bluuebunny/crossref_metadata_2025 huggingface dataset:
Comprehensive geriatric assessment (CGA)-adapted chemotherapy (CT) in 100 elderly patients (pts) (>70 years) with diffuse large B-cell non-Hodgkin’s lymphoma (DLBCL)
Authors: Tirelli U. , Balzarotti M. , Uziel L. , Ferreri A. , Fratino L. , Vaccher E. , Santoro A. , Spina M.
Published: March 2020

19515

Rituximab+CHOP (R-CHOP) is the standard CT regimen for elderly pts with CD20+ DLBCL. However, many pts ≥70 yrs are often unable to received R-CHOP and are excluded from clinical trials. Moreover, CGA has been demonstrated a useful instrument to predict the clinical outcome of elderly cancer pts even if it has never been tested prospectively. Within the GOL (Onco-hematological Lymphoma Group) from June 2000 to March 2006 we started a phase II prospective study to evaluate the feasibility and activity of a CGA-driven CT for elderly pts with DLBCL. Rituximab was used in all pts after February 2002. Pts with no comorbidity received CHOP or R-CHOP; in pts with mild cardiopathy epirubicin was used instead of doxorubicin (CEOP or R-CEOP); in pts with moderate or severe cardiopathy the use of antracyclines was omitted (CVP or R-CVP). CT dosage was decided according to CGA: pts with a good CGA score (ADL=6, IADL>6) received full doses of CT; pts with an intermediate score (ADL=5, IADL>4) received 75% of the planned dose; pts with a poor score (ADL<5, IADL<5) received 50% dose. All pts received prophylactic filgrastim; 100 pts (41 males and 59 females) have been treated and no pt was excluded from this approach. Median age was 75 yrs (range 70–89) and 51% were stages III-IV. Sixty-one per cent of pts received full doses of CT, 86% received antracycline (doxorubicin in 56% and epirubicin in 30%) and 54% received rituximab plus CT. The following regimens were used: R-CHOP 22%, CHOP 16%, 75%-R-CHOP 10%, 75%-CHOP 8%, CEOP 11%, R-CEOP 4%, 75%-R-CEOP 9%, 75%-CEOP 6%. The remaining pts received CVP in 5% of cases and reduced R-CVP in 9% of cases. The toxicity was quite acceptable, however 4 toxic deaths occurred (2 septic shock, 1 acute respiratory failure and 1 acute myocardial infarction). Overall, 76% achieved CR and with a median follow-up of 24 months (range 1–71 months) only 16% relapsed. Seventy-three pts are alive and 63% in CR. Our results demonstrated that a CGA-driven approach is feasible and highly active in elderly pts with DLBCL. Moreover this strategy allows a potentially curative approach to all pts with aggressive NHL avoiding both to under-treat elderly pts with a curable disease and to over-treat elderly pts with comorbidities.

No significant financial relationships to disclose.
Prevalence of osteoporosis in glioma patients on enzyme inducing anticonvulsants (EIAC) and/or glucocorticoids
Authors: Jones L. , Affronti M. L. , Bohlin C. W. , Herndon J. E. , Quinn J. A. , Reardon D. A. , Rich J. N. , Friedman H. S. , Vredenburgh J. J.
Published: March 2020

