bluuebunny/crossref_metadata_2025 huggingface dataset:
Outpatient stem cell transplantation for multiple myeloma
Authors: Ghavamzadeh A. , Alimoghaddam K. , Karimi A. , Manookian A. , Asadi M. , Maheri R. , Shamshiri A.
Published: August 2020

e19553

Background: The aim of this study was to explore the feasibility and safety of performing aoutologous stem cell transplantation (ASCT) on an outpatient basis. Methods: 142 patients with multiple myeloma (MM) in complete remission (CR) or partial remission (PR) received ASCT on an outpatient or inpatient basis. In the inpatient group 77 patients and in outpatient group 65 patients received 200 or 140 mg/m2 melphalan as conditioning regimen respectively. In outpatient group all the patients were programmed to go home the day after ASCT and to be re-hospitalized in the case of febrile neutropenia or other sever toxicities. We used caregiver, general physician, staff nurse as an outpatient and visit team and also unequipped routine house of the patients during neutropenia. Results: Median age was 50.2 years (ranged 27–68) with 70% male. Median hospital stay were 25 days in inpatient and. 4.8 days in outpatient respectively (p<0.01). There were not significant differences between these groups in aphresis days, granulocyte colony stimulating factor requirement for mobilization and mononuclear cell, There were also significant reduction (p<0.001) in parenteral antibiotic, blood product requirement and need for total parenteral nutrition. The most frequent causes of re-admission (outpatient group) were febrile neutropenia and sever mucositis need TPN. 2 years overall survival rate was 98.2% (SE=2%) in inpatient groups and 86.6% (SE=5.7) in outpatient groups.We did not have any death in first month after transplantatio in outpatient group. Conclusions: We describe an outpatient program based on management of the patient in his/her house during aplastic phase. Our results clearly indicate that such a procedure is feasible and safe in a patient population with a caregiver.

No significant financial relationships to disclose.
Therapeutic and palliative benefit from single-agent irinotecan in multiply treated and highly refractory cases of lymphoma
Authors: Caces D. D. , Halaas J. , Hamlin P. , Noy A. , Kewalramani T. , Portlock C. S. , Zelenetz A. D. , O'Connor O. A. , Gerecitano J. F.
Published: August 2020

e19554

Background: Multiple reports corroborate a role for irinotecan in the treatment of lymphoma. This study describes the Memorial Sloan Kettering experience with single-agent irinotecan in the management of heavily pretreated and highly refractory cases of lymphoma. Methods: Adult patients with histologically diagnosed relapsed or refractory lymphoma treated with irinotecan between 1/2001 and 8/2008 were identified. Treatment responses were evaluated based on the Revised Response Criteria for Malignant Lymphoma. Adverse reactions were evaluated based on the NCI Common Terminology Criteria for Adverse Events. Results: 30 patients were identified, 27 (90%) of whom received irinotecan after 3 or more prior regimens. 4 patients had Hodgkin Lymphoma (HL) and 26 had Non-Hodgkin lymphoma (NHL): 17 DLBCL, 6 transformed follicular lymphoma, 1 mantle cell lymphoma, 1 T-cell lymphoma and 1 Burkitt's. 25 patients were evaluable for response. 5 achieved an objective response (overall response rate 20%); 2 achieved complete remission (CR) and 3 partial remissions (PR). 8 patients (32%) had stable disease and 12 (48%) progressed on treatment. The median duration of response was 2.8 months (2.6–3.2), the median progression-free survival was 1.3 months (0.36 to 7.67) and the median overall survival was 3.9 months (0.30–63.4). Of the total cohort, 11 (36.6%) attained a clinically demonstrable improvement in symptomatology; 3 had resolution of pain syndromes, 5 had a reduction in the size or quantity of palpable masses, 2 had diminished fluid retention and 1 had an overall improvement in functional status. Adverse events occurring in more than 20% of cases included diarrhea (80%), leukopenia (67%), fatigue (36.6%) and thrombocytopenia (26.7%). Less common reactions included fever, febrile neutropenia, neuropathy, nausea and vomiting. Conclusions: Irinotecan has utility even in multiply treated and highly refractory cases of lymphoma. It can mitigate symptoms resulting from bulky disease and shows potential as a palliative treatment option. Although ORR was only 20%, two CRs were achieved suggesting benefit in select patients. Strategies that limit adverse reactions may enhance the agent's effectiveness in refractory lymphoma.

No significant financial relationships to disclose.
Activity of bortezomib (B) in plasma cell dyscrasia (PCD) with POEMS-like syndrome
Authors: Haddad P. A.
Published: August 2020

e19564

Background: POEMS (polyneuropathy, organomegaly, endocrinopathy, m-protein, and skin changes) syndrome is a rare multi-system disorder associated with PCD. Although several reports revealed significant clinical benefit of IMIDs in POEMS syndrome cases that are not transplant candidates, no such published reports of B in this disease were found. Methods: We report the first case of PCD with POEMS like syndrome in addition to pulmonary hypertension, secondary right heart failure, and membranoproliferative glomerulonephritis that was successfully treated with single agent B. After presenting with the aforementioned signs and symptoms, a 64 year old white man, was diagnosed with PCD (bone marrow plasma cells 15%, IgG-λ, mild-moderate anemia, normal PET/CT, normal Cr and Ca) with ISS stage III. Due to being high risk for thromboembolic events, he was started on single agent B at 1.3mg/m2 days 1,4,8,11 Q21 days (cycles 1–4) which was reduced to 1.0mg/m2 days 1,4,8,11 Q21 days (cycles 5–6) due to grade 1 thrombocytopenia and neuropathy. This was followed by 3 maintenance cycles of 4 out of 5 weekly 1.0mg/m2. Results: Patient's breathing was subjectively better after cycle#1 despite experiencing side-effects from his pulmonary hypertension medications which had to be held and subsequently improved back to his baseline by cycle#4. By cycle#2, he was found to be in nCR with complete normalization of his bone marrow and serum electrophoresis by the end of therapy. He has been in nCR for almost 12 months so far. By cycle#3 his Raynaud's syndrome was significantly better with less dysesthesia which completely resolved by cycle#6. Conclusions: This case demonstrates for the first time the significant activity of B as a single agent in PCD with POEMS like syndrome. Further evaluation of the role of B as a first line agent in this disease, whether as single agent or in combination, is warranted.

