bluuebunny/crossref_metadata_2025_split huggingface dataset:
Randomized trial of sequence vs. combination of capecitabine (X) and docetaxel (T): XT vs. T followed by X after progression as first-line therapy for patients (pts) with metastatic breast cancer (MBC)
Authors: Beslija S. , Obralic N. , Basic H. , Tatarevic A. , Naila M. , Banjin M. , Cardzic A. , Sosevic A. , Pasic A. , Ceric T. , Salkic B. 
Published: March 2020

571 Background: Capecitabine (Xeloda [X]) and docetaxel (Taxotere [T]) are highly active single agents in MBC. The XT combination leads to superior overall survival (OS), time to progression (TTP) and response rate (RR) vs. T alone in anthracycline-preatreated MBC [O’Shaughnessy et al. J Clin Oncol 2002], although only one third of pts in the T group received X after progression. We designed this study to determine whether XT is better than sequential T→X in first-line MBC. Methods: 100 pts with measurable MBC, prior adjuvant anthracyclines (100%) but no prior chemotherapy for MBC and KPS ≥70 received 3-weekly cycles of either XT (X 1250mg/m2 bid d1–14 + T 75mg/m2 d1) or T→X (T 100mg/m2 d1 followed after progression by X 1250mg/m2 bid d1–14). X monotherapy data were not considered in the RR or TTP analyses but were included for OS and safety. Results: The XT and T→X arms were well balanced for prognostic factors: median age 48 (29–59) vs. 51 (31–64) years; median KPS 100 (70–100) in both arms; hormone-responsive disease 20 vs. 16%; dominant metastatic sites (liver 42 vs. 44%, lymph nodes 34 vs. 36%, lung 28 vs 24%, bone 20 vs 18%); number of involved organs (1 = 58 vs. 52%, >1 = 42 vs. 48%); median interval since prior adjuvant anthracyclines (18.5 vs. 17.0 months). Efficacy findings are shown in the table . 74% of the pts in the T→X arm crossed-over to X on progression. The post-study treatment rate was similar in both arms. The most common grade 3/4 adverse events (>5% of pts) with XT vs. T→X were: hand-foot syndrome 18 vs. 4%; stomatitis 16 vs. 8%; neutropenia 12 vs. 14%; neutropenic fever 12 vs. 14%; diarrhea 12 vs. 8%; fatigue 8 vs. 12%; alopecia 6 vs. 8%; edema 4 vs. 8%. Dose reductions were necessary for 52% of pts on XT and 36% of pts on T→X. Conclusions: XT provides significant RR, TTP and OS advantages over T→X. XT should be the standard therapy in fit poor-prognosis pts with aggressive disease. [Table: see text] No significant financial relationships to disclose.
Weekly cisplatin-epirubicin-paclitaxel (PET) with granulocyte-colony stimulating factor support versus tri-weekly epirubicin-paclitaxel in locally advanced breast cancer: Final comprehensive and subgroup analysis of a SICOG phase III study
Authors: Frasci G. , D’Aiuto G. , Comella P. , Thomas R. , Botti G. , Rubulotta M. , Iodice G. , Costanzo R. , Di Bonito M. , Comella G. 
Published: March 2020

