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  • 1
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    Online Resource
    Understanding the path to diagnosis and clinical presentation of patients with PIK3CA -related overgrowth spectrum (PROS) through an innovative patient-centered data platform.
    American Society of Clinical Oncology (ASCO) ; 2022
    In:  Journal of Clinical Oncology Vol. 40, No. 16_suppl ( 2022-06-01), p. e18707-e18707
    Details
    In: Journal of Clinical Oncology, American Society of Clinical Oncology (ASCO), Vol. 40, No. 16_suppl ( 2022-06-01), p. e18707-e18707
    Abstract: e18707 Background: PROS is a group of rare disorders driven by activating mutations in PIK3CA. Overactivation of the PI3K pathway, which regulates growth and proliferation, results in asymmetric malformations/overgrowths. Localized interventions are often not curative and no medical therapy for PROS is approved; however, mTOR inhibitors (ie sirolimus) are used off-label with modest success. Using a patient (pt)-focused approach, we seek to better understand the current path to diagnosis (dx), course of disease, interventions, and pt outcomes to optimize future therapies. Methods: Pts treated in the US are being actively recruited via interactions with pt advocacy groups, pt communities, social media, and allstripes.com. Following research and HIPAA authorization from each pt/guardian, AllStripes’ proprietary real-world evidence (RWE) platform collects pt medical records into a master medical record from which study data are abstracted. All activities are covered under AllStripes’ IRB-approved protocol. To enroll in the PROS cohort, pts must have a confirmed PROS dx via PIK3CA genetic testing. Data completeness and nomenclature are dependent on physician documentation. Results: To date 14 pts (7 female, 7 male) have enrolled; median age at enrollment was 10.5 y (range, 1-38). Of the 14 pts, 71.4% of pts (n = 10) had congenital onset. PIK3CA genetic testing was primarily (n = 12, 85.7%) completed as a part of a multigene panel. The most frequent specialties involved in dx were medical genetics (n = 4, 28.6%) and pediatric heme-oncology (n = 3, 21.4%). Clinical presentation commonly included vascular malformations (n = 8, 57.1%). Most pts were diagnosed with CLOVES (n = 12, 85.7%). Seven pts (50.0%) had documented lesions at dx, median of 2 (range, 1-13) lesions per pt, increasing after dx to 3 (range, 1-14). All pts reported PROS-related complications; 50.0% (n = 7) required hospitalization/ER visit. Musculoskeletal, neurological, and gastrointestinal related complications were each reported by ≥50% of pts. All pts required ≥1 surgery; ≥50% of pts had diagnostic, debulking, vascular, or other procedures. Median number of surgeries per pt was 7 (range, 1-28), corresponding to a median of 0.76 surgeries per pt per year. Eight pts (57.1%) received PROS related medications: 6 (42.9%) received alpelisib, 5 (35.7%) received sirolimus. Conclusions: While each pt is unique, similarities in the path to dx (eg, specialties involved) and disease history (eg, clinical presentation, symptoms experienced) exist. RWE abstracted from medical records rapidly provides data in an otherwise limited field, helping to address key questions. Preliminary results highlight the burden of PROS and the reliance on repetitive surgical interventions for management, suggesting there remains a high unmet medical need for effective therapeutic strategies.
    Type of Medium: Online Resource
    ISSN: 0732-183X , 1527-7755
    URL: Article
    DOI: 10.1200/JCO.2022.40.16_suppl.e18707
    RVK:
    XA 52760
    RVK:
    XA 10000
    Language: English
    Publisher: American Society of Clinical Oncology (ASCO)
    Publication Date: 2022
    detail.hit.zdb_id: 2005181-5
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  • 2
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    Molecular Characterization of Circulating Tumor DNA in Pediatric Rhabdomyosarcoma: A Feasibility Study
    American Society of Clinical Oncology (ASCO) ; 2022
    In:  JCO Precision Oncology , No. 6 ( 2022-10)
    Details
    In: JCO Precision Oncology, American Society of Clinical Oncology (ASCO), , No. 6 ( 2022-10)
    Abstract: Rhabdomyosarcomas (RMS) are rare neoplasms affecting children and young adults. Efforts to improve patient survival have been undermined by a lack of suitable disease markers. Plasma circulating tumor DNA (ctDNA) has shown promise as a potential minimally invasive biomarker and monitoring tool in other cancers; however, it remains underexplored in RMS. We aimed to determine the feasibility of identifying and quantifying ctDNA in plasma as a marker of disease burden and/or treatment response using blood samples from RMS mouse models and patients. METHODS We established mouse models of RMS and applied quantitative polymerase chain reaction (PCR) and droplet digital PCR (ddPCR) to detect ctDNA within the mouse plasma. Potential driver mutations, copy-number alterations, and DNA breakpoints associated with PAX3/ 7-FOXO1 gene fusions were identified in the RMS samples collected at diagnosis. Patient-matched plasma samples collected from 28 patients with RMS before, during, and after treatment were analyzed for the presence of ctDNA via ddPCR, panel sequencing, and/or whole-exome sequencing. RESULTS Human tumor-derived DNA was detectable in plasma samples from mouse models of RMS and correlated with tumor burden. In patients, ctDNA was detected in 14/18 pretreatment plasma samples with ddPCR and 7/7 cases assessed by sequencing. Levels of ctDNA at diagnosis were significantly higher in patients with unfavorable tumor sites, positive nodal status, and metastasis. In patients with serial plasma samples (n = 18), fluctuations in ctDNA levels corresponded to treatment response. CONCLUSION Comprehensive ctDNA analysis combining high sensitivity and throughput can identify key molecular drivers in RMS models and patients, suggesting potential as a minimally invasive biomarker. Preclinical assessment of treatments using mouse models and further patient testing through prospective clinical trials are now warranted.