19527

Background: Glioma patients are at risk for osteoporosis and associated morbidity as a result of neurological deficits, anticonvulsants and glucocorticoid therapy. The prevalence of osteoporosis in glioma patients has not been reported. We hypothesized that the prevalence of the osteopenia (defined by bone mineral density (BMD) T-score < -1) or osteoporosis (defined by T- score < -2: spine; T-score < - 2.5: femur) in glioma patients supports consideration of bisphosphonate treatment to prevent or reduce the severity of osteoporosis and skeletal complications. Methods: BMD was conducted on 19 eligible patients. Eligibility criteria included: (1) histologically confirmed diagnosis of a primary glioma, (2) age ≥ 18 years, (3) KPS ≥ 60%, (4) treated with valproate or an EIAC and/or on more than physiologic replacement steroid therapy, (5) creatinine < 2.0 mg/dl and calculated creatinine clearance of >60 ml/min, (6) bilirubin < 1.5 x nl, LFTs < 2.5 x nl, (7) recovery from surgery, (8) life expectancy >12 wks, and (9) written informed consent. Exclusion criteria: Previously diagnosed with osteoporosis requiring oral bisphosphonates. Results: 89% were diagnosed with a glioblastoma. Mean age, 54.6 (±SD 9.4; range 35–70). 68% (13/19) were male and all were white race. 53% (10/19) had a KPS of ≥90: 42% (5/19) KPS ≥80: 5% (1/19) KPS ≥70%. AC use: 64% phenytoin; 11% valproate; 5% phenobarbital; 5% oxcarbazepine; 10% levetiracetam; and 5% none. 37% were on dexamethasone, 16% other steroids, and 47% off steroids. Mean N-telopeptide (a marker of bone turn over) was 12.6 (±SD 5.5; range 5.6–22.2). 22% of patients (4/19) had osteopenia and 16% (3/19) had osteoporosis. Conclusions: Overall 38% percent of glioma patients had evidence of osteopenia and 16% had osteoporosis. Thus, bisphosphonates should be considered to prevent skeletal complications. Subsequently, we have initiated an open-labeled Phase II trial to further determine the prevalence of osteoporosis in glioma patients and the effect of every three month prophylactic zoledronic acid on bone density. An update of the prevalence of osteoporosis in patients enrolled on this trial will be presented.

No significant financial relationships to disclose.
Development of a functional assessment of side-effects to therapy (FAST) questionnaire to assess dermatology-related quality of life in patients treated with EGFR inhibitors (EGFRI): The FAST-EGFRI
Authors: Wagner L. , Lai S. E. , Aneja M. , Lorusso P. , Perez-Soler R. , O’Brien B. , Patel J. , Lacouture M. E.
Published: March 2020

19532

Background: Despite their beneficial antitumor effects, 75–87% patients who undergo EGFRI therapy develop dermatological toxicities (derm tox), including rash, paronychia, hair alterations, and pruritus. The purpose of this study was to develop a patient (pts) self-report questionnaire based on pts and expert (exp) input and to identify the most significant skin tox health-related quality of life (HRQL) factors. Methods: To generate the questionnaire, 20 pts with derm tox to EGFRIs and 12 expert clinicians (>50 treated pts) were asked interview questions and rated 62 items to assess the most bothersome aspects of derm tox and the impact on pts’ skin-specific HRQL. The questionnaire included items from the Skindex-29, a validated skin disease-specific HRQL questionnaire. Items were rated from 0 (not at all important) to 3 (extremely important) (range = 0–3) based on the items’ significance to patients’ HRQL. Both groups were also asked to circle 20 of the most concerning HRQL factors. Results: Eighteen pts and 11 exp completed the questionnaire. Symptoms reported frequently by both pts and exp that affected patients’ HRQL included painful (mean score 2.29 (pts), 2.70, (exp), burning (2.41 (pts), 2.70 (exp)), itchy (2.00 (pts), 2.20 (exp) skin, pain in fingers/toes (2.00 (pts), 2.40 (exp)) increased facial hair (1.93(pts), 1.70 (exp)). Both pts and exp also frequently reported that the patient’s skin condition makes them feel depressed (1.88 (pts), 2.60 (exp)) and makes work or hobbies difficult (2.00 (pts), 2.20 (exp)). The top three most concerning HRQL factors for pts were skin pain, burning and stinging, and irritation, while exp reported depression, skin pain, and derm tox affecting pts’ social life. Conclusions: These results document the trajectory of symptom burden and derm tox HRQL in EGFRI treated pts. These findings underscore that in addition to the psychosocial discomfort, physical symptoms impact HRQL. Further studies to validate the FAST-EGFRI, so that effects on HRQL of interventions against derm tox and differences between agents can be assessed are underway.

