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Updates from #ASCO20
Jun 7, 2020

8 June 2020

The 2020 American Society of Clinical Oncology meeting was held virtually this year, from May 29-31. The abstracts below (title and conclusion) were curated by Dr. Erika Hamilton (@ErikaHamilton9), Dr. Stephanie Graff (@DrSGraff), Dr. Neelima Denduluri (@ndenduluri1) and Dr. Maryam Lustberg (@maryam_lustberg) – we are grateful for all they do for patients and for the #BCSM community! – DJA

Education Book Articles:

Scientific Abstracts: (link to all abstracts)

Metastatic:

1000, Cortes et al: KEYNOTE-355: Randomized, double-blind, phase III study of pembrolizumab + chemotherapy versus placebo + chemotherapy for previously untreated locally recurrent inoperable or metastatic triple-negative breast cancer. Pembro combined with several chemo partners showed a statistically significant and clinically meaningful improvement in PFS vs chemo alone in pts with previously untreated locally recurrent inoperable or metastatic TNBC whose tumors expressed PD-L1 (CPS ≥10). Pembro + chemo was generally well tolerated, with no new safety concerns.

1005, Lin et al: Tucatinib versus placebo added to trastuzumab and capecitabine for patients with previously treated Her2+ metastatic breast cancer with brain metastases (HER2CLIMB). In pts with heavily previously treated HER2+ MBC with BM, TUC in combination with T and C doubled the ORR-IC, reduced risk of IC progression or death by two thirds and reduced risk of death by nearly half. If approved, TUC in combination with T and C has the potential to become a new standard of care in pts with HER2+ MBC with and without BM. Clinical trial information: NCT02614794. The full manuscript has been published in the Journal of Clinical Oncology: Intracranial Efficacy and Survival with Tucatinib plus Trastuzumab and Capecitabine for Patients Previously Treated with Her2 Positive Breast Cancer with Brain Metastases HER2CLIMB)

1006, Rugo et al: Alpelisib (ALP) + fulvestrant (FUL) in patients (pts) with PIK3CA-mutated (mut) hormone receptor-positive (HR+), human epidermal growth factor receptor 2-negative (HER2-) advanced breast cancer (ABC) previously treated with cyclin-dependent kinase 4/6 inhibitor (CDKi) + aromatase inhibitor (AI): BYLieve study results. With follow-up still ongoing, BYLieve shows in a large number of pts that ALP + FUL demonstrates clinically meaningful efficacy and manageable toxicity post CDKi tx. Building on findings from SOLAR-1, BYLieve further supports use of ALP + FUL for HR+, HER2–PIK3CA-mut ABC. Clinical trial information: NCT03056755.

1007, Llombart-Cussac et al: PARSIFAL: A randomized, multicenter, open-label, phase II trial to evaluate Palbociclib in combination with fulvestrant or letrozole in endocrine-sensitive patients with estrogen receptor (ER)[+]/Her2[-] metastatic breast cancer. This study was not able to identify an improvement in PFS for PF over PL in patients with endocrine-sensitive ER[+]/HER2[-] MBC. As both arms demonstrated comparable 4 years-OS, PF is a reasonable alternative to PL in this setting. Clinical trial information: NCT02491983.

1008, Temel et al: Randomized trial of a collaborative palliative and oncology care intervention to improve communication about end-of-life care in patients with metastatic breast cancer. This novel collaborative palliative care intervention significantly improved communication and documentation regarding EOL care for women with MBC. Further work is needed to examine the effect of this care model on healthcare utilization at the end of life.

1009, Andre et al: Pooled ctDNA analysis of the MONALEESA (ML) phase III advanced breast cancer (ABC) trials. Results of this pooled analysis of the ML-2, 3, and 7 trials, the largest biomarker analysis of any CDK4/6 inhibitor in ABC, revealed several potential biomarkers of response (FRS2, MDM2, PRKCA, ERBB2, AKT1, and BRCA1/2) or resistance (CHD4, BCL11B, ATM, or CDKN2A/2B/2C) to RIB. Clinical trial information: NCT01958021; NCT02422615; NCT02278120.

1080, Ubbaonu et al: Disparities in the receipt of National Comprehensive Cancer Network (NCCN) guideline adherent care in triple-negative breast cancer (TNBC) by race/ethnicity, socioeconomic status, and insurance type. A significant portion of TNBC patients in California continue to receive non-guideline adherent care. Non-Hispanic black patients and lower SES quintile groups were less likely to receive guideline adherent care. Patients with non-adherent care had worse disease specific survival compared to recipients of NCCN-adherent care.

