bluuebunny/crossref_metadata_2025 huggingface dataset:
An overview of SELECTTION: Survey of European lung cancer evaluating choice of treatment and tolerability in observed second-line non-small cell lung cancer (NSCLC)
Authors: Smit E. F. , Vergnenegre A. , Arellano J. , Kraaij K. , Kral A. , Langer F. , Visseren-Grul C.
Published: March 2020

18204

Background: In addition to established second-line treatments for NSCLC in Europe, docetaxel and pemetrexed; erlotinib, has recently been approved. The only study directly comparing alternative options in second-line NSCLC showed no significant difference in efficacy between docetaxel and pemetrexed (median survival 7.9 vs 8.3 months, p = 0.226) but significant differences in toxicity profile (Hanna et al, 2004). It is of interest to observe how different second-line treatment options are used in real life settings, particularly length of therapy, reasons for discontinuation and its impact on patient’s outcomes. Methods: In observational studies patients are not assigned to different treatments at random and physicians and patients decide on treatment. A careful design is paramount to ensure the correct interpretation of data obtained. SELECTTION is the first observational, non-interventional, prospective study to be carried out in Europe in second-line NSCLC treatment. The primary objective of SELECTTION is to assess the time from treatment initiation to treatment discontinuation. Secondary objectives are to observe the reasons for treatment discontinuation and assess its impact on patient’s outcomes. A total of 13 countries will participate including: France, Portugal, Germany, Denmark, and UK with approximately 200 sites enrolling 950 patients. Information regarding patients and disease characteristics and treatment history are collected. Patients may be enrolled if they have received first-line chemotherapy for locally advanced or metastatic NSCLC, and have subsequently progressed, are at least 18 years old and are about to initiate second line treatment. Treatment cohorts will be constructed based on the distribution of patients across second-line treatments by physician decision. Results: At this stage details about design and analyses planned as well as evolution of the study, will be presented. Conclusions: SELECTTION will provide a unique set of data on how patients with stage IIIb\/IV NSCLC previously treated with chemotherapy, are treated in routine clinical practice.

No significant financial relationships to disclose.
Stage III and stage IV non-small cell carcinoma patients triple chemotherapy combination (carboplatin, paclitaxel, and gemcitabine) in good performance status
Authors: Webb R. T. , Gill L. M.
Published: March 2020

18205

Background: Triple drug chemotherapy combinations for nonsmall cell lung cancer (NSCLC) have most recently begun to show promising results in regards to response rate and time to progression (TTP) of disease. This abstract presents data from 99 patients with advanced unresectable disease who were not felt to be candidates for concurrent radiation and chemotherapy for 1999 to 2005 treated with a split dose regimen of paclitaxel 65mg/m2 (d1, 8,15 q29 days), carboplatin AUC 2 (d1, 8,15 q29days), and gemcitabine 650 mb/m2 (d1, 8 or15 q29 days). All patients have completed a minimum of 3 courses of therapy. Methods: 57 males with mean age 72 years, and 42 females, mean age of 69 yrs with performance status of < 1. Stage III A&B-33 patients and Stage IV-56 patients. The regimen was well tolerated with 4% grade 3 to 4 neutropenia, 30% 2-to3 thrombocytopenia. There were no septic deaths, grade 3 to 4 nonhematologic toxicity included alopecia, universally, fatigue at 24% and emesis at 8%. Results: CR-14.4%, PR-31%, minimal/stable-26% with 27.6% progressive/resistant disease with a median survival time of 20.5 months. 37 patients did receive radiation therapy to the primary lesion. Conclusions: This 3-drug regimen administered in split dosing has proven to be highly active and well tolerated in good performance status patients seen in a community practice setting. This cohort of patients was representative and typical for the 85% of patients seen in community oncology practices.

No significant financial relationships to disclose.
Mitomycin (M) in combination with cisplatin (P) or vinorelbine (V) and erythropoietin (Epo) in patients with in field relapse after radiation therapy of non-small cell lung cancer: A phase II study of the AIO
Authors: Griesinger F. , Stenger I. , Tomala C. , Olgemoeller U. , Koerber W. , Fischer B. , Sebastian M. , Overbeck T.
Published: March 2020

18208

Background: Therapy for in radiation field relapse of NSCLC is challenging. Tumors are regularly resistant to chemotherapy, most likely due to a high proportion of hypoxic tumor. Mitomycin (M) is effective in hypoxic environment. However, in outer regions of the tumor, normoxic conditions might exist. Therefore, a combination of M and cytotoxic agents (cisplatin (P) and vinorelbine (V)) which are effective under normoxic conditions as well as Epo which decreases tumor hypoxia might represent an effective way to treat in radiation field relapses. Therefore, this approach was investigated in a multicenter phase II trial. Patients and Methods: 12 patients with a progressing symptomatic relapse within the radiation field have been enrolled in the study as of yet: 12 male, 0 female, 8 squamous cell, 4 adenocarcinoma, 5 stage IIIB, 7 stage IV, median age 63 y. Pts were to receive 4 cycles M 8 mg/m2 d1 and V 25 mg/m2 d1, 8 q22 days in case of P pretreatment, or M 8 mg/m2 and P 40 mg/m2 d1,8 q22 days in case of no P pre-treatment. Epo 40.000 IE s.c. q7 days was administered to maintain Hb levels between 12 and 13.0 g%. Response (WHO criteria), time to progression, survival and toxicities, Hb values, as well as quality of life (not shown) were evaluated. Results: A median of 2 cycles were administered (1–4). Stable disease was observed in 7/12 evaluable patients (58%, 95% CI 28–84%). Median time to progression was 2.3 months (1.0–2.9 months), median survival was 3.8 months (2.9–6.2 months). Grade 3/4 toxicities were: dyspnea 1/12, loss of appetite 1/12, leukocytopenia 4/12, lymphocytopenia 1/12, neutropenia 3/12, nausea 1/12. Median Hb levels were maintained above 12 g%. Discussion: Cinical benefit was observed in 58% of patients with in radiation field relapse. To the knowledge of the authors, this is the first study specifically addressing the efficacy of chemotherapy for in radiation field relapses of NSCLC. M in combination with P or V and Epo results in similar response rates as second line chemotherapy for chemotherapy pretreated relapses. These results warrant further studies in NSCLC relapsing within radiation fields.