No significant financial relationships to disclose.
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.
Correlation between fatigue level and irradiated volume of the whole body, lung and heart in breast cancer patients receiving adjuvant radiotherapy after breast-conserving surgery
Authors: Rucinska M. , Langkjer S. T.
Published: March 2020

19608

Background: Fatigue - an unpleasant, persistent, subjective sense of tiredness - is one of the most common symptoms experienced by cancer patients. It is multidimensional and is associated with both - malignancy itself and the anti-neoplastic treatment. The aim of the study was to assess the level of fatigue during and after adjuvant postoperative radiotherapy in breast cancer patients and evaluate its correlation with the irradiated volume of the whole body, lung and heart. Methods: 48 patients (age 33–76 years, mean 57 years) with early breast cancer after breast-conserving surgery were treated with adjuvant radiotherapy (48Gy/24fractions/5weeks; 12 patients received boost 10Gy/5fractions/1week to the tumor-bed). The patients′ subjective feeling of fatigue intensity was measured according to 10- score visual analog scale (VAS) before the start and weekly during radiotherapy, as well as 14 days and 3 months after radiotherapy. Results: Fatigue intensity increased gradually during radiotherapy (mean fatigue-VAS before and in the last week of treatment was 1.21 and 2.31 respectively; p=0.004). 14 days after the end of radiotherapy, the fatigue intensity was still higher than before treatment (1.88 and 1.21 respectively; p=0.04), but 3 months later, fatigue was lower than at the pretreatment level (n.s.). Irradiation of the large volume of the whole body was correlated with higher fatigue level during and after radiotherapy. If 15% or more of the unilateral lung volume received 20Gy, patients reported higher fatigue level than patients receiving 20Gy for less than 15% of the unilateral lung volume. There were no statistical differences in fatigue level between patients with different percentage of the heart volume receiving irradiation. Patients with boost did not manifest higher fatigue level. Conclusions: Fatigue increased over the course of radiotherapy, but 3 months after the end of therapy it was reduced to lower than at the preliminary level. There was a positive correlation between fatigue level during and after radiotherapy and the irradiated whole body and lung volume, but not heart volume.

No significant financial relationships to disclose.
The variations in symptom clusters related to well-being in palliative care patients during the final weeks of life
Authors: Olson K. L. , Hayduk L. , Cree M. , Tsui Y. , Quan H. , Hanson J. , Lawlor P.
Published: March 2020

19612

Background: The purpose of this study was to determine whether the relationships between symptoms and well-being, as experienced by palliative care patients, changed as patients approached death. Methods: Data were extracted from a database that included Edmonton Symptom Assessment System scores collected from palliative care patients on Day 7 of Weeks 5 (n=123), 2 (n=115), and 1 (n=113) prior to death between 1995 and 2000. The model contained 18 effect parameters. Based on standard sample size requirements for structural equation modeling of 10 cases per indicator variable, the study was adequately powered for all three time points. The majority of patients had advanced cancer and were receiving care in either a tertiary palliative care or hospice setting. All participants had Folstein Mini- Mental Status Examination scores of 22 or higher at the time of original data collection. A causal model, based primarily on clinical discussions, linking pain, anxiety, nausea, shortness of breath, drowsiness, loss of appetite, tiredness, depression, and well-being was proposed. The model was tested against the data from all three time points, using LISREL, version 8.7.2s. Results: The model fit the data for all time points, but was revised slightly based on the modification indices. The final Goodness of Fit Test values were χ2= 4.2 (d.f.=8, p=.84), χ2= 13.3 (d.f.=9, p=.15), and χ2= 5.5 (d.f.=9, p=.79) respectively. With respect to tiredness, depression and well-being, the model explained at least 70% of the variance at Week 5, between 57% and 83% of the variance at Week 2, and 42% to 58% of the variance in Week 1. Nausea was unimportant in all of the models. The two strongest effects, persisting over all three time periods, were those linking anxiety to depression, and drowsiness to tiredness, reflecting strong stability in patient rankings even as health declined and treatment changed. Conclusions: The symptom clusters in this study changed over time, in disagreement with existing research that assumes the relationships between symptoms within symptom clusters remain stable. An improved understanding of alterations in symptom clusters may contribute to improved control of patient comfort, quality of life, and quality of death.