1086, Ekpo et al. Outcomes for black versus white women with stage IV breast cancer enrolled on investigator-initiated clinical trials at Emory. Black women with MBC who enrolled on IIT trials at Emory had worse treatment response and a trend towards poorer survival compared to White women. More research is needed to determine whether this is due to adverse biology. These results reinforce the need for exploration of biomarkers of response by race and ethnicity and improved representation of Blacks in clinical trials to inform real world efficacy.

Early Stage / Adjuvant:

503, Cortes et al Chemotherapy (CT) de-escalation using an FDG-PET/CT (F-PET) and pathological response-adapted strategy in Her2[+] early breast cancer (EBC): PHERGain Trial. F-PET identify pts with HER2[+] EBC who are more likely to benefit from CT-free dual HER2-blockade with HP. Follow-up is ongoing for iDFS endpoint. Depending on the results of this second co-primary endpoint, this strategy could select a group of HER2[+] EBC pts who would not need CT. Clinical trial information: NCT03161353.

507, Wang et al: Phase III trial of metronomic capecitabine maintenance after standard treatment in operable triple-negative breast cancer (SYSUCC-001). Maintenance therapy with metronomic capecitabine for one year following standard treatment significantly improved DFS in operable TNBC, which was safe and well tolerated. (SYSUCC-001, Clinical trial information: NCT01112826.

508, Cobleigh et al: Primary results of NRG Oncology / NSABP B-43: Phase III trial comparing concurrent Trastuzumab (T) and radiation therapy (RT) with RT alone for women with Her2-positive ductal carcinoma in situ (DCIS) after lumpectomy. The addition of T  to RT did not achieve the protocol objective of 36% reduction in the IBTR rate but did achieve a modest, statistically non-significant reduction of 19%. Support: U10-180868, -180822, UG1-189867; Genentech. The authors thank Elaina Harper and Marlon Jones for data management. Clinical trial information: NCT00769379.

512, Liefers et al. : Breast Cancer Index (BCI) predicts benefit of two-and-a-half versus five years of extended endocrine therapy in HR+ breast cancer patients treated in the IDEAL trial. Novel findings from this study demonstrate that BCI predicts endocrine benefit from extended letrozole in postmenopausal patients treated with primary adjuvant AI. These results support the growing body of evidence that BCI by H/I status predicts preferential endocrine response in distinct subgroups of patients, and further support its role as an important genomic tool to inform the risk-benefit regarding duration of extended endocrine therapy. Clinical trial information: NTR3077, BOOG 2006-05, Eudra-CT 2006-003958-16.

513, Paterson et al: Validation of MAF biomarker for response prediction to adjuvant bisphosphonates in 2 clinical trials: AZURE and NSABP-B34. MAF benefit prediction from adjuvant bisphosphonates was confirmed using specimens from 2 randomized clinical trials (AZURE and NSABP-B-34) conducted and analyzed in similar manner using the same validated tests and clinical endpoints. These results are evidence towards introducing MAF testing into clinical practice.

517, Lim et al. Comprehensive profiling of androgen receptor-positive (AR+) triple-negative breast cancer (TNBC) patients (pts) treated with standard neoadjuvant therapy (NAT) =+/- enzalutamide. The LAR TNBC subtype has a low pCR rate to NAT. Among pts with AC- TNBC, baseline upregulated androgen response pathway and LAR subtype may benefit from the ZT regimen, potentially by PI3K targeting. Clinical trial information: NCT02689427.

525, Elder et al. Early-stage breast cancer (BC) patients: Factors associated with aromatase inhibitor-induced musculoskeletal symptoms. 56% of BC pts on adjuvant AI therapy experienced AIMSS. 24% of these changed, held or discontinued AI regimen due to severe AIMSS. Higher BMI at diagnosis was associated with a higher risk of AIMSS. Our results confirm clinical significance of AIMSS among BC pts on AI therapy and suggest BMI as a modifiable factor for AIMSS. A larger study is warranted to replicate our findings and seek other possible risk factors for AIMSS.

