Abstract
Background: Guideline-concordant care (GCC) for DCIS includes surgery, radiation, and endocrine treatment. Active surveillance (AS) is a strategy under study for management of low risk DCIS. ...The PORTAL Study was designed to evaluate patient reported outcomes (PROs) after GCC for DCIS compared to women who received AS for DCIS combined with women with a history of other atypical lesions (atypical ductal hyperplasia (ADH), or atypical lobular hyperplasia/lobular carcinoma in situ (LN), as proxies for AS-managed DCIS. Methods: The PORTAL Study invited women age≥ 18, diagnosed with DCIS, ADH, or LN between 2012-2017 from 4 academic centers to complete a one-time, cross-sectional survey. Clinical, pathological, and treatment information was obtained from medical record review. The primary outcome was breast/chest wall pain assessed with the Breast Cancer Pain Questionnaire (BCPQ) including severity (10-point scale, ≥3=clinically relevant), a Pain Burden Index (PBI), which is a composite of severity, frequency, and location (breast, arm, side, axilla) and assessments of sensory disturbances, and impact of pain on emotional and physical functioning. Additional PROs included measures of generalized pain (Brief Pain Inventory), anxiety (STAI-Short Form), depression (CES-D), and QOL (Quality of Life in Adult Cancer Survivors). Pain, psychosocial, and QOL outcomes were compared between the GCC vs. AS groups using Wilcoxon Rank Sum and Chi-Square tests. Results: Of 1565 patients invited and sent a survey, 927 (59%) responded to the survey with evaluable pain outcome data. Median time from diagnosis was 3.8 years. Median age at survey completion was 58 (range: 26-94) years; 13% identified as non-White; 4% Hispanic. Among those with DCIS (n=554), 97% had GCC (62%, lumpectomy, 38%, mastectomy; 48%, radiation), representing 58% of participants vs 42% representing AS. The prevalence of clinically relevant pain was higher in the GCC vs. AS group (16.5% vs 9%, p=.0009). Median BCPQ-PBI, sensory disturbance, physical, and emotional impact scores were all higher (p<.0001) in the GCC vs. AS group (Table); BPI scores for pain severity and interference were similar between groups. QOL, anxiety and depressive symptoms were similar among women who had GCC compared to the AS group. Conclusion: Women with DCIS who have undergone GCC experience more breast/chest wall pain and report greater impact of pain on physical and emotional functioning in long term follow-up, compared to women who have undergone AS for DCIS or are managed for other atypical lesions. Given that many women with low risk DCIS may be unlikely to develop invasive cancer, improved understanding of the potential trade-offs of GCC vs AS can help support informed decision making in women with DCIS who are considering their treatment options. Ongoing prospective trials will provide further information regarding risks and benefits of AS vs GCC for women with low risk DCIS.
BCPQ Scores, GCC vs. ASGCCASMean (range)Median (IQR)Mean (range)Median (IQR)p*PBI6.4 (0-80)0 (0-9)2.9 (0-64)0 (0-0)<.0001Sensory disturbance1.4 (0-9)0 (0-2)0.6 (0-9)0 (0-0)<.0001Physical impact9.6 (0-67)0 (0-19)4.4 (0-56)0 (0-0)<.0001Emotional impact1.4 (0-33)0 (0-1)0.6 (0-38)0 (0-0)<.0001*Wilcoxon rank sum test comparing median scores
Citation Format: Shoshana M Rosenberg, Laura H Hendrix, Kristin L Schreiber, Alastair M Thompson, Isabelle Bedrosian, Kevin S Hughes, Thomas Lynch, Desiree Basila, Deborah E Collyar, Elizabeth S Frank, Sonja Darai, Conor Lanahan, Jeffrey R Marks, Jennifer K Plichta, Terry Hyslop, Ann H Partridge, E. Shelley Hwang. The Patient-reported Outcomes after Routine Treatment of Atypical Lesions (PORTAL) study: Pain, psychosocial wellbeing, and quality of life among women undergoing guideline concordant care for DCIS vs. active surveillance for in situ and atypical lesions abstract. In: Proceedings of the 2019 San Antonio Breast Cancer Symposium; 2019 Dec 10-14; San Antonio, TX. Philadelphia (PA): AACR; Cancer Res 2020;80(4 Suppl):Abstract nr P1-21-07.
