Manisha Palta

Overview:

Clinical research in gastrointestinal malignancies, lymphomas and breast malignancies.

Positions:

Associate Professor of Radiation Oncology

Radiation Oncology
School of Medicine

Member of the Duke Cancer Institute

Duke Cancer Institute
School of Medicine

Education:

M.D. 2007

University of Florida, College of Medicine

Intern, Internal Medicine

University of North Carolina - Chapel Hill

Resident, Radiation Oncology

Duke University School of Medicine

Grants:

PROCEED

Administered By
Radiation Oncology
Awarded By
Merck Sharp & Dohme
Role
Principal Investigator
Start Date
End Date

GTI-4711-201 GRECO-2: A Randomized, Phase 2 Study of Stereotactic Body Radiation Therapy (SBRT) in combination with GC4711

Administered By
Radiation Oncology
Awarded By
Galera Therapeutics, Inc.
Role
Principal Investigator
Start Date
End Date

Publications:

Oligometastases Treated With an Elective Simultaneous Integrated Boost Have Reduced Marginal Recurrence Rates.

<h4>Purpose/objective(s)</h4>Radiation is increasingly used to treat oligometastatic patients (OM). Following metastasis directed radiation therapy, progression in nearby nodal basins or bones is common. We previously reported clinical outcomes of OM treated with an elective simultaneous integrated boost (SIB) technique delivering higher doses to known metastases and reduced doses to adjacent bones/nodal basins. Here we compare outcomes of OM receiving radiation to metastases alone (MA) versus those treated via an SIB. We hypothesized that use of SIB would maintain treated metastasis control (TMC) while reducing MR.<h4>Materials/methods</h4>OM patients with ≤5 active metastases treated with either SIB or MA at our IRB approved sites from 2013-2018 were analyzed for toxicities, pain control, and recurrence patterns. TMC was defined as absence of progression in high dose planning target volume (PTV). Marginal recurrence (MR) was defined as recurrence outside elective PTV, but within the adjacent bone or nodal chain. Distant recurrence (DR) was defined as any recurrence outside of the treatment PTVs not meeting other criteria. Outcome rates were estimated using the Kaplan-Meier method. Patients treated with the two techniques were compared using the log rank test.<h4>Results</h4>101 patients were treated to 90 SIB (58% nodal and 42% osseous) and 46 MA (22% nodal and 78% osseous) sites. The most common primary tumors were prostate (37%), lung (15%), and breast (7%). Median follow up among surviving patients was 24.6 months (range 1.4-71.0). Of the MA treated patients, doses ranged from 18 Gy in 1 fraction (22%) to 50 Gy in 10 fractions (50%). Most patients treated with SIB received 50 Gy to the treated metastases and 30 Gy to the elective PTV in 10 fractions (88%). No patients in either cohort experienced acute grade ≥3 toxicity. Late grade ≥3 toxicity occurred in 3 SIB patients (vocal cord paralysis n = 1, vertebral body compression n = 2) and no MA patients. There was similar crude pain relief between cohorts: 82% with MA (9/11 patients reporting improved pain) and 86% with SIB (19/22). Crude MR were more frequent in the MA group 13% (n = 6) compared to SIB group 2% (n = 2). MR-free survival at 2 years was 87% (95% CI: 70%, 95%) in the MA group and 98% (95% CI: 87%, 99%) in the SIB group (P = 0.07). Crude TMC was 89% (41/46) in the MA group and 94% (85/90) in the SIB group. There were no significant differences found in DR-free survival (P = 0.24) or Disease-free survival (P = 0.4) and Overall survival (P = 0.26) between MA and SIB cohorts.<h4>Conclusion</h4>Both SIB and MA irradiation of OM achieved high rates of TMC and similar pain control, with a trend towards improved MR-free survival for OM treated with SIB. Although more late grade 3 toxicities were seen in the SIB cohort, these were mechanistically related to the high dose PTV and not the elective volume, with differences in treated metastasis location/characteristics. Further investigation of this technique with prospective trials is warranted.
Authors
Shenker, RF; Price, JG; Jacobs, CD; Niedzwiecki, D; Oyekunle, T; Song, H; Palta, M; Czito, B; Kirkpatrick, JP; Mowery, YM; Jr, MJM; Salama, JK
MLA Citation
Shenker, R. F., et al. “Oligometastases Treated With an Elective Simultaneous Integrated Boost Have Reduced Marginal Recurrence Rates.International Journal of Radiation Oncology, Biology, Physics, vol. 111, no. 3S, 2021, p. e480. Epmc, doi:10.1016/j.ijrobp.2021.07.1331.
URI
https://scholars.duke.edu/individual/pub1502890
PMID
34701552
Source
epmc
Published In
International Journal of Radiation Oncology, Biology, Physics
Volume
111
Published Date
Start Page
e480
DOI
10.1016/j.ijrobp.2021.07.1331

Survey of Healthcare Providers Utilization and Perception of Telehealth On-Treatment Visits During COVID-19 Pandemic.

