A Sexual and Gender Minority Inclusive Tool to Identify and Reduce Psychological Distress Related to Vaginal Brachytherapy Treatment
PURPOSE/OBJECTIVE(S): Evidence has shown treatments for gynecologic cancers can pose a significant impact to quality of life (QoL) and psychosocial functioning for cancer patients and cancer survivors, with very limited understanding of the impact of such treatments on the lesbian, gay, bisexual, transgender and queer/questioning community, also referred to as sexual and gender minorities (SGM), a diverse and medically underserved population. Specifically, intracavitary vaginal brachytherapy (ICVBT) for endometrial cancers can cause a negative impact on QoL and can even result in PTSD after treatment. Thus, better understanding a patient's unique identity and chosen sexual preferences, as well as assessing underlying anxiety, psychosocial issues, and/or prior non-consensual sexual encounter(s) can potentially alleviate distress during and after this sensitive treatment. Here, we present an innovative, SGM-inclusive assessment tool to identify potential risk factors for physical and/or psychosocial distress that may occur in patients undergoing ICVBT. MATERIALS/METHODS: We combined two previously published, validated tools to assess for urinary, bowel, and sexual symptoms in patients undergoing ICVBT. Next, as part of the ongoing LGBTQ initiative at our academic comprehensive cancer center, our department's LGBTQ Task Force, which is composed of volunteer patients, physicians, nurses, physicists, dosimetrists, and support staff reviewed the questionnaire and provided critical feedback for inclusivity. We subsequently had the questionnaire reviewed for health literacy by our Patient Education Liaisons.
RESULT(S): The task force recommended inclusion of sexual orientation and gender identity (SOGI) demographic questions to the survey, and adjustment of previous questions for improved inclusivity of SGM-identifying patients, especially those who identify as transgender, gender non-binary, and/or who choose to not engage in penetrative vaginal intercourse. Additionally, it was recommended to include a question that screens for a history of non-consensual sexual encounters to reduce triggering past trauma. The task force felt these items were important for the practitioner to discuss with their patient prior to the procedure, with the goal to reduce acute anxiety and possibly prevent acute and long-term negative physical and/or emotional outcomes.
CONCLUSION(S): Our ICVBT survey tool is designed to screen for "at-risk" patients, and provide a pathway for open dialogue between patients and physicians to potentially reduce undue harm during this important, yet sensitive treatment. To the best of our knowledge, this is the first such ICVBT survey tool to assess for a history of sexual trauma, and include SOGI and gender-inclusive questions. This adaptation has allowed our team to approach patients in a sensitive manner inclusive of their identity and prior experiences. Preliminary data is being collected and will be presented at the conference.
Development of a Big Data Radiation Oncology Dashboard
PURPOSE/OBJECTIVE(S): Healthcare data often exist in silos and in unstructured formats that limit interoperability and require tedious manual extraction. Our institution has adopted a flexible and scalable big data platform built on Hadoop that integrates data from Epic/Clarity as well as Aria and allows users to leverage modern data science tools to facilitate access. We hypothesize that a data analytics and visualization dashboard can be built using open-source tools that will (1) allow non-technical users to explore de-identified clinical data within our institutional big data platform and (2) connect with repositories of molecular data to demonstrate potential methods of integrating clinical and basic science data. MATERIALS/METHODS: De-identified patient-level radiation oncology data from the institutional big data platform (Hadoop) were extracted with the python packages pyodbc and pandas. For the purposes of this dashboard, radiation oncology specific clinical data elements were queried including the date of first radiation treatment, treatment location, treatment modality (SBRT, external beam, SRS, TBI, LDR/HDR brachytherapy), ICD10 codes, anatomic treatment site, number of fractions, treatment prescription, and dose per fraction. A python client connection with the publicly accessible instance of cBioPortal for Cancer Genomics was established using the Bravado library. Data transformation and cleaning was performed in python using panda's data frames. A web-based dashboard to facilitate user-defined visualizations was implemented using the Dash python library and interactive visualizations of subsets of extracted data were generated in real-time using the plotly plotting library.
RESULT(S): We developed a web-based dashboard that gives users without extensive programming expertise the ability to explore de-identified clinical data extracted from Hadoop. As proof of principle, the dashboard was used to visualize the clinical impact of the COVID-19 pandemic on radiation oncology patient volumes, revealing a significant decline in new radiation treatments in April and May of 2020 (-54% and -36% compared to 2019) during the initial COVID-19 surge. Furthermore, the dashboard allows users to interact with the cBioPortal for Cancer Genomics repository, which currently houses clinical and molecular data from 301 publicly available studies spanning 869 different cancer types. This interface with cBioPortal illustrates the potential for future integration of clinically meaningful sequencing results with clinical outcomes data.
