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.

Patient characteristics associated with primary prophylactic granulocyte colony-stimulating factor (G-CSF) use among women treated for early-stage breast cancer.

e12605 Background: The National Comprehensive Cancer Network (NCCN) recommends several chemotherapy regimens for early-stage breast cancer that have elevated risk of neutropenia (>20%). In these regimens, primary prophylactic use of granulocyte colony-stimulating factor (G-CSF) is recommended. Little is known about how patient-level factors relate to receipt of prophylactic G-CSF among women receiving these regimens. Methods: In the Optimal Breast Cancer Chemotherapy Dosing (OBCD) Study, we examined use of G-CSF among women with stage I-IIIA breast cancer between 2005-2019 in Kaiser Permanente Northern California (KPNC) and Kaiser Permanente Washington (KPWA). We evaluated the patient-level factors associated with primary prophylactic G-CSF use (≤7 days before to ≤3 days after first day of chemotherapy) among women receiving chemotherapy regimens with high risk of neutropenia, for which the NCCN guidelines recommend prophylactic G-CSF use. Multivariable-adjusted prevalence ratios (PR) and their corresponding 95% Confidence Intervals (95% CI) were calculated using generalized linear models of the Poisson family with a log link-function and robust standard errors. Results: Overall, while all 3,083 women receiving these regimens ultimately received G-CSF, 2412 (79%) received primary prophylactic G-CSF within the period 7 days prior to 3 days post first cycle. Younger women had higher prevalence of prophylactic G-CSF receipt (82.7% in ages 18-39 years vs. 58.1% in 70+ years). Black women had higher prevalence of receipt compared to white women (82.7% in non-Hispanic Black women vs 76.1% in White women). Women with a higher body mass index (BMI) had lower prevalence of receipt compared to normal weight women (73.3% in 35+ kg/m2 group vs 81.5% in 18.5-<25 kg/m2 group). In multivariable models, older women were less likely to receive prophylactic G-CSF (PR70+ vs 18-39: 0.69; 95% CI: 0.57-0.84; p-trend<0.001), as were those with a higher BMI (PRBMI 35+ vs 18.5-<25: 0.92; 95% CI: 0.85, 0.97; p-trend=0.006), and a later year of diagnosis (PR2016-19 vs 2005-07: 0.81; 95% CI: 0.77, 0.85; p-trend<0.001). Although race/ethnicity was not significantly associated with receipt of prophylactic G-CSF use overall in multivariable models, we observed Non-Hispanic Black women to experience slightly higher likelihood of G-CSF receipt than Non-Hispanic White women (PR: 1.08; 95% CI: 1.02, 1.15). Conclusions: Women of older age and those with higher BMI were less likely to receive primary prophylactic G-CSF, as were women treated in later years. Further research looking at timing of G-CSF use is warranted, as are studies examining provider/facility-level factors in relation to patterns of G-CSF use, G-CSF’s impact on survival outcomes, and the real-world impact of decisions around G-CSF use across age, BMI, and racial/ethnic groups.

