Patients Receiving Chemotherapy Regimens Research Articles

The Impact of Adjuvant Chemotherapy on the Long-Term Prognosis of Breast Malignant Phyllodes Tumors: A Propensity Score-Matched Study.

Malignant phyllodes tumors (MPTs) are rare breast tumors with high risks of local recurrence and distant metastasis. Surgical intervention is the primary treatment, but the effectiveness of adjuvant therapies is uncertain. This study was designed to analyze the prognostic risk factors associated with MPTs and evaluate the efficacy of postoperative adjuvant chemotherapy. Patients who were first diagnosed with MPT without distant metastasis and received R0 resection surgery between 1999 and 2023 were included in the present study and stratified into 2 groups: chemotherapy and nonchemotherapy groups. Propensity score matching (PSM) was used to balance baseline characteristics between groups. Kaplan-Meier curves were used to estimate local recurrence-free survival (LRFS) and overall survival (OS). Cox proportional hazards analyses (univariate and multivariate) were conducted to identify prognostic risk factors. We conducted a study involving 145 patients, 31 of whom underwent a total of 12 different chemotherapy regimens following initial surgical resection. Most patients received chemotherapy regimens primarily consisting of anthracyclines, including anthracycline + ifosfamide (AI) or anthracycline + cyclophosphamide/docetaxel (AC-T) regimens. After a median follow-up of 54.5 months, 37 (25.5%) patients experienced local recurrence and 24 (16.6%) experienced distant metastasis. No significant difference was detected in the rates of local recurrence or distant metastasis between the 2 groups. Axillary lymph node positivity was the only risk factor for LRFS, whereas older age, larger tumors, axillary lymph node positivity, local recurrence, and distant metastasis were significantly associated with worse OS. Chemotherapy did not emerge as a protective factor for LRFS (P=.501) or OS (P=.854). After PSM, patients in the chemotherapy group did not exhibit better 5-year LRFS (P=.934) or 5-year OS (P=.328). According to our retrospective evaluation, postoperative adjuvant chemotherapy was not associated with improved survival in patients with MPTs without distant metastasis.

Hematologic Recovery in Pediatric Patients with Acute Lymphoblastic Leukemia After Induction Chemotherapy

Link of Video Abstract: https://youtu.be/ulLjSscae2Q Introduction: Myelosuppression in Acute Lymphoblastic Leukemia (ALL) children was associated with high morbidity and mortality. Chemotherapy was aimed to achieve remission conditions, including the elimination of blast cells in the bone marrow. However, the evidence of hematologic recovery after induction chemotherapy was poorly described. This study aimed to evaluate the profile of peripheral blood and the outcome of children with ALL after induction chemotherapy. Methods: A prospective study was conducted in the Hematology-Oncology Pediatric Department at Saiful Anwar Hospital Malang. Patients <15 years old who were newly diagnosed as ALL were enrolled in this study. Peripheral blood examinations were performed on the 1st, 2nd, 4th, and 6th weeks. Clinical outcomes were evaluated by remission status. Comparison and correlation analysis were done by IBM SPSS for Windows, version 26. P-value <0,05 was considered significant. Result: There were 27 children included in this study. The median age was 5 years. There were 15 males and 17 females, 18 patients with LLA-L2 and 9 patients with LLA-L1. All patients received chemotherapy regimens according to the 2018 National Protocol for ALL. The median hemoglobin level was significantly increased after induction chemotherapy (p< 0.05). Meanwhile, the reticulocyte count increased in the 2nd week after induction chemotherapy. The Absolute Neutrophil Count (ANC) significantly improved and reached the normal limit in 4th week after chemotherapy induction. The platelet count and Immature Platelet Fraction (IPF) also increased significantly (p< 0.05) and reached the normal limit in 4th week after induction of chemotherapy. Conclusion: Three cell lines regenerate at different rates at induction chemotherapy, with rapid erythrocyte recovery and slow neutrophil and platelet recovery.

Risk Factors of Capecitabine-Induced Hand-Foot Syndrome: A Single-Institution, Retrospective Study

Introduction: This retrospective study was conducted to identify risk factors for developing hand-foot syndrome (HFS) and to determine new strategies for improving quality of life (QoL) in patients undergoing chemotherapy. Methods: Between April 2014 and August 2018, we enrolled 165 cancer patients at our outpatient chemotherapy center who were undergoing capecitabine chemotherapy. Variables related to the development of HFS were extracted from the clinical records of patients for use in regression analysis. HFS severity was assessed at the time of completing capecitabine chemotherapy. The degree of HFS was classified in accordance with the National Cancer Institute Common Terminology Criteria for Adverse Events version 5. Multivariate ordered logistic regression analysis was performed to identify risk factors for the development of HFS. Results: Risk factors for the development of HFS included concomitant use of a renin-angiotensin system (RAS) inhibitor (odds ratio [OR] = 2.85, 95% confidence interval [CI] = 1.20–6.79; p = 0.018), body surface area (BSA) (high) (OR = 12.7, 95% CI = 2.29–70.94; p = 0.004), and albumin (low) (OR = 0.44, 95% CI = 0.20–0.96; p = 0.040). Discussion/Conclusion: Concomitant use of RAS inhibitor, high BSA, and low albumin were identified as risk factors for the development of HFS. The identification of potential risk factors of HFS may assist in the development of strategies that can be used to improve QoL in patients receiving chemotherapy regimens that include capecitabine.