CONCLUSION(S): We built an interactive web-based dashboard to enable general users' easy access to de-identified clinical data stored within the institutional big data platform. Additional data sources, including external molecular data can be connected to the dashboard allowing for future integration.
Retrospective Cohort Study of Oligometastatic and Oligoprogressive Malignancy Treated With Stereotactic Body Radiation Therapy (SBRT) With Intent to Delay New Systemic Therapy
PURPOSE/OBJECTIVE(S): Use of local therapy such as stereotactic body radiation therapy (SBRT) to treat oligometastatic malignancy is a well-established paradigm, but whether benefit extends to the oligoprogressive setting remains unclear. We present our institutional series of patients with oligometastatic or oligoprogressive malignancy treated with SBRT. MATERIALS/METHODS: We performed a retrospective study of patients with oligometastatic and oligoprogressive malignancy treated with SBRT between 2014 and 2019. Oligometastatic patients were defined as those with five or fewer metastatic lesions in total. Oligoprogressive patients were defined as those with more than five and up to twenty metastatic lesions in total, of which five or fewer metastases were progressing on current systemic therapy. Patients lacking complete treatment records or follow-up imaging were excluded. The study was approved by the NYU Institutional Review Board.
RESULT(S): A total of 114 patients were treated with 123 courses of SBRT, of which 96 treated oligometastasis and 27 treated oligoprogression. Primary sites of disease included lung (38%), prostate (20%), and GI (12%), as well as gynecologic, abdominal, and cutaneous malignancies. Median follow-up was 21 months. No grade 3 or higher radiation-related adverse events were reported. Patients with oligometastatic malignancy had longer 2-year overall survival (79% vs 59%; P=0.003), local control (73% vs 55%; P=0.01), and progression-free survival (26% vs 8%; P < 0.001), but similar freedom from new systemic therapy (36% vs 31%; P=0.8). This result held true in subgroup analysis regardless of lung vs non-lung primary site, and regardless of the presence or absence of a targetable mutation.
CONCLUSION(S): In this hypothesis-generating retrospective cohort study, patients with oligoprogressive malignancy treated with SBRT have similar freedom from new systemic therapy to patients with oligometastatic malignancy, strengthening the rationale for treating oligoprogressive malignancy with SBRT.
Modern Management of High-risk Soft Tissue Sarcoma With Neoadjuvant Chemoradiation: A Single-center Experience
OBJECTIVE:Neoadjuvant chemoradiation (NA-CRT), followed by resection of high-risk soft tissue sarcoma (STS), may offer good disease control and toxicity outcomes. We report on a single institution's modern NA-CRT experience. MATERIALS AND METHODS/METHODS:Delay to surgical resection, resection margin status, extent of necrosis, tumor cell viability, presence of hyalinization, positron emission tomography (PET)/computed tomography data, and treatment toxicities were collected. Using the Kaplan-Meier survival analysis, 5-year overall survival, disease-free survival, distant metastasis-free survival, and local control (LC) were estimated. Clinicopathologic features and PET/computed tomography avidity changes were assessed for their potential predictive impact using the log-rank test. RESULTS:From 2011 to 2018, 37 consecutive cases of localized high-risk STS were identified. Twenty-nine patients underwent ifosfamide-based NA-CRT to a median dose of 50â€‰Gy before en bloc resection. At a median follow-up of 40.3 months, estimated 5-year overall survival was 86.1%, disease-free survival 70.2%, distant metastasis-free survival 75.2%, and LC 86.7%. Following NA-CRT, a median reduction of 54.7% was observed in tumor PET avidity; once resected, median tumor necrosis of 60.0% with no viable tumor cells was detected in 13.8% of the cases. Posttreatment resection margins were negative in all patients, with 27.6% having a margin of â‰¤1â€‰mm. Delays of over 6 weeks following the end of radiation treatment to surgical resection occurred in 20.7% cases and was suggestive of inferior LC (92.8% vs. 68.6%, P=0.025). CONCLUSIONS:This single-institution series of NA-CRT demonstrates favorable disease control. Delay in surgical resection was associated with inferior LC, a finding that deserves further evaluation in a larger cohort. LEVEL OF EVIDENCE/METHODS:Level III-retrospective cohort study.