No significant financial relationships to disclose.
Wisconsin Comorbidity Assessment Scale (WCAS): A novel, comprehensive, performance-based assessment scale of geriatric syndromes and medical comorbidities in older cancer patients
Authors: Krishnamachary M. K. , Swain-Eng R. J. , Barnet J. , Maloney J. , Stewart J. A. , Asthana S.
Published: March 2020

19619

Background: Elderly patients with cancer have potential for multiple geriatric syndromes that influence treatment and outcomes. No single clinical assessment tool has targeted all the major geriatric syndromes and their interaction on cancer management and outcomes. We developed WCAS to evaluate cognitive and physical function, risk of falls and gait disorders, polypharmacy, and medical comorbidities. Methods: Eighteen newly diagnosed patients with breast cancer (age 55–82), were enrolled prior to cancer treatment. Cognitive function was evaluated with a comprehensive battery of neuropsychological tests targeting the domains of memory, executive function, attention, language, and praxis. Physical function skills were assessed with novel performance-based tasks (e.g., bed-making) and computerized assessments of balance, gait and risk of falls. Cancer treatment included surgery in all patients with variable use of adjuvant radiation and medical therapy. WCAS was administered at baseline and at month 6. Results: Ten subjects have completed both baseline and month 6 visits. Surgical treatment occurred at a mean of ten days after baseline assessment (SD 6.7). The mean (SD) of the age, years of education and baseline Mini Mental Status Exam (MMSE) was 66 years (7.3), 15.2 years (3.7) and 29.3 (1.1). From baseline to month six assessment performance on the WAIS Digit Symbol test, a measure of working memory and processing speed, declined (mean change −11.7, p<0.01). Likewise, the performance on the WAIS letter number sequence test (mean change −1.3, p=0.09) and the MMSE (mean change −1.1, p=0.12) declined. Interestingly, four subjects with pre-existing hypothyroidism on replacement treatment showed a greater decline (p<0.01) in memory than those without this common condition. Conclusions: Findings indicate that breast cancer diagnosis and therapy can be associated with significant decline in aspects of cognition in older adults with cancer. These changes can last at least 6 months and are more pronounced in those with hypothyroidism. Larger, longer term prospective studies utilizing WCAS are necessary to confirm our preliminary findings.

No significant financial relationships to disclose.
Development of symptom assessment tool for terminal cancer patients
Authors: Koh S. , Lee K. , Hong Y. , Kang J. , Woo I. , Lee M. , Choi S.
Published: March 2020

19634

Background: A symptom assessment is important to control the terminal cancer patients’ symptoms successfully and improve their quality of life. Our research team has developed the objective assessment method for the terminal patients’ symptoms and compared the results with the patient self-reported outcomes using Memorial Symptom Assessment Scale (MSAS). Methods: From September in 2004, the 121 inpatients without anti-cancer therapy in terminal stage of cancer were evaluated in Kangnam St. Mary's Hospital. The 17 common symptoms were graded as four categories; none(0), mild(1), moderate(2), and severe(3) with reference to NCI-CTC and WHO toxicity criteria. An attending physician assessed 17 symptoms at the similar hour every day. Among the inpatients, those who had clear consciousness and could communicate normally were investigated every week to evaluate the frequency and severity of common symptoms and their distress degree using MSAS. Results: Only 54 patients (44.6%) could be examined to evaluate the symptoms by MSAS. However, the symptoms estimated by our assessment tool were less serious in the terms of severity and distress degree than that patients felt actually. This tendency was shown more obviously in the mental symptoms; Drowsiness (p=0.0001), Nervousness (p=0.0001), and Anxiety (p=0.005). However, the physical symptoms had no statistical difference between the results from patients and physician. Conclusions: Patient-reported outcomes using MSAS could be obtained from 44.6% of the inpatients with terminal cancer every week. However, the objective assessment tool to evaluate the common symptoms of terminal cancer patients can be applied for all patients including the incommunicable, every day. Furthermore, this assessment tool may be more suitable for examining the physical symptoms of terminal cancer patients.