The efficacy of honey or olive oil on the severity of oral mucositis and pain compared to placebo (standard care) in children with leukemia receiving intensive chemotherapy: A randomized controlled trial (RCT)

BackgroundOral mucositis (OM) is a significant complication occurring in approximately 40 to 80% of patients receiving chemotherapy regimens. Although a wide variety of agents have been tested to prevent OM or reduce its severity, none have provided conclusive evidence. ObjectivesTo determine the efficacy of honey or olive oil on the severity and OM pain in children with leukemia and suffering from OM compared to placebo (standard care) and, to assess which of the two interventions is more beneficial. MethodsA single blind randomized controlled study (RCT) was used to evaluate the effect of Manuka honey or olive oil, in the treatment of chemotherapy-related OM in 42 children with leukemia. The primary outcome was the severity of mucositis, using the World Health Organization (WHO) scale and the secondary outcome was the pain assessed using the Visual analogue scale (VAS). ResultsChildren who received the honey had less severe OM (assessed on the (WHO) scale), p = 0.00 and less pain (assessed on the VAS scale), p = 0.00, compared to the control group. Children who received the olive oil had less pain than the control group, p = 0.00), although not lower than the honey group. ConclusionManuka honey or olive oil can be used as alternative therapies by nurses to children with leukemia and suffering from OM, especially in low and middle-income countries where more expensive therapies may not be available or economical. Practice implicationsPediatric nurses may recommend Manuka honey to treat OM in children with leukemia as it is safe and inexpensive compared to other treatment modalities.

G-CSF filgrastim biosimilar-Sandoz reduces the incidence of febrile neutropenia in patients receiving chemotherapy regimens with rest periods not exceeding 14 days: A French, multicenter, prospective, non-interventional study

PurposeThe objective of this study was to describe filgrastim biosimilar-Sandoz modalities of use in patients receiving cytotoxic chemotherapy regimens with a rest period of ≤14 days and to investigate the incidence of febrile neutropenia (FN) in routine clinical practice. MethodsThis was a French, multicenter, prospective and descriptive, non‐interventional study including patients with breast, lung, gastrointestinal cancer or a lymphoma initiating filgrastim biosimilar-Sandoz treatment and in the context of cytotoxic chemotherapy with a rest period not exceeding 14 days. Data were collected during two routine clinical visits on the modalities of use of filgrastim biosimilar-Sandoz, on the incidence of neutropenia events and on adverse events. ResultsBetween November 2015 and June 2018, 1080 patients were enrolled in the study in 129 centers. Overall, 941 patients were evaluable for efficacy and 937 for safety. Of the 941 patients, 84.8% had a solid tumor and 15.2% had a lymphoid hemopathy. Filgrastim biosimilar-Sandoz was prescribed as primary prophylaxis in 74.0% of the patients and as secondary prophylaxis in 22.4% of the patients. FN was reported in 1.5% of patients with a solid tumor and 12.6% of patients with a lymphoma. A chemotherapy relative dose intensity of over 85% with regard to the reference dose was achieved by more than 80% of the patients in all tumor localizations. ConclusionsThe study showed that filgrastim biosimilar-Sandoz is safe to use and effective in preventing FN and in allowing to maintain the dose intensity of chemotherapy.

ODP336 Nephrogenic Diabetes Insipidus and Fanconi Syndrome Induced by Ifosfamide in a Patient with Femur Osteosarcoma. A Case Report

Abstract Background Fanconi syndrome and diabetes insipidus are rare adverse effects of ifosfamide. They usually present with high cumulative doses of this medication. They are mainly related to type II proximal renal tubular dysfunction. These complications typically present with severe polydipsia and polyuria accompanied by glycosuria, proteinuria, and some electrolyte abnormalities including hypokalemia, hypophosphataemia, and non-anion gap metabolic acidosis. Clinical case: A 15-year-old male with, a diagnosis of metastatic osteoblastic osteosarcoma in the right distal treated with ifosfamide three years prior to this hospitalization, was admitted to the emergency department complaining of 3 episodes of vomiting, 6 days history of increase volume of the right lower limb and fever. On admission, blood pressure of 80/50 mm Hg, heart rate of 110 beats / minute, respiratory rate of 30 breaths / minute, axillary temperature of 38.3 ° C. It was evident phlogosis at level of the proximal third of the right lower limb. CBC revealed pancytopenia (WBC 5 x10 9 L, Hb 6.8 g/dL, platelets 25×10 3 /mm 3) and ABG and CMP were compatible with mild metabolic acidosis normal AG (pH 7.285, K 1.9 meq / L, Na 156 meq / L, lactate: 0.9 meq / L, HCO3: 17 meq / L). A diagnosis of sepsis was made and the patient was started on meropenem 2g IV every 8 hours, vancomycin 1 g IV every 12 hours, filgastrim 120 ug/daily and one unit of packed RBC. Patient improved after 5 days over the course of his hospitalization. However, on the 18 th day after his hospital admission, he developed a new episode of polyuria, associated with hypocalcemia (7 mg/dL), hypokalemia (2 mEq/L), hypomagnesemia (0.95 mg/dL), hypophosphatemia (0.9 mg/dL) and metabolic acidosis (pH 7.2, bicarbonate 15 mEq/L). Urine analysis revealed glucosuria and proteinuria. Desmopressin test did not showed increase urinary osmolarity thus nephrogenic diabetes insipidus and Fanconi syndrome were diagnosed due to the multiple laboratory abnormalities and sign/symptoms. Patient received electrolyte replacement and ifosfamide was stopped from his chemotherapy regimen. After this, patient recovers and he was discharge at 25 th day of his admission. Conclusion : Ifosfamide causes tubular cell dysfunction leading to both nephrogenic diabetes insipidus and Fanconi syndrome. These complications might event present several years after receiving this chemotherapeutic agent. Full electrolyte repletion and hydration are the gold standard for management The present case report emphasizes the importance of the prevention of nephrotoxicity associated with ifosfamide, since its presentation could increase poor outcomes in patients receiving chemotherapy regimens that include ifosfamide. Presentation: No date and time listed