[Table: see text]
Retrospective analysis and chemotherapy results in extra-nodal NHL patients in a large super-speciality hospital in North India
Authors: Aggarwal S. , Prakhar P. , Kohli S. , Negi A. , Jauhari M. , Bhalla S.
Published: August 2020

e19566

Background: We retrospectively analysed records of the Patients visiting the pathology department of Sir Ganga Ram Hospital, New Delhi a super-speciality hospital, between February 2007- February 2008. Out of a total of 16,500 cases, NHL was reported in 154 (0.93%)cases. The median age was 52 yrs and the no. of male patients were 104 and female were 50 making M:F = 2:1. The type of NHL was B-Cell type (CD-20+ve) in 132(85%) and T-Cell type (CD 3+ve) in 22 (15%) cases. Out of 154 patients, 77 were nodal and 77 were extra nodal. Additional features - HIV positivity in 2 patients, autoimmune haemolytic disease in 1 patient and thalessemia major in 1 patient. In extra-nodal group of NHL patients the no. Of male and female patients were 55 & 22 respectively (M:F=2.5:1). Out of 77 extra-nodal cases, 31(20%) were GIT NHL (Stomach -16, Colon-8, Ileum-4, and Duodenum-3) and out of the rest 46 extra-nodal cases the site of origin was - head & neck-14, skin n soft tissues -8, primary CNS-6, testicular-4, para-spinal- 3, breast mass-3, perinephric-2, bones-2 and 1 each in cervix, lung mass, liver and cervical plexus. Methods: A detailed analysis of 31 GIT NHL cases was carried out. 28 out of 31 were B-Cell type and 3 were T-Cell type. 26 out of 31 were diffuse large cell variety, 2 were mixed small & large cell variety and 1 MALT variety. In 2 patients the type of lymphoma could not be ascertained. Bone marrow infiltration was present in 2 out of 31 cases of GIT Lymphoma. Surgery was carried out in 15 of 31 GIT NHL cases and these were arising from Colon, Ileum and Duodenum. No surgery was performed in patients with stomach lymphoma. Results: Of all the extra-nodal cases chemotherapy was given to 39 patients - R-CHOP = 20 patients, CHOP = 13 patients, high dose MTX in primary CNS NHL = 6 patients. CR was achieved 16 out of 20 R-CHOP patients (80%), 8 out of 13 CHOP Patients (61 %) and 4 out of 6 high dose MTX patients (66%).

No significant financial relationships to disclose.
Metastasectomy for melanoma in the VATS era
Authors: Bhargava A. , Schuchert M. J. , Wilson D. O. , Landreneau R. J. , Luketich J. D. , Christie N. A.
Published: August 2020

e20001

Background: The role for metastasectomy in the setting of metastatic melanoma remains ill-defined. The aim of this study is to evaluate resection of limited metastases in the setting of melanoma comparing VATS and open approaches, specifically looking at perioperative morbidity and survival. Methods: All patients undergoing metastasectomy for melanoma with curative intent between January 1, 2001 and September 30, 2007 were included. Data was collected retrospectively from the UPMC tumor registry and chart review. Differences between groups were compared with the student's t-test. Results: Of 43 patients undergoing metastasectomy for melanoma, 31 patients were resected with intent to cure (16 VATS, 15 open). Complications were similar between the VATS (12%) and open (13%) groups. There were no perioperative deaths in either group. The median survival in the VATS group was 20.7 months, compared to 26.5 months in the open group (p = 0.17). Importantly, the VATS patients more frequently underwent resection of smaller, peripheral lesions via wedge resection (81%) and only 2 patients (13%) underwent lobectomy. Conversely, patients undergoing open procedures were more likely to have larger, more central lesions and undergo anatomic resections. There were 9 (60%) lobectomies, 3 (20%) segmentectomies 1 (7%) en bloc resection and only 2 (13%) wedge resections in the open group. Conclusions: Metastasectomy for metastatic melanoma in the thoracic cavity can be performed safely by a VATS or open approach. The two approaches have comparable morbidity, mortality and survival outcomes. Careful patient resection remains the hallmark of care in identifying appropriate candidates for metastasectomy. In the setting of patients with short life-expectancy, it may be advantageous to employ a VATS approach when possible to preserve quality of life while achieving similar oncologic outcomes to open procedures. Individuals with a radiographic indication of limited peripheral disease should be considered for a VATS approach to resection of melanoma metastases.