<h4>Purpose/objective(s)</h4>Patients undergoing radiotherapy during the COVID-19 pandemic have experienced unique changes to care, including increased use of telehealth for radiotherapy on-treatment visits (OTVs). The objective of this study was to determine telehealth utilization and provider perceptions towards effectively assessing, managing and treating patients via telehealth OTVs during the pandemic.<h4>Materials/methods</h4>As part of this IRB-approved single institution study, a survey was developed to capture the percentage of OTVs that were conducted via telehealth and provider perceptions on management effectiveness. Participants included attending and resident physicians and advanced practice providers (APPs). Likert scale questions assessed the provider perceptions in the following areas: ability to fully evaluate patient, manage symptoms, minimize acute care, and prevent COVID19 exposure. The survey was sent at 3 timepoints: April 15th, May 22nd, and December 18, 2020 (1, 2, and 7 months since declaration of COVID-19 as a national emergency). Respondents were not linked across the 3 surveys. Response frequencies and percentages are presented for each survey and global trends in responses are described.<h4>Results</h4>Surveys were sent to 34 radiation oncology providers. 22 (65%), 20 (59%), and 21 (62%) participants responded to the April, May, and December survey, respectively. 13, 12, 13 attending physicians; 8, 6, and 3 resident physicians; and 2, 2, and 5 APPs responded to the 3 surveys, respectively. In the April survey 59% of respondents indicated that 75-100% of patients were evaluated weekly by telehealth. This percentage dropped to 8% in May and 0% in December. Most respondents reported agreement with the ability to fully evaluate patients (70% vs 55%; 55%), manage symptoms (80% vs 59%; 60%) and minimize acute care (70% vs 64%; 60%) with in-person OTVs (% December vs April; May). Agreement of an appropriate balance of patient care and COVID-19 risk prevention dropped from 86% in April to 75% in May and 68% in December. Respondents reported a preference for patient-specific management strategies (telehealth vs in-person visits) at all time points (95% in April and May; 90% in December).<h4>Conclusion</h4>Based on our results, telehealth was widely used during the beginning of the pandemic, but shifted to essentially zero by December 2020. The increase of in person visits by December appears to correlate with agreement to fully evaluate a patient, manage symptoms, and minimize acute care. However, as in person OTVs increased, there was more concern for COVID-19 prevention by providers. By implementing systems into our electronic medical record that can accurately predict patients that may imminently require acute intervention, we may strike a balance of providing the best care for our cancer patients and minimize exposure risk.
Authors
Shenker, RF; Hong, JC; Eclov, N; Fairchild, A; Patel, P; Niedzwiecki, D; Palta, M
MLA Citation
Shenker, R. F., et al. “Survey of Healthcare Providers Utilization and Perception of Telehealth On-Treatment Visits During COVID-19 Pandemic.International Journal of Radiation Oncology, Biology, Physics, vol. 111, no. 3S, 2021, p. S112. Epmc, doi:10.1016/j.ijrobp.2021.07.258.
URI
https://scholars.duke.edu/individual/pub1502972
PMID
34700417
Source
epmc
Published In
International Journal of Radiation Oncology, Biology, Physics
Volume
111
Published Date
Start Page
S112
DOI
10.1016/j.ijrobp.2021.07.258

The Role of Hypofractionated Radiation Therapy in the Management of Unresectable Hepatocellular Carcinoma (HCC).