572 Background: We previously reported the preliminary pathological response data of a phase III trial comparing a weekly dose-dense approach (PET) to a standard epirubicin-paclitaxel q3wk combination, in LABC pts. (ASCO 2004; abstr.511). In the present abstract, we report the final data on response and PFS, and a subgroup analysis according to the hormone-receptor, and HER2/neu status. Methods: Overall, 200 patients with stage IIIB disease were randomised to receive either 12 weekly cycles of cisplatin 30 mg/m2, epirubicin 50 mg/m2, and paclitaxel 120 mg/m2 (PET) plus granulocyte-colony stimulating factor support, or 4 cycles of epirubicin 90 mg/m2 + paclitaxel 175 mg/m2 (ET) every 3 weeks. Results: Overall, a pCR in both breast and axilla occurred in 16 (16%) PET patients and in 6 (6%) ET patients (P=0.02). The higher activity of PET was evident only in ER negative (27.5% vs 5.4%; P=0.026), and in HER/neu 3+ (31% vs 5%; P=0.037) tumours. The 2 arms yielded similar pCR rate in ER positive (PET/ET=7.5%/7.1%) and HER/neu negative (PET/ET=10%/6%) patients. At a 45 months median follow-up, 78 patients showed a progression or relapse (PET= 32 vs ET= 46). The 5-year Failure-free survival rates in PET/ET arms were: Total =27%/21%; ER+= 26%/23%; ER- =25%/9%; HER2+=.18%/11%; HER2- =29%/25%. Conclusions: The PET weekly regimen is superior to ET in terms of pCR rate in LABC patients. The advantage of such an aggressive approach is limited to ER negative and HER2 positive pts. A large randomised trial comparing weekly PET to a standard regimen in ER- LABC pts., with FFS as the main end-point, is highly recommendable. No significant financial relationships to disclose.
Comorbidity and outcomes in elderly women treated with breast-conserving therapy
Authors: Harris E. E. , Urtishak S. L. , Hwang W. , Kinosian B. , Solin L. J. 
Published: March 2020

599 Background: Breast cancer incidence increases with age and is a major cause of morbidity and mortality among elderly women. Co-morbidities are often considered in treatment management of elderly women. Methods: Between 1979 and 2002, 238 women age 70 or older with unilateral stage I or II invasive breast cancer underwent conventional breast conservation treatment with radiation. The age distribution was 122 women (51%) age 70–74 years, 71 women (30%) age 75–79 years, and 45 women (19%) age ≥80 years. Surgical axillary staging was performed in 73% (n= 173) of patients, of which 73% (n=126) were N0, and 27% (n=47) were N1. Co-morbidities were scored using the Charlson Comorbidity Index and Cumulative Illness Rating Scale (CIRS). Median follow-up was 6.2 years. Results: On analysis by age groups, the 10-year cancer specific outcomes were not significantly different (see Table ). However, distant metastases were the most common site of first failure in all age groups: 9% for age 70–74; 12% for age 75–79 and 11% for age >/= 80. Second malignancies were the second most common cause of first failure in all age groups. Death from intercurrent disease was significantly more likely in the older age groups. In this cohort, moderate and severe co-morbidities were not significantly more common in the older age groups, and CIRS score did not correlate with overall survival. Conclusions: Breast conserving surgery and definitive breast irradiation provide excellent outcomes in appropriately selected elderly women. Older age itself is not a contraindication to breast conserving therapy. Women of any age with lower co-morbidity indices should be offered standard treatment. [Table: see text] No significant financial relationships to disclose.
Model-based predictions of expected anti-tumor response and survival in phase III studies based on phase II data of an investigational agent
Authors: Claret L. , Girard P. , O’shaughnessy J. , Hoff P. , Van Cutsem E. , Blum J. , Zuideveld K. , Jorga K. , Fagerberg J. , Bruno R. 
Published: March 2020

