bluuebunny/crossref_metadata_2025_split huggingface dataset:
What can physicians do to promote patient involvement in decision making (DM) in the oncology consultation?
Authors: Ellis P. M. , Dimitry S. , Charles C. , O’Brien M. , Whelan T. J. 
Published: March 2020

19553 Background: Facilitating patient involvement in TDM is a desirable feature of the oncology consultation. Greater patient involvement in TDM may lead to improved patient satisfaction, compliance and reduced psychological morbidity. However, there is little empiric evidence defining physician behaviors and attributes that facilitate patient involvement in TDM. This study used qualitative methods to identify such behaviors and attributes suggested by both practicing oncologists and patients. Methods: Semi-structured interviews were conducted with 11 medical, 10 radiation oncologists and 19 patients with breast, lung, GI, or GU cancer to determine physician behaviors and attributes that facilitate patient involvement in TDM. Interviews were audiotaped and transcribed verbatim, then analyzed independently by two researchers using inductively derived coding categories and predetermined coding rules. Behaviors and attributes were identified and coded into common themes. Six focus groups with an additional 37 patients were conducted to review these behaviors and attributes. Results: A total of 231 individual physician behaviors and attributes were identified by physicians (179) and patients (52) that facilitate patient involvement in DM. Common behaviors and attributes identified from the interviews include: assessing patient’s understanding and preferences, providing information, explaining the DM process, providing information on treatment options, allowing time to consider treatment options, checking patient understanding of options and inviting patient input into decisions. Other behaviors such as physicians’ communication skills were reported as facilitating TDM. Specific physician personality attributes, such as empathy, were identified as important facilitators. Conclusions: Physicians and patients identify a large number of physician behaviors and attributes that may facilitate patient involvement in TDM. These include both behaviors that are important in general physician-patient communication, as well as those that are specifically related to the decision making process. Further research is ongoing to determine the importance of these factors and approaches to encourage their use in the oncology consultation. No significant financial relationships to disclose.
Management of rash to erlotinib (E) and cetuximab (C): Results from the SERIES (Skin and Eye Reactions to Inhibitors of EGFR and kinaseS) clinic algorithm
Authors: Martin N. V. , Pacifico V. , Lai S. E. , Rademaker A. , Ortiz S. , Aneja M. , West D. P. , Bennett C. , Lacouture M. 
Published: March 2020

19556 Background: Rash develops in approximately 90% of patients (pts) treated with epidermal growth factor receptor inhibitors (EGFRIs) E and C, leading to significant physical/psychosocial discomfort and inconsistent therapy. This study characterizes outcomes of a rash management algorithm developed in the multidisciplinary dermatology-oncology SERIES clinic. Methods: Retrospective chart analysis was performed of pts with E and C rashes (n=45) who were treated with: oral tetracyclines (doxycycline or minocycline) bid and topical calcineurin inhibitors (pimecrolimus/ tacrolimus) or corticosteroids bid. After a baseline visit, pts were assessed at 2–4 week intervals and CTC graded (G). Management data, skin biopsies and photographs were evaluated. Response was defined as: Complete Response (CR) = severity decrease (decr) by 2G, Partial Response (PR) = 1G decr, Stable Disease (SD) = no G change, and Progressive Disease (PD) = increase by = 1G. Best response (BR) was defined as the patient’s best rash outcome at any point in time. Results: 43 out of 45 pts had evaluable data. Of 27 women and 16 men, mean age = 60 yrs (range 34–88), 60% received E and 40% C. For BR, 51% of patients had a CR, 42% had PR, 7% had SD, and 0% had PD. Age was related to BR (p=0.036), with median ages (in years) of 66, 57.5 and 48 for 22, 18 and 3 pts with CR, PR and SD respectively. BR was related to grade (p=0.045), with CR in 69% of G1 pts, 35% in G2 pts, and 54% in G3 pts. BR was not related to E or C (p=0.40). Dose modification was required in 8% (E) and 22% (C) and dose discontinuation in 0% (E) and 17% (C) pts. Conclusions: SERIES algorithm rash management demonstrates that combined oral tetracyclines, topical calcineurin inhibitors and corticosteroids result in improvement in a majority of subjects. The greater rate of dose modification/discontinuation with C supports the need for proactive/early intervention. Trials are underway to evaluate prophylactic therapies against rash to EGFRIs. No significant financial relationships to disclose.
Initiating epoetin alfa (EPO) 120,000 U every three weeks (Q3W) in pts with chemotherapy (CT)-induced anemia (CIA)
Authors: Glaspy J. , Charu V. , Moyo V. , Kamin M. , Wilhelm F. E. 
Published: March 2020