ПЕРЕНОСИМОСТЬ ПРОТИВОТУБЕРКУЛЕЗНОЙ ТЕРАПИИ У ДЕТЕЙ

Objective: to evaluate tolerability of different chemotherapy regimens in children with pulmonary TB and input of second-line drugs to the development of adverse drug reactions (ADR). Materials and methods. The study enrolled 92 children aged 2–12 years (a median of 6 years of age) with newly diagnosed active pulmonary TB, who received treatment in 2019–2022. The initial drug combination was based on drug susceptibility of both infection source and patient (chemotherapy regimens 1/3, 2 and 4/5); the number of TB drugs and chemotherapy duration was determined by severity of TB process. The patients were divided into groups based on the chemotherapy regimen: group 1 included 29 patients only administered first-line drugs (1/3), 16 patients of group 2 received chemotherapy regimen 2, and 47 patients of group 3 received 4/5 chemotherapy regimen. Results. ADR were observed in 61 of 92 children (66,3%); satisfactory tolerability was observed in 31 children (33.7%). ADR occurred most frequently in patients of group 3 (85.1%) compared to group 2 (68.8%) and group 1 (34.5%) (χ2 = 20.624, p < 0.001). ADR, which required withdrawal of the offending drug, were more frequent among children, who received chemotherapy regimen 4/5 or 2 (55.3% and 50.0% respectively) compared to children, who received chemotherapy regimen 1/3 (10.3%) (χ2 = 15,372, p = 0,001). Allergic reactions were reliably more frequent under chemotherapy regimen 4/5 compared to chemotherapy regimen 1/3 (31.9% and 6.9% respectively) (χ2 = 6,464, p < 0,012). Clinical and laboratory manifestations of allergic reactions were identical and did not depend on the chemotherapy regimen. Toxic reactions were reliably more frequent under chemotherapy regimen 4/5 compared to 1/3 (48.9% and 20.8% respectively) (χ2 = 6.064, p = 0.014). The range of toxic reactions increased under administration of second-line drugs and demonstrated more clinical and laboratory manifestations under chemotherapy regimen 4/5. Intractable ADR most frequently occurred under administration of amikacin/capreomycin (41.7%), protionamide (30.0%), levofloxacin/moxifloxacin (17.0%), or cycloserine (11.6%). Conclusion. The frequency of ADR to TB treatment in children depends on the administered drugs. The least incidence of adverse reactions was observed in patients, who received first ling drugs (chemotherapy regimen 1/3). Toxic reactions prevailed over allergic ones. The range of toxic reactions increased in patients, who received second-line drugs.

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.

The Effects of Chemotherapy on the Levels of Serum Anti-Müllerian Hormone in Patients with Gestational Trophoblastic Neoplasia.

Gestational trophoblastic neoplasia (GTN) is a group of tumors highly responsive to chemotherapy. It has been suggested that cancer therapies have detrimental effects on female fertility. Anti-Müllerian hormone (AMH) is considered fertility potential and ovarian reserves in women. The aim of this study was to compare serum AMH levels between the patients with GTN treated with chemotherapy and the patients with hydatidiform mole who underwent suction curettage without receiving any chemotherapy. In 35 patients with GTN, serum AMH levels were measured before suction curettage and after the administration of chemotherapy and compared with serum AMH levels measured in 35 patients with hydatidiform mole, who did not receive any chemotherapy as a control. In controls, serum levels of AMH were measured before suction curettage and at the time when beta human chorionic gonadotrophin (ß-hCG) levels approached zero concentration. The mean serum AMH levels in the GTN group were significantly lower than those measured in the control group after chemotherapy. In addition, serum AMH levels measured after intervention in each group significantly decreased compared to the basal levels (p=0.034). Serum AMH levels showed significant differences between the patients who received chemotherapy regimens with methotrexate (MTX) alone, actinomycin-D (Act-D) alone, or the combination of MTX and Act-D (p=0.001). Our study showed that fertility preservation is of great importance in patients with GTN treated with chemotherapy. Furthermore, both MTX and Act-D could have potential adverse effects on ovarian reserve.

Cardiac function in women receiving dual anti-Her2 antibodies (trastuzumab and pertuzumab) combined with chemotherapy for breast cancer.

Chemotherapy regimens containing a combination of anti-Her2 antibodies are effective but can be associated with cardiac toxicity. We evaluate the outcome with a particular focus on the cardiac function of patients with Her2 over-expressed breast cancer receiving Chemotherapy regimens combined with Trastuzumab and Pertuzumab in routine clinical practice settings. The initial cohort of patients who started Chemotherapy regimens in combination with Trastuzumab and Pertuzumab before September 2019 in four cancer units were reviewed retrospectively. All patients had regular measurements of left ventricular ejection fraction by Doppler ultrasound. Sixty-seven patients were identified. Chemotherapy regimens in combination with Trastuzumab and Pertuzumab treatment were administered in the neoadjuvant and palliative settings in 28 (41.8%) and 39 (58.2%) patients, respectively. All patients underwent left ventricular ejection fraction assessment prior to starting Chemotherapy regimens in combination with Trastuzumab and Pertuzumab treatment and at 3 and 6 months later. Subsequently, left ventricular ejection fraction was measured at 9, 12, 15, 18, 21, and 24 months as long as patients are still receiving any of the treatment components. Compared to baseline, the mean left ventricular ejection fraction was not significantly different at any of the subsequent time points (range; decrease by 0.936% to increase by 1.087%: T-test P value not statistically significant for all comparisons). Trastuzumab and Pertuzumab administration was withheld temporarily for two patients due to clinically suspected cardiac toxicity which was excluded upon further investigations. In the neoadjuvant cohort, 82.3% of patients were relapse free at 3 years. The median progression-free survival was 20 months, and the median overall survival was 41 months in the palliative cohort. In this cohort describing our limited initial experience, dual anti-Her2 antibodies (Trastuzumab and Pertuzumab) combined with chemotherapy is effective and not associated with significant cardiac toxicity when the left ventricular ejection fraction is measured every 3 months. This may suggest that previous concerns about cardiotoxicity may have been overemphasized. Further studies investigating less frequent left ventricular ejection fraction monitoring may be warranted.