No significant financial relationships to disclose.
Clinical presentation, pathological features, and natural course of metastatic uveal melanoma (MUM) as an orphan and commonly fatal disease
Authors: Cerbone L. , Van Ginderdeuren R. , Van den Oord J. , Fieuws S. , Spileers W. , Van Eenoo L. , Wozniak A. , Sternberg C. N. , Schöffski P.
Published: August 2020

e20005

Background: Uveal melanoma (UM) is a rare disease characterized by an unpredictable course and variable outcome ranging from cure by local treatment to the occurrence of untreatable metastasis. The current project analyzed patients with the metastatic phenotype. Methods: We performed data collection in 76 pts with MUM treated in Leuven between 1957–2008. Statistical analysis involved nonparametric tests, Kaplan Meyer and log rank test. Results: The med. age at diagnosis of UM was 58 yrs (range 30–94). Common initial treatments were surgery (71%), brachytherapy (20%) and external beam RT (7%). MUM was more common in women (F:M ratio 48:28) and independent from the side of the primary tumor (left vs. right eye). Synchronous metastasis was found in 9% of cases, all others had metachronous disease after a med. interval of 40 mos (range, 7–420). Statistical analysis failed to identify predisposing factors for MUM with the exception of a significant negative correlation between age at diagnosis of UM and time until metastatic disease (Spearman ρ = -0.4, p<0.001). Metastasis in >1 organ, usually liver plus another site, was seen in 47% of cases. The most frequent sites were liver (96%), lung (23%), subcutaneous (13%), bone (11%) and brain (3%).The med. OS from diagnosis of UM was 46 mos (range, 2–182), and 4,5 mos after diagnosis of metastasis (range, 1–128). 65% of MUM pts qualified for further treatment, including systemic therapy (60%), radiotherapy (7%) and surgery (7%). Systemic therapy (45 pts) included mainly chemo- (50%), chemo- plus hormones (12%), immuno- (3%) or hormonal therapy (3%). The most common drugs given were DTIC (43%), cisplatin (27%), tamoxifen (10%) or phase I agents (8%). Patient benefit (PR+SD) was seen in 16/45 pts (36%), including 2 PR. Conclusions: In this orphan disease with female predominance metastasis occurs late, is mainly found but not confined to the liver, and is associated with high morbidity, as >1/3 of pts do not qualify for further therapy. Advances in MUM can only be achieved by networking of sites interested in this tumor with systematic collection of data and tissue to improve our understanding of the molecular biology of the disease.

No significant financial relationships to disclose.
Quality-of-life (QoL) impairment in melanoma patients receiving high-dose interferon alpha 2b (IFNa2b)
Authors: Mohr P. , Hauschild A. , Rass K. , Trefzer U. , Enk A. , Haalck T. , Koller J. , Gutzmer R. , Küchler T. , Weichenthal M. ,   DeCOG Melanoma Study Group
Published: August 2020

e20011

Background: High-dose interferon (HDI) for patients with malignant melanoma (MM) has consistently demonstrated benefits as an adjuvant treatment. Side effects and impairment of QoL have played a major role in patients motivation to continue treatment. The adjuvant, randomized, controlled phase III DeCOG MM-ADJ-5 trial evaluates QoL and tolerability of pulsed high-dose intravenous (iv) IFNα2b compared to standard HDI regimen. In the pulsed arm, 3 courses of IFNα2b, 20 Mio IU/m2 iv 5 days a wk for 4 wks, repeated every 4 months was administered, whereas the subcutaneous (sc) treatment was 10 Mio IU/m2 3 times a wk for 11 months, after 4 wks of iv therapy. As a secondary endpoint, health related QoL was evaluated during iv and sc treatment and during treatment free intervals. Methods: 631 patients have been recruited for an expected 300 events (distant metastasis) during 4 years of follow-up. A planned interim analysis was performed after a third of the expected events occurred. The EORTC QLQ-C30 questionnaire modified for typical IFN side effects, was administered to pts before therapy, at 4, 16, 24, and 40 wks of treatment. Global QoL questions were completed by pts weekly by a visual analogue scale over the entire year of treatment. Results: Out of 377 patients having completed treatment, 300 were evaluable for QoL analysis. The iv HDI treatment led to a globally decreased QoL score in 84% of patients. During the 4 wk course of iv IFN, impairment of QoL was mainly due to physical symptoms. During the sc treatment phase, global QoL remained reduced by an average of 24%, despite dose adjustments in a majority of patients. Analysis of particular dimensions of decreased QoL revealed that fatigue was the most important determinant, especially during continuous treatment. In contrast, depression only played a minor role, being less important than physical and cognitive impairment. Conclusions: QoL impairment caused by long term sc HDI is mostly mediated by chronic fatigue, and more likely to interfere with treatment adherence than short term iv HDI treatment.

[Table: see text]
Response to sunitinib in Chinese KIT-mutated metastatic mucosal melanoma
Authors: Zhu Y. , Si L. , Kong Y. , Chi Z. , Yuan X. , Cui C. , Sheng X. , Guo J. , Shen L.
Published: August 2020

e20017

Background: To investigate the possible relationship between sunitinib response and KIT mutation as well as KIT expression. Methods: We find that a 75-year male patient with KIT-mutated metastatic mucosal (primary: nasal, metastasis: left adrenal gland, lungs and right eye) melanoma has a very good response to sunitinib 37.5mg/d consecutively. We apply IHC sp assay to detect S100, HMB-45, CD117, VEGFR, PDGFR and EGFR in the melanoma sample of this patient. DNA is also extracted from paraffin-embedded melanoma sample of this patient and PCR is carried out to amplify several exons of C-KIT (exon11,13,17,18),B-RAF(exon11, 15) and N- RAS(exon1, 2). PCR products are sent to be directly sequenced. Clinical response, PFS and OS of the patient are evaluated. Results: Strong expression of S100, HMB45, CD117, VEFGR and PDGFR is detected by IHC in the tissue sample of the patient. Furthermore, direct sequencing after PCR reveals that V559A substitution is detected in exon 11 of KIT, with mutation of T into C at 1776, leading to substitution of Valine by Alanine at 559. No mutation was detected in exon 9, 13, 17, 18 of KIT, B-RAF15, 11 or N-RAS1, 2. The patient received sunitinib 37.5mg/d from July 2008 consecutively and evaluated PR (Recist: tumors shrink 70%) lasting for 5 months with Grade II myelosuppression and stomatitis. Now the patient is still alive and received sunitinib. Conclusions: Our case report suggests that response of melanoma patients to sunitinib might be correlated to KIT mutation and expression, and large-scale clinical trial in patients with KIT mutation and over-expression might be useful to shed light on treatment of melanoma patients with individual targeted therapy.