19564 Background: Emerging data suggest that initiating EPO therapy earlier (at a higher hemoglobin [Hb] trigger) in the setting of active CT may provide better maintenance of Hb within a target range with no adverse safety consequence. Reported here are the final results of the first study to explore the efficacy and safety of early vs standard intervention with EPO initiated Q3W at 120,000 U. Methods: This 16-wk open-label randomized study enrolled pts with non-myeloid malignancy, baseline (BL) Hb =11.0 and =12.0 g/dL, and CT planned for =9 wks. Pts were randomized (1:1) to receive EPO 120,000 U subcutaneously Q3W immediately (early intervention group, EIG) or when their Hb fell to <11.0 g/dL (standard intervention group, SIG). If, at any dosing visit after the first EPO dose, Hb decreased to <10.0 g/dL, pts were switched to EPO 40,000 U weekly (QW). Dose was withheld for Hb >13.0 g/dL at any dosing visit; dose was reduced for Hb >12.0 g/dL or Hb increase >1.5 g/dL in a 3-wk period (current prescribing information recommends target Hb not to exceed 12 g/dL). Hb response was defined as Percent Values in Range (PVR; the mean proportion of weekly Hb levels that were =11.0 and =13.0 g/dL) and by mean Hb change from BL. Hb data following switch to 40,000 U QW were censored. Results: A total of 136 pts were randomized (68 per group). Demographics were similar; BL Hb was 11.5 g/dL in both groups. PVR was 60% in the EIG and SIG. Mean Hb change from BL to final value on Q3W dosing was -0.1 g/dL in both groups. Among the 51 pts whose Hb fell below 11 g/dL in the SIG, their Hb decreased to a mean of 10.4 g/dL before initiation of EPO. Their subsequent mean Hb increase was 0.7 g/dL at the final visit on Q3W therapy. PRBC transfusion rates after the first 4 wks of EPO treatment were 8.8% (6/68) and 7.8% (4/51) for the EIG and SIG, respectively. In the EIG vs SIG, EPO was withheld in 38% vs 22% of pts and reduced in 43% vs 26% of pts. Two deaths and 6 clinically relevant TVEs while on EPO treatment were reported in each group. Conclusions: This is the first study to show EPO may be initiated at 120,000 U every 3 wks. Hb outcomes in the EIG and SIG were similar. These data provide further evidence that half-life of erythropoietins may not correlate with their effectiveness when used at extended dosing intervals. Future research is warranted. No significant financial relationships to disclose.
Evaluation of sensitivity to change of the MPAC scale, validated in Spanish, in pain measurement in cancer patients
Authors: Escobar Y. , Domine M. , Valcarcel F. , Contreras J. , Lobo F. 
Published: March 2020

19567 Background: The Memorial Pain Assessment Card (MPAC) allows an easy measurement of oncologic pain in the clinical practice. In 2004, a Spanish version of the MPAC scale was validated in cancer pain. The goal of the present work was to evaluate the sensitivity to change of the validated Spanish version by oncologic patients. Methods: Epidemiological, prospective, 2-months multicenter study, conducted at 4 services of oncology. The included patients suffered continuous chronic cancer pain and were in a susceptible situation of change (pain intensity ≥ 3 in a Visual Analogue Scale). The MPAC card was administered at baseline and at 1 and 2 months, including the 4 subscales (pain relief [VASPR], pain intensity measured by VAS [VASPI] and by an 8-items descriptors subscale [Tursky], and psychological distress [VASMOOD]). Data about clinical situation and satisfaction of the patient and the health care professionals with the MPAC card was also collected. Sensitivity to change was evaluated by comparing 2-months versus baseline results in the MPAC subscales. Results: Fifty-four patients with oncologic pain (76% men) with a mean (SD) age of 57(11) years were included. 74% of patients presented metastasis, and in 80% of cases the treatment was palliative. All the MPAC VAS subscales showed sensitivity to change across the 2-months period: mean VASPI at baseline 6.6(1.7) vs 3.5(2.0) at 2 months (p<0.0001, Wilcoxon test [WX]); VASPR 4.5(1.9) vs 6.3(2.3) (p<0.0001 [WX]); VASMOOD 5.5(2.1) vs 4.0(2.1) (p=0.0008 [WX]). Furthermore, 90.5% of patients showed changes in Tursky subscale (78.6% less pain, 11.9% increased pain), being these changes significantly associated with VASPI scores (p=0.0006, Kruskal-Wallis test). Both patients and medical personnel agreed in the card use facility (63% and 71% of cases, respectively). Conclusions: The Spanish MPAC version has demonstrated sensitivity to change in all the MPAC subscales (pain relief, pain intensity and psychological distress). Its facility of administration may allow a useful and quick evaluation of the cancer pain in the clinical practice. No significant financial relationships to disclose.
Influence of hyperglycemia on toxicity in older patients receiving chemotherapy
Authors: Brunello A. , Kapoor R. , Extermann M. 
Published: March 2020

