Chemotherapy In Treatment Of Patients Research Articles

Quality of life in women with breast cancer undergoing neoadjuvant chemotherapy: comparison between PICC and PICC-port

BackgroundPeripherally inserted central catheters (PICCs) and new type of arm-port, the PICC-port, are currently used for neoadjuvant chemotherapy treatment in patients with breast cancer. We aimed to compare Quality of Life (QoL) of patients receiving one of these two devices investigating overall satisfaction, psychological impact, as well as the impact on professional, social and sport activities, and local discomfort.MethodsWe did a prospective observational before–after study of PICCs versus PICC-ports. Adult (aged ≥ 18 years) females with breast cancer candidate to neoadjuvant chemotherapy were included. The primary outcome was QoL according to the Quality-of-Life Assessment Venous Device Catheters (QLAVD) questionnaire assessed 12 months after device implantation.ResultsBetween May 2019 and November 2020, of 278 individuals screened for eligibility, 210 were enrolled. PICC-ports were preferred over PICCs with a QLAVD score of 29 [25; 32] vs 31 [26; 36.5] (p = 0.014). Specifically, most QLAVD constructs related to psychological impact, social aspects, and discomfort were in favor of PICC-ports vs PICC, especially in women under the age of 60. Overall, pain scores at insertion and during therapy administration were not significantly different between the two groups, as well as infection, secondary malpositioning, thrombosis, or obstruction of the device.ConclusionsIn women with breast cancer undergoing neoadjuvant chemotherapy, PICC-ports were overall better accepted than PICCs in terms of QoL, especially in those who were younger. Device-related complications were similar.

503P Effect of probiotics on gut microbiota diversity during chemotherapy treatment in patients with gastrointestinal cancer

503P Effect of probiotics on gut microbiota diversity during chemotherapy treatment in patients with gastrointestinal cancer

Intra-arterial chemotherapy for locally advanced nasal cavity and sinonasal tract cancers

Introduction. Malignant tumors of the nasal cavity and sinonasal tract are rare, less than 3 % of all of the head and neck malignant neoplasm. The leading treatment is combined methods with surgery as a first step. However, operation is limited in a locally advanced process due to requires the use of complex reconstructive techniques and removal of aesthetic and functionally important structures. In this regard, the interest of specialists is understandable in use of organ-preserving techniques with comparable oncological results. Intra-arterial chemotherapy has shown high effectiveness in various localizations of malignant neoplasms, so its use in locally advanced tumors of the nasal cavity and sinonasal tract seems promising.Aim. To evaluate the results of complex treatment of patients with locally advanced cancer of the nasal cavity and sinonasal tract using induction intra-arterial chemotherapy.Materials and methods. The study included 28 from 2017 to 2023 with locally advanced cancer of the nasal cavity and sinonasal tract underwent TPF induction intra-arterial chemotherapy, followed by radiation or chemoradiotherapy. The primary endpoint of the study was survival, secondary – objective response rate, treatment toxicity and the possibility of organ preservation.Results. The median follow-up was 19.1 months. We obtained results for all patients of 1-year overall survival – 85.7 % (T3 – 100 %, T4a – 92.7 %, T4b – 55.6 %), and 1-year progression-free survival – 66.7 % (T3 – 75 %, T4a – 71.4 %, T4b – 50 %), respectively. The response rate after intra-arterial chemotherapy was 85.2 %. Overall survival and progression-free survival did not differ significantly between patients with complete response, partial response, and stable disease. However, in patients with a complete response after chemoradiotherapy, 1-year overall survival was 100 % (p = 0.009) and progression-free survival – 90 % (p <0.001). The main side effect in patients in the study was the development of neutropenia (35.7 %), and occurrence of neurological complications was noted in 10.7 %. Of the 35.7 % of patients with tumor orbital invasion, survival with preserved visual function in the first year of life was 80 %; all patients retained vision; as a result of treatment, not a single patient underwent surgery with exenteration.Conclusion. Induction intra-arterial chemotherapy in treatment of patients with locally advanced cancer of the nasal cavity and sinonasal tract demonstrates high efficiency and a high level of complete responses with a fairly low level of toxicity, and also allows preserve the eye function for the majority of patients.

Patient perceptions of altering chemotherapy treatment due to peripheral neuropathy.