Clinical features and treatment outcomes of 14 patients with hepatosplenic γ δ T-cell lymphoma.

Hepatosplenic γ δ T-cell lymphoma (HSTCL) is a rare subtype of peripheral T-cell lymphoma (PTCL) with aggressive clinical behavior. To date, no standard therapy for HSTCL has been established. This study analyzed the clinical features, treatment, and prognosis for patients with HSTCL to determine the best therapeutic approach. We reviewed the clinical characteristics, treatments, and responses to treatment of patients in our center between January 2001 and June 2021, and also reviewed related literature. Median patient age was 38years (range 16-60years) and the patients included eight males and six females. HSTCL in these patients typically presented with B symptoms (71.4%), splenomegaly (100%), and hepatomegaly (50.0%), but lymphadenopathy was extremely rare. In these patients, routine laboratory testing showed elevated lactate dehydrogenase (71.4%), liver dysfunction (42.9%), and decreased fibrinogen (35.7%). In the induction phase, five of the 14 patients received chemotherapy regimens containing anthracycline (CHOP, or CHOP plus bortezomib or Chidamide), and six were treated with non-CHOP chemotherapy. Seven patients responded to induction treatment, four of whom received allogeneic hematopoietic cell transplantation and then achieved a complete response in the consolidation phase. survival time of patients who received alloHCT range from 10 to 27months. Hepatosplenic γ δ T-cell lacks a standard therapy and is often refractory to conventional chemotherapy regimens. Intensive induction chemotherapy followed by hematopoietic cell transplantation may improve the prognosis of HSTCL.

Post-PACIFIC trial era: Patterns of outcomes and toxicities from a single private institution in a developing country.

e21005 Background: Despite the twenty-first century, NSCLC remains the leading cause of cancer related deaths in a great variety of nations around the globe. However, the scenario has changed dramatically in the past 5 years. Immunotherapy features have opened a gigantic range of combinations now possible towards a better suited treatment for these patients. And we have seen results as we have never before - even in developing countries. Therefore, the goal of this study was to retrospectively analyze the patterns of outcomes, toxicities and safeness in the post-PACIFIC trial era, reporting results on patients that underwent chemoradiation followed by immunotherapy. Methods: We retrospectively collected and analyzed data on patients diagnosed with locally-advanced NSCLC treated in a single private institution in Rio de Janeiro, Brazil, between January 2017 and May 2019. All electronic medical records were accessed in order to obtain demographics, treatment and follow-up pattern data. Patients that received full chemoradiation treatment were included. Patients that did not meet the inclusion criteria were excluded from the study. Results: 121 patients were analyzed. 38 did not meet the inclusion criteria, and were excluded. The median age was 73.5y (50-95). 55% (46) were females. 59% (49) patients were smokers, 12% non-smokers. 29% of them did not have that info on their EMR. Adenocarcinoma was the most common histologic subtype (67%). All patients received chemotherapy regimen according to the best suited to patient, being carbo-taxol the most commonly used one (73%). All patients received radiation therapy, and the mostly used scheme was 60Gy in 30 fractions (38.5%). During a medium follow-up of 1.2 years on Durvalumab, 8 patients died (9.6%), none of them being a treatment-related death. Most toxicities presented during treatment and follow-up were mucositis (62.5%), cough (52%), cutaneous rash (48.8%). Other minor toxicities were nauseas (22.9%) and hematologic (14.5%). No grade 5 toxicity was reported. Conclusions: This study carries limitations inherent to retrospective analysis. Yet, we found the utmost importance on understanding how our patient population is responding to this new era of NSCLC-oncology. Despite all issues related within a developing nation, we showed that our results are compatible with the current data published. The treatment of locally advanced NSCLC brings exciting results and a big hope for these patients.

Ground-glass opacity-featured lung adenocarcinoma has no response to chemotherapy.