527, Foldi et al. Adherence to extended adjuvant endocrine therapy following Breast Cancer Index (BCI) testing in women with early-stage hormone receptor (HR)-positive breast cancers. In pts who continued ET beyond 5 years based on BCI testing and discussion with their oncologist, the rates of adherence and persistence to EET were higher than those previously published. EET may increase the number of DXA scans performed.

528, Owusu et al. Safety and efficacy of single-agent adjuvant Trastuzumab in older women with early-stage breast cancer. Among older women with stage I-III HER2-positive breast cancer who decline chemotherapy or are not chemotherapy candidates, treatment with her2 targeted therapy only without chemotherapy may offer a reasonable treatment option without an inordinate rate of cardiac toxicity. Clinical trial information: NCT00796978.

533, Neuner et al. Factors associated with adjuvant endocrine therapy adherence in non-metastatic breast cancer. Medication delivery factors are associated with adherence to breast cancer AET. Future work should investigate whether interventions to streamline medication delivery could improve adherence for this population.

534, Dankwa-Mullan et al. Disparities in receipt of and time to adjuvant therapy after lumpectomy. Results from this cohort of privately insured patients demonstrate disparities in receipt of post-BCS adjuvant radiation and systemic therapy along multiple demographic dimensions and expose opportunities to promote timely receipt of care.

536, Woodward et al: Trends in utilization of hypo fractionated whole breast radiation in breast cancer: An analysis of the National Cancer Database. Despite studies demonstrating the efficacy of its use and the support of ASTRO, HR utilization in the U.S. is still lacking. By understanding which patient populations are still not receiving the benefit of this therapy we can improve our utilization of HR in the U.S. leading to reduced healthcare costs and patient satisfaction.

537, Lee et al. Impact of delays in initiation of adjuvant endocrine therapy and survival among patients with breast cancer. These results suggest that there may be no detriment to survival if initiation of adjuvant endocrine therapy occurs 12 to 24 months after initial diagnosis compared to within 12 months of diagnosis, as currently recommended.

539, Woodward et al: Is hypofractionated radiation associated with improved timely completion of adjuvant radiation in breast conserving therapy? A National Cancer Database study. The decision between use of HR or TR in BCT is an essential component in treatment of breast cancer patients. Providers may improve mortality and DFS by identifying patients who are more likely to finish HR or TR on time based on patient, facility, and tumor factors.

Surgery:

LBA2, Khan et al. A randomized phase III trial of systemic therapy plus local early therapy versus systemic therapy alone in women with de novo stage IV breast cancer: A trial of the ECOG-ACRIN Research Group (E2108). Early local therapy does not improve survival in patients with de novo metastatic breast cancer and an IPT. Although there was a 2.5-fold higher risk of local disease progression without LRT, LRT of the IPT did not lead to improved HRQOL. Clinical trial information: NCT01242800.

519, Ryser et al: Ipsilateral invasive breast cancer risk after diagnosis with ductal carcinoma in situ (DCIS): Comparison of patients with and without index surgery. Despite an increased risk of iIBC in SV patients compared to BCS patients, the 8-year risk did not exceed 10% in either group. The risk of recurrence in BCS patients was comparable to previously reported estimates. These data demonstrate a considerable degree of overtreatment among patients with non-high grade DCIS. Prospective clinical trials will help determine the tradeoffs between universally directed as opposed to selectively applied surgery for low risk DCIS.

520, Pfob et al. Towards data-driven decision-making for breast cancer patients undergoing mastectomy and reconstruction: Prediction of individual patient-reported outcomes at two-year follow up using machine learning. We reveal the crucial role of patient-reported outcomes in determining post-operative outcomes and that Machine Learning algorithms are suitable to identify individuals who might benefit from alternative treatment decisions than suggested by group-level evidence. We provide a web-based tool for individuals considering mastectomy and reconstruction. importdemo.com. Clinical trial information: NCT01723423.

569, McManus et al: Breast cancer patient reported outcomes, depression, and objective measures of cosmesis. Our study suggests that PROs may not always reflect the effects of cancer treatment. For patients treated with BCT, baseline depression strongly influenced patient reported happiness with overall cosmetic outcome 1 year post-XRT. Perceived differences in the treated vs. untreated breast correlated with objective measures of breast asymmetry. Our data suggests that this PRO may be more indicative of treatment-related toxicities than patient ratings of overall satisfaction and happiness with cosmetic outcome. Clinical trial information: NCT03167359.