No significant financial relationships to disclose.
Rituximab-induced viral infections in lymphoma patients
Authors: Aksoy S. , Harputluoglu H. , Kilickap S. , Sener Dede D. , Dizdar O. , Altundag K. , Barista I.
Published: March 2020

18509

Background: Recently, a chimeric mouse human monoclonal antibody, rituximab, has been used successfully to treat cases of B-cell non-Hodgkin’s lymphoma (NHL) and some autoimmune diseases. However, several viral infections related to rituximab have been reported in literature, but not well characterized. Methods: To further investigate this topic, relevant English language studies were identified through Medline. For our search we used the generic name rituximab, and the key phrases virus/virus infection. The references from the identified articles were reviewed for additional sources. Results: There were 64 previously reported cases (26 male, 23 female, and 15 gender not reported) that had experienced serious viral infection after rituximab treatment. The median age of the cases was 61 years (range; 21–79 years). The median time period from the start of rituximab treatment to viral infection diagnosis was 5.0 months (range, 1–20). Most frequently experienced viral infections were hepatitis B virus infection in 25 (39.1%) cases, Cytomegalovirus infection in 15 (23.4%) cases, varicella zoster infection in 6 (9.4%) cases, and other viral infections in 18 (28.1%) cases. Thirteen (52.0%) of the patients with hepatitis B virus infection died due to hepatic failure. Thirty-nine of the cases had viral infections other than HBV and 13 of them died due to these specific infections. Conclusions: Viral infections after the rituximab treatment in lymphoma patients are important to recognize and treat early because of their association with substantial morbidity and mortality. In these case series, about 40% of these viral infections resulted in death. Close monitoring for viral infections in patients receiving rituximab is necessary.

[Table: see text]

No significant financial relationships to disclose.
Outcome of localized and advanced diffuse large B-cell non-Hodgkin bone lymphoma (DBL)
Authors: Aubin F. , Isler M. , Turcotte R. , Ducruet T. , Beaudet J.
Published: March 2020

18527

Background: DBL represents less than 2% of all lymphomas in adults. Over the years, combined-modality treatment (CMT) using an anthracycline-based chemotherapy regimen (ChT) and radiotherapy (RT) has emerged for the treatment of localized DBL (LDBL). Methods: Data were collected from the HMR oncology orthopaedic data bank. Thirty patients with localized and advanced DBL at diagnosis treated at HMR between December 1993 and August 2004 were included. Primary end-points were event-free survival (EFS) and overall survival (OS). Statistical analyses were performed using Kaplan-Meier and Cox proportional hazard models. Results: The median follow-up was 38.6 months. Fourteen patients had limited stage I-II disease while 16 patients had stage IV disease. Femur (33%) and spine (33%) were the most frequently involved bone sites. Ten patients had bulky disease (>10cm). Patients were treated as followed: 50% with CMT, 33% ChT alone and 17% only RT. CHOP (cyclophosphamide, doxorubicin, vincristine, prednisone) was the only chemotherapy regimen used. Four patients received rituximab (R-) combined with CHOP. Patients received an average of 5 cycles of ChT (range 1–8). RT dose was between 30 and 40 Gy for 70% of patients. Doses of 30 Gy and higher show a tendency to offer an OS advantage (hazard ratio (HR) =0.2, 95%CI 0.03- 1.35). The 5-year estimates EFS and OS were respectively 48% (95%CI 27%-71%) and 60% (95%CI 38%-82%) for the whole group and 70% (95%CI 50%-99%) and 81% (95%CI 57%-99%) for patients with LDBL. All four patients treated with R-CHOP have a sustained complete remission (CR). Patients receiving CMT have significantly improved EFS (p=0.02, HR=0.25, 95%CI0.08–0.83) but not OS. Patients with advanced disease may benefit from CMT for EFS (HR=0.23, 95%CI 0.05–1.12). Factors which adversely affect EFS and/or OS (univariate analyses) are: stage IV disease (p<0.05 EFS/OS), axial localisation (p<0.05 EFS) and IPI 4 (p=0.072 EFS, p<0.05 OS). Conclusion: This study supports CMT as an efficient treatment for DBL. Patients treated with R-CHOP have a favourable outcome. RT dose of 30–40 Gy appears sufficient to obtain a prolonged CR.