We aimed to investigate the treatment effect of chemotherapy on ground-glass opacity (GGO)-featured lung adenocarcinoma radiologically and pathologically. This retrospective study included patients who met the following criteria: (1) presence of lung GGO lesions before chemotherapy for other concurrent malignancies; (2) underwent surgical resection of GGO-featured primary lung adenocarcinoma. The last computed tomography images before chemotherapy (CT1) and the last images before GGO resection (CT2) were reviewed to assess radiologic response. Specimens of the resected tumors were reviewed to evaluate the histopathologic response. Immunohistochemical staining of ki-67, caspase-3 and β-gal was performed and compared between these tumors and a propensity score-matched (1:1) cohort of GGO-featured lung adenocarcinoma without prior chemotherapy. Forty-four patients with 55 GGO lesions were included. There were 20 mixed GGOs and 22 invasive adenocarcinomas. These patients all received at least three cycles of chemotherapy for other concurrent malignancies in breast, lung, cervix, ovary or rectum. Thirty-four (77%) patients received chemotherapy regimens that contained platinum, pemetrexed, paclitaxel, docetaxel or gemcitabine. The median interval between CT1 and CT2 was 10months. Radiologically, all the GGO lesions either remained unchanged or enlarged. There was no chemotherapy-induced histopathologic response (necrosis, fibrosis or inflammation) in any of these tumors. The protein expression of ki-67, caspase-3 and β-gal was comparable between GGO-featured lung adenocarcinoma with or without prior chemotherapy. GGO-featured lung adenocarcinoma has no response to chemotherapy. For these patients, chemotherapy should not be a treatment option.

Abstract P2-08-24: Risk of chemotherapy-induced febrile neutropenia (FN) in patients with metastatic cancer of the breast or other sites not receiving colony-stimulating factor prophylaxis (CSF) in US clinical practice

Abstract Background: Clinical practice guidelines recommend CSF prophylaxis for patients receiving chemotherapy regimens with a high risk of FN (>20%), and consideration of CSF prophylaxis for those receiving intermediate-risk regimens (10-20%) who have ≥1 risk factor for FN. The objective of this study was to estimate the use of CSF prophylaxis among patients with metastatic cancer, and the risk of FN among eligible patients not receiving it. Methods: This retrospective study was conducted at four US health systems—Geisinger Health System (PA), Henry Ford Health System (MI), Kaiser Permanente Northwest (OR, WA), and Reliant Medical Group (MA). Study population comprised patients who received chemotherapy for metastatic solid tumors (breast, colon/rectum, lung) or non-Hodgkin’s lymphoma (NHL) from 2009-2017. For each eligible patient, data on chemotherapy course, cycles, and regimens, as well as the use of supportive care (CSF, antimicrobials) and FN episodes during the course, were collected via a standardized case report form using electronic data warehouses, cancer registries, and medical charts. Analyses were non-comparative and descriptive only. Results: Study population totaled 1,457 patients (26% breast; 25% colon/rectum; 43% lung; 6% NHL). Nearly half of all patients received a chemotherapy regimen classified as either high-risk for FN (21%), or intermediate-risk for FN and had ≥1 FN risk factor (28%). Among patients receiving high-risk regimens, 51% did not receive primary prophylaxis with CSF (PP-CSF), and among those receiving an intermediate-risk regimen with ≥1 risk factor, 86% did not receive PP-CSF; among all remaining patients, 89% did not receive PP-CSF. Across these three subgroups of patients who did not receive PP-CSF (ie, high-risk regimen, intermediate-risk regimen with ≥1 risk factor, all others), FN risk during the course was 17%, 16%, and 14%, respectively. More than 90% of FN episodes required hospitalization, and FN-related mortality was 14%. Among metastatic breast cancer patients, 56% received a high-risk regimen (46%) or an intermediate-risk regimen and had ≥1 FN risk factor (10%); among this subset, 30% did not receive PP-CSF and their FN risk was 16%. Conclusions: In this real-world evaluation of patients with metastatic cancer of the breast or other sites receiving chemotherapy at four large US health systems, over two-thirds of patients who were candidates for PP-CSF (per clinical guidelines) did not receive it. Among the subset of candidates who did not receive PP-CSF, FN risk was high (16%) and associated consequences were severe. Careful consideration should be given to identifying metastatic patients at elevated risk of FN—based on their chemotherapy regimen and risk factors—to ensure appropriate use of supportive care. Table. FN risk factors and chemotherapy FN risk level among metastatic patientsBreast Cancer (N = 380)Colorectal Cancer (N = 360)Lung Cancer (N = 626)NHL (N = 91)All (N = 1,457)FN Risk FactorsAge ≥65y, %20.821.137.240.729.2Prior chemotherapy or radiation therapy, %39.234.248.445.142.3Prior neutropenia, %1.82.22.69.92.7Bone marrow involvement, %27.12.830.024.222.2Recent surgery, %40.042.216.914.329.0Liver dysfunction (bilirubin >2.0), %0.81.40.50.00.8Renal dysfunction (creatinine clearance <50), %45.362.259.365.956.8Chemotherapy FN Risk Level, %High45.80.017.417.620.5Intermediate10.554.726.450.530.7Low8.922.541.20.025.6Unclassified34.722.815.031.923.1 Citation Format: Derek Weycker, Amanda Silvia, Ahuva Hanau, Lois Lamerato, Kathryn Richert-Boe, Manpreet Kaur, Neel Shah, Mark Hatfield, Gary H Lyman. Risk of chemotherapy-induced febrile neutropenia (FN) in patients with metastatic cancer of the breast or other sites not receiving colony-stimulating factor prophylaxis (CSF) in US clinical practice [abstract]. In: Proceedings of the 2019 San Antonio Breast Cancer Symposium; 2019 Dec 10-14; San Antonio, TX. Philadelphia (PA): AACR; Cancer Res 2020;80(4 Suppl):Abstract nr P2-08-24.