No significant financial relationships to disclose.
Metastatic melanoma in the elderly: Case series of clinical outcome and immune characteristics
Authors: Hegde U. P. , Chakraborty N. , Chhabra A. , Ray S.
Published: August 2020

e20018

Background: Cutaneous melanoma incidence is rapidly rising in the elderly population. Imbalances of the immune system are described due to aging associated changes between CD4+, CD8+, T helper (Th) 1, Th 2 and T regulatory and T effector lymphocytes (lym). We describe clinical outcome in 10 elderly patients (pts) with cutaneous metastatic melanoma (CMM) and results of the immune studies done in a subgroup. Methods: Between October 2002 and October 2008, 10 elderly pts with treatment naïve CMM, 6 males and 4 female, median ages 76, range 57–84 years were treated at the University of Connecticut Health Center. Metastatic sites included soft tissue in 2 patients (pts), lung and/or liver with lymph node (LN) involvement (6 pts) and distant LN metastasis (2pts). Eight pts opted for treatment and received single or combination chemotherapy (5pts), high dose Interleukin 2 (2 pts), complete tumor resection followed by tumor derived heat shock protein vaccine (1 pt on clinical trial) and bio chemotherapy (1pt). One patient declined treatment (included in follow up). In vitro immune characteristics were studied in HLA-A2 positive subgroup (5pts) and included cytotoxic T lym (CTL) generation against self and non self peptides (Mart-1 27–35 and influenza MP derived peptide flu 58–66), proliferative activity of CD4+ lym in response to anti CD3 antibody under Th1 and Th2 conditions and regulatory T lym activity of CD4+CD25+ lym against CTL. Results: All patients tolerated treatments well resulting in 1 complete response, 4 partial responses, and 4 stable diseases. During 6 year follow up period, 6 patients died while 4 patients are living (one with disease). The median survival of all patients is 28.1 month (mo) while in those surviving (4pts) is 72 mo. Immune studies revealed preserved proliferative activity of CD4+ lym with stronger Th1 induction than Th2. The CTL responses to self and non self antigens were preserved while regulatory T lym showed weak activity against CTL. Conclusions: Some elderly patients with metastatic melanoma demonstrate improved outcomes and favorable immune characteristics. Further studies are needed to understand the impact of aging immune system on cutaneous melanoma.

No significant financial relationships to disclose.
Use of analysis of iron metabolism with CRP-dependent ferritin index and reticulocyte hemoglobin to determine treatment strategy for chemotherapy-related anemia
Authors: Steinmetz T. , Schmitz S. , Tsamaloukas A. , Rohrberg R. , Thomas L.
Published: August 2020

e20510

Background: Intravenous iron (IV Fe) can increase the efficacy of erythropoiesis stimulating agents (ESA). However it is still unsettled whether all patients (pts) do so. We conducted a phase II trial to analyze various parameters for the addition of IV Fe to ESA in chemotherapy treated anemic cancer pts. Methods: Pts with an indication for ESA following the EORTC guidelines and a serum ferritin (SF) level ≥20ng/ml were screened in a central laboratory. Those with a C-reactive protein (CRP)-dependent ferritin index (FI = soluble transferrin receptor (sTFR)/log ferritin ratio) above threshold (* FI ≥3.2 if CRP <5mg/l, or FI >2.0 if CRP ≥5 mg/l) were treated with iron only. Those with a sub-threshold FI received Epoetin beta (Epo) 30.000E/wk sc., and from these, those with a reticulocyte hemoglobin (Hb) content (CHr) ≤28pg/ml additionally received Fe-saccharat 200mg/wk iv up to 1g. Results: 11 centers recruited 303 pts (median age 65y, male 41%) from 10/04 to 10/06; 230 (76%) had a sub threshold FI (group Q I+IV), of whom 23 (8%, Q IV) had a CHr ≤28pg. 73 pts (24%) had an increased FI (Q II+III), indicating relative iron deficiency, of whom 27 (9%, Q III) had a CHr ≤28pg. There was no correlation between assignment to one of the groups (Q I-IV) and age, gender, body-mass-index, type or stage of tumor, endogenous Epo level, and hematokrit. In 265 pts evaluable for response Hb on d1 was 9.8 ±1.2 g/dl (mean ± SD) and 10.7 ±1.3 g/dl in 4th week. Mean increase of Hb from d1 to 8th week was 1.4 ± 1.7 g/dl. 36% pts received a transfusion within 12 weeks and 18% after the 4th week. The table shows response according to groups. Conclusions: At study onset we expected nearly all pts to receive Epo and searched for those who might have a benefit from additional IV Fe. However, we conclude in synopsis with other studies, that all pts might have a benefit from IV Fe but only 76%, those with a sub-threshold FI, have a benefit from Epo.

