome of patients with limited-stage small-cell lung cancer receiving daily thoracic irradiation (RT) to approximately 60 Gy. METHODS AND MATERIALS: The records of patients treated with RT for limited-stage small-cell lung cancer between 1991 and 1999 at Duke University were retrospectively reviewed. Sixty-five patients were identified who had received continuous course once-daily 1.8-2 Gy fractions to approximately 60 Gy (range 58-66). All patients received chemotherapy (CHT); 32 received concurrent RT/CHT and 33 sequential CHT and then RT. Prophylactic cranial RT was administered to 17 patients. The time from diagnosis to local failure, tumor progression, and death was assessed using actuarial methods. The median follow-up for all patients was 16.7 months and for surviving patients was 29.6 months. The median age was 64 years (range 36-83), and the median Karnofsky performance status was 80 (range 50-100). RESULTS: The 3-year actuarial rate of local failure, progression-free survival, and overall survival was 40%, 25%, and 23%, respectively. One case of acute Grade 3 esophagitis developed. Ten late complications occurred: four pulmonary, two esophageal, two infectious, one leukemia, and one retinal toxicity with prophylactic cranial RT. Six were mild and resolved with treatment. CONCLUSION: CHT plus approximately 60 Gy of once-daily RT for limited-stage small-cell lung cancer was generally well tolerated. The survival rates were less than have been reported using 45 Gy in 1.5-Gy twice-daily fractions (2-year overall survival rate 47% compared with 30% in this study), but may be comparable because fewer than one-half our patients received concurrent CHT/RT and only 26% received prophylactic cranial RT. The relatively low rate of normal tissue morbidity in our patients supports the use of conventional once-daily fractionation to > or = 60 Gy. A randomized trial would be required to compare the outcomes after maximally tolerated dose twice-daily RT vs. maximally tolerated dose daily RT.
Authors
Miller, KL; Marks, LB; Sibley, GS; Clough, RW; Garst, JL; Crawford, J; Shafman, TD
MLA Citation
Miller, Keith L., et al. “Routine use of approximately 60 Gy once-daily thoracic irradiation for patients with limited-stage small-cell lung cancer.Int J Radiat Oncol Biol Phys, vol. 56, no. 2, June 2003, pp. 355–59. Pubmed, doi:10.1016/s0360-3016(02)04493-0.
URI
https://scholars.duke.edu/individual/pub766865
PMID
12738309
Source
pubmed
Published In
International Journal of Radiation Oncology, Biology, Physics
Volume
56
Published Date
Start Page
355
End Page
359
DOI
10.1016/s0360-3016(02)04493-0

Assessment of the impact of adjunctive proactive telephone counseling to promote smoking cessation among lung cancer patients' social networks.

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), the cessation rate in the intervention group was higher than in the control group at 2 weeks postintervention (16% vs. 4%, p  =  .046). For older 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.
Authors
Bastian, LA; Fish, LJ; Peterson, BL; Biddle, AK; Garst, J; Lyna, P; Molner, S; Bepler, G; Kelley, M; Keefe, FJ; McBride, CM
MLA Citation
Bastian, Lori A., et al. “Assessment of the impact of adjunctive proactive telephone counseling to promote smoking cessation among lung cancer patients' social networks.Am J Health Promot, vol. 27, no. 3, Jan. 2013, pp. 181–90. Pubmed, doi:10.4278/ajhp.101122-QUAN-387.
URI
https://scholars.duke.edu/individual/pub930135
PMID
23286595
Source
pubmed
Published In
Am J Health Promot
Volume
27
Published Date
Start Page
181
End Page
190
DOI
10.4278/ajhp.101122-QUAN-387