570, Lim et al: Psychosocial outcomes following surgery in women with unilateral, nonhereditary breast cancer. Definitive surgical procedure affects the trajectory of psychosocial functioning over time. This emerging data may be used to further facilitate surgical decision-making in women considering contralateral prophylactic mastectomy.

576, Chavez-MacGregor et al: Re-excision rates among older breast cancer patients undergoing breast-conserving surgery (BCS): Impact of the SSO-ASTRO consensus guideline on margins. There has been a statistically significant decrease in the re-excision rate after BCS associated with the dissemination of the SSO-ASTRO consensus guideline on invasive margins. Our study confirms the impact that guidelines have modifying patterns or practice, reducing the frequency of unnecessary interventions.

Male Breast Cancer:

587, Leone et al. Efficacy of neoadjuvant chemotherapy (NAC) in male breast cancer (MaBC) compared with female breast cancer (FBC): A national cancer database (NCDB) study. Men receiving achieved lower proportions of pCR than women and had significantly worse OS. However, pCR is prognostic in both MaBC and FBC. Limitations include small sample sizes for HR-/HER2+ hormone receptor negative / Her2/neu positive and triple-negative TS and lack of detailed regimen information. Nevertheless, our results suggest that, compared with FBC, MaBC may be intrinsically more resistant to NAC.

e13619, Cavalcante et al. Male breast cancer: Epidemiological and clinical outcomes. Our results are consistent with those from previous literature, regarding histology, biomarkers and later stage at diagnosis. A quarter of our patients had high CCI and this could had impacted on best treatment option choices. Treatment approaches use to be similar from those of female population. However, as disease biology and hormonal physiology are different between gender, there is a lack of specific protocols and trials in male population.

e13690, Khoury et al. Characteristics and survival of secondary male breast cancer: SEER database analysis. Men diagnosed with breast cancer are at increased risk of sMBC in addition to other malignancies which require careful monitoring after completing initial treatment. Contralateral mammogram screening or prophylactic contralateral mastectomy can be considered based on patient’s preferences and values.

Survivorship:

LBA110, Warner et al. Clinical impact of COVID-19 on patients with cancer: Data from the COVID-19 and Cancer Consortium (CCC19). All-cause 30-day mortality and severe illness in this cohort were significantly higher than previously reported for the general population and were associated with general risk factors as well as those unique to patients with cancer. Cancer type and treatment were not independently associated with increased 30-day mortality. Longer follow-up is needed to better understand the impact of COVID-19 on outcomes in patients with cancer, including the ability to continue specific cancer treatments.

12003, Wardley et al. ACUFOCIN: Randomized clinical trial of ACUpuncture plus standard care versus standard care FOr Chemotherapy Induced peripheral Neuropathy (CIPN). In this patient cohort, a 10 week course of acupuncture significantly improved symptoms of CIPN. These results support further investigation within a phase III trial. Clinical trial information: NCT02275403.

12004, Mao et al. Effects of electroacupuncture and auricular acupuncture for chronic pain in cancer survivors: The PEACE randomized controlled trial. Among cancer survivors with chronic musculoskeletal pain, both EA and AA effectively reduced pain and improved quality of life. AA was non-inferior to EA at reducing pain but associated with higher discontinuation rates. These results will guide implementation of acupuncture in oncology care to address the unmet pain management needs of cancer survivors in the era of the opioid epidemic. Clinical trial information: NCT02979574.

12005, Mustian et al. Effects of YOCAS yoga, cognitive behavioral therapy, and survivorship health education on insomnia: A URCC NCORP Research Base Phase III RTC in740 cancer survivors. YOCAS yoga is better than SHE and results are inconclusive as to whether yoga is non-inferior to CBT-I for treating insomnia among survivors. Clinicians should consider prescribing YOCAS and CBT-I for survivors reporting insomnia. Funding: NCI UG1CA189961, R01CA181064, T32CA102618. Clinical trial information: NCT02613364.

12008, Grimison et al. Results of crossover phase II component of randomized placebo-controlled trial evaluating oral THC/cannabis extract for refractory chemotherapy-induced nausea and vomiting (CINV). Addition of oral THC/CBD to standard anti-emetics was associated with less nausea & vomiting but additional side effects. Most preferred THC/CBD to placebo. Based on these positive results, the definitive parallel phase 3 trial component continues (additional n=170). Acknowledgements: Trial participants, investigators, research staff. Funding from NSW Government Dept of Health. Clinical trial information: ACTRN12616001036404.