[Table: see text]

[Table: see text]
Determining the preferred dose of the serotonin antagonist (5-HT3) palonosetron: Results of an individual patient data meta-analysis (MA) of 1,947 patients in all randomized double blinded (RDB) trials
Authors: Lesser M. , Gralla R. , Napolitano B. , Raftopoulos H. , Kline M. , Bria E. , Budman D. R.
Published: August 2020

e20512

Background: Progress in antiemetic therapy has had a major impact on the administration of cancer chemotherapy (chemo). 5-HT3 agents are among the most used drugs in oncology and are considered the primary agents in guideline-recommended combination antiemetic regimens. Randomized trials have demonstrated advantages for palonosetron (palo) when compared with other 5-HT3 drugs in single agent trials (Ann Oncol 2003, Ann Oncol 2004) and recently in a combination trial with dexamethasone (Yoshizawa, ESMO 2008). With different doses of palo in use, we undertook this MA to determine if efficacy differs for palo doses of 0.75 mg or 0.25 mg. This has an impact on clinical dosing and on guideline recommendations as to whether there should be a preferred palo dose and a preferred 5-HT3 antiemetic. Methods: After a literature search and colleague inquiry, we identified 8 RDB trials; 4 in highly emetic (HEC) and 4 in moderately emetic (MEC) chemo that included treatment arms with 0.25 mg and 0.75 mg of palo; 6 IV and 2 PO trials. Primary endpoint: Complete Response (CR - no vomiting, no rescue) over days 1–5 after chemo. Secondary endpoints: Complete Control (CC - no vomiting, days 1–5); Acute emesis (day 1); Delayed emesis (days 2 - 5); by chemo (HEC / MEC); by other prognostic factors; by side-effects. Logistic regression, stratifying for protocol and including a treatment x protocol interaction term, was first used to test for heterogeneity (Het) of odds ratios (OR). In the absence of significant Het, the protocols were “pooled” in a protocol-stratified analysis. OR>1 favors palo 0.75 mg. Results: Individual patient data were obtained for the 1947 subjects. Half were randomized to palo 0.25. No significant heterogeneity was found for CR or CC. For CR, the pooled OR = 1.00 (95% CI: 0.83–1.20); for CC, OR = 0.99 (95% CI: 0.83–1.89). Similar ORs for CR and CC were found for HEC and MEC, with no Het. Conclusions: We conclude that trials using 0.25 mg or 0.75 mg palonosetron doses yield similar efficacy for CR and CC so that reports with either dose can be used clinically or in guideline considerations. Findings are true for HEC and MEC regimens as well.

[Table: see text]
In women with terminal cancer does having a family meeting affect the place of death?
Authors: Shields R. , Young W. , Bilodeau L. , Bergren W. , Dizon D.
Published: August 2020

e20516

Background: An important objective of the patient self determination act is for patients to see their wishes fulfilled, particularly at the end of life. Studies by Tiernan et al have shown that up to 80% of patients prefer to die at home however only a small proportion of patients actually die at home. Our work on support care networks show that a large proportion of women with cancer rely on multiple persons for health care proxy roles and for primary support. Given this, we sought to determine whether conducting a formal family meeting predicts whether a patient's preferred place of death corresponds with their actual place of death. Methods: We conducted a retrospective review of 105 women seen at Women & Infants’ Hospital within the last 12 weeks of their death and stratified patients between those who had a documented family meeting and those who did not. Results: Seventy-two percent (n= 105) of the study sample had family meetings in the last 12 weeks of life. Of those who had family meetings, 61% of patients whose preference of place of death coincide with their actual place of death (p<0.0001). In the sample of patients whose wishes coincide with their family meetings (n=76), almost 60% died at home and 34% died at inpatient hospice. Of those who did not have family meetings, 89% had unknown preferences of place of death, 48% died at the nursing home, 24% died in the hospital and 24% died at home. These results reached statistical significance (p= 0.001). Conclusions: Women who had a family meeting within the last 12 weeks of life were significantly more likely to die at home or with hospice services as compared to those who did not. This highlights the importance of including a patient's support networks into any communication between those dying from cancer and their healthcare providers. A larger study is warranted to determine whether this experience is specific to women with terminal cancer or is applicable to all patients with cancer facing the end of life.

No significant financial relationships to disclose.
Test of weight gain prevention intervention in stage II and III breast cancer patients receiving neoadjuvant chemotherapy
Authors: Basen-Engquist K. , Perkins H. Y. , Carmack Taylor C. L. , Hughes D. C. , Jovanovic J. L. , Arun B. K. , Murray J. L.
Published: August 2020

e20523

Background: Weight gain is common in women with breast cancer and is worrisome, as may affect prognosis and risk of other chronic diseases. This randomized study pilot tested a weight gain prevention intervention for breast cancer patients receiving neoadjuvant chemotherapy. Methods: Breast cancer patients receiving neoadjuvant chemotherapy were randomized to a weight gain prevention intervention or a usual care control arm. The intervention used a body acceptance approach, which emphasized changes in diet (low energy density food) and exercise behavior (resistance training) rather than focusing on weight loss. It was administered in weekly sessions delivered in-person and by telephone. Assessments were done at baseline, mid-chemotherapy, pre-surgery, after surgical recovery, after a 9 week post-surgical booster intervention, and 6 months after surgery. The data on weight changes from baseline (T0) to mid-chemotherapy (T1) and presurgery (T2) is presented. Results: 33 participants were randomized the intervention (n=16) or usual care (n=17). Three control participants withdrew before assessments were done. Of the 30 remaining women, 70% had stage II and 30% had stage III breast cancer. Their mean age was 49.7 (SD=12.2), and half were premenopausal. Mean BMI was 29.3 (SD=6.1) and 70% were physically inactive. The sample was diverse with regard to self-reported ethnicity (57% white, 27% African-American, 7% Hispanic, 10% other). Change in weight from T0 to T1 was -0.9 kg in the intervention group and +1.4 kg in the usual care group (n=27, p=0.126); from T0 to T2 the change was -2.0 kg in the intervention group and +0.8 kg in the usual care group (n=20, p=0.056). When weights from a chart review were used for patients with missing assessments the T0 to T2 changes were -2.9 kg for the intervention group and 0 kg for the usual care group (n=30, p=0.065). Conclusions: Based on a preliminary analysis, there was a trend approaching statistical significance for weight loss from a diet and exercise intervention based on the body acceptance approach compared to a usual care control group. These results indicate this intervention should be tested in a larger randomized controlled trial.

