bluuebunny/crossref_metadata_2025 huggingface dataset:
Endocrine therapy discontinuation rates in older women with early stage breast cancer who are candidates for omission of radiation.
Authors: Egloff Heidi , Swartz Leigh Klaus , Fang Fang , Kidwell Kelley M. , Schott Anne F.
Published: May 2019

e23018

Background: As the treatment for early-stage breast cancer continually evolves, there has been a pragmatic shift with regard to standard treatment placing a high-value on multidisciplinary management. Recent studies have shown that sentinel lymph node biopsy (SLNB) and adjuvant radiation (RT) can be omitted in a subset of older women with early-stage hormone receptor positive breast cancer who plan to take adjuvant endocrine therapy (ET). Prior analyses estimate a wide range of discontinuation rates, with studies citing 31-73%. The primary aim of this analysis is to estimate the discontinuation rate of endocrine therapy in women ages 70 and older with early stage breast cancer who omit radiation therapy at our institution. Methods: We performed a retrospective review of institutional cancer registry and EMR data to identify all women with breast cancer, ages 70 or older, AJCC 7 stage I or II, hormone receptor positive, HER2 negative, who underwent lumpectomy at the University of Michigan inclusive of years 2014 through 2017. Multiple variables of interest were collected and analyzed. Results: 174 women met initial inclusion criteria for ER/PR positive, HER2 negative, Stage I/II disease, who underwent lumpectomy. Of these, N = 10 pursued adjuvant radiation therapy with omission of ET, and N = 19 declined both ET and RT upfront. The remaining 145 women chose to pursue ET alone (N = 78) or ET+RT (N = 67). 30/145 (21%) discontinued endocrine therapy, 22% (N = 15) in the ET+RT, 19% (N = 15) in the ET alone groups. There was no statistically significant difference between groups with regard to the discontinuation of ET upon comparison, log-rank p-value 0.4. The primary reason for ET discontinuation, N = 27 (90%) was secondary to side effects. Conclusions: This review demonstrated that a significant number (54%) of older women opt to omit radiation in favor of ET alone after multidisciplinary discussion, in accordance with NCCN guidelines. Endocrine therapy discontinuation rates among older women at our institution were comparable to rates in the literature for women of all ages, and the reason for discontinuation was attributed to side effects. The pivotal clinical trials (PRIME II and CALGB 9343) exploring ET alone versus ET+RT did not report on ET discontinuation rates. In our analysis, almost 20% of women receiving ET alone discontinued ET therapy, calling into question a missed radiation treatment opportunity in a curative setting.
Comprehensive geriatric assessment prior to autologous stem cell transplant as a predictor of patient outcomes: A retrospective review.
Authors: Sokol Kelsey , Rhoades Ruben , Leiby Benjamin E. , Binder Adam , Chapman Andrew E. , Porcu Pierluigi , Flomenberg Neal , Grosso Dolores , Palmisiano Neil David
Published: May 2019

e23023

Background: While autologous stem cell transplant (ASCT) has been shown to be safe and effective in the geriatric population, age alone is not a sufficient predictor of outcomes. Minimal data exists regarding the use of a comprehensive geriatric assessment (CGA) tool prior to ASCT as a predictor of patient outcomes. This study aims to assess our institution’s pre-ASCT CGA on its ability to predict transplant-related outcomes in the elderly. Methods: We retrospectively analyzed all patients age 65 years of age and older (n = 68) who received ASCT at Thomas Jefferson University Hospital between 2012 and 2018 for multiple myeloma (MM) (n = 52), AL amyloidosis (n = 1), combined MM/amyloidosis (n = 2), B-NHL (n = 11), T cell lymphoma (n = 2), and Hodgkin lymphoma (n = 1). The CGA consists of 13 components, culminating in an overall frailty status. Kaplan-Meier survival estimates were used to assess overall survival (OS) and progression free survival (PFS), and multivariable logistic regression and Cox proportional hazard regression were used to determine associations between CGA variables and relevant post-ASCT outcomes. Results: Among the 68 patients (43 males, 25 females) who received ASCT, the median age was 68 years (range 65-78). Fifty-one patients (75%) underwent pre-transplant CGA. Among the entire cohort, 2-year OS and PFS were 95.4% and 79.6%, respectively. Median OS was not reached, and median PFS was 48.5 months. There was no difference in OS between patients who underwent CGA and those who did not (P = 0.937). Multivariate analysis revealed that none of the variables in the CGA were predictive of patient outcomes, such as OS, length of stay on ASCT admission, 30-day readmissions, and falls. Conclusions: This single-institution data suggests that ASCT is safe and highly effective in geriatric patients. Undergoing a CGA was not associated with improved outcomes, and none of the CGA components including frailty status were predictive of outcomes in this preliminary data set. Our data suggest that further refinement of the CGA may improve its predictive ability. Future studies examining additional outcomes, including patient-reported quality-of-life outcomes, are warranted.
Effect of fractures on overall survival in cancer patients: The NHANES database.
Authors: Edwards Beatrice Jara-Almonte , Zhang Xiaotao
Published: May 2019

