Defining the impact of the use of granulocyte colony stimulating factors on the incidence of chemotherapy-induced neutropenia in patients with gynecologic malignancies

Purpose The objectives of this study were to characterize the incidence of chemotherapy-induced neutropenia (CIN) and febrile neutropenia (FN) with specific chemotherapy agents commonly used in the treatment of gynecologic malignancies, as well as defining the impact of granulocyte colony stimulating factors (G-CSF) on the prevention of CIN and FN in this patient population. Methods This retrospective analysis was conducted from a database of 635 gynecologic cancer patients who received chemotherapy between 1 September 2007 and 31 August 2008. A logistic regression analysis was conducted to determine the impact of potential covariates on the overall incidence of CIN. Results Overall, 28.3% of patients experienced CIN with one or more cycles chemotherapy, and 13.1% had treatment delays or dose reduction associated with CIN. The use of G-CSF prior to administration of chemotherapy resulted in a decrease in the incidence of CIN from 29.8% to 19.6% compared to no G-CSF use. No difference was observed in number of treatment delays or dose reductions in the 46 (7.2%) of gynecologic cancer patients that received G-CSF prophylaxis. Multivariate analysis found that both age and the number of current cycles jointly may predict risk of CIN. Conclusions Patients with gynecologic malignancies appear to be at a higher risk of development of neutropenia when treated with chemotherapy. The proactive use of G-CSF did decrease the risk of CIN by over 30%. Prospective study is warranted to determine the impact of G-CSF to reduce CIN in patients with gynecologic malignancies receiving chemotherapy.

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Clinical Impact of COVID-19 Outbreak on Cancer Patients: A Retrospective Study

Clinical Medicine Insights Oncology ◽

10.1177/11795549211043427 ◽

2021 ◽

Vol 15 ◽

pp. 117955492110434

Author(s):

Sebastiano Buti ◽

Fabiana Perrone ◽

Teresa Zielli ◽

Giulia Mazzaschi ◽

Chiara Casartelli ◽

...

Keyword(s):

Cancer Therapy ◽

Cancer Patients ◽

Clinical Impact ◽

Treatment Schedule ◽

Short Term ◽

Treatment Delays ◽

Anticancer Treatment ◽

Starting Failure ◽

Oncologic Treatment ◽

The Impact

Background: Coronavirus disease (COVID-19), an acute respiratory syndrome caused by a novel severe acute respiratory syndrome coronavirus (SARS-CoV-2), has rapidly spread worldwide, significantly affecting the outcome of a highly vulnerable group such as cancer patients. The aim of the present study was to evaluate the clinical impact of COVID-19 infection on outcome and oncologic treatment of cancer patients. Patient and methods: We retrospectively enrolled cancer patients with laboratory and/or radiologic confirmed SARS-CoV-2 infection, admitted to our center from February to April 2020. Descriptive statistics were used to summarize the clinical data and univariate analyses were performed to investigate the impact of anticancer treatment modifications due to COVID-19 outbreak on the short-term overall survival (OS). Results: Among 61 patients enrolled, 49 (80%) were undergoing anticancer treatment and 41 (67%) had metastatic disease. Most patients were men; median age was 68 years. Median OS was 46.6 days (40% of deaths occurred within 20 days from COVID-19 diagnosis). Among 59 patients with available data on therapeutic course, 46 experienced consequences on their anticancer treatment schedule. Interruption or a starting failure of the oncologic therapy correlated with significant shorter OS. Anticancer treatment delays did not negatively affect the OS. Lymphocytopenia development after COVID was significantly associated with worst outcome. Conclusions: COVID-19 diagnosis in cancer patients may affect their short-term OS, especially in case of interruption/starting failure of cancer therapy. Maintaining/delaying cancer therapy seems not to influence the outcome in selected patients with recent COVID-19 diagnosis.

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Proper dosage of primary pegylated G-CSF prophylactic use for breast cancer patients receiving adjuvant or neo-adjuvant chemotherapy.