No significant financial relationships to disclose.
Trastuzumab in the elderly: Is it age or cardiovascular risk profile that really matters?
Authors: Serrano C. , Cortés J. , Bellet M. , Gómez P. , Saura C. , Martínez P. , Pérez J. , Atzori F. , Baselga J. , Di Cosimo S.
Published: August 2020

e20527

Background: Elderly breast cancer (BC) patients (pts) are usually excluded from clinical trials. Nevertheless, with the increased use of trastuzumab (T) there is a need to assess and predict T-related cardiotoxicity in this population. Methods: Data were collected from women ≥70 years with BC and serial cardiac monitoring treated with T at our institution since 2005. Cardiovascular risk factors (CRF) were analysed together with left ventricular systolic function (LVEF) assessed at baseline and during T. Results: Thirty pts with early (10) or advanced (20) BC, median age 75.7 years (range 70–87), were identified. WHO performance status was 0–1 in 90% of pts. Median duration of treatment was 45 weeks (range 2–87). Basal LVEF was 63.8% (range 46.3–76). Five of 30 pts (16.6%) experienced asymptomatic cardiotoxicity defined as an absolute drop ≥10% with a final LVEF < 50% (13.3%, 4/30 pts) or any absolute drop >20% (3.3%, 1/30 pts). Four of 30 patients (13.3%) developed symptomatic cardiac heart failure. Median time to LVEF decline was 9 weeks (range 3–87). LVEF recovered to normal values in a median time of 4 weeks (range 3–48) in all but one patient. CRF are shown in Table 1 . Pts with T-related cardiotoxicity presented more often with history of cardiac disease (22.2% versus 9.5%), diabetes (22.2% versus 5%) and BMI>30 (68% versus 45%) as compared to the rest. No relevant difference was seen in terms of hyperlipemia, tobacco or hypertension. Previous or concomitant exposure to anthracyclines was not found as a risk factor either. Conclusions: Despite the limited numbers, this series shows that elderly BC pts treated with T experience reversible cardiac events similarly to those already described in younger pts. However, particular attention may be paid to cardiac history, diabetic and obese pts who appear more likely to develop T-related cardiotoxicity.

[Table: see text]

No significant financial relationships to disclose.
Impact of socioeconomic status on treatment outcome in patients with advanced esophagogastric cancer in Northern Ireland
Authors: Manikyam Y. , Hanna G. G. , Harte R. J. , Henry P. G. , Houston R. F. , Eatock M. M.
Published: August 2020

e20531

Background: The survival advantage for combination chemotherapy in advanced gastroesophageal adenocarcinoma is well documented. Epirubicin and cisplatin in combination with either 5FU (ECF) or capecitabine (ECX) result in response rates of 35–46% and a median survival of around 9 months in RCT. We report the impact of socioeconomic status on the outcome of ECF and ECX treatment in advanced gastroesophageal cancer patients in Northern Ireland between 2000 and 2007. Methods: All patients with advanced esophageal (O), gastric (G), or esophagogastric junction (OGJ) adenocarcinoma, receiving palliative chemotherapy from January 2000 to August 2007, were identified from our institutional database. Baseline demographics, clinical characteristics, treatment details, and clinical outcomes were recorded. Patients receiving chemotherapy in a clinical trial were excluded. Survival was estimated using the Kaplan-Meier method. Deprivation was assessed using the patient's home address deprivation index (DPI) (Northern Ireland Multiple Deprivation Measure 2005; May 2005. Northern Ireland Statistics and Research Agency. www.nisra.gov.uk ). Results: 274 eligible patients (m=200, f=74, O=114, OGJ=19, G=141) were identified. Median age was 62 years (range 22–83). 172 (62.8%) had ECOG performance status 0 or 1. 231 patients (84.3%) had metastatic disease, 43 (15.7%) had locally advanced disease. 216 (78.8%) patients received ECF and 58 (21.2%) patients received ECX. Overall median survival was 7.3 months. Treatment response and performance status were strong predictors of survival, however disease extent did not influence survival. Median survival was significantly longer in those with DPIs in the upper two quintiles than the lower 3 quintiles (9.5 months vs. 6.8 months, p=0.032). Conclusions: Outcomes achieved with palliative ECF/ECX treatment are similar to the reference clinical trials. Socioeconomic deprivation is significantly associated with reduced survival in this group of patients and is unrelated to disease extent at presentation; however it may be related to nutritional status and comorbidity and requires further investigation.