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.

МІНІІНВАЗИВНА ТОРАКОПЛАСТИКА ПРИ ХІРУРГІЧНОМУ ЛІКУВАННІ ДЕСТРУКТИВНОГО ТУБЕРКУЛЬОЗУ ЛЕГЕНЬ

Aim: to evaluate results of application of the developed technique of minimally invasive extrapleural thoracoplasty in the surgical treatment of patients with destructive pulmonary tuberculosis. Object and methods. Minimally invasive thoracoplasty was performed in 15 patients (study group): men made up 100 %, in the age range from 26 to 58 years. Chronic forms of pulmonary tuberculosis were diagnosed in 10 (66.6 %) patients, newly diagnosed tuberculosis in 5 (33.4 %). Multidrugresistant tuberculosis was observed in 78 % of patients. Bacterial excretion was observed in 86 % of patients. The size of the cavity in the lung did not exceed 6 cm. All patients in the pre- and postoperative periods received chemotherapy regimens based on the prescription of the CMAC / CRTB treatment regimen. The following effectiveness criteria were assessed: cessation of bacterial excretion 1 month after surgery (negative Bactec culture); closure of the destructive cavity confirmed on chest CT scan, the number of postoperative complications and the presence of relapses in the postoperative period. A new method of minimally invasive thoracoplasty was developed to improve the method of collapse-surgical treatment of patients with destructive pulmonary tuberculosis. It uses a resection of small segments of ribs, both in length and in number, extrapleural apicolysis and mediastinal pneumolysis, fixation of the lowered apex of the lung with polypropylene mesh, sealing the created extrapleural cavity with collagen to achieve adequate collapse of the lung in the cavernous zone and accelerate reparative pericavitary processes. The results. 15 patients were operated on according to this technique. Postoperative complications were observed in 1 (6.6 %) patient. Cessation of bacterial excretion after 1 month of treatment was registered in 100 % of patients, closure of the cavity after 2 months of treatment was achieved in 14 (93.3 %) patients. Key words: minimally invasive thoracoplasty, destructive pulmonary tuberculosis, polypropylene mesh, collagen plates.

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

Efficiency of chemotherapy GemCap + mitotane as second and subsequent lines of therapy for metastatic adrenocortical cancer

Background. Combination of gemcitabine, metronomic capecitabine and mitotane (GemCap + m) is the most studied regimen in second and subsequent lines of therapy for advanced adrenocortical cancer (ACC). Previously published studies do not give a definitive answer to the question- what plays a key role in realizing the response to treatment: chemotherapy or mitotane in therapeutic concentration.Aim. Evaluation the efficacy and safety of GemCap + m combination with the standard dosing regimen of capecitabine in patients with metastatic ACC.Materials and methods. This retrospective single-center clinical study included patients over 18 years of age with histologically confirmed ACC with disease progression after completion of platinum-containing therapy. They received chemotherapy regimen gemcitabine 800 mg/m2 for days 1, 8 and capecitabine 1000 mg/m2 orally 2 times at days 1–14 of the 21-day cycle with mitotane. we evaluated objective response, stabilization of disease, 6-months disease control rate and median progression-free and overall survival. Radiological assessment according to RECIST 1.1 criteria was carried out every 6–8 weeks of treatment.Results. The study included 25 patients. mitotane concentration above 14 ng/mL was achieved in 22 (88 %) patients, of which 21 (84 %) reached therapeutic concentration in previous treatment lines. 80 % of patients received treatment as 2nd line, 20 % as 3rd and subsequent lines. The objective responses and disease stabilization was observed in 1 (4 %) and 11 (44 %) of patients, respectively. Disease control for at least 6 months rate was 24 %. median progression-free and overall survival were 3.2 months and 12.17 months, respectively. Toxicity grade 3–4 was observed in 28 % of patients. gemcitabine dose reductions due to thrombocytopenia grade 1–2 were required in 2 cases (8 %), no capecitabine reductions were necessary.Conclusion. This study demonstrates the effectiveness of a new dose regimen of chemotherapy GemCap + m in the second and subsequent lines of therapy for metastatic ACC. The progression of the disease against the background of previous lines of therapy at a therapeutic concentration of mitotane in the majority of patients indicates the effectiveness of the chemotherapeutic component of gemCap in a cohort of patients resistant to platinum and mitotane.