12009, Mohile et al. A geriatric assessment (GA) intervention to reduce treatment toxicity in older patients with advanced cancer: A University of Rochester Cancer Center NCI community oncology research program cluster randomized clinical trial (CRCT). Providing GA information to oncologists reduces the proportion of older pts who experience grade 3-5 toxicity from high-risk palliative cancer treatment, without compromising OS. Reduced treatment intensity at cycle 1 may explain these results. Funding: R01CA177592, U01CA233167, UG1CA189961. Clinical trial information: NCT02054741.

12016, Greenee et al. Risk of cardiovascular disease in women with and without a history of breast cancer: The Pathways Heart Study. Women with BC were at increased risk of heart failure, cardiomyopathy, cardiac arrest, VTE and carotid disease. These risks varied by cancer treatment, with higher risk in those who received chemotherapy. Future studies should explore the effects of chemotherapy class and radiation dose exposure on diverse CVD endpoints in BC survivors.

12017, Kwan et al: Onset of cardiovascular disease risk factors in women with and without a history of breast cancer: The Pathways Heart Study. The risk of developing hypertension and diabetes is increased in women with BC who received chemotherapy, radiation therapy, and/or endocrine therapy. Future studies should examine the roles of CVD risk factor diagnosis and management on cardiometabolic risk in women with a BC history.

12019, Hershman et al. Predictive model of aromatase inhibitor non-adherence using patient-reported outcomes in women with breast cancer (SWOG S1105). Presence of multiple baseline risk factors identified through PRO instruments increases non-adherence to AI’s 4-fold. Use of PROs can identify patients for targeted interventions to improve adherence.

12073, Landier et al: Financial toxicity among breast cancer survivors with health insurance. Financial toxicity is prevalent among insured breast cancer survivors several years after cancer diagnosis, and is exacerbated among the younger survivors who are single, with low household income, and endorse poorer physical and mental quality of life. These findings inform the need to develop interventions to mitigate financial toxicity among at-risk breast cancer survivors.

12072, Giordano et al. Patient reported outcomes in older breast cancer survivors. Older breast cancer survivors, particularly those who were treated with chemotherapy, experience a high symptom burden.

12053, Sheng et al. The impact of weight loss on physical function in overweight or obese breast cancer survivors. For overweight/obese breast cancer survivors, PF and other PROs improved among patients who lost ≥5%. These results support the patient-centered benefits of weight loss in this population. 

12115, Liu et al: CIFeR: A novel clinician-lead intervention to address fear of cancer recurrence (FCR) in breast cancer survivors. A brief oncologist-delivered intervention to address FCR is helpful and feasible, and has shown preliminary efficacy in reducing FCR. Plans for an implementation study amongst oncologists in Australia are underway. Clinical trial information: ACTRN12618001615279.

Palliative Care:

12001, Smith et al. A Randomized trial of a palliative care intervention for patients on phase I studies. Palliative care interventions can improve QOL outcomes and distress for patients participating in phase 1 trials. Greater integration of PC is needed to provide quality care to these patients and to support transitions from treatment to supportive care, especially at the end of life. Clinical trial information: NCT01828775.

12002 Manz et al. Effect of integrating machine learning mortality estimates with behavioral nudges to increase serious illness conversations among patients with cancer: A stepped-wedge cluster randomized trial. An intervention consisting of machine learning mortality estimates and behavioral nudges to oncology clinicians increased SICs by three-fold over 16 weeks, a significant difference.This is one of the first studies evaluating a machine learning-based behavioral intervention to improve serious illness communication in oncology. Secondary analyses (completed April 2020) will clarify whether this intervention leads to a sustained increase in SIC rates and improves goal-concordant care and end-of-life outcomes. Clinical trial information: NCT03984773.

12021, Subbiah et al. Integrating PROs with prognostic value into oncologic care: High ESAS global distress score associated with lower overall survival in advanced cancer patients. Higher GDS score was associated with a clinically significant decrease in overall survival highlighting the potential of the ESAS as a PRO tool in prognostication and clinical decision making for patients with advanced cancers with a high symptom burden. In the realm of increasingly complex PRO instruments, the ESAS represents a simple, well-validated tool which, in our studies and 25 years of clinical experience, takes the patient less than a minute to complete, with subscores such as the GDS which carry a highly prognostic utility for patients with advanced cancers.

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