No significant financial relationships to disclose.
Cytokine expression profiles of patients with acute myelogenous leukemia (AML) and non-Hodgkin lymphoma (NHL) detected by multiplex assay
Authors: Reddy V. B. , Oelschlager D. K. , Nolan J. S. , Taylor K. L. , Post J. , Grizzle W. E. , Manne U.
Published: March 2020

18530

Background: To determine the cytokine expression profiles of patients with AML and NHL using a sensitive bead-based Luminex multiplex assay in a routine clinical diagnostic setting. Methods: Blood (plasma/serum) samples were collected from ten AML and five NHL patients. Six control samples from patients diagnosed as non-neoplastic/non-autoimmune/non-inflammatory were also analyzed for comparison. All samples were frozen prior to analysis. Using a bead-based Luminex assay (Human Cytokine 8-Plex Assay, Bio- Rad, Hercules, CA) we analyzed these samples for a panel of cytokines (IL-2, IL-4, IL-6, IL-10, GM-CSF, IFN-gamma, and TNF-alpha). This assay uses polystyrene microspheres, which provides simultaneous quantitation of these cytokines in a single sample. The expression levels were presented in picograms/mL. Average values for each of these markers were obtained for each group of patients (AML versus NHL versus Controls), and their expression levels were compared using χ2 analysis. Results: Overall, there was a significant difference in the expression profiles of all these cytokines among three patients groups (χ2, P < 0.001). All cytokines were consistently expressed at low levels in NHL patients as compared to control group. However, the levels of IL-6 and IL-8 were increased by 2.7 and 5.8 times, respectively in AML patients as compared to controls. Conclusions: The low levels of cytokines in NHL and AML patients suggest suppressed immune system in these two disease conditions; however, these findings warrant further studies to explore the underlying mechanisms for the increased levels of IL-6 and IL-8 in AML patients. Currently, studies are in progress to compare the levels of cytokines measured by Luminiex assay in different stages of leukemias and lymphomas (initial, post treatment and recovery phase etc.). These studies are partially funded by grants from the National Institute of Health/National Cancer Institute (RO1-CA98932–01 and U24-CA086359).

No significant financial relationships to disclose.
Thyroid lymphoma: A single institution’s experience
Authors: Wallace E. M. , Power D. G. , Leonard G. D. , Carney D. N.
Published: March 2020

18533

Background: Extranodal lymphomas account for a significant proportion of non-Hodgkin’s lymphomas. Thyroid lymphoma accounts for <2% of these. Lymphoma represents approximately 2% of all malignant thyroid tumours and is almost always of B-cell lineage. The main presenting symptom is a rapidly enlarging goiter and approximately half present with disease limited to the thyroid gland, designated stage IE. Due to its rarity, there is limited information with regard to prognosis or management. Pre-existing chronic autoimmune (Hashimoto’s) thyroiditis is the only known risk factor. Methods: We retrospectively reviewed all cases of thyroid lymphoma found in our institution over a 15 year period (1985–2000). Eleven patients were identified as suitable for analysis. Diagnosis and staging involved a full history and physical examination with relevant serology. Radiological imaging included computerized tomography, plain radiographs and ultrasound. Bone marrow aspirate and biopsy were performed in ten of the patients and patients were then staged according to the Ann Arbour Classification. We specifically analysed patients for their epidemiological features, presentation, treatment and their overall outcome. We compared our data to those from earlier series. Results: Seven of the 11 patients were female with a median age of diagnosis of 56. Most patients complained of neck swelling for a number of months but dysphagia, dyspnoea and hoarseness (80%) were the symptoms that prompted presentation. Hashimoto’s thyroiditis was not found. The commonest histological subtype was diffuse large B cell lymphoma (45% of cases). Seven patients had stage I disease, 3 stage II and 1 stage IV. Nine patients received chemotherapy and radiotherapy was administered in the adjuvant setting to nearly half of the patients. No correlation between presentation and other diagnostic tests or survival was found. Two-year survival for our patients was 100% and no cases died from their disease. Conclusion: Thyroid lymphoma is a rare disease and valuable information on this subject has been provided by single institution studies. Our encouraging survival figures are likely a combination of the predominance of early stage disease and the use of combined modality therapy. The use of monoclonal antibodies may provide a further benefit to these patients.

No significant financial relationships to disclose.
Outcome of poor prognostic phenotype non-Hodgkin lymphoma treatment among HIV-positive patients compared with HIV-negative counterparts in the HAART era: Experience from Hurlingham Oncology Clinic, Nairobi
Authors: Othieno-Abinya N. A. , Abwao H. O. , Kiarie G. W.
Published: March 2020

18535

Background: In human immunedeficiency virus (HIV) related non-Hodgkin’s lymphoma (HIV-NHL) two interrelated life- threatening diseases are considered for treatment decision. Before highly active antiretroviral therapy (HAART), chemotherapy associated toxicity made it difficult for HIV-NHL patients to tolerate treatment. This has remarkably changed in the HAART era. These patients are best treated with standard protocols including: cyclophosphamde, doxorubicin, vincristine and prednisone (CHOP); rituximab-CHOP (R-CHOP): methotrexate, doxorubicin, cyclophosphamide, vincrstine, prednisone and bleomycin (MACOP-B). Methods: We reviewed records of patients with aggressive and highly aggressive phenotype NHLs aged 13 years and above, treated from June 1994 to May 2006. Information included demographic details, pathologic subtype, extent of disease, treatment, outcome. Results: Seventy-five patients - 43 M; 32 F. Age range 13–78 years, median 44.5. Thirty-two (42.7%) were HIV+, 32 (42.7%) HIV- and 11 (14.7%) HIV status undetermined. All HIV+ patients took HAART. Twenty-four (32%) were diffuse large B-cell, 7 (9.3%) transformed follicular, 3 (4%) Burkitt’s 32 (42.7%) only referred to as aggressive/highly aggressive and 9 (12%) others. Thirty-eight (50.7%) were in the high risk International Prognostic Index (IPI) category and 27 (36%) had IPI undetermined. Nine of 21 (42.9%) HIV+ patients had CD4+ cell counts <100/ml. Treatments given upfront were: CHOP-35 patients (46.7%), MACOP-B-14 (18.7%), R-CHOP-11 (14.7%), and dropouts - 8 (10.7%). Seven of 32 (21.9%) HIV-NHL achieved complete remission (CR) vs 24 of 32 (75%) HIV-patients; highly significant (P<0.0001). Five (15.6%) of HIV+ patients had treatment related deaths vs none in HIV- group (P<0.00001). No significant correlation emerged between treatment outcome and IPI score (P= 0.22), or CD4+ cell counts (P = 0.15). HIV+ patients had a median follow-up of 5.5 months, mean of 9; those for HIV- patients were 17 and 30 months respectively; highly significant (P = 0.0036 and 0.0018 respectively). Conclusions: The outcome of treatment was significantly inferior among HIV+ patients.