No significant financial relationships to disclose.
A pilot crossover study to evaluate the use of Regenecare topical wound gel in patients with cutaneous toxicity caused by epidermal growth factor receptor (HER1/EGFR) inhibitors
Authors: Wong S. , Osann K. E. , Lloyd K. P. , Vasko C. M. , Arcinas R. L. , Mummaneni M.
Published: March 2020

19643

Background: Acneform rash, including pain and pruritus, presents as a dose-limiting toxicity for HER1/EGFR (epidermal growth factor receptor) inhibitors which can lead to secondary skin infection. Antibiotics and corticosteroids are treatment options with minimal or moderate success. Better rash management is desirable for optimal use of these agents. Regenecare™ Gel contains 2% lidocaine for local pain management, marine collagen to promote tissue formation, aloe vera to promote circulation and emollient effect, and sodium alginate to absorb exudates. This study evaluates the effectiveness of Regenecare™ Gel in relieving the clinical symptoms of HER1/EGFR inhibitors-induced skin rash. The secondary objective assesses patient tolerability and satisfaction. Methods: A single center, prospective pilot cross- over study of 10–15 cancer patients treated with HER1/EGFR inhibitor. At the occurrence of grade 2 skin rash, subjects who signed an informed consent started applying study gel on the right side of the face and then crossed-over to both sides of the face after 1 week. Subjects were examined weekly for facial evaluations and photographs. The study continued for a total of six weeks. Results: Eight patients were enrolled with 6 evaluable (3 cetuximab, 2 panitumumab, 1 erlotinib). A summary of the itch and pain score responses are outlined below. Comparative analysis for Treatment vs. No Treatment show significant improvement with respect to self-reported level of itch (p=0.019) and pain (p=0.033). All patients tolerated the study gel without any adverse effect and 5 patients were very satisfied with the effectiveness of the gel. Conclusions: Regenecare™ Gel appears effective in relieving EGFR inhibitors rash-associated pruritus and pain based on these preliminary analyses. Study is ongoing for further assessment.

No significant financial relationships to disclose.

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Hypocalcemia induced by bisphophonates in cancer patients with vitamin D deficiency
Authors: Yazbeck C. F. , Gonzalez-Angulo A. M. , Shaw S. A. , Waguespack S. G. , Vassilopoulou-Sellin R. , Busaidy N. L.
Published: March 2020

19644

Background: The use of bisphosphonates for treatment of hypercalcemia, bone pain and reduction of skeletal morbidity in metastatic breast cancer is increasing. Moreover, vitamin D deficiency is commonly associated with cancer. Hypocalcemia has been reported following IV bisphosphonate use. Methods: We present the clinical and lab findings in 6 cases of bisphosphonate-induced hypocalcemia, caused by unmasked vitamin D deficiency. Results: Our 1st patient was diagnosed with breast cancer and developed metastases 6yrs later. She was given Zolendronic acid 4 mg IV with a baseline calcium level (Ca) of 9.7 mg/dl, normal albumin, and elevated alkaline phosphatase. 3 days later, she developed symptomatic severe hypocalcemia with tetany: Ca dropped to 6.1 mg/dl with recovery. After her 2nd dose of Zolendronic acid, Ca dropped again to 6 mg/dl with normal albumin, intact parathyroid hormone (PTH) of 637 pg/ml (range 10–65) and 25-hydroxy vitamin D levels (25-OHD) of 4 ng/ml (range 20–100). Our 2nd patient presented with metastatic breast cancer and was treated with Zolendronic acid for hypercalcemia with a baseline Ca of 13 mg/dl, PTH-related protein of 2.8 pmol/l (range <1.8) and PTH of 7 pg/ml. She then developed hypocalcemia with corrected Ca of 7.7 mg/dl and 25-OHD of 13 ng/ml. Our 3rd patient with breast cancer was also treated with Zolendronic acid for bone metastases and hypercalcemia. She then presented with symptomatic hypocalcemia: ionized Ca level of 1.09 mmol/l (range 1.13–1.32), PTH of 211 pg/ml and 25-OHD of 13 ng/ml. Our other 3 cases had similar presentations to the above and will be discussed in detail. All 6 cases were treated with ergocalciferol and long-term oral calcium and vitamin D therapy. All of our cases presented with symptomatic hypocalcemia with vitamin D levels less than 30ng/mL. Conclusions: Since bisphosphonate use is increasing in cancer patients and vitamin D deficiency is not an uncommon finding in this population, consideration should be given to routine checking of 25-OHD levels before initiating treatment with bisphosphonates and supplementing with calcium and vitamin D when necessary (<30ng/mL). This could potentially prevent further morbidity. Further prospective studies would be needed for early replacement with vitamin D and calcium in those with vitamin D deficiency.