e23024

Background: Fractures are a significant cause of morbidity, institutionalization and mortality in older adults who are cancer-free. We evaluated the effect of fractures on overall survival in older patients with cancer. Methods: The National Health and Nutrition Study (NHANES) assessed the health and nutritional status of the U.S. The NHANES database is publicly available, and this study was exempt from approval by an institutional review board. All participants provided informed consents both before the interview and examination stages. A total of 62,160 individuals participated in NHANES during 1999-2010. We restricted our analyses to older adults (65 years of age and older) with self-reported cancer diagnosis, with a follow-up till 2011. Results: In total, 1,718 older adults with cancer and with available follow up were included for final analysis. There were 303 participants with fractures (17.6%) and 581 deaths (33.8%) that occurred over a median follow up 4.3 years (range 0.1-12.8 years). Mean age was 74.8 ± 0.2, with females 49.6%. Cancer types included solid tumors and hematologic malignancies. Among solid tumors, colorectal 9.0%, breast cancer 17.4%, prostate cancer 17.7%, lung 3.0%. Among hematologic malignancies, lymphoma 1.6%, myeloma 7.2%, CLL 1.2%. Hip fractures were associated with advanced age, obesity, diabetes, stroke, functional impairment, and mortality. Spine fractures were associated with advanced age, cardiovascular disease, functional impairment and mortality. Univariate analysis for factors associated with overall survival in older adults in NHANES revealed an increased risk with spine fractures H.R. = 1.89, (95% CI 1.11, 3.2, p = 0.02) and hip fractures H.R. = 2.66, (95% CI 1.41, 5.02, p < 0.01). Conclusions: In older cancer patients vertebral and hip fractures were associated with an increased risk for mortality.
Propensity score matching analysis of the survival outcome and toxicity of different treatment modalities for the elderly nasopharyngeal carcinoma patients.
Authors: Tan Mingyu , Feng Mei , Huang Yecai , Xu Peng , Xu Ke , Yin Jun , Li Lu , Qi Yunxiang , Lang Jinyi
Published: May 2019

e23029

Background: With the aging society was coming, more elderly nasopharyngeal carcinoma NPC patients should be pay attention. However, no guideline is proposed for them due to lack of prospective clinical trials. We aimed to use propensity score matching method to evaluate the survival outcome and toxicity of the different treatment modalities for them. Methods: II-IV(UICC 8th) elderly NPC patients (≥65 years) were retrospectively enrolled between 2004 to 2016 in our center. All the patients received definitive IMRT, and were allocated into radiotherapy only (RT), concurrent chemoradiotherapy (CCRT) and neoadjuvant chemotherapy followed with CCRT (NACT). Cisplatin-based chemotherapy was used. Survival outcomes and toxicity were analyzed using propensity score-matching method. Results: There were 142 patients included, and the median age was 68 years. The median follow-up time was 47 months. 23 patients received RT only, 61 patients received CCRT and 58 patients received NACT. After matching for gender, age, T and N stage, chemotherapy and non-chemotherapy patients (22 pairs) were analyzed and shown the chemotherapy group had a better OS (86% vs 68%, p= 0.031). The 3-years LRFS, DMFS and DFS of chemotherapy and non-chemotherapy was 95% and 85% ( p= 0.251), 95% and 86% ( p= 0.307), 86% and 73% ( p= 0.309). Furthermore, 41 pairs who underwent chemotherapy were sub-analyzed according to different modalities. CCRT group showed a comparable 3-years LRFS (100% vs 94%, p= 0.143), DMFS (87% vs 89%, p= 0.608), DFS (81% vs 84%, p= 0.892) and OS (79% vs 66%, p= 0.080) with NACT. For acute toxicity, the incidence of G3-5 bone marrow suppression in non-chemotherapy was significantly lower than chemotherapy group (8.7% vs 36.4%, p= 0.31), and the incidence of G3-5 mucositis was similar ( p= 0.517). Besides that, there was no significant difference in the incidence of G3-5 bone marrow suppression and mucositis between CCRT and NACT group ( p= 0.824, p= 0.618). Conclusions: Chemoradiotherapy could improve the survival rate of the elderly NPC patients compared with radiotherapy only. The acute toxicity of CCRT and NACT was similar and acceptable. CCRT was still the standard treatment modality for them. As for the elderly NPC patients who are in good performance status and comorbidity conditions, NACT might be also worthy of recommendation.
Analysis of proportion of geriatric patients in phase III cancer clinical trials.
Authors: Gopishetty Swathi , Kota Vamsi , Guddati Achuta Kumar
Published: May 2019

e23032

Background: Geriatric patients are often under-represented in cancer clinical trials. The presence of multiple comorbidities makes geriatric patients ineligible for most clinical trials. However, the increase in cancer incidence in geriatric patients raises the question of applicability of the results is such clinical trials. Methods: Data about Phase 3 trials was extracted from the clinical trials.gov for 3 common solid organs and 3 hematological malignancies [breast, colon, lung, diffuse large B-cell lymphoma (DLBCL), acute myeloid leukemia (AML) and acute lymphoblastic leukemia (ALL)]. The time period studied was for the past 10 years and included only adult patients (≥ 18 years). The age distribution of the patient population in these trials were extracted and analyzed. Results: Geriatric patients are heavily under-represented in all phase 3 cancer clinical trials. Table shows the proportion of patients below 65 years, above 65 years and older in clinical trials for each organ specific malignancy. The range of the proportion of geriatric patients varied from 10% to 40%. Conclusions: The results of phase 3 clinical trials that are currently conducted on non-geriatric patient population may not meaningfully be applicable to geriatric patients. This study highlights the disparity of age for patients enrolled in clinical trials as against the patients seen in the real world.[Table: see text]
Baseline laboratory tests as predictors of early death risk in 746 elderly oncologic patients: A prospective cohort study.
Authors: Telles Sales Letícia , Telles O Lima Jurema , Mello Maria Julia Gonçalves , Torres Leuridan , Pires maria Luiza lemos , Rebello Mirella , d'Almeida Carolina Vanderley Menezes , Orange Flavia , Bergmann Anke , Thuler Luiz Claudio Santos , Orange Flavia
Published: May 2019