34910 Shared decision making in patients with breast and gynecologic malignancies receiving chemotherapy regimens associated with persistent alopecia

Persistent chemotherapy-induced alopecia (pCIA), a readily visible adverse event of chemotherapy, has psychosocial impacts and may affects patient decision making. This study describes the role of shared decision making (SDM), a model that encourages patients to participate in the decision-making process, in selecting cytotoxic chemotherapy and the possible psychosocial impacts of pCIA in gynecologic and breast cancer patients. Sixty-two patients were included, 32 with breast and 30 with gynecologic cancer, and responded to the Shared Decision-Making Questionnaire (SDM-Q-9), after the understanding of the advantages and disadvantages of the treatment options, including the risk of pCIA. In this study patients felt involved in and favored the SDM model, and they have accepted their chemotherapy decision after they recognize the risk of pCIA vs. benefits of chemotherapy. This process also may help with the anticipated psychosocial impacts of pCIA.

Preventing effect of astragalus polysaccharide on cardiotoxicity induced by chemotherapy of epirubicin: A pilot study.

To assess the clinical effect of astragalus polysaccharide in preventing cardiotoxicity induced by chemotherapy of epirubicin. Two hundred forty-eight patients with breast cancer or malignant lymphoma were randomly divided into the experimental group (EG) (n = 124) and the control group (CG) (n = 124). The EG received chemotherapy regimen containing anthracycline epirubicin and astragalus injection, while CG received only chemotherapy regimen containing anthracycline epirubicin. We detected myocardial function (cardiac troponin I [cTnI], creatine kinase isoenzyme [CK-MB], left ventricular ejection fraction [LVEF], and the ratio of mitral annular diastolic peak velocity to atrial systolic velocity [E/A]) and incidences of cardiotoxicity to assess cardiac function, they were compared at before the first treatment course (T1), end of the second course (T2) and 6-month follow-up. We also detected proinflammatory cytokines (IL-6 and TNF-α), reactive oxygen species and antioxidant enzymes, glutathione peroxidase (GPx), and superoxide dismutase (SOD) aimed to discover potential mechanism. There were no statistical significances in differences of LVEF and E/A between 2 groups (P > .05) at T1 and T2, while levels of LVEF and E/A of EG were significant higher than those of the CG at 6 month follow-up, with statistically significant differences (P < .05). At T1, there were no statistical significances in differences of cTnI and CK-MB between 2 groups (P > .05); at T2 and 6 months follow-up, the cTnI, and CK-MB levels of EG was significantly lower than those of the CG, with statistically significant differences (P < .05). The incidence of cardiotoxicity of EG was 15% (17/113), which was significant lower than that of the CG (60%, 66/110), with statistically significant difference (P < .05). Moreover, the level of TNF-α, GPx, and SOD did not show significant difference (P > .05). The data in this pilot study suggested that astragalus polysaccharide may be an effective therapy for preventing cardiotoxicity induced by chemotherapy of epirubicin. Furthermore, larger, placebocontrolled, perspective studies are needed to assess the efficacy of astragalus injection treatment for preventing cardiotoxicity induced by chemotherapy of epirubicin.