Clinical practice guidelines recommend altering neurotoxic chemotherapy treatment in patients experiencing intolerable chemotherapy-induced peripheral neuropathy (CIPN). The primary objective of this survey was to understand patient's perspectives on altering neurotoxic chemotherapy treatment, including their perceptions of the benefits of preventing irreversible CIPN and the risks of reducing treatment efficacy. A cross-sectional online survey was distributed via social networks to patients who were currently receiving or had previously received neurotoxic chemotherapy for cancer. Survey results were analyzed using descriptive statistics and qualitative analysis. Following data cleaning, 447 participants were included in the analysis. The median age was 57 years, 93% were white, and most were from the UK (53%) or USA (38%). Most participants who were currently or recently treated expected some CIPN symptom resolution (86%), but 45% of those who had completed treatment more than a year ago reported experiencing no symptom resolution. Participants reported that they would discontinue chemotherapy treatment for less severe CIPN if they knew their symptoms would be permanent than if symptoms would disappear after treatment. Most patients stated that the decision to alter chemotherapy or not was usually made collaboratively between the patient and their treating clinician (61%). The most common reason participants were reluctant to talk with their clinician about CIPN was fear that treatment would be altered. Participants noted a need for improved understanding of CIPN symptoms and their permanence, better patient education relating to CIPN prior to and after treatment, and greater clinician understanding and empathy around CIPN. This survey highlights the importance of shared decision-making, including a consideration of both the long-term benefits and risks of altering neurotoxic chemotherapy treatment due to CIPN. Additional work is needed to develop decision aids and other communication tools that can be used to improve shared decision making and help patients with cancer achieve their treatment goals.

Chemo-Toxicity Calculator use in shared decision-making for chemotherapy treatment planning.

403 Background: Chemotherapy related symptoms and toxicities are frequent among cancer patients, especially those ≥ 65 years old. These symptoms and toxicities can contribute to patients having a decreased quality of life and unmet treatment outcomes. The modified CARG, Chemo-Toxicity Calculator, is an assessment of function, comorbidity, cognition, psychological state, social activity/support and nutrition. The goal of using the calculator, was to improve shared decision-making between the physician, patient and caregiver. Discussions focused on treatment, modifying treatment regimens and other alternatives such as palliative or hospice. Methods: Rocky Mountain Cancer Centers introduced the modified CARG, Chemo-Toxicity Calculator, in 2022 as part of cancer patient workflow for 10 physicians. In 2022, 156 patients completed the Chemo-Toxicity Calculator to identify and predict the risk of initiation or continuation of chemotherapy treatment in patients ≥ 65 years old. Using the CARG assessment allowed the physician and patient to have open discussions about the pros and cons of initiation or continuation of chemotherapy treatment or if they should pursue alternative treatment. 27 of these patients (17.3%) elected to receive hospice care in lieu of traditional treatment. The Chemo-Toxicity Calculator link was added in the electronic health record (EHR) for access at the point of care. Process: 1. Review patients at the time of initial treatment and subsequent lines of therapy. 2. CARG assessment completed for patients ≥ 65 years old. 3. Shared decision-making discussion including the voice of the patient. 4. Psychosocial interventions and care coordination. Results: As of May 2023,10 providers administered the modified CARG assessment on 244 patients. The tool identified patients that would not benefit from treatment and instances where cycle one dose reduction would be appropriate to reduce toxicity risk. Of the 244 patients who completed the assessment, 47 (19.2%) elected alternative treatment. Conclusions: The Chemo-Toxicity Calculator is a functional, practical first step toward the inclusion of a geriatric assessment for all patients ≥ 65 years old. Patients understand it, and it sets the stage for shared decision-making discussions. This valued intervention aids subsequent discussions about dose reduction and ongoing risks of treatment. Actions taken based on the results of the Chemo-Toxicity Calculator, reduced toxicity by dose reductions and helped patients choose an alternative to chemotherapy.

Cost-utility analysis of Pembrolizumab compared to other alternative immunotherapy and chemotherapy treatments for patients with advanced melanoma in Iran

ABSTRACT Objectives Immunotherapy drugs like Pembrolizumab have shown significant improvements in treatment outcomes of advanced melanoma. This study aimed to evaluate the cost-utility of Pembrolizumab compared to other immunotherapy and chemotherapy drugs in the first-line treatment of advanced melanoma in Iran. Methods A partitioned-survival model, based on data from a recent randomized phase 3 study (KEYNOTE-006) and recent meta-analysis, was used to divide Overall survival (OS) time into Progression-free survival (PFS) and post-progression survival for Pembrolizumab, Nivolumab, Ipilimumab, Dacarbazine, Temozolomide, Carboplatin, and Paclitaxel combination. Quality Life Years (QALY) and Incremental Cost-Effectiveness Ratio (ICER) were considered as the final outcome. Results The ICER of Ipilimumab, Nivolumab, Nivolumab & Ipilimumab, and Pembrolizumab compared to Temozolomide was calculated as $40,365.53, $19,591.13, $24,578, and $47,324.2 per QALY, respectively. Scenario analysis demonstrated if the price of one vial of Nivolumab 100 is $90.51, each vial of Pembrolizumab is $119.20, and each vial of Ipilimumab is $101.54, they will be cost-effective in Iran. Conclusion None of the immunotherapy drugs studied were found to be cost-effective when considering the cost-effectiveness threshold of $3,532. Therefore, a cost reduction of more than 90% in the prices of immunotherapy drugs would be necessary for them to be considered cost-effective in Iran.