    Type of Medium: Online Resource
    ISSN: 2473-4284
    URL: Article
    DOI: 10.1200/PO.21.00534
    Language: English
    Publisher: American Society of Clinical Oncology (ASCO)
    Publication Date: 2022
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  • 3
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    Impact of Breast Cancer Early Detection Training on Rwandan Health Workers’ Knowledge and Skills
    American Society of Clinical Oncology (ASCO) ; 2018
    In:  Journal of Global Oncology , No. 4 ( 2018-12), p. 1-10
    Details
    In: Journal of Global Oncology, American Society of Clinical Oncology (ASCO), , No. 4 ( 2018-12), p. 1-10
    Abstract: In April 2015, we initiated a training program to facilitate earlier diagnosis of breast cancer among women with breast symptoms in rural Rwanda. The goal of this study was to assess the impact of the training intervention in breast cancer detection on knowledge and skills among health center nurses and community health workers (CHWs). Methods We assessed nurses’ and CHWs’ knowledge about breast cancer risk factors, signs and symptoms, and treatability through a written test administered immediately before, immediately after, and 3 months after trainings. We assessed nurses’ skills in clinical breast examination immediately before and after trainings and then during ongoing mentorship by a nurse midwife. We also examined the appropriateness of referrals made to the hospital by health center nurses. Results Nurses’ and CHWs’ written test scores improved substantially after the trainings (overall percentage correct increased from 73.9% to 91.3% among nurses and from 75.0% to 93.8% among CHWs ( P 〈 .001 for both), and this improvement was sustained 3 months after the trainings. On checklists that assessed skills, nurses’ median percentage of actions performed correctly was 24% before the training. Nurses’ skills improved significantly after the training and were maintained during the mentorship period (the median score was 88% after training and during mentorship; P 〈 .001). In total, 96.1% of patients seen for breast concerns at the project’s hospital-based clinic were deemed to have been appropriately referred. Conclusion Nurses and CHWs demonstrated substantially improved knowledge about breast cancer and skills in evaluating and managing breast concerns after brief trainings. With adequate training, mentorship, and established care delivery and referral systems, primary health care providers in sub-Saharan Africa can play a critical role in earlier detection of breast cancer.
    Type of Medium: Online Resource
    ISSN: 2378-9506
    URL: Article
    DOI: 10.1200/JGO.17.00098
    Language: English
    Publisher: American Society of Clinical Oncology (ASCO)
    Publication Date: 2018
    detail.hit.zdb_id: 3018917-2
    detail.hit.zdb_id: 2840981-4
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  • 4
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    Cluster Randomized Trial to Facilitate Breast Cancer Early Diagnosis in a Rural District of Rwanda
    American Society of Clinical Oncology (ASCO) ; 2019
    In:  Journal of Global Oncology , No. 5 ( 2019-12), p. 1-13
    Details
    In: Journal of Global Oncology, American Society of Clinical Oncology (ASCO), , No. 5 ( 2019-12), p. 1-13
    Abstract: Feasible and effective strategies are needed to facilitate earlier diagnosis of breast cancer in low-income countries. The goal of this study was to examine the impact of health worker breast health training on health care utilization, patient diagnoses, and cancer stage in a rural Rwandan district. METHODS We conducted a cluster randomized trial of a training intervention at 12 of the 19 health centers (HCs) in Burera District, Rwanda, in 2 phases. We evaluated the trainings’ impact on the volume of patient visits for breast concerns using difference-in-difference models. We used generalized estimating equations to evaluate incidence of HC and hospital visits for breast concerns, biopsies, benign breast diagnoses, breast cancer, and early-stage disease in catchment areas served by intervention versus control HCs. RESULTS From April 2015 to April 2017, 1,484 patients visited intervention HCs, and 308 visited control HCs for breast concerns. The intervention led to an increase of 4.7 visits/month for phase 1 HCs ( P = .001) and 7.9 visits/month for phase 2 HCs ( P = .007) compared with control HCs. The population served by intervention HCs had more hospital visits (115.1 v 20.5/100,000 person-years, P 〈 .001) and biopsies (36.6 v 8.9/100,000 person-years, P 〈 .001) and higher breast cancer incidence (6.9 v 3.3/100,000 person-years; P = .28). The incidence of early-stage breast cancer was 3.3 per 100,000 in intervention areas and 0.7 per 100,000 in control areas ( P = .048). CONCLUSION In this cluster randomized trial in rural Rwanda, the training of health workers and establishment of regular breast clinics were associated with increased numbers of patients who presented with breast concerns at health facilities, more breast biopsies, and a higher incidence of benign breast diagnoses and early-stage breast cancers.