Journal of Clinical Oncology ◽

10.1200/jco.2019.37.15_suppl.e18354 ◽

2019 ◽

Vol 37 (15_suppl) ◽

pp. e18354-e18354

Author(s):

Liang Yu ◽

Xin Lei ◽

Ying Lin

Keyword(s):

Breast Cancer ◽

Logistic Regression ◽

Regression Analysis ◽

Cancer Patients ◽

Logistic Regression Analysis ◽

Insurance Coverage ◽

Breast Cancer Patients ◽

Treatment Delays ◽

Surgical Department ◽

Dose Reductions

e18354 Background: Myelosuppression during chemotherapy can lead to life-threatening infections, dose reductions, treatment delays, as well as prolonged hospitalizations, early morbidity, and early mortality. According to NCCN guideline, Pegfilgrastim 6mg per cycle is recommended for breast cancer patients receiving chemotherapy, and dosage modification based on body weight is not required. However, primary PEGylated G-CSF prophylaxis comes with significant extra cost, which has a great impact on health care resources, especially for patients without insurance coverage. Methods: We analyzed clinical data of patients, weighing between 45 and 65 kilogram, received a single subcutaneous PEGylated recombinant human G-CSF injection at fixed doses of either 3 mg or 6 mg per chemotherapy cycle approximately 24 hours after completion of each cycle of chemotherapy. Data for this retrospective study were obtained from Thyroid and Breast Surgical Department of the First Affiliated Hospital of Sun Yat-sen University between July 1, 2017, and October 31, 2017. Results: 41 cycles in 33 patients were included in 3mg PEGylated G-CSF group, and 46 cycles in 39 patients were included in 6mg PEGylated G-CSF group. Among chemotherapy cycles, the incidence of neutropenic event was19.5%and 2.2% in 3mg PEGylated G-CSF group and 6mg PEGylated G-CSF group, respectively. No patients experienced dose reductions or treatment delays in both groups. Using single-factor Logistic Regression Analysis, we found that dose of PEGylated G-CSF(3mg vs 6mg) was significantly associated with occurrence of neutropenic event(p = 0.028). Multi-factor Logistic Regression Analysis also showed that dose of PEGylated G-CSFwas significantly associated with occurrence of neutropenic event (p = 0.031). Conclusions: Our study showed that dose of prophylactic PEGylated G-CSF was significantly associated with occurrence of neutropenic events. So adequate dose of PEGylated G-CSF is important to reduce chemotherapy induced neutropenic events and to guarantee the quality of chemotherapy in patients with breast cancer.

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Evaluation of the impact of treatment delays and dose reductions in human ovarian cancer orthotopic mouse models

Integrative Cancer Science and Therapeutics ◽

10.15761/icst.1000155 ◽

2016 ◽

Vol 2 (6) ◽

Author(s):

Scott Mosley ◽

Jing-Hong Chen ◽

Anjali Gaikwad ◽

Elizabeth K. Nugent ◽

Judith A. Smith

Keyword(s):

Ovarian Cancer ◽

Mouse Models ◽

Human Ovarian Cancer ◽

Treatment Delays ◽

The Impact ◽

Dose Reductions

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Use of nivolumab as salvage therapy in heavily pretreated patients with gynecologic malignancies.

Journal of Clinical Oncology ◽

10.1200/jco.2019.37.15_suppl.5593 ◽

2019 ◽

Vol 37 (15_suppl) ◽

pp. 5593-5593

Author(s):

Heather Williams ◽

Jennifer Wang ◽

Lynn Tran ◽

Sara Mobley ◽

Bunja Jane Rungruang ◽

...

Keyword(s):