Cost-utility analysis of genomic profiling in early breast cancer in Colombia

BackgroundIn Colombia, the best strategy to establish indication for adjuvant chemotherapy in early breast cancer (EBC) remains unknown. This study aimed to identify the cost-utility of Oncotype DX™ (ODX) or Mammaprint™ (MMP) tests to establish the necessity of adjuvant chemotherapy.MethodsThis study used an adapted decision-analytic model to compare cost and outcomes of care between ODX or MMP tests and routine care without ODX or MMP tests (adjuvant chemotherapy for all patients) over a 5-year time horizon from the perspective of the Colombian National Health System (NHS; payer). Inputs were obtained from national unit cost tariffs, published literature, and clinical trial database. The study population comprised women with hormone-receptor-positive (HR +), HER2-negative, lymph-node-negative (LN0) EBC with high-risk clinical criteria for recurrence. The outcome measures were discounted incremental cost-utility ratio (ICUR; 2021 United States dollar per quality-adjusted life-year [QALY] gained) and net monetary benefit (NMB). Probabilistic (PSA) and deterministic sensitivity analysis (DSA) were performed.ResultsODX increases QALYs by 0.05 and MMP by 0.03 with savings of $2374 and $554 compared with the standard strategy, respectively, and were cost-saving in cost-utility plane. NMB for ODX was $2203 and for MMP was $416. Both tests dominate the standard strategy. Sensitivity analysis revealed that with a threshold of 1 gross domestic product per capita, ODX will be cost-effective in 95.5% of the cases compared with 70.2% cases involving MMP.DSA showed that the variable with significant influence was the monthly cost of adjuvant chemotherapy. PSA revealed that ODX was a consistently superior strategy.ConclusionsGenomic profiling using ODX or MMP tests to define the need of adjuvant chemotherapy treatment in patients with HR + and HER2 −EBC is a cost-effective strategy that allows Colombian NHS to maintain budget.

Underutilization or appropriate care? Assessing adjuvant chemotherapy use and survival in 3 heterogenous subpopulations with stage II/III colorectal cancer within a large integrated health system.

BACKGROUND: Clinical guidelines have recommended adjuvant chemotherapy (ACT) for patients with high-risk stage II colon cancer, although the survival benefit is unclear. ACT is also recommended for patients with stage III colon cancer to reduce the risk of recurrence and mortality. For stage II/III rectal cancer, however, the role of perioperative chemotherapy (PCT, adjuvant or neoadjuvant) remains controversial, resulting in substantial variation in its use in clinical practice. OBJECTIVES: To understand real-world use and predictors of ACT or PCT use and survival outcomes in 3 heterogeneous patient groups with colorectal cancer (CRC), and to inform the evidence gap between guideline-based care and clinical practice. METHODS: This retrospective cohort study included patients with an initial stage II/III CRC diagnosis between 2008 and 2013 identified from Kaiser Permanente Southern California electronic health record databases. Patients were eligible if they were aged 18-74 years at diagnosis and received primary curative surgery. We fitted mixed effects logistic regression models to evaluate predictors of ACT receipt and Cox proportional hazards models on propensity score-matched (PS-matched) samples to assess the association between ACT/PCT receipt and survival. RESULTS: We included 1,690 patients with colon cancer (stage II: 820 and stage III: 870) and 587 patients with rectal cancer (stage II: 241 and stage III: 346). We found that 65% of patients with high-risk stage II colon cancer, 15% of those with stage III colon, and 15% of those with stage II/III rectal cancer did not receive ACT/PCT. Patients with stage II colon cancer with T4 stage (odds ratio [OR] = 5.79, 95% CI = 3.33 - 10.06) and a lower comorbidity score were more likely to receive ACT (high vs low Charlson score: OR = 0.69, 95% CI = 0.55 - 0.87). Patients with stage III rectal cancer were more likely to receive PCT than those with stage II disease (OR = 7.85, 95% CI = 2.07 - 29.74). Patients with another cancer diagnosis prior to CRC diagnosis were less likely to receive PCT (OR = 0.37, 95% CI = 0.16 - 0.85). ACT/PCT use was associated with improved overall survival among patients with high-risk stage II colon cancer (PS-matched hazard ratio [HR] = 0.42, 95% CI = 0.25 - 0.70) and those with stage III CRC (stage III colon: PS-matched HR = 0.3, 95% CI = 0.25 - 0.36; stage III rectal: PS-matched HR = 0.2, 95% CI = 0.13 - 0.31). CONCLUSIONS: We found potential underuse of appropriate chemotherapy treatment in patients with high-risk stage II colon cancer and stage III CRC. Clinicians' and providers' decisions on ACT administration may not be fully guided by the risk of recurrence and 5-year survival benefits in stage II colon cancer. DISCLOSURES: This research was supported by the National Cancer Institute of the National Institutes of Health (NIH) (under R37-CA218413). The content is solely the responsibility of the authors and does not necessarily represent the official views of the NIH.