e23039

Background: The elderly population is the thoroughly affected by new cases of cancer, as well as by its complications. The occurrence of early death (in the first six months after diagnosis) is one of the most important outcomes to be studied in this population. This study aims to identify if simple baseline laboratory tests can be used as predictive factors for early death in older cancer patients. Methods: Prospective cohort enrolled elderly patients ≥ 60 years with a recent cancer diagnosis admitted between 2015 -2017. Sociodemographic, tumor-related and laboratorial (leukocytes, creatinine, platelets and hemoglobin) variables were collected at admission and analyzed. Survival analysis (Kaplan-Meier) and Cox proportional hazard regression was performed. The outcome was a six-month death. Descriptive, univariate and multivariate analysis of Cox proportional hazards and Kaplan-Meier global survival were performed. Results: A total of 746 patients with an average of 71 (± 7.4) years were eligible. 16.5% died in the first six months after diagnosis. Risk factors for early death were controlled by age. Leukocytes < 4,000 / mm3 or > 12,000 / mm3 (HR 2.51 IC95% 1.68-3.75), Creatinine > 1.7mg / dL (HR 2.14 95% CI 1.37-3.36), Platelets < 150,000 / mm3 or > 300,000 / mm3 (HR 1.92 CI 95% 1.31-2.80) and Hemoglobin < 12 g / dL if female, or < 13 g / dL, if male (HR 1.89 95% CI 1.27-2.83) were all associated with greater risk of dying in the first six months after diagnosis (log rank < 0.001). Conclusions: Baseline laboratory tests performed at the hospital admission of the elderly cancer patient may be a simple way to help the clinician to identify patients at higher risk of early death.
The effects of wheatgrass juice administration in colon cancer patients during adjuvant chemotherapy and the treatment reflection on the extracellular vesicles.
Authors: Bar-Sela Gil , Avisar Adva , Shentzer Kutiel Talia , Cohen Miri , Aharon Anat
Published: May 2019

e23045

Background: Adjuvant chemotherapy is recommended in stage II-III colorectal cancer (CC). Wheatgrass juice (WGJ), has high nutritional values may attenuate chemotherapy adverse events (AE). Extracellular vehicles (EVs) are subcellular membrane blebs that provide information on cellular processes. Aim: To evaluate the incidence of chemotherapy AE and to elucidate the effects of supportive treatment of WGJ on CC patients’ EVs characteristics. Methods: In a prospective trial between 3/2014- 7/2017, 99 patients stage II-III CC, treated with standard adjuvant chemotherapy were enrolled. According to patient preference, they were divided into: control group of 50 (CC-C) patients and intervention group of 49 patients who received chemotherapy plus consumption of daily 60cc frozen WGJ (CC-W). EVs were isolated from the blood samples of 15 healthy controls (HC) and 25 patients from each study group. Blood samples were taken before, during and at the end of chemotherapy, EVs characterized by membrane antigens/cytokine content Results: Study groups were well balanced. Median follow-up time was 15 months. Eleven patients had died at the time of analysis, 3 in the WGJ and 8 in the control ( p= 0.142). 11/50 (22%) and 8/49 (16.3%) had severe diarrhea in the control and WGJ groups, respectively ( p= 0.47). There was no difference between the groups in RFS (HR = 1.19 , p= 0.69). Higher levels of endothelial EVs (CD34+41, CD144), indicating vascular injury, were found in CC-C patients- compared to CC-W during and at the end of treatment. Increased EVs thrombogenicity in patients was documented, while EVs thrombogenicity was lowered in CC-W compared to CC-C during or at the end of treatment (TF, P = 0.029; TF/TF-pathway inhibitor (TFPI) ratio, p = 0.008; endothelial protein C receptor 0.005 and annexin-V 0.05). Following treatment, the majority of growth-factors/pro-inflammatory cytokines were found to be lower in CC-W than in CC-C. Conclusions: Daily consumption of WGJ during chemotherapy may reduce vascular damage and thrombogenicity. There was no statistical difference in overall survival. However, the large difference in death rate may relate to other long-standing effects of daily WGJ consumption. Clinical trial information: NCT01991080.
Exercise trends among previously non-exercising breast cancer survivors: Analysis of an ethnically diverse sample.
Authors: Oza Sonal , Blinder Victoria Susana , Tran Christina , Patil Sujata , Gany Francesca , Roberts Nicole , Kampel Lewis J. , Malik Manmeet , Bao Ting
Published: May 2019

e23048

Background: Exercise is associated with improved symptoms and breast cancer (BC) survival. Little is known about personal and social factors that determine exercise participation in diverse BCS. The study seeks to characterize exercise trends and distinguish factors associated with initiating exercise among pre-diagnosis employed, non-exercising, ethnically and socioeconomically diverse BCS. Methods: BCS were recruited from academic and community medical centers. Women with stage I-III BC were surveyed during and 4 months post-completion of active treatment (surgery +/- chemo +/- radiation). The primary outcome was exercise initiation 4 months post treatment. Variables were self-reported except for clinical cancer variables, which were abstracted from the medical record. Results: Our sample (n = 494) included 22% black, 20% Chinese, 8% Korean, 27% Latina, and 21% non-Latina white women (3% other). 56% were born outside of the US; 30% reported an income < 200% of the federal poverty level (FPL). 72% of BCS exercised the year before diagnosis; 28% did not. Significant correlates (p < 0.05) of NOT exercising pre-diagnosis included lack of post-secondary education, Chinese or Korean ethnicity, lack of alcohol consumption, and lower acculturation level, resilience, and income. Among 138 non-exercisers, 63% reported exercising at follow-up. Significant correlates of exercise initiation are listed in table. In a multivariable model that included age, acculturation, job loss, insurance status, chemo-, and radiotherapy (RT), receipt of RT was significantly associated with exercise initiation (OR 3.1, 95% CI 1.4-7.1). Conclusions: A BC diagnosis may be an impetus to initiate exercise among previously sedentary, employed women. Patients who undergo radiotherapy appear to be more likely to start exercising. Additional research is needed to understand why some patients initiate exercise while others do not. [Table: see text]
Annual lung cancer screening by chest x-ray results in higher profits for the exclusion of lung cancer.
Authors: Kimura Tatsuo , Fukumoto Shinya , Morikawa Hiroyasu , Nakano Akemi , Otani Koji , Tauchi Yukie , Uemura Risa , Suzumura Tomohiro , Ogawa Koichi , Kawaguchi Tomoya , Kawada Norifumi
Published: May 2019