1812P - Modalities of biosimilar filgrastim use in clinical practice in > 1000 patients receiving chemotherapy regimens with a rest period of ≤ 14 days: The TOPAZE study

BackgroundInternational guidelines recommend the use of granulocyte colony stimulating factors (G-CSF), such as filgrastim, to prevent chemotherapy-induced febrile neutropenia (FN) and maintain chemotherapy dose to improve clinical outcomes. However, there are no clear recommendations for regimens with a rest period (duration between two cytotoxic administrations, within one cycle or between two different cycles) of≤14 days. This study aimed to describe modalities of daily clinical use of biosimilar filgrastim in patients (pts) receiving chemotherapy regimens with a rest period of≤14 days. MethodsThis multicentre, prospective, non‐interventional study was performed in France in pts receiving biosimilar filgrastim during cytotoxic chemotherapy with rest period of≤14 days. ResultsA total of 1080 pts were enrolled, of which 953 were included in the full analysis set: 144 had lymphoma (DLBCL, N=39; Hodgkin’s lymphoma, N=105), and 809 had solid tumours (breast, N=299; lung, N=144; gastrointestinal [GI], N=366 [colorectal, N=203; pancreatic, N=106; gastric N=39; oesophageal, N=18]). The Table shows modalities of filgrastim treatment for pts receiving chemotherapy for curative intent. Similar results were reported in pts receiving chemotherapy for palliative intent. Pts with solid tumours were planned to receive filgrastim on Day 2 of treatment for ≤5 days duration. Pts with lymphoma were planned to receive filgrastim on Day ≥3 for 4–8 days duration. Of the patients receiving chemotherapy for curative intent, FN was reported in 2 pts with GI cancer, 1pt with lung cancer and 7 pts with lymphoma. ConclusionsBiosimilar filgrastim treatment in pts receiving chemotherapy with a rest period of≤14 days results in a low incidence of FN in real-world clinical practice. Editorial acknowledgementCaroline McGown of Spirit Medical Communications Ltd, supported by Sandoz. Table1812P Modalities of use of biosimilar filgrastim in patients receiving chemotherapy for curative intentTableFull group N (%)Lymphoma 144 (15.1)Solid tumours 809 (85)Subgroup (intent of chemotherapy)DLBCL (i) N=35HL (i) N=100Breast cancer (c) N=139GI cancers (c) N=126Lung cancer (c) N=58Regimen‡biw N=23m N=12biw N=100qw N=91biw N=37m N=11qw N=1biw N=120m N=5qw N=1m N=57Relative dose intensity with planned dose, % Mean (SD)97.7 (4.4)-109.5 (94.9)100.9 (21.8)97.2 (10.4)95.2 (12.6)-99.5 (24.0)96.4 (8.0)-95.1 (28.4)Patients with at least one episode of grade 4 neutropenia†Yes n (%)3 (13.0)1 (8.3)11 (11.0)02 (5.4)001 (0.8)002 (3.5)Number of patients with at least one episode of FN†Yes n (%)1 (4.3)1 (8.3)5 (5.0)00002 (1.7)001 (1.8)DLBCL: R-ACVBP; R-CHOP 14.HL: ABVD; increased-dose BEACOPP.Breast cancer: eribulin; paclitaxel weekly.Digestive cancers: simplified FolFOx4 (colorectal, gastric and oesophageal cancers); FolFlrinOx (pancreatic cancer).Lung cancer: carboplatin + paclitaxel (weekly); vinorelbine + platinum salt (carboplatin or cisplatin) 21-day cycle.biw, twice weekly regimen; c, curative; DLBCL, diffuse large B-cell lymphoma; FN, febrile neutropenia; GI, gastrointestinal; HL, Hodgkin’s lymphoma; i, induction; m, mixed regimen; N, number of patients in group; n, number of patients with event; qw, once weekly regimen; SD, standard deviation.†Note: percentages are calculated compared to completed data (i.e. not including missing data).‡The most frequently used chemotherapies in the overall study population were: Legal entity responsible for the studySandoz. FundingSandoz. DisclosureJ.M. Phelip: Advisory / Consultancy: Roche; Advisory / Consultancy: Merck; Advisory / Consultancy: Amgen; Advisory / Consultancy: Sanofi; Advisory / Consultancy: Bayer; Advisory / Consultancy: Servier; Advisory / Consultancy: Lilly; Advisory / Consultancy: MSD; Advisory / Consultancy: Pierre Favre; Research grant / Funding (institution): Merck Serono. P. Souquet: Honoraria (self), Speaker Bureau / Expert testimony, Non-remunerated activity/ies: Sandoz (a Novartis company). M. Declerck: Full / Part-time employment: Sandoz. E. Nabirotchkina: Full / Part-time employment: Sandoz. O. Tredan: Non-remunerated activity/ies: Sandoz; Honoraria (self): Roche; Honoraria (self): Novartis; Honoraria (self): Pfizer; Honoraria (self): Lilly; Honoraria (self): Astra-Zeneca; Honoraria (self): MSD-Merck; Honoraria (self): BMS. All other authors have declared no conflicts of interest.