Evaluating the safety and effectiveness of PegaGen® (pegfilgrastim) for the prevention of chemotherapy-induced febrile neutropenia: a post-marketing surveillance study.

Phase IV clinical trials are required to evaluate the real-world safety and effectiveness of drugs. This study aimed to evaluate the safety and effectiveness of once-per-cycle administration of PegaGen® (pegfilgrastim, CinnaGen, Iran) in cancer patients. In this open-label, multicenter, prospective, real-world, post-marketing surveillance study, patients with any type of cancer receiving chemotherapy regimens with a high risk of febrile neutropenia (FN) were included if they were prescribed pegfilgrastim for FN prophylaxis. The primary objective of this study was to assess the safety and the secondary objective was to assess the effectiveness of pegfilgrastim in the prevention of FN in cancer patients. A total of 654 patients (51.73 ± 15.12years of age) were enrolled and 3615 cycles of pegfilgrastim injections were recorded. The most common malignancies among the study patients were breast cancer (n = 192, 29.36%), lymphoma (n = 131, 20.03%), and gastric cancer (n = 65, 9.94%). The median (Q1, Q3) number of pegfilgrastim cycles per patient was 6 (4, 7). A single 6mg dose was injected in 99.17% of the cycles. A total number of 816 adverse events (AEs) were reported in 246 patients (37.62%). Bone pain was recorded in 141 patients (21.56%) and in 440 cycles (12.17%). Among all patients, 45 patients (6.88%) experienced FN 51 times, and FN frequency was 1.4% among cycles. Moreover, 14 (2.14%) patients were hospitalized following FN. Antibiotics were administered to 24 patients (3.67%) for FN treatment. The results from this post-marketing surveillance study support the safety and effectiveness of PegaGen® used for the prevention of chemotherapy-induced FN in patients with various types of cancer and treatment regimens. Clinicaltrials.gov identifier: NCT04460079.

КОГОРТНЫЙ АНАЛИЗ РЕЗУЛЬТАТИВНОСТИ ЛЕЧЕНИЯ БОЛЬНЫХ ТУБЕРКУЛЕЗОМ, В ТОМ ЧИСЛЕ С УСТОЙЧИВОСТЬЮ К РИФАМПИЦИНУ, С МНОЖЕСТВЕННОЙ И ШИРОКОЙ ЛЕКАРСТВЕННОЙ УСТОЙЧИВОСТЬЮ ВОЗБУДИТЕЛЯ К ПРОТИВОТУБЕРКУЛЕЗНЫМ ПРЕПАРАТАМ В РОССИЙСКОЙ ФЕДЕРАЦИИ ЗА 2016–2020 гг.

Objective: to analyze treatment outcomes in patients with TB, including multiple and extensive drug resistant TB (MDR/XDR-TB), in the Russian Federation in 2016–2020. Materials and methods. We used data from the state statistical observation and specialized inquiries. Results. During the five years the treatment success rate decreased from 64.9% in 2016 to 61.4% in 2020 while the proportion of unfavourable outcomes (treatment failure, death, lost for observation) grew from 27.1% in 2016 to 28.0% in 2020. The treatment success rate for chemotherapy regimens 1, 2, and 3 decreased from 69.0% in 2017 to 66.0% in 2020, which produced a negative impact on the indicative rate of treatment success for all TB cases (r = 0.99; p &lt; 0.05). There was persistent growth in the number of cases (15,896 in 2011, 28,336 in 2018) and the treatment success rate for chemotherapy regimens 4 and 5 (MDR-TB cases) (37.1% in 2011, 56.1% in 2017). In 2020 the proportion of favourable outcomes for MDR-TB cases decreased from 56.1% in 2019 to 54.9% due to a growing number of treatment interrupters. During the recent five years we observed a dramatic growth in the number of XDR-TB cases (from 1,318 in 2012 to 4,968 in 2018) and the growing treatment success rate for XDR-TB cases (from 26.1% in 2012 to 42.9% in 2017 and 39.7% in 2018) while the lethality from XDR-TB decreased from 25.3% of cases notified in 2012 to 19.8% of cases notified in 2018. In 2017 and 2018 we observed the growing proportion of treatment failure cases (from 21.0% to 23.9%) and treatment interrupters (from 7.4% to 10.3%). Conclusion. The current dynamics of treatment success rate cannot lead to achieving the goals of the «Stop TB» strategy in the Russian Federation by 2025. The goals might be achieved by increasing effectiveness of treatment of TB patients, which receive chemotherapy regimens 1, 2, and 3. The treatment success rate for chemotherapy regimens 4 and 5 has grown from 54.7% to 56.1% due to decreased lethality from TB or other causes; this was preconditioned by the wide use of modern drugs (bedaquiline), new treatment protocols, and increased implementation of molecular genetic examinations for TB. The proportion of transferred out cases decreased due to the implementation of the Federal register of TB cases and improved access to ultimate treatment outcomes. In 2018 the number of MDR/XDR-TB cases continued to grow predominantly due to newly diagnosed cases. However, the treatment success rate fell due to a growing proportion of treatment interrupters (the typical effect of the COVID-19 pandemic) and increasing lethality from causes other than TB (including deaths from COVID-19). Effectiveness of XDR-TB treatment is slowly growing because of undeveloped infrastructure for testing novel drugs. The proportion of cases lost for the observation increased in the cohort of 2018 due to the COVID-19 pandemic; the general death rate decreased.Keywords: TB, multiple drug resistance, extensive drug resistance, the WHO «Stop TB» strategy, TB treatment, chemotherapy regimens, cohort analysis, deaths from TB.