Treatment Response ◽

Immune Checkpoint ◽

Immune Checkpoint Inhibitor ◽

Checkpoint Inhibitor ◽

Gynecologic Cancer ◽

Low Grade ◽

Significant Activity ◽

Gynecologic Malignancies ◽

Heavily Pretreated ◽

The Impact

5593 Background: There are limited effective treatments for gynecologic cancer patients who have been previously treated with multiple lines of chemotherapy. Immune checkpoint inhibitor (ICI) therapy has demonstrated significant activity in certain cancers but has been inconclusive in most gynecologic malignancies. The objective of this study was to determine the impact of salvage ICI therapy in heavily pretreated gynecologic oncology patients. Methods: An IRB approved retrospective study was performed of women with gynecologic cancer treated with nivolumab on a compassionate use program between October 2015 and January 2018. Patient demographics, disease characteristics, pathology and treatment history were collected. Survival probabilities were calculated. Results: Twenty-eight women were identified. Median age at start of treatment was 63 years with a median of 4 prior lines of chemotherapy. Median ECOG status was 2. Disease site was evenly distributed among uterus, ovary and cervix. 67.9% of patients completed 3 or more cycles of treatment. Median PFS of all patients was only 2.6 months however when comparing patients who received 2-3 cycles (n = 13) with those who received 4 or more (n = 9), median PFS was statistically significant 2.4 months vs 6.4 months (p = 0.0005). When looking at treatment response, 7 patients had partial response/stable disease after 3 cycles (25%). Median PFS of the 7 “responders” was 6.6 months vs 2.5 months of the non-responders (p < 0.001). Only 1 of 9 patients with uterine cancer had a disease response and that patient’s tumor was MSI high. Five patients had low grade serous ovarian cancer. Four of them had a treatment response with a median PFS of 6.1 months (range 3.8 – 25 months). Adverse events were experienced by 68% of patients; most commonly being fatigue (46.4%), arthralgia (25%), and anemia (21.4%). Only 1 patient experienced a grade 3-4 event (a diffuse maculopapular rash). Conclusions: In patients with heavily pretreated gynecologic malignancies with suboptimal performance status, immune checkpoint inhibitor therapy may prolong survival without significant toxicity. Also, there may be a role for ICI in patients with historically chemo resistant low grade serous ovarian cancers.

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Usefulness of Vascular Clips in Surgery for Gynecologic Cancer

10.21203/rs.3.rs-910348/v1 ◽

2021 ◽

Author(s):

Kazuho Nakanishi ◽

Takashi Yamada ◽

Shunji Suzuki

Keyword(s):

Cervical Cancer ◽

Endometrial Cancer ◽

Pelvic Floor ◽

Cancer Patients ◽

Gynecologic Cancer ◽

Pelvic Lymphadenectomy ◽

Gynecological Surgery ◽

Gynecologic Malignancies ◽

Result Analysis ◽

Titanium Clips

Abstract In gynecological surgery for cervical cancer and endometrial cancer with lymphadenectomy, many lymph vessels are ligated to prevent postoperative lymph leakage and lymphocele, and many blood vessels leading to the pelvic floor are ligated. Therefore, the labors required for ligation are very large. However, no studies have examined ligation methods in gynecologic cancer surgery. Therefore, we retrospectively examined gynecologic cancer patients who had been treated at our hospital by dividing them into a group using absorbent threads and a group using titanium clips. In addition, the surgical procedure was classified into three groups: a group with only pelvic lymphadenectomy, a group with pelvic and para-aortic lymphadenectomy, and a group with radical hysterectomy with pelvic lymphadenectomy. As a result, analysis of all cases clearly showed less complications and less time for surgery in the clip group. Furthermore, the analysis of RH + PLN group showed that surgery time was clearly shorter and less complications tended to occur in the clip group. In conclusion, by using this easily usable device, surgery for gynecologic malignancies will be more comfortable and safer.

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Comparison of standard versus reduced-dose pegfilgrastim on clinical outcomes and chemotherapy dose intensity in patients with advanced pancreatic cancer receiving cytotoxic combination chemotherapy (NAPPCG) in an outpatient oncology infusion clinic.

Journal of Clinical Oncology ◽

10.1200/jco.2017.35.15_suppl.e15710 ◽

2017 ◽

Vol 35 (15_suppl) ◽

pp. e15710-e15710

Author(s):

Krystal Hicks ◽

Adam Odeh

Keyword(s):