Dermoscopy and confocal microscopy for different chemotherapy‐induced alopecia (CIA) phases characterization: Preliminary study

Chemotherapy-induced alopecia (CIA) affects 65% of patients receiving chemotherapy regimens and is often identified with the massive hair loss stage. Reflectance confocal microscopy (RCM) is a noninvasive technique used in alopecia assessment for disease characterization and state of activity. To describe RCM features of CIA in different timing and identify specific phases of alopecia development. A total of 16 patients treated with chemotherapy underwent dermoscopy and RCM evaluations four times during the observation: 2 and 4-6weeks after starting and 3 and 6months after the end of chemotherapy. Ten examinations for each stage were performed. Four phases of CIA have been identified. Initial hair loss showed specific dots not previously described, named CIA dots. massive hair loss phase was characterized by black dots (10/10 pt), CIA dots (8/10 pt) and hair shaft abnormalities. Three months after the end of chemotherapy, during the partial regrowth phase, 10/10 patients showed thin hair in regrowth and 8/10 presented black and yellow dots. At 6months, normal hair in regrowth appears in all patients (total regrowth phase). Chemotherapy-induced alopecia has to be considered as a dynamic process with specific phases characterized by distinctive dermoscopic and confocal features.

PB2156 RISK FACTORS ASSOCIATED WITH EARLY MORTALITY IN PATIENTS WITH MULTIPLE MYELOMA

Background:Early mortality (EM) in multiple myeloma (MM) ranges from 4% to 25% mostly depending on the patients included and on treatment options. EM tends to be lower in clinical trials including younger, transplant‐eligible patients or in bortezomib‐ and lenalidomide‐based regimens in comparison with elderly patients and conventional chemotherapy treatment.Aims:To estimate risk factors associated with EM in patients with newly diagnosed MM.MethodsPatients with newly diagnosed MM were included into the study (from Jan 2013 to Feb 2019). EM was defined if it occurred within 1 year of entry into the study. Adverse cytogenetic abnormalities were specified as gain(1q), t(4;14), t(14;16), t(14;20) or del(17p).Results:A total of 174 patients with newly diagnosed MM (82 male, 92 female; median age 61 years) were involved in the study. Follow‐up period was 1‐71.4 months (median 8 months). The majority of patients developed an advanced stage of disease (Duriе‐Salmon stage 3–141 (81.1%), ISS stage 3–99 (56.9%)). All patients received chemotherapy regimens containing proteasome inhibitors as first‐line therapy and immunomodulatory drugs, intensive and conventional chemotherapy regimens as second‐ or next‐line therapy. During follow‐up period fatal outcome was observed in 45 (25.9%) of 174 patients, of them 16 (9.2%) patients with EM. Median early mortality was 4.7 months. The age of patients with EM and patients survived > 1 year was comparable (median age 64.5 vs. 61, respectively). A larger proportion of patients with EM had Durie‐Salmon stage 3 (93.8% vs 79.7%), ISS stage 3 (75.0% vs 55.1%). Fish in situ hybridization analysis was conducted in 126 (72.4%) patients, adverse cytogenetic abnormalities were present in 4/8 (50.0%) patients with EM and 33/118 (27.9%) patients survived >1 year. Risk factors assotiated with EM were ECOG performance status ≥ 3 score (87.5% vs 40.5%, p = 0.0003), C‐reactive protein level > 10 mg/L (62.5% vs 26.6%, p = 0.007), high lactic acid dehydrogenase activity (81.3% vs 46.2%, p = 0.008), platelet count < 150 × 109/L (43.8% vs 18.9%, p = 0.047) (tab.). For the 16 patients with EM, 11 (68.8%) of deaths were related to MM progression, 4 (25.0%) were due to infections and 1 (6.2%) ‐ heart failure.Summary/Conclusion:EM in patients with newly diagnosed MM was 9.2%. Risk factors associated with EM were poor performance status, elevated serum LDH activity, low platelet count, high serum C‐reactive protein.image

Cost-effectiveness of primary prophylaxis with pegfilgrastim in early-stage breast cancer patients receiving chemotherapy in China.