6025 Background: Decision making during early oncology drug development remains very empirical. A drug-disease simulation model to predict expected clinical response and survival in phase III studies from observed longitudinal tumor size in phase II trials offers a science-based alternative. Methods: We developed the following: 1) longitudinal exposure-response models of drug effect (and resistance) on tumor growth dynamics based on phase II data on capecitabine (X) in metastatic breast (MBC) and colorectal cancer (MCRC) and on historical phase III data on docetaxel (T) in MBC and 5-FU in MCRC; and 2) a survival model relating change in tumor size and patient characteristics to survival time in MBC and MCRC based on phase III data. The models were validated and used to predict expected anti-tumor response and survival in phase III studies of XT vs. T alone in MBC and X vs. 5-FU in MCRC. Multiple replicates (n = 1000) of simulated phase III studies were compared to actual results. Results: Change of tumor size and survival time distributions in X arms were well predicted. In MBC, expected median (90% prediction interval) survival for patients treated with XT was 412 (range 330 to 526) days (vs. 431 days observed) with an improvement over T of 57 days (range -17 to 148) (vs. 78 days observed). For MCRC patients, X treatment resulted in a potential survival improvement of 39 (range -21 to 110) days (vs. 35 days observed) compared to patients treated with 5-FU. Conclusions: The dose-tumor size-survival model succeeded in predicting survival in phase III trials based on X phase II data in MBC (in combination with T) and as a single agent in MCRC. This model is a useful tool to compare expected clinical response of new compounds to various competitors and to support end-of-phase II decisions and design of phase III studies. [Table: see text]
Understanding of prognosis among parents of children with cancer: Parental optimism and the role of the parent-physician interaction
Authors: Mack J. W. , Cook E. F. , Wolfe J. , Grier H. E. , Cleary P. D. , Weeks J. C. 
Published: March 2020

6033 Background: Patients often overestimate their chances of surviving cancer. Factors that contribute to accurate understanding of prognosis among parents of children with cancer are not known. Methods: We conducted a cross-sectional survey of 194 parents of children with cancer (overall response rate 70%), treated at the Dana-Farber Cancer Institute and Children’s Hospital, Boston, Mass, and the children’s physicians. Our main outcome measure was agreement between parent and physician ratings of the child’s likelihood of cure. Results: The majority of parents (61%) were more optimistic about the likelihood of their child’s cure than their child’s physician was. Most parents, however, believed that their opinions about prognosis either matched (70%) or were more pessimistic (26%) than those of their physicians. When physicians were confident in their knowledge of the child’s prognosis, parent and physician perceptions of prognosis were more likely to agree (OR 2.55, P = .004). Parents whose role in decision-making matched their ideal role were more likely to give prognostic estimates that agreed with physician perceptions of prognosis (OR 1.89, P = .019). In contrast, parent confidence in knowledge (OR .07, P < .0001), coping strategies (disengagement, OR .31, P = .007; reliance on emotional support from others, OR .31, P = .029), and use of intuition to understand prognosis (OR .51, P = .012), were associated with overestimation of likelihood of cure. Conclusions: Many parents overestimate their children’s chances of being cured of cancer. Neither physician nor parent attributes alone account for this finding; rather, successful communication about prognosis requires that physicians relate to parents’ individual communication and decision-making needs. No significant financial relationships to disclose.
Social and racial disparities in the use of non-standard breast cancer adjuvant chemotherapy regimens
Authors: Griggs J. J. , Culakova E. , Sorbero M. E. , Crawford J. , Dale D. C. , Wolff D. A. , Poniewierski M. S. , Lyman G. H. 
Published: March 2020

6036 Background: Economically disadvantaged and black women have worse stage-specific breast cancer outcomes than other women, even after controlling for tumor histologic features. Disparities quality of chemotherapy may contribute to differences in outcome. The purpose of this study was to investigate the use of non-standard breast cancer adjuvant chemotherapy regimens in black women and those of lower socioeconomic status (SES). Methods: Detailed information on patient, disease, and treatment factors was collected prospectively on 1,006 patients receiving adjuvant chemotherapy for early-stage breast cancer in 115 oncology practices throughout the US. All patients signed informed consent. Regimens included in the guidelines of the National Comprehensive Cancer Network were considered standard regimens; all others were considered non-standard. Receipt of non-standard regimens was examined according to clinical and non-clinical factors. Differences between groups were assessed using a chi-square test. Multivariate logistic regression was used to identify factors associated with use of non-standard regimens. Results: Non-standard regimens were used in the treatment of 136 (14%) of the participants. Black patients were twice as likely to receive a non-standard regimen as whites (23% vs. 12%, p = .0014). Patients with less than a high school education were twice as likely to receive a non-standard regimen compared with those with a college education (21% vs. 8%, p = 0.0011). Other factors associated with non-standard chemotherapy regimens were past chemotherapy exposure (p < .0001), higher stage disease (p < .0001) and geographic location (p = 0.0059). Age, comorbidity, body mass index, type of insurance, and employment status were not associated with receipt of non-standard chemotherapy. In multivariate analysis, all variables that were significant in the bivariate analysis remained independently associated with receipt of non-standard chemotherapy. Conclusions: The more frequent use of non-guideline concordant adjuvant chemotherapy regimens in black women and women with lower SES may contribute to their less favorable outcomes. These findings offer an opportunity to improve patient care and perhaps cancer outcomes. [Table: see text]
Complementary systems: Quality and timeliness of passive vs. active adverse event reporting and regulatory vs. peer-reviewed adverse drug reaction (ADR) dissemination
Authors: Bennett C. L. , Angelotta C. , Lurie A. J. , Lyons E. A. , Yarnold P. R. , Raisch D. W. 
Published: March 2020