Effects of laparoscopic hyperthermic intraperitoneal perfusion chemotherapy combined with intraperitoneal and systemic chemotherapy treatment in patients with untreated gastric cancer with peritoneal metastasis

Objective: To investigate the efficacy of laparoscopic hyperthermic intraperitoneal perfusion chemotherapy combined with intraperitoneal and systemic chemotherapy (HIPEC-IP-IV) in the treatment of peritoneal metastases from gastric cancer (GCPM). Methods: This was a descriptive case series study. Indications for HIPEC-IP-IV treatment include: (1) pathologically confirmed gastric or esophagogastric junction adenocarcinoma; (2) age 20-85 years; (3) peritoneal metastases as the sole form of Stage IV disease, confirmed by computed tomography, laparoscopic exploration, ascites or peritoneal lavage fluid cytology; and (4) Eastern Cooperative Oncology Group performance status 0-1. Contraindications include: (1) routine blood tests, liver and renal function, and electrocardiogram showing no contraindications to chemotherapy; (2) no serious cardiopulmonary dysfunction; and (3) no intestinal obstruction or peritoneal adhesions. According to the above criteria, data of patients with GCPM who had undergone laparoscopic exploration and HIPEC from June 2015 to March 2021 in the Peking University Cancer Hospital Gastrointestinal Center were analyzed, after excluding those who had received antitumor medical or surgical treatment. Two weeks after laparoscopic exploration and HIPEC, the patients received intraperitoneal and systemic chemotherapy. They were evaluated every two to four cycles. Surgery was considered if the treatment was effective, as shown by achieving stable disease or a partial or complete response and negative cytology. The primary outcomes were surgical conversion rate, R0 resection rate, and overall survival. Results: Sixty-nine previously untreated patients with GCPM had undergone HIPEC-IP-IV, including 43 men and 26 women; with a median age of 59 (24-83) years. The median PCI was 10 (1-39). Thirteen patients (18.8%) underwent surgery after HIPEC-IP-IV, R0 being achieved in nine of them (13.0%). The median overall survival (OS) was 16.1 months. The median OS of patients with massive or moderate ascites and little or no ascites were 6.6 and 17.9 months, respectively (P<0.001). The median OS of patients who had undergone R0 surgery, non-R0 surgery, and no surgery were 32.8, 8.0, and 14.9 months, respectively (P=0.007). Conclusions: HIPEC-IP-IV is a feasible treatment protocol for GCPM. Patients with massive or moderate ascites have a poor prognosis. Candidates for surgery should be selected carefully from those in whom treatment has been effective and R0 should be aimed for.

Abstract OT2-08-03: Immunogenicity of pembrolizumab and doxorubicin in a phase I trial for patients with metastatic triple negative breast cancer