Patient advocates' role in clinical trials Katz, Mira L.; Archer, Laura E.; Peppercorn, Jeffrey M. ...
Cancer,
1 October 2012, Letnik:
118, Številka:
19
Journal Article
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Background: Both Cb and Bev demonstrate activity when combined with standard chemotherapy in TNBC. CALGB 40603 is a 2x2 randomized trial that previously demonstrated that adding Cb ...to NACT significantly increased pathologic complete responses in the breast/axilla (pCR), while adding Bev did not (Sikov, JCO 2015). Here we report 5-year LTOs and assess factors that influenced them. Methods: 443 patients with clinical stage II-III previously untreated TNBC received 12 weeks of paclitaxel (wP) +/- Cb then dose-dense AC, +/- Bev before surgery. The primary endpoint was pCR. Analyses of LTOs (event-free survival (EFS), distant recurrence-free interval (DRFI) and overall survival (OS)), impact of residual cancer burden and other variables were secondary. Results: Median follow-up was 5.7 years (y); 5y EFS was 70.9% (95% CI; 66.7%-75.4%), DRFI 76.3% (72.3%-80.5%) and OS 76.9% (72.9%-81.2%). Pretreatment clinical stage and achieving pCR correlated with LTOs, while age, race, subtype (basal-like vs. not) and tumor grade did not. Among pCR 5y EFS was 86.4% vs. 57.5% for non-pCR (HR 0.28, 0.19-0.43), OS was 88.7% vs 66.5% (HR = 0.28, 0.17-0.44). This relationship was similar in all trial arms. Any residual disease conferred poorer outcome; compared with pCR/Residual Cancer Burden (RCB) 0, EFS HRs were 2.29 (1.32-3.97), 3.01 (1.90-4.74), and 9.67 (5.66-16.51) for RCBI, II and III, respectively. There were no improvements in LTOs with Cb (EFS HR 0.99, 0.70-1.40) or Bev (EFS HR 0.91, 0.64-1.29). In an exploratory analysis, receipt of ≥11 doses of wP was associated with better EFS (HR 1.92, 1.33-2.77); this was particularly notable in Cb-treated arms. Conclusions: As expected, regardless of treatment arm pCR was associated with markedly better LTOs, and pts with any residual disease had significantly worse outcomes. The addition of Cb or Bev to standard NACT for TNBC did not improve LTOs in this trial, although it should be noted that the trial was not powered for this endpoint. Omission of chemotherapy doses may result in poorer outcomes, especially among Cb-treated pts, which may warrant further evaluation. Support: U10CA180821; U10CA180882; Genentech; https://acknowledgments.alliancefound.org ; NCT00861705 Clinical trial information: NCT00861705.