No significant financial relationships to disclose.
Cases of extranodal lymphoma in the head and neck region
Authors: Bilge S. , Mayadagli A. , Ozseker N. , Parlak C. , Oruc F. , Ozturk N. , Gumus M.
Published: March 2020

18544

Background: Primary extranodal lymphomas of the head and neck region constitute 10–20% of all NHLs. Since they are frequently encountered as localised disease, radiotherapy accounts for the important part in the treatment although other modalities are also available. Cases with the diagnosis of primary extranodal lymphomas of the head and neck region, who administered to our clinic were evaluated retrospectively and presented here. Materials and Methods: Total 13 patients who administered to the Radiation Oncology Clinic of Kartal Education and Research Hospital between years 2000 and 2005, with the diagnosis of primary extranodal lymphoma of the head and neck region were enrolled into the study. All information was gathered from the patients‘ files and evaluated in the electronic environment. Results: Median age was 61 (36–80). Nine patients (69%) were female, and 4 patients (41%) were male. Primary site was found to be tonsil in 8 cases (61%), nasopharynx in 4 cases (30%), and thyroid in one case (7%). Of the 13 cases, 5 (38%) had stage 1, 4 (30%) stage II, 3 (23%) stage III, and 1 (9%) stage IV diseases. Histological type was diffuse large B-cell lymphoma in 8 patients (7 originating from tonsil, 1 from thyroid), T-cell lymphoma in 2 patients (originating from nasopharynx), poorly differentiated histiocytic lymphoma in 1 patient (originating from nasopharynx), and diffuse mixed large B-cell and small B-cell lymphoma in 1 patient. Therapeutic approach was CT+RT in 7 cases, CT+RT+surgery in 3 cases, CT+ surgery in 1 case, RT+ surgery in 1 case, and CT alone in 1 case. Total 44 Gy RT was performed in 22 fractions to involved fields and regional lymph nodes by using cobalt 60 machine. Median 4 cycles of CT that consisted of CHOP were performed to the patients. Of the 13 patients 10 are still under control with no medical problem. One patient with stage 4 disease was lost under treatment after 3 cycles of CT. One case with nasopharyngeal lymphoma was referred due to progression after 2 series of CT, and died 1 month after palliative RT. One case with stage IB tonsil lymphoma received 2 cycles of CT+ RT+ 2 cycles of CT, and died of other medical reason during her 12th month follow up period. Conclusion: Primary extranodal lymphomas of the head and neck region constitute a heterogeneous group of patients, and RT represents an important part of the treatment.

No significant financial relationships to disclose.
Monitoring of NK cell activity and serum LDH in metastatic melanoma patients treated with DTIC and interferon-alpha2a, with or without retinoic acid
Authors: Konjevic G. , Jovic V. , Vuletic A. , Radulovic S. , Jelic S. , Spuzic I.
Published: March 2020

19000

Background: The activity of NK cells, expression of CD69, and serum LDH were evaluated in terms of response to therapy in metastatic melanoma patients. Methods: In phase II clinical study metastatic melanoma (MM) patients were treated with DTIC (800 mg/m2, d1) and IFN-alpha 2a (5×106 IU/m2 s.c., d2–6 (group A, n=25) and 28 patients received the same therapy supplemented with RA, 60 mg/d, d1–10 (group B). Before and after each therapy cycle NK cell activity, CD69+NKcells and LDH were monitored in patients and 39 healthy controls. Results: There is no significant difference in OR (group A 32%, B 21%), in time to progression between groups. NK cell activity was significantly decreased pretherapy in both groups, with a significant increase in the 1st cycle in both groups. NK cell activity did not show significant correlation with OS in group A compared to group B (p=0.445). 20% of patients in group A with pretherapy NK cell cytotoxicity above 30% had better survival from month 3 to 12 of follow-up and a longer maximal survival (1.2 vs. 1.0 year, respectively). In comparison to pre-therapy values, all responding MM patients had a significantly higher increase of CD69 expression on CD56+ NK cells, while the increase was only significantly higher in responders in group B. Analyses of serum LDH level show a significantly higher time and therapy cycle-dependent decrease in group A compared to group B (50% vs. 25%, respectively). However, it is shown that responders in group B had a significantly greater decrease in serum LDH level compared to responders in group B (70% vs. 20%, respectively), if the level after a cycle was evaluated in terms of pretherapy values, as well as a greater decrease if the evaluation in each cycle was done compared to each pretherapy value (35% vs. 20%, respectively). Conclusions: Even though there is no significance in clinical response between patients in group A and B, in agreement with a steady-state pattern of NK cell activity, the fact that only responders in group B had a significant increase in CD69 expression on CD56+ NK cells, as well as the finding that the decrease in serum LDH was significantly greater in patients in group B, implicates favorable imunopotentiating and antitumor effect of RA in the therapy of metastatic melanoma.