19579 Background: Few data are available concerning how glycemic control can affect outcomes in cancer patients (pts) treated with chemotherapy (CHT), particularly with those regimens that are more likely to cause increases in glycemia. Methods: Charts of non-Hodgkin lymphoma (NHL) and prostate cancer (PC) pts treated at Moffitt Cancer Center from January 1999 to September 2006 were reviewed, and pts who received Cyclophosphamide, Doxorubicin, Vincristine, Prednisone and Rituximab or Docetaxel-based CHT plus steroids were eligible. Demographics, vitals, comorbidity, biochemicals including baseline and average glucose level during chemotherapy, G4 hematological (HemT) and G3-G4 non hematological toxicity (NHemT), progression and death dates were recorded. Upper Limits of Normal for glycemia were set at 100 (fasting) and 140 mg/dL (post-prandial). Results: Three hundred forty-nine pts were eligible (NHL/PC: 62/187). Pts’ characteristics are outlined in Table I . Thirty-three pts in the NHL group and 48 pts in the PC group had received previous chemotherapy. G4 HemT was experienced by 76 (47%) NHL and 9 (5%) PC pts. 79 NHL and 86 PC pts had G3-G4 NHemT: neuropathy (25.3%), fever (not neutropenic, 18.9%), fatigue (15.2%), for NHL and fatigue (22.1%), thrombosis (11.6%) and diarrhea (9.3%) for PC. For NHL pts, G3–4 NHemT was associated with baseline hyperglycemia (p=0.0384, Wilcoxon Rank-Sum test) as well as with average glycemia during CHT (p=0.0048), while there was no significant correlation for HemT. For PC pts, a positive correlation was found between baseline hyperglycemia and G4 HemT (p=0.0241), while correlations between average glycemia during CHT and G4 HemT and between both baseline and average glycemia with NHemT were not significant. Conclusions: In NHL pts receiving CHT, often with a curative intent, hyperglycemia entails greater toxicity. Prospective studies are needed in order to assess whether a better glycemic control can improve the toxicity rate and the outcomes in elderly patients receiving chemotherapy. [Table: see text] [Table: see text]
Prevalence and temporal patterns of persistence of symptoms in 165 rectal cancer patients receiving preoperative chemoradiation therapy
Authors: Krishnan S. , Mendoza T. , Zhang Y. , Wang X. S. , Das P. , Delclos M. E. , Crane C. , Cleeland C. , Janjan N. 
Published: March 2020