Pancreatic Cancer ◽

Dose Intensity ◽

Treatment Delays ◽

Myelosuppressive Chemotherapy ◽

Full Dose ◽

Reduced Dose ◽

Chemotherapy Dose ◽

The Impact ◽

Dose Reductions ◽

Chemotherapy Dose Intensity

e15710 Background: Pegfilgrastim use has been shown to reduce the incidence of febrile neutropenia when given at recommended dosage (6 mg) following myelosuppressive chemotherapy. Despite lack of supportive data, many prescribers have adopted the practice of utilizing reduced dosages (3-4 mg) of pegfilgrastim, often citing bone pain as reason for dose reduction. We sought to explore the impact of reduced-dose pegfilgrastim on chemotherapy dose intensity in patients with pancreatic cancer treated with the triplet combination of nab-paclitaxel, cisplatin and gemcitabine (NabPlagem) at our facility. Methods: A retrospective analysis was conducted on all patients who received NabPlagem chemotherapy in combination with pegfilgrastim during the period of 1/1/16 - 9/30/16. Patients who received at least 2 cycles were considered evaluable. Chemotherapy was administered on Days 1 and 8 of a 21-day cycle with pegfilgrastim administered Days 2 and 9. Chemotherapy doses were considered full-intensity if no reduction made from original treatment schema (i.e. 125 mg/m2 nab-paclitaxel, 25 mg/m2 cisplatin and gemcitabine 1000 mg/m2) with no doses delayed or omitted from treatment plan. Results: A total of 54 chemotherapy cycles were administered, with patients receiving between 5-13 cycles. Of these 54 cycles, 14 were given with reduced-dose pegfilgrastim (26%) and 40 at full dosage (74%). In the patients receiving full dose pegfilgrastim, treatment delays and omissions were observed in 5% cycles (n = 2), with no dose reductions required. Full dose-intensity was obtained in 90% cycles (36/40). In comparison, treatment delays and omissions were observed in 14% cycles given with reduced-dose pegfilgrastim. Dose reductions were required in 10/14 cycles (71%). Full dose-intensity was observed in 28.5% cycles (4/14). Conclusions: Based on this data, dosage of pegfilgrastim dose is an important factor in maintaining dose-intensity of chemotherapy, and full dosing (6 mg) should be preferred dosing schedule when used with myelosuppressive chemotherapy.

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Patient-reported benefit from proposed interventions to reduce financial hardship during cancer treatment.

Journal of Clinical Oncology ◽

10.1200/jco.2020.38.15_suppl.7080 ◽

2020 ◽

Vol 38 (15_suppl) ◽

pp. 7080-7080

Author(s):

Emeline Aviki ◽

Fumiko Chino ◽

Julia Ramirez ◽

Victoria Susana Blinder ◽

Jennifer Jean Mueller ◽

...

Keyword(s):

Cancer Treatment ◽

Cancer Patients ◽

Financial Burden ◽

Gynecologic Cancer ◽

Financial Hardship ◽

Care Providers ◽

Financial Toxicity ◽

The Past ◽

Patient Reported ◽

The Impact

7080 Background: Awareness of cancer patients’ financial toxicity (FT) has increased substantially over the past decade; however, interventions to minimize financial burden remain underdeveloped and understudied. This survey-based study explores patient beliefs on which potential mitigating strategies could improve their financial hardship during cancer treatment. Methods: Interviewer-administered surveys were conducted with consecutive patients in an outpatient, urban, private academic Gynecologic Cancer clinic waiting room for 2 weeks in August 2019. The survey items included patient demographics, disease characteristics, the Comprehensive Score for Financial Toxicity (COST) tool (validated measure of FT with score 0-44; lower scores indicate worse FT), assessment of cost-coping strategies, and patient-reported anticipated benefit from described potential interventions (items that were feasible and relevant to implement in clinic). Results: Of 101 patients who initiated the survey, 87 (86%) completed it and were included in this analysis. The median age was 66 (range, 32-87). Thirty-eight patients (44%) had ovarian, 29 (33%) uterine, 5 (6%) cervical, and 15 (17%) an “other” gynecologic cancer. The median COST score was 32 (range, 6-44). Twenty-nine patients (33%) had COST scores ≤25 and 16 (18%) had COST scores ≤18. The most frequent cost-coping strategy reported was reducing leisure activities (n = 36, 41%) and using savings to pay for medical bills (n = 34, 39%). Six patients (7%) reported not taking a prescribed medication in the past 12 months due to the inability to pay and 0 reported skipping a recommended imaging study. When it came to interventions patients anticipated would improve their current financial hardships, 34 (39%) indicated access to transportation assistance to and from appointments, 31 (36%) said “knowing up front how much I’m going to have to pay for my healthcare”, 29 (33%) indicated “minimizing wait time associated with appointments, which keeps me away from work”, and 22 (25%) indicated “access to free food during/around appointments and treatments”. Only 26 (30%) noted they were not experiencing financial hardship. Conclusions: For an outpatient population of gynecologic cancer patients, several focused, feasible interventions could be implemented to potentially decrease patient FT. Our study can help health care providers in the design of interventions to create meaningful improvements in patient financial burden. Next steps should assess the impact of targeted interventions on patient outcomes.