Abstract Background: Combination of immune checkpoint inhibitor pembrolizumab and chemotherapy are standard of care therapy for patients with programmed death-ligand 1 positive (PD-L1+) metastatic triple negative breast cancer (mTNBC). However, a greater understanding of how immune checkpoint inhibitors and chemotherapies synergize to yield anti-tumor T cell responses is needed. The current phase I study evaluated the immunogenicity of doxorubicin plus pembrolizumab in patients with mTNBC. Patients and Methods: Patients with mTNBC, no prior anthracycline use, and 0-2 lines of prior systemic chemotherapies received pembrolizumab 200 mg IV and doxorubicin 50-60 mg/m2 IV every 3 weeks for 6 cycles followed by pembrolizumab maintenance until disease progression or intolerance. Patients were not selected based on PD-L1 expression. The primary objectives were safety and objective response rate per RECIST 1.1. Peripheral blood samples were collected at baseline, Cycle 2 Day 1 (C2D1), and post Cycle 3 for analysis by high parameter flow cytometry. Results: Ten patients were enrolled between March 2016 and November 2019. Best responses included one patient with complete response (CR), five with partial responses (PR), two with stable disease (SD), and one with progression of disease (PD). Flow cytometry showed increased CD3+ T cells (p=0.03) from pre-treatment to C2D1 with substantial inter-patient variation in CD3+ T cells. The expansion of proliferative exhausted-like PD-1+ CD8+ T cell population was identified in 8/9 patients, and exhausted CD8+ T cells were significantly expanded from pre-treatment to C2D1 in the patient with CR (p=0.01). Notably, frequencies of PD-1 high proliferative CD8+ T cells contracted significantly from C2D1 to post Cycle 3 (p=0.005), with a return to near baseline frequencies in the majority of the patients. In the context of all identified T cell subsets, PD-1hi proliferative CD8+ T cells demonstrated the greatest increase in fold change from pre-treatment to C2D1. In contrast, PD-1lo proliferative CD8+ T cells demonstrated the greatest decrease in fold change from pre-treatment to C3D1. Conclusion: Anthracycline-naïve patients with mTNBC treated with the combination of pembrolizumab and doxorubicin yielded robust peripheral blood T cell responses. Further studies dissecting the dynamics and durability of anti-tumor T cell responses and concurrent tumor immune microenvironment changes are needed to optimize combined immune checkpoint inhibitor and chemotherapy treatment for patients with mTNBC. Citation Format: Colt A. Egelston, Weihua Guo, Susan E. Yost, Xuan Ge, Jin Sun Lee, Paul H. Frankel, Yujie Cui, Christopher Ruel, Daniel Schmolze, Mireya Murga, Aileen Tang, Norma Martinez, Misagh Karimi, George Somlo, Peter Lee, James Waisman, Yuan Yuan. Immunogenicity of pembrolizumab and doxorubicin in a phase I trial for patients with metastatic triple negative breast cancer [abstract]. In: Proceedings of the 2022 San Antonio Breast Cancer Symposium; 2022 Dec 6-10; San Antonio, TX. Philadelphia (PA): AACR; Cancer Res 2023;83(5 Suppl):Abstract nr OT2-08-03.

Analysis of the efficacy and tolerability of FOLFIRINOX chemotherapy treatment in patients over 65 years of age with diagnosis of advanced adenocarcinoma of the pancreas.

Systemic treatment of pancreatic adenocarcinoma in the population of people over 65 years old is a challenge resulting from both the extremely unfavourable prognosis of this cancer and the particularly high sensitivity to the toxicity of chemotherapy in the elderly. This article presents the effectiveness and side effects of first-line chemotherapy according to the FOLFIRINOX regimen in patients over 65 years of age diagnosed with advanced pancreatic adenocarcinoma. The analysis was conducted in a group of 43 patients diagnosed with locally advanced inoperable pancreatic cancer or metastatic pancreatic cancer. Patients were treated between 2017 and 2021 in the Clinical Oncology Department, University Clinical Centre, Katowice, Poland. In the study group, the median overall survival was 9.8 months; the median progression-free survival was 8.8 months. Treatment toxicity occurred in all patients. Adverse events of G3 and G4 severity (common terminology criteria for adverse events 5.0) occurred in 8% of patients. In 2 patients (5%), chemotherapy toxicity was the reason for discontinuation of systemic treatment. Triple-drug chemotherapy in a group of patients aged over 65 years with a diagnosis of advanced pancreatic cancer shows similar effectiveness to the general treated population, and with proper medical supervision the severity of side effects is at an acceptable level.

Comparative proteomic analysis of patients with acute myeloid leukemia before and after induction therapy.

Acute myeloid leukemia (AML) is a malignant disorder of hematopoietic stem and progenitor cells, characterized by accumulation of immature blasts in the bone marrow and peripheral blood of affected patients. Response to chemotherapy treatment in patients with AML is wide-ranging, and to date there are no adequate molecular biomarkers used to predict clinical outcome. The aim of this study was to identify potential protein biomarkers which could help predict response to induction treatment in AML patients. Peripheral blood samples were obtained from 15 AML patients both before and after treatment. A comparative proteomic analysis was performed using 2D gel electrophoresis followed by Mass Spectrometry. This comparative proteomic study, combined with a protein network analysis, revealed several proteins that could be considered potential biomarkers of poor prognosis in AML: GAPDH which favors increased glucose metabolism; eEF1A1 and Annexin A1 that promote proliferation and migration, cofilin 1 which plays a role in the activation of apoptosis; and GSTP1 which is involved in the processes of detoxification and chemoresistance. This study gives an insight into a panel of protein biomarkers with prognostic potential that should be further investigated.

Immediate adverse reactions in the chemotherapy treatment of patients with cancer at an oncology day hospital.