e23050

Background: Chest X ray (CXR) has been the most common screen procedure for detection of lung cancer. However, if patients had old inflammatory shadows such as tuberculosis, calcification and fibrotic changes, it would become increasingly difficult to detect the lung cancer. In that case, the previous CXR helps the detection of new shadows. We examine whether the repeat participants (pts) who received the medical checkup annually, may improve the rate of lung cancer detection. Methods: Our clinic “MedCity21” was a university outpatient clinic to undergo a complete medical checkup in private health screening program. The pts with abnormalities detected in CXR were announced by call request and invited to our specialty clinic for chest CT scan as further examination. We examined the varieties of abnormal shadows by CXR and CT scans in recent 3 years. Furthermore, we compared the differences between the repeat and the first-time pts using the chi-square tests. Results: In 2016, 2017 and 2018, a total of 10020, 11925 and 12540 pts were enrolled, respectively.　The CXR abnormalities for further examinations were detected in 282 (2.8%), 344 (2.9%) and 335 (2.6%) pts, respectively. After the call requests, 203 (72.0%), 239 (69.4%) and 239 (71.3%) pts received chest CT scan in our clinic. In 2016 and 2017, 7 and 9 pts were diagnosed as lung cancer within 12 months follow-up. In 2018, 6 pts were diagnosed as lung cancer, and another 4 pts were now observed. The numbers of lung cancer detections by CXR per 100,000 people were 70.0, 75.5 and ≥47.8, respectively. The repeat / first time pts in 2018 were 6898/5642 pts (55/45%), and 142/193 pts (2.1/3.4%) had CXR abnormalities (p < 0.01), respectively. The varieties of abnormal shadows by CT scans showed that 8.3/20.8% of old inflammatory shadows (p < 0.01), 11.9/20.7% of nodule or GGO (p = 0.47), 12.8/12.3% of Mycobacterial infections or suspected (p = 0.46), and 11.0/6.9% of acute bacterial infections (p = 0.98). Lung cancer was detected in 3/3 pts (p = 0.86), respectively. Conclusions: The repeat pts had significantly lower rate of CXR abnormalities detection, and the first time pts had higher rate of error detection old inflammatory changes as significant. In private health screening program, the repeat pts may have higher profits for the exclusion of lung cancer than the first time pts.
Neighborhood effects and obesity in adult survivors of pediatric cancer: A report from the St. Jude Lifetime Cohort Study.
Authors: Howell Carrie R. , Wilson Carmen Louise , Yasui Yutaka , Srivastava Deo Kumar , Liu Wei , Bjornard Kari L. , Ehrhardt Matthew J. , Brinkman Tara M. , Chemaitilly Wassim , Hodges Jason R. , Lanctot Jennifer Q. , Robison Leslie L. , Hudson Melissa M. , Ness Kirsten K.
Published: May 2019

e23051

Background: Survivors of childhood cancer are at risk for obesity and associated chronic health conditions - risks that are potentially modifiable if survivors adopt a lifestyle with adequate physical activity and a healthy diet. Neighborhoods where survivors reside may influence uptake of health behaviors. We examined associations between neighborhood factors and obesity in survivors. Methods: Adult survivors participating in the St. Jude Lifetime cohort with addresses available for geocoding were eligible for analysis [N = 2265, mean assessment age 32.5 (SD 9.1) years, 46% female, and 85% white]. Survivors completed questionnaires regarding individual behaviors; percent body fat was assessed via dual x-ray absorptiometry (obesity: ≥25% males; ≥35% females); and neighborhood effects were characterized using census tract of residence (e.g. neighborhood socioeconomic status (SES), rurality). Structural equation modeling (SEM) was used to determine associations between neighborhood effects, physical activity, diet, smoking, treatment exposures, and obesity. Results: Obese survivors (n = 1420, 62.7%) lived in neighborhoods with less access to exercise opportunities (63% vs 66%, p = 0.01) and lower SES (22% vs 18%, p < 0.001); and were more likely to live in small town/rural areas (14% vs 10%, p = 0.04) compared to non-obese survivors. Obese survivors who lived in the lowest SES neighborhoods were more likely to be CNS tumor survivors (17% vs 12%, p = 0.02) and received higher mean doses of cranial radiation (CRT) (15Gy vs 11Gy, p = 0.02) than obese survivors living in higher SES neighborhoods. Resource poor neighborhoods (standardized effect: 0.09, p < 0.001) and CRT (0.14, p < 0.001) had direct effects on percent body fat. Associations between neighborhood of residence and percent body fat were attenuated (-0.02, p < 0.001) among individuals with a better diet. Conclusions: The neighborhood in which a childhood cancer survivor resides as an adult is associated with obesity, and obese survivors treated with CRT are more likely to live in neighborhoods with lower SES. Interventions targeting survivors should incorporate strategies that address environmental influences on obesity.
Cancer patients: Assessing awareness, attitudes and claimed behavior around key decision points upon being diagnosed.
Authors: Lehrhaupt Kerri , Tauber Marcus Lori , Quinn Young Anne , Isaacson Jenny , Hurlbert Marc , McKenna Colleen , Wenger Linda , Giusti Kathy
Published: May 2019