Treating through the surge: institutional experience of definitive management of cervical cancer patients at an urban institution during the COVID-19 pandemic [Meeting Abstract]
Factors associated with delay in treatment initiation of locally advanced cervical cancer [Meeting Abstract]
Objective: We aimed to explore the disparities associated with the delay of initiating chemoradiation therapy (CRT) and brachytherapy (BT) beyond the recommended 8 weeks for patients with cervical cancer and the effect on outcomes.
Method(s): Patients with FIGO stage IB2-IVA cervical cancer treated at an academic medical center and an urban public hospital by the same team of gynecologic and radiation oncologists with definitive CRT and BT from July 2009 to September 2017 were included. Patients received CRT followed by BT (7 Gy x 4 fractions) delivered via 2 insertions 1 week apart with image-guided CT/MR delineation. Patients who initiated CRT within 8 weeks from diagnosis as recommended (rCRT) were compared across demographic and cancer outcomes to patients who received delayed CRT after 8 weeks (dCRT). Disease-free survival (DFS) and overall survival (OS) were analyzed using adjusted Cox regression analysis (P < 0.05).
Result(s): In our cohort of 97 patients, 72 (75.0%) had rCRT and 24 (25.0%) had dCRT. At a median follow-up of 31.5 months, overall local control was achieved in 94.8% of patients. Patients with dCRT were more likely to be African-American (37.5% vs 17.8%, P = 0.046) and be uninsured or on Medicaid (87.5% vs 61.6%, P = 0.023). There were no differences in stage and grade. Patients with dCRT were more likely to recur or progress (OR = 2.65, 95% CI 1.02-6.86). Of those who recurred, 35.0% of rCRT patients had locoregional recurrence versus 66.7% of dCRT patients (P = 0.144). When controlling for age, race, insurance, referring hospital, and stage, patients with dCRT had lower DFS than patients with rCRT (50.6 vs 63.2 months, aHR = 6.11, 95% CI 2.00-18.62). However, there were no differences in OS.
Conclusion(s): Patients receiving delayed CRT tended to have worse recurrence and DFS than those initiating CRT by 8 weeks from diagnosis. African-American and uninsured patients were more likely to experience a delay in care. Navigator and social work services may help improve access to treatments for these patients.
Intraoperative Ultrasound Guided Intracavitary Brachytherapy: Improving Toxicity and Precision of Tandem Applicator Placement in Cervical Cancer [Meeting Abstract]
Nomogram to Predict the Benefit of Intensive Treatment for Locoregionally Advanced Head and Neck Cancer
PURPOSE/OBJECTIVE:Previous studies indicate the benefit of therapy depends on patients' risk for cancer recurrence relative to non-cancer mortality (Ï‰ ratio). We sought to test the hypothesis that head and neck cancer (HNC) patients with a higher Ï‰ ratio selectively benefit from intensive therapy. EXPERIMENTAL DESIGN/METHODS:We analyzed 2688 patients with stage III-IVB HNC undergoing primary radiation therapy (RT) with or without systemic therapy on three phase III trials (RTOG 9003, RTOG 0129, and RTOG 0522). We used generalized competing event regression to stratify patients according to Ï‰ ratio, and compared the effectiveness of intensive therapy as a function of predicted Ï‰ ratio (i.e., Ï‰ score). Intensive therapy was defined as treatment on an experimental arm with altered fractionation (AFX) and/or multiagent concurrent systemic therapy. A nomogram was developed to predict patients' Ï‰ score based on tumor, demographic, and health factors. Analysis was by intention-to-treat. RESULTS:Decreasing age, improved performance status, higher body mass index, node positive status, P16 negative status, and oral cavity primary predicted a higher Ï‰ ratio. Patients with Ï‰ score â‰¥ 0.80 were more likely to benefit from intensive treatment (5-year OS, 70.0% vs. 56.6%; HR 0.73, 95% CI 0.57-0.94; P=0.016) than those with a Ï‰ score < 0.80 (5-year OS, 46.7% vs. 45.3%; HR 1.02, 95% CI 0.92-1.14; P=0.69;P=0.019 for interaction). In contrast, the effectiveness of intensive therapy did not depend on risk of progression. CONCLUSION/CONCLUSIONS:HNC patients with a higher Ï‰ score selectively benefit from intensive treatment. A nomogram was developed to help select patients for intensive therapy.