No significant financial relationships to disclose.
Longitudinal analysis of the quality of life (QoL) within a randomized phase III trial: Octreotide versus placebo for the patients having advanced hepato-cellular carcinoma (HCC)
Authors: Dumas F. , Barbare J. , Aparicio T. , Bouché O. , Lombard-Bohas C. , Faroux R. , Seitz J. , Raoul J. , Bedenne L. , Bonnetain F.
Published: August 2020

e20537

Background: The primary objective of this ancillary study is to longitudinally compare QoL. Secondary objective was to explore definitions of time until definitive deterioration (TUDD) of QoL scores according to minimal clinically important difference cut off (MCID). Methods: Inclusion criteria were age > 18 years, diagnosis of HCC with CLIP 0 - 3 and to be ineligible for curative treatments. Patients (pts) were randomized 1:1 to receive octreotide (30 mg, every 4 weeks for 2 years or until death) or placebo (2 mL NaCl). QoL was evaluated using EORTC QLQ-C30 every 4 weeks up to 24 months. We focused analyses on the following scores: Global Health (GH), Mental Health (EF), Physical Health (PF) and Pain (P). Firstly mean differences of QoL scores between last available measurement and inclusion were compared using Wilcoxon test. Secondly TUDD were estimated using Kaplan Meier, and compared using log-rank tests. They were defined as the time interval between randomization and the first occurrence of a decrease in QLQ-C30 score of ≥ 5 points without any further improvement in QoL score of ≥ 5 points or any further available QoL data. These analyses were repeated using a 10 points MCID, and by including deaths as event. Results: Between July 2002 and October 2003 135 pts in octreotide and 137 pts in placebo arm were included. Mean differences of QoL did not differed between octreotide and placebo arm. Using a 5 points MCID, TUDD of GH score is significantly longer in the placebo group (stratified log rank p= 0.033); median was 2.3 (95% CI: 1.37–3.66) vs 4 months(2.23–5.7). Using a 10 points MCID, TUDD of GH score differed, median time was 2.5 (1.9- 3.73) for the octreotide and 4.7 months (2.73 - 5.8) for the placebo group (stratified log rank p=0.026). Including death as event for a 10 points MCID, median was 2.4 (1.83–3.17) for octreotide and 4.1 months (2.5–5) for placebo group (stratified log rank p=0.012). Conclusions: These results suggest that octreotide could have a negative effect on global QoL. We have investigated QoL analyses modalities using survival techniques dealing with binding drop out missing data and with an easier clinical interpretation of results.

No significant financial relationships to disclose.
Use of advanced care directives by ambulatory chemotherapy patients with malignant disease: Likely predictors and impact of physician intervention
Authors: Hassan S. R. , Kilari D. , Politsmakher A. , Chakraborthy S. , Fogel J. , Dosik H.
Published: August 2020

e20544

Background: Despite their poor prognosis, few cancer patients have advanced care directives (ACD). Most often, ACD is discussed in an inpatient setting, when the patient is acutely ill and often nearing the end of life. Timely and thoughtful discussion would be better accomplished for both the patient and the family before such hospitalization. Methods: Interviews were done in 108 outpatients in an ambulatory chemotherapy center. A questionnaire noted whether ACD was executed or not, demographics (including education, religion and insurance status), performance status, characteristics of their cancer, and family status. All patients without ACD were counseled on the importance of ACD. The presence of an ACD was documented at each visit. Statistical comparison of patients with and without ACD at each visit was done. Results: The following variables were significantly associated with having an ACD at the first visit. Patients living alone could not be included in the logistic regression model, as none had advanced directives. However ACD execution differed significantly in patients living alone, compared with those living with family (0/33 vs 15/75; p=0.005). An additional 42 patients executed an ACD by the third visit. At the third visit, only living with family vs living alone remained significantly associated with having ACD. [OR=3.17 95% CI: 1.34, 7.50; p=0.009]. Conclusions: The following findings are noteworthy. Only 15/108 (14%) cancer outpatients had ACD. This disturbingly low rate increased to 55/108 (51%) after physician- initiated discussion. The following characteristics predicted not having ACD before intervention: younger age, absence of metastasis, better performance status, lower education status and living alone. After several physician interventions, only living alone remained a significant barrier to ACD execution by cancer outpatients. These results provide new insights and strategies to encourage improved advanced directive execution.

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No significant financial relationships to disclose.
Use of complementary medicine (CAM) among women receiving chemotherapy for ovarian cancer: A comparison of attitudes between two patient populations
Authors: Helpman Bek L. , Ferguson S. E. , Mackean M. , Le L. , Rogerson A. , Dewan A. , Mackay H.
Published: August 2020

e20545

Background: CAM use in cancer patients (pts) is common. The aim of this study was to compare patterns of CAM use and attitudes to CAM among ovarian cancer (EOC) pts in Canada and Scotland. Methods: Patients receiving chemotherapy for EOC in Princess Margaret Hospital (PMH), Toronto and the Edinburgh Cancer Centre (ECC), Scotland, completed a survey on CAM taken within the previous month as well as a questionnaire assessing patient attitudes and perceptions of CAM. A comparison between the 2 patient populations and between CAM users and non-users was made. Results: 194 pts (100 ECC: 94 PMH) were enrolled on study. The use of CAM in PMH was significantly higher than in ECC (52% vs. 36%, p=0.02). Whilst both populations thought it important for their oncologist to be aware of CAM usage (86% PMH: 93% ECC), pts from PMH were less likely to inform their compared to pts from ECC (50% vs 81%, p=0.02). Patterns of CAM use differed between the 2 populations: Multivitamins were the most common CAM in both populations (31% PMH:13% ECC). They were not considered CAM for the purpose of analysis. Most commonly used CAM in PMH were Soy products (12%), vitamin C (10%) and Green Tea (9%); in ECC pts used Omega 3 and fish oil (9%), Evening Primrose (7%) and vitamin C (6%). Although the majority of CAM users in both populations found CAM to be helpful (57% PMH: 61% ECC) only a minority thought they would cure their cancer (18% PMH: 6% ECC), prevent its spread (31% PMH: 14% ECC) or prevent a recurrence (20% PMH: 11% ECC). Users more often felt CAM relieved symptoms (45% PMH: 42% ECC), boosted the immune system (55% PMH: 56% ECC) or improved their quality of life (43% PMH: 53% ECC). ECC CAM users were more likely than PMH users to concede that CAMs have side effects (39% vs 29%) or could impact the efficacy of conventional treatment (17% vs 6%). CAM users were more likely than non-users to agree with positive statements and to disagree with negative statements about CAM. Conclusions: CAM use is common among pts receiving chemotherapy for EOC. CAM use was more prevalent among North American pts than Scottish pts. Attitudes and patterns of CAM usage differ and are culturally sensitive. Oncologists need to be aware of this when initiating discussion about CAM with their patients during cancer treatment.