No significant financial relationships to disclose.
Management of pain in patients (PTS) receiving active therapy for cancer
Authors: Campora E. , Schellino M. , Ardissone F. , Balbo A. , Bandiera A. , Borea M. , Cimino S. , Floccia M. , Mura M. , Salamone F. , Di Lonardo A.
Published: March 2020

19645

Background: The World Health Organization (WHO) estimates suggest that moderate to severe pain is experienced by one- third of pts receiving active therapy for their disease and by 60–90% of patients with advanced disease. Procedures that make pain assessment and effective management strategies a routine part of every patient care are recommended. The aim of this study was to integrate nursing intervention with physician management of cronic cancer pain experienced by pts receiving active therapy for cancer. Methods: An Oncology Nurse measured pain in all patients (universal screening) presenting at the Day Hospital for active therapy. Pain was measured using a validated instrument: the Visual Analog Scale (VAS). The pain intensity VAS scale is a 10 cm line anchored on either end by the terms least possible pain and worst possible pain. In addition. the Memorial Pain Assessment Care (MPAC) that consists of 3 VAS scales that measure pain intensity, pain relief and mood and a set of pain severity descriptors adapted from the Tursky rating scale was used. Results: From April 2004 to June 2006 a total of 704 pts were evaluated for pain, 334 (47%) males and 370 (53 %) females with median age 65 years (range 19–85). Results of pain measurement can be synthesized as follows: Pts with VAS = 4 were referred to the oncologist on the same day that pain was measured and analgesics were prescribed according to intensity and type of pain. Conclusions: Results indicate that pain can be universally evaluated and successfully managed in an Oncology Day Hospital. Assessment and treatment of cancer pain should be integrated into routine cancer care. Intervention by the oncology nursing staff is an integral part of effective cancer pain management.

No significant financial relationships to disclose.

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Preventing the Preventable—Improving thromboprophylaxis in oncology in-patients
Authors: Stevens R. , Jones R. , Oliveras S. , Abdullah T. , Leonard R.
Published: March 2020

19648

Background: Cancer and its treatments are well recognised risk factors for venous thromboembolism (VTE). The risk of VTE complications in malignancy can be increased with surgery, chemotherapy (including adjuvant chemotherapy), hormone therapy and central indwelling catheters. Low molecular weight heparin (LMWH) has been shown to safely reduce the incidence of VTE in cancer patients however it is often not a standard of care within the oncology in-patient setting. Method: A retrospective study was carried out on admissions to the oncology ward for 1 month. Individual VTE risk was assessed using the modified THRiFT II risk assessment model and it was documented whether patients received any form of prophylaxis and the incidence of VTE. Following this study a VTE prophylaxis protocol was designed and implemented on the oncology ward and a repeat prospective study was carried out. Results: The initial study showed that in the very high risk group only 15% patients received thromboprophylaxis. 4 episodes of VTE occurred during the initial study period and these all occurred in patients stratified as very high risk. On the repeat study the results showed 50% of patients assessed as very high risk were now receiving prophylaxis. There was also a reduction in the rate of inappropriate prophylaxis from 17% to 0% in those assessed as lower risk. Conclusion: Primary prevention of VTE helps to reduce the morbidity and mortality associated with this common complication of malignancy. This study shows how a simple risk assessment model coupled with raised awareness of VTE risk improved the prophylaxis of those at highest risk and also reduced inappropriate usage in those at lesser risk.

No significant financial relationships to disclose.