19580 Background: The symptom burden during preoperative chemoradiation therapy for rectal cancer (CRT) has not been objectively characterized previously. The severity and temporal patterns of patient self-reported symptoms during CRT were assessed using the MD Anderson Symptom Inventory (MDASI). Methods: 165 consecutive patients with T3/T4/N+ rectal cancer received 45–55 Gy in 25–30 fractions concurrently with capecitabine chemotherapy. No additional intervention beyond standard supportive care was triggered by the MDASI score severity. The mean symptom scores were grouped into three time points; weeks 0–1 (“baseline”), 2–3 (“early treatment”), and 4–6 (“late treatment”) of CRT. Lowess curves were used to demonstrate the severity and pattern of individual symptoms. Linear mixed models were used to assess changes in symptom severity. Repeated measures analyses compared the mean severity of the reported symptoms at the three time points. Results: The median number of data points per patient was 3.0 (range, 1–6), for a total of 533 data points. Lowess curves demonstrated increasing symptom severity during CRT, which was confirmed by the linear mixed models analysis for each symptom (p<0.05). Using repeated measures with the three time points, these symptoms, except fatigue, showed statistically significant differences in mean severity ( Table 1 ). High baseline fatigue levels blunted statistical power to detect differences during CRT. Despite normal hemoglobin levels, fatigue remained the most severe symptom. Placed in context, the mean symptom levels remained mild throughout CRT. Conclusions: CRT was associated with a high prevalence of and progressive increase in symptom burden during therapy although the functional impact was limited. All symptoms followed clinically recognized patterns. The linear mixed model, a more sensitive measure of these trends, is recommended for prospective studies of interventions for symptom control [Table: see text] No significant financial relationships to disclose.
Spirituality and religion in terminally ill patients with cancer
Authors: Heras P. , Kritikos K. , Georgopoulou A. , Hatzopoulos A. , Kritikos N. 
Published: March 2020

19587 Background: The importance of spirituality and religion in coping with a terminal illness is becoming increasingly recognised. We aimed to assess the relation between spiritual well-being, religiosity, depression, and end-of-life despair in terminally-ill cancer patients. Methods: One hundred forty three terminally ill cancer patients with a life expectancy of less than 6 months were interviewed with a series of standardised instruments, including the FACIT Spiritual Well-Being Scale, a religiosity index similar to those used in previous research, the Hamilton depression rating scale, the Memorial Symptom Assessment Scale and the Duke-UNC Functional Social Support Questionnaire. Results: A strong negative association was observed between the FACIT Spiritual Well-Being scale and the HDRS, but no such relationship was found for religiosity. Similar patterns were observed for the FACIT subscales, finding a strong negative association between the meaning and peace subscale (which corresponds to the more existential aspects of spirituality) and HDRS scores, whereas a positive, albeit nonsignificant, association was observed for the faith subscale (which corresponds more closely to religiosity). Conclusions: These results suggest that the beneficial aspects of religion may be primarily those that relate to spiritual well-being rather than to religious practices per se. Spiritual well-being offers some protection against end-of-life despair in those for whom death is imminent. The area of spiritual work is fertile ground for further investigation, especially interventions aimed at improving spiritual health and general quality of life among terminally ill patients with cancer. No significant financial relationships to disclose.
Clinical trials, case reports, and observational databases as sources of information on serious cancer-related adverse drug reactions (sADRs): Lessons learned from the Research on Adverse Drug Events and Reports (RADAR) project
Authors: Bennett C. , Gleason K. , Djulbegovic B. , Raisch D. 
Published: March 2020

19591 Background: Serious adverse drug reactions (sADRs) such as venous thromboembolism resulting from cancer pharmaceutical use are underappreciated and often misattributed to the cancer diagnosis, rather than the therapy. The Research on Adverse Drug events And Reports (RADAR) group evaluated factors associated with identification of serious cancer-related sADRs (i.e. an adverse drug reaction that results in death or severe organ failure). Methods: Information on sources of clinical information, incidence, setting, and time from FDA approval to initial identification was obtained for sADRs that resulted in death or severe organ failure. Most of the ADRs are described as Black Box warnings or in “Dear Doctor” letters. Results: Summarized in table . Conclusion: Clinical trial safety reports from off-label settings facilitate identification of common (>3% rate) cancer associated sADRs. Case reports and observational databases from on-label settings facilitate detection of rare cancer-associated sADRs (<1%) often at lengthy time intervals from initial FDA approval. No significant financial relationships to disclose. [Table: see text]
Osteonecrosis of the jaw (ONJ) in androgen-independent prostate cancer (AIPC) patients receiving ATTP (bevacizumab, docetaxel, thalidomide, and prednisone)
Authors: Aragon-Ching J. B. , Ning Y. M. , Latham L. , Guadagnini J. , Arlen P. M. , Gulley J. L. , Wright J. , Parnes H. , Figg W. D. , Dahut W. L. 
Published: March 2020