No significant financial relationships to disclose.
Impact of surgical treatment on survival in patients with primary rectal melanoma
Authors: Yap J. C. , Yang G.
Published: March 2020

19001

Background: Reports of melanoma of the lower GI tract, especially in the rectal area, were often grouped with diseases from the anal canal region. Outcome and pattern of care regarding primary melanoma of the rectum only were not well described in the literature. This review examined the utilization of surgery, radiotherapy (RT), and the potential impact on survival outcome in this subgroup of patients. Methods: The Surveillance, Epidemiology, and End Results (SEER) database (1973 to 2003) was searched. Only patients with primary melanoma of the rectum (excluding anal lesions) with recordable pathology reports were included. 79 patients were identified. 61 of them had melanoma of the rectum as the sole primary disease, and these patients were the focus of this study. Kaplan Meier estimation and Cox-Mantel test were used to calculate and compare survival rates. Results: Among the 61 patients, 20 patients did not have further surgery after biopsy. Another 20 patients had surgery, but the types of procedure were unknown. Of the remaining 21 patients eligible for analysis, eight patients had abdominoperineal resection (APR), and one of them received postoperative RT. Thirteen patients had partial proctectomy (PP), and none had RT. In univariate analysis, the 5-year overall survival rates for APR and PP groups were 12.5% and 7.7% respectively (p=0.63). There were one survivor in each group at the last follow up period with crude survival time of 15 years and 13.5 years respectively. More patients in APR group had locoregional disease (extramural and nodal) than in PP group (63% versus 0% respectively) at diagnosis. Comparing the time intervals by decade between 1973 to 1982, 1983 to 1992, and 1993 to 2003 in all 61 patients, use of postoperative RT was relatively limited at 1 in 14 cases, 1 in 19 cases, 2 in 28 cases respectively. RT was used mostly in patients who were not candidate for surgery and in patients with metastatic disease at diagnosis presumably for palliation. Conclusions: Primary melanoma of the rectum is a rare disease. Data for analysis were limited. There was no significant difference in overall survival between patients who had APR versus PP although APR group had higher tumor burden at diagnosis than PP group. Use of adjuvant RT is rare, and its role has yet to be further defined.

No significant financial relationships to disclose.
Peg-filgrastim (Peg-F) on day 4 of (R-)CHOP-14 chemotherapy compared to day 2 in elderly patients with diffuse large B-cell lymphoma (DLBCL): Results of a randomized trial of the German high-grade non-Hodgkin’s lymphoma study group (DSHNHL)
Authors: Hartmann F. , Zeynalova S. , Nickenig C. , Reiser M. , Lengfelder E. , Duerk H. , de Witt M. , Schubert J. , Loeffler M. , Pfreundschuh M. G.
Published: March 2020

19511

Background: Application of peg-f is recommended on day 2 of chemotherapy, but later application has not been studied. Objective: To compare the effects of peg-f given on day 4 instead of day 2 on the endpoints feasibility, leukocyte counts, rate of infections and therapy-associated deaths after CHOP-14 with and without rituximab (R). Methods: Intention-to-treat-analysis of 109 elderly patients (median 69 years) with DLBCL receiving CHOP-14 or R-CHOP-14 randomized to peg-f on day 2 or day 4 (D4). Results: Of 103 evaluable pats., 51 received peg-f on day 2 (D2) and 52 on day 4 (D4). D2 and D4 populations were well balanced for known risk factors, and there was no difference between pats. receiving CHOP-14 and R-CHOP-14 with respect to the above mentioned endpoints. Both D2 and D4 allowed for an excellent adherence to (R)-CHOP-14 protocol, with a median relative dose of myelosuppressive drugs of 98% (D2) and 99% (D4), respectively. Leukocytopenia <2,000/mm3lasted for 3 (day 8 to 10) after D2 and 1 day (day 9) after D4. Grade 4 leukocytopenia (<1,000/mm3) occurred in 47% of all cycles after D2 and in 20.5% after D4 (p<0.001). Grade 3 and 4 infections occurred in 9.4% of D2 and 6.0% of D4 cycles (p=0.118). There were 4 therapy-associated deaths (all infection-associated) in the D2 and 1 (none infection-associated) in the D4 group (p=0.205 for all and p=0.057 for infection-associated deaths). Conclusions: Peg-f allows for excellent adherence of elderly patients to (R)-CHOP-14. Peg-f should be given on day 4 instead of day 2, because D4 results in less leukocytopenia, less infections and less therapy-associated deaths.