: Clinical trials are essential in developing new treatments, care, and prevention for people with cancer. Unfortunately U.S. accrual rates for adult cancers are approximately 2–3%, partly due to the ...way the clinical trial system operates. Breast cancer patient advocates know enrollment has to accelerate to translate the many new scientific discoveries into effective use. Most newly diagnosed women, however, know nothing about clinical trials or why to consider them. The way a woman is approached about clinical trials can create fear and misunderstanding during a time when her body puts her into a physiological state of shock. These misunderstandings exacerbate the situation, and can lead to mistrust that will taint future medical interactions if they are not assuaged immediately. Many women, family members, and friends want to investigate clinical trials, but have no guide to help them through this daunting process. They have to contact many sources, decipher medical jargon, find a “clinical trial doctor,” and fight for insurance coverage. It is time for new approaches that make sense to patients. Clear information that helps people understand the value of research studies must also be presented in caring ways that reinforce the support people seek during crisis. Working together, cancer patient advocates and cancer researchers can provide this kind of useful information. The Clinical Trials Information Project (CTIP), a nonprofit organization established by patients and family members, has introduced a new approach through the CTIP Breast Cancer Kit
IntroductionDuctal carcinoma in situ (DCIS) is a non-invasive non-obligate precursor of invasive breast cancer. With guideline concordant care (GCC), DCIS outcomes are at least as favourable as some ...other early stage cancer types such as prostate cancer, for which active surveillance (AS) is a standard of care option. However, AS has not yet been tested in relation to DCIS. The goal of the COMET (Comparison of Operative versus Monitoring and Endocrine Therapy) trial for low-risk DCIS is to gather evidence to help future patients consider the range of treatment choices for low-risk DCIS, from standard therapies to AS. The trial will determine whether there may be some women who do not substantially benefit from current GCC and who could thus be safely managed with AS. This protocol is version 5 (11 July 2018). Any future protocol amendments will be submitted to Quorum Centralised Institutional Review Board/local institutional review boards for approval via the sponsor of the study (Alliance Foundation Trials).Methods and analysisCOMET is a phase III, randomised controlled clinical trial for patients with low-risk DCIS. The primary outcome is ipsilateral invasive breast cancer rate in women undergoing GCC compared with AS. Secondary objectives will be to compare surgical, oncological and patient-reported outcomes. Patients randomised to the GCC group will undergo surgery as well as radiotherapy when appropriate; those in the AS group will be monitored closely with surgery only on identification of invasive breast cancer. Patients in both the GCC and AS groups will have the option of endocrine therapy. The total planned accrual goal is 1200 patients.Ethics and disseminationThe COMET trial will be subject to biannual formal review at the Alliance Foundation Data Safety Monitoring Board meetings. Interim analyses for futility/safety will be completed annually, with reporting following Consolidated Standards of Reporting Trials (CONSORT) guidelines for non-inferiority trials.Trial registration numberNCT02926911; Pre-results.
Ductal carcinoma in situ (DCIS) is a non-invasive breast neoplasia that accounts for 25% of all screen-detected breast cancers diagnosed annually. Neoplastic cells in DCIS are confined to the ductal ...system of the breast, although they can escape and progress to invasive breast cancer in a subset of patients. A key concern of DCIS is overtreatment, as most patients screened for DCIS and in whom DCIS is diagnosed will not go on to exhibit symptoms or die of breast cancer, even if left untreated. However, differentiating low-risk, indolent DCIS from potentially progressive DCIS remains challenging. In this Review, we summarize our current knowledge of DCIS and explore open questions about the basic biology of DCIS, including those regarding how genomic events in neoplastic cells and the surrounding microenvironment contribute to the progression of DCIS to invasive breast cancer. Further, we discuss what information will be needed to prevent overtreatment of indolent DCIS lesions without compromising adequate treatment for high-risk patients.
The current leaders labor under assumptions that markets primed for profit are the priorities, independent of patient needs or promising scientific leads, forgetting how their companies once ...flourished. It is time to refocus the research system on the true meaning of translational research—to transform scientific discoveries into clinical tools that solve real patient problems. This chapter offers a glimpse into the (im)patient side of fundamental problems that thwart medical research efforts, confuse markets, discourage patients, and ultimately rescind profitability. There is no more time for systemic tweaking that produces but little frustration. Patients deal with the dilemmas posed by this broken system every day. It is time for all of the players to center the research culture on patients and turn collaboration into the norm. A candid discussion is presented on how our current system looks to patients who often feel betrayed by simplistic (and sometimes duplicitous) images about medical research and health delivery in the United States. It will take true understanding and new partnerships between traditional competitors, many stakeholders, and patient representatives to resolve the barriers that keep relevant and timely solutions from people. Many look forward to working toward a coherent process that puts patient needs first.
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