A Post-Marketing Surveillance Study to Evaluate the Safety Profile of AlvotereⓇ (Docetaxel) in Iranian Patients Diagnosed with Different Types of Cancers Receiving Chemotherapy

BackgroundDocetaxel is a clinically well established antimitotic chemotherapy medication. Labeled docetaxel indications are breast cancer, gastric cancer, head and neck cancer, non–small cell lung cancer, and prostate cancer.ObjectiveThis is a Phase IV study to evaluate the safety profile of docetaxel (Alvotere; NanoAlvand, Iran) in Iranian patients diagnosed with different types of cancers receiving chemotherapy regimens with docetaxel.MethodsPatients who received Alvotere as a part of their chemotherapy regimen were enrolled in this Phase IV, observational, multicenter, open-label study. Alvotere was administrated as a single agent or in combination with other chemotherapy agents. Safety parameters in each cycle were assessed, and the related data were recorded in booklets.FindingsA total of 411 patients with different types of cancers were enrolled from 25 centers in Iran. The most common malignancies among participants were breast cancer (49.88%), followed by gastric cancer (22.63%). Participants’ mean age was 53.33 years, and the mean total dose used in each cycle was 132 mg. According to the results, 341 patients experienced at least 1 adverse event, that the most common was alopecia (41.12%). In total, 92 (22.38%) patients had at least 1 adverse event of grade 3 or 4, and 25 (6.08%) patients showed 54 serious adverse events, which the causality assessment for all was possibly related to Alvotere. There was a significant difference between men and women in the incidence of skin and subcutaneous tissue disorders (55.63% in women vs 41.73% in men; P = 0.009). Also, the incidence of gastrointestinal disorders, nervous system disorders, skin and subcutaneous tissue disorders, hepatic enzymes increase, and fluid retention was significantly higher (P < 0.05) in patients receiving anthracyclines in their chemotherapy regimens.ConclusionsThe findings of this open-label, observational, multicenter, postmarketing surveillance showed that Alvotere appears to have an acceptable safety profile in Iranian cancer patients receiving chemotherapeutic regimens. (Curr Ther Res Clin Exp. 2022; 82:XXX–XXX) © 2022 Elsevier HS Journals, Inc.

Comparison of Primary and Secondary Prophylaxis Using PEGylated Recombinant Human Granulocyte-Stimulating Factor as a Cost-Effective Measure in Malignant Neoplasms: A Multicenter Retrospective Study.