6062 Background: RADAR, a NIH funded R01 project, obtains reports of serious ADRs by conducting hypothesis-driven active surveillance efforts in hematology/oncology. The FDA and pharmaceutical sponsors conduct passive surveillance efforts based on review of reports voluntarily submitted by health care workers. Methods: Completeness and timeliness of ADR reports and dissemination efforts by RADAR versus the FDA/pharmaceutical sponsors were compared. Results: Individual reports were more complete in RADAR databases with fewer total reports (341 versus 1,341). Pharmaceutical sponsors disseminated ADR data 1 year (median) earlier as revised package inserts (PIs), but RADAR publications were more complete. Conclusion: Compared to pharmacovigilance efforts by the FDA/pharmaceutical suppliers, RADAR is more complete but less timely. [Table: see text] No significant financial relationships to disclose.
The impact of non-compliance with imatinib (IM) therapy on health care costs
Authors: Henk H. J. , Thomas S. K. , Feng W. , Jean-Francois B. , Goldberg G. A. , Hatfield A. 
Published: March 2020

6083 Background: While compliance to drug therapy is vital to receive optimal patient benefits, the costs of delivering adequate medical care for cancer patients remain an important consideration for society and payers. This study examined the relationship between compliance with IM therapy and health care costs for patients with CML and GIST. Methods: Claims data from 6/1/01–3/31/04 from a US health plan were used to identify non-Medicare IM-treated patients with a CML or GIST diagnosis who had continuous pharmacy and medical benefits in the 3 months prior and 12 months following initiation of IM therapy. Compliance was defined by medication possession ratio (MPR=total days IM supply in the first year ÷365) and patients were stratified into three segments by MPR (<50%, 50–90%, 90–100%). Total health care costs include hospital, laboratory testing, office, ER, and pharmacy charges. Disease-related health care costs were also analyzed. Multivariate analyses were used to examine the relationship between MPR and first-year health care costs, controlling for age, sex, number of medications, initial starting dose, diagnosis (CML or GIST), year of initial IM fill, and complications due to underlying disease. Results: Total 878 IM-treated patients were identified of whom 413 had at least 15 months of continuous eligibility. Of these, 307 were non-Medicare CML or GIST patients. Total health care costs per patient in the first year of therapy in MPR < 50%, 50–90%, and 90–100% groups were $163,828, $53,924, and $40,924 respectively (p < 0.001). The corresponding numbers for disease-related health care costs were $103,118, $36,436, and $34,086 (p<0.001). Controlling for the variables listed above, a 10% increase in MPR is associated with a 5% decrease in total health care costs (p=0.021). Similar association was found between MPR and disease-related health care costs. Conclusions: Improved compliance with imatinib therapy is associated with decreased total health care costs and disease-related health care costs. Improving compliance to imatinib therapy may not only optimize clinical outcomes but may also reduce the overall societal burden of health care costs associated with cancer. [Table: see text]
A comparison of patient and physician attributes that promote patient involvement in treatment decision making in the oncology consultation
Authors: Ellis P. M. , Dimitry S. J. , O’Brien M. A. , Charles C. A. , Whelan T. J. 
Published: March 2020