A descriptive and cross-sectional study was performed to characterize the degree of immediate adverse reaction and the type of causative antineoplastic drug presented by 371 different patients treated for cancer at the oncology day hospital unit of the San Carlos Clinical Hospital (Madrid, Spain), during the period between January 2015 and December 2019. In the case series, 488 immediate adverse reactions secondary to chemotherapy toxicity were detected. The dominating factors were: Female sex, age from 51-70 years old, skin melanoma and the use of vinca alkaloids and analogs. Among the most frequent adverse reactions, the following stood out: Disorders of the nervous and musculoskeletal systems and of the connective tissue. There was a higher number of moderate adverse reactions (grade 2 according to the Common Terminology Criteria for Adverse Events Version 4.0) between the first and third chemotherapy cycles, with a latency period of between 6 and 15 min., generally lasting less than 30 min. Association with the degree of immediate adverse reaction (grade) has been observed in male subjects over 71 years of age, with soft tissue neoplasm type and monoclonal antibodies therapeutic group.

Management of chemotherapy-induced febrile neutropenia and use of granulocyte colony-stimulating factor in patients with soft tissue or bone sarcoma.

Febrile neutropenia, an oncological complication related to myelosuppressive chemotherapy, can lead to unplanned hospitalization, morbidity, mortality, and changes in the oncological therapeutic plan. The present study aimed (1) to determine the prevalence of chemotherapy-induced febrile neutropenia requiring hospitalization and the use of granulocyte colony-stimulating factor and (2) to evaluate its consequences for the oncological treatment of patients with soft tissue or bone sarcomas. This is a cross-sectional and retrospective study (January 2018 to December 2019) carried out in a reference oncology hospital in the Brazilian public health system. Inpatients diagnosed with chemotherapy-induced febrile neutropenia, older than the age of 18 years, and treated with granulocyte colony-stimulating factor were included in the study. Twenty-nine chemotherapy-induced febrile neutropenia events were identified, involving 25 patients. Among the febrile neutropenia events, 90% were grade 4, and 59% occurred during palliative chemotherapy. Among patients with febrile neutropenia, 31% had arterial hypertension or/and diabetes mellitus comorbidities, 34% had infectious skin sites, such as compression ulcers and tumor wounds, and 31% had infections with defined etiologic agents. Treatment of hospitalized patients was performed with cefepime in combinations or alone (97%) and filgrastim. The outcomes related to chemotherapy-induced febrile neutropenia were chemotherapy dose reduction (31%), chemotherapy cycle delays (21%), chemotherapy treatment suspension (17%), deaths (7%), and other associated complications (10%). Granulocyte colony-stimulating factor prophylaxis was prescribed in 72.41% of febrile neutropenia events. The frequency of febrile neutropenia concerning total chemotherapy cycles was 2.15%. Even with granulocyte colony-stimulating factor prophylaxis, an overall prevalence of 2.15% of febrile neutropenia associated with hospitalization was observed, causing negative outcomes in chemotherapy treatment of patients.

Association of a home-based nursing service during chemotherapy with the transfer to home care immediately after the last chemotherapy treatment in patients with advanced cancer.

BackgroundThe appropriate timing of introducing the home-based nursing service to patients with advanced cancer has not been clarified. This study conducted a retrospective cohort study to investigate the associations of the early utilization of the home-based nursing service during chemotherapy with the place of care immediately after the last chemotherapy treatment in patients with advanced cancer.MethodsAmong the patients referred to the palliative care team of the University of Tsukuba Hospital between January 2018 and December 2019, patients with advanced cancer undergoing chemotherapy or before the start of chemotherapy at referral were included. The study patients who utilized the home-based nursing service during chemotherapy were classified into the early utilization group. The primary endpoint was the place of care immediately after the last chemotherapy treatment.ResultsOf the 1154 patients referred to the palliative care team during the study period, 261 were eligible for this study. Of these patients, 15.3% of patients (n = 40) received the home-based nursing service during chemotherapy. The proportion of patients transferred to home care after the last chemotherapy treatment was 17.5% in the early utilization group and 7.2% in the control group. The multivariate analysis revealed that the early utilization of the home-based nursing service during chemotherapy was significantly associated with the transfer to home care (odds ratio = 3.077; 95% confidence interval, 1.113–8.502).ConclusionThe early utilization of the home-based nursing service during chemotherapy might be associated with the transfer to home care immediately after the last chemotherapy treatment.

Myocardial microvascular function assessed by CMR first-pass perfusion in patients treated with chemotherapy for gynecologic malignancies.