e23052

Background: As precision medicine becomes increasingly important in oncology, patients need to be educated on making decisions at diagnosis to optimize their outcomes. The HBS Kraft Precision Medicine Accelerator is working with national cancer organizations to understand and address gaps in knowledge and action. Informed by prior patient and physician research, the Accelerator developed the Right Track framework, which addresses the unmet educational needs of patients as they navigate their journey. Methods: Participants with newly diagnosed cancer were recruited by the 5 participating foundations from their databases of affiliated patients (MMRF: n = 63, PanCAN: n = 202, LUNGevity: n = 51, PCF: n = 71, MBC Alliance: n = 66). Inclusion criteria included currently living in the US, 25 years or older, diagnosed with a qualifying cancer in the past 12 months (past 18 months for LUNGevity), self-reported as being at least somewhat knowledgeable in their disease, and self-reported as having some input in treatment decisions. The study was conducted by Kantar Health and sponsored by the HBS Kraft Precision Medicine Accelerator. The fielding was conducted in October 2018. Potential respondents were e-mailed an invitation to complete a 20-minute online survey. Potential respondents were also exposed to an invitation via social media from the participating study sponsors. The respondents were asked a series of customized questions that assessed their awareness and behavior on items within each of the four pillars of the Right Track framework. Results: Descriptive analyses were conducted on each of the four pillars (Right Team, Right Tests, Right Treatment, Sharing at Every Step) and it was found that educational gaps exist across all five cancers. Patients require guidance on selecting a knowledgeable team and facility, understanding their specific cancer sub-type and genomic information, participation in clinical trials and the importance of sharing their data. Conclusions: There is a strong need for patient advocacy foundations to work as unbiased, patient-focused organizations, such that they are well-positioned to help close these knowledge gaps.
Contraception and fertility counseling in patients receiving chemotherapy.
Authors: Calfee Alexa , Hasley Taylor , Daily Laura Becca , Tillmanns Todd D. , ElNaggar Adam
Published: May 2019

e23055

Background: Cancer care advances allow more patients to pursue fertility. Unfortunately, treatments may have detrimental effects both on fertility and risks to fetus should pregnancy occur. This study examines patient perceptions of fertility and contraception counseling, as well as physician documentation thereof. Methods: After IRB approval, a cross-sectional study was performed identifying men and women, ages 18-50, seen between May 2017 and 2018 with newly diagnosed malignancy. Patients with previous sterilization procedures, a secondary or synchronous cancer, or prior lines of chemotherapy, were excluded. Consented patients received a survey regarding their perception receipt and quality of counseling. Demographic data, including contraception use, reproductive history, and physician documentation were obtained. Differences in receipt of counseling and perception of received counseling were evaluated using chi-square tests. Results: Of 179 patients identified, 53 ultimately participated. Majority were women (75 v 25%). Counseling documentation for contraception and fertility occurred in 5% and 32% of charts, respectively. Though 42% and 49% perceived receipt, respectively. Of those receiving counseling, it was perceived as sufficient by 64% regarding contraception and 72% regarding fertility. Race, gender, and reproductive history were not found to be associated to whether patients perceived counseling on contraception (p > 0.1). Men were more likely than women to be perceive counseling regarding fertility (85 v 43%, p = 0.010). However, both felt fertility counseling to be sufficient with similar rates of documentation. Caucasians were more likely to perceive receipt of fertility counseling and to perceive it to be sufficient, then African Americans (68 v 29% and 70 v 40%, respectively) at same rate of documentation (35%). Conclusions: Significant discrepancies in perception of contraception and fertility counseling were seen, though documentation rates were similar across all groups examined. Despite equal rates of physician documentation, gender and race were important factors for the perception of fertility counseling, while race was a factor to quality of perceived counseling.
Risk of secondary hematologic malignancies and tolerability in patients with ovarian cancer treated with PARP inhibitors: A systematic review and meta-analysis of four phase III randomized controlled trials.
Authors: Thein Kyaw Zin , Ball Somedeb , Sultan Anita , Swarup Sriman , Zaw Myo , WIN Htut Thura , Hlaing Pwint Phyu , Myat Yin Mon , Yendala Rachana , D'Cunha Nicholas C. , Quick Donald , Tijani Lukman Aderoju
Published: May 2019

e23056

Background: Poly adenosine diphosphate ribose polymerase (PARP) inhibitors have shown to improve survival in ovarian cancer (OC) through synthetic lethality with potentiation of double-strand breaks in tumor cells. Yet, there are concerns of secondary hematologic malignancies (SHM) and notable adverse events (AE) leading to treatment discontinuation (TD), interruption (TI), or dose reduction (DR). Methods: MEDLINE, EMBASE databases and meeting abstracts from inception through January 2019 were queried. Phase 3 RCTs utilizing PARP inhibitors maintenance in OC were eligible. Mantel-Haenszel (MH) method was used to calculate the estimated pooled risk ratio (RR) with 95% confidence interval (CI). Random effects model was applied. Results: A total of 1792 patients from four phase III RCTs were included. The study arm used olaparib or niraparib or rucaparib while the control arm utilized placebo. Almost all patients in the SOLO-2 & -1 trials had a gBRCA mutation, while there were patients with and without the said mutation in the other two studies. The SHM incidence was 1.25% in PARP inhibitors group vs 0.83% in control group (RR, 1.15; 95% CI: 0.41–3.22, p = 0.79). TI due to AE was 59.71% in study group versus 11.39% in control arm (RR, 4.94; 95% CI: 2.44 – 9.96, P < 0.001). DR was reported in 47.73% in PARP inhibitors arm versus 6.86% in control group (RR, 7.73; 95% CI: 4.17 – 14.31, P < 0.001). TD rate was 10.97% higher in study group compared to control arm (RR, 6.63; 95% CI: 3.55 – 11.31, P < 0.001). Conclusions: The risk of SHM was not significantly increased in PARP inhibitors group. However, patients on PAPR inhibitors arm experienced significant drop outs due to AE, despite showing significant improvement in PFS in studies. Proper supportive care may enhance compliance.
Chronic adverse effects after axillary lymphadenectomy in breast cancer patients after weaker and stronger postoperative analgesia: Results of a prospective double-blind randomized study.
Authors: Besic Nikola , Smrekar Jaka , Strazisar Branka
Published: May 2019