No significant financial relationships to disclose.
Functioning profile changes in cancer patients participating in comprehensive cancer rehabilitation
Authors: Dennehy C. A.
Published: March 2020

19518

Background: Recommendations for inclusion of cancer rehabilitation as part of cancer care are notable. Treatment impact on patients’ functional status suggests integrating supportive and therapeutic care would be appropriate for most patients. Methods: Data were from two outpatient cancer rehabilitation centers (N=515) on referred patients receiving or completing treatment. Patients performed an initial assessment for cardiopulmonary (CP), physical therapy (PT), quality of life (QOL), and nutritional status evaluations. Qualifying patients completed 8 weeks of supportive and rehabilitative therapies specifically prescribed for side effect and presenting symptoms. Data were collected pre and post intervention. Measurements included descriptives with crosstabulations for all variables, acuity (A), stress (S), pain (P), energy (E), resting, target and highest heart rates (RHR) (TRH) (HHR), blood pressure (BP), treadmill speed and grade (S) (G) and QOL (total (T), health/function (HF), social/economic (SE), psychological/spiritual (PS) and family (F). Descriptive statistics are determined using means and frequencies. Pre and post intervention differences were determined using paired T-tests. Subsequent factor analyses were performed using principle component analysis with varimax rotation. Results: Descriptive statistics yielded characteristics on 53 different cancer types. Factor analysis produced 7 factors: heart rate (HR p=0.279), blood pressure (p=0.060), pulmonary (p=0.721), O2 saturation (p=0.387), intensity (p=0.598), SPE (p=0.000), AS (p=0.002). Differences were not expected for pulmonary function and O2 saturation. QOL differences were (T: p=0.000), (HF: p=0.000), (SE: p=0.022), (PS: p=0.001), (F: p=0.099). Conclusions: While many studies have noted a significant decline in functioning during and following treatments, patients participating in therapeutic cancer rehabilitation maintained or improved functional status and quality of life. Comprehensive cancer rehabilitation can be utilized for a number of cancer types and should be strongly considered as part of the continuum of care.

No significant financial relationships to disclose.
Does self-reported functional limitation attributed to symptoms persist 1 year after initial treatment for early breast cancer?
Authors: Sehl M. , Satariano W. A. , Ragland D. R. , Reuben D. B. , Sawhney R. , Naeim A.
Published: March 2020

19519

Background and Significance: Comorbidity, disability and compromised functional status increase with age. It is unclear to what extent the symptoms related to the diagnosis and treatment of cancer play a role in activity limitation in older adults. We examined the prevalence of self-reported functional limitation in a breast cancer population, whether this limitation is attributed to various symptoms, and how this attribution changes over time from early in treatment to 9-months later. Methods: 1,011 patients with breast cancer were surveyed 3 months after diagnosis (baseline) and 933 of those patients were surveyed at 12 months after diagnosis (9 month follow up). In each survey, participants were asked whether or not they had each of 21 symptoms and whether or not each symptom caused significant activity limitation. Results: Of the 933 patients (mean age 62.7 years) who completed baseline and follow up evaluations, 420 were aged 65 years and older. At baseline, 47% of patients 65 years and older reported functional limitation compared with 44% of patients younger than 65 years (p=0.29). Activity limitation at baseline was attributed to nausea in 4% of older patients, (O) and 8% of younger patients (Y) (p=0.016), to pains in the chest area in 11% (O) and 9% (Y) (p=0.21), to joint or muscle aches in 20% (O) and 16% (Y) (p=0.13), to tiring easily in 31% (O and Y), and to depression in 9% (O) and 13% (Y) (p=0.19). At follow up 47% of patients 65 years and older reported functional limitation compared with 40% of patients younger than 65 years (p=0.02). Activity limitation at follow up was attributed to nausea in 3% (O) and 7% (Y) (p=0.003), to pains in the chest area in 11% (O) and 9% (Y) (p=0.21), to joint or muscle aches in 23% (O) and 17% (Y) (p=0.01), to tiring easily in 26% (O) and 24% (Y) (p=0.60), and to depression in 8% (O and Y). Conclusion: Self-reported functional limitation is prevalent 3 months and 1 year after breast cancer diagnosis. Self reported activity limitation in older and younger patients is not significantly different at baseline, and is significantly higher in older patients at follow up, with older patients having significantly less nausea and significantly more joint and muscle aches.

No significant financial relationships to disclose.
A pilot international survey of oncologists’ opinions and self-reported practice patterns on complementary and alternative medicine
Authors: Lee R. T. , Hlubocky F. J. , Hu J. J. , Stafford R. , Daugherty C. K.
Published: March 2020

19526

Background: Prior research has indicated that the prevalence of complementary and alternative medicine (CAM) use among cancer patients often exceeds 80%. Information about the prevalence of CAM use is important because many biologically-based therapies or alternative medical systems can potentially interfere with chemotherapy efficacy and increase the risk for treatment related toxicity and other complications. Methods: In 2004–2005, oncologists from the United States, mainland China, and Taiwan were surveyed regarding their perceptions and self-reported practice patterns regarding CAM. Results: A total 95 oncologists returned surveys providing a 38.2% response rate. Four out of five respondents (78%) felt unprepared to integrate CAM modalities into their practice. However, 71% reported they would allow CAM use during active cancer treatment, even in the setting of curable disease. Surveyed Chinese/Taiwanese oncologists were more likely than their US colleagues to inquire about their patients use of CAM (ask >10% of patients) - 80.6% vs. 52.4% (p<0.05). The same was true for individuals who felt their previous training had prepared them for CAM use, as compared to those who felt unprepared (80.9% vs. 57.0% (p<0.01). Chinese/Taiwanese respondents felt no more prepared for CAM use than US respondents (25.8.1% vs. 20.6%, p=0.57), were less likely to report integrating CAM with curable disease (48.3% vs. 69.8%, p<0.05), and were more likely to report concern about patients’ motivations for CAM use (83.9% vs. 46.8%, p<0.01). Conclusions: Despite a stated lack of preparedness, the majority of surveyed oncologists would allow cancer patients with curable disease to integrate CAM therapies. Although routinely exposed to CAM modalities, such as traditional Chinese medicine, responding Chinese/Taiwanese oncologists felt just as unprepared as their US colleagues. In addition, increased concern about patients’ motivations was associated with decreased integration of CAM. Continued education is needed to improve oncologists’ knowledge about patients’ use of CAM.