Cancer chemotherapy potentially increases the risk of myocardial ischemia. This study assessed myocardial microvascular function by cardiac magnetic resonance (CMR) first-pass perfusion in patients treated with chemotherapy for gynecologic malignancies. A total of 81 patients treated with chemotherapy for gynecologic malignancies and 39 healthy volunteers were prospectively enrolled and underwent CMR imaging. Among the patients, 32 completed CMR follow-up, with a median interval of 6 months. The CMR sequences comprised cardiac cine, rest first-pass perfusion, and late gadolinium enhancement. There were no significant differences in the baseline characteristics between the patients and normal controls (all p > 0.05). Compared with the normal controls, the patients had a lower myocardial perfusion index (PI) (13.62 ± 2.01% vs. 12% (11 to 14%), p = 0.001) but demonstrated no significant variation with an increase in the number of chemotherapy cycles at follow-up (11.79 ± 2.36% vs. 11.19 ± 2.19%, p = 0.234). In multivariate analysis with adjustments for clinical confounders, a decrease in the PI was independently associated with chemotherapy treatment (β = - 0.362, p = 0.002) but had no correlation with the number of chemotherapy cycles (r = - 0.177, p = 0.053). Myocardial microvascular dysfunction was associated with chemotherapy treatment in patients with gynecologic malignancies, and can be assessed and monitored by rest CMR first-pass perfusion. • Chemotherapy was associated with but did not aggravate myocardial microvascular dysfunction in patients with gynecologic malignancies. • Rest CMR first-pass perfusion is an ideal modality for assessing and monitoring alterations in myocardial microcirculation during chemotherapy treatment.

Pertuzumab (Perjeta)

&#x0D; CADTH reimbursement reviews are comprehensive assessments of the clinical effectiveness and cost-effectiveness, as well as patient and clinician perspectives, of a drug or drug class.&#x0D; The assessments inform non-binding recommendations that help guide the reimbursement decisions of Canada's federal, provincial, and territorial governments, with the exception of Quebec.&#x0D; This review assesses pertuzumab (Perjeta), 420 mg/14 mL vial for IV infusion.&#x0D; Indication: In combination with trastuzumab and chemotherapy for neoadjuvant treatment of patients with HER2-positive, locally advanced, inflammatory, or early-stage breast cancer (either &gt; 2 cm in diameter or node-positive).&#x0D;

Appropriate Selection of PARP Inhibitors in Ovarian Cancer.

Poly-ADP-ribose polymerase inhibitors (PARPi) are a class of anti-cancer drugs that target DNA repair pathways and have shown promising efficacy in patients with ovarian cancer in recent clinical trials. To date, there have been 9 FDA PARPi approvals/indications in ovarian cancer since 2014, highlighting the importance of this class of agents in the treatment of ovarian cancer. BRCA1/2-mutated tumors or other forms of homologous recombination deficient (HRD) tumors are particularly susceptible to PARP inhibition and have seen the greatest benefits of improvement in response rate and progression-free survival (PFS) in clinical trials. Patients with homologous recombination-proficient tumors also receive benefit, especially when a nice response to paltinum is noted, but to a lesser extent. PARP inhibitors now have FDA approval and indications in first-line and recurrent maintenance, and treatment. PARP inhibitor use as maintenance therapy in the front-line setting is now considered the standard of care in patients with BRCA1/2 mutations based on the SOLO-1/GOG-3004/ENGOT study. PARP inhibitors are also recommended per ASCO guidelines in all patients with ovarian cancer as front-line maintenance therapy based on the PRIMA/ENGOT-OV26/GOG-3012 trial. The combination of PARP inhibitor, olaparib, and the anti-angiogenesis inhibitor bevacizumab is also approved as maintenance therapy after front-line chemotherapy treatment in patients with HRD tumors and is an option for patients who have initiated bevacizumab with their chemotherapy treatment. PARPi are also FDA approved and can be utilized as a treatment in third-line and beyond in recurrent ovarian cancer patients with BRCA1/2 mutations and HRD tumors. In this review, we will cover in detail when PARP inhibitor use is appropriate in ovarian cancer, as well as the various clinical factors to take into consideration when selecting a PARP inhibitor regimen.

A monocentric, first-in-human (FIH), safety and preliminary efficacy study of (neo) adjuvant, model-based, whole-body hyperthermia (WBHT) treatment in advanced solid cancer patients or stage IV metastatic pancreatic adenocarcinoma patients.