e23066

Background: Tramadol is commonly used for pain treatment, but it is not known if stronger postoperative analgesia has an effect on chronic adverse effects in breast cancer patients. The aim of this study was to compare the rate of chronic adverse effects after weaker and stronger postoperative analgesia. Methods: A prospective double-blind randomized study included 118 breast cancer patients receiving tramadol for pain relief after axillary lymphadenectomy from 2015 to 2018 (Study EUDRA CT: 2015-000992-28). All patients used one of two analgesic regimens for 4 weeks after lymphadenectomy. Patients with larger dose received 75/650 mg of tramadol with paracetamol every 8 hours and a group with lower dose received 37.5/325 mg of tramadol with paracetamol every 8 hours. All patients received for four weeks twice daily naproxen sodium 550 mg and once a day pantoprazole 20 mg. One year after surgery patients were evaluated for the presence of neuropathic pain, chronic pain, arm symptoms and lymphedema. The association between dose of tramadol and chronic postoperative adverse effects was evaluated using asymptotic z-test and chi-square test. Results: Neuropathic pain was more common one year in comparison to one month after lymphadenectomy (p = 0.0001). There was a trend for lower rate of neuropathic pain after stronger analgesia in comparison to weaker analgesia (p = 0.058). Chronic pain was present in 18% of patients one year after lymphadenectomy. There was no difference in rate of chronic pain after stronger and weaker postoperative analgesia. Patients had less arm symptoms after stronger analgesia than after weaker analgesia (p = 0.02). Furthermore, there was a trend for lower rate of lymphedema of forearm after stronger analgesia than after lower analgesia (p = 0.078). Conclusions: The patients who received stronger postoperative analgesia had a statistical trend for less often neuropathic pain in comparison to patients who received weaker analgesia. The patients who received stronger postoperative analgesia had less arm symptoms and better quality of life in comparison to patients who received weaker analgesia. Clinical trial information: EudraCT 2015-000992-28.
Needs assessment for sexual health support following cancer diagnosis.
Authors: Welton Lindsay Louise , Guntupalli Saketh R , Flink Dina M
Published: May 2019

e23071

Background: Women report distress over relationships, body image and sexual function after cancer; those < 50 have a 3-times greater risk of sexual dysfunction following treatment. Survivors desire integrated and multifaceted interventions to maintain optimal sexual health. Methods: We employed a mixed-method (concurrent nested) design to identify women’s need for sexual health support after diagnosis. Women 18-50 years old were recruited at a national conference for young survivors and local breast/gynecologic clinics. Qualitative and quantitative assessments identified sexual health factors and support needs most prevalent. Summary statistics and theme analysis using grounded theory was conducted. Results: Participants included 128 women (mean diagnosis age 35.6) and were: married (71%), breast cancer (46%), mastectomy (40%), hysterectomy (30%), chemotherapy (81%), radiation (51%) and completed treatment (67%). Nearly 1/3 of women reported their relationship worsening, 97% contribute it to less sexual activity; 71% were unsatisfied with their sexual relationship compared to before diagnosis. Women (77%) feel their oncologist should discuss sexual health and 74% prefer information prior to treatment. When asked to identify resources 82% desired helpful products/strategies; other desired resources include: written education (65%), medications/lubricants (68%), personal counseling (37%), sex therapist (41%) and local/web-based support groups (36%). When asked to describe their experience with sexual health women reported the following themes: supportive partners, sexual health status, guilt, stolen identity, loss of desire, isolation, treatment side effects, menopause, vaginal changes, maintaining relationships, coping mechanisms, fertility, self-image, grief, intimacy, and desire for oncologist support. Conclusions: Sexual health support after diagnosis is an unmet need that can be integrated into treatment to greatly improve the quality of life for survivors. Women desire their oncologist to provide information before treatment and through survivorship on products/strategies, education, and medications/lubricants to maintain sexual function. Young women do not desire social support resources.
Persistent radiation-induced alopecia in patients with central nervous system tumors and head and neck sarcomas.
Authors: Phillips Gregory S. , Friedman Danielle Novetsky , Trelles Sabrina , Kukoyi Oluwaseun , Freret Morgan , Freites Martinez Azael David , Unger Robin H. , Disa Joseph J. , Wexler Leonard H. , Beal Kathryn , Wolden Suzanne L. , Lacouture Mario E.
Published: May 2019