    Type of Medium: Online Resource
    ISSN: 2378-9506
    URL: Article
    DOI: 10.1200/JGO.19.00209
    Language: English
    Publisher: American Society of Clinical Oncology (ASCO)
    Publication Date: 2019
    detail.hit.zdb_id: 3018917-2
    detail.hit.zdb_id: 2840981-4
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  • 5
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    Integrating Breast Cancer Early Detection Into a Resource-Constrained Primary Health Care System: Health Care Workers' Experiences in Rwanda
    American Society of Clinical Oncology (ASCO) ; 2022
    In:  JCO Global Oncology , No. 8 ( 2022-12)
    Details
    In: JCO Global Oncology, American Society of Clinical Oncology (ASCO), , No. 8 ( 2022-12)
    Abstract: There is limited evidence to guide incorporation of breast cancer early detection into resource-constrained health systems where mammography screening is not yet available. To inform such strategies, we sought to understand health care workers' perspectives on a breast cancer early detection initiative integrated into community, primary, and secondary levels of care in Rwanda. METHODS We conducted a qualitative study using semistructured interviews with 33 community health workers, clinicians, and administrators at health facilities participating in the Women's Cancer Early Detection Program (WCEDP), through which women received clinical breast examination if they were receiving cervical cancer screening, or had breast concerns. Through thematic analysis, we identified dynamics and patterns associated with successes and challenges of the program's breast health services. RESULTS Successes and challenges identified by participants corresponded with the community- and primary care–based steps of cancer early diagnosis identified by the WHO. Regarding step 1 (community awareness/access), participants noted increases in awareness and care-seeking. Challenges included difficulty overcoming stigma and engaging older women. Regarding step 2 (clinical evaluation), all participants described increased breast health knowledge, skills, and confidence. Integrating the WCEDP with other services was challenging because of inadequate staffing; offering WCEDP services on a designated day/week had advantages and disadvantages. Although participants appreciated WCEDP referral mechanisms, they desired more communication from referral facilities. Patients' poverty was the most consistently identified impediment to referral completion. CONCLUSION Rwandan health care workers identified real-world successes and challenges of implementing principles of early cancer diagnosis for breast cancer early detection. Future interventions should focus on engagement of older women, community awareness, patient socioeconomic support, and optimizing integration into primary care.
    Type of Medium: Online Resource
    ISSN: 2687-8941
    URL: Article
    DOI: 10.1200/GO.22.00181
    Language: English
    Publisher: American Society of Clinical Oncology (ASCO)
    Publication Date: 2022
    detail.hit.zdb_id: 3018917-2
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  • 6
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    Presenting Symptoms and Stage at Diagnosis Among Women Diagnosed With Breast Cancer Through a Combined Breast Cancer and Cervical Cancer Screening Program in Rwanda
    American Society of Clinical Oncology (ASCO) ; 2022
    In:  JCO Global Oncology Vol. 8, No. Supplement_1 ( 2022-05), p. 50-50
    Details
    In: JCO Global Oncology, American Society of Clinical Oncology (ASCO), Vol. 8, No. Supplement_1 ( 2022-05), p. 50-50
    Abstract: There is interest in leveraging cervical cancer (CC) screening to facilitate early breast cancer (BC) detection in low- and middle-income countries (LMIC). We sought to determine whether adding clinical breast exams (CBE) to CC screening led to early BC diagnoses among asymptomatic women in Rwanda's Women's Cancer Early Detection Program (WCEDP). The WCEDP provided CBE to women aged 30-49 who were receiving CC screening, as well as any individual with breast symptoms. METHODS The WCEDP was launched in three Rwandan districts (total population 1.3 million) in July 2018, August 2018 and May 2019 respectively. This analysis included patients presenting to health centers (HCs) through December 31, 2019. Follow-up data were collected through April 2021 using clinicians' weekly reports, patient navigator referral data, and the cancer hospital's electronic medical record. We determined patients' initial symptoms from HC records, patient interviews, and phone surveys. RESULTS Nine thousand seven hundred sixty-three women received CC screening and CBE together; 7,616 additional women received CBE alone. Five hundred eighty-five women were referred from HCs to a district hospital (DH) for abnormal CBE; 200 were referred from the DH to the referral hospital. Twenty-nine women were diagnosed with BC; of these 19 (66%) were 50 or older and 23 (79%) had stage III/IV disease. Median interval from HC visit to referral hospital visit was 19 days (IQR 11.0-26.0). Among the 23 women with BC for whom we could identify their reason for initial HC presentation, all had sought care for breast symptoms. The remaining six had advanced-stage disease and symptomatic tumors at diagnosis. CONCLUSION During the initial rollout of this combined BC and CC screening program, no BC was diagnosed among asymptomatic women and 2/3 women diagnosed with BC were older than the target CC screening age. Adding CBE for all women receiving CC screening in LMIC may be low-yield. Given the high proportion of late-stage diagnoses, community awareness of early BC symptoms, high-quality CBE and timely referrals are important areas of focus.