TPS625 Background: Whole-Body Hyperthermia (WBHT) represents the only hyperthermia modality available for patients with disseminated malignancies. The rationale for the treatment of malignant disease by heat is based on a direct cell-killing effect at temperatures in the range of 41– 42°C and driven by a number of reasons. Phase-I mining and phase-I veterinary (dog) clinical study proved the safety of WBHT treatment alone and in combination with standard of care therapy in dogs with cancer. A systematic review addressed clinical trials that used WBHT in pancreatic cancer patients. In these trials, the weighted estimate of the treated population median overall survival was 11.7 compared to 5.6 for the control cohorts. Methods: The is a first in-human, mono-centric, non-randomized trial to establish the safety and preliminary efficacy of WBHT treatment with the TempoCure (medical device) alone in patients with advanced solid cancer (cohort A) or in combination to SOC chemotherapy treatment in patients with stage IV metastatic pancreatic adenocarcinoma (cohort B). The study of 12 to 20 patients is not powered for any statistical analysis. The analysis will be limited to descriptive statistics, considered the doses provided and the extra blood sampling taken at different time points. The treatment is applied under deep anaesthesia in a unit connected to the operating room at the hospital. Cohort A1. Three patients with advanced solid cancer will be subjected to repetitive WBHT starting with 2 hours (day 1), 4 hours (day 8) and 6 hours (day 15) using the TempoCure to keep the patient at a temperature of 41.5°C. The patient’s body temperature will be monitored by specific sensors (liver, oesophageal, rectal and cutaneous). Cohort A2. The highest WBHT duration with acceptable side effects from cohort A1 will be applied to three additional patients with advanced solid cancer, once a week and for 15 days in total. Cohort B1. Three pancreatic cancer patients will be subjected to repetitive WBHT starting with 2 hours (day 1), 4 hours (day 8) and 6 hours (day 15) using the TempoCure to keep the patient at a temperature of 41.5°C and in combination with the standard of care chemotherapy. Cohort B2. The highest WBHT duration with acceptable side effects from cohort B1 will be applied in combination with chemotherapy to three pancreatic cancer patients, once a week and for 15 days in total. Major inclusion criteria are: Adequate liver structure (confirmed by CT scan) allowing the placement of the liver sensor; Adequate coagulation defined as; PT (%) ≥ 70%; aPTT ≤ ULN; Von Willebrand Factor Antigen ≥ LLN; Von Willebrand Factor Activity ≥ LLN; PFA COL/EPI CT ≤ 1.15 ULN; PFA COL/ADP CT ≤ 1.15 ULN. Enrollment to Cohort A1 began in July 2021. Clinical trial information: NCT04467593.

Treatment Patterns and Outcomes in Chinese Patients with Gastric Cancer by HER2 Status: A Noninterventional Registry Study (EVIDENCE).

Real-world safety and effectiveness data for trastuzumab plus chemotherapy treatment of patients with HER2-positive metastatic gastric cancer (mGC) in China are lacking. EVIDENCE was a prospective, multicenter, noninterventional registry study evaluating the safety and effectiveness of trastuzumab in five cohorts of Chinese patients with gastric cancer, stratified by HER2 status and trastuzumab treatment. Effectiveness was analyzed for cohorts I (HER2-positive, trastuzumab treated), II (HER2-positive, trastuzumab untreated), and IV (HER2-negative, trastuzumab untreated); trastuzumab-related adverse events (AEs) were analyzed for cohort I. Cohorts I, II, and IV included 174, 113, and 422 patients, respectively. Most patients received first-line chemotherapy (87.6%). Median overall survival (OS1) for first-line treatment was 22.3, 17.2, and 17.4 months in cohorts I, II, and IV, respectively. After excluding patients who had surgery, respective median OS1 was 19.9, 15.3, and 12.9 months. Respective first-line progression-free survival (PFS1) was 8.2, 6.9, and 6.2 months; and respective first-line response rates (RR) were 51.7%, 18.4%, and 32.8%. Cohort I was significantly favored over cohort II for propensity score-matched first-line median OS1 (hazard ratio [HR], 0.61), PFS1 (HR, 0.64), and RR (odds ratio, 4.93). Trastuzumab-related AEs, grade 3-5 AEs, serious AEs, and AEs with a fatal outcome occurred in 23.6%, 3.4%, 2.3%, and 0.6% of cohort I patients, respectively. Safety profiles were consistent with those known for trastuzumab and chemotherapy; trastuzumab treatment improved outcomes. Our study provides real-world data supporting first-line trastuzumab plus chemotherapy in Chinese patients with HER2-positive mGC. This prospective, noninterventional registry study aimed to provide safety and effectiveness data for the use of trastuzumab in combination with chemotherapy in Chinese patients with HER2-positive metastatic gastric cancer (mGC) from the real-world clinical setting. Trastuzumab plus first-line chemotherapy was shown to be safe and to improve outcomes when compared with patients treated with chemotherapy alone. Trastuzumab was effective within a range of treatment regimens; subgroup analysis showed that trastuzumab paired most effectively with the XELOX regimen. This study provides real-world clinical safety and effectiveness data supporting the use of trastuzumab in the treatment of Chinese patients with HER2-positive mGC.