e23072

Background: Persistent radiation-induced alopecia (pRIA), or incomplete hair regrowth 6 months following radiotherapy (RT) completion, poses a significant quality of life burden, but its clinical characteristics and management outcomes are not well understood. Methods: Retrospective database query of patients with primary central nervous system tumors or head and neck sarcomas evaluated at an oncodermatology clinic and diagnosed with pRIA between 1/1/11 and 9/19/18. Clinical data and standardized clinical photographs were analyzed. Alopecia was graded according to the CTCAE v5. Results: Sixty-two patients with pRIA were identified (mean [SD] age, 33 [19]; 75% female; 18 < 21 years at pRIA diagnosis). The most common diagnoses were medulloblastoma (20, 32%) and glioblastoma multiforme (17, 27%). Mean duration between RT and pRIA diagnosis was 3.1 years (95% CI, 2.3-4.2). Additional cancer therapies included surgery (57, 92%), cytotoxic chemotherapy (35, 57%), and combination cytotoxic + targeted therapy (24, 39%). Cancer type, age, number of chemotherapy agents, and duration between RT and pRIA diagnosis were significantly associated with alopecia type: mixed pattern (localized and diffuse) alopecia was predominant in younger patients with medulloblastoma exposed to greater number of agents (p < .005). Alopecia grade 2 ( > 50% hair loss) was predominant in patients that received concurrent chemotherapy and RT (p = .046). Among 22 patients treated with 5% minoxidil topical solution, a response was noted in 16 (73%) (Table). One patient receiving hair transplantation and one receiving scalp reconstruction had complete resolution of pRIA. Conclusions: Concurrent chemotherapy with RT may be a risk factor for grade 2 pRIA. Topical minoxidil may provide some benefit in pRIA; however, prospective trials are needed to assess efficacy. Procedural interventions should be considered as a viable therapeutic option in a subset of patients. [Table: see text]
Clinical course of patients with cisplatin (CDDP)-associated neuropathy compared to other neurotoxic chemotherapy.
Authors: Albany Costantine , Dockter Travis , Wolfe Eric G , Pachman Deirdre R. , Wagner-Johnston Nina D. , Lazzara Kayla Marie , Sego Lina M , Edwards Sara I , Snow Christin I , Hanna Nasser , Einhorn Lawrence , Loprinzi Charles L. , Costello Brian Addis
Published: May 2019

e23078

Background: There are limited patient (pt) reported outcome data regarding CDDP neurotoxicity. Methods: CDDP-induced peripheral neuropathy was evaluated in pts with testicular cancer planning to receive CDDP (20 mg/m2/d for 5 days) for ≥ 3 cycles. Neurotoxicity was assessed with the EORTC QLQ-CIPN20 tool before each CDDP cycle and every 2-4 months after, out to 18 months. We compared these data to our studies evaluating pts receiving doxorubicin/cyclophosphamide (AC), paclitaxel and oxaliplatin. The total score of the EORTC QLQ-CIPN20, each of the three subscale scores and each individual item was computed following the standard scoring algorithm and converted to a 0-100 scale. Descriptive statistics and graphical plots were utilized. Results: 54 pts receiving CDDP (mean age 33 years) and 18 pts receiving AC were evaluated. Following completion of CDDP, neuropathy symptoms (sensory neuropathy score and numbness/tingling in toes/feet) worsened for about 6 months (consistent with the so-called “coasting phenomena”), similar to what had previously been seen with oxaliplatin (but different than what had been seen with paclitaxel). For CDDP pts, during therapy, numbness and tingling in fingers/hands were more prominent, than the same symptoms in the toes/feet. After therapy was completed, numbness, and tingling became more prominent in toes/feet, but improved in the fingers/hands. After stopping therapy, shooting/burning pain did not worsen in upper or lower extremities. During therapy, CDDP pts had less problems than had previously been seen with oxaliplatin or paclitaxel, maybe because of the younger ages of the CDDP pts. With AC, all of the CIPN-20 sensory neuropathy scores were better than was seen in the pts receiving CDDP and also in pts receiving paclitaxel and oxaliplatin in previous evaluations. Conclusions: CDDP-induced neuropathy is more similar to oxaliplatin-induced neuropathy than paclitaxel-induced neuropathy. AC chemotherapy pts do not have substantial changes in CIPN 20 scores, consistent with the CIPN 20 instrument being a measure of chemotherapy-induced neuropathy, as opposed to more general chemotherapy-induced toxicities. Clinical trial information: NCT02677727.
Systematic review and meta-analysis of definitions and reported incidences of anthracycline cardiotoxicity.
Authors: Jang Sae , Ruddy Kathryn Jean , Loprinzi Charles L. , Armenian Saro , Lenihan Daniel John , Herrmann Joerg
Published: May 2019

e23081

Background: Anthracycline-induced cardiotoxicity (AIC) is a well-known phenomenon, but the true incidence is poorly defined, and definitions of AIC in the literature are variable. We performed a systematic review and meta-analysis to elucidate AIC definitions and the incidence of clinical heart failure (HF) and subclinical AIC reported in adult breast cancer and lymphoma patients after anthracycline (AC) therapy. Methods: 3,428 abstract and titles were identified via PubMed search. Inclusion criteria for full text review included minimum of 100 adult patients receiving ACs; median/mean follow up of at least 12 months; and specified evaluation of left ventricular ejection fraction. Outcomes were divided into clinical HF and subclinical AIC. Meta-analysis was performed with MedCalc software with random effects model. Results: 366 full text articles were reviewed. 24 studies, including a total of 11,065 patients, reported clinical HF findings; 21 studies, including a total of 8,098 patients, reported subclinical AIC findings. Meta-analysis showed an overall incidence of clinical HF of 3.1% (range 0 to 29%, CI 1.9 to 4.6%, I2= 93.9%); an incidence of 2.0% (CI 0.9 to 3.6%, I2 = 91.6%) in breast cancer patients receiving AC; and 4.8% in lymphoma patients receiving AC (CI 2.1 to 8.6%, I2 = 93.6%). Subclinical AIC was seen in 13.8% overall patients (range 2 to 45%, CI 10.4 to 17.7%, I2= 95.3%); 10.3% of breast cancer patients (CI 7.0 to 14.3%, I2= 95.0%); and 19.8% of lymphoma patients (CI 12.3 to 28.6%, I2= 94.4%). Incidence of HF correlated with increasing age (r = 0.51, p = 0.06) and cumulative dose (r = 0.51 , p = 0.19). There was notable heterogeneity of AIC definitions between studies (Table). Conclusions: Cardiotoxicity is not uncommon among patients who receive AC, particularly at doses given for the treatment of lymphoma. However, there was considerable heterogeneity in HF incidences. More uniform criteria and precise estimates are needed to inform clinical practice and trials. [Table: see text]
Impact of cisplatin-related hearing loss (HL) and tinnitus on patient functioning.
Authors: Ardeshirrouhanifard Shirin , Adra Nabil , Monahan Patrick O. , Norton Kelli , Fung Chunkit , Einhorn Lawrence H. , Frisina Robert D. , Travis Lois B.
Published: May 2019