19594 Background: ONJ has been associated with IV bisphosphonate use in cancer patients (pts) and chemotherapy may be an additional risk factor. ONJ is believed to result from localized vascular insufficiency due to faulty bone remodeling. ONJ incidence in pts not receiving chemotherapy (e.g. Paget's disease) is reportedly only 0.8%; prostate cancer pts have an incidence of 6.5%. Methods: We reviewed data from pts with advanced AIPC who developed ONJ while being treated on a Phase II study of ATTP. Results: Six of 36 (17%) pts treated with ATTP had ONJ confirmed by oral surgery. Four of the 6 pts presented with pain and, in five, the ONJ was mandibular in location. All pts were treated conservatively with either sequestrectomy or oral cleansing with chlorhexidine. All pts had been treated monthly with IV zoledronic acid (ZA). The mean duration of ZA use before diagnosis of ONJ was 20 months (mos). One patient had been treated with oral alendronate for 3 years and then developed ONJ after 5 mos of ZA. Of the 36 pts on-study, previous dental history could be verified in 24 pts. ONJ was diagnosed in 4 of the 5 pts with a prior dental infection or invasive dental procedure. Pts received an average of 11 cycles of ATTP before ONJ was diagnosed. All pts with ONJ had received full doses of bevacizumab and most had received full doses of all medications for all cycles. Conclusions: The possibility exists that the risk for ONJ may be higher with specific chemotherapy regimens, particularly those that include steroids or anti-angiogenic agents. However, at this time prior dental infections or procedures remain the greatest known risk factor. It is also possible that the relatively high incidence of ONJ in prostate cancer patients may reflect increased awareness in this population. Randomized phase III trials in AIPC, specifically addressing the incidence of ONJ, are needed to determine whether specific chemotherapy regimens are associated with an increased risk of this complication. No significant financial relationships to disclose.
Osteonecrosis of the jaw (ONJ) in cancer patients (pts) treated with bisphosphonates (B): Results of a monoinstitutional monitoring program
Authors: La Verde N. , Borgonovo K. , Garassino M. C. , Sburlati P. , Pedretti D. , Perrone S. , Mihali D. , Mantica C. , Galassi B. , Farina G. 
Published: March 2020

19601 Background: B reduce bone metastases complications. ONJ is a serious adverse event during B treatment. Therefore, it's necessary to identify some procedures to reduce ONJ injures in a monitoring program. Patients and Methods: We retrospectively reviewed how an active program of prevention based on clinical oral cavity examination, dentists and pts education might improve ONJ outcome in pts receiving pamidronate (P) 90 mg monthly or zoledronate (Z) 4 mg monthly. Results: from October 2003 to October 2006, 154 consecutive pts were treated; 95 females, 59 males; primary tumors: 66 breast, 28 prostate, 26 lung, 9 myeloma, 4 NHL, 21 other. In June 2005 the monitoring program started on all our pts. ONJ was diagnosed in 15/154 (9.7%) pts, 8 before and 7 after June 2005; all pts were treated with Z (total 2,987 courses, range 8–43; median courses/pt 19.4) and 4 pts pretreated also with P (total 124 courses, range 12–43, median courses/pt 31. Tumors: 7 breast, 1 kidney, 2 lung, 1 head-neck, 1 thyroid, 1 NHL, 1 prostate, 1 sarcoma. Concomitant therapies: 14 pts chemotherapy; 7 hormonotherapy; 2 head-neck radiotherapy; 5 steroids. Significant anamnesis: 9 recent dentoalveolar procedures, 4 diabetes. First symptoms: multiple recurrent alveolar abscesses 9, pain 3, dental mobility 1, paresthesia of the lower lip 1, exposed bone 1. Main treatments were: antibiotics and antifungals 11, curettages 3, surgical resections 4 (1 partial maxillectomy, complicated by septic shock and oronasal communication, 2 partial mandibulectomies, 1 segmental mandibular resection). These last 4 pts, that had the worst prognosis, were diagnosed before starting the monitoring program, and they had been treated with aggressive dental procedures at the exordium. 7 new ONJ cases, diagnosed after June 2005 were successfully treated without aggressive dentist interventions, achieving a good control. Conclusions: We remark that ONJ B related is a frequent adverse event (9.7%), especially with Z. A monitoring program based on non- surgical treatment and patients and physicians education may improve its management. No significant financial relationships to disclose.