No significant financial relationships to disclose.
Time to symptomatic progression: An emerging clinical trial endpoint in oncology
Authors: Aronson N. , Melilli L. , Cella D. , Gondek K.
Published: March 2020

19529

Background: One of the critical challenges in oncology today is assessment of clinical trial results to inform clinical decision making. Because trials typically focus on overall survival, it is often difficult to determine individual patient benefits early on treatment. Surrogate endpoints such as time to disease progression and progression-free survival may not correlate with survival. Based on a growing body of evidence, cancer symptom assessment has been shown to provide immediate treatment responses and to predict long-term outcomes_including tumor response, disease progression and survival. Methods: Results from a comprehensive literature review of oncology clinical trials and observational studies with symptom endpoints to date are provided. Analyses methods are described including potential biases. To illustrate the potential clinical value of time to symptomatic progression (TTSP) in longitudinal clinical trials, a retrospective analysis of data from a three-arm (cisplatin/etoposide versus two dosage regimens of cisplatin/paclitaxel arms) randomized cooperative-group clinical trial in non-small-cell lung cancer (NSCLC) was conducted. Results: In a three-arm randomized cooperative group clinical trial of NSCLC, TTSP was significantly associated with best clinical response (p<0.01) and survival (p<0.05). Conclusion: The utility of cancer symptom response for comparing cancer treatments has been well documented. This endpoint has been shown to act as an early signal of disease progression and death. Opportunities for refinement include methods for more accurate assessment, reduction in the number of symptoms evaluated, and refined statistical methods for reducing bias due to missing data. Given the success demonstrated in clinical trials, clinicians may consider ongoing cancer symptom evaluation in clinical practice.

No significant financial relationships to disclose.
Validation of a new questionnaire to assess the patient perception of cancer-related fatigue (CRF): The Perform Questionnaire (PQ)
Authors: Rodríguez C. , Gascón P. , García-Mata J. , Colomer R. , Cassinello J. , Carulla J. , Valentín V. , Baró E. , Gasquet J. A. , Sánchez J.
Published: March 2020

19533

Background: CRF is a frequently reported complaint in cancer patients and survivors. There are scales available to measure the intensity, frequency and duration of CRF but there are few scales to assess patient perceptions and beliefs about CRF. The recently developed PQ attempts to fill this need. This study aims to validate the new measure. Methods: An observational and longitudinal multi- centre study was carried out on a sample of cancer patients with CRF. Data were collected at inclusion and 3 months later. The PQ was administered, as well as the FACT-F and Nottingham Health Profile (NHP) health measures, at both visits. Sociodemographic data, key clinical indicators, fatigue intensity (by means of a visual analogue scale) and self-rated stability for patient health status were also collected. Viability, reliability (internal consistency and test-retest) and validity were assessed for the PQ. Results: 431 patients were included in the study: 60.2% women, mean age 58.9 years, mean time since diagnosis 2.21 years 31.0% with breast cancer, 54.9% with metastatic disease, Karnofsky mean score 80.9, 28.8% with anaemia. Answering the PQ was considered moderately easy to very easy for 80.7% of patients. Answering the questionnaire took less than 10 minutes for 76.3% of the sample. Overall and dimension internal consistency were high (Cronbach alpha = 0.93 range 0.80–0.89). Test-retest reliability for overall score (intra-class correlation coefficient (ICC) = 0.81) and dimension scores (range 0.59–0.77) were also good in patients without changes in health status. The PQ had a stronger correlation with FACT (r=0.82) than with NHP (r=0.71), a moderate correlation with fatigue intensity (r=0.43), and low correlation with Karnofsky (r=0.26). Patients requiring third party care had a worse overall score for the PQ than patients who did not (30 vs. 37; p<0.0001), while patients with anaemia showed a worse health- related quality of life than patients without anaemia (31.7 vs. 36.4; p<0.0001). Conclusions: The PQ has demonstrated good reliability and validity for assessing patient perception of CRF in the study sample. Additional research is needed to obtain further insight into how the PQ performs with specific cancer populations.

No significant financial relationships to disclose.
Renal function among cancer patients with bone metastases treated with zoledronic acid in a real world setting
Authors: Nordstrom B. L. , Langer C. , Hussain A. , Barghout V. , Modi D. , Lacerna L. , Gralow J. R.
Published: March 2020