No significant financial relationships to disclose.
Platinum-based combination chemotherapy in the treatment of older non-small cell lung cancer (NSCLC) patients (pts): Is there a role for Complete Geriatric Assessment (CGA)? Final results from the prospective multicenter NVALT-3 study
Authors: Wymenga M. , Biesma B. , Vincent A. , Dalesio O. , Groen H.
Published: August 2020

e20547

Background: Nearly 50% of NSCLC pts are aged over 70 years, but only few receive combination chemotherapy. CGA is often advocated to assess the benefits and risks of chemotherapy in older pts. Methods: A total of 182 NSCLC pts ≥ 70 years with stage IIIb/IV disease were randomized to 4 cycles carboplatin/gemcitabine (CG) or carboplatin/paclitaxel (CP). Primary endpoint was change in QoL at week18. At baseline, CGA was performed with nine different tests. Toxicity (tox) was scored using NCI-CTC v2. Tox related outcomes were defined as all grade III/IV tox, SAEs, ≥ grade II neurological or neuropsychiatric (NP) tox and the ability to finish all cycles. Relationship of CGA and QoL scores with tox endpoints were investigated. Results: Median age was 74 yrs (70–87). PS was 0 in 30%, 1 in 54% and 2 in 17%. Median OS was 8.6 mo (95% CI, 7.2–10.2) for CG and 6.9 mo (95% CI, 5.6–10.0) for CP. Median PFS was 4.7 mo (95% CI, 3.9–5.8) for CG and 4.5 mo (95% CI, 4.1–5.3) for CP. One year survival was 29% (95% CI, 21–41%) for CG and 23% (95% CI, 16–35%) for CP. There was no difference in the change in global QoL between arms. Quality-adjusted survival curves were not different. PS was prognostic, but not different for both arms. Pts with better Activities of Daily Living (ADL), instrumental ADL, or physical functioning were more likely to finish all chemotherapy cycles. Pts with worse emotional or role functioning or Geriatric Depression Score were more likely to experience NP tox. None of the CGA or QoL summary scores were associated with the occurrence of the other tox endpoints at p< 0.01. Conclusions: Carboplatinum based combination chemotherapy in older NSCLC pts is feasible. The choice for adding paclitaxel or gemcitabine to carboplatin cannot be made based on effects on QoL. CGA predicts toxicity to a limited extent but does not add substantial information to PS.

No significant financial relationships to disclose.
Individual risk factors for venous thromboembolism (VTE) in cancer patients treated with targeted therapies (TT)
Authors: Soini B. , Caffo O. , Ferro A. , Ambrosini G. , Murgia V. , Valduga F. , Caldara A. , Eccher C. , Tumulo S. , Galligioni E.
Published: August 2020

e20549

Background: Many anticancer drugs, alone or in combination, can significantly increase the risk of VTE in cancer patients. Vascular complications however, including VTE, have emerged as a relevant toxicity also with targeted therapies (TT) (Elice, Am. J. Hematol.2008). Recently, a simple model for predicting risk of VTE in cancer patients receiving chemotherapy (CT) has been developed, based on a number of clinical and laboratory variables (Khorana, Blood 2008). In this report, we have evaluated the incidence of VTE and assessed the predictive value of the Khorana's model, in cancer patients receiving TT, alone or combined with CT. Methods: From a consecutive series of 278 patients, treated with TT ± CT between January 2006 and August 2008, we have identified for each patient the baseline values, before TT treatment, of the following variables: age, performance status, primary site of cancer, stage, comorbidities, body mass index, hemoglobin, leukocyte and platelet count and use of erythropoiesis stimulating agents. All variables have been correlated with the occurrence of VTE, at the uni- and multivariate analysis. Results: TT treatment consisted of trastuzumab in 103 patients (37%), bevacizumab in 69 (25%), cetuximab in 29 (10%), rituximab in 41 (15%), sunitinib in 16 (6%), erlotinib in 12 (4%) and sorafenib in 8 (3%). In 163 patients (59%) TT were administered concurrently with CT. In a period of 2–360 days (median 125), 14 patients (5%) developed deep vein thrombosis, complicated by pulmonary embolism in 5. None of the variables of Khorana's model has shown any significant value, in predicting VTE risk, as well as any association with different TT (i.e. bevacizumab or sunitinib) or the concomitant administration of CT. Conclusions: In our experience, the Khorana's model does not appear able to predict the risk of VTE, in patiens receiving TT treatments. Other models may be required for identifying high risk patients, who would benefit from a prophylaxis of thrombotic events.

No significant financial relationships to disclose.