6098 Background: Cancer patients have indicted a desire to be more involved in treatment decision making (TDM). However, little is known about the attributes of patients, physicians and their interaction that promotes patient involvement in TDM in the oncology consultation. This study compared attributes generated by patients and physicians that make it easier for patients to be involved in TDM. Methods: Semi-structured interviews were undertaken with 19 patients with cancer (lung, breast, prostate, GI) and 21 medical and radiation oncologists at a regional cancer centre. Participants were asked to identify attributes of physicians, patients and their interaction that promotes patient involvement in TDM. Interview transcripts were independently coded by 2 analysts using decision rules to identify specific attributes. Attributes identified by each analyst were compared and a high level of agreement was found. The analysts then independently compared the physician and patient generated lists and identified common vs unique items. There was a high level of agreement on which attributes were common to both lists versus unique. Results: Oncologists identified 173 physician, 59 patient and 9 interaction items. Patients identified 50 physician, 42 patient and 11 interaction items. Patients and physicians identified 17 common physician items, 29 common patients items and 1 common interaction item. Physicians identified 138 more attributes than patients, most of which were physician related. Common patient attributes centred on information seeking (eg prepare for the consultation by reading, be aware of all treatment options and question the options). Common physician attributes focused on specific communication behaviors (eg, make eye contact, tailor information to patient needs, be direct with patients, ensure patient understands information). The common interaction item was to keep the discussion informal. Conclusions: Patients and physicians appear to have different ideas about what is important to promote patient involvement in TDM. Many of the attributes identified can be easily incorporated into current practice. There is a need to develop and evaluate communication skills training to promote patient involvement in TDM. No significant financial relationships to disclose.
Health promotion and cancer screening services for African refugee women
Authors: Carroll J. K. , Epstein R. , Fiscella K. , Volpe E. , Jean-Pierre P. , Morrow G. 
Published: March 2020

6101 Background: Previous work has shown that refugee women do not receive adequate preventive healthcare services, especially cancer screening. To identify factors that could affect the provision of cancer screening services to African Somali refugee women living in Rochester, NY, we assessed beliefs these women have about health promotion, access to care and use of preventive healthcare services. Methods: Individual in-depth interviews were conducted on a community-based sample of 34 resettled Somali-born women who were older than 18 years. Interviews were audiotaped and transcribed verbatim. A professional interpreter listened to all audiotaped interviews to check accuracy of transcription and translation. Content was analyzed by a multidisciplinary team using a grounded theory approach. Results: Median age of the women was 27 years. Length of residence in US was two months to nine years. For these women, health maintenance for acute survival took precedence over long-term prevention of disease. All women were familiar with basic health promotion practices, immunizations and routine medical examinations, and participants used both US-based and traditional techniques to prevent illness. Most women (71%, n=24), recognized the importance of maintaining good hygiene (59%, n=20) understood the need to have an adequate source of safe food and water, (74%, n=25) saw the need for access to a regular source of healthcare and (65%, n=22) acknowledged the need to function well at home. Few women understood cancer prevention services. Only three (9%) women recognized that the purpose of the Papanicalaou test was to screen for cervical cancer. Only six women (18%) recognized mammography (either the term or the procedure) and all of them were English-speaking, had lived in the US five years or longer, and had worked in the healthcare field. Conclusions: While traditional beliefs about health promotion did not appear to impede delivery of most preventive services, and participants understood prevention of infectious disease, their familiarity with cancer and cancer screening services was poor. Future health promotion programs need to increase refugee women’s knowledge about these services while building on other positive health-promoting beliefs. Supported by AHRQ 5R03HS014105 and NCI 1R25CA102618 No significant financial relationships to disclose.