<h4>Purpose/objective(s)</h4>Management of HCC without surgical resection or transplantation is poorly defined with no standard. Stereotactic body radiation therapy (SBRT) or hypofractionated image-guided radiotherapy (HIGRT), is an evolving, non-invasive, therapeutic option for patients with HCC delivering ablative doses with modest toxicity.<h4>Materials/methods</h4>We retrospectively identified all patients with unresectable, non-metastatic HCC treated with SBRT/HIGRT who presented to our University and Veterans Affairs (VA) radiation oncology departments from 2013 to 2019. Primary study endpoints included freedom from local progression, progression free survival, overall survival, and treatment-related toxicity.<h4>Results</h4>149 patients were included in our analysis with median delivered radiation dose of 50 Gy in 5 fractions. This included a total of 172 treatment courses, as 21 patients received more than one course (19 patients received 2 courses; 2 patients received 3 courses). Twenty-two of the re-treatment courses were to previously unirradiated lesions, while one course was delivered to a previously treated lesion exhibiting local progression. Sixty-nine percent (69%) of patients were Child-Pugh A and 89% had a baseline ALBI grade of 1-2 prior to treatment. A majority of patients (59%) had a single lesion with a median size of 2.70 cm (Q1 2.00, Q3 3.95). Fifty-seven percent (57%) of patients received a biologically effective dose (BED<sub>α/β = 10</sub>) of at least 75 Gy and 48% of patients had undergone prior liver-directed therapy. All patients completed their intended treatment course with 1 patient (0.7%) experiencing Grade 3+ acute and 4 patients (2.6%) experiencing Grade 3+ late toxicities. Fifteen treatment courses (8.7%) resulted in non-classical radiation-induced liver disease (RILD), defined as an increase of 2 or more points in Child-Pugh score following radiation. With median follow up of 40 months, median overall survival was 25 months (95% CI 18-30 months). The 2-year freedom from local progression was 75% (95% CI 65-83%) overall, 64% (95% CI 48-77%) among patients who received BED ≤75 Gy and 86% (95% CI 72-93%) among those who received BED > 75 Gy. Median progression free survival was not reached. During the study period, 8.1% of patients developed regional nodal progression and 18.8% developed distant metastatic disease (42.9% osseous, 50.0% lung, 46.4% soft tissue/peritoneal/other involvement; multiple patients with more than one site of metastatic involvement).<h4>Conclusion</h4>SBRT/HIGRT results in high rates of local control with minimal treatment related toxicities. Randomized, prospective trials should seek to establish SBRT/HIGRT as a standard local therapeutic option for patients with unresectable, non-metastatic HCC.
Authors
MLA Citation
Stephens, S. J., et al. “The Role of Hypofractionated Radiation Therapy in the Management of Unresectable Hepatocellular Carcinoma (HCC).International Journal of Radiation Oncology, Biology, Physics, vol. 111, no. 3S, 2021, pp. e78–79. Epmc, doi:10.1016/j.ijrobp.2021.07.444.
URI
https://scholars.duke.edu/individual/pub1502973
PMID
34701968
Source
epmc
Published In
International Journal of Radiation Oncology, Biology, Physics
Volume
111
Published Date
Start Page
e78
End Page
e79
DOI
10.1016/j.ijrobp.2021.07.444

Toxicity and Dosimetric Parameters of Ablative Radiation Therapy in the Management of Patients with Child-Pugh B/C Liver Function and Unresectable Hepatocellular Carcinoma (HCC).

<h4>Purpose/objective(s)</h4>To date there is no clear standard non-surgical therapeutic option for HCC patients. Ablative radiation therapy (SBRT/HIGRT) is an emerging non-invasive treatment for patients with HCC. However, there is concern about the risk for radiation-induced liver toxicity following radiation in patients with decompensated liver function (Child-Pugh B/C).<h4>Materials/methods</h4>We retrospectively identified all patients with unresectable, non-metastatic HCC treated with SBRT/HIGRT and underlying Child-Pugh B or C liver function prior to radiation therapy at our University and Veterans Affairs (VA) radiation oncology departments from 2014 to 2019. Primary endpoints included treatment-related toxicity, as well as, evaluation of dosimetric parameters for OAR.<h4>Results</h4>38 patients (39 treatment courses) were included. Most patients (97%) had Child-Pugh B7-B9 (62% CP B7, 21% CP B8, 15% CP B9) or ALBI grade 2-3 (69% ALBI grade 2, 31% ALBI grade 3) liver disease prior to radiation therapy. A single patient had Child-Pugh C10 liver function. The most commonly utilized regimens include 50 Gy in either 5 or 10 fractions. The median delivered dose was 50 Gy (range 30-50) in an average of 7.5 fractions (range 5-10). Most patients had a single lesion (63%) with a median lesion size of 3.2 cm (range 1.10-7.40 cm). The mean liver dose was 9.40 Gy (range 3.38-23.94) with a liver D800cc of 4.14 Gy (range 0.35-17.31). All patients completed their intended treatment course with a median follow up of 43 months. Four (10.3%) treatment courses resulted in non-classical radiation-induced liver disease (RILD) (defined as an increase of 2 or more points in Child-Pugh score), compared to 8.3% for patients with Child-Pugh A liver function treated during a similar time period. Otherwise, one patient (2.6%) experienced acute grade 3+ (non-RILD) hepatobiliary toxicity (transient transaminitis). Two-year freedom from local progression was 73% (95% CI 37-90%), median overall survival 12 months (95% CI 5-25 months), and median progression free-survival was not reached.<h4>Conclusion</h4>Ablative radiation therapy as definitive management for patients with unresectable, non-metastatic HCC appears to be reasonably well tolerated in patients with decompensated liver function at baseline (Child-Pugh B7-B9), with low rates of RILD and encouraging local control. With careful selection, these patients appear to be reasonable candidates for consideration of SBRT/HIGRT. Our analysis did not include enough patients with Child-Pugh C10+ disease to draw meaningful conclusions.
Authors
Sperduto, W; Oyekunle, T; Niedzwiecki, D; Czito, B; Willett, CG; Salama, JK; Palta, M; Stephens, SJ
MLA Citation
Sperduto, W., et al. “Toxicity and Dosimetric Parameters of Ablative Radiation Therapy in the Management of Patients with Child-Pugh B/C Liver Function and Unresectable Hepatocellular Carcinoma (HCC).International Journal of Radiation Oncology, Biology, Physics, vol. 111, no. 3S, 2021, p. e78. Epmc, doi:10.1016/j.ijrobp.2021.07.443.
URI
https://scholars.duke.edu/individual/pub1502974
PMID
34701967
Source
epmc
Published In
International Journal of Radiation Oncology, Biology, Physics
Volume
111
Published Date
Start Page
e78
DOI
10.1016/j.ijrobp.2021.07.443