e18349 Background: Guidelines recommend primary prophylaxis(PP) use for patients receiving chemotherapy regimens with a high risk of febrile neutropenia (FN), which is 20% or higher. This study aim to evaluate the cost effectiveness of PP with pegfilgrastim (Brand name:Jinyouli), PP with filgrastim or no prophylaxis in women with early-stage breast cancer(BC) in China. Methods: A two-phase Markov model was developed for a hypothetical cohort of patients age 45 with stage II BC. First phase modeled costs/outcomes of 4 cycles docetaxel combined cyclophosphamide(TC×4) chemotherapy, with assumptions based on literature reviews including FN rates(Base-case (DSA range),0.29(0.24–0.35)) and related events (FN case-fatality, 3.4 (2.7–4.1)). Second phase models the long term survival which was suggested to link with the relative dose intensity (RDI)( Mortality HR for RDI < 85% vs. ≥85%,1.45 (1.00–2.32)). Clinical effectiveness, costs, and utilities were estimated from peer-reviewed publications and expert opinions in case of unavailability of published evidences. Results: Compared to PP filgrastim and no prophylaxis, PP pegfilgrastim was associated with higher costs 5208.19RMB and 5222.73RMB respectively, and increased quality-adjusted life-year (QALY) gained 0.066 and 0.297 respectively. Accordingly, the incremental cost effectiveness ratios (ICERs) are 79146.3RMB and 17558.77 RMB per QALY, which are both below the three times GDP per capita as the willingness to pay (WTP) threshold suggested by the WHO. Conclusions: Although the cost of PP pegfilgrastim is higher, considering the additional benefits, the administrating of PP pegfilgrastim is likely to be a cost-effective alternative to PP filgrastim and no prophylaxis in patients with early stage breast cancer in China.

Use of colony-stimulating factor primary prophylaxis and incidence of febrile neutropenia from 2010 to 2016: a longitudinal assessment

Background: Guidelines recommend primary prophylactic use of colony-stimulating factor (PP-CSF) when risk of febrile neutropenia (FN) – based on chemotherapy and patient risk factors – is high. Whether and how PP-CSF use may have changed over time (e.g. due to guideline revisions, increasing use of myelosuppressive regimens, controversy regarding inappropriate CSF use), and whether there has been a concomitant change in the incidence of FN, is unknown.Methods: A retrospective cohort design and data from two US healthcare claims repositories were employed. The study population included patients who had non-metastatic cancer of the breast, colon/rectum, lung or ovaries, or non-Hodgkin’s lymphoma (NHL), and who received myelosuppressive chemotherapy regimens with an intermediate/high risk for FN. For each patient, the first cycle of the first course was characterized in terms of PP-CSF use and FN episodes. Crude incidence proportions for PP-CSF and FN during the first cycle were estimated by calendar quarter (2010–2016); multivariable logistic regression models were used to estimate quarter-specific adjusted mean probabilities of FN by PP-CSF use.Results: The study population totaled 142,730 patients with breast cancer (61%), colorectal cancer (14%), NHL (11%), ovarian cancer (10%) or lung cancer (5%). PP-CSF use increased from 52% in 1Q2010 to 58% in 4Q2016; pegfilgrastim was the most commonly used agent (>96% across quarters). PP-CSF administration on the same day as chemotherapy ranged from 8 to 11% until 1Q2015, and increased to 64% by 4Q2016. Adjusted incidence proportions for FN in the first chemotherapy cycle ranged from 2.7% (95% CI: 2.3–3.0) to 3.7% (95% CI: 3.1–4.3) among those who did not receive PP-CSF, and was 2.6% (95% CI: 2.5–2.7) across quarters among those who received PP-CSF.Conclusions: Although the use of PP-CSF is commonplace in current US clinical practice, underutilization in cancer patients receiving chemotherapy regimens with an intermediate/high risk for FN may still be an issue. Use of same-day PP-CSF increased markedly from the end of 2015, although this finding reflects (at least in part) increased uptake of pegfilgrastim delivered via an on-body injector as well as the recent change in clinical practice guidelines. Overall, patients receiving PP-CSF appear to have a lower risk of FN during the first cycle of chemotherapy.

Antimicrobial Prophylaxis for Adult Patients With Cancer-Related Immunosuppression: ASCO and IDSA Clinical Practice Guideline Update

To provide an updated joint ASCO/Infectious Diseases Society of America (IDSA) guideline on antimicrobial prophylaxis for adult patients with immunosuppression associated with cancer and its treatment. ASCO and IDSA convened an update Expert Panel and conducted a systematic review of relevant studies from May 2011 to November 2016. The guideline recommendations were based on the review of evidence by the Expert Panel. Six new or updated meta-analyses and six new primary studies were added to the updated systematic review. Antibacterial and antifungal prophylaxis is recommended for patients who are at high risk of infection, including patients who are expected to have profound, protracted neutropenia, which is defined as < 100 neutrophils/µL for > 7 days or other risk factors. Herpes simplex virus-seropositive patients undergoing allogeneic hematopoietic stem-cell transplantation or leukemia induction therapy should receive nucleoside analog-based antiviral prophylaxis, such as acyclovir. Pneumocystis jirovecii prophylaxis is recommended for patients receiving chemotherapy regimens that are associated with a > 3.5% risk for pneumonia as a result of this organism (eg, those with ≥ 20 mg prednisone equivalents daily for ≥ 1 month or on the basis of purine analog usage). Treatment with a nucleoside reverse transcription inhibitor (eg, entecavir or tenofovir) is recommended for patients at high risk of hepatitis B virus reactivation. Recommendations for vaccination and avoidance of prolonged contact with environments that have high concentrations of airborne fungal spores are also provided within the updated guideline. Additional information is available at www.asco.org/supportive-care-guidelines .