    Type of Medium: Online Resource
    ISSN: 2687-8941
    URL: Article
    DOI: 10.1200/GO.22.56000
    Language: English
    Publisher: American Society of Clinical Oncology (ASCO)
    Publication Date: 2022
    detail.hit.zdb_id: 3018917-2
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  • 7
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    Integrating breast cancer screening into a cervical cancer screening program in three rural districts in Rwanda.
    American Society of Clinical Oncology (ASCO) ; 2020
    In:  Journal of Clinical Oncology Vol. 38, No. 15_suppl ( 2020-05-20), p. 2025-2025
    Details
    In: Journal of Clinical Oncology, American Society of Clinical Oncology (ASCO), Vol. 38, No. 15_suppl ( 2020-05-20), p. 2025-2025
    Abstract: 2025 Background: In low-income countries where mammography is not widely available, optimal strategies to facilitate earlier breast cancer detection are not known. We previously conducted a cluster randomized clinical trial of clinician trainings in Burera District in rural Rwanda to facilitate earlier diagnosis among symptomatic women; 1.3% of women evaluated at intervention health centers (HCs) were diagnosed with cancer. Early stage breast cancer incidence was higher in intervention areas. Subsequently, Rwanda Biomedical Centre, Rwanda’s national health implementation agency, adapted the program in 3 other districts, offering screening clinical breast exams (CBE) to all women aged 30-50 years receiving cervical cancer screening and any other woman requesting CBE. A navigator facilitated patient tracking. We sought to examine patient volume, service provision and cancer detection rate in the adapted program. Methods: We abstracted data from weekly HC reports, facility registries, and the referral hospital’s electronic medical record to determine numbers of patients seen, referrals made, biopsies, and cancer diagnoses from July 2018-December 2019. Results: CBE was performed at 17,239 visits in Rwamagana, Rubavu and Kirehe Districts (total population 1.34 million) over 18, 17 and 7 months of program implementation respectively. At 722 visits (4.2%), CBE was abnormal. 571 patients were referred to district hospitals (DH); their average age was 35 years. Of those referred, 388 (68.0%) were seen at DH; 32% were not. Of those seen, 142 (36.6%) were referred to a referral facility; 121 of those referred (85.2%) actually went to the referral facility. Eighty-eight were recommended to have biopsies, 83 (94.3%) had biopsies, and 29 (34.9% of those biopsied; 0.17% of HC visits) were diagnosed with breast cancer. Conclusions: Integrating CBE screening into organized cervical cancer screening in rural Rwandan HCs led to a large number of patients receiving CBE. As expected, patients were young and the cancer detection rate was much lower than in a trial focused on symptomatic women. Even with navigation efforts, loss-to-follow-up was high. Analyses of stage, outcomes, patient and provider experience and cost are planned to characterize CBE screening’s benefits and harms in Rwanda. However, these findings suggest building health system capacity to facilitate referrals and retain patients in care are needed prior to further screening scaleup. In the interim, early diagnosis programs targeting symptomatic women may be more efficient and feasible.
    Type of Medium: Online Resource
    ISSN: 0732-183X , 1527-7755
    URL: Article
    DOI: 10.1200/JCO.2020.38.15_suppl.2025
    RVK:
    XA 52760
    RVK:
    XA 10000
    Language: English
    Publisher: American Society of Clinical Oncology (ASCO)
    Publication Date: 2020
    detail.hit.zdb_id: 2005181-5
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