19540

Background: Zoledronic acid (ZA) is a bisphosphonate that reduces skeletal related events (SREs) in cancer patients (pts) with bone metastases but can impact renal function in some pts. This retrospective study examined serum creatinine (sCr) elevations and subsequent treatment changes among pts receiving ZA in community based medical practices. Methods: Data were obtained from the Varian Medical Oncology database of electronic medical records from 17 US oncology practices. Cancer pts with bone metastases and at least one ZA infusion in 2002–06 were followed; all available sCr levels were examined. SCr measurements ≤4 weeks after a ZA infusion were considered levels while on ZA. Elevated sCr was defined as an increase over baseline of ≥0.5 mg/dL or a doubling from baseline for pts with baseline levels <1.4 mg/dL (or ≥1.0 mg/dL for higher baseline levels). Pts with a sCr elevation on ZA were followed to observe changes in ZA dosing and sCr. Results: The study included 875 pts (318 with breast cancer, 131 lung, 154 prostate, 23 multiple myeloma, and 249 other or unknown cancer) with ≥1 sCr level during baseline and ≥1 (median 6) while on ZA. Median age was 66, 41% were male, and 90% had baseline sCr under 1.4 mg/dL. Pts received a median of 6 ZA infusions. SCr elevations occurred in 87 pts (10%), at a median of 19 weeks (range 0.6–126) after the start of ZA. Pts with baseline sCr over 2.0 mg/dL were more likely to experience an elevation (11 pts, 33%). Following the elevated sCr, 37 pts (43%) discontinued ZA; dose reductions and delays were infrequent. Among 49 pts who remained on ZA after elevated sCr and had further sCr while on ZA, 20 (41%) returned to within 10% of baseline, at a median of 7 weeks (range 0.3–31) after the first measured elevation. The proportion returning to normal is a conservative estimate given limited follow-up sCr data. Conclusions: The observed incidence of elevated sCr of 10% in this community based study is similar to clinical trials. Most pts either discontinued ZA or returned to baseline levels despite continued ZA treatment. Few practitioners adhered to recommendations to withhold ZA until levels return to within 10% of baseline.

No significant financial relationships to disclose.
Erythropoietin stimulating agent dose and use patterns in cancer patients
Authors: Daniel G. W. , Hurley D. L. , Whyte J. L. , Grochulski W. D. , Willey V. J. , Kallich J. D.
Published: March 2020

19547

Background: Patients with cancer who develop anemia are often treated with erythropoietin-stimulating agents (ESAs), such as darbepoetin alfa (DA) or epoetin alfa (EA). This study compared baseline characteristics, patterns of ESA use, and dosing among cancer patients as observed in a large managed care claims database. Methods: Medical and pharmacy claims from a U.S. managed care database were used to identify 15,007 unique episodes of care (7,238 with DA, 7,769 with EA) among cancer patients between January 2004 and January 2006. Episodes were defined as the time over which consecutive ESA claims occurred with =42 day gap between claims, plus a duration of clinical benefit (DCB) based on the median days between consecutive doses for each product. Six sensitivity analyses were performed that examined the robustness of findings to study methods and assumptions. Results: The mean (± SD) number of administrations per episode was 3.7 (± 4.1) for DA and 5.3 (± 6.4) for EA. The mean ESA episode duration was 55.5 (± 64.7) days for DA and 59.2 (± 59.2) days for EA and median times between consecutive claims was 15 and 8 days, respectively. The estimated mean weekly dose, including the DCB, was 105 (± 56) mcg for DA and 34,242 (± 28,174) U for EA. Average weekly doses were found to be sensitive to the inclusion/exclusion of the duration of clinical benefit (dose ratio 1:326 vs 1:237, respectively). Compared to EA episodes, DA episodes were associated with younger age (75% <65 years, for DA vs. 69% <65 for EA), more platinum containing chemotherapy (31.9% DA vs. 28.4% EA (p<.001), more classes of chemotherapy used (77% with one or more classes (DA) vs. 65% with one or more classes (EA) (p<.001)) and higher comorbidity burden, as measured by the Deyo-Charlson index (54.3% with a score =8 (DA) vs. 46.6% (EA) (p<.001). Conclusions: Patterns of ESA use differed significantly between DA and EA. Additionally, patients receiving DA differed significantly in baseline characteristics compared to patients receiving EA. Adjustments for patterns of use are necessary to appropriately compare the use of the two ESA’s.

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The value of FACT-G in screening cancer patients for depression
Authors: Jang S. , Ackler J. , Braitman L. , Tester W.
Published: March 2020

19557

Background: The prevalence of depression in cancer patients varies greatly, reported in the range of 5–50% depending upon the population studied. Several tools have been used to screen for depression, but it remains uncertain which tool is most valuable. The Zung self-rating depression scale (ZSDS) is one of the commonly used screening tools for depression. Using a cutoff value of ≥ 40, one study reported sensitivity of 100% and specificity of 55% in diagnosing depression. This study was designed (1) to investigate the prevalence of major depression in our population of outpatients receiving chemotherapy, (2) to determine the correlation between the ZSDS score and Functional Assessment of Cancer Therapy - General version (FACT-G) score and (3) to examine whether statements from the FACT-G can be used as a screening tool for major depression. Methods: Sixty-two chemotherapy patients completed both ZSDS and FACT-G. Median age was 62 years (range 22–81); 55% were female. Patients with ZSDS scores ≥ 40 were interviewed, using standard DSM-IV criteria to evaluate for major depression. Pearson’s correlation was used to examine the correlation between ZSDS and FACT-G scores. We then analyzed responses to FACT-G statements to evaluate if certain questions from the FACT-G could be used as a screening tool for major depression. Results: Thirty patients had ZSDS score < 40, and were considered to not have major depression. Among the 32 patients with ZSDS score = 40, 30 underwent clinical interviews. Seven of these 30 were diagnosed with major depression. The prevalence of major depression was 7/60, or 12% (95% CI: 5% - 23%). The ZSDS score and FACT-G score had strong correlation (R= -0.75). If the total score (range 0–24) of six statements from FACT-G were ≤12, then these six FACT-G statements had sensitivity of 100% and specificity of 81% in predicting major depression. Conclusions: The prevalence of major depression was 12% in our population of chemotherapy patients. The ZSDS and FACT-G scores showed strong correlation. Patient responses to six selected statements from the FACT-G appear to be useful as a screening tool for depression. A confirmatory study with larger numbers of patients is planned.

No significant financial relationships to disclose.