Purpose: The aim of the study was to evaluate the cost-effectiveness of PEGylated recombinant human granulocyte–stimulating factor (PEG-rhG-CSF) as a means of achieving primary and secondary prophylaxis against chemotherapy-induced neutropenia cancer cases. Methods: Individuals who underwent PEG-rhG-CSF therapeutics were monitored for 12 months, together with thorough examination of individual medical records for extracting medical care costs. Both prophylaxis-based therapeutic options (primary/secondary) were scrutinized for cost-effectiveness, using a decision-making analysis model which derived the perspective of Chinese payers. One-way and probabilistic sensitivity analyses were used to assess the robustness of the model. Results: In summary, 130 clinical cases treated using PEG-rhG-CSF prophylaxis were included in this study: 51 within the primary prophylaxis (PP) group and 79 within the secondary prophylaxis (SP) group. Compared with SP, PP-based PEG-rhG-CSF successfully contributed to a 14.3% reduction in febrile neutropenia. In general, PP was estimated to reduce costs by $4,701.81 in comparison to SP, with a gain of 0.02 quality-adjusted life years (QALYs). Equivalent results were found in differing febrile neutropenia (FN) risk subgroups. Sensitivity analyses found the model outputs to be most affected for the average time of hospitalization and for the cost of FN. Conclusion: From the perspective of Chinese payers, PP with PEG-rhG-CSF should be considered cost-effective compared to SP strategies in patients who received chemotherapy regimens with a middle- to high-risk of FN.

Tackling Refractory Metastatic Colorectal Cancer: Future Perspectives.

Simple SummaryMetastatic colorectal cancer (mCRC) accounts for relevant cancer-related morbidity and mortality. Novel investigations have reshaped the molecular makeup of mCRC, emphasizing a high degree of heterogeneity that can be leveraged to establish a new concept of biomarker-guided therapy. In contrast to the old-fashioned, “one-size-fits-all” therapeutic approach, within a precision oncology approach, a deeper molecular selection is indeed felt to improve the efficacy of targeted systemic treatments. Here, we review available treatment options in patients with refractory mCRC, who have already received chemotherapy regimens containing fluoropyrimidines, oxaliplatin, irinotecan, antiangiogenic agents, and, when indicated, epidermal growth factor receptor inhibitors. In addition, we examine those molecular pathways now included among the most promising areas of clinical research that will eventually drive innovative and more individualized treatment strategies.Substantial improvements have characterized the systemic treatment of metastatic colorectal cancer (mCRC) over the past 20 years. Besides strong evidence that supports the use of RAS and BRAF status as prognostic and predictive indicators of disease and response, novel technologies have made possible the incorporation of emerging biomarkers for the management of mCRC. On one hand, the discovery of point mutations, amplifications, fusions, and gene expression profiles highlights the genomic and dynamic complexity of CRC. On the other, such discoveries are leading to newer biomarker-driven strategies that add to existing anti-epidermal growth factor receptor (EGFR) and anti-angiogenic approaches. In addition, the availability of a wide molecular profiling has relevant implications for patient prognosis and treatment benefits. Here, we will review the molecular underpinnings and clinical data supporting novel targeted treatments under development for refractory mCRC harboring BRAF mutations, KRAS G12C mutations, HER2 amplification, and less common molecular alterations, such as the re-arrangements of NTRK, ALK, and ROS1. Additionally, we will discuss novel strategies driving the rechallenge of EGFR antibodies and the incorporation of newer anti-angiogenic agents in the therapeutic armamentarium.

Comparative Assessment of Liver Function During the Intensive Phase of Treatment of Respiratory Tuberculosis Patients Treated with First Line and Reserve Drugs

The objective: to compare liver function of respiratory tuberculosis patients during the intensive phase of treatment with first line drugs (chemotherapy regimen 1) and reserve drugs (chemotherapy regimens 4 and 5).Subjects and Methods: Data of 144 respiratory tuberculosis patients were analyzed, those patients were divided into 2 groups. Group 1 included 67 patients receiving chemotherapy regimen 1 and Group 2 included 77 patients treated with chemotherapy regimens 4 or 5. During the first 3 months of treatment, the frequency and severity of changes in the liver function were assessed.Conclusion: in patients with chronic viral hepatitis, parenchymal liver damage is more frequent and it improves slower. Transaminase levels returned to normal levels more frequently and rapidly with chemotherapy regimen 1, whereas with chemotherapy regimens 4 and 5, reduction of alanine aminotransferase level was observed only from the 2nd month of treatment.