Evolving role of an oncology telehealth nurse at an NCI-designated cancer institute.

<jats:p> 277 </jats:p><jats:p> Background: Oncology telehealth (TH) services may improve access, mitigate care delays, and augment care in select settings. However, logistical and workflow barriers hinder the sustainable adoption of TH services by providers. We created a novel oncology TH nurse (OTN) position to address these barriers. Methods: An OTN was introduced into oncology provider groups (physician + advanced practice provider) in a staggered, opt-in fashion across the Duke Cancer Institute between 9/2020 and 12/2020. The OTN performed individualized interventions to decrease provider burden, improve TH workflows, and increase TH utilization. Specific interventions performed by the OTN were recorded. We monitored the primary outcome, TH utilization, as a proportion of all visits at baseline (month 0) and 3 months post-OTN intervention. Patient TH satisfaction surveys were reviewed at baseline and 3 months post-OTN intervention. Provider surveys were sent 3 months post-OTN intervention. Results: The OTN was implemented across 10 provider groups and 25 providers [gastrointestinal (GI) medical oncology (n = 10), thoracic medical oncology (n = 3), melanoma medical oncology (n = 3), adult bone marrow transplant (n = 2), lung cancer screening (n = 2), melanoma surgical oncology (n = 1), hematological malignancies (n = 1), head and neck medical oncology (n = 1), central nervous system radiation oncology (n = 1), and GI radiation oncology (n = 1)]. 25 providers utilized 1 or more OTN interventions: support for patients on the TH platform (n = 13), construction of TH clinic schedule templates (n = 6), creation of workflows to order and obtain outside imaging/labs (n = 5), provider TH education (n = 4), creation of Epic SmartPhrases (n = 4), and identifying patients appropriate for TH (n = 3). Baseline TH utilization was 15.6% of all visits, and 3-month post-OTN utilization was 23.8%. TH patient satisfaction data was available for 10 providers at baseline and 13 providers at 3 months post-OTN. Patients’ global approval rating of TH was 85.0% at baseline and 98.5% at month 3. 16/25 providers returned the post-intervention survey. Providers requested continued assistance from the OTN for supporting patients on the TH platform (43.5%), staff TH education (43.5%), provider TH education (25%), creation of SmartPhrases (25%), and creation of TH clinic templates (13%). Providers requested new additional OTN support to 1) order and retrieve imaging/laboratory tests for TH visits and 2) explore patients' willingness to undergo TH visits. Conclusions: OTN interventions were individualized to providers and evolved over time. While TH utilization was increased at 3 months post-OTN, it is possible that utilization was confounded by the dynamic COVID-19 pandemic and provider/patient preferences over time. Nevertheless, these results demonstrate feasibility of OTN implementation and provide support for this novel role in promoting TH services in oncology. </jats:p>
Authors
Natesan, D; Old, HEE; Emmons, A; Hatheway, E; Zafar, Y; Palta, M
MLA Citation
Natesan, Divya, et al. “Evolving role of an oncology telehealth nurse at an NCI-designated cancer institute.Journal of Clinical Oncology, vol. 39, no. 28_suppl, American Society of Clinical Oncology (ASCO), 2021, pp. 277–277. Crossref, doi:10.1200/jco.2020.39.28_suppl.277.
URI
https://scholars.duke.edu/individual/pub1500424
Source
crossref
Published In
Journal of Clinical Oncology : Official Journal of the American Society of Clinical Oncology
Volume
39
Published Date
Start Page
277
End Page
277
DOI
10.1200/jco.2020.39.28_suppl.277