Food as medicine: A randomized controlled trial (RCT) of home delivered, medically tailored meals (HDMTM) on quality of life (QoL) in metastatic lung and noncolorectal GI cancer patients [Meeting Abstract]
Background: Malnutrition incidence in cancer approaches 85%, disproportionately burdening those with lung, GI, and advanced stage cancers. Malnourished patients have impaired chemotherapy response, shorter survival, longer hospital stays, and decreased QoL. Home delivered meals are nutritional interventions that improve patient well- being, nutrition, and lower healthcare costs in the elderly but have not been studied as an intervention in cancer patients. HDMTM are nutritionist prescribed home delivered meals tailored to patient's symptoms, co-morbidities, and health needs. Preliminary data in 211 cancer patients showed with HDMTM 87% ate more than half of meals, 91% lived more independently, 89% ate more nutritiously, and 70% had less fatigue. HDMTM may be a strategy to reduce financial toxicity and healthcare utilization and improve QoL in cancer patients, but no primary data exists evaluating its efficacy.
Method(s): We sought to develop the first RCT evaluating patientcentered QoL improvement from nutritional intervention with HDMTM in those with metastatic lung and non-colorectal GI cancer. We established a partnership with God's Love We Deliver, a 501c3 non-profit specializing in HDMTM.
Result(s): We developed a protocol for a single-institution RCT of standard of care (SoC) versus SoC and HDMTM in metastatic lung and non-colorectal GI cancer patients with primary aim comparing QoL between arms at 12 weeks using the FACT-G questionnaire. Sample size is 180. Secondary aims assess HDMTM's impact on nutritional status, weight, mood, survival, food security, financial toxicity, healthcare utilization, and cost effectiveness. Eligible patients tolerate oral alimentation, have PS 0-3, and newly diagnosed (< 6 weeks) metastatic cancer. All patients have pre-randomization nutritional evaluation by an oncologic dietician.
Conclusion(s):We present the first PRMC reviewed and IRB approved RCT evaluating the efficacy of HDMTM in metastatic cancer patients with primary endpoint of patient reported QoL. Investigating HDMTM expands our knowledge of nutrition as an effective arm of palliative oncology
Gastrointestinal fistula formation in cervical cancer patients who received bevacizumab [Meeting Abstract]
Objective: The Gynecologic Oncology Group (GOG) study 240 demonstrated a 3.5-month improvement in overall survival when bevacizumab (bev) was added to a combination chemotherapy regimen. This study established a bev-containing regimen as standard therapy for women with recurrent, persistent, or metastatic cervical cancer (CC). Gastrointestinal fistula (GIF) formation is a known complication of bev, and the long-term data of GOG 240 reported that a GIF rate of 15% in women who were treated with bev compared to 1% in the control group women. We sought to evaluate our experience with women treated with bev for CC and to identify associated risk factors for GIF formation.
Method(s): All patients who have received bev for CC from 2012 to 2018 at two academic institutions were identified, and their records were reviewed. Standard two-sided statistical analyses were performed.
Result(s): A total of 43 women were treated with a bev-containing chemotherapy regimen; among them, 34 (79.1%) were treated for CC recurrence, and the remaining were treated for metastatic disease at initial presentation or persistent disease following primary treatment. Thirty-three women (76.6%) received prior radiation therapy (RT); of these, 10 (32.3%) received external beam radiation therapy (EBRT), and 21 (67.7%) had prior EBRT and brachytherapy (BT). The median dose of bev was 15 mg/kg for both EBRT only and EBRT and BT groups. Eleven women developed GIF after bev treatment (11/43, 25.6%). All 11 (100%) had been previously treated with RT, and six (54.5%) had received EBRT plus BT. This resulted in rates of 33.3% (11/33) for GIF formation among women who received EBRT, and 28.6% (6/21) for GIF formation among women who received EBRT plus BT. The median number of bev cycles prior to GIF development was 8 (1-29), and 7 (7/11, 63.6%) received the dose of bev (15 mg/kg) as prescribed in GOG 240. See Table 1.
Conclusion(s): In our cohort of women with CC who were treated with bev, over 25% developed GIF. This is more than expected based on the 15% seen in GOG 240. Notably almost all who developed GIF had recurrent disease and were treated with prior RT. A third of women treated with RT followed by bev formed GIF, representing a considerable proportion of the cohort. GIF development and the possibility of requiring a colostomy should be a part of counseling prior to bev initiation especially in those who have had prior RT. [Figure presented]