e23085

Background: Patients given cisplatin-based chemotherapy (CBC) experience HL and tinnitus. However, the impact of these toxicities on psychosocial and physical functioning in cancer survivors has not been systematically evaluated. Methods: Eligible testicular cancer survivors (TCS) aged ≤ 55 y at diagnosis and given first-line CBC at Indiana U., completed comprehensive questionnaires. The validated 25-item Hearing Handicap Inventory for Adults (HHIA) quantified emotional (13 items) and social difficulties (12 items) related to HL. The validated 20-item Tinnitus Primary Function Questionnaire (TPFQ) assessed domains affected by tinnitus, i.e., concentration, emotion, hearing, sleep (5 items each). For each HHIA scale, TCS were grouped into 3 standard handicap levels: 016% (none/minimal), 18-42% (mild/moderate), and 44-100% (significant). Proportions of social vs. emotional handicap were compared with a McNemars test. For TPFQ, each scale score is continuous (0: [no interference] to 100% [total interference by tinnitus]) and computed as the mean of 5 items. TPFQ measures were compared by signed-rank tests (P < 0.05 was significant). Results: Of 43 TCS (median age: 35 y, range 2074 y; median time since chemotherapy completion: 7 y, range 2-27 y), 95% were white, and 70% had at least a college degree. Median cumulative cisplatin dose was 300 (range 200-600 mg/m2). The most commonly administered regimen was bleomycin, etoposide and cisplatin; 23 (53.5%) reported HL, and 25 (58%) had tinnitus. Of TCS with HL, 25% had some degree of related handicap (total HHIA scale: 20% and 5% for mild/moderate and significant handicap, respectively). More TCS had social vs. emotional handicap (33.3% vs. 14.3%, P = 0.13). Tinnitus had significantly greater interference with emotion (median: 14, range 0-84) compared to concentration [(median 6, range 0-41), p = 0.04)], and sleep [(median: 0, range (0-78), p = 0.001)]. Other comparisons were not significant. Conclusions: Cisplatin-related HL has a considerably greater negative impact on social vs. emotional measures, and affected TCS may benefit from hearing aids. TCS experiencing significant issues related to emotion due to tinnitus may benefit from interventions to lessen their impact.
Detection of bone metastases through diffusion-weighted whole-body imaging with background body signal suppression (DWIBS) compared with PET/CT 18F-NaF.
Authors: Barragan-Campos Hector Manuel , Le Faou Anne Laurence , Burgos-Jaramillo Martín , Lopez-Soto Fernando , Altamirano Ley Javier , De la Peña-Lopez Roberto
Published: May 2019

e23086

Background: To evaluate a diagnostic test which can allow the comparison between Diffusion-weighted imaging with background suppression (DWIBS) the novel diagnostic modality versus PET/CT 18F-NaF, the gold standard for the diagnosis of bone metastases (BM). Methods: University bioethics committee authorized the protocol. Patients with solid cancer and suspicion of BM (by clinical findings, imaging, and tumor biomarkers), who met inclusion criteria were included and provided their signed informed consent. The DWIBS in a MR 3.0 T was performed first and then the PET/CT 18F-NaF. Each study was interpreted blinded. Statistics to evaluate a diagnostic test were performed. Results: From April 2014 to April 2016, 91 patients (100%) were interviewed, 88 (93.4%) met the inclusion criteria. Nine patients (8%) were excluded: death 3, respiratory failure 2, refused participating 2, pacemaker 1, claustrophobia 1. Seventy-nine patients (86.8%) were included, of which 81.0% (64/79) were women. Primary cancer was: a) breast 73.4 b) prostate 15.2%; c) Non-Hodgkin lymphoma 2.5%; d) cervical 2.5%; e) thyroid 2.5%; f) lung 1.3%; g) colon 1.3%; and h) testicular 1.3%. Diagnostic performance of DWIBS compared to PET/CT 18F-NaF, sensitivity 88.1% (Confidence Interval [CI95%, 73.3-96.0), specificity of 48.7% (CI 95%, 31.9-65.6), PPV of 66.0% (CI 95%, 58.2-73.1), NPV of 78.3% (CI 95%, 59.7-89.7), PLR 1.7 (CI 95%, 1.2-2-4), NLR 0.2 (CI 95%, 0.1-0.6) and prevalence of 53.1% (CI 95%, 41.6-54.5). Results were stratified in quartiles (excellent, good, fair, and poor). Conclusions: DWIBS has excelent sensibility, fair specificity, good PPV, and excellent NPV. These data suggest DWIBS could be used as a proxy of PET/CT 18F-NaF.