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Use of G-CSF to Sustain Dose Intensity in Breast Cancer Patients Receiving Adjuvant Chemotherapy: A Pilot Study

Cancer Control ◽

10.1177/107327489600300605 ◽

1996 ◽

Vol 3 (6) ◽

pp. 1-4 ◽

Cited By ~ 18

Author(s):

Jack Webster ◽

Nicole Kuderer ◽

Gary H. Lyman

Keyword(s):

Breast Cancer ◽

Adjuvant Chemotherapy ◽

Dose Reduction ◽

Cancer Patients ◽

Dose Intensity ◽

Treatment Delay ◽

Breast Cancer Patients ◽

Treatment Delays ◽

Prospective Trials ◽

The Impact

Background Adjuvant chemotherapy for breast cancer is frequently accompanied by neutropenia requiring dose reduction or treatment delay that can potentially compromise therapeutic effectiveness. Recombinant granulocyte-colony stimulating factor (G-CSF) reduces the duration and severity of neutropenia. Methods Nineteen patients with newly diagnosed breast cancer receiving adjuvant systemic chemotherapy met criteria for dose reduction or treatment delay due to neutropenia. All were treated with G-CSF. The mean duration of G-CSF therapy was five days. Results An increase in mean absolute neutrophil count was seen in cycles with G-CSF. Chemotherapy treatment was delayed less often following the use of G-CSF. Conclusions Breast cancer patients receiving adjuvant chemotherapy who face treatment delays or dose reductions can continue on full-dose intensity therapy using supportive G-CSF. Prospective trials are needed to accurately measure the impact of G-CSF on dose intensity and long-term disease control.

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Are XELOX and FOLFOX equivalent in colorectal cancer? Dose intensity, toxicity, and treatment duration in clinical practice.

Journal of Clinical Oncology ◽

10.1200/jco.2013.31.15_suppl.e14556 ◽

2013 ◽

Vol 31 (15_suppl) ◽

pp. e14556-e14556

Author(s):

Ya Ning Gao ◽

Aline Mamo ◽

Michael Ostaric Palumbo ◽

Gerald Batist ◽

Prosanto Chaudhury ◽

...

Keyword(s):

Clinical Practice ◽

Treatment Duration ◽

Dose Intensity ◽

Sensory Neuropathy ◽

Treatment Delays ◽

Metastatic Setting ◽

Impact On Survival ◽

Peripheral Sensory ◽

The Impact ◽

Dose Reductions

e14556 Background: Xelox and Folfox regimens have been shown to be equivalent in clinical trials for colorectal cancers. However, concerns about toxicity induced by Xelox in clinical practice have been reported, resulting in reduced dose intensity. In this retrospective analysis, we compared the dose intensity of Xelox to Folfox in relation to toxicity. Methods: 208 patients were treated in adjuvant (Xelox: n=56, median age 65 years; Folfox: n=40, median age 66 years) or metastatic (Xelox: n=65, median age 66 years; Folfox: n=47 median age 62 years) settings. 90% of patients had ECOG 0-1. Results: In the adjuvant setting, 86% of patients treated with Xelox received a lower dose of the drug up front, compared to only 10% of Folfox-treated patients. Additional dose reductions occurred in subsequent cycles in 23% of Xelox-treated patients (mean relative dose intensity (RDI) Oxaliplatin: 72%; Capecitabine: 74%) but not Folfox-treated patients (mean RDI Oxaliplatin: 85%, 5-FU: 86%). A higher percentage of Folfox-treated patients had toxicities compared to Xelox-treated patients: nausea (30% vs 18%), diarrhea (47% vs 24%), and peripheral sensory neuropathy (32% vs 3%). Treatment delays were more frequent in Folfox (40%); mean cumulative delay, 9.4 (range 2.1-52.4) weeks, compared to Xelox (20%); mean cumulative delay, 10.2 (3.1-48.1) weeks. Mean treatment duration was equal (Xelox: 22.8 (3.0-78.1); Folfox: 22.6 (2.3-64.4) weeks). In the metastatic setting, results followed a similar pattern. 75% of Xelox-treated patients received a lower dose up front compared to 33% of Folfox-treated patients. Further dose reductions occurred in 31% of Xelox-treated patients (mean RDI Oxaliplatin: 70%; Capecitabine: 67%) compared to 20% of Folfox-treated patients (mean RDI oxaliplatin: 75%; 5-FU: 69%). Treatment delays occurred in 60% of Folfox-treated patients and 43% of Xelox-treated patients becauseof toxicities. Mean treatment duration was 24.9 (3.0-65.0) and 26.1 (4.0-60.1) weeks respectively. Conclusions: The higher dose reduction of Xelox compared to Folfox appeared to enable treatment completion with less toxicities. The impact on survival and cost of treatments will be presented.

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