Antineoplastic agents exacerbating Charcot Marie Tooth disease: red flags to avoid permanent disability

Background: Charcot Marie Tooth (CMT) disease is the most common form of hereditary neuropathy. Due to the high prevalence of mild and undiagnosed forms, patients with CMT disease may be exposed to severe neurotoxicity following the administration of neurotoxic chemotherapies. The aim of this report is to alert oncologists to the potential to precipitate severe irreversible peripheral neuropathies when administering neurotoxic compounds to undiagnosed CMT patients.Material and methods: A retrospective research in the OncoNeuroTox database was performed (2010–2016), searching for patients with the diagnosis of chemotherapy-induced peripheral neuropathy (CIPN) and CMT disease. A comprehensive literature review for previously published cases was performed using the Pubmed and Cochrane databases (1972–2017).Results: Among 428 patients with CIPN, we identified eight patients with concomitant CMT disease. Seven patients out of the eight had no previous diagnosis of CMT disease, although accurate familial history disclosed mild signs of peripheral neuropathy in five cases. Patients themselves had minor stigmata of long-standing peripheral damage. Patients received chemotherapy regimens based on vinca alkaloids, taxanes or a combination of vinca alkaloids and platinum compounds. In two cases, cumulative doses were below or equal to the expected neurotoxic threshold. Following chemotherapy administration, patients developed severe length-dependent sensory-motor deficits. Despite early drug discontinuation, most patients remained severely disabled.Conclusion: A brief checklist to disclose long-standing signs of peripheral neuropathy could be helpful to detect patients with undiagnosed hereditary neuropathies who could be at risk of developing severe irreversible neurotoxicity following the administration of neurotoxic agents.

An Optimal Approach for Fluoroquinolone Garenoxacin Prophylaxis in Patients with Hematological Malignancies and Chemotherapy-induced Neutropenia

Antibiotic prophylaxis such as that with fluoroquinolone reportedly reduces infectious episodes in patients receiving chemotherapy regimens with the risk of febrile neutropenia. However, optimum patient characteristics, the timing of initiation, and antibiotics for prophylactic treatments have yet to be identified. We herein conducted a single-arm monocenter clinical study to elucidate the therapeutic profiles of fluoroquinolone garenoxacin prophylaxis for patients with hematological malignancies (HMs). Fever was not present for the duration of chemotherapyinduced neutropenia in 29 (43.9%) out of 66 patients. A shorter duration of prophylaxis until chemotherapy-induced neutropenia had a more potent effect on delaying febrile episodes, even in patients with fever. Excessive neutropenia (minimum zero neutrophils/l) negatively affected prophylactic effects. Garenoxacin accounted for 4.5% of the minor adverse events observed such as mild renal damage and skin reactions. Therefore, the study suggests that the initiation of garenoxacin prophylaxis from the introduction of neutropenia could be an effectual strategy for preventing chemotherapy-induced febrile episodes in HM patients with moderate neutropenia.

A URCC NCORP nationwide randomized controlled trial investigating the effect of exercise on chemotherapy-induced peripheral neuropathy in 314 cancer patients.

10000Background: Over 50% of cancer patients receiving chemotherapy regimens including platinums, vinca alkaloids, and taxanes experience chemotherapy-induced peripheral neuropathy (CIPN), which pr...

Reduction of Inappropriate Prophylactic Pegylated Granulocyte Colony-Stimulating Factor Use for Patients With Non-Small-Cell Lung Cancer Who Receive Chemotherapy: An ASCO Quality Training Program Project of the Cleveland Clinic Taussig Cancer Institute.

Routine prophylactic pegylated granulocyte colony-stimulating factor (pGCSF) administration for patients receiving chemotherapy regimens associated with low risk (< 10%) for neutropenic fever (LRNF) is not recommended. Inappropriate use of pGCSF increases patient morbidity and health care costs. A multidisciplinary team reviewed the charts of patients with non-small-cell lung cancer (NSCLC) at the Taussig Cancer Institute in whom a new chemotherapy regimen was initiated from April through November 2013. pGCSF use was identified and deemed appropriate if prescribed for chemotherapy associated with high risk of neutropenic fever (> 20%) or intermediate risk (10% to 20%) if other risk factors for neutropenic fever were present. Use with LRNF chemotherapy was recorded as inappropriate. One hundred eighty patients with NSCLC received a new chemotherapy regimen during the specified time period. Thirty-four of 119 patients (28%) treated with LRNF chemotherapy received pGCSF. Each patient received an average of 2.6 doses of pGCSF (total, 89 doses). We implemented three plan-do-study-act cycles: education of providers, development of Taussig Cancer Institute consensus guidelines for pGCSF in NSCLC, and removal of standing pGCSF orders from LRNF chemotherapy in the electronic medical record. Analysis during the change period revealed 4% of patients with NSCLC treated with LRNF chemotherapy received pGCSF. Cost analysis showed an 84% decrease in billed charges per month. No increase in neutropenic fever admissions was found. pGCSF was excessively prescribed for patients with NSCLC. Factors contributing to inappropriate use included provider lack of familiarity with guidelines and knowledge with regard to the risk of neutropenic fever for individual chemotherapy regimens, and electronic medical record chemotherapy templates that contain standing GCSF orders. Interventions to address these gaps quickly produced improved compliance